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The Characteristics of Surgeons Performing Total Shoulder Arthroplasty: Volume Consistency, Training, and Specialization
ABSTRACT
Total shoulder arthroplasty (TSA) has proved a cost-effective, reproducible procedure for multiple shoulder pathologies. As utilization of TSA continues to grow, it is important to investigate procedure diversity, training, and other characteristics of surgeons performing TSA. To identify surgeons performing TSA in the Medicare population, the Medicare Provider Utilization and Payment Databases from 2012 through 2014 were used. This dataset includes any provider who bills Medicare >10 times with a single billing code. A web-based search was performed for each physician performing >10 TSA in all years of the study to identify their surgical training characteristics. Between 2012 and 2014, 1374 surgeons (39 females [2.8%]) performed >10 TSA in Medicare patients in at least 1 year (71,973 TSA). Only 44.3% (609/1374) of surgeons met this threshold for all 3 years (55,538 TSA). Of these 609 surgeons, 191 (31.3%) were shoulder and elbow fellowship trained (21,444 TSA). Shoulder and elbow fellowship-trained surgeons were at earlier points in their careers and practiced in large referral-based centers with other surgeons performing TSA. In addition to TSA, surgeons performed other non-arthroplasty shoulder procedures (80.2% of surgeons), total knee arthroplasty (46.3%), repairs of traumatic injuries (29.8%), total hip arthroplasty (27.8%), non-arthroplasty knee surgeries (27.2%), elbow procedures (19.6%), and hand surgery (15.4%) during the study period. With less than one-third of TSA performed by shoulder and elbow fellowship-trained surgeons with consistent moderate-volume practices, the impact of consistent high-volume practices and targeted fellowship training on quality must be determined.
Continue to: With the adoption of reverse shoulder arthroplasty...
With the adoption of reverse shoulder arthroplasty, utilization of total shoulder arthroplasty (TSA) has increased substantially over the last decade.1–3 Such increases are likely secondary to an aging population, increased comfort with the procedure, and the adoption of broadened indications for reverse shoulder arthroplasty, especially in the setting of proximal humerus fractures in the elderly.4–7 Between 2012 and 2014 alone, the number of surgeons performing >10 TSA in Medicare patients annually increased by 28.6% (824 to 1060 surgeons) providing a 26.6% (20,824-26,365 procedures) increase in national volume in the Medicare population.2 With this boom in utilization, scrutiny of this now routine procedure and those performing it is necessary.
Prior reviews have demonstrated a strong link between surgeon and hospital TSA volume and outcomes of the procedure.8–10 Somerson and colleagues11 investigated fellowship training among surgeons performing TSA in 2012 and found that only 28% had completed a shoulder and elbow fellowship. In addition to prior analyses2, 12, Somerson and colleagues confirmed a persistent geographic variation in utilization of TSA.11 In conjunction with the evolution of shoulder arthroplasty, dedicated shoulder and elbow fellowship training has expanded. With a shift toward specialization in care, nearly 90% of orthopedic surgery residents plan to pursue shoulder and elbow fellowships, comprising 4.6% of (42/897) of available positions.13
What remains unknown is the specialization of surgeons performing TSA, the regularity of their arthroplasty volume, and trends in TSA specialization over time. Therefore, this study aims to (a) identify surgeons performing shoulder arthroplasty and cohort changes over time, (b) determine the case profile of surgeons consistently performing shoulder arthroplasty, and (c) establish the characteristics of shoulder arthroplasty surgeons with a specific focus on fellowship training.
METHODS
Prior to collecting surgeon-specific data, we identified surgeons performing TSA through the Centers for Medicare and Medicaid Services’ public release of “Medicare Provider Utilization and Payment Data: Physician and Other Supplier.”14 Datasets from 2012, 2013, and 2014 were used to identify all surgeons performing >10 TSAs (Current Procedural Terminology [CPT] Code 23472) during at least 1 of those years. This dataset provides the name, identification number, address, and all billing (by volume) for each unique CPT code submitted ≥10 times in a calendar year.
Once the cohort of surgeons had been generated, the number of surgeons consistently performing TSA year-over-year was determined. This allowed for an analysis of the consistency with which surgeons are performing moderate- to high-volume TSA. To form a case profile of surgeons performing TSA and observe how this shifted over time, a count and a description of each CPT code submitted by each surgeon was identified. To maintain patient privacy, only those claims made >10 times are reported for a provider (both physicians and physician-extenders are included in this dataset). First, all CPT codes were reviewed and tagged as surgical or non-surgical events. Then, every procedural CPT code identified was reviewed and categorized based upon anatomic location and procedure (eg, total knee arthroplasty [TKA]). It is important to note that all claims in this dataset are limited to those patients participating in Medicare’s fee-for-service program.
Specialization was defined as the number of categorized procedures as a percentage of all procedures performed on Medicare patients. The trends for national, regional, and individual specialization of TSA, arthroplasty (major joint), and shoulder procedures were determined.
Continue to: To investigate the characteristics of surgeons...
To investigate the characteristics of surgeons consistently performing TSA, all surgeons performing a minimum of 11 TSA in Medicare fee-for-service beneficiaries in all years between 2012 and 2014 were identified. Such surgeons were defined as consistent TSA surgeons. Investigation of this cohort included a web-based search of their self-reported post-graduate fellowship training and year of graduation from medical school. Using these data, the percentage of surgeons performing TSA who underwent formal shoulder and elbow training was determined. In addition, the impact of fellowship training on shoulder specialization and practice location was determined. Surgeons who had completed multiple fellowships were categorized under all of them. As such, there may be some duplication of surgeons in the comparisons. In addition, other potential characteristics of shoulder and elbow fellowship-trained surgeons were investigated: number of regional shoulder surgeons, urban area, total number of Medicare beneficiaries, average reimbursement for TSA, ethnicity of Medicare beneficiaries, and percentage of Medicare patients eligible for Medicaid. Geographic regions were defined by the Dartmouth Atlas and assigned by hospital referral region.15 These defined regions were used to assess the beneficiaries (number and characteristics) that individual surgeons were likely serving. The United States Census Bureau characterization of zip code-based regions as urban areas (population >50,000), urban clusters (2500 to 50,000), and rural region (<2500) was used to categorize practice location.16
Descriptive statistics were used initially to report these findings. To analyze predictors of utilization and specialization, comparative statistics were undertaken. For comparison of binomial variables between groups, a χ2analysis was utilized. For continuous variables, data normality was assessed. A skewness and kurtosis <2 and 12, respectively, was considered to represent parametric data. For parametric data, the mean was reported; conversely, the median is reported for non-parametric data. To assess continuous variables between groups, a t test or a Wilcoxon rank-sum test was used for parametric and non-parametric distributions, respectively.
RESULTS
Between 2012 and 2014, 1374 surgeons (39 females [2.8%]) performed >10 TSA in Medicare patients in at least 1 year, for a combined total of 71,973 TSAs (Table 1). In 2012, only 834 surgeons (13 females [1.6%]) performed a minimum of 10 TSA in Medicare patients (21,137 arthroplasties; 25.3 per surgeon). This increased to 1078 surgeons (33 females [3.1%]; P = .04) performing 26,865 TSA (24.92 per surgeon) in 2014. Utilization of non-physician assistants in TSA also increased significantly over this period, with 307 assisting in 6885 TSAs (22.4 per provider) in 2012 and 465 assisting 10,433 TSA (22.4 per provider) in 2014. When all procedures were considered, including those performed at outpatient visits, 1319 physicians (95.9% of cohort) were active in 2012—providing either surgical procedures or outpatient consults to the Medicare population. Yet, only 63.2% performed >10 TSA in Medicare patients. The number of active surgeons performing TSA increased to 79.6% (1078/1353) in 2014 (P < .001).
Table 1. Trends in the Number of Providers Performing TSA between 2012 and 2014*
2012 | 2013 | 2014 | Total | |
| Providers (no.) | 1141 | 1373 | 1543 | 1994 |
Physicians | 834 | 984 | 1,078 | 1,374 |
Non-physicians | 307 | 389 | 465 | 620 |
| TSA (no.) | 28,022 | 32,641 | 37,298 | 97,961 |
| Physicians | 21,137 | 23,971 | 26,865 | 71,973 |
| Non-physicians | 6,885 | 8,670 | 10,433 | 25,988 |
| TSA per provider | 24.5 | 23.8 | 24.2 | 49.2 |
| Physicians | 25.3 | 24.3 | 24.9 | 52.4 |
| Non-physicians | 22.4 | 22.3 | 22.4 | 41.2 |
| Procedures (no.) | 210,845 | 224,123 | 227,305 | 662,273 |
| Physicians | 152,862 | 160,114 | 160,851 | 473,827 |
| Non-physicians | 57,983 | 64,009 | 66,454 | 188,446 |
| Procedure per provider | 114.4 | 116.8 | 116.5 | 332.13 |
| Physicians | 115.9 | 118.9 | 118.9 | 344.9 |
| Non-physicians | 110.7 | 111.9 | 111.1 | 303.9 |
| Active providers (no.) | 1843 | 1919 | 1951 | 1994 |
| Physicians | 1319 | 1347 | 1353 | 1374 |
| Non-physicians | 524 | 572 | 598 | 620 |
* Included are the number of arthroplasties and total procedures over time among this cohort. The number of active providers, determined by billing Medicare for office or surgical procedures within that year, is reported.
Abbreviation: TSA, total shoulder arthroplasty.
In addition to TSA, this cohort of surgeons submitted 240 unique CPT codes with case volumes >10 annually over the 3-year study period. Of these, 80.2% (1102/1374) of surgeons performed non-arthroplasty shoulder procedures on Medicare patients, for a combined total of 202,335 procedures over the 3-year study period (Table 2). A significant proportion of these procedures were arthroscopic debridement (60,014 procedures performed by 908 surgeons) and arthroscopic rotator cuff repair (47,089 procedures performed by 809 surgeons). Just under half (49.1%; 674/1374) of surgeons performing TSA also performed TKA during this period (77,873 arthroplasties). Fewer surgeons (27.8%; 382/1374) performed total hip arthroplasty during this period (27,322 arthroplasties). Other procedure types that this group of surgeons routinely performed on Medicare patients were repairs of traumatic injuries (29.8%), non-arthroplasty knee surgeries (27.2%), elbow procedures (19.6%), and hand surgery (15.4%). By case load, non-arthroplasty shoulder procedures consisted of 43% of Medicare volume over the study period (Figure 1). Between 2012 and 2014, the average proportion of Medicare cases that were shoulder arthroplasties increased from 13.8% (21,137/152,862) to 16.7% (26,865/160,851; P = .001). Shoulder arthroplasty constituted 100% of the Medicare surgical case volume for 67 (4.9%; 67/1374) of the surgeons.

Table 2. Case Volumes over Time with All Procedures Categorized by Anatomic Region and Arthroplasty vs Non-arthroplasty*
2012 | 2013 | 2014 | Total | |
| Shoulder arthroplasty | 21,351 (n=837) | 24,128 (n=984) | 26,902 (n=1,078) | 72,381 (n=1,374) |
23472: total shoulder arthroplasty | 21,137 (n=834) | 23,971 (n=984) | 26,865 (n=1,078) | 71,973 (n=1,374) |
23470: Hemiarthroplasty | 214 (n=14) | 84 (n=6) | 37 (n=2) | 335 (n=15) |
| Shoulder (non-arthroplasty) | 65,947 (n=887) | 68,746 (n=942) | 67,642 (n=932) | 202,335 (n=1,102) |
29826: arthroscopic acromioplasty | 19,152 (n=724) | 20,367 (n=760) | 20,495 (n=754) | 60,014 (n=908) |
29827: arthroscopic rotator cuff repair | 14,700 (n=613) | 15,963 (n=664) | 16,426 (n=658) | 47,089 (n=809) |
23412: open rotator cuff repair | 1957 (n=88) | 2046 (n=90) | 2112 (n=2,112) | 6115 (n=143) |
23430: Open biceps tenodesis | 4063 (n=178) | 3998 (n=167) | 4601 (n=185) | 12,662 (n=288) |
29823: arthroscopic major debridement | 7428 (n=301) | 7745 (n=309) | 5202 (n=210) | 20,375 (n=417) |
Total knee arthroplasty | 25,640 (n=565) | 26,558 (n=587) | 25,675 (n=580) | 77,873 (n=637) |
Total hip arthroplasty | 8729 (n=316) | 9226 (n=318) | 9367 (n=330) | 27,322 (n=382) |
Trauma | 6454 (n=260) | 6396 (n=254) | 6364 (n=261) | 19,214 (n=410) |
27245: surgical treatment of broken thigh bone (intertrochanteric) | 2602 (n=162) | 2654 (n=164) | 2537 (n=160) | 7793 (n=274) |
27236: surgical treatment of broken thigh bone (hemiarthroplasty) | 1961 (n=123) | 1703 (n=111) | 1702 (n=112) | 5366 (n=205) |
Hand | 6343 (n=139) | 7321 (n=154) | 8006 (n=172) | 21,670 (n=211) |
Elbow | 6113 (n=198) | 6139 (n=204) | 6131 (n=198) | 18,383 (n=270) |
Knee (non-arthroplasty) | 8514 (n=275) | 8140 (n=275) | 7689 (n=230) | 24,343 (n=374) |
Outpatient visits | 879,740 (n=1,282) | 907,124 (n=1,320) | 921,291 (n=1,327) | 2,708,155 (n=1,342) |
New patient | 195,898 (n=1,276) | 192,937 (n=1,305) | 191,427 (n=1,315) | 571,203 (n=1,332) |
Existing patient | 740,307 (n=1,279) | 714,187 (n=1,316) | 729,864 (n=1,324) | 2,29,976 (n=1,338) |
* Procedures of interest with high case volumes are reported individually.

Only 44.3% (609/1374) of surgeons performed TSA in a minimum of 11 Medicare patients in all 3 years of the study period (consistent providers of TSA), providing a total of 55,538 TSA (77.2%; 55,538/71,973). When fellowship training was evaluated, 191 (31.4%; 191/609) of these surgeons were shoulder and elbow fellowship trained (21,444 TSA; 38.6%; Table 3). More than one-third (36.6%; 223/609) had completed a sports surgery fellowship (18,899 TSA; 34.0%). Surgeons trained in hand surgery (12.5%; 76/609) and adult reconstruction (5.3%; 32/610) also made contributions to meeting the TSA demand with 6971 (12.6%) and 2485 (4.5%) TSA, respectively. One-fifth of this cohort (18.1%; 110/609) had unknown fellowship training: they either reported no fellowship (13.6%; 83/609) or did not specify the type of training (4.4%; 27/609). Shoulder and elbow fellowship-trained surgeons performed more TSA (median: 89.0 TSA per surgeon between 2012 and 2014) than surgeons without shoulder and elbow fellowship training (median: 67.0 TSA per surgeon; P < 0.001). More than one-third (37%) of shoulder and elbow fellowship-trained surgeons’ surgical case volume was comprised of TSA, with an additional 35% from non-arthroplasty shoulder procedures (Figure 2). In order for the current supply of shoulder and elbow fellowship-trained surgeons to meet the Medicare TSA demand, each fellowship graduate would have to perform 140.6 TSA in Medicare patients annually. Shoulder and elbow fellowship-trained surgeons were more likely to practice in referral regions with an increased Medicare population (P < .001), an increased number of surgeons performing TSA (P < .001), and a higher proportion of Medicaid-eligible patients (P = .01; Table 4). Shoulder and elbow fellowship-trained surgeons (18.7 years post-medical school graduation) were also earlier in their careers than other consistent TSA surgeons (23.1 years post-graduation; P < .001).
Table 3. A Representation of Fellowships Among TSA Surgeons and Their Shoulder Arthroplasty Case Load*
| Fellowship | Surgeons (%) | 2012-2014 (no, %) | SA Medicare Cases (%) | Average Surgeon Annual SA Volume |
| Shoulder and elbow | 191 (31.4%) | 21,444 (38.6%) | 29.3% | 37.4 |
| Hand surgery | 76 (12.5%) | 6971 (12.6%) | 17.1% | 30.6 |
| Sports | 223 (36.6%) | 18,899 (34.0%) | 19.4% | 28.3 |
| Trauma | 14 (2.3%) | 1270 (2.3%) | 10.9% | 30.2 |
| Adult reconstruction | 32 (5.3%) | 2485 (4.5%) | 10.2% | 25.9 |
| Unknown/none | 110 (18.1%) | 8489 (15.3%) | 16.3% | 25.7 |
|
|
|
| |
| 1 Fellowship | 459 (75.3%) | 42,065 (75.7%) | 20.7% | 30.5 |
| ≥2 Fellowships | 67 (11.0%) | 7122 (12.8%) | 22.5% | 35.4 |
* Not all fellowships (eg, oncology) included due to small numbers. Also, many surgeons performed multiple fellowships.
Abbreviations: SA, shoulder arthroplasty; TSA, total shoulder arthroplasty.
Table 4. Breakdown of Geographic Characteristics of Orthopedic Surgeons Consistently
Performing TSA between 2012 and 2014 Stratified by Fellowship Training
Abbreviations: HRR, hospital referral region; TSA, total shoulder arthroplasty.
| Fellowship | Percentage in Non-Urban Area | Average No. of Other TSA Surgeons within HRR | Median Proportion of Patients Eligible for Medicaid within HRR | Average Proportion of Caucasian Patients within HRR | Average Population in Practicing Zip Code | Average No. of Medicare Beneficiaries in HRR | Average No. Years from Medical School Graduation |
| Shoulder and elbow | 7.3% | 10.5 | 12.6 | 84.7 | 26,620.1 | 224,868.3 | 18.7 |
| Other fellowships | 10.3% | 8.6 | 11.1 | 85.6 | 27,619.7 | 177,939.7 | 23.1 |
P value | 0.29 | <0.001 | 0.01 | 0.30 | 0.41 | <0.001 | <0.001 |
Hand surgery | 7.9% | 8.1 | 12.8 | 83.7 | 24,022.8 | 179,370.8 | 23.9 |
Sports | 11.2% | 8.9 | 11.9 | 85.6 | 28,588.9 | 185,902.4 | 21.2 |
Trauma | 21.4% | 7.7 | 13.8 | 85.5 | 20,065.9 | 170,807.6 | 25.6 |
Adult reconstruction | 6.3% | 8.7 | 12.8 | 86.9 | 26,601.5 | 173,280.1 | 22.4 |
None/unknown | 10.9% | 8.5 | 12.0 | 86.4 | 28,173.6 | 166,522.5 | 27.0 |
Continue to: DISCUSSION...
DISCUSSION
Utilization of TSA has continued to rise; however, access to this cost-effective procedure was recently demonstrated to be limited.11 In a separate analysis, we established the continued rise in use of TSA in the Medicare population, coupled with an increase in the number of surgeons routinely performing TSA.2 Multiple analyses have demonstrated the importance of high-volume surgeons and hospitals familiar with the intricacies of shoulder arthroplasty concepts in minimizing complications, improving the quality and decreasing the cost of TSA.6,10,17 Specifically, Singh and colleagues18 demonstrated from a multi-center registry that surgeons and hospitals with greater shoulder arthroplasty volumes had decreased intra-operative blood loss, operative time, and hospital length of stay. As the demand for TSA, both anatomic and reverse, continues to rise, it is imperative that the healthcare delivery system is optimized to provide the best possible care. Before we can determine whether specialized training in shoulder arthroplasty influences surgical outcomes, characteristics and training of surgeons performing TSA should be described.
The number of surgeons performing >10 TSA in the Medicare population rose significantly between 2012 and 2014 (29.3%). However, the number of TSAs per surgeon over this time period remained consistent (approximately 25 per surgeon). Furthermore, the increase in the number of surgeons performing a reportable volume of TSA by 2014 was from the addition of already active surgeons (ie, the growth in TSA was not from the addition of newly trained arthroplasty surgeons but originated from the existing orthopedic surgeon workforce). In a recently published analysis, Somerson and colleagues, 11 using this same dataset, demonstrated persistent limitations in access to high-volume TSA surgeons. In a more recent analysis, we showed that while still lacking for some patients, access to a high-volume TSA surgeon has improved significantly over the past 3 years, with 96.9% of the United States population residing within 200 kilometers of a high-volume TSA surgeon (>20 Medicare cases).2 This analysis validates those findings, with the caveat that the average annual volume per surgeon is not increasing. What remains unknown, due to limitations of this dataset, is how many surgeons are not identified because they are performing ≤10 TSA each year or are performing TSA in non-Medicare patients.
With the specialization of healthcare delivery, specifically in orthopedics, it is imperative that mechanisms for providing specialty-focused care be established. However, the proportion of their practice that surgeons dedicate to TSA was unknown. This study demonstrates that this proportion is increasing. Including non-arthroplasty procedures, more than half (58%) of the procedures performed by this surgeon cohort were shoulder-specific. Furthermore, this analysis demonstrates that surgeons performing TSA have significant case diversity, including nearly half of the cohort performing TKA. Repeated evidence has demonstrated the effect of case volume on improved outcomes following orthopedic procedures.8,19–21 The pre-existing location-based model for delivering orthopedic care supports case diversity; however, this model continues to be challenged with high-volume centers of excellence and patient travel.22–24 Hip and knee arthroplasty experienced a similar surge in demand, with a subsequent shift in care to high-volume surgeons and centers.25 Shoulder and elbow fellowship-trained surgeons would need to nearly quadruple their current Medicare TSA volume to meet the entire current demand for TSA in the Medicare population (and this does not account for TSA performed by very low-volume surgeons not included in this cohort). With increased utilization of TSA, policymakers and the orthopedic community must determine the structure of delivery (centers of excellence or medium-volume disseminated throughout the country) that is optimal.
For those surgeons consistently performing TSA over the study period, fellowship training was diverse. While the current focus in orthopedics is on case volume, research in other specialties, namely general surgery, has provided repeated evidence that surgical specialization (more so than high case volume) provides improved outcomes.26–29Furthermore, Leopold and colleagues30 demonstrated an inverse relationship between competency in performing a procedure and confidence in one’s ability to do so. In their study, educational intervention provided improved competency in the procedure. Less than one-third (29.8%) of TSA in this cohort were performed by a shoulder and elbow fellowship-trained surgeon consistently performing this procedure. Approximately another quarter (26.2%) were performed by consistent TSA surgeons trained in sports surgery. Meanwhile, 34.6% of TSA in this study cohort were performed by a surgeon who did not consistently meet the minimum threshold in all study years (16,435 TSA; 22.8%) or by a surgeon performing TSA without fellowship training (8,489 TSA; 11.8%). There has been a trend toward orthopedic subspecialty training with an increased demand for fellowship-trained surgeons.31 Despite this and the complexities of TSA, many continue to be performed by surgeons with an inconsistent volume and those without arthroplasty-specific fellowship training. The available evidence supports a push toward the fellowship-trained, high-volume TSA surgeon in providing reproducible high-quality shoulder arthroplasty care. For now, that surgeon is more likely to be earlier in his/her career and reside in large, referral-based centers surrounded by other surgeons performing TSA.
These findings must be considered in the light of the study limitations. First, this is a large publicly available database. While this type of database provides a unique opportunity to assess the geographic distributions and characteristics of orthopedic surgeons, specifically those performing TSA, it completely prevents any assessment of the relationship between these findings and quality. As such, while the reader may generate hypotheses regarding the implications of our findings on the quality of TSA delivery, the true effects cannot be determined. In the same vein, for the purpose of privacy, surgeons performing ≤10 TSA were not included in this dataset. This limitation prevents the identification of low-volume TSA surgeons. Also, it is likely that the observed increase in surgeons over time is likely a reflection of small increases in volume for surgeons already performing TSA. Lastly, a web-based search was undertaken to identify surgeons’ self-reported fellowship training. The results of this web-based search could not be validated, and it is possible that fellowship training, or the lack thereof, was mischaracterized and simply not obtainable through a web-based search. Furthermore, it is not possible to fully assess the extent of high-quality TSA training in these various fellowships.
CONCLUSION
In just the past decade, the utilization of TSA in the Medicare population has increased significantly. However, this increase was not achieved by the addition of highly specialized, high-volume surgeons but by the addition of many surgeons performing lower numbers of TSA surgeries. Furthermore, for those performing this cost-effective procedure, TSA constitutes a relatively small proportion of the surgeries they perform. Shoulder and elbow fellowship-trained surgeons currently account for a low percentage of the overall number of surgeons performing TSA. The implications of these findings must be considered and investigated.
1. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
2. Zmistowski B, Padegimas EM, Howley M, Abboud J, Williams G, Namdari S. Trends and Variability in the Use of Total Shoulder Arthroplasty for Medicare Patients. J Am Acad Orthop Surg. 2018;26(4):133-141. doi:10.5435/JAAOS-D-16-00720
3. Day JS, Lau E, Ong KL, Williams GR, Ramsey ML, Kurtz SM. Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015. J Shoulder Elbow Surg. 2010;19(8):1115-1120. doi: http://www.jshoulderelbow.org/article/S1058-2746(10)00110-2/abstract.
4. Day JS, Paxton ES, Lau E, Gordon VA, Abboud JA, Williams GR. Use of reverse total shoulder arthroplasty in the Medicare population. J Shoulder Elbow Surg. 2015;24(5):766-772. doi:10.1016/j.jse.2014.12.023.
5. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(1):91-97. doi:10.1016/j.jse.2014.08.026.
6. Westermann RW, Pugely AJ, Martin CT, Gao Y, Wolf BR, Hettrich CM. Reverse shoulder arthroplasty in the United States: A comparison of national volume, patient demographics, complications, and surgical indications. Iowa Orthop J. 2015;35:1-7.
7. Acevedo DC, Mann T, Abboud JA, Getz C, Baumhauer JF, Voloshin I. Reverse total shoulder arthroplasty for the treatment of proximal humeral fractures: patterns of use among newly trained orthopedic surgeons. J Shoulder Elbow Surg. 2014;23(9):1363-1367. doi: http://www.jshoulderelbow.org/article/S1058-2746(14)00036-6/abstract.
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12. Fisher ES, Bell J-E, Tomek IM, Esty AR, Goodman DC. Trends and regional variation in hip, knee, and shoulder Replacement. Atlases and Reports. Dartmouth Atlas of Health Care. https://www.dartmouthatlas.org/atlases-and-reports/. Accessed December 14, 2018.
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14. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Physician and other supplier Data 2012 CY 2012. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Tren.... Published October 5, 2015. Accessed July 25, 2016.
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19. Jain N, Pietrobon R, Hocker S, Guller U, Shankar A, Higgins LD. The relationship between surgeon and hospital volume and outcomes for shoulder arthroplasty. J Bone Joint Surg Am. 2004;86(3):496-505.
20. Taylor HD, Dennis DA, Crane HS. Relationship between mortality rates and hospital patient volume for Medicare patients undergoing major orthopaedic surgery of the hip, knee, spine, and femur. J Arthroplasty. 1997;12(3):235-242. doi:10.1016/S0883-5403(97)90018-8.
21. Walch G, Bacle G, Lädermann A, Nové-Josserand L, Smithers CJ. Do the indications, results, and complications of reverse shoulder arthroplasty change with surgeon’s experience? J Bone Joint Surg Am. 2012;21(11):1470-1477. doi:10.1016/j.jse.2011.11.010.
22. FitzGerald JD, Soohoo NF, Losina E, Katz JN. Potential impact on patient residence to hospital travel distance and access to care under a policy of preferential referral to high-volume knee replacement hospitals. Arthritis Care Res. 2012;64(6):890-897. doi:10.1002/acr.21611.
23. Maradit Kremers H, Salduz A, Schleck CD, Larson DR, Berry DJ, Lewallen DG. Referral bias in primary total knee arthroplasty: retrospective analysis of 22,614 surgeries in a tertiary referral center. J Arthroplasty. doi:10.1016/j.arth.2016.08.014.
24. Robinson JC, MacPherson K. Payers test reference pricing and centers of excellence to steer patients to low-price and high-quality providers. Health Affairs. 2012;31(9):2028-2036. doi: 10.1377/hlthaff.2011.1313
25. Laucis NC, Chowdhury M, Dasgupta A, Bhattacharyya T. Trend toward high-volume hospitals and the influence on complications in knee and hip arthroplasty. J Bone Joint Surg Am. 2016;98(9):707-712. doi:10.2106/JBJS.15.00399.
26. Anwar S, Fraser S, Hill J. Surgical specialization and training–its relation to clinical outcome for colorectal cancer surgery. J Eval Clin Pract. 2012;18(1):5-11. doi:10.1111/j.1365-2753.2010.01525.x.
27. Snow BW, Catwright PC, Young MD. Does surgical subspecialization in pediatrics provide high-quality, cost-effective patient care? Pediatrics. 1996;97(1):14-17.
28. Smith J a. E, King PM, Lane RHS, Thompson MR. Evidence of the effect of ‘specialization’ on the management, surgical outcome and survival from colorectal cancer in Wessex. Br J Surg. 2003;90(5):583-592. doi:10.1002/bjs.4085.
29. Hall BL, Hsaio EY, Majercik S, Hirbe M, Hamilton BH. The impact of surgeon specialization on patient mortality: Examination of a continuous Herfindahl-Hirschman Index. Ann Surg. 2009;249(5):708-716. doi: 10.1097/SLA.0b013e3181a335f8.
30. Leopold SS, Morgan HD, Kadel NJ, Gardner GC, Schaad DC, Wolf FM. Impact of educational intervention on confidence and competence in the performance of a simple surgical task. J Bone Joint Surg Am. 2005;87(5):1031-1037. doi:10.2106/JBJS.D.02434.
31. Morrell NT, Mercer DM, Moneim MS. Trends in the orthopedic job market and the importance of fellowship subspecialty training. Orthopedics. 2012;35(4):e555-e560. doi:10.3928/01477447-20120327-13.
ABSTRACT
Total shoulder arthroplasty (TSA) has proved a cost-effective, reproducible procedure for multiple shoulder pathologies. As utilization of TSA continues to grow, it is important to investigate procedure diversity, training, and other characteristics of surgeons performing TSA. To identify surgeons performing TSA in the Medicare population, the Medicare Provider Utilization and Payment Databases from 2012 through 2014 were used. This dataset includes any provider who bills Medicare >10 times with a single billing code. A web-based search was performed for each physician performing >10 TSA in all years of the study to identify their surgical training characteristics. Between 2012 and 2014, 1374 surgeons (39 females [2.8%]) performed >10 TSA in Medicare patients in at least 1 year (71,973 TSA). Only 44.3% (609/1374) of surgeons met this threshold for all 3 years (55,538 TSA). Of these 609 surgeons, 191 (31.3%) were shoulder and elbow fellowship trained (21,444 TSA). Shoulder and elbow fellowship-trained surgeons were at earlier points in their careers and practiced in large referral-based centers with other surgeons performing TSA. In addition to TSA, surgeons performed other non-arthroplasty shoulder procedures (80.2% of surgeons), total knee arthroplasty (46.3%), repairs of traumatic injuries (29.8%), total hip arthroplasty (27.8%), non-arthroplasty knee surgeries (27.2%), elbow procedures (19.6%), and hand surgery (15.4%) during the study period. With less than one-third of TSA performed by shoulder and elbow fellowship-trained surgeons with consistent moderate-volume practices, the impact of consistent high-volume practices and targeted fellowship training on quality must be determined.
Continue to: With the adoption of reverse shoulder arthroplasty...
With the adoption of reverse shoulder arthroplasty, utilization of total shoulder arthroplasty (TSA) has increased substantially over the last decade.1–3 Such increases are likely secondary to an aging population, increased comfort with the procedure, and the adoption of broadened indications for reverse shoulder arthroplasty, especially in the setting of proximal humerus fractures in the elderly.4–7 Between 2012 and 2014 alone, the number of surgeons performing >10 TSA in Medicare patients annually increased by 28.6% (824 to 1060 surgeons) providing a 26.6% (20,824-26,365 procedures) increase in national volume in the Medicare population.2 With this boom in utilization, scrutiny of this now routine procedure and those performing it is necessary.
Prior reviews have demonstrated a strong link between surgeon and hospital TSA volume and outcomes of the procedure.8–10 Somerson and colleagues11 investigated fellowship training among surgeons performing TSA in 2012 and found that only 28% had completed a shoulder and elbow fellowship. In addition to prior analyses2, 12, Somerson and colleagues confirmed a persistent geographic variation in utilization of TSA.11 In conjunction with the evolution of shoulder arthroplasty, dedicated shoulder and elbow fellowship training has expanded. With a shift toward specialization in care, nearly 90% of orthopedic surgery residents plan to pursue shoulder and elbow fellowships, comprising 4.6% of (42/897) of available positions.13
What remains unknown is the specialization of surgeons performing TSA, the regularity of their arthroplasty volume, and trends in TSA specialization over time. Therefore, this study aims to (a) identify surgeons performing shoulder arthroplasty and cohort changes over time, (b) determine the case profile of surgeons consistently performing shoulder arthroplasty, and (c) establish the characteristics of shoulder arthroplasty surgeons with a specific focus on fellowship training.
METHODS
Prior to collecting surgeon-specific data, we identified surgeons performing TSA through the Centers for Medicare and Medicaid Services’ public release of “Medicare Provider Utilization and Payment Data: Physician and Other Supplier.”14 Datasets from 2012, 2013, and 2014 were used to identify all surgeons performing >10 TSAs (Current Procedural Terminology [CPT] Code 23472) during at least 1 of those years. This dataset provides the name, identification number, address, and all billing (by volume) for each unique CPT code submitted ≥10 times in a calendar year.
Once the cohort of surgeons had been generated, the number of surgeons consistently performing TSA year-over-year was determined. This allowed for an analysis of the consistency with which surgeons are performing moderate- to high-volume TSA. To form a case profile of surgeons performing TSA and observe how this shifted over time, a count and a description of each CPT code submitted by each surgeon was identified. To maintain patient privacy, only those claims made >10 times are reported for a provider (both physicians and physician-extenders are included in this dataset). First, all CPT codes were reviewed and tagged as surgical or non-surgical events. Then, every procedural CPT code identified was reviewed and categorized based upon anatomic location and procedure (eg, total knee arthroplasty [TKA]). It is important to note that all claims in this dataset are limited to those patients participating in Medicare’s fee-for-service program.
Specialization was defined as the number of categorized procedures as a percentage of all procedures performed on Medicare patients. The trends for national, regional, and individual specialization of TSA, arthroplasty (major joint), and shoulder procedures were determined.
Continue to: To investigate the characteristics of surgeons...
To investigate the characteristics of surgeons consistently performing TSA, all surgeons performing a minimum of 11 TSA in Medicare fee-for-service beneficiaries in all years between 2012 and 2014 were identified. Such surgeons were defined as consistent TSA surgeons. Investigation of this cohort included a web-based search of their self-reported post-graduate fellowship training and year of graduation from medical school. Using these data, the percentage of surgeons performing TSA who underwent formal shoulder and elbow training was determined. In addition, the impact of fellowship training on shoulder specialization and practice location was determined. Surgeons who had completed multiple fellowships were categorized under all of them. As such, there may be some duplication of surgeons in the comparisons. In addition, other potential characteristics of shoulder and elbow fellowship-trained surgeons were investigated: number of regional shoulder surgeons, urban area, total number of Medicare beneficiaries, average reimbursement for TSA, ethnicity of Medicare beneficiaries, and percentage of Medicare patients eligible for Medicaid. Geographic regions were defined by the Dartmouth Atlas and assigned by hospital referral region.15 These defined regions were used to assess the beneficiaries (number and characteristics) that individual surgeons were likely serving. The United States Census Bureau characterization of zip code-based regions as urban areas (population >50,000), urban clusters (2500 to 50,000), and rural region (<2500) was used to categorize practice location.16
Descriptive statistics were used initially to report these findings. To analyze predictors of utilization and specialization, comparative statistics were undertaken. For comparison of binomial variables between groups, a χ2analysis was utilized. For continuous variables, data normality was assessed. A skewness and kurtosis <2 and 12, respectively, was considered to represent parametric data. For parametric data, the mean was reported; conversely, the median is reported for non-parametric data. To assess continuous variables between groups, a t test or a Wilcoxon rank-sum test was used for parametric and non-parametric distributions, respectively.
RESULTS
Between 2012 and 2014, 1374 surgeons (39 females [2.8%]) performed >10 TSA in Medicare patients in at least 1 year, for a combined total of 71,973 TSAs (Table 1). In 2012, only 834 surgeons (13 females [1.6%]) performed a minimum of 10 TSA in Medicare patients (21,137 arthroplasties; 25.3 per surgeon). This increased to 1078 surgeons (33 females [3.1%]; P = .04) performing 26,865 TSA (24.92 per surgeon) in 2014. Utilization of non-physician assistants in TSA also increased significantly over this period, with 307 assisting in 6885 TSAs (22.4 per provider) in 2012 and 465 assisting 10,433 TSA (22.4 per provider) in 2014. When all procedures were considered, including those performed at outpatient visits, 1319 physicians (95.9% of cohort) were active in 2012—providing either surgical procedures or outpatient consults to the Medicare population. Yet, only 63.2% performed >10 TSA in Medicare patients. The number of active surgeons performing TSA increased to 79.6% (1078/1353) in 2014 (P < .001).
Table 1. Trends in the Number of Providers Performing TSA between 2012 and 2014*
2012 | 2013 | 2014 | Total | |
| Providers (no.) | 1141 | 1373 | 1543 | 1994 |
Physicians | 834 | 984 | 1,078 | 1,374 |
Non-physicians | 307 | 389 | 465 | 620 |
| TSA (no.) | 28,022 | 32,641 | 37,298 | 97,961 |
| Physicians | 21,137 | 23,971 | 26,865 | 71,973 |
| Non-physicians | 6,885 | 8,670 | 10,433 | 25,988 |
| TSA per provider | 24.5 | 23.8 | 24.2 | 49.2 |
| Physicians | 25.3 | 24.3 | 24.9 | 52.4 |
| Non-physicians | 22.4 | 22.3 | 22.4 | 41.2 |
| Procedures (no.) | 210,845 | 224,123 | 227,305 | 662,273 |
| Physicians | 152,862 | 160,114 | 160,851 | 473,827 |
| Non-physicians | 57,983 | 64,009 | 66,454 | 188,446 |
| Procedure per provider | 114.4 | 116.8 | 116.5 | 332.13 |
| Physicians | 115.9 | 118.9 | 118.9 | 344.9 |
| Non-physicians | 110.7 | 111.9 | 111.1 | 303.9 |
| Active providers (no.) | 1843 | 1919 | 1951 | 1994 |
| Physicians | 1319 | 1347 | 1353 | 1374 |
| Non-physicians | 524 | 572 | 598 | 620 |
* Included are the number of arthroplasties and total procedures over time among this cohort. The number of active providers, determined by billing Medicare for office or surgical procedures within that year, is reported.
Abbreviation: TSA, total shoulder arthroplasty.
In addition to TSA, this cohort of surgeons submitted 240 unique CPT codes with case volumes >10 annually over the 3-year study period. Of these, 80.2% (1102/1374) of surgeons performed non-arthroplasty shoulder procedures on Medicare patients, for a combined total of 202,335 procedures over the 3-year study period (Table 2). A significant proportion of these procedures were arthroscopic debridement (60,014 procedures performed by 908 surgeons) and arthroscopic rotator cuff repair (47,089 procedures performed by 809 surgeons). Just under half (49.1%; 674/1374) of surgeons performing TSA also performed TKA during this period (77,873 arthroplasties). Fewer surgeons (27.8%; 382/1374) performed total hip arthroplasty during this period (27,322 arthroplasties). Other procedure types that this group of surgeons routinely performed on Medicare patients were repairs of traumatic injuries (29.8%), non-arthroplasty knee surgeries (27.2%), elbow procedures (19.6%), and hand surgery (15.4%). By case load, non-arthroplasty shoulder procedures consisted of 43% of Medicare volume over the study period (Figure 1). Between 2012 and 2014, the average proportion of Medicare cases that were shoulder arthroplasties increased from 13.8% (21,137/152,862) to 16.7% (26,865/160,851; P = .001). Shoulder arthroplasty constituted 100% of the Medicare surgical case volume for 67 (4.9%; 67/1374) of the surgeons.

Table 2. Case Volumes over Time with All Procedures Categorized by Anatomic Region and Arthroplasty vs Non-arthroplasty*
2012 | 2013 | 2014 | Total | |
| Shoulder arthroplasty | 21,351 (n=837) | 24,128 (n=984) | 26,902 (n=1,078) | 72,381 (n=1,374) |
23472: total shoulder arthroplasty | 21,137 (n=834) | 23,971 (n=984) | 26,865 (n=1,078) | 71,973 (n=1,374) |
23470: Hemiarthroplasty | 214 (n=14) | 84 (n=6) | 37 (n=2) | 335 (n=15) |
| Shoulder (non-arthroplasty) | 65,947 (n=887) | 68,746 (n=942) | 67,642 (n=932) | 202,335 (n=1,102) |
29826: arthroscopic acromioplasty | 19,152 (n=724) | 20,367 (n=760) | 20,495 (n=754) | 60,014 (n=908) |
29827: arthroscopic rotator cuff repair | 14,700 (n=613) | 15,963 (n=664) | 16,426 (n=658) | 47,089 (n=809) |
23412: open rotator cuff repair | 1957 (n=88) | 2046 (n=90) | 2112 (n=2,112) | 6115 (n=143) |
23430: Open biceps tenodesis | 4063 (n=178) | 3998 (n=167) | 4601 (n=185) | 12,662 (n=288) |
29823: arthroscopic major debridement | 7428 (n=301) | 7745 (n=309) | 5202 (n=210) | 20,375 (n=417) |
Total knee arthroplasty | 25,640 (n=565) | 26,558 (n=587) | 25,675 (n=580) | 77,873 (n=637) |
Total hip arthroplasty | 8729 (n=316) | 9226 (n=318) | 9367 (n=330) | 27,322 (n=382) |
Trauma | 6454 (n=260) | 6396 (n=254) | 6364 (n=261) | 19,214 (n=410) |
27245: surgical treatment of broken thigh bone (intertrochanteric) | 2602 (n=162) | 2654 (n=164) | 2537 (n=160) | 7793 (n=274) |
27236: surgical treatment of broken thigh bone (hemiarthroplasty) | 1961 (n=123) | 1703 (n=111) | 1702 (n=112) | 5366 (n=205) |
Hand | 6343 (n=139) | 7321 (n=154) | 8006 (n=172) | 21,670 (n=211) |
Elbow | 6113 (n=198) | 6139 (n=204) | 6131 (n=198) | 18,383 (n=270) |
Knee (non-arthroplasty) | 8514 (n=275) | 8140 (n=275) | 7689 (n=230) | 24,343 (n=374) |
Outpatient visits | 879,740 (n=1,282) | 907,124 (n=1,320) | 921,291 (n=1,327) | 2,708,155 (n=1,342) |
New patient | 195,898 (n=1,276) | 192,937 (n=1,305) | 191,427 (n=1,315) | 571,203 (n=1,332) |
Existing patient | 740,307 (n=1,279) | 714,187 (n=1,316) | 729,864 (n=1,324) | 2,29,976 (n=1,338) |
* Procedures of interest with high case volumes are reported individually.

Only 44.3% (609/1374) of surgeons performed TSA in a minimum of 11 Medicare patients in all 3 years of the study period (consistent providers of TSA), providing a total of 55,538 TSA (77.2%; 55,538/71,973). When fellowship training was evaluated, 191 (31.4%; 191/609) of these surgeons were shoulder and elbow fellowship trained (21,444 TSA; 38.6%; Table 3). More than one-third (36.6%; 223/609) had completed a sports surgery fellowship (18,899 TSA; 34.0%). Surgeons trained in hand surgery (12.5%; 76/609) and adult reconstruction (5.3%; 32/610) also made contributions to meeting the TSA demand with 6971 (12.6%) and 2485 (4.5%) TSA, respectively. One-fifth of this cohort (18.1%; 110/609) had unknown fellowship training: they either reported no fellowship (13.6%; 83/609) or did not specify the type of training (4.4%; 27/609). Shoulder and elbow fellowship-trained surgeons performed more TSA (median: 89.0 TSA per surgeon between 2012 and 2014) than surgeons without shoulder and elbow fellowship training (median: 67.0 TSA per surgeon; P < 0.001). More than one-third (37%) of shoulder and elbow fellowship-trained surgeons’ surgical case volume was comprised of TSA, with an additional 35% from non-arthroplasty shoulder procedures (Figure 2). In order for the current supply of shoulder and elbow fellowship-trained surgeons to meet the Medicare TSA demand, each fellowship graduate would have to perform 140.6 TSA in Medicare patients annually. Shoulder and elbow fellowship-trained surgeons were more likely to practice in referral regions with an increased Medicare population (P < .001), an increased number of surgeons performing TSA (P < .001), and a higher proportion of Medicaid-eligible patients (P = .01; Table 4). Shoulder and elbow fellowship-trained surgeons (18.7 years post-medical school graduation) were also earlier in their careers than other consistent TSA surgeons (23.1 years post-graduation; P < .001).
Table 3. A Representation of Fellowships Among TSA Surgeons and Their Shoulder Arthroplasty Case Load*
| Fellowship | Surgeons (%) | 2012-2014 (no, %) | SA Medicare Cases (%) | Average Surgeon Annual SA Volume |
| Shoulder and elbow | 191 (31.4%) | 21,444 (38.6%) | 29.3% | 37.4 |
| Hand surgery | 76 (12.5%) | 6971 (12.6%) | 17.1% | 30.6 |
| Sports | 223 (36.6%) | 18,899 (34.0%) | 19.4% | 28.3 |
| Trauma | 14 (2.3%) | 1270 (2.3%) | 10.9% | 30.2 |
| Adult reconstruction | 32 (5.3%) | 2485 (4.5%) | 10.2% | 25.9 |
| Unknown/none | 110 (18.1%) | 8489 (15.3%) | 16.3% | 25.7 |
|
|
|
| |
| 1 Fellowship | 459 (75.3%) | 42,065 (75.7%) | 20.7% | 30.5 |
| ≥2 Fellowships | 67 (11.0%) | 7122 (12.8%) | 22.5% | 35.4 |
* Not all fellowships (eg, oncology) included due to small numbers. Also, many surgeons performed multiple fellowships.
Abbreviations: SA, shoulder arthroplasty; TSA, total shoulder arthroplasty.
Table 4. Breakdown of Geographic Characteristics of Orthopedic Surgeons Consistently
Performing TSA between 2012 and 2014 Stratified by Fellowship Training
Abbreviations: HRR, hospital referral region; TSA, total shoulder arthroplasty.
| Fellowship | Percentage in Non-Urban Area | Average No. of Other TSA Surgeons within HRR | Median Proportion of Patients Eligible for Medicaid within HRR | Average Proportion of Caucasian Patients within HRR | Average Population in Practicing Zip Code | Average No. of Medicare Beneficiaries in HRR | Average No. Years from Medical School Graduation |
| Shoulder and elbow | 7.3% | 10.5 | 12.6 | 84.7 | 26,620.1 | 224,868.3 | 18.7 |
| Other fellowships | 10.3% | 8.6 | 11.1 | 85.6 | 27,619.7 | 177,939.7 | 23.1 |
P value | 0.29 | <0.001 | 0.01 | 0.30 | 0.41 | <0.001 | <0.001 |
Hand surgery | 7.9% | 8.1 | 12.8 | 83.7 | 24,022.8 | 179,370.8 | 23.9 |
Sports | 11.2% | 8.9 | 11.9 | 85.6 | 28,588.9 | 185,902.4 | 21.2 |
Trauma | 21.4% | 7.7 | 13.8 | 85.5 | 20,065.9 | 170,807.6 | 25.6 |
Adult reconstruction | 6.3% | 8.7 | 12.8 | 86.9 | 26,601.5 | 173,280.1 | 22.4 |
None/unknown | 10.9% | 8.5 | 12.0 | 86.4 | 28,173.6 | 166,522.5 | 27.0 |
Continue to: DISCUSSION...
DISCUSSION
Utilization of TSA has continued to rise; however, access to this cost-effective procedure was recently demonstrated to be limited.11 In a separate analysis, we established the continued rise in use of TSA in the Medicare population, coupled with an increase in the number of surgeons routinely performing TSA.2 Multiple analyses have demonstrated the importance of high-volume surgeons and hospitals familiar with the intricacies of shoulder arthroplasty concepts in minimizing complications, improving the quality and decreasing the cost of TSA.6,10,17 Specifically, Singh and colleagues18 demonstrated from a multi-center registry that surgeons and hospitals with greater shoulder arthroplasty volumes had decreased intra-operative blood loss, operative time, and hospital length of stay. As the demand for TSA, both anatomic and reverse, continues to rise, it is imperative that the healthcare delivery system is optimized to provide the best possible care. Before we can determine whether specialized training in shoulder arthroplasty influences surgical outcomes, characteristics and training of surgeons performing TSA should be described.
The number of surgeons performing >10 TSA in the Medicare population rose significantly between 2012 and 2014 (29.3%). However, the number of TSAs per surgeon over this time period remained consistent (approximately 25 per surgeon). Furthermore, the increase in the number of surgeons performing a reportable volume of TSA by 2014 was from the addition of already active surgeons (ie, the growth in TSA was not from the addition of newly trained arthroplasty surgeons but originated from the existing orthopedic surgeon workforce). In a recently published analysis, Somerson and colleagues, 11 using this same dataset, demonstrated persistent limitations in access to high-volume TSA surgeons. In a more recent analysis, we showed that while still lacking for some patients, access to a high-volume TSA surgeon has improved significantly over the past 3 years, with 96.9% of the United States population residing within 200 kilometers of a high-volume TSA surgeon (>20 Medicare cases).2 This analysis validates those findings, with the caveat that the average annual volume per surgeon is not increasing. What remains unknown, due to limitations of this dataset, is how many surgeons are not identified because they are performing ≤10 TSA each year or are performing TSA in non-Medicare patients.
With the specialization of healthcare delivery, specifically in orthopedics, it is imperative that mechanisms for providing specialty-focused care be established. However, the proportion of their practice that surgeons dedicate to TSA was unknown. This study demonstrates that this proportion is increasing. Including non-arthroplasty procedures, more than half (58%) of the procedures performed by this surgeon cohort were shoulder-specific. Furthermore, this analysis demonstrates that surgeons performing TSA have significant case diversity, including nearly half of the cohort performing TKA. Repeated evidence has demonstrated the effect of case volume on improved outcomes following orthopedic procedures.8,19–21 The pre-existing location-based model for delivering orthopedic care supports case diversity; however, this model continues to be challenged with high-volume centers of excellence and patient travel.22–24 Hip and knee arthroplasty experienced a similar surge in demand, with a subsequent shift in care to high-volume surgeons and centers.25 Shoulder and elbow fellowship-trained surgeons would need to nearly quadruple their current Medicare TSA volume to meet the entire current demand for TSA in the Medicare population (and this does not account for TSA performed by very low-volume surgeons not included in this cohort). With increased utilization of TSA, policymakers and the orthopedic community must determine the structure of delivery (centers of excellence or medium-volume disseminated throughout the country) that is optimal.
For those surgeons consistently performing TSA over the study period, fellowship training was diverse. While the current focus in orthopedics is on case volume, research in other specialties, namely general surgery, has provided repeated evidence that surgical specialization (more so than high case volume) provides improved outcomes.26–29Furthermore, Leopold and colleagues30 demonstrated an inverse relationship between competency in performing a procedure and confidence in one’s ability to do so. In their study, educational intervention provided improved competency in the procedure. Less than one-third (29.8%) of TSA in this cohort were performed by a shoulder and elbow fellowship-trained surgeon consistently performing this procedure. Approximately another quarter (26.2%) were performed by consistent TSA surgeons trained in sports surgery. Meanwhile, 34.6% of TSA in this study cohort were performed by a surgeon who did not consistently meet the minimum threshold in all study years (16,435 TSA; 22.8%) or by a surgeon performing TSA without fellowship training (8,489 TSA; 11.8%). There has been a trend toward orthopedic subspecialty training with an increased demand for fellowship-trained surgeons.31 Despite this and the complexities of TSA, many continue to be performed by surgeons with an inconsistent volume and those without arthroplasty-specific fellowship training. The available evidence supports a push toward the fellowship-trained, high-volume TSA surgeon in providing reproducible high-quality shoulder arthroplasty care. For now, that surgeon is more likely to be earlier in his/her career and reside in large, referral-based centers surrounded by other surgeons performing TSA.
These findings must be considered in the light of the study limitations. First, this is a large publicly available database. While this type of database provides a unique opportunity to assess the geographic distributions and characteristics of orthopedic surgeons, specifically those performing TSA, it completely prevents any assessment of the relationship between these findings and quality. As such, while the reader may generate hypotheses regarding the implications of our findings on the quality of TSA delivery, the true effects cannot be determined. In the same vein, for the purpose of privacy, surgeons performing ≤10 TSA were not included in this dataset. This limitation prevents the identification of low-volume TSA surgeons. Also, it is likely that the observed increase in surgeons over time is likely a reflection of small increases in volume for surgeons already performing TSA. Lastly, a web-based search was undertaken to identify surgeons’ self-reported fellowship training. The results of this web-based search could not be validated, and it is possible that fellowship training, or the lack thereof, was mischaracterized and simply not obtainable through a web-based search. Furthermore, it is not possible to fully assess the extent of high-quality TSA training in these various fellowships.
CONCLUSION
In just the past decade, the utilization of TSA in the Medicare population has increased significantly. However, this increase was not achieved by the addition of highly specialized, high-volume surgeons but by the addition of many surgeons performing lower numbers of TSA surgeries. Furthermore, for those performing this cost-effective procedure, TSA constitutes a relatively small proportion of the surgeries they perform. Shoulder and elbow fellowship-trained surgeons currently account for a low percentage of the overall number of surgeons performing TSA. The implications of these findings must be considered and investigated.
ABSTRACT
Total shoulder arthroplasty (TSA) has proved a cost-effective, reproducible procedure for multiple shoulder pathologies. As utilization of TSA continues to grow, it is important to investigate procedure diversity, training, and other characteristics of surgeons performing TSA. To identify surgeons performing TSA in the Medicare population, the Medicare Provider Utilization and Payment Databases from 2012 through 2014 were used. This dataset includes any provider who bills Medicare >10 times with a single billing code. A web-based search was performed for each physician performing >10 TSA in all years of the study to identify their surgical training characteristics. Between 2012 and 2014, 1374 surgeons (39 females [2.8%]) performed >10 TSA in Medicare patients in at least 1 year (71,973 TSA). Only 44.3% (609/1374) of surgeons met this threshold for all 3 years (55,538 TSA). Of these 609 surgeons, 191 (31.3%) were shoulder and elbow fellowship trained (21,444 TSA). Shoulder and elbow fellowship-trained surgeons were at earlier points in their careers and practiced in large referral-based centers with other surgeons performing TSA. In addition to TSA, surgeons performed other non-arthroplasty shoulder procedures (80.2% of surgeons), total knee arthroplasty (46.3%), repairs of traumatic injuries (29.8%), total hip arthroplasty (27.8%), non-arthroplasty knee surgeries (27.2%), elbow procedures (19.6%), and hand surgery (15.4%) during the study period. With less than one-third of TSA performed by shoulder and elbow fellowship-trained surgeons with consistent moderate-volume practices, the impact of consistent high-volume practices and targeted fellowship training on quality must be determined.
Continue to: With the adoption of reverse shoulder arthroplasty...
With the adoption of reverse shoulder arthroplasty, utilization of total shoulder arthroplasty (TSA) has increased substantially over the last decade.1–3 Such increases are likely secondary to an aging population, increased comfort with the procedure, and the adoption of broadened indications for reverse shoulder arthroplasty, especially in the setting of proximal humerus fractures in the elderly.4–7 Between 2012 and 2014 alone, the number of surgeons performing >10 TSA in Medicare patients annually increased by 28.6% (824 to 1060 surgeons) providing a 26.6% (20,824-26,365 procedures) increase in national volume in the Medicare population.2 With this boom in utilization, scrutiny of this now routine procedure and those performing it is necessary.
Prior reviews have demonstrated a strong link between surgeon and hospital TSA volume and outcomes of the procedure.8–10 Somerson and colleagues11 investigated fellowship training among surgeons performing TSA in 2012 and found that only 28% had completed a shoulder and elbow fellowship. In addition to prior analyses2, 12, Somerson and colleagues confirmed a persistent geographic variation in utilization of TSA.11 In conjunction with the evolution of shoulder arthroplasty, dedicated shoulder and elbow fellowship training has expanded. With a shift toward specialization in care, nearly 90% of orthopedic surgery residents plan to pursue shoulder and elbow fellowships, comprising 4.6% of (42/897) of available positions.13
What remains unknown is the specialization of surgeons performing TSA, the regularity of their arthroplasty volume, and trends in TSA specialization over time. Therefore, this study aims to (a) identify surgeons performing shoulder arthroplasty and cohort changes over time, (b) determine the case profile of surgeons consistently performing shoulder arthroplasty, and (c) establish the characteristics of shoulder arthroplasty surgeons with a specific focus on fellowship training.
METHODS
Prior to collecting surgeon-specific data, we identified surgeons performing TSA through the Centers for Medicare and Medicaid Services’ public release of “Medicare Provider Utilization and Payment Data: Physician and Other Supplier.”14 Datasets from 2012, 2013, and 2014 were used to identify all surgeons performing >10 TSAs (Current Procedural Terminology [CPT] Code 23472) during at least 1 of those years. This dataset provides the name, identification number, address, and all billing (by volume) for each unique CPT code submitted ≥10 times in a calendar year.
Once the cohort of surgeons had been generated, the number of surgeons consistently performing TSA year-over-year was determined. This allowed for an analysis of the consistency with which surgeons are performing moderate- to high-volume TSA. To form a case profile of surgeons performing TSA and observe how this shifted over time, a count and a description of each CPT code submitted by each surgeon was identified. To maintain patient privacy, only those claims made >10 times are reported for a provider (both physicians and physician-extenders are included in this dataset). First, all CPT codes were reviewed and tagged as surgical or non-surgical events. Then, every procedural CPT code identified was reviewed and categorized based upon anatomic location and procedure (eg, total knee arthroplasty [TKA]). It is important to note that all claims in this dataset are limited to those patients participating in Medicare’s fee-for-service program.
Specialization was defined as the number of categorized procedures as a percentage of all procedures performed on Medicare patients. The trends for national, regional, and individual specialization of TSA, arthroplasty (major joint), and shoulder procedures were determined.
Continue to: To investigate the characteristics of surgeons...
To investigate the characteristics of surgeons consistently performing TSA, all surgeons performing a minimum of 11 TSA in Medicare fee-for-service beneficiaries in all years between 2012 and 2014 were identified. Such surgeons were defined as consistent TSA surgeons. Investigation of this cohort included a web-based search of their self-reported post-graduate fellowship training and year of graduation from medical school. Using these data, the percentage of surgeons performing TSA who underwent formal shoulder and elbow training was determined. In addition, the impact of fellowship training on shoulder specialization and practice location was determined. Surgeons who had completed multiple fellowships were categorized under all of them. As such, there may be some duplication of surgeons in the comparisons. In addition, other potential characteristics of shoulder and elbow fellowship-trained surgeons were investigated: number of regional shoulder surgeons, urban area, total number of Medicare beneficiaries, average reimbursement for TSA, ethnicity of Medicare beneficiaries, and percentage of Medicare patients eligible for Medicaid. Geographic regions were defined by the Dartmouth Atlas and assigned by hospital referral region.15 These defined regions were used to assess the beneficiaries (number and characteristics) that individual surgeons were likely serving. The United States Census Bureau characterization of zip code-based regions as urban areas (population >50,000), urban clusters (2500 to 50,000), and rural region (<2500) was used to categorize practice location.16
Descriptive statistics were used initially to report these findings. To analyze predictors of utilization and specialization, comparative statistics were undertaken. For comparison of binomial variables between groups, a χ2analysis was utilized. For continuous variables, data normality was assessed. A skewness and kurtosis <2 and 12, respectively, was considered to represent parametric data. For parametric data, the mean was reported; conversely, the median is reported for non-parametric data. To assess continuous variables between groups, a t test or a Wilcoxon rank-sum test was used for parametric and non-parametric distributions, respectively.
RESULTS
Between 2012 and 2014, 1374 surgeons (39 females [2.8%]) performed >10 TSA in Medicare patients in at least 1 year, for a combined total of 71,973 TSAs (Table 1). In 2012, only 834 surgeons (13 females [1.6%]) performed a minimum of 10 TSA in Medicare patients (21,137 arthroplasties; 25.3 per surgeon). This increased to 1078 surgeons (33 females [3.1%]; P = .04) performing 26,865 TSA (24.92 per surgeon) in 2014. Utilization of non-physician assistants in TSA also increased significantly over this period, with 307 assisting in 6885 TSAs (22.4 per provider) in 2012 and 465 assisting 10,433 TSA (22.4 per provider) in 2014. When all procedures were considered, including those performed at outpatient visits, 1319 physicians (95.9% of cohort) were active in 2012—providing either surgical procedures or outpatient consults to the Medicare population. Yet, only 63.2% performed >10 TSA in Medicare patients. The number of active surgeons performing TSA increased to 79.6% (1078/1353) in 2014 (P < .001).
Table 1. Trends in the Number of Providers Performing TSA between 2012 and 2014*
2012 | 2013 | 2014 | Total | |
| Providers (no.) | 1141 | 1373 | 1543 | 1994 |
Physicians | 834 | 984 | 1,078 | 1,374 |
Non-physicians | 307 | 389 | 465 | 620 |
| TSA (no.) | 28,022 | 32,641 | 37,298 | 97,961 |
| Physicians | 21,137 | 23,971 | 26,865 | 71,973 |
| Non-physicians | 6,885 | 8,670 | 10,433 | 25,988 |
| TSA per provider | 24.5 | 23.8 | 24.2 | 49.2 |
| Physicians | 25.3 | 24.3 | 24.9 | 52.4 |
| Non-physicians | 22.4 | 22.3 | 22.4 | 41.2 |
| Procedures (no.) | 210,845 | 224,123 | 227,305 | 662,273 |
| Physicians | 152,862 | 160,114 | 160,851 | 473,827 |
| Non-physicians | 57,983 | 64,009 | 66,454 | 188,446 |
| Procedure per provider | 114.4 | 116.8 | 116.5 | 332.13 |
| Physicians | 115.9 | 118.9 | 118.9 | 344.9 |
| Non-physicians | 110.7 | 111.9 | 111.1 | 303.9 |
| Active providers (no.) | 1843 | 1919 | 1951 | 1994 |
| Physicians | 1319 | 1347 | 1353 | 1374 |
| Non-physicians | 524 | 572 | 598 | 620 |
* Included are the number of arthroplasties and total procedures over time among this cohort. The number of active providers, determined by billing Medicare for office or surgical procedures within that year, is reported.
Abbreviation: TSA, total shoulder arthroplasty.
In addition to TSA, this cohort of surgeons submitted 240 unique CPT codes with case volumes >10 annually over the 3-year study period. Of these, 80.2% (1102/1374) of surgeons performed non-arthroplasty shoulder procedures on Medicare patients, for a combined total of 202,335 procedures over the 3-year study period (Table 2). A significant proportion of these procedures were arthroscopic debridement (60,014 procedures performed by 908 surgeons) and arthroscopic rotator cuff repair (47,089 procedures performed by 809 surgeons). Just under half (49.1%; 674/1374) of surgeons performing TSA also performed TKA during this period (77,873 arthroplasties). Fewer surgeons (27.8%; 382/1374) performed total hip arthroplasty during this period (27,322 arthroplasties). Other procedure types that this group of surgeons routinely performed on Medicare patients were repairs of traumatic injuries (29.8%), non-arthroplasty knee surgeries (27.2%), elbow procedures (19.6%), and hand surgery (15.4%). By case load, non-arthroplasty shoulder procedures consisted of 43% of Medicare volume over the study period (Figure 1). Between 2012 and 2014, the average proportion of Medicare cases that were shoulder arthroplasties increased from 13.8% (21,137/152,862) to 16.7% (26,865/160,851; P = .001). Shoulder arthroplasty constituted 100% of the Medicare surgical case volume for 67 (4.9%; 67/1374) of the surgeons.

Table 2. Case Volumes over Time with All Procedures Categorized by Anatomic Region and Arthroplasty vs Non-arthroplasty*
2012 | 2013 | 2014 | Total | |
| Shoulder arthroplasty | 21,351 (n=837) | 24,128 (n=984) | 26,902 (n=1,078) | 72,381 (n=1,374) |
23472: total shoulder arthroplasty | 21,137 (n=834) | 23,971 (n=984) | 26,865 (n=1,078) | 71,973 (n=1,374) |
23470: Hemiarthroplasty | 214 (n=14) | 84 (n=6) | 37 (n=2) | 335 (n=15) |
| Shoulder (non-arthroplasty) | 65,947 (n=887) | 68,746 (n=942) | 67,642 (n=932) | 202,335 (n=1,102) |
29826: arthroscopic acromioplasty | 19,152 (n=724) | 20,367 (n=760) | 20,495 (n=754) | 60,014 (n=908) |
29827: arthroscopic rotator cuff repair | 14,700 (n=613) | 15,963 (n=664) | 16,426 (n=658) | 47,089 (n=809) |
23412: open rotator cuff repair | 1957 (n=88) | 2046 (n=90) | 2112 (n=2,112) | 6115 (n=143) |
23430: Open biceps tenodesis | 4063 (n=178) | 3998 (n=167) | 4601 (n=185) | 12,662 (n=288) |
29823: arthroscopic major debridement | 7428 (n=301) | 7745 (n=309) | 5202 (n=210) | 20,375 (n=417) |
Total knee arthroplasty | 25,640 (n=565) | 26,558 (n=587) | 25,675 (n=580) | 77,873 (n=637) |
Total hip arthroplasty | 8729 (n=316) | 9226 (n=318) | 9367 (n=330) | 27,322 (n=382) |
Trauma | 6454 (n=260) | 6396 (n=254) | 6364 (n=261) | 19,214 (n=410) |
27245: surgical treatment of broken thigh bone (intertrochanteric) | 2602 (n=162) | 2654 (n=164) | 2537 (n=160) | 7793 (n=274) |
27236: surgical treatment of broken thigh bone (hemiarthroplasty) | 1961 (n=123) | 1703 (n=111) | 1702 (n=112) | 5366 (n=205) |
Hand | 6343 (n=139) | 7321 (n=154) | 8006 (n=172) | 21,670 (n=211) |
Elbow | 6113 (n=198) | 6139 (n=204) | 6131 (n=198) | 18,383 (n=270) |
Knee (non-arthroplasty) | 8514 (n=275) | 8140 (n=275) | 7689 (n=230) | 24,343 (n=374) |
Outpatient visits | 879,740 (n=1,282) | 907,124 (n=1,320) | 921,291 (n=1,327) | 2,708,155 (n=1,342) |
New patient | 195,898 (n=1,276) | 192,937 (n=1,305) | 191,427 (n=1,315) | 571,203 (n=1,332) |
Existing patient | 740,307 (n=1,279) | 714,187 (n=1,316) | 729,864 (n=1,324) | 2,29,976 (n=1,338) |
* Procedures of interest with high case volumes are reported individually.

Only 44.3% (609/1374) of surgeons performed TSA in a minimum of 11 Medicare patients in all 3 years of the study period (consistent providers of TSA), providing a total of 55,538 TSA (77.2%; 55,538/71,973). When fellowship training was evaluated, 191 (31.4%; 191/609) of these surgeons were shoulder and elbow fellowship trained (21,444 TSA; 38.6%; Table 3). More than one-third (36.6%; 223/609) had completed a sports surgery fellowship (18,899 TSA; 34.0%). Surgeons trained in hand surgery (12.5%; 76/609) and adult reconstruction (5.3%; 32/610) also made contributions to meeting the TSA demand with 6971 (12.6%) and 2485 (4.5%) TSA, respectively. One-fifth of this cohort (18.1%; 110/609) had unknown fellowship training: they either reported no fellowship (13.6%; 83/609) or did not specify the type of training (4.4%; 27/609). Shoulder and elbow fellowship-trained surgeons performed more TSA (median: 89.0 TSA per surgeon between 2012 and 2014) than surgeons without shoulder and elbow fellowship training (median: 67.0 TSA per surgeon; P < 0.001). More than one-third (37%) of shoulder and elbow fellowship-trained surgeons’ surgical case volume was comprised of TSA, with an additional 35% from non-arthroplasty shoulder procedures (Figure 2). In order for the current supply of shoulder and elbow fellowship-trained surgeons to meet the Medicare TSA demand, each fellowship graduate would have to perform 140.6 TSA in Medicare patients annually. Shoulder and elbow fellowship-trained surgeons were more likely to practice in referral regions with an increased Medicare population (P < .001), an increased number of surgeons performing TSA (P < .001), and a higher proportion of Medicaid-eligible patients (P = .01; Table 4). Shoulder and elbow fellowship-trained surgeons (18.7 years post-medical school graduation) were also earlier in their careers than other consistent TSA surgeons (23.1 years post-graduation; P < .001).
Table 3. A Representation of Fellowships Among TSA Surgeons and Their Shoulder Arthroplasty Case Load*
| Fellowship | Surgeons (%) | 2012-2014 (no, %) | SA Medicare Cases (%) | Average Surgeon Annual SA Volume |
| Shoulder and elbow | 191 (31.4%) | 21,444 (38.6%) | 29.3% | 37.4 |
| Hand surgery | 76 (12.5%) | 6971 (12.6%) | 17.1% | 30.6 |
| Sports | 223 (36.6%) | 18,899 (34.0%) | 19.4% | 28.3 |
| Trauma | 14 (2.3%) | 1270 (2.3%) | 10.9% | 30.2 |
| Adult reconstruction | 32 (5.3%) | 2485 (4.5%) | 10.2% | 25.9 |
| Unknown/none | 110 (18.1%) | 8489 (15.3%) | 16.3% | 25.7 |
|
|
|
| |
| 1 Fellowship | 459 (75.3%) | 42,065 (75.7%) | 20.7% | 30.5 |
| ≥2 Fellowships | 67 (11.0%) | 7122 (12.8%) | 22.5% | 35.4 |
* Not all fellowships (eg, oncology) included due to small numbers. Also, many surgeons performed multiple fellowships.
Abbreviations: SA, shoulder arthroplasty; TSA, total shoulder arthroplasty.
Table 4. Breakdown of Geographic Characteristics of Orthopedic Surgeons Consistently
Performing TSA between 2012 and 2014 Stratified by Fellowship Training
Abbreviations: HRR, hospital referral region; TSA, total shoulder arthroplasty.
| Fellowship | Percentage in Non-Urban Area | Average No. of Other TSA Surgeons within HRR | Median Proportion of Patients Eligible for Medicaid within HRR | Average Proportion of Caucasian Patients within HRR | Average Population in Practicing Zip Code | Average No. of Medicare Beneficiaries in HRR | Average No. Years from Medical School Graduation |
| Shoulder and elbow | 7.3% | 10.5 | 12.6 | 84.7 | 26,620.1 | 224,868.3 | 18.7 |
| Other fellowships | 10.3% | 8.6 | 11.1 | 85.6 | 27,619.7 | 177,939.7 | 23.1 |
P value | 0.29 | <0.001 | 0.01 | 0.30 | 0.41 | <0.001 | <0.001 |
Hand surgery | 7.9% | 8.1 | 12.8 | 83.7 | 24,022.8 | 179,370.8 | 23.9 |
Sports | 11.2% | 8.9 | 11.9 | 85.6 | 28,588.9 | 185,902.4 | 21.2 |
Trauma | 21.4% | 7.7 | 13.8 | 85.5 | 20,065.9 | 170,807.6 | 25.6 |
Adult reconstruction | 6.3% | 8.7 | 12.8 | 86.9 | 26,601.5 | 173,280.1 | 22.4 |
None/unknown | 10.9% | 8.5 | 12.0 | 86.4 | 28,173.6 | 166,522.5 | 27.0 |
Continue to: DISCUSSION...
DISCUSSION
Utilization of TSA has continued to rise; however, access to this cost-effective procedure was recently demonstrated to be limited.11 In a separate analysis, we established the continued rise in use of TSA in the Medicare population, coupled with an increase in the number of surgeons routinely performing TSA.2 Multiple analyses have demonstrated the importance of high-volume surgeons and hospitals familiar with the intricacies of shoulder arthroplasty concepts in minimizing complications, improving the quality and decreasing the cost of TSA.6,10,17 Specifically, Singh and colleagues18 demonstrated from a multi-center registry that surgeons and hospitals with greater shoulder arthroplasty volumes had decreased intra-operative blood loss, operative time, and hospital length of stay. As the demand for TSA, both anatomic and reverse, continues to rise, it is imperative that the healthcare delivery system is optimized to provide the best possible care. Before we can determine whether specialized training in shoulder arthroplasty influences surgical outcomes, characteristics and training of surgeons performing TSA should be described.
The number of surgeons performing >10 TSA in the Medicare population rose significantly between 2012 and 2014 (29.3%). However, the number of TSAs per surgeon over this time period remained consistent (approximately 25 per surgeon). Furthermore, the increase in the number of surgeons performing a reportable volume of TSA by 2014 was from the addition of already active surgeons (ie, the growth in TSA was not from the addition of newly trained arthroplasty surgeons but originated from the existing orthopedic surgeon workforce). In a recently published analysis, Somerson and colleagues, 11 using this same dataset, demonstrated persistent limitations in access to high-volume TSA surgeons. In a more recent analysis, we showed that while still lacking for some patients, access to a high-volume TSA surgeon has improved significantly over the past 3 years, with 96.9% of the United States population residing within 200 kilometers of a high-volume TSA surgeon (>20 Medicare cases).2 This analysis validates those findings, with the caveat that the average annual volume per surgeon is not increasing. What remains unknown, due to limitations of this dataset, is how many surgeons are not identified because they are performing ≤10 TSA each year or are performing TSA in non-Medicare patients.
With the specialization of healthcare delivery, specifically in orthopedics, it is imperative that mechanisms for providing specialty-focused care be established. However, the proportion of their practice that surgeons dedicate to TSA was unknown. This study demonstrates that this proportion is increasing. Including non-arthroplasty procedures, more than half (58%) of the procedures performed by this surgeon cohort were shoulder-specific. Furthermore, this analysis demonstrates that surgeons performing TSA have significant case diversity, including nearly half of the cohort performing TKA. Repeated evidence has demonstrated the effect of case volume on improved outcomes following orthopedic procedures.8,19–21 The pre-existing location-based model for delivering orthopedic care supports case diversity; however, this model continues to be challenged with high-volume centers of excellence and patient travel.22–24 Hip and knee arthroplasty experienced a similar surge in demand, with a subsequent shift in care to high-volume surgeons and centers.25 Shoulder and elbow fellowship-trained surgeons would need to nearly quadruple their current Medicare TSA volume to meet the entire current demand for TSA in the Medicare population (and this does not account for TSA performed by very low-volume surgeons not included in this cohort). With increased utilization of TSA, policymakers and the orthopedic community must determine the structure of delivery (centers of excellence or medium-volume disseminated throughout the country) that is optimal.
For those surgeons consistently performing TSA over the study period, fellowship training was diverse. While the current focus in orthopedics is on case volume, research in other specialties, namely general surgery, has provided repeated evidence that surgical specialization (more so than high case volume) provides improved outcomes.26–29Furthermore, Leopold and colleagues30 demonstrated an inverse relationship between competency in performing a procedure and confidence in one’s ability to do so. In their study, educational intervention provided improved competency in the procedure. Less than one-third (29.8%) of TSA in this cohort were performed by a shoulder and elbow fellowship-trained surgeon consistently performing this procedure. Approximately another quarter (26.2%) were performed by consistent TSA surgeons trained in sports surgery. Meanwhile, 34.6% of TSA in this study cohort were performed by a surgeon who did not consistently meet the minimum threshold in all study years (16,435 TSA; 22.8%) or by a surgeon performing TSA without fellowship training (8,489 TSA; 11.8%). There has been a trend toward orthopedic subspecialty training with an increased demand for fellowship-trained surgeons.31 Despite this and the complexities of TSA, many continue to be performed by surgeons with an inconsistent volume and those without arthroplasty-specific fellowship training. The available evidence supports a push toward the fellowship-trained, high-volume TSA surgeon in providing reproducible high-quality shoulder arthroplasty care. For now, that surgeon is more likely to be earlier in his/her career and reside in large, referral-based centers surrounded by other surgeons performing TSA.
These findings must be considered in the light of the study limitations. First, this is a large publicly available database. While this type of database provides a unique opportunity to assess the geographic distributions and characteristics of orthopedic surgeons, specifically those performing TSA, it completely prevents any assessment of the relationship between these findings and quality. As such, while the reader may generate hypotheses regarding the implications of our findings on the quality of TSA delivery, the true effects cannot be determined. In the same vein, for the purpose of privacy, surgeons performing ≤10 TSA were not included in this dataset. This limitation prevents the identification of low-volume TSA surgeons. Also, it is likely that the observed increase in surgeons over time is likely a reflection of small increases in volume for surgeons already performing TSA. Lastly, a web-based search was undertaken to identify surgeons’ self-reported fellowship training. The results of this web-based search could not be validated, and it is possible that fellowship training, or the lack thereof, was mischaracterized and simply not obtainable through a web-based search. Furthermore, it is not possible to fully assess the extent of high-quality TSA training in these various fellowships.
CONCLUSION
In just the past decade, the utilization of TSA in the Medicare population has increased significantly. However, this increase was not achieved by the addition of highly specialized, high-volume surgeons but by the addition of many surgeons performing lower numbers of TSA surgeries. Furthermore, for those performing this cost-effective procedure, TSA constitutes a relatively small proportion of the surgeries they perform. Shoulder and elbow fellowship-trained surgeons currently account for a low percentage of the overall number of surgeons performing TSA. The implications of these findings must be considered and investigated.
1. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
2. Zmistowski B, Padegimas EM, Howley M, Abboud J, Williams G, Namdari S. Trends and Variability in the Use of Total Shoulder Arthroplasty for Medicare Patients. J Am Acad Orthop Surg. 2018;26(4):133-141. doi:10.5435/JAAOS-D-16-00720
3. Day JS, Lau E, Ong KL, Williams GR, Ramsey ML, Kurtz SM. Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015. J Shoulder Elbow Surg. 2010;19(8):1115-1120. doi: http://www.jshoulderelbow.org/article/S1058-2746(10)00110-2/abstract.
4. Day JS, Paxton ES, Lau E, Gordon VA, Abboud JA, Williams GR. Use of reverse total shoulder arthroplasty in the Medicare population. J Shoulder Elbow Surg. 2015;24(5):766-772. doi:10.1016/j.jse.2014.12.023.
5. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(1):91-97. doi:10.1016/j.jse.2014.08.026.
6. Westermann RW, Pugely AJ, Martin CT, Gao Y, Wolf BR, Hettrich CM. Reverse shoulder arthroplasty in the United States: A comparison of national volume, patient demographics, complications, and surgical indications. Iowa Orthop J. 2015;35:1-7.
7. Acevedo DC, Mann T, Abboud JA, Getz C, Baumhauer JF, Voloshin I. Reverse total shoulder arthroplasty for the treatment of proximal humeral fractures: patterns of use among newly trained orthopedic surgeons. J Shoulder Elbow Surg. 2014;23(9):1363-1367. doi: http://www.jshoulderelbow.org/article/S1058-2746(14)00036-6/abstract.
8. Hammond JW, Queale WS, Kim TK, McFarland EG. Surgeon experience and clinical and economic outcomes for shoulder arthroplasty. J Bone Joint Surg Am. 2003;85-A(12):2318-2324.
9. Jain NB, Kuye I, Higgins LD, Warner JJP. Surgeon volume is associated with cost and variation in surgical treatment of proximal humeral fractures. Clin Orthop Relat Res. 2012;471(2):655-664. doi:10.1007/s11999-012-2481-6.
10. Lyman S, Jones EC, Bach PB, Peterson MGE, Marx RG. The association between hospital volume and total shoulder arthroplasty outcomes. Clin Orthop Relat Res. 2005;(432):132-137. doi:10.1097/01.blo.0000150571.51381.9a.
11. Somerson JS, Stein BA, Wirth MA. Distribution of high-volume shoulder arthroplasty surgeons in the United States: Data from the 2014 Medicare provider utilization and payment data release. J Bone Joint Surg Am. 2016;98(18):e77. doi:10.2106/JBJS.15.00776.
12. Fisher ES, Bell J-E, Tomek IM, Esty AR, Goodman DC. Trends and regional variation in hip, knee, and shoulder Replacement. Atlases and Reports. Dartmouth Atlas of Health Care. https://www.dartmouthatlas.org/atlases-and-reports/. Accessed December 14, 2018.
13. Daniels AH, DiGiovanni CW. Is subspecialty fellowship training emerging as a necessary component of contemporary orthopaedic surgery education? J Grad Med Educ. 2014;6(2):218-221. doi:10.4300/JGME-D-14-00120.1.
14. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Physician and other supplier Data 2012 CY 2012. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Tren.... Published October 5, 2015. Accessed July 25, 2016.
15. The Dartmouth Institute for Health Policy and Clinical Practice. Dartmouth Atlas of Health Care. Understanding the Efficiency and Effectiveness of the Health Care System. http://www.dartmouthatlas.org/. Accessed January 31, 2014.
16. United States Department of Commerce. United States Census Bureau. 2010 Census Urban and Rural Classification and Urban Area Criteria. https://www.census.gov/geo/reference/ua/urban-rural-2010.html. Accessed September 30, 2016.
17. Kempton LB, Ankerson E, Wiater JM. A complication-based learning curve from 200 reverse shoulder arthroplasties. Clin Orthop Relat Res. 2011;469(9):2496-2504. doi:10.1007/s11999-011-1811-4.
18. Singh A, Yian EH, Dillon MT, Takayanagi M, Burke MF, Navarro RA. The effect of surgeon and hospital volume on shoulder arthroplasty perioperative quality metrics. J Bone Joint Surg Am. 2014;23(8):1187-1194. doi:10.1016/j.jse.2013.11.017.
19. Jain N, Pietrobon R, Hocker S, Guller U, Shankar A, Higgins LD. The relationship between surgeon and hospital volume and outcomes for shoulder arthroplasty. J Bone Joint Surg Am. 2004;86(3):496-505.
20. Taylor HD, Dennis DA, Crane HS. Relationship between mortality rates and hospital patient volume for Medicare patients undergoing major orthopaedic surgery of the hip, knee, spine, and femur. J Arthroplasty. 1997;12(3):235-242. doi:10.1016/S0883-5403(97)90018-8.
21. Walch G, Bacle G, Lädermann A, Nové-Josserand L, Smithers CJ. Do the indications, results, and complications of reverse shoulder arthroplasty change with surgeon’s experience? J Bone Joint Surg Am. 2012;21(11):1470-1477. doi:10.1016/j.jse.2011.11.010.
22. FitzGerald JD, Soohoo NF, Losina E, Katz JN. Potential impact on patient residence to hospital travel distance and access to care under a policy of preferential referral to high-volume knee replacement hospitals. Arthritis Care Res. 2012;64(6):890-897. doi:10.1002/acr.21611.
23. Maradit Kremers H, Salduz A, Schleck CD, Larson DR, Berry DJ, Lewallen DG. Referral bias in primary total knee arthroplasty: retrospective analysis of 22,614 surgeries in a tertiary referral center. J Arthroplasty. doi:10.1016/j.arth.2016.08.014.
24. Robinson JC, MacPherson K. Payers test reference pricing and centers of excellence to steer patients to low-price and high-quality providers. Health Affairs. 2012;31(9):2028-2036. doi: 10.1377/hlthaff.2011.1313
25. Laucis NC, Chowdhury M, Dasgupta A, Bhattacharyya T. Trend toward high-volume hospitals and the influence on complications in knee and hip arthroplasty. J Bone Joint Surg Am. 2016;98(9):707-712. doi:10.2106/JBJS.15.00399.
26. Anwar S, Fraser S, Hill J. Surgical specialization and training–its relation to clinical outcome for colorectal cancer surgery. J Eval Clin Pract. 2012;18(1):5-11. doi:10.1111/j.1365-2753.2010.01525.x.
27. Snow BW, Catwright PC, Young MD. Does surgical subspecialization in pediatrics provide high-quality, cost-effective patient care? Pediatrics. 1996;97(1):14-17.
28. Smith J a. E, King PM, Lane RHS, Thompson MR. Evidence of the effect of ‘specialization’ on the management, surgical outcome and survival from colorectal cancer in Wessex. Br J Surg. 2003;90(5):583-592. doi:10.1002/bjs.4085.
29. Hall BL, Hsaio EY, Majercik S, Hirbe M, Hamilton BH. The impact of surgeon specialization on patient mortality: Examination of a continuous Herfindahl-Hirschman Index. Ann Surg. 2009;249(5):708-716. doi: 10.1097/SLA.0b013e3181a335f8.
30. Leopold SS, Morgan HD, Kadel NJ, Gardner GC, Schaad DC, Wolf FM. Impact of educational intervention on confidence and competence in the performance of a simple surgical task. J Bone Joint Surg Am. 2005;87(5):1031-1037. doi:10.2106/JBJS.D.02434.
31. Morrell NT, Mercer DM, Moneim MS. Trends in the orthopedic job market and the importance of fellowship subspecialty training. Orthopedics. 2012;35(4):e555-e560. doi:10.3928/01477447-20120327-13.
1. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
2. Zmistowski B, Padegimas EM, Howley M, Abboud J, Williams G, Namdari S. Trends and Variability in the Use of Total Shoulder Arthroplasty for Medicare Patients. J Am Acad Orthop Surg. 2018;26(4):133-141. doi:10.5435/JAAOS-D-16-00720
3. Day JS, Lau E, Ong KL, Williams GR, Ramsey ML, Kurtz SM. Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015. J Shoulder Elbow Surg. 2010;19(8):1115-1120. doi: http://www.jshoulderelbow.org/article/S1058-2746(10)00110-2/abstract.
4. Day JS, Paxton ES, Lau E, Gordon VA, Abboud JA, Williams GR. Use of reverse total shoulder arthroplasty in the Medicare population. J Shoulder Elbow Surg. 2015;24(5):766-772. doi:10.1016/j.jse.2014.12.023.
5. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(1):91-97. doi:10.1016/j.jse.2014.08.026.
6. Westermann RW, Pugely AJ, Martin CT, Gao Y, Wolf BR, Hettrich CM. Reverse shoulder arthroplasty in the United States: A comparison of national volume, patient demographics, complications, and surgical indications. Iowa Orthop J. 2015;35:1-7.
7. Acevedo DC, Mann T, Abboud JA, Getz C, Baumhauer JF, Voloshin I. Reverse total shoulder arthroplasty for the treatment of proximal humeral fractures: patterns of use among newly trained orthopedic surgeons. J Shoulder Elbow Surg. 2014;23(9):1363-1367. doi: http://www.jshoulderelbow.org/article/S1058-2746(14)00036-6/abstract.
8. Hammond JW, Queale WS, Kim TK, McFarland EG. Surgeon experience and clinical and economic outcomes for shoulder arthroplasty. J Bone Joint Surg Am. 2003;85-A(12):2318-2324.
9. Jain NB, Kuye I, Higgins LD, Warner JJP. Surgeon volume is associated with cost and variation in surgical treatment of proximal humeral fractures. Clin Orthop Relat Res. 2012;471(2):655-664. doi:10.1007/s11999-012-2481-6.
10. Lyman S, Jones EC, Bach PB, Peterson MGE, Marx RG. The association between hospital volume and total shoulder arthroplasty outcomes. Clin Orthop Relat Res. 2005;(432):132-137. doi:10.1097/01.blo.0000150571.51381.9a.
11. Somerson JS, Stein BA, Wirth MA. Distribution of high-volume shoulder arthroplasty surgeons in the United States: Data from the 2014 Medicare provider utilization and payment data release. J Bone Joint Surg Am. 2016;98(18):e77. doi:10.2106/JBJS.15.00776.
12. Fisher ES, Bell J-E, Tomek IM, Esty AR, Goodman DC. Trends and regional variation in hip, knee, and shoulder Replacement. Atlases and Reports. Dartmouth Atlas of Health Care. https://www.dartmouthatlas.org/atlases-and-reports/. Accessed December 14, 2018.
13. Daniels AH, DiGiovanni CW. Is subspecialty fellowship training emerging as a necessary component of contemporary orthopaedic surgery education? J Grad Med Educ. 2014;6(2):218-221. doi:10.4300/JGME-D-14-00120.1.
14. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Physician and other supplier Data 2012 CY 2012. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Tren.... Published October 5, 2015. Accessed July 25, 2016.
15. The Dartmouth Institute for Health Policy and Clinical Practice. Dartmouth Atlas of Health Care. Understanding the Efficiency and Effectiveness of the Health Care System. http://www.dartmouthatlas.org/. Accessed January 31, 2014.
16. United States Department of Commerce. United States Census Bureau. 2010 Census Urban and Rural Classification and Urban Area Criteria. https://www.census.gov/geo/reference/ua/urban-rural-2010.html. Accessed September 30, 2016.
17. Kempton LB, Ankerson E, Wiater JM. A complication-based learning curve from 200 reverse shoulder arthroplasties. Clin Orthop Relat Res. 2011;469(9):2496-2504. doi:10.1007/s11999-011-1811-4.
18. Singh A, Yian EH, Dillon MT, Takayanagi M, Burke MF, Navarro RA. The effect of surgeon and hospital volume on shoulder arthroplasty perioperative quality metrics. J Bone Joint Surg Am. 2014;23(8):1187-1194. doi:10.1016/j.jse.2013.11.017.
19. Jain N, Pietrobon R, Hocker S, Guller U, Shankar A, Higgins LD. The relationship between surgeon and hospital volume and outcomes for shoulder arthroplasty. J Bone Joint Surg Am. 2004;86(3):496-505.
20. Taylor HD, Dennis DA, Crane HS. Relationship between mortality rates and hospital patient volume for Medicare patients undergoing major orthopaedic surgery of the hip, knee, spine, and femur. J Arthroplasty. 1997;12(3):235-242. doi:10.1016/S0883-5403(97)90018-8.
21. Walch G, Bacle G, Lädermann A, Nové-Josserand L, Smithers CJ. Do the indications, results, and complications of reverse shoulder arthroplasty change with surgeon’s experience? J Bone Joint Surg Am. 2012;21(11):1470-1477. doi:10.1016/j.jse.2011.11.010.
22. FitzGerald JD, Soohoo NF, Losina E, Katz JN. Potential impact on patient residence to hospital travel distance and access to care under a policy of preferential referral to high-volume knee replacement hospitals. Arthritis Care Res. 2012;64(6):890-897. doi:10.1002/acr.21611.
23. Maradit Kremers H, Salduz A, Schleck CD, Larson DR, Berry DJ, Lewallen DG. Referral bias in primary total knee arthroplasty: retrospective analysis of 22,614 surgeries in a tertiary referral center. J Arthroplasty. doi:10.1016/j.arth.2016.08.014.
24. Robinson JC, MacPherson K. Payers test reference pricing and centers of excellence to steer patients to low-price and high-quality providers. Health Affairs. 2012;31(9):2028-2036. doi: 10.1377/hlthaff.2011.1313
25. Laucis NC, Chowdhury M, Dasgupta A, Bhattacharyya T. Trend toward high-volume hospitals and the influence on complications in knee and hip arthroplasty. J Bone Joint Surg Am. 2016;98(9):707-712. doi:10.2106/JBJS.15.00399.
26. Anwar S, Fraser S, Hill J. Surgical specialization and training–its relation to clinical outcome for colorectal cancer surgery. J Eval Clin Pract. 2012;18(1):5-11. doi:10.1111/j.1365-2753.2010.01525.x.
27. Snow BW, Catwright PC, Young MD. Does surgical subspecialization in pediatrics provide high-quality, cost-effective patient care? Pediatrics. 1996;97(1):14-17.
28. Smith J a. E, King PM, Lane RHS, Thompson MR. Evidence of the effect of ‘specialization’ on the management, surgical outcome and survival from colorectal cancer in Wessex. Br J Surg. 2003;90(5):583-592. doi:10.1002/bjs.4085.
29. Hall BL, Hsaio EY, Majercik S, Hirbe M, Hamilton BH. The impact of surgeon specialization on patient mortality: Examination of a continuous Herfindahl-Hirschman Index. Ann Surg. 2009;249(5):708-716. doi: 10.1097/SLA.0b013e3181a335f8.
30. Leopold SS, Morgan HD, Kadel NJ, Gardner GC, Schaad DC, Wolf FM. Impact of educational intervention on confidence and competence in the performance of a simple surgical task. J Bone Joint Surg Am. 2005;87(5):1031-1037. doi:10.2106/JBJS.D.02434.
31. Morrell NT, Mercer DM, Moneim MS. Trends in the orthopedic job market and the importance of fellowship subspecialty training. Orthopedics. 2012;35(4):e555-e560. doi:10.3928/01477447-20120327-13.
TAKE-HOME POINTS
- Between 2012 and 2014, 1,374 surgeons performed >10 total shoulder arthroplasties (TSA) in Medicare patients in at least one year.
- From 2012 to 2014, the number of surgeons performing at least 10 TSA in Medicare patients increased from 834 to 1,078, while the number of TSA increased from 21,137 (25.3 per surgeon) to 26,765 (24.9 per surgeon).
- Many of these surgeons had a diverse surgical practice, with nearly one-half performing total knee arthroplasty, one-third performing non-arthroplasty knee surgeries, and >80% performing non-arthroplasty shoulder procedures.
- Only one-third of these surgeons had formal fellowship training specific to shoulder and elbow.
- In order for the current supply of shoulder and elbow fellowship-trained surgeons to meet the Medicare TSA demand, each currently practicing fellowship graduate would have to perform 140.6 TSA in Medicare patients annually.
Can robotics reduce hepatic surgery conversions?
The conversion rate from minimally invasive to open surgery for liver resection has been known to be high, but researchers from the University of Illinois, Chicago, have reported that conversion rates are considerably lower in robot-assisted liver resections, which may ultimately improve survival and complication rates.
Their study, published in the International Journal of Medical Robotics and Computer Assisted Surgery, found that the overall conversion rate of robot-assisted to open surgery for liver resection was 4.4%, considerably lower than that for the pure laparoscopic approach. “The robotic assist could potentially help in decreasing the conversion rate,” said Federico Gheza, MD, and his coauthors. They claimed that this is the first paper to focus on reasons for conversion from robot-assisted liver resection to open surgery.
The study findings are based on a systematic review of 29 series of 1,091 patients who had robot-assisted liver resection, including Dr. Gheza’s and his coauthors’ own series of 139 patients who had the operation from 2007 to 2017. The series were published from 2009 to 2017.
Dr. Gheza’s and his coauthors’ series had a conversion rate of 7.9%. When their results were included with those of the previously published studies, the conversion rate was 4.8%.
Dr. Gheza and his coauthors noted that the conversion rate for minimally invasive hepatic operations is one of the highest among all types of laparoscopic operations, with rates reported as high as 23% in published series (Ann Surg. 2016;263:761-77). “More importantly, preliminary database analysis and large series review suggested an association between conversion and higher morbidity and mortality,” the study noted.
The purpose of the systematic review was to better understand reasons for conversion from robotic to open in liver resections, Dr. Gheza and his coauthors said. They noted a study of 2,861 laparoscopic resections reported that more than one-third of patients were converted for bleeding, and almost one-fifth (18.9%) for peritoneal adhesions (Ann Surg. 2017;268:1051-7). “In the whole literature on hepatic robotic surgery, no conversion due to adhesion was reported,” Dr. Gheza and his coauthors said.
A subanalysis of nine series that included both robotic (360 patients) and laparoscopic (462 patients) surgeries found conversion rates of 2.5% vs. 8%, respectively (P less than .01).
Dr. Gheza and his coauthors called for a prospective trial to further define the impact of robotic surgery on conversions, but the clinical implications of conversions to open surgery in minimally invasive hepatic surgery remain unclear.
Dr. Gheza disclosed relationships with Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
SOURCE: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018; doi:10.1002/rcs.1976.
The conversion rate from minimally invasive to open surgery for liver resection has been known to be high, but researchers from the University of Illinois, Chicago, have reported that conversion rates are considerably lower in robot-assisted liver resections, which may ultimately improve survival and complication rates.
Their study, published in the International Journal of Medical Robotics and Computer Assisted Surgery, found that the overall conversion rate of robot-assisted to open surgery for liver resection was 4.4%, considerably lower than that for the pure laparoscopic approach. “The robotic assist could potentially help in decreasing the conversion rate,” said Federico Gheza, MD, and his coauthors. They claimed that this is the first paper to focus on reasons for conversion from robot-assisted liver resection to open surgery.
The study findings are based on a systematic review of 29 series of 1,091 patients who had robot-assisted liver resection, including Dr. Gheza’s and his coauthors’ own series of 139 patients who had the operation from 2007 to 2017. The series were published from 2009 to 2017.
Dr. Gheza’s and his coauthors’ series had a conversion rate of 7.9%. When their results were included with those of the previously published studies, the conversion rate was 4.8%.
Dr. Gheza and his coauthors noted that the conversion rate for minimally invasive hepatic operations is one of the highest among all types of laparoscopic operations, with rates reported as high as 23% in published series (Ann Surg. 2016;263:761-77). “More importantly, preliminary database analysis and large series review suggested an association between conversion and higher morbidity and mortality,” the study noted.
The purpose of the systematic review was to better understand reasons for conversion from robotic to open in liver resections, Dr. Gheza and his coauthors said. They noted a study of 2,861 laparoscopic resections reported that more than one-third of patients were converted for bleeding, and almost one-fifth (18.9%) for peritoneal adhesions (Ann Surg. 2017;268:1051-7). “In the whole literature on hepatic robotic surgery, no conversion due to adhesion was reported,” Dr. Gheza and his coauthors said.
A subanalysis of nine series that included both robotic (360 patients) and laparoscopic (462 patients) surgeries found conversion rates of 2.5% vs. 8%, respectively (P less than .01).
Dr. Gheza and his coauthors called for a prospective trial to further define the impact of robotic surgery on conversions, but the clinical implications of conversions to open surgery in minimally invasive hepatic surgery remain unclear.
Dr. Gheza disclosed relationships with Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
SOURCE: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018; doi:10.1002/rcs.1976.
The conversion rate from minimally invasive to open surgery for liver resection has been known to be high, but researchers from the University of Illinois, Chicago, have reported that conversion rates are considerably lower in robot-assisted liver resections, which may ultimately improve survival and complication rates.
Their study, published in the International Journal of Medical Robotics and Computer Assisted Surgery, found that the overall conversion rate of robot-assisted to open surgery for liver resection was 4.4%, considerably lower than that for the pure laparoscopic approach. “The robotic assist could potentially help in decreasing the conversion rate,” said Federico Gheza, MD, and his coauthors. They claimed that this is the first paper to focus on reasons for conversion from robot-assisted liver resection to open surgery.
The study findings are based on a systematic review of 29 series of 1,091 patients who had robot-assisted liver resection, including Dr. Gheza’s and his coauthors’ own series of 139 patients who had the operation from 2007 to 2017. The series were published from 2009 to 2017.
Dr. Gheza’s and his coauthors’ series had a conversion rate of 7.9%. When their results were included with those of the previously published studies, the conversion rate was 4.8%.
Dr. Gheza and his coauthors noted that the conversion rate for minimally invasive hepatic operations is one of the highest among all types of laparoscopic operations, with rates reported as high as 23% in published series (Ann Surg. 2016;263:761-77). “More importantly, preliminary database analysis and large series review suggested an association between conversion and higher morbidity and mortality,” the study noted.
The purpose of the systematic review was to better understand reasons for conversion from robotic to open in liver resections, Dr. Gheza and his coauthors said. They noted a study of 2,861 laparoscopic resections reported that more than one-third of patients were converted for bleeding, and almost one-fifth (18.9%) for peritoneal adhesions (Ann Surg. 2017;268:1051-7). “In the whole literature on hepatic robotic surgery, no conversion due to adhesion was reported,” Dr. Gheza and his coauthors said.
A subanalysis of nine series that included both robotic (360 patients) and laparoscopic (462 patients) surgeries found conversion rates of 2.5% vs. 8%, respectively (P less than .01).
Dr. Gheza and his coauthors called for a prospective trial to further define the impact of robotic surgery on conversions, but the clinical implications of conversions to open surgery in minimally invasive hepatic surgery remain unclear.
Dr. Gheza disclosed relationships with Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
SOURCE: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018; doi:10.1002/rcs.1976.
FROM THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY
Key clinical point: Robotic liver resection has the potential to lower conversion rates.
Major finding: The conversion rate in robot-assisted liver resection was 4.8%.
Study details: Systematic review of 29 series of 1,091 robot-assisted liver resections published from 2009 to 2017, including the authors’ own cohort of 139 consecutive patients from May 2007 to September 2017.
Disclosures: Dr. Gheza disclosed being a consultant for Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
Source: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018. doi: 10.1002/rcs.1976.
Positive results reported for ixekizumab versus adalimumab in PsA
Eli Lilly and Co. has announced positive results from the phase 3b/4, multicenter, randomized, open-label, parallel-group SPIRIT-H2H trial, which compared ixekizumab (Taltz) with adalimumab (Humira) in patients with psoriatic arthritis who had previously not taken a biologic disease-modifying antirheumatic drug.
The 52-week study included 566 patients with psoriatic arthritis. Patients received either ixekizumab at 80 mg every 4 weeks after a 160-mg loading dose or adalimumab at 40 mg every 2 weeks. The primary endpoint was the proportion of patients achieving at least a 50% reduction in American College of Rheumatology (ACR50) criteria at 24 weeks.
After 24 weeks, patients in the ixekizumab group were more likely to achieve ACR50, compared with those in the adalimumab group. In addition, patients receiving ixekizumab were more likely to achieve 100% skin clearance according to the Psoriasis Area and Severity Index. Ixekizumab also met all secondary trial endpoints.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the press release.
More detailed results will be presented at meetings and published in peer-reviewed journals in 2019, the company said.
Eli Lilly and Co. has announced positive results from the phase 3b/4, multicenter, randomized, open-label, parallel-group SPIRIT-H2H trial, which compared ixekizumab (Taltz) with adalimumab (Humira) in patients with psoriatic arthritis who had previously not taken a biologic disease-modifying antirheumatic drug.
The 52-week study included 566 patients with psoriatic arthritis. Patients received either ixekizumab at 80 mg every 4 weeks after a 160-mg loading dose or adalimumab at 40 mg every 2 weeks. The primary endpoint was the proportion of patients achieving at least a 50% reduction in American College of Rheumatology (ACR50) criteria at 24 weeks.
After 24 weeks, patients in the ixekizumab group were more likely to achieve ACR50, compared with those in the adalimumab group. In addition, patients receiving ixekizumab were more likely to achieve 100% skin clearance according to the Psoriasis Area and Severity Index. Ixekizumab also met all secondary trial endpoints.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the press release.
More detailed results will be presented at meetings and published in peer-reviewed journals in 2019, the company said.
Eli Lilly and Co. has announced positive results from the phase 3b/4, multicenter, randomized, open-label, parallel-group SPIRIT-H2H trial, which compared ixekizumab (Taltz) with adalimumab (Humira) in patients with psoriatic arthritis who had previously not taken a biologic disease-modifying antirheumatic drug.
The 52-week study included 566 patients with psoriatic arthritis. Patients received either ixekizumab at 80 mg every 4 weeks after a 160-mg loading dose or adalimumab at 40 mg every 2 weeks. The primary endpoint was the proportion of patients achieving at least a 50% reduction in American College of Rheumatology (ACR50) criteria at 24 weeks.
After 24 weeks, patients in the ixekizumab group were more likely to achieve ACR50, compared with those in the adalimumab group. In addition, patients receiving ixekizumab were more likely to achieve 100% skin clearance according to the Psoriasis Area and Severity Index. Ixekizumab also met all secondary trial endpoints.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the press release.
More detailed results will be presented at meetings and published in peer-reviewed journals in 2019, the company said.
Natural killer cells implicated in psoriatic arthritis
CHICAGO –
This natural killer cell interacts with the CD94/NKG2A receptor, part of a system believed to have been in place in humans for more than 90 million years.
“We believe there is a possible role for the innate immune system in the development of psoriatic arthritis and its distinction from psoriasis,” Vinod Chandran, MD, PhD, declared at the annual meeting of the American College of Rheumatology.
Dr. Chandran, of the University of Toronto, presented an analysis of a discovery cohort comprising 1,155 patients with dermatologist-diagnosed psoriasis of greater than 10 years duration, 664 rheumatologist-diagnosed psoriatic arthritis patients, and 3,118 controls, all participants in the International Psoriasis and Arthritis Research Team program. These findings were then independently confirmed in a separate University of Toronto replication cohort of 659 psoriasis patients, 1,177 psoriatic arthritis patients of European ancestry, and 1,096 controls.
By way of background, the rheumatologist explained that psoriasis and psoriatic arthritis are known to differ in terms of their genetic architecture, the biggest difference being in the HLA class I region, where HLA-C predominates in psoriasis and HLA-B in psoriatic arthritis. These structurally unrelated forms of HLA class I are known to educate natural killer cells and shape their function. Dr. Chandran and his coinvestigators were eager to shed new light on the mechanisms by which this leads to rheumatic disease.
Humans can be divided into three groups based upon whether they are HLA-B21 methionine/methionine (M/M), HLA-B21 M/threonine (T), or HLA-B21 T/T. The B21 M types educate CD94/NKG2A-positive natural killer cells by delivering functional peptides to the CD94/NKG2A receptor, while the B21 T/T version does not.
In the discovery cohort, individuals with psoriatic arthritis turned out to be 36% more likely to be HLA-B21 M/M or HLA-B21 M/T than were the psoriasis patients, while the psoriasis patients were 22% less likely to be B21 M–positive than controls. These relationships were confirmed in the replication cohort, where psoriatic arthritis patients were 40% more likely to be B21 M–positive than psoriasis patients, and psoriasis patients were 18% less likely to be B21 M–positive than controls, with all of these differences being statistically significant.
While this is translational science, Dr. Chandran explained that it has important clinical implications. He and his coinvestigators are developing a genetic marker panel to differentiate psoriatic arthritis from psoriasis, as are other research groups. And the Toronto investigators are now convinced that including HLA-B21 M/M and HLA-B21 M/T in their evolving genetic test is worthwhile in terms of boosting the test’s predictive power. The 36%-40% increased risk of psoriatic arthritis associated with B21 M–positivity isn’t sufficiently large for it to serve as a standalone test, but when the genetic test panel is finalized and the investigators can evaluate its positive and negative predictive value, it will be clear that the B21 M component will provide added value, he predicted.
Because psoriatic arthritis can take on a variety of disparate forms clinically, Dr. Chandran and his coworkers believe their genetic test will prove most useful for nonrheumatologists, especially dermatologists and primary care physicians.
He reported having no relevant financial relationships regarding this study, funded by the Canadian Institutes of Health Research, the Krembil Foundation, and the Arthritis Foundation.
SOURCE: Chandran V et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 2787.
CHICAGO –
This natural killer cell interacts with the CD94/NKG2A receptor, part of a system believed to have been in place in humans for more than 90 million years.
“We believe there is a possible role for the innate immune system in the development of psoriatic arthritis and its distinction from psoriasis,” Vinod Chandran, MD, PhD, declared at the annual meeting of the American College of Rheumatology.
Dr. Chandran, of the University of Toronto, presented an analysis of a discovery cohort comprising 1,155 patients with dermatologist-diagnosed psoriasis of greater than 10 years duration, 664 rheumatologist-diagnosed psoriatic arthritis patients, and 3,118 controls, all participants in the International Psoriasis and Arthritis Research Team program. These findings were then independently confirmed in a separate University of Toronto replication cohort of 659 psoriasis patients, 1,177 psoriatic arthritis patients of European ancestry, and 1,096 controls.
By way of background, the rheumatologist explained that psoriasis and psoriatic arthritis are known to differ in terms of their genetic architecture, the biggest difference being in the HLA class I region, where HLA-C predominates in psoriasis and HLA-B in psoriatic arthritis. These structurally unrelated forms of HLA class I are known to educate natural killer cells and shape their function. Dr. Chandran and his coinvestigators were eager to shed new light on the mechanisms by which this leads to rheumatic disease.
Humans can be divided into three groups based upon whether they are HLA-B21 methionine/methionine (M/M), HLA-B21 M/threonine (T), or HLA-B21 T/T. The B21 M types educate CD94/NKG2A-positive natural killer cells by delivering functional peptides to the CD94/NKG2A receptor, while the B21 T/T version does not.
In the discovery cohort, individuals with psoriatic arthritis turned out to be 36% more likely to be HLA-B21 M/M or HLA-B21 M/T than were the psoriasis patients, while the psoriasis patients were 22% less likely to be B21 M–positive than controls. These relationships were confirmed in the replication cohort, where psoriatic arthritis patients were 40% more likely to be B21 M–positive than psoriasis patients, and psoriasis patients were 18% less likely to be B21 M–positive than controls, with all of these differences being statistically significant.
While this is translational science, Dr. Chandran explained that it has important clinical implications. He and his coinvestigators are developing a genetic marker panel to differentiate psoriatic arthritis from psoriasis, as are other research groups. And the Toronto investigators are now convinced that including HLA-B21 M/M and HLA-B21 M/T in their evolving genetic test is worthwhile in terms of boosting the test’s predictive power. The 36%-40% increased risk of psoriatic arthritis associated with B21 M–positivity isn’t sufficiently large for it to serve as a standalone test, but when the genetic test panel is finalized and the investigators can evaluate its positive and negative predictive value, it will be clear that the B21 M component will provide added value, he predicted.
Because psoriatic arthritis can take on a variety of disparate forms clinically, Dr. Chandran and his coworkers believe their genetic test will prove most useful for nonrheumatologists, especially dermatologists and primary care physicians.
He reported having no relevant financial relationships regarding this study, funded by the Canadian Institutes of Health Research, the Krembil Foundation, and the Arthritis Foundation.
SOURCE: Chandran V et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 2787.
CHICAGO –
This natural killer cell interacts with the CD94/NKG2A receptor, part of a system believed to have been in place in humans for more than 90 million years.
“We believe there is a possible role for the innate immune system in the development of psoriatic arthritis and its distinction from psoriasis,” Vinod Chandran, MD, PhD, declared at the annual meeting of the American College of Rheumatology.
Dr. Chandran, of the University of Toronto, presented an analysis of a discovery cohort comprising 1,155 patients with dermatologist-diagnosed psoriasis of greater than 10 years duration, 664 rheumatologist-diagnosed psoriatic arthritis patients, and 3,118 controls, all participants in the International Psoriasis and Arthritis Research Team program. These findings were then independently confirmed in a separate University of Toronto replication cohort of 659 psoriasis patients, 1,177 psoriatic arthritis patients of European ancestry, and 1,096 controls.
By way of background, the rheumatologist explained that psoriasis and psoriatic arthritis are known to differ in terms of their genetic architecture, the biggest difference being in the HLA class I region, where HLA-C predominates in psoriasis and HLA-B in psoriatic arthritis. These structurally unrelated forms of HLA class I are known to educate natural killer cells and shape their function. Dr. Chandran and his coinvestigators were eager to shed new light on the mechanisms by which this leads to rheumatic disease.
Humans can be divided into three groups based upon whether they are HLA-B21 methionine/methionine (M/M), HLA-B21 M/threonine (T), or HLA-B21 T/T. The B21 M types educate CD94/NKG2A-positive natural killer cells by delivering functional peptides to the CD94/NKG2A receptor, while the B21 T/T version does not.
In the discovery cohort, individuals with psoriatic arthritis turned out to be 36% more likely to be HLA-B21 M/M or HLA-B21 M/T than were the psoriasis patients, while the psoriasis patients were 22% less likely to be B21 M–positive than controls. These relationships were confirmed in the replication cohort, where psoriatic arthritis patients were 40% more likely to be B21 M–positive than psoriasis patients, and psoriasis patients were 18% less likely to be B21 M–positive than controls, with all of these differences being statistically significant.
While this is translational science, Dr. Chandran explained that it has important clinical implications. He and his coinvestigators are developing a genetic marker panel to differentiate psoriatic arthritis from psoriasis, as are other research groups. And the Toronto investigators are now convinced that including HLA-B21 M/M and HLA-B21 M/T in their evolving genetic test is worthwhile in terms of boosting the test’s predictive power. The 36%-40% increased risk of psoriatic arthritis associated with B21 M–positivity isn’t sufficiently large for it to serve as a standalone test, but when the genetic test panel is finalized and the investigators can evaluate its positive and negative predictive value, it will be clear that the B21 M component will provide added value, he predicted.
Because psoriatic arthritis can take on a variety of disparate forms clinically, Dr. Chandran and his coworkers believe their genetic test will prove most useful for nonrheumatologists, especially dermatologists and primary care physicians.
He reported having no relevant financial relationships regarding this study, funded by the Canadian Institutes of Health Research, the Krembil Foundation, and the Arthritis Foundation.
SOURCE: Chandran V et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 2787.
REPORTING FROM THE ACR ANNUAL MEETING
Key clinical point: A genetic panel designed to differentiate psoriatic arthritis from psoriasis is drawing closer to fruition.
Major finding: The prevalence of HLA-B21 methionine is increased by roughly 40% in patients with psoriatic arthritis, compared with psoriasis patients.
Study details: This translational study included two independent cohorts totaling 1,814 psoriasis patients, 1,841 with psoriatic arthritis, and 4,214 controls.
Disclosures: The presenter reported having no relevant financial relationships regarding this study, which was funded by the Canadian Institutes of Health Research, the Krembil Foundation, and the Arthritis Foundation.
Source: Chandran V et al. Arthritis Rheumatol. 2018;70(Suppl 10), Abstract 2787.
Insulin loses its starting spot
, fewer migraines in women are linked to increased type 2 diabetes risk, the U.S. Preventive Services Task Force looks to prevent opioid abuse in primary care, and there’s an uncomfortable truth in new guidelines for posttraumatic stress disorder.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
, fewer migraines in women are linked to increased type 2 diabetes risk, the U.S. Preventive Services Task Force looks to prevent opioid abuse in primary care, and there’s an uncomfortable truth in new guidelines for posttraumatic stress disorder.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
, fewer migraines in women are linked to increased type 2 diabetes risk, the U.S. Preventive Services Task Force looks to prevent opioid abuse in primary care, and there’s an uncomfortable truth in new guidelines for posttraumatic stress disorder.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Drug may be new option for transfusion-dependent β-thalassemia
SAN DIEGO—Luspatercept can produce “clinically meaningful” results in transfusion-dependent adults with β-thalassemia, according to a speaker at the 2018 ASH Annual Meeting.
In the phase 3 BELIEVE trial, β-thalassemia patients were significantly more likely to experience a reduction in transfusion burden if they were treated with luspatercept rather than placebo.
“Luspatercept showed a statistically significant and clinically meaningful . . . reduction in transfusion burden compared with placebo at any 12- or 24-week [period] along this study,” said Maria Domenica Cappellini, MD, of the University of Milan in Italy.
“At this point, we believe [luspatercept] is a potential new treatment for adult patients with β-thalassemia who are requiring regular blood transfusions.”
Dr. Cappellini presented these results at ASH as abstract 163.
The BELIEVE trial (NCT02604433) enrolled 336 patients from 65 sites in 15 countries. All patients had β-thalassemia or hemoglobin E/β‑thalassemia. They required regular transfusions of six to 20 red blood cell (RBC) units in the 24 weeks prior to randomization, and none had a transfusion-free period lasting 35 days or more.
The patients were randomized 2:1 to receive luspatercept—at a starting dose of 1.0 mg/kg with titration up to 1.25 mg/kg—(n=224) or placebo (n=112) subcutaneously every 3 weeks for at least 48 weeks.
All patients continued to receive RBC transfusions and iron chelation therapy as necessary (so they maintained the same baseline hemoglobin level).
The median age was 30 in both treatment arms (range, 18-66). More than half of patients were female—58.9% in the luspatercept arm and 56.3% in the placebo arm.
A similar percentage of patients in both arms had the β0, β0 genotype—30.4% in the luspatercept arm and 31.3% in the placebo arm.
The median hemoglobin level at baseline was 9.31 g/dL in the luspatercept arm and 9.15 g/dL in the placebo arm. The median RBC transfusion burden was 6.12 units/12 weeks and 6.27 units/12 weeks, respectively.
Other baseline characteristics were similar as well.
Efficacy
“[L]uspatercept showed a statistically significant improvement in the primary endpoint,” Dr. Cappellini noted.
The primary endpoint was at least a 33% reduction in transfusion burden—of at least two RBC units—from week 13 to week 24, as compared to the 12-week baseline period.
This endpoint was achieved by 21.4% (n=48) of patients in the luspatercept arm and 4.5% (n=5) in the placebo arm (odds ratio=5.79; P<0.0001).
“Statistical significance was also demonstrated with luspatercept versus placebo for all the key secondary endpoints,” Dr. Cappellini said.
There were more patients in the luspatercept arm than the placebo arm who achieved at least a 33% reduction in transfusion burden from week 37 to 48—19.6% and 3.6%, respectively (P<0.0001).
Similarly, there were more patients in the luspatercept arm than the placebo arm who achieved at least a 50% reduction in transfusion burden from week 13 to 24—7.6% and 1.8%, respectively (P=0.0303)—and from week 37 to 48—10.3% and 0.9%, respectively (P=0.0017).
During any 12-week interval, 70.5% of luspatercept-treated patients and 29.5% of placebo-treated patients achieved at least a 33% reduction in transfusion burden (P<0.0001), and 40.2% and 6.3%, respectively (P<0.0001), achieved at least a 50% reduction in transfusion burden.
During any 24-week interval, 41.1% of luspatercept-treated patients and 2.7% of placebo-treated patients achieved at least a 33% reduction in transfusion burden (P<0.0001), and 16.5% and 0.9%, respectively (P<0.0001), achieved at least a 50% reduction in transfusion burden.
Safety
Ninety-six percent of patients in the luspatercept arm and 92.7% in the placebo arm had at least one treatment-emergent adverse event (TEAE).
Grade 3 or higher TEAEs occurred in 29.1% of patients in the luspatercept arm and 15.6% of those in the placebo arm. Serious TEAEs occurred in 15.2% and 5.5%, respectively.
One patient in the placebo arm had a TEAE-related death (acute cholecystitis), but there were no treatment-related deaths in the luspatercept arm.
TEAEs leading to treatment discontinuation occurred in 5.4% of luspatercept-treated patients and 0.9% of placebo-treated patients.
TEAEs that occurred more frequently in the luspatercept arm than in the placebo arm (respectively) included bone pain (19.7% and 8.3%), arthralgia (19.3% and 11.9%), and dizziness (11.2% and 4.6%).
Grade 3/4 TEAEs (in the luspatercept and placebo arms, respectively) included anemia (3.1% and 0%), increased liver iron concentration (2.7% and 0.9%), hyperuricemia (2.7% and 0%), hypertension (1.8% and 0%), syncope (1.8% and 0%), back pain (1.3% and 0.9%), bone pain (1.3% and 0%), blood uric acid increase (1.3% and 0%), increased aspartate aminotransferase (1.3% and 0%), increased alanine aminotransferase (0.9% and 2.8%), and thromboembolic events (0.9% and 0%).
Dr. Cappellini noted that thromboembolic events occurred in eight luspatercept-treated patients and one placebo-treated patient. In all cases, the patients had multiple risk factors for thrombosis.
This study was sponsored by Celgene Corporation and Acceleron Pharma. Dr. Cappellini reported relationships with Novartis, Celgene, Sanofi-Genzyme, and Vifor.
SAN DIEGO—Luspatercept can produce “clinically meaningful” results in transfusion-dependent adults with β-thalassemia, according to a speaker at the 2018 ASH Annual Meeting.
In the phase 3 BELIEVE trial, β-thalassemia patients were significantly more likely to experience a reduction in transfusion burden if they were treated with luspatercept rather than placebo.
“Luspatercept showed a statistically significant and clinically meaningful . . . reduction in transfusion burden compared with placebo at any 12- or 24-week [period] along this study,” said Maria Domenica Cappellini, MD, of the University of Milan in Italy.
“At this point, we believe [luspatercept] is a potential new treatment for adult patients with β-thalassemia who are requiring regular blood transfusions.”
Dr. Cappellini presented these results at ASH as abstract 163.
The BELIEVE trial (NCT02604433) enrolled 336 patients from 65 sites in 15 countries. All patients had β-thalassemia or hemoglobin E/β‑thalassemia. They required regular transfusions of six to 20 red blood cell (RBC) units in the 24 weeks prior to randomization, and none had a transfusion-free period lasting 35 days or more.
The patients were randomized 2:1 to receive luspatercept—at a starting dose of 1.0 mg/kg with titration up to 1.25 mg/kg—(n=224) or placebo (n=112) subcutaneously every 3 weeks for at least 48 weeks.
All patients continued to receive RBC transfusions and iron chelation therapy as necessary (so they maintained the same baseline hemoglobin level).
The median age was 30 in both treatment arms (range, 18-66). More than half of patients were female—58.9% in the luspatercept arm and 56.3% in the placebo arm.
A similar percentage of patients in both arms had the β0, β0 genotype—30.4% in the luspatercept arm and 31.3% in the placebo arm.
The median hemoglobin level at baseline was 9.31 g/dL in the luspatercept arm and 9.15 g/dL in the placebo arm. The median RBC transfusion burden was 6.12 units/12 weeks and 6.27 units/12 weeks, respectively.
Other baseline characteristics were similar as well.
Efficacy
“[L]uspatercept showed a statistically significant improvement in the primary endpoint,” Dr. Cappellini noted.
The primary endpoint was at least a 33% reduction in transfusion burden—of at least two RBC units—from week 13 to week 24, as compared to the 12-week baseline period.
This endpoint was achieved by 21.4% (n=48) of patients in the luspatercept arm and 4.5% (n=5) in the placebo arm (odds ratio=5.79; P<0.0001).
“Statistical significance was also demonstrated with luspatercept versus placebo for all the key secondary endpoints,” Dr. Cappellini said.
There were more patients in the luspatercept arm than the placebo arm who achieved at least a 33% reduction in transfusion burden from week 37 to 48—19.6% and 3.6%, respectively (P<0.0001).
Similarly, there were more patients in the luspatercept arm than the placebo arm who achieved at least a 50% reduction in transfusion burden from week 13 to 24—7.6% and 1.8%, respectively (P=0.0303)—and from week 37 to 48—10.3% and 0.9%, respectively (P=0.0017).
During any 12-week interval, 70.5% of luspatercept-treated patients and 29.5% of placebo-treated patients achieved at least a 33% reduction in transfusion burden (P<0.0001), and 40.2% and 6.3%, respectively (P<0.0001), achieved at least a 50% reduction in transfusion burden.
During any 24-week interval, 41.1% of luspatercept-treated patients and 2.7% of placebo-treated patients achieved at least a 33% reduction in transfusion burden (P<0.0001), and 16.5% and 0.9%, respectively (P<0.0001), achieved at least a 50% reduction in transfusion burden.
Safety
Ninety-six percent of patients in the luspatercept arm and 92.7% in the placebo arm had at least one treatment-emergent adverse event (TEAE).
Grade 3 or higher TEAEs occurred in 29.1% of patients in the luspatercept arm and 15.6% of those in the placebo arm. Serious TEAEs occurred in 15.2% and 5.5%, respectively.
One patient in the placebo arm had a TEAE-related death (acute cholecystitis), but there were no treatment-related deaths in the luspatercept arm.
TEAEs leading to treatment discontinuation occurred in 5.4% of luspatercept-treated patients and 0.9% of placebo-treated patients.
TEAEs that occurred more frequently in the luspatercept arm than in the placebo arm (respectively) included bone pain (19.7% and 8.3%), arthralgia (19.3% and 11.9%), and dizziness (11.2% and 4.6%).
Grade 3/4 TEAEs (in the luspatercept and placebo arms, respectively) included anemia (3.1% and 0%), increased liver iron concentration (2.7% and 0.9%), hyperuricemia (2.7% and 0%), hypertension (1.8% and 0%), syncope (1.8% and 0%), back pain (1.3% and 0.9%), bone pain (1.3% and 0%), blood uric acid increase (1.3% and 0%), increased aspartate aminotransferase (1.3% and 0%), increased alanine aminotransferase (0.9% and 2.8%), and thromboembolic events (0.9% and 0%).
Dr. Cappellini noted that thromboembolic events occurred in eight luspatercept-treated patients and one placebo-treated patient. In all cases, the patients had multiple risk factors for thrombosis.
This study was sponsored by Celgene Corporation and Acceleron Pharma. Dr. Cappellini reported relationships with Novartis, Celgene, Sanofi-Genzyme, and Vifor.
SAN DIEGO—Luspatercept can produce “clinically meaningful” results in transfusion-dependent adults with β-thalassemia, according to a speaker at the 2018 ASH Annual Meeting.
In the phase 3 BELIEVE trial, β-thalassemia patients were significantly more likely to experience a reduction in transfusion burden if they were treated with luspatercept rather than placebo.
“Luspatercept showed a statistically significant and clinically meaningful . . . reduction in transfusion burden compared with placebo at any 12- or 24-week [period] along this study,” said Maria Domenica Cappellini, MD, of the University of Milan in Italy.
“At this point, we believe [luspatercept] is a potential new treatment for adult patients with β-thalassemia who are requiring regular blood transfusions.”
Dr. Cappellini presented these results at ASH as abstract 163.
The BELIEVE trial (NCT02604433) enrolled 336 patients from 65 sites in 15 countries. All patients had β-thalassemia or hemoglobin E/β‑thalassemia. They required regular transfusions of six to 20 red blood cell (RBC) units in the 24 weeks prior to randomization, and none had a transfusion-free period lasting 35 days or more.
The patients were randomized 2:1 to receive luspatercept—at a starting dose of 1.0 mg/kg with titration up to 1.25 mg/kg—(n=224) or placebo (n=112) subcutaneously every 3 weeks for at least 48 weeks.
All patients continued to receive RBC transfusions and iron chelation therapy as necessary (so they maintained the same baseline hemoglobin level).
The median age was 30 in both treatment arms (range, 18-66). More than half of patients were female—58.9% in the luspatercept arm and 56.3% in the placebo arm.
A similar percentage of patients in both arms had the β0, β0 genotype—30.4% in the luspatercept arm and 31.3% in the placebo arm.
The median hemoglobin level at baseline was 9.31 g/dL in the luspatercept arm and 9.15 g/dL in the placebo arm. The median RBC transfusion burden was 6.12 units/12 weeks and 6.27 units/12 weeks, respectively.
Other baseline characteristics were similar as well.
Efficacy
“[L]uspatercept showed a statistically significant improvement in the primary endpoint,” Dr. Cappellini noted.
The primary endpoint was at least a 33% reduction in transfusion burden—of at least two RBC units—from week 13 to week 24, as compared to the 12-week baseline period.
This endpoint was achieved by 21.4% (n=48) of patients in the luspatercept arm and 4.5% (n=5) in the placebo arm (odds ratio=5.79; P<0.0001).
“Statistical significance was also demonstrated with luspatercept versus placebo for all the key secondary endpoints,” Dr. Cappellini said.
There were more patients in the luspatercept arm than the placebo arm who achieved at least a 33% reduction in transfusion burden from week 37 to 48—19.6% and 3.6%, respectively (P<0.0001).
Similarly, there were more patients in the luspatercept arm than the placebo arm who achieved at least a 50% reduction in transfusion burden from week 13 to 24—7.6% and 1.8%, respectively (P=0.0303)—and from week 37 to 48—10.3% and 0.9%, respectively (P=0.0017).
During any 12-week interval, 70.5% of luspatercept-treated patients and 29.5% of placebo-treated patients achieved at least a 33% reduction in transfusion burden (P<0.0001), and 40.2% and 6.3%, respectively (P<0.0001), achieved at least a 50% reduction in transfusion burden.
During any 24-week interval, 41.1% of luspatercept-treated patients and 2.7% of placebo-treated patients achieved at least a 33% reduction in transfusion burden (P<0.0001), and 16.5% and 0.9%, respectively (P<0.0001), achieved at least a 50% reduction in transfusion burden.
Safety
Ninety-six percent of patients in the luspatercept arm and 92.7% in the placebo arm had at least one treatment-emergent adverse event (TEAE).
Grade 3 or higher TEAEs occurred in 29.1% of patients in the luspatercept arm and 15.6% of those in the placebo arm. Serious TEAEs occurred in 15.2% and 5.5%, respectively.
One patient in the placebo arm had a TEAE-related death (acute cholecystitis), but there were no treatment-related deaths in the luspatercept arm.
TEAEs leading to treatment discontinuation occurred in 5.4% of luspatercept-treated patients and 0.9% of placebo-treated patients.
TEAEs that occurred more frequently in the luspatercept arm than in the placebo arm (respectively) included bone pain (19.7% and 8.3%), arthralgia (19.3% and 11.9%), and dizziness (11.2% and 4.6%).
Grade 3/4 TEAEs (in the luspatercept and placebo arms, respectively) included anemia (3.1% and 0%), increased liver iron concentration (2.7% and 0.9%), hyperuricemia (2.7% and 0%), hypertension (1.8% and 0%), syncope (1.8% and 0%), back pain (1.3% and 0.9%), bone pain (1.3% and 0%), blood uric acid increase (1.3% and 0%), increased aspartate aminotransferase (1.3% and 0%), increased alanine aminotransferase (0.9% and 2.8%), and thromboembolic events (0.9% and 0%).
Dr. Cappellini noted that thromboembolic events occurred in eight luspatercept-treated patients and one placebo-treated patient. In all cases, the patients had multiple risk factors for thrombosis.
This study was sponsored by Celgene Corporation and Acceleron Pharma. Dr. Cappellini reported relationships with Novartis, Celgene, Sanofi-Genzyme, and Vifor.
CHMP backs dasatinib for kids with newly diagnosed ALL
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for dasatinib (Sprycel).
The CHMP’s recommendation is to approve dasatinib in combination with chemotherapy to treat pediatric patients with newly diagnosed, Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
The CHMP’s recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.
The EC usually makes a decision within 67 days of a CHMP recommendation.
Dasatinib is already EC-approved to treat:
- Adults with newly diagnosed, Ph+ chronic myelogenous leukemia (CML) in the chronic phase
- Adults with chronic, accelerated, or blast phase CML with resistance or intolerance to prior therapy including imatinib
- Adults with Ph+ ALL and lymphoid blast CML with resistance or intolerance to prior therapy
- Pediatric patients with newly diagnosed, Ph+ CML in chronic phase
- Pediatric patients with Ph+ CML in chronic phase that is resistant or intolerant to prior therapy including imatinib.
Phase 2 trial
The CHMP’s recommendation to approve dasatinib in pediatric patients with newly diagnosed, Ph+ ALL is based on data from a phase 2 trial (NCT01460160). In this trial, researchers are evaluating dasatinib in combination with a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone.
Results from the trial were presented at the 2017 ASH Annual Meeting.
At that time, 106 patients had been treated. They received continuous daily dasatinib (60 mg/m2) beginning at day 15 of induction chemotherapy. All treated patients achieved complete remission.
Patients who had evidence of minimal residual disease (MRD) ≥ 0.05% at the end of the first block of treatment (day 78) and those with MRD 0.005% to 0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks were eligible for hematopoietic stem cell transplant (HSCT) in first remission.
Nineteen patients met these criteria, and 15 (14.2%) received HSCT. The remaining 85.8% of patients received dasatinib plus chemotherapy for two years.
The 3-year event-free survival rate was 65.5%, and the 3-year overall survival rate was 91.5%.
Two patients discontinued dasatinib due to toxicity—one due to allergy and one due to prolonged thrombocytopenia.
Grade 3/4 adverse events attributed to dasatinib included elevated alanine aminotransferase (21.7%), elevated aspartate transaminase (10.4%), pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%), and cardiac failure (0.8%).
Five patients died while receiving chemotherapy (three from sepsis, one due to pneumonia, and one of an unknown cause). Two deaths were HSCT-related.
This trial was sponsored by Bristol-Myers Squibb.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for dasatinib (Sprycel).
The CHMP’s recommendation is to approve dasatinib in combination with chemotherapy to treat pediatric patients with newly diagnosed, Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
The CHMP’s recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.
The EC usually makes a decision within 67 days of a CHMP recommendation.
Dasatinib is already EC-approved to treat:
- Adults with newly diagnosed, Ph+ chronic myelogenous leukemia (CML) in the chronic phase
- Adults with chronic, accelerated, or blast phase CML with resistance or intolerance to prior therapy including imatinib
- Adults with Ph+ ALL and lymphoid blast CML with resistance or intolerance to prior therapy
- Pediatric patients with newly diagnosed, Ph+ CML in chronic phase
- Pediatric patients with Ph+ CML in chronic phase that is resistant or intolerant to prior therapy including imatinib.
Phase 2 trial
The CHMP’s recommendation to approve dasatinib in pediatric patients with newly diagnosed, Ph+ ALL is based on data from a phase 2 trial (NCT01460160). In this trial, researchers are evaluating dasatinib in combination with a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone.
Results from the trial were presented at the 2017 ASH Annual Meeting.
At that time, 106 patients had been treated. They received continuous daily dasatinib (60 mg/m2) beginning at day 15 of induction chemotherapy. All treated patients achieved complete remission.
Patients who had evidence of minimal residual disease (MRD) ≥ 0.05% at the end of the first block of treatment (day 78) and those with MRD 0.005% to 0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks were eligible for hematopoietic stem cell transplant (HSCT) in first remission.
Nineteen patients met these criteria, and 15 (14.2%) received HSCT. The remaining 85.8% of patients received dasatinib plus chemotherapy for two years.
The 3-year event-free survival rate was 65.5%, and the 3-year overall survival rate was 91.5%.
Two patients discontinued dasatinib due to toxicity—one due to allergy and one due to prolonged thrombocytopenia.
Grade 3/4 adverse events attributed to dasatinib included elevated alanine aminotransferase (21.7%), elevated aspartate transaminase (10.4%), pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%), and cardiac failure (0.8%).
Five patients died while receiving chemotherapy (three from sepsis, one due to pneumonia, and one of an unknown cause). Two deaths were HSCT-related.
This trial was sponsored by Bristol-Myers Squibb.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for dasatinib (Sprycel).
The CHMP’s recommendation is to approve dasatinib in combination with chemotherapy to treat pediatric patients with newly diagnosed, Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
The CHMP’s recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.
The EC usually makes a decision within 67 days of a CHMP recommendation.
Dasatinib is already EC-approved to treat:
- Adults with newly diagnosed, Ph+ chronic myelogenous leukemia (CML) in the chronic phase
- Adults with chronic, accelerated, or blast phase CML with resistance or intolerance to prior therapy including imatinib
- Adults with Ph+ ALL and lymphoid blast CML with resistance or intolerance to prior therapy
- Pediatric patients with newly diagnosed, Ph+ CML in chronic phase
- Pediatric patients with Ph+ CML in chronic phase that is resistant or intolerant to prior therapy including imatinib.
Phase 2 trial
The CHMP’s recommendation to approve dasatinib in pediatric patients with newly diagnosed, Ph+ ALL is based on data from a phase 2 trial (NCT01460160). In this trial, researchers are evaluating dasatinib in combination with a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone.
Results from the trial were presented at the 2017 ASH Annual Meeting.
At that time, 106 patients had been treated. They received continuous daily dasatinib (60 mg/m2) beginning at day 15 of induction chemotherapy. All treated patients achieved complete remission.
Patients who had evidence of minimal residual disease (MRD) ≥ 0.05% at the end of the first block of treatment (day 78) and those with MRD 0.005% to 0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks were eligible for hematopoietic stem cell transplant (HSCT) in first remission.
Nineteen patients met these criteria, and 15 (14.2%) received HSCT. The remaining 85.8% of patients received dasatinib plus chemotherapy for two years.
The 3-year event-free survival rate was 65.5%, and the 3-year overall survival rate was 91.5%.
Two patients discontinued dasatinib due to toxicity—one due to allergy and one due to prolonged thrombocytopenia.
Grade 3/4 adverse events attributed to dasatinib included elevated alanine aminotransferase (21.7%), elevated aspartate transaminase (10.4%), pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%), and cardiac failure (0.8%).
Five patients died while receiving chemotherapy (three from sepsis, one due to pneumonia, and one of an unknown cause). Two deaths were HSCT-related.
This trial was sponsored by Bristol-Myers Squibb.
Food allergies linked to increased MS relapses, lesions
Patients with multiple sclerosis (MS) and food allergies had more relapses and gadolinium-enhancing lesions than patients with MS but no food allergies, according to a recent analysis of a longitudinal study.
Patients with food allergies had a 1.3-times higher rate for cumulative number of attacks and a 2.5-times higher likelihood of enhancing lesions on brain MRI in the analysis of patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB).
By contrast, there were no significant differences in relapse or lesion rates for patients with environmental or drug allergies when compared with those without allergies, reported Tanuja Chitnis, MD, of Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, Boston, and her coinvestigators.
“Our findings suggest that MS patients with allergies have more active disease than those without allergies, and that this effect is driven by food allergies,” Dr. Tanuja and her coauthors wrote in their report, which appeared in the Journal of Neurology, Neurosurgery and Psychiatry.
Previous investigations have looked at whether allergy history increases risk of developing MS, with conflicting results, they added, noting a meta-analysis of 10 observational studies suggesting no such link.
By contrast, whether allergies lead to more or less intense MS activity has not been addressed, according to investigators, who said this is the first study tying allergy history to MS disease course using clinical and MRI variables.
Their study was based on a subset of 1,349 patients with a diagnosis of MS who were enrolled in CLIMB and completed a self-administered questionnaire on food, environmental, and drug allergies. Of those patients, 922 reported allergies, while 427 reported no known allergies.
Patients with food allergies had a significantly increased rate of cumulative number of attacks, compared with those with no allergies, according to investigators, even after adjusting the analysis for gender, age at symptom onset, disease category, and time on treatment (relapse rate ratio, 1.274; 95% confidence interval, 1.023-1.587; P = .0305).
Food allergy patients were more than twice as likely as no-allergy patients were to have gadolinium-enhancing lesions on brain MRI after adjusting for other covariates (odds ratio, 2.53; 95% CI, 1.25-5.11; P = .0096), they added.
Patients with environmental and drug allergies also appeared to have more relapses, compared with patients with no allergies, in univariate analysis, but the differences were not significant in the adjusted analysis, investigators said. Likewise, there were trends toward a link between number of lesions and presence of environmental or drug allergies that did not hold up on multivariate analysis.
It is unknown what underlying biological mechanisms might potentially link food allergies to MS disease severity; however, findings of experimental studies support the hypothesis that gut microbiota might affect the risk and course of MS, Dr. Chitnis and her coauthors wrote in their report.
The CLIMB study was supported by Merck Serono and the National MS Society Nancy Davis Center Without Walls. Dr. Chitnis reported consulting fees from Biogen Idec, Novartis, Sanofi, Bayer, and Celgene outside the submitted work. Coauthors provided additional disclosures related to Merck Serono, Genentech, Verily Life Sciences, EMD Serono, Biogen, Teva, Sanofi, and Novartis, among others.
SOURCE: Fakih R et al. J Neurol Neurosurg Psychiatry. 2018 Dec 18. doi: 10.1136/jnnp-2018-319301.
Patients with multiple sclerosis (MS) and food allergies had more relapses and gadolinium-enhancing lesions than patients with MS but no food allergies, according to a recent analysis of a longitudinal study.
Patients with food allergies had a 1.3-times higher rate for cumulative number of attacks and a 2.5-times higher likelihood of enhancing lesions on brain MRI in the analysis of patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB).
By contrast, there were no significant differences in relapse or lesion rates for patients with environmental or drug allergies when compared with those without allergies, reported Tanuja Chitnis, MD, of Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, Boston, and her coinvestigators.
“Our findings suggest that MS patients with allergies have more active disease than those without allergies, and that this effect is driven by food allergies,” Dr. Tanuja and her coauthors wrote in their report, which appeared in the Journal of Neurology, Neurosurgery and Psychiatry.
Previous investigations have looked at whether allergy history increases risk of developing MS, with conflicting results, they added, noting a meta-analysis of 10 observational studies suggesting no such link.
By contrast, whether allergies lead to more or less intense MS activity has not been addressed, according to investigators, who said this is the first study tying allergy history to MS disease course using clinical and MRI variables.
Their study was based on a subset of 1,349 patients with a diagnosis of MS who were enrolled in CLIMB and completed a self-administered questionnaire on food, environmental, and drug allergies. Of those patients, 922 reported allergies, while 427 reported no known allergies.
Patients with food allergies had a significantly increased rate of cumulative number of attacks, compared with those with no allergies, according to investigators, even after adjusting the analysis for gender, age at symptom onset, disease category, and time on treatment (relapse rate ratio, 1.274; 95% confidence interval, 1.023-1.587; P = .0305).
Food allergy patients were more than twice as likely as no-allergy patients were to have gadolinium-enhancing lesions on brain MRI after adjusting for other covariates (odds ratio, 2.53; 95% CI, 1.25-5.11; P = .0096), they added.
Patients with environmental and drug allergies also appeared to have more relapses, compared with patients with no allergies, in univariate analysis, but the differences were not significant in the adjusted analysis, investigators said. Likewise, there were trends toward a link between number of lesions and presence of environmental or drug allergies that did not hold up on multivariate analysis.
It is unknown what underlying biological mechanisms might potentially link food allergies to MS disease severity; however, findings of experimental studies support the hypothesis that gut microbiota might affect the risk and course of MS, Dr. Chitnis and her coauthors wrote in their report.
The CLIMB study was supported by Merck Serono and the National MS Society Nancy Davis Center Without Walls. Dr. Chitnis reported consulting fees from Biogen Idec, Novartis, Sanofi, Bayer, and Celgene outside the submitted work. Coauthors provided additional disclosures related to Merck Serono, Genentech, Verily Life Sciences, EMD Serono, Biogen, Teva, Sanofi, and Novartis, among others.
SOURCE: Fakih R et al. J Neurol Neurosurg Psychiatry. 2018 Dec 18. doi: 10.1136/jnnp-2018-319301.
Patients with multiple sclerosis (MS) and food allergies had more relapses and gadolinium-enhancing lesions than patients with MS but no food allergies, according to a recent analysis of a longitudinal study.
Patients with food allergies had a 1.3-times higher rate for cumulative number of attacks and a 2.5-times higher likelihood of enhancing lesions on brain MRI in the analysis of patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB).
By contrast, there were no significant differences in relapse or lesion rates for patients with environmental or drug allergies when compared with those without allergies, reported Tanuja Chitnis, MD, of Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, Boston, and her coinvestigators.
“Our findings suggest that MS patients with allergies have more active disease than those without allergies, and that this effect is driven by food allergies,” Dr. Tanuja and her coauthors wrote in their report, which appeared in the Journal of Neurology, Neurosurgery and Psychiatry.
Previous investigations have looked at whether allergy history increases risk of developing MS, with conflicting results, they added, noting a meta-analysis of 10 observational studies suggesting no such link.
By contrast, whether allergies lead to more or less intense MS activity has not been addressed, according to investigators, who said this is the first study tying allergy history to MS disease course using clinical and MRI variables.
Their study was based on a subset of 1,349 patients with a diagnosis of MS who were enrolled in CLIMB and completed a self-administered questionnaire on food, environmental, and drug allergies. Of those patients, 922 reported allergies, while 427 reported no known allergies.
Patients with food allergies had a significantly increased rate of cumulative number of attacks, compared with those with no allergies, according to investigators, even after adjusting the analysis for gender, age at symptom onset, disease category, and time on treatment (relapse rate ratio, 1.274; 95% confidence interval, 1.023-1.587; P = .0305).
Food allergy patients were more than twice as likely as no-allergy patients were to have gadolinium-enhancing lesions on brain MRI after adjusting for other covariates (odds ratio, 2.53; 95% CI, 1.25-5.11; P = .0096), they added.
Patients with environmental and drug allergies also appeared to have more relapses, compared with patients with no allergies, in univariate analysis, but the differences were not significant in the adjusted analysis, investigators said. Likewise, there were trends toward a link between number of lesions and presence of environmental or drug allergies that did not hold up on multivariate analysis.
It is unknown what underlying biological mechanisms might potentially link food allergies to MS disease severity; however, findings of experimental studies support the hypothesis that gut microbiota might affect the risk and course of MS, Dr. Chitnis and her coauthors wrote in their report.
The CLIMB study was supported by Merck Serono and the National MS Society Nancy Davis Center Without Walls. Dr. Chitnis reported consulting fees from Biogen Idec, Novartis, Sanofi, Bayer, and Celgene outside the submitted work. Coauthors provided additional disclosures related to Merck Serono, Genentech, Verily Life Sciences, EMD Serono, Biogen, Teva, Sanofi, and Novartis, among others.
SOURCE: Fakih R et al. J Neurol Neurosurg Psychiatry. 2018 Dec 18. doi: 10.1136/jnnp-2018-319301.
FROM THE JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY
Clinical trial: The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
Massive Rotator Cuff Tears in Patients Older Than Sixty-five: Indications for Cuff Repair versus Reverse Total Shoulder Arthroplasty
ABSTRACT
The decision to perform rotator cuff repair (RCR) versus reverse total shoulder arthroplasty (rTSA) for massive rotator cuff tear (MCT) without arthritis can be difficult. Our aim was to identify preoperative variables that are influential in a surgeon's decision to choose one of the two procedures and evaluate outcomes.
We retrospectively reviewed 181 patients older than 65 who underwent RCR or rTSA for MCT without arthritis. Clinical and radiographic data were collected and used to evaluate the preoperative variables in each of these two patient populations and assess outcomes.
Ninety-five shoulders underwent RCR and 92 underwent rTSA with an average followup of 44 and 47 months, respectively. Patients selected for RCR had greater preoperative flexion (113 vs 57), abduction (97 vs 53), and external rotation (42 vs 32), higher SST (3.1 vs 1.9) and ASES scores (43.8 vs 38.6), and were less likely to have had previous cuff surgery (6.3% vs 35.9%). Patients selected for rTSA had a smaller acromiohumeral interval (4.8 vs 8.7) and more superior subluxation (50.6% vs 14.1%). Similar preoperative characteristics included pain, comorbidities, and BMI. Patients were satisfied in both groups and had significant improvement in motion and function postoperatively.
Both RCR and rTSA can result in significant functional improvement and patient satisfaction in the setting of MCT without arthritis in patients older than 65. At our institution, patients who underwent rTSA had less pre-operative motion, lower function, more evidence of superior migration, and were more likely to have had previous rotator cuff surgery.
Continue to: The treatment of patients...
The treatment of patients with massive rotator cuff tears (MCTs) without osteoarthritis is challenging. This population is of considerable interest, as the prevalence of MCT has been reported to be as high as 40% of all rotator cuff tears.1Options for surgical treatment in patients who have failed conservative management are numerous and include tendon debridement, partial or complete arthroscopic or open rotator cuff repair (RCR), tendon transfers, reverse total shoulder arthroplasty (rTSA), arthroscopic superior capsular reconstruction (ASCR), and other grafting procedures.2 Arthroscopic superior capsular reconstruction shows promise as a novel technique, but it is not yet well studied. Other procedures such as tendon transfers fit into the treatment algorithm for only a small subset of patients. Open rotator cuff repair and rTSA are the 2 most commonly utilized procedures for MCT, and both have been shown to reliably achieve significant functional improvement and patient satisfaction.3–6
The dilemma for the treating surgeon is deciding which patients to treat with RCR and who to treat with rTSA. Predicting which surgical procedure will provide a better functional result is difficult and controversial.7 The RCR method is a bone-conserving procedure with relatively low surgical risk and allows the option for rTSA to be performed as a salvage surgery should repair fail. It also may be less costly in the appropriate population.8 However, large rotator cuff tears in elderly patients have low healing potential, and the prospect of participating in a lengthy rehabilitation after an operation that may not prove successful can be deterring.9,10 In the elderly population, rTSA may be a reliable option, as tendon healing of the cuff is not necessary to restore function. However, rTSA does not conserve bone, provides a non-anatomic solution, and has had historically high complication rates.4,5
In an effort to aid in the decision-making process when considering these 2 surgical options, we compared RCR and rTSA performed at a single institution for MCT in patients >65 years. Our aim was to identify preoperative patient variables that influence a surgeon’s decision to proceed with 1 of the 2 procedures. Moreover, we evaluated clinical outcomes in these 2 patient populations. We hypothesized that (1) patients selected for rTSA would have worse preoperative function, less range of motion, more comorbidities, more evidence of radiographic subluxation, and a higher likelihood of having undergone previous RCR than those selected for RCR, and (2) both RCR and rTSA would be successful and result in improved clinical outcomes with high patient satisfaction.
MATERIALS AND METHODS
PATIENT SELECTION
We performed a retrospective chart review using our practice database of all patients undergoing arthroscopic RCR and rTSA for any indication by the senior author (M.A.F.) between January 2004 and April 2015. A total of 1503 RCRs and 1973 rTSAs were conducted during the study period. Patient medical records were reviewed, and those meeting the following criteria were included in the study: >65 years at the time of surgery, MCT, no preoperative glenohumeral arthritis, minimum follow-up of 12 months, functional deltoid muscle on physical examination, and no prior shoulder surgery except for RCR or diagnostic arthroscopy. A total of 92 patients who underwent arthroscopic RCR and 89 patients who underwent rTSA met the inclusion criteria. For patients with bilateral shoulder surgery, we measured each shoulder independently. Three patients underwent bilateral rTSA, and 3 patients underwent bilateral RCR, leaving 95 shoulders in the RCR group and 92 in the rTSA group. The Western Institutional Review Board determined this study to be exempt from review.
RADIOGRAPHIC EVALUATION
All patient charts included a radiology report and documented interpretation of the images by the treating surgeon prior to surgery. Radiographs were assessed to assure the absence of preoperative glenohumeral osteoarthritis. The images were also graded based on the Hamada classification.11 Stage 1 is associated with minimal radiographic change with an acromiohumeral interval (AHI) >6 mm; stage 2 is characterized by narrowing of the AHI <6 mm; and Stage 3 is defined by narrowing of the AHI with radiographic changes of the acromion. Stages 4 and higher include arthritic changes to the glenohumeral joint, and they were not included in the study population. The AHI measurements and the presence or absence of glenohumeral subluxation were documented.
Continue to: MASSIVE CUFF TEAR DETERMINATION...
MASSIVE CUFF TEAR DETERMINATION
We defined MCT on the basis of previously described criteria of tears involving ≥2 tendons or tears measuring ≥5 cm in greatest dimension.12,13 Patient charts were screened, and those whose clinical notes or radiology reports indicated an absence of MCT were excluded. Preoperative imaging of the remaining patients was then evaluated by 3 fellowship-trained shoulder surgeons to confirm MCT in all patients with a clinically documented MCT, as well as to assess those who had insufficient documentation of tear size in the notes.
Advanced imaging was evaluated for fatty atrophy of the rotator cuff musculature, and Goutallier classification was assigned.14,15 Length of retraction was measured from the tendon end to the medial aspect of the footprint on coronal imaging, and the subscapularis and teres minor were assessed and documented as torn or intact.16,17
DATA COLLECTION
We reviewed clinical charts and patient questionnaire forms from both the preoperative and follow-up visits. Clinical data collected included gender, age at surgery, active range of motion (forward elevation, abduction, external rotation, and internal rotation), comorbidities, smoking status, BMI, history of shoulder surgery, and any postoperative complications or need for secondary surgery. All patients completed patient-centered questionnaires regarding shoulder pain and dysfunction at each visit or via telephone communication with clinic staff. Outcome measurements used for analysis included American Shoulder and Elbow Surgeons (ASES) Score, simple shoulder test (SST), visual analog score (VAS) pain scale, and patient-reported satisfaction (Graded 1-10; 1 = poor outcome; 4 = satisfactory outcome; 7 = good outcome; 10 = excellent outcome).
DATA ANALYSIS AND STATISTICAL METHODS
Statistical tests were selected based on the result of Shapiro–Wilk test for normality. Continuous variables were evaluated with either independent t test or Mann–Whitney U test. Dependent t test was used to evaluate outcome variables. For categorical variables, either Pearson’s χ2or Fisher’s exact test was performed depending on the sample size. Alpha was set at P =.05.
Continue to: RESULTS...
RESULTS
PREOPERATIVE CHARACTERISTICS
Of the 187 shoulders in the study group, 95 had RCR and 92 had rTSA. Demographic information and preoperative variables for both groups are summarized in Table 1 and Table 2. Patients in the RCR group had greater preoperative forward elevation, abduction, and external rotation and higher preoperative functional scores than those in the rTSA group. Patients in the rTSA group were older and more likely to be female than those in the RCR group. More patients in the rTSA group had undergone prior RCR compared with those in the RCR group. Each of these differences was statistically significant. Subjective pain scores, BMI, and comorbidities were similar between the 2 groups.
Table 1. Patient demographics
| RCR | rTSA | P value |
Age (yr; mean ± SD) | 71 ± 5 | 74 ± 6 | <.0001 |
Gender *male (no.; %) *female (no.; %) | 57 (60%) 38 (40%) | 30 (33%) 62 (67%) | <.0001 |
BMI (mean ± SD) | 28.5 ± 4.4 | 28.1 ± 4.5 | .578 |
Abbreviations: BMI, body mass index; RCR, rotator cuff repair; rTSA, reverse total shoulder arthroplasty.
Table 2. Preoperative variables
| RCR (n=95) | rTSA (n=92) | P value |
Radiographic parameters | |||
AB interval | 9 ± 3 | 5 ± 3 | <.0001 |
Humeral escape | 14.1% | 50.6% | <.0001 |
Hamada 1 | 76.1% | 15.6% | <.0001 |
Hamada 2 | 13.0% | 50.6% | |
Hamada 3 | 10.9% | 33.8% | |
Goutallier grade 1 | 7.8% | 19.3% | .227 |
Goutallier grade 2 | 66.7% | 52.6% | |
Goutallier grade 3 | 21.6% | 19.3% | |
Goutallier grade 4 | 3.9% | 8.8% | |
Clinical measures | |||
Preop FE | 113 ± 50 | 57 ± 34 | <.0001 |
Preop AB | 97 ± 45 | 53 ± 35 | <.0001 |
Preop ER | 42 ± 25 | 32 ± 28 | .029 |
Preop IR | 2.9 ± 1.6 | 2.6 ± 1.8 | .247 |
Preop pain | 5.7 ± 2.3 | 5.6 ± 2.5 | .927 |
Preop ASES | 44 ± 17 | 39 ± 16 | .04 |
Preop SST | 3.1 ± 2.6 | 1.9 ± 1.7 | .001 |
Patients parameters | |||
Previous cuff surgery | 6.3% | 35.9% | <.0001 |
Comorbidity count | 1.7 ± 1.4 | 2.1 ± 2.7 | .126 |
Abbreviations: AB, abduction; ASES, American Shoulder and Elbow Society score; ER, external rotation; FE, forward elevation; IR, internal rotation; preop, preoperative; SST, simple shoulder test.
Radiographically, patients selected to undergo rTSA had a smaller AHI (4.8 vs 8.7, P < .0001) and more evidence of superior subluxation (50.6% vs 14.1%, P < .0001) than those in the RCR group. Average Hamada grade was 1.4 ± 0.7 and 2.2 ± 0.7 for the RCR and rTSA groups, respectively (P < .0001). Average Goutallier grade was similar between the groups (2.2 ± 0.6 for RCR vs 2.2 ± 0.8 for rTSA, P =.227), and 25.5% of the RCR group had Grade 3 or 4 atrophy compared with 28.1% of the rTSA group.
POSTOPERATIVE OUTCOMES
The average follow-up time was 44 months for RCR and 47 months for rTSA. Patients in the RCR and rTSA groups were highly satisfied with the surgery (8.5 ± 2.6 vs 8.2 ± 2.6, P = .461) and had significantly increased range of motion in all planes and improved functional scores (Table 3). The rTSA group had greater net improvement in forward elevation, abduction, and external rotation than the RCR group. Both groups demonstrated similar improvement in ASES, SST, and VAS pain scores.
Table 3. Postoperative outcomes
| RCR (n=95) | P value | rTSA (n=92) | P value | ||
Preoperative | Postoperative | Preoperative | Postoperative | |||
FE | 113 ± 50 | 166 ± 26 | <.0001 | 57 ± 34 | 136 ± 46 | <.0001 |
AB | 97 ± 45 | 155 ± 37 | <.0001 | 53 ± 35 | 129 ± 44 | <.0001 |
ER | 42 ± 25 | 48 ± 20 | .033 | 32 ± 28 | 57 ± 32 | <.0001 |
IR | 2.9 ± 1.6 | 4.6 ± 1.6 | <.0001 | 2.6 ± 1.8 | 4.7 ± 2.4 | <.0001 |
VAS pain | 5.7 ± 2.3 | 1.7 ± 2.4 | <.0001 | 5.6 ± 2.5 | 1.6 ± 2.5 | <.0001 |
ASES | 44 ± 17 | 83 ± 18 | <.0001 | 39 ± 16 | 77 ± 22 | <.0001 |
SST | 3.1 ± 2.6 | 9.3 ± 2.9 | <.0001 | 1.9 ± 1.7 | 7.1 ± 3.4 | <.0001 |
Abbreviations: AB, abduction; ASES, American Shoulder and Elbow Society score; ER, external rotation; FE, forward elevation; IR, internal rotation; SST, simple shoulder test; VAS – visual analog score.
In the RCR group, 5 patients (5.3%) required reoperation: 3 patients underwent conversion to rTSA, 1 patient underwent biceps tenotomy with subacromial decompression, and 1 patient underwent arthroscopic irrigation and debridement for a postoperative Propionibacterium acnes infection. In the rTSA group, 2 patients (2.2%) required reoperation: 1 patient underwent open reduction internal fixation for a scapula fracture that failed conservative management, and 1 patient had an open irrigation and debridement with polyethylene exchange for an acute postoperative infection of unknown source.
DISCUSSION
Massive, retracted rotator cuff tears are a common and difficult problem.1 The treatment options are numerous and depend on a variety of preoperative factors including patient-specific characteristics and factors specific to the tear. For certain patients, nonoperative management may be a reasonable first step, as an MCT does not necessarily preclude painless, functional shoulder motion. Elderly, lower demand individuals have been shown to do well with physical rehabilitation.18 Similarly, for the same category of elderly patients who do not respond to conservative measures, arthroscopic tendon debridement with or without subacromial decompression and/or biceps tenotomy may be effective.1,19 This technique has been described as “limited goals surgery;” despite some mixed results in the literature, multiple studies have reported symptomatic and functional improvement after simple debridement.2,19–21The consensus among several authors has been that this procedure continues to play a role for elderly, low-demand patients whose functional goals are limited and whose primary complaint is pain.1,2,20
For the majority of patients with MCT who desire pain relief and a restoration of shoulder function, RCR remains the gold standard of treatment and should be the primary aim if feasible. Complete RCR has consistently outperformed both partial repair and debridement in multiple studies in terms of pain relief and functional improvement.10,21,22However, elderly patients with chronic, massive tears, particularly in the setting of muscle atrophy, are at high risk of failure with attempted cuff repair.9,23 Novel techniques such as superior capsular reconstruction and subacromial balloon spacer implantation may offer a minimally invasive method of re-centering the humeral head and stabilizing the glenohumeral joint; however, these new treatment options lack any long-term data in the literature to support their widespread use.24–26 Alternatively, rTSA has been shown to be a reliable option to restore shoulder function in the setting of a massive irreparable rotator cuff tear, even in the absence of arthritis.5,27-31
Continue to: The decision-making process...
The decision-making process for selecting RCR or rTSA in the setting of MCT without arthritis in the older population (age >65 years) remains challenging. We attempted to quantify the data of a high-volume surgeon and identify the differences and similarities between those patients selected for either procedure. At our institution, we generally performed rTSA on patients with low preoperative range of motion, poor function based on SST and ASES scores, small AHI, and strong evidence of superior subluxation. We were also more likely to perform rTSA if the patient had a history of rotator cuff surgery. There was a predilection for older age and female gender in those who underwent rTSA.
For our study, we elected to focus on patients >65 years. In our experience, the choice of which surgical procedure to perform is generally easier in younger patients. Most surgeons appropriately opt for an arthroscopic procedure or tendon transfer to preserve bone and maintain the option of rTSA as a salvage procedure if necessary in the future. Studies have reported that <60 years is a predictor of poor outcome with rTSA, and patients <65 years who undergo rTSA have been shown to have high complication rates.30-32 Furthermore, the longevity of the implant in young patients is a significant concern, and revision surgery after rTSA is technically demanding and known to result in poor functional outcomes.32,33
Although the indications for rTSA are expanding, attempts at RCR in the setting of MCT remain largely appropriate. Preserved preoperative anterior elevation >90° has been associated with loss of motion after rTSA and poor satisfaction, and one should exercise caution when considering rTSA in this setting.3 The current study confirmed that even older patients with MCT may be very satisfied with arthroscopic RCR (Figure 1). Both range of motion and function significantly improved, and patients were largely satisfied with the procedure with an average self-reported outcome of good to excellent. At the time of final follow-up for this study, only 3 shoulders in the RCR group had undergone conversion to rTSA. This number may be expected to rise with long follow-up periods, and we feel that prolonging the time before arthroplasty is generally in the best interest of the patient.
Our results were consistent with several reported studies in which RCR has been shown to be successful in the setting of MCT.34–37 Henry and colleagues36 performed a systematic review that evaluated 954 patients who underwent partial or complete anatomic RCR for MCT. Although the average age was 63 years (range, 37–87), functional outcome scores, VAS pain score, and overall range of motion consistently and significantly improved.
rTSA may be a “more reliable” option than RCR in treating MCT in the older population because it does not rely on tendon healing. However, the relationship between tendon healing and clinical outcomes after RCR is unclear. The aforementioned systematic review reported re-tear rates to be as high as 79%, but several studies have reported high satisfaction even in the setting of retear.36 Yoo and colleagues38 and Chung and colleagues9 reported re-tear rates of 45.5% and 39.8%, respectively, but both studies noted that there was no difference in outcome measures between those patients with and without re-tears. In particular, for patients who have had no prior rotator cuff surgery, an attempt at arthroscopic repair may be a prudent option with relatively low risk.
Although certain patients may clinically improve despite suffering a re-tear (or inability to heal in the first place), others continue to experience pain and dysfunction that negatively affect their quality of life.39–41 These patients are more often appropriate candidates for rTSA. Indeed, several studies have demonstrated a higher re-tear rate in patients with a history of surgery than in those without.23,31,38,42 Shamsudin and colleagues43 found revision arthroscopic RCR, even in a younger age group with tears of all sizes, to be twice as likely to re-tear. Notably, re-tear after revision repair may be more likely to be symptomatic, as these re-tears are routinely associated with pain, stiffness, and loss of function. Even in the hands of experienced surgeons in a younger population, revision repair has only been able to reverse pseudoparalysis in 43% of patients, leading to only 39% return to sport or full activity.44 In examining our data, we were much less likely to perform an RCR in patients who had a history of cuff repair surgery than in those without this history.
Continue to: Overall, those patients selected for rTSA...
Overall, those patients selected for rTSA in our study population performed well postoperatively (Figure 2 and Figure 3). Vast improvements were noted in range of motion, function, and pain scores at final follow up. Moreover, no patients in the study group required revision arthroplasty during the follow-up period. Although the average follow-up period was only 47 months, these results suggested that elderly patients with MCT without arthritis may be particularly ideal candidates for rTSA with regard to implant survival and anticipated revision rate when chosen appropriately.
Several weaknesses were noted within this paper. First, the study was retrospective, precluding randomization of treatment groups and standardization of data collection and follow-up. The outcomes of RCR and rTSA could not be compared directly due to the inherent selection bias. The groups clearly differed in many respects, and these preoperative factors likely played a role in postoperative outcomes. However, the primary goal of this study was not to compare outcomes of the treatment groups but to analyze the patterns of patient selection by an experienced treating surgeon and contribute to published data that each surgery can be successful in this patient population when chosen appropriately.
Second, our data were based on a single surgeon’s decisions, and results may not be generalizable. Furthermore, the senior author has had a longstanding interest in reverse shoulder arthroplasty and has published data illustrating successful outcomes for rTSA in patients with MCT. For this reason, one could presume that there may have been some bias toward treating patients with rTSA. However, we feel that the senior author’s unique and longstanding experience in treating MCT allows for a thorough evaluation and comparison of preoperative variables and outcomes declared within this study. Indeed, many patients included in this study were referred from outside institutions specifically for rTSA but instead were deemed more appropriate candidates for RCR and underwent successful arthroscopic repair, a common scenario which served as an impetus for this study.
CONCLUSION
RCR and rTSA are both viable options for patients >65 years with MCT without arthritis. Treatment must be individualized for each patient with careful consideration of a number of preoperative variables and patient characteristics. At our institution, patients with previous RCR, decreased range of motion, poor function, and strong radiographic evidence of subluxation are more likely to undergo rTSA. When chosen appropriately, both RCR and rTSA can result in improved range of motion, function, and high patient satisfaction in this patient population.
- Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010;92:1894-1908. doi:10.2106/JBJS.I.01531.
- Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015;24:1493-1505. doi:10.1016/j.jse.2015.04.005.
- Boileau P, Gonzalez JF, Chuinard C, Bicknell R, Walch G. Reverse total shoulder arthroplasty after failed rotator cuff surgery. J Shoulder Elbow Surg. 2009;18:600-606. doi:10.1016/j.jse.2009.03.011.
- Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008;90:1244-1251. doi:10.2106/JBJS.G.00775.
- Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010;92:2544-2556.doi:10.2106/JBJS.I.00912.
- Wall B, Nove-Josserand L, O'Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007;89:1476-1485. doi:10.2106/JBJS.F.00666.
- Pill SG, Walch G, Hawkins RJ, Kissenberth MJ. The role of the biceps tendon in massive rotator cuff tears. Instr Course Lect. 2012;61:113-120.
- Makhni EC, Swart E, Steinhaus ME, Mather RC 3rd, Levine WN, Bach BR Jr et al. Cost-effectiveness of reverse total shoulder arthroplasty versus arthroscopic rotator cuff repair for symptomatic large and massive rotator cuff tears. Arthroscopy. 2016;32(9):1771-1780. doi:10.1016/j.arthro.2016.01.063.
- Chung SW, Kim JY, Kim MH, Kim SH, Oh JH. Arthroscopic repair of massive rotator cuff tears: outcome and analysis of factors associated with healing failure or poor postoperative function. Am J Sports Med. 2013;41:1674-1683. doi:10.1177/0363546513485719.
- Holtby R, Razmjou H. Relationship between clinical and surgical findings and reparability of large and massive rotator cuff tears: a longitudinal study. BMC Musculoskelet Disord. 2014;15:180. doi:10.1186/1471-2474-15-180.
- Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;254:92-96.
- DeOrio JK, Cofield RH. Results of a second attempt at surgical repair of a failed initial rotator-cuff repair. J Bone Joint Surg Am. 1984;66:563-567.
- Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000;82:505-515.
- Fuchs B, Weishaupt D, Zanetti M, Hodler J, Gerber C. Fatty degeneration of the muscles of the rotator cuff: assessment by computed tomography versus magnetic resonance imaging. J Shoulder Elbow Surg. 1999;8:599-605.
- Goutallier D, Bernageau J, Patte D. Assessment of the trophicity of the muscles of the ruptured rotator cuff by CT scan. In: Post M, Morrey B, Hawkins R, eds. Surgery of the Shoulder. St. Louis, MO: Mosby, 1990;11-13.
- Meyer DC, Farshad M, Amacker NA, Gerber C, Wieser K. Quantitative analysis of muscle and tendon retraction in chronic rotator cuff tears. Am J Sports Med. 2012;40(3):606-610.
- Meyer DC, Wieser K, Farshad M, Gerber C. Retraction of supraspinatus muscle and tendon as predictors of success of rotator cuff repair. Am J Sports Med. 2012;40:2242-2247.
- Williams GR Jr, Rockwood CA Jr, Bigliani LU, Ianotti JP, Stanwood W. Rotator cuff tears: why do we repair them? J Bone Joint Surg Am. 2004;86-A(12):2764-2776.
- Rockwood CA Jr, Williams GR Jr, Burkhead WZ Jr. Debridement of degenerative, irreparable lesions of the rotator cuff. J Bone Joint Surg Am. 1995;77:857-866.
- Berth A, Neumann W, Awiszus F, Pap G. Massive rotator cuff tears: functional outcome after debridement or arthroscopic partial repair. J Orthopaed Traumatol. 2010;11:13-20. doi 10.1007/s10195-010-0084-0.
- Heuberer PR, Kolblinger R, Buchleitner S, Pauzenberger L, Laky B, Auffarth A, et al. Arthroscopic management of massive rotator cuff tears: an evaluation of debridement, complete, and partial repair with and without force couple restoration. Knee Surg Sports Traumatol Arthrosc. 2016;24:3828-3837.
- Moser M, Jablonski MV, Horodyski M, Wright TW. Functional outcome of surgically treated massive rotator cuff tears: a comparison of complete repair, partial repair, and debridement. Orthopedics.2007;30(6):479-482.
- Rhee YG, Cho NS, Yoo JH. Clinical outcome and repair integrity after rotator cuff repair in patients older than 70 years versus patients younger than 70 years. Arthroscopy. 2014;30:546-554. doi:10.1016/j.arthro.2014.02.006.
- Denard PJ, Brady PC, Adams CR, Tokish JM, Burkhart SS. Preliminary results of arthroscopic superior capsule reconstruction with dermal allograft. Arthroscopy. 2018;34(1):93-99. doi: 10.1016/j.arthro.2017.08.265.
- Mihata T, Lee TQ, Watanabe C, Fukunishi K, Ohue M, Tsujimura T, Kinoshita M. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy.2013;29:459-70.
- Piekaar RSM, Bouman ICE, van Kampen PM, van Eijk F, Huijsmans PE. Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear. Musculoskelet Surg. 2018;102(3):247-255. doi: 10.1007/s12306-017-0525-5.
- Al-Hadithy N, Domos P, Sewell MD, Pandit R. Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. J Shoulder Elbow Surg. 2014;23:1662-1668. doi:10.1016/j.jse.2014.03.001.
- Boileau P, Watkinson DJ, Hatzidakis AM, Balg F. Grammont reverse prosthesis: design, rationale, and biomechanics. J Shoulder Elbow Surg. 2005;14:147S-161S. doi:10.1016/j.jse.2004.10.006.
- Grammont PM, Baulot E. Delta shoulder prosthesis for rotator cuff rupture. Orthopedics 1993;16:65-68. doi: 10.3928/0147-7447-19930101-11.
- Hartzler RU, Steen BM, Hussey MM, Cusick MC, Cottrell BJ, Clark RE, Frankle MA. Reverse shoulder arthroplasty for massive rotator cuff tear: risk factors for poor functional improvement. J Shoulder Elbow Surg. 2015;24:1698-1706. doi:10.1016/j.jse.2015.04.015.
- Kim HM, Caldwell JM, Buza JA, Fink LA, Ahmad CS, Bigliani LU, Levine WN. Factors affecting satisfaction and shoulder function in patients with a recurrent rotator cuff tear. J Bone Joint Surg Am. 2014;96:106-112. doi:10.2106/JBJS.L.01649.
- Ek ET, Neukom L, Catanzaro S, Gerber C. Reverse total shoulder arthroplasty for massive irreparable rotator cuff tears in patients younger than 65 years old: results after five to fifteen years. J Shoulder Elbow Surg. 2013;22:1199-1208. doi:10.1016/j.jse.2012.11.016.
- Sershon RA, Van Thiel GS, Lin EC, McGill KC, Cole BJ, Verma NN, et al. Clinical outcomes of reverse total shoulder arthroplasty in patients aged younger than 60 years. J Shoulder Elbow Surg.2014;23:395-400. doi:10.1016/j.jse.2013.07.047.
- Denard PJ, Ladermann A, Jiwani AZ, Burkhart SS. Functional outcome after arthroscopic repair of massive rotator cuff tears in individuals with pseudoparalysis. Arthroscopy. 2012;28:1214-1219. doi:10.1016/j.arthro.2012.02.026.
- Denard PJ, Ladermann A, Brady PC, Narbona P, Adams CR, Arrigoni P, et al. Pseudoparalysis from a massive rotator cuff tear is reliably reversed with an arthroscopic rotator cuff repair in patients without preoperative glenohumeral arthritis. Am J Sports Med. 2015;43:2373-2378. doi: 10.1177/0363546515597486.
- Henry P, Wasserstein D, Park S, Dwyer T, Chahal J, Slobogean G, Schemitsch E. Arthroscopic repair for chronic massive rotator cuff tears: a systematic review. Arthroscopy. 2015;31:2472-2480. doi:10.1016/j.arthro.2015.06.038.
- Oh JH, Kim SH, Shin SH, Chung SW, Kim JY, Kim SJ. Outcome of rotator cuff repair in large-to-massive tear with pseudoparalysis: a comparative study with propensity score matching. Am J Sports Med.2011;39:1413-1420.
- Yoo JC, Ahn JH, Koh KH, Lim KS. Rotator cuff integrity after arthroscopic repair for large tears with less-than-optimal footprint coverage. Arthroscopy. 2009;25:1093-1100. doi:10.1016/j.arthro.2009.07.010.
- Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000;82:304-314.
- Klepps S, Bishop J, Lin J, Cahlon O, Strauss A, Hayes P, Flatow EL Prospective evaluation of the effect of rotator cuff integrity on the outcome of open rotator cuff repairs. Am J Sports Med. 2004;32:1716-1722.
- Liu SH, Baker CL. Arthroscopically assisted rotator cuff repair: correlation of functional results with integrity of the cuff. Arthroscopy. 1994;10:54-60.
- Papadopoulos P, Karataglis D, Boutsiadis A, Fotiadou A, Christoforidis J, Christodoulou A. Functional outcome and structural integrity following mini-open repair of large and massive rotator cuff tears: a 3-5 year follow-up study. J Shoulder Elbow Surg. 2011;20:131-137. doi:10.1016/j.jse.2010.05.026.
- Shamsudin A, Lam PH, Peters K, Rubenis I, Hackett L, Murrell GA. Revision versus primary arthroscopic rotator cuff repair: a 2-year analysis of outcomes in 360 patients. Am J Sports Med.2015;43:557-564. doi:10.1177/0363546514560729.
- Ladermann A, Denard PJ, Burkhart SS. Midterm outcome of arthroscopic revision repair of massive and nonmassive rotator cuff tears. Arthroscopy. 2011;27:1620-1627. doi:10.1016/j.arthro.2011.08.290.
ABSTRACT
The decision to perform rotator cuff repair (RCR) versus reverse total shoulder arthroplasty (rTSA) for massive rotator cuff tear (MCT) without arthritis can be difficult. Our aim was to identify preoperative variables that are influential in a surgeon's decision to choose one of the two procedures and evaluate outcomes.
We retrospectively reviewed 181 patients older than 65 who underwent RCR or rTSA for MCT without arthritis. Clinical and radiographic data were collected and used to evaluate the preoperative variables in each of these two patient populations and assess outcomes.
Ninety-five shoulders underwent RCR and 92 underwent rTSA with an average followup of 44 and 47 months, respectively. Patients selected for RCR had greater preoperative flexion (113 vs 57), abduction (97 vs 53), and external rotation (42 vs 32), higher SST (3.1 vs 1.9) and ASES scores (43.8 vs 38.6), and were less likely to have had previous cuff surgery (6.3% vs 35.9%). Patients selected for rTSA had a smaller acromiohumeral interval (4.8 vs 8.7) and more superior subluxation (50.6% vs 14.1%). Similar preoperative characteristics included pain, comorbidities, and BMI. Patients were satisfied in both groups and had significant improvement in motion and function postoperatively.
Both RCR and rTSA can result in significant functional improvement and patient satisfaction in the setting of MCT without arthritis in patients older than 65. At our institution, patients who underwent rTSA had less pre-operative motion, lower function, more evidence of superior migration, and were more likely to have had previous rotator cuff surgery.
Continue to: The treatment of patients...
The treatment of patients with massive rotator cuff tears (MCTs) without osteoarthritis is challenging. This population is of considerable interest, as the prevalence of MCT has been reported to be as high as 40% of all rotator cuff tears.1Options for surgical treatment in patients who have failed conservative management are numerous and include tendon debridement, partial or complete arthroscopic or open rotator cuff repair (RCR), tendon transfers, reverse total shoulder arthroplasty (rTSA), arthroscopic superior capsular reconstruction (ASCR), and other grafting procedures.2 Arthroscopic superior capsular reconstruction shows promise as a novel technique, but it is not yet well studied. Other procedures such as tendon transfers fit into the treatment algorithm for only a small subset of patients. Open rotator cuff repair and rTSA are the 2 most commonly utilized procedures for MCT, and both have been shown to reliably achieve significant functional improvement and patient satisfaction.3–6
The dilemma for the treating surgeon is deciding which patients to treat with RCR and who to treat with rTSA. Predicting which surgical procedure will provide a better functional result is difficult and controversial.7 The RCR method is a bone-conserving procedure with relatively low surgical risk and allows the option for rTSA to be performed as a salvage surgery should repair fail. It also may be less costly in the appropriate population.8 However, large rotator cuff tears in elderly patients have low healing potential, and the prospect of participating in a lengthy rehabilitation after an operation that may not prove successful can be deterring.9,10 In the elderly population, rTSA may be a reliable option, as tendon healing of the cuff is not necessary to restore function. However, rTSA does not conserve bone, provides a non-anatomic solution, and has had historically high complication rates.4,5
In an effort to aid in the decision-making process when considering these 2 surgical options, we compared RCR and rTSA performed at a single institution for MCT in patients >65 years. Our aim was to identify preoperative patient variables that influence a surgeon’s decision to proceed with 1 of the 2 procedures. Moreover, we evaluated clinical outcomes in these 2 patient populations. We hypothesized that (1) patients selected for rTSA would have worse preoperative function, less range of motion, more comorbidities, more evidence of radiographic subluxation, and a higher likelihood of having undergone previous RCR than those selected for RCR, and (2) both RCR and rTSA would be successful and result in improved clinical outcomes with high patient satisfaction.
MATERIALS AND METHODS
PATIENT SELECTION
We performed a retrospective chart review using our practice database of all patients undergoing arthroscopic RCR and rTSA for any indication by the senior author (M.A.F.) between January 2004 and April 2015. A total of 1503 RCRs and 1973 rTSAs were conducted during the study period. Patient medical records were reviewed, and those meeting the following criteria were included in the study: >65 years at the time of surgery, MCT, no preoperative glenohumeral arthritis, minimum follow-up of 12 months, functional deltoid muscle on physical examination, and no prior shoulder surgery except for RCR or diagnostic arthroscopy. A total of 92 patients who underwent arthroscopic RCR and 89 patients who underwent rTSA met the inclusion criteria. For patients with bilateral shoulder surgery, we measured each shoulder independently. Three patients underwent bilateral rTSA, and 3 patients underwent bilateral RCR, leaving 95 shoulders in the RCR group and 92 in the rTSA group. The Western Institutional Review Board determined this study to be exempt from review.
RADIOGRAPHIC EVALUATION
All patient charts included a radiology report and documented interpretation of the images by the treating surgeon prior to surgery. Radiographs were assessed to assure the absence of preoperative glenohumeral osteoarthritis. The images were also graded based on the Hamada classification.11 Stage 1 is associated with minimal radiographic change with an acromiohumeral interval (AHI) >6 mm; stage 2 is characterized by narrowing of the AHI <6 mm; and Stage 3 is defined by narrowing of the AHI with radiographic changes of the acromion. Stages 4 and higher include arthritic changes to the glenohumeral joint, and they were not included in the study population. The AHI measurements and the presence or absence of glenohumeral subluxation were documented.
Continue to: MASSIVE CUFF TEAR DETERMINATION...
MASSIVE CUFF TEAR DETERMINATION
We defined MCT on the basis of previously described criteria of tears involving ≥2 tendons or tears measuring ≥5 cm in greatest dimension.12,13 Patient charts were screened, and those whose clinical notes or radiology reports indicated an absence of MCT were excluded. Preoperative imaging of the remaining patients was then evaluated by 3 fellowship-trained shoulder surgeons to confirm MCT in all patients with a clinically documented MCT, as well as to assess those who had insufficient documentation of tear size in the notes.
Advanced imaging was evaluated for fatty atrophy of the rotator cuff musculature, and Goutallier classification was assigned.14,15 Length of retraction was measured from the tendon end to the medial aspect of the footprint on coronal imaging, and the subscapularis and teres minor were assessed and documented as torn or intact.16,17
DATA COLLECTION
We reviewed clinical charts and patient questionnaire forms from both the preoperative and follow-up visits. Clinical data collected included gender, age at surgery, active range of motion (forward elevation, abduction, external rotation, and internal rotation), comorbidities, smoking status, BMI, history of shoulder surgery, and any postoperative complications or need for secondary surgery. All patients completed patient-centered questionnaires regarding shoulder pain and dysfunction at each visit or via telephone communication with clinic staff. Outcome measurements used for analysis included American Shoulder and Elbow Surgeons (ASES) Score, simple shoulder test (SST), visual analog score (VAS) pain scale, and patient-reported satisfaction (Graded 1-10; 1 = poor outcome; 4 = satisfactory outcome; 7 = good outcome; 10 = excellent outcome).
DATA ANALYSIS AND STATISTICAL METHODS
Statistical tests were selected based on the result of Shapiro–Wilk test for normality. Continuous variables were evaluated with either independent t test or Mann–Whitney U test. Dependent t test was used to evaluate outcome variables. For categorical variables, either Pearson’s χ2or Fisher’s exact test was performed depending on the sample size. Alpha was set at P =.05.
Continue to: RESULTS...
RESULTS
PREOPERATIVE CHARACTERISTICS
Of the 187 shoulders in the study group, 95 had RCR and 92 had rTSA. Demographic information and preoperative variables for both groups are summarized in Table 1 and Table 2. Patients in the RCR group had greater preoperative forward elevation, abduction, and external rotation and higher preoperative functional scores than those in the rTSA group. Patients in the rTSA group were older and more likely to be female than those in the RCR group. More patients in the rTSA group had undergone prior RCR compared with those in the RCR group. Each of these differences was statistically significant. Subjective pain scores, BMI, and comorbidities were similar between the 2 groups.
Table 1. Patient demographics
| RCR | rTSA | P value |
Age (yr; mean ± SD) | 71 ± 5 | 74 ± 6 | <.0001 |
Gender *male (no.; %) *female (no.; %) | 57 (60%) 38 (40%) | 30 (33%) 62 (67%) | <.0001 |
BMI (mean ± SD) | 28.5 ± 4.4 | 28.1 ± 4.5 | .578 |
Abbreviations: BMI, body mass index; RCR, rotator cuff repair; rTSA, reverse total shoulder arthroplasty.
Table 2. Preoperative variables
| RCR (n=95) | rTSA (n=92) | P value |
Radiographic parameters | |||
AB interval | 9 ± 3 | 5 ± 3 | <.0001 |
Humeral escape | 14.1% | 50.6% | <.0001 |
Hamada 1 | 76.1% | 15.6% | <.0001 |
Hamada 2 | 13.0% | 50.6% | |
Hamada 3 | 10.9% | 33.8% | |
Goutallier grade 1 | 7.8% | 19.3% | .227 |
Goutallier grade 2 | 66.7% | 52.6% | |
Goutallier grade 3 | 21.6% | 19.3% | |
Goutallier grade 4 | 3.9% | 8.8% | |
Clinical measures | |||
Preop FE | 113 ± 50 | 57 ± 34 | <.0001 |
Preop AB | 97 ± 45 | 53 ± 35 | <.0001 |
Preop ER | 42 ± 25 | 32 ± 28 | .029 |
Preop IR | 2.9 ± 1.6 | 2.6 ± 1.8 | .247 |
Preop pain | 5.7 ± 2.3 | 5.6 ± 2.5 | .927 |
Preop ASES | 44 ± 17 | 39 ± 16 | .04 |
Preop SST | 3.1 ± 2.6 | 1.9 ± 1.7 | .001 |
Patients parameters | |||
Previous cuff surgery | 6.3% | 35.9% | <.0001 |
Comorbidity count | 1.7 ± 1.4 | 2.1 ± 2.7 | .126 |
Abbreviations: AB, abduction; ASES, American Shoulder and Elbow Society score; ER, external rotation; FE, forward elevation; IR, internal rotation; preop, preoperative; SST, simple shoulder test.
Radiographically, patients selected to undergo rTSA had a smaller AHI (4.8 vs 8.7, P < .0001) and more evidence of superior subluxation (50.6% vs 14.1%, P < .0001) than those in the RCR group. Average Hamada grade was 1.4 ± 0.7 and 2.2 ± 0.7 for the RCR and rTSA groups, respectively (P < .0001). Average Goutallier grade was similar between the groups (2.2 ± 0.6 for RCR vs 2.2 ± 0.8 for rTSA, P =.227), and 25.5% of the RCR group had Grade 3 or 4 atrophy compared with 28.1% of the rTSA group.
POSTOPERATIVE OUTCOMES
The average follow-up time was 44 months for RCR and 47 months for rTSA. Patients in the RCR and rTSA groups were highly satisfied with the surgery (8.5 ± 2.6 vs 8.2 ± 2.6, P = .461) and had significantly increased range of motion in all planes and improved functional scores (Table 3). The rTSA group had greater net improvement in forward elevation, abduction, and external rotation than the RCR group. Both groups demonstrated similar improvement in ASES, SST, and VAS pain scores.
Table 3. Postoperative outcomes
| RCR (n=95) | P value | rTSA (n=92) | P value | ||
Preoperative | Postoperative | Preoperative | Postoperative | |||
FE | 113 ± 50 | 166 ± 26 | <.0001 | 57 ± 34 | 136 ± 46 | <.0001 |
AB | 97 ± 45 | 155 ± 37 | <.0001 | 53 ± 35 | 129 ± 44 | <.0001 |
ER | 42 ± 25 | 48 ± 20 | .033 | 32 ± 28 | 57 ± 32 | <.0001 |
IR | 2.9 ± 1.6 | 4.6 ± 1.6 | <.0001 | 2.6 ± 1.8 | 4.7 ± 2.4 | <.0001 |
VAS pain | 5.7 ± 2.3 | 1.7 ± 2.4 | <.0001 | 5.6 ± 2.5 | 1.6 ± 2.5 | <.0001 |
ASES | 44 ± 17 | 83 ± 18 | <.0001 | 39 ± 16 | 77 ± 22 | <.0001 |
SST | 3.1 ± 2.6 | 9.3 ± 2.9 | <.0001 | 1.9 ± 1.7 | 7.1 ± 3.4 | <.0001 |
Abbreviations: AB, abduction; ASES, American Shoulder and Elbow Society score; ER, external rotation; FE, forward elevation; IR, internal rotation; SST, simple shoulder test; VAS – visual analog score.
In the RCR group, 5 patients (5.3%) required reoperation: 3 patients underwent conversion to rTSA, 1 patient underwent biceps tenotomy with subacromial decompression, and 1 patient underwent arthroscopic irrigation and debridement for a postoperative Propionibacterium acnes infection. In the rTSA group, 2 patients (2.2%) required reoperation: 1 patient underwent open reduction internal fixation for a scapula fracture that failed conservative management, and 1 patient had an open irrigation and debridement with polyethylene exchange for an acute postoperative infection of unknown source.
DISCUSSION
Massive, retracted rotator cuff tears are a common and difficult problem.1 The treatment options are numerous and depend on a variety of preoperative factors including patient-specific characteristics and factors specific to the tear. For certain patients, nonoperative management may be a reasonable first step, as an MCT does not necessarily preclude painless, functional shoulder motion. Elderly, lower demand individuals have been shown to do well with physical rehabilitation.18 Similarly, for the same category of elderly patients who do not respond to conservative measures, arthroscopic tendon debridement with or without subacromial decompression and/or biceps tenotomy may be effective.1,19 This technique has been described as “limited goals surgery;” despite some mixed results in the literature, multiple studies have reported symptomatic and functional improvement after simple debridement.2,19–21The consensus among several authors has been that this procedure continues to play a role for elderly, low-demand patients whose functional goals are limited and whose primary complaint is pain.1,2,20
For the majority of patients with MCT who desire pain relief and a restoration of shoulder function, RCR remains the gold standard of treatment and should be the primary aim if feasible. Complete RCR has consistently outperformed both partial repair and debridement in multiple studies in terms of pain relief and functional improvement.10,21,22However, elderly patients with chronic, massive tears, particularly in the setting of muscle atrophy, are at high risk of failure with attempted cuff repair.9,23 Novel techniques such as superior capsular reconstruction and subacromial balloon spacer implantation may offer a minimally invasive method of re-centering the humeral head and stabilizing the glenohumeral joint; however, these new treatment options lack any long-term data in the literature to support their widespread use.24–26 Alternatively, rTSA has been shown to be a reliable option to restore shoulder function in the setting of a massive irreparable rotator cuff tear, even in the absence of arthritis.5,27-31
Continue to: The decision-making process...
The decision-making process for selecting RCR or rTSA in the setting of MCT without arthritis in the older population (age >65 years) remains challenging. We attempted to quantify the data of a high-volume surgeon and identify the differences and similarities between those patients selected for either procedure. At our institution, we generally performed rTSA on patients with low preoperative range of motion, poor function based on SST and ASES scores, small AHI, and strong evidence of superior subluxation. We were also more likely to perform rTSA if the patient had a history of rotator cuff surgery. There was a predilection for older age and female gender in those who underwent rTSA.
For our study, we elected to focus on patients >65 years. In our experience, the choice of which surgical procedure to perform is generally easier in younger patients. Most surgeons appropriately opt for an arthroscopic procedure or tendon transfer to preserve bone and maintain the option of rTSA as a salvage procedure if necessary in the future. Studies have reported that <60 years is a predictor of poor outcome with rTSA, and patients <65 years who undergo rTSA have been shown to have high complication rates.30-32 Furthermore, the longevity of the implant in young patients is a significant concern, and revision surgery after rTSA is technically demanding and known to result in poor functional outcomes.32,33
Although the indications for rTSA are expanding, attempts at RCR in the setting of MCT remain largely appropriate. Preserved preoperative anterior elevation >90° has been associated with loss of motion after rTSA and poor satisfaction, and one should exercise caution when considering rTSA in this setting.3 The current study confirmed that even older patients with MCT may be very satisfied with arthroscopic RCR (Figure 1). Both range of motion and function significantly improved, and patients were largely satisfied with the procedure with an average self-reported outcome of good to excellent. At the time of final follow-up for this study, only 3 shoulders in the RCR group had undergone conversion to rTSA. This number may be expected to rise with long follow-up periods, and we feel that prolonging the time before arthroplasty is generally in the best interest of the patient.
Our results were consistent with several reported studies in which RCR has been shown to be successful in the setting of MCT.34–37 Henry and colleagues36 performed a systematic review that evaluated 954 patients who underwent partial or complete anatomic RCR for MCT. Although the average age was 63 years (range, 37–87), functional outcome scores, VAS pain score, and overall range of motion consistently and significantly improved.
rTSA may be a “more reliable” option than RCR in treating MCT in the older population because it does not rely on tendon healing. However, the relationship between tendon healing and clinical outcomes after RCR is unclear. The aforementioned systematic review reported re-tear rates to be as high as 79%, but several studies have reported high satisfaction even in the setting of retear.36 Yoo and colleagues38 and Chung and colleagues9 reported re-tear rates of 45.5% and 39.8%, respectively, but both studies noted that there was no difference in outcome measures between those patients with and without re-tears. In particular, for patients who have had no prior rotator cuff surgery, an attempt at arthroscopic repair may be a prudent option with relatively low risk.
Although certain patients may clinically improve despite suffering a re-tear (or inability to heal in the first place), others continue to experience pain and dysfunction that negatively affect their quality of life.39–41 These patients are more often appropriate candidates for rTSA. Indeed, several studies have demonstrated a higher re-tear rate in patients with a history of surgery than in those without.23,31,38,42 Shamsudin and colleagues43 found revision arthroscopic RCR, even in a younger age group with tears of all sizes, to be twice as likely to re-tear. Notably, re-tear after revision repair may be more likely to be symptomatic, as these re-tears are routinely associated with pain, stiffness, and loss of function. Even in the hands of experienced surgeons in a younger population, revision repair has only been able to reverse pseudoparalysis in 43% of patients, leading to only 39% return to sport or full activity.44 In examining our data, we were much less likely to perform an RCR in patients who had a history of cuff repair surgery than in those without this history.
Continue to: Overall, those patients selected for rTSA...
Overall, those patients selected for rTSA in our study population performed well postoperatively (Figure 2 and Figure 3). Vast improvements were noted in range of motion, function, and pain scores at final follow up. Moreover, no patients in the study group required revision arthroplasty during the follow-up period. Although the average follow-up period was only 47 months, these results suggested that elderly patients with MCT without arthritis may be particularly ideal candidates for rTSA with regard to implant survival and anticipated revision rate when chosen appropriately.
Several weaknesses were noted within this paper. First, the study was retrospective, precluding randomization of treatment groups and standardization of data collection and follow-up. The outcomes of RCR and rTSA could not be compared directly due to the inherent selection bias. The groups clearly differed in many respects, and these preoperative factors likely played a role in postoperative outcomes. However, the primary goal of this study was not to compare outcomes of the treatment groups but to analyze the patterns of patient selection by an experienced treating surgeon and contribute to published data that each surgery can be successful in this patient population when chosen appropriately.
Second, our data were based on a single surgeon’s decisions, and results may not be generalizable. Furthermore, the senior author has had a longstanding interest in reverse shoulder arthroplasty and has published data illustrating successful outcomes for rTSA in patients with MCT. For this reason, one could presume that there may have been some bias toward treating patients with rTSA. However, we feel that the senior author’s unique and longstanding experience in treating MCT allows for a thorough evaluation and comparison of preoperative variables and outcomes declared within this study. Indeed, many patients included in this study were referred from outside institutions specifically for rTSA but instead were deemed more appropriate candidates for RCR and underwent successful arthroscopic repair, a common scenario which served as an impetus for this study.
CONCLUSION
RCR and rTSA are both viable options for patients >65 years with MCT without arthritis. Treatment must be individualized for each patient with careful consideration of a number of preoperative variables and patient characteristics. At our institution, patients with previous RCR, decreased range of motion, poor function, and strong radiographic evidence of subluxation are more likely to undergo rTSA. When chosen appropriately, both RCR and rTSA can result in improved range of motion, function, and high patient satisfaction in this patient population.
ABSTRACT
The decision to perform rotator cuff repair (RCR) versus reverse total shoulder arthroplasty (rTSA) for massive rotator cuff tear (MCT) without arthritis can be difficult. Our aim was to identify preoperative variables that are influential in a surgeon's decision to choose one of the two procedures and evaluate outcomes.
We retrospectively reviewed 181 patients older than 65 who underwent RCR or rTSA for MCT without arthritis. Clinical and radiographic data were collected and used to evaluate the preoperative variables in each of these two patient populations and assess outcomes.
Ninety-five shoulders underwent RCR and 92 underwent rTSA with an average followup of 44 and 47 months, respectively. Patients selected for RCR had greater preoperative flexion (113 vs 57), abduction (97 vs 53), and external rotation (42 vs 32), higher SST (3.1 vs 1.9) and ASES scores (43.8 vs 38.6), and were less likely to have had previous cuff surgery (6.3% vs 35.9%). Patients selected for rTSA had a smaller acromiohumeral interval (4.8 vs 8.7) and more superior subluxation (50.6% vs 14.1%). Similar preoperative characteristics included pain, comorbidities, and BMI. Patients were satisfied in both groups and had significant improvement in motion and function postoperatively.
Both RCR and rTSA can result in significant functional improvement and patient satisfaction in the setting of MCT without arthritis in patients older than 65. At our institution, patients who underwent rTSA had less pre-operative motion, lower function, more evidence of superior migration, and were more likely to have had previous rotator cuff surgery.
Continue to: The treatment of patients...
The treatment of patients with massive rotator cuff tears (MCTs) without osteoarthritis is challenging. This population is of considerable interest, as the prevalence of MCT has been reported to be as high as 40% of all rotator cuff tears.1Options for surgical treatment in patients who have failed conservative management are numerous and include tendon debridement, partial or complete arthroscopic or open rotator cuff repair (RCR), tendon transfers, reverse total shoulder arthroplasty (rTSA), arthroscopic superior capsular reconstruction (ASCR), and other grafting procedures.2 Arthroscopic superior capsular reconstruction shows promise as a novel technique, but it is not yet well studied. Other procedures such as tendon transfers fit into the treatment algorithm for only a small subset of patients. Open rotator cuff repair and rTSA are the 2 most commonly utilized procedures for MCT, and both have been shown to reliably achieve significant functional improvement and patient satisfaction.3–6
The dilemma for the treating surgeon is deciding which patients to treat with RCR and who to treat with rTSA. Predicting which surgical procedure will provide a better functional result is difficult and controversial.7 The RCR method is a bone-conserving procedure with relatively low surgical risk and allows the option for rTSA to be performed as a salvage surgery should repair fail. It also may be less costly in the appropriate population.8 However, large rotator cuff tears in elderly patients have low healing potential, and the prospect of participating in a lengthy rehabilitation after an operation that may not prove successful can be deterring.9,10 In the elderly population, rTSA may be a reliable option, as tendon healing of the cuff is not necessary to restore function. However, rTSA does not conserve bone, provides a non-anatomic solution, and has had historically high complication rates.4,5
In an effort to aid in the decision-making process when considering these 2 surgical options, we compared RCR and rTSA performed at a single institution for MCT in patients >65 years. Our aim was to identify preoperative patient variables that influence a surgeon’s decision to proceed with 1 of the 2 procedures. Moreover, we evaluated clinical outcomes in these 2 patient populations. We hypothesized that (1) patients selected for rTSA would have worse preoperative function, less range of motion, more comorbidities, more evidence of radiographic subluxation, and a higher likelihood of having undergone previous RCR than those selected for RCR, and (2) both RCR and rTSA would be successful and result in improved clinical outcomes with high patient satisfaction.
MATERIALS AND METHODS
PATIENT SELECTION
We performed a retrospective chart review using our practice database of all patients undergoing arthroscopic RCR and rTSA for any indication by the senior author (M.A.F.) between January 2004 and April 2015. A total of 1503 RCRs and 1973 rTSAs were conducted during the study period. Patient medical records were reviewed, and those meeting the following criteria were included in the study: >65 years at the time of surgery, MCT, no preoperative glenohumeral arthritis, minimum follow-up of 12 months, functional deltoid muscle on physical examination, and no prior shoulder surgery except for RCR or diagnostic arthroscopy. A total of 92 patients who underwent arthroscopic RCR and 89 patients who underwent rTSA met the inclusion criteria. For patients with bilateral shoulder surgery, we measured each shoulder independently. Three patients underwent bilateral rTSA, and 3 patients underwent bilateral RCR, leaving 95 shoulders in the RCR group and 92 in the rTSA group. The Western Institutional Review Board determined this study to be exempt from review.
RADIOGRAPHIC EVALUATION
All patient charts included a radiology report and documented interpretation of the images by the treating surgeon prior to surgery. Radiographs were assessed to assure the absence of preoperative glenohumeral osteoarthritis. The images were also graded based on the Hamada classification.11 Stage 1 is associated with minimal radiographic change with an acromiohumeral interval (AHI) >6 mm; stage 2 is characterized by narrowing of the AHI <6 mm; and Stage 3 is defined by narrowing of the AHI with radiographic changes of the acromion. Stages 4 and higher include arthritic changes to the glenohumeral joint, and they were not included in the study population. The AHI measurements and the presence or absence of glenohumeral subluxation were documented.
Continue to: MASSIVE CUFF TEAR DETERMINATION...
MASSIVE CUFF TEAR DETERMINATION
We defined MCT on the basis of previously described criteria of tears involving ≥2 tendons or tears measuring ≥5 cm in greatest dimension.12,13 Patient charts were screened, and those whose clinical notes or radiology reports indicated an absence of MCT were excluded. Preoperative imaging of the remaining patients was then evaluated by 3 fellowship-trained shoulder surgeons to confirm MCT in all patients with a clinically documented MCT, as well as to assess those who had insufficient documentation of tear size in the notes.
Advanced imaging was evaluated for fatty atrophy of the rotator cuff musculature, and Goutallier classification was assigned.14,15 Length of retraction was measured from the tendon end to the medial aspect of the footprint on coronal imaging, and the subscapularis and teres minor were assessed and documented as torn or intact.16,17
DATA COLLECTION
We reviewed clinical charts and patient questionnaire forms from both the preoperative and follow-up visits. Clinical data collected included gender, age at surgery, active range of motion (forward elevation, abduction, external rotation, and internal rotation), comorbidities, smoking status, BMI, history of shoulder surgery, and any postoperative complications or need for secondary surgery. All patients completed patient-centered questionnaires regarding shoulder pain and dysfunction at each visit or via telephone communication with clinic staff. Outcome measurements used for analysis included American Shoulder and Elbow Surgeons (ASES) Score, simple shoulder test (SST), visual analog score (VAS) pain scale, and patient-reported satisfaction (Graded 1-10; 1 = poor outcome; 4 = satisfactory outcome; 7 = good outcome; 10 = excellent outcome).
DATA ANALYSIS AND STATISTICAL METHODS
Statistical tests were selected based on the result of Shapiro–Wilk test for normality. Continuous variables were evaluated with either independent t test or Mann–Whitney U test. Dependent t test was used to evaluate outcome variables. For categorical variables, either Pearson’s χ2or Fisher’s exact test was performed depending on the sample size. Alpha was set at P =.05.
Continue to: RESULTS...
RESULTS
PREOPERATIVE CHARACTERISTICS
Of the 187 shoulders in the study group, 95 had RCR and 92 had rTSA. Demographic information and preoperative variables for both groups are summarized in Table 1 and Table 2. Patients in the RCR group had greater preoperative forward elevation, abduction, and external rotation and higher preoperative functional scores than those in the rTSA group. Patients in the rTSA group were older and more likely to be female than those in the RCR group. More patients in the rTSA group had undergone prior RCR compared with those in the RCR group. Each of these differences was statistically significant. Subjective pain scores, BMI, and comorbidities were similar between the 2 groups.
Table 1. Patient demographics
| RCR | rTSA | P value |
Age (yr; mean ± SD) | 71 ± 5 | 74 ± 6 | <.0001 |
Gender *male (no.; %) *female (no.; %) | 57 (60%) 38 (40%) | 30 (33%) 62 (67%) | <.0001 |
BMI (mean ± SD) | 28.5 ± 4.4 | 28.1 ± 4.5 | .578 |
Abbreviations: BMI, body mass index; RCR, rotator cuff repair; rTSA, reverse total shoulder arthroplasty.
Table 2. Preoperative variables
| RCR (n=95) | rTSA (n=92) | P value |
Radiographic parameters | |||
AB interval | 9 ± 3 | 5 ± 3 | <.0001 |
Humeral escape | 14.1% | 50.6% | <.0001 |
Hamada 1 | 76.1% | 15.6% | <.0001 |
Hamada 2 | 13.0% | 50.6% | |
Hamada 3 | 10.9% | 33.8% | |
Goutallier grade 1 | 7.8% | 19.3% | .227 |
Goutallier grade 2 | 66.7% | 52.6% | |
Goutallier grade 3 | 21.6% | 19.3% | |
Goutallier grade 4 | 3.9% | 8.8% | |
Clinical measures | |||
Preop FE | 113 ± 50 | 57 ± 34 | <.0001 |
Preop AB | 97 ± 45 | 53 ± 35 | <.0001 |
Preop ER | 42 ± 25 | 32 ± 28 | .029 |
Preop IR | 2.9 ± 1.6 | 2.6 ± 1.8 | .247 |
Preop pain | 5.7 ± 2.3 | 5.6 ± 2.5 | .927 |
Preop ASES | 44 ± 17 | 39 ± 16 | .04 |
Preop SST | 3.1 ± 2.6 | 1.9 ± 1.7 | .001 |
Patients parameters | |||
Previous cuff surgery | 6.3% | 35.9% | <.0001 |
Comorbidity count | 1.7 ± 1.4 | 2.1 ± 2.7 | .126 |
Abbreviations: AB, abduction; ASES, American Shoulder and Elbow Society score; ER, external rotation; FE, forward elevation; IR, internal rotation; preop, preoperative; SST, simple shoulder test.
Radiographically, patients selected to undergo rTSA had a smaller AHI (4.8 vs 8.7, P < .0001) and more evidence of superior subluxation (50.6% vs 14.1%, P < .0001) than those in the RCR group. Average Hamada grade was 1.4 ± 0.7 and 2.2 ± 0.7 for the RCR and rTSA groups, respectively (P < .0001). Average Goutallier grade was similar between the groups (2.2 ± 0.6 for RCR vs 2.2 ± 0.8 for rTSA, P =.227), and 25.5% of the RCR group had Grade 3 or 4 atrophy compared with 28.1% of the rTSA group.
POSTOPERATIVE OUTCOMES
The average follow-up time was 44 months for RCR and 47 months for rTSA. Patients in the RCR and rTSA groups were highly satisfied with the surgery (8.5 ± 2.6 vs 8.2 ± 2.6, P = .461) and had significantly increased range of motion in all planes and improved functional scores (Table 3). The rTSA group had greater net improvement in forward elevation, abduction, and external rotation than the RCR group. Both groups demonstrated similar improvement in ASES, SST, and VAS pain scores.
Table 3. Postoperative outcomes
| RCR (n=95) | P value | rTSA (n=92) | P value | ||
Preoperative | Postoperative | Preoperative | Postoperative | |||
FE | 113 ± 50 | 166 ± 26 | <.0001 | 57 ± 34 | 136 ± 46 | <.0001 |
AB | 97 ± 45 | 155 ± 37 | <.0001 | 53 ± 35 | 129 ± 44 | <.0001 |
ER | 42 ± 25 | 48 ± 20 | .033 | 32 ± 28 | 57 ± 32 | <.0001 |
IR | 2.9 ± 1.6 | 4.6 ± 1.6 | <.0001 | 2.6 ± 1.8 | 4.7 ± 2.4 | <.0001 |
VAS pain | 5.7 ± 2.3 | 1.7 ± 2.4 | <.0001 | 5.6 ± 2.5 | 1.6 ± 2.5 | <.0001 |
ASES | 44 ± 17 | 83 ± 18 | <.0001 | 39 ± 16 | 77 ± 22 | <.0001 |
SST | 3.1 ± 2.6 | 9.3 ± 2.9 | <.0001 | 1.9 ± 1.7 | 7.1 ± 3.4 | <.0001 |
Abbreviations: AB, abduction; ASES, American Shoulder and Elbow Society score; ER, external rotation; FE, forward elevation; IR, internal rotation; SST, simple shoulder test; VAS – visual analog score.
In the RCR group, 5 patients (5.3%) required reoperation: 3 patients underwent conversion to rTSA, 1 patient underwent biceps tenotomy with subacromial decompression, and 1 patient underwent arthroscopic irrigation and debridement for a postoperative Propionibacterium acnes infection. In the rTSA group, 2 patients (2.2%) required reoperation: 1 patient underwent open reduction internal fixation for a scapula fracture that failed conservative management, and 1 patient had an open irrigation and debridement with polyethylene exchange for an acute postoperative infection of unknown source.
DISCUSSION
Massive, retracted rotator cuff tears are a common and difficult problem.1 The treatment options are numerous and depend on a variety of preoperative factors including patient-specific characteristics and factors specific to the tear. For certain patients, nonoperative management may be a reasonable first step, as an MCT does not necessarily preclude painless, functional shoulder motion. Elderly, lower demand individuals have been shown to do well with physical rehabilitation.18 Similarly, for the same category of elderly patients who do not respond to conservative measures, arthroscopic tendon debridement with or without subacromial decompression and/or biceps tenotomy may be effective.1,19 This technique has been described as “limited goals surgery;” despite some mixed results in the literature, multiple studies have reported symptomatic and functional improvement after simple debridement.2,19–21The consensus among several authors has been that this procedure continues to play a role for elderly, low-demand patients whose functional goals are limited and whose primary complaint is pain.1,2,20
For the majority of patients with MCT who desire pain relief and a restoration of shoulder function, RCR remains the gold standard of treatment and should be the primary aim if feasible. Complete RCR has consistently outperformed both partial repair and debridement in multiple studies in terms of pain relief and functional improvement.10,21,22However, elderly patients with chronic, massive tears, particularly in the setting of muscle atrophy, are at high risk of failure with attempted cuff repair.9,23 Novel techniques such as superior capsular reconstruction and subacromial balloon spacer implantation may offer a minimally invasive method of re-centering the humeral head and stabilizing the glenohumeral joint; however, these new treatment options lack any long-term data in the literature to support their widespread use.24–26 Alternatively, rTSA has been shown to be a reliable option to restore shoulder function in the setting of a massive irreparable rotator cuff tear, even in the absence of arthritis.5,27-31
Continue to: The decision-making process...
The decision-making process for selecting RCR or rTSA in the setting of MCT without arthritis in the older population (age >65 years) remains challenging. We attempted to quantify the data of a high-volume surgeon and identify the differences and similarities between those patients selected for either procedure. At our institution, we generally performed rTSA on patients with low preoperative range of motion, poor function based on SST and ASES scores, small AHI, and strong evidence of superior subluxation. We were also more likely to perform rTSA if the patient had a history of rotator cuff surgery. There was a predilection for older age and female gender in those who underwent rTSA.
For our study, we elected to focus on patients >65 years. In our experience, the choice of which surgical procedure to perform is generally easier in younger patients. Most surgeons appropriately opt for an arthroscopic procedure or tendon transfer to preserve bone and maintain the option of rTSA as a salvage procedure if necessary in the future. Studies have reported that <60 years is a predictor of poor outcome with rTSA, and patients <65 years who undergo rTSA have been shown to have high complication rates.30-32 Furthermore, the longevity of the implant in young patients is a significant concern, and revision surgery after rTSA is technically demanding and known to result in poor functional outcomes.32,33
Although the indications for rTSA are expanding, attempts at RCR in the setting of MCT remain largely appropriate. Preserved preoperative anterior elevation >90° has been associated with loss of motion after rTSA and poor satisfaction, and one should exercise caution when considering rTSA in this setting.3 The current study confirmed that even older patients with MCT may be very satisfied with arthroscopic RCR (Figure 1). Both range of motion and function significantly improved, and patients were largely satisfied with the procedure with an average self-reported outcome of good to excellent. At the time of final follow-up for this study, only 3 shoulders in the RCR group had undergone conversion to rTSA. This number may be expected to rise with long follow-up periods, and we feel that prolonging the time before arthroplasty is generally in the best interest of the patient.
Our results were consistent with several reported studies in which RCR has been shown to be successful in the setting of MCT.34–37 Henry and colleagues36 performed a systematic review that evaluated 954 patients who underwent partial or complete anatomic RCR for MCT. Although the average age was 63 years (range, 37–87), functional outcome scores, VAS pain score, and overall range of motion consistently and significantly improved.
rTSA may be a “more reliable” option than RCR in treating MCT in the older population because it does not rely on tendon healing. However, the relationship between tendon healing and clinical outcomes after RCR is unclear. The aforementioned systematic review reported re-tear rates to be as high as 79%, but several studies have reported high satisfaction even in the setting of retear.36 Yoo and colleagues38 and Chung and colleagues9 reported re-tear rates of 45.5% and 39.8%, respectively, but both studies noted that there was no difference in outcome measures between those patients with and without re-tears. In particular, for patients who have had no prior rotator cuff surgery, an attempt at arthroscopic repair may be a prudent option with relatively low risk.
Although certain patients may clinically improve despite suffering a re-tear (or inability to heal in the first place), others continue to experience pain and dysfunction that negatively affect their quality of life.39–41 These patients are more often appropriate candidates for rTSA. Indeed, several studies have demonstrated a higher re-tear rate in patients with a history of surgery than in those without.23,31,38,42 Shamsudin and colleagues43 found revision arthroscopic RCR, even in a younger age group with tears of all sizes, to be twice as likely to re-tear. Notably, re-tear after revision repair may be more likely to be symptomatic, as these re-tears are routinely associated with pain, stiffness, and loss of function. Even in the hands of experienced surgeons in a younger population, revision repair has only been able to reverse pseudoparalysis in 43% of patients, leading to only 39% return to sport or full activity.44 In examining our data, we were much less likely to perform an RCR in patients who had a history of cuff repair surgery than in those without this history.
Continue to: Overall, those patients selected for rTSA...
Overall, those patients selected for rTSA in our study population performed well postoperatively (Figure 2 and Figure 3). Vast improvements were noted in range of motion, function, and pain scores at final follow up. Moreover, no patients in the study group required revision arthroplasty during the follow-up period. Although the average follow-up period was only 47 months, these results suggested that elderly patients with MCT without arthritis may be particularly ideal candidates for rTSA with regard to implant survival and anticipated revision rate when chosen appropriately.
Several weaknesses were noted within this paper. First, the study was retrospective, precluding randomization of treatment groups and standardization of data collection and follow-up. The outcomes of RCR and rTSA could not be compared directly due to the inherent selection bias. The groups clearly differed in many respects, and these preoperative factors likely played a role in postoperative outcomes. However, the primary goal of this study was not to compare outcomes of the treatment groups but to analyze the patterns of patient selection by an experienced treating surgeon and contribute to published data that each surgery can be successful in this patient population when chosen appropriately.
Second, our data were based on a single surgeon’s decisions, and results may not be generalizable. Furthermore, the senior author has had a longstanding interest in reverse shoulder arthroplasty and has published data illustrating successful outcomes for rTSA in patients with MCT. For this reason, one could presume that there may have been some bias toward treating patients with rTSA. However, we feel that the senior author’s unique and longstanding experience in treating MCT allows for a thorough evaluation and comparison of preoperative variables and outcomes declared within this study. Indeed, many patients included in this study were referred from outside institutions specifically for rTSA but instead were deemed more appropriate candidates for RCR and underwent successful arthroscopic repair, a common scenario which served as an impetus for this study.
CONCLUSION
RCR and rTSA are both viable options for patients >65 years with MCT without arthritis. Treatment must be individualized for each patient with careful consideration of a number of preoperative variables and patient characteristics. At our institution, patients with previous RCR, decreased range of motion, poor function, and strong radiographic evidence of subluxation are more likely to undergo rTSA. When chosen appropriately, both RCR and rTSA can result in improved range of motion, function, and high patient satisfaction in this patient population.
- Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010;92:1894-1908. doi:10.2106/JBJS.I.01531.
- Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015;24:1493-1505. doi:10.1016/j.jse.2015.04.005.
- Boileau P, Gonzalez JF, Chuinard C, Bicknell R, Walch G. Reverse total shoulder arthroplasty after failed rotator cuff surgery. J Shoulder Elbow Surg. 2009;18:600-606. doi:10.1016/j.jse.2009.03.011.
- Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008;90:1244-1251. doi:10.2106/JBJS.G.00775.
- Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010;92:2544-2556.doi:10.2106/JBJS.I.00912.
- Wall B, Nove-Josserand L, O'Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007;89:1476-1485. doi:10.2106/JBJS.F.00666.
- Pill SG, Walch G, Hawkins RJ, Kissenberth MJ. The role of the biceps tendon in massive rotator cuff tears. Instr Course Lect. 2012;61:113-120.
- Makhni EC, Swart E, Steinhaus ME, Mather RC 3rd, Levine WN, Bach BR Jr et al. Cost-effectiveness of reverse total shoulder arthroplasty versus arthroscopic rotator cuff repair for symptomatic large and massive rotator cuff tears. Arthroscopy. 2016;32(9):1771-1780. doi:10.1016/j.arthro.2016.01.063.
- Chung SW, Kim JY, Kim MH, Kim SH, Oh JH. Arthroscopic repair of massive rotator cuff tears: outcome and analysis of factors associated with healing failure or poor postoperative function. Am J Sports Med. 2013;41:1674-1683. doi:10.1177/0363546513485719.
- Holtby R, Razmjou H. Relationship between clinical and surgical findings and reparability of large and massive rotator cuff tears: a longitudinal study. BMC Musculoskelet Disord. 2014;15:180. doi:10.1186/1471-2474-15-180.
- Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;254:92-96.
- DeOrio JK, Cofield RH. Results of a second attempt at surgical repair of a failed initial rotator-cuff repair. J Bone Joint Surg Am. 1984;66:563-567.
- Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000;82:505-515.
- Fuchs B, Weishaupt D, Zanetti M, Hodler J, Gerber C. Fatty degeneration of the muscles of the rotator cuff: assessment by computed tomography versus magnetic resonance imaging. J Shoulder Elbow Surg. 1999;8:599-605.
- Goutallier D, Bernageau J, Patte D. Assessment of the trophicity of the muscles of the ruptured rotator cuff by CT scan. In: Post M, Morrey B, Hawkins R, eds. Surgery of the Shoulder. St. Louis, MO: Mosby, 1990;11-13.
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- Meyer DC, Wieser K, Farshad M, Gerber C. Retraction of supraspinatus muscle and tendon as predictors of success of rotator cuff repair. Am J Sports Med. 2012;40:2242-2247.
- Williams GR Jr, Rockwood CA Jr, Bigliani LU, Ianotti JP, Stanwood W. Rotator cuff tears: why do we repair them? J Bone Joint Surg Am. 2004;86-A(12):2764-2776.
- Rockwood CA Jr, Williams GR Jr, Burkhead WZ Jr. Debridement of degenerative, irreparable lesions of the rotator cuff. J Bone Joint Surg Am. 1995;77:857-866.
- Berth A, Neumann W, Awiszus F, Pap G. Massive rotator cuff tears: functional outcome after debridement or arthroscopic partial repair. J Orthopaed Traumatol. 2010;11:13-20. doi 10.1007/s10195-010-0084-0.
- Heuberer PR, Kolblinger R, Buchleitner S, Pauzenberger L, Laky B, Auffarth A, et al. Arthroscopic management of massive rotator cuff tears: an evaluation of debridement, complete, and partial repair with and without force couple restoration. Knee Surg Sports Traumatol Arthrosc. 2016;24:3828-3837.
- Moser M, Jablonski MV, Horodyski M, Wright TW. Functional outcome of surgically treated massive rotator cuff tears: a comparison of complete repair, partial repair, and debridement. Orthopedics.2007;30(6):479-482.
- Rhee YG, Cho NS, Yoo JH. Clinical outcome and repair integrity after rotator cuff repair in patients older than 70 years versus patients younger than 70 years. Arthroscopy. 2014;30:546-554. doi:10.1016/j.arthro.2014.02.006.
- Denard PJ, Brady PC, Adams CR, Tokish JM, Burkhart SS. Preliminary results of arthroscopic superior capsule reconstruction with dermal allograft. Arthroscopy. 2018;34(1):93-99. doi: 10.1016/j.arthro.2017.08.265.
- Mihata T, Lee TQ, Watanabe C, Fukunishi K, Ohue M, Tsujimura T, Kinoshita M. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy.2013;29:459-70.
- Piekaar RSM, Bouman ICE, van Kampen PM, van Eijk F, Huijsmans PE. Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear. Musculoskelet Surg. 2018;102(3):247-255. doi: 10.1007/s12306-017-0525-5.
- Al-Hadithy N, Domos P, Sewell MD, Pandit R. Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. J Shoulder Elbow Surg. 2014;23:1662-1668. doi:10.1016/j.jse.2014.03.001.
- Boileau P, Watkinson DJ, Hatzidakis AM, Balg F. Grammont reverse prosthesis: design, rationale, and biomechanics. J Shoulder Elbow Surg. 2005;14:147S-161S. doi:10.1016/j.jse.2004.10.006.
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- Hartzler RU, Steen BM, Hussey MM, Cusick MC, Cottrell BJ, Clark RE, Frankle MA. Reverse shoulder arthroplasty for massive rotator cuff tear: risk factors for poor functional improvement. J Shoulder Elbow Surg. 2015;24:1698-1706. doi:10.1016/j.jse.2015.04.015.
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- Sershon RA, Van Thiel GS, Lin EC, McGill KC, Cole BJ, Verma NN, et al. Clinical outcomes of reverse total shoulder arthroplasty in patients aged younger than 60 years. J Shoulder Elbow Surg.2014;23:395-400. doi:10.1016/j.jse.2013.07.047.
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- Denard PJ, Ladermann A, Brady PC, Narbona P, Adams CR, Arrigoni P, et al. Pseudoparalysis from a massive rotator cuff tear is reliably reversed with an arthroscopic rotator cuff repair in patients without preoperative glenohumeral arthritis. Am J Sports Med. 2015;43:2373-2378. doi: 10.1177/0363546515597486.
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- Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000;82:304-314.
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- Liu SH, Baker CL. Arthroscopically assisted rotator cuff repair: correlation of functional results with integrity of the cuff. Arthroscopy. 1994;10:54-60.
- Papadopoulos P, Karataglis D, Boutsiadis A, Fotiadou A, Christoforidis J, Christodoulou A. Functional outcome and structural integrity following mini-open repair of large and massive rotator cuff tears: a 3-5 year follow-up study. J Shoulder Elbow Surg. 2011;20:131-137. doi:10.1016/j.jse.2010.05.026.
- Shamsudin A, Lam PH, Peters K, Rubenis I, Hackett L, Murrell GA. Revision versus primary arthroscopic rotator cuff repair: a 2-year analysis of outcomes in 360 patients. Am J Sports Med.2015;43:557-564. doi:10.1177/0363546514560729.
- Ladermann A, Denard PJ, Burkhart SS. Midterm outcome of arthroscopic revision repair of massive and nonmassive rotator cuff tears. Arthroscopy. 2011;27:1620-1627. doi:10.1016/j.arthro.2011.08.290.
- Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010;92:1894-1908. doi:10.2106/JBJS.I.01531.
- Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015;24:1493-1505. doi:10.1016/j.jse.2015.04.005.
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TAKE-HOME POINTS
- Rotator cuff repair and reverse total shoulder arthroplasty are both viable options for patients >65 years with massive rotator cuff tears without arthritis.
- Treatment must be individualized for each patient, with careful consideration of a number of preoperative variables and patient characteristics.
- At our institution, patients with previous rotator cuff repair, decreased range of motion, poor function, and strong radiographic evidence of subluxation were more likely to undergo reverse total shoulder arthroplasty.
- Patients selected for rotator cuff repair had greater preoperative flexion, abduction, and external rotation, as well as higher functional scores, and were less likely to have had previous cuff surgery.
- When chosen appropriately, both rotator cuff repair and reverse total shoulder arthroplasty can result in improved range of motion, function, and high patient satisfaction in this patient population.








