Additional training may be needed for providers who administer DTaP vaccine to prevent errors in vaccination, but there are no new or unexpected safety concerns surrounding the DTaP vaccine itself, reported Pedro Moro, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases and his associates in Pediatrics.

After Dr. Moro and his associates performed an automated analysis of all reports included in the Vaccine Adverse Event Reporting System (VAERS), which is coadministered by the CDC and the Food and Drug Administration, as well as a clinical review of reported deaths and a random sampling of serious reports in the database, they concluded that safety findings concerning DTaP were consistent with those from prelicensure trials and postlicensure studies.

Yarinca/istockphoto

SOURCE: Moro P et al. Pediatrics. 2018. doi: 10.1542/peds.2017-4171.

Additional training may be needed for providers who administer DTaP vaccine to prevent errors in vaccination, but there are no new or unexpected safety concerns surrounding the DTaP vaccine itself, reported Pedro Moro, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases and his associates in Pediatrics.

After Dr. Moro and his associates performed an automated analysis of all reports included in the Vaccine Adverse Event Reporting System (VAERS), which is coadministered by the CDC and the Food and Drug Administration, as well as a clinical review of reported deaths and a random sampling of serious reports in the database, they concluded that safety findings concerning DTaP were consistent with those from prelicensure trials and postlicensure studies.

Yarinca/istockphoto

SOURCE: Moro P et al. Pediatrics. 2018. doi: 10.1542/peds.2017-4171.

Additional training may be needed for providers who administer DTaP vaccine to prevent errors in vaccination, but there are no new or unexpected safety concerns surrounding the DTaP vaccine itself, reported Pedro Moro, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases and his associates in Pediatrics.

After Dr. Moro and his associates performed an automated analysis of all reports included in the Vaccine Adverse Event Reporting System (VAERS), which is coadministered by the CDC and the Food and Drug Administration, as well as a clinical review of reported deaths and a random sampling of serious reports in the database, they concluded that safety findings concerning DTaP were consistent with those from prelicensure trials and postlicensure studies.

Yarinca/istockphoto

SOURCE: Moro P et al. Pediatrics. 2018. doi: 10.1542/peds.2017-4171.

ABSTRACT

It has been suggested that the utilization of joint arthroplasty in patients with rheumatoid arthritis (RA) is decreasing; however, this observation is largely based upon evidence pertaining to lower-extremity joint arthroplasty. It remains unknown if these observed trends also hold true for shoulder arthroplasty. The purpose of this study is to utilize a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. Secondarily, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and to compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. Using a large population database in the US, we determined the annual rates of shoulder arthroplasty (overall and individual) in RA patients between 2002 and 2011. Early adverse events, length of stay, and hospitalization costs were determined and compared with those of non-RA patients undergoing shoulder arthroplasty. Overall, we identified 332,593 patients who underwent shoulder arthroplasty between 2002 and 2011, of whom 17,883 patients (5.4%) had a diagnosis of RA. Over the study period, there was a significant increase in the utilization of shoulder arthroplasty in RA patients, particularly total shoulder arthroplasty. Over the same period, there was a significant increase in the number of RA patients who underwent shoulder arthroplasty with a diagnosis of rotator cuff disease. There were no significant differences in adverse events or mean hospitalization costs between RA and non-RA patients. Non-RA patients had a significantly shorter length of stay; however, the difference did not appear to be clinically significant. In conclusion, the utilization of shoulder arthroplasty in patients with RA significantly increased from 2002 to 2011, which may partly reflect a trend toward management of rotator cuff disease with arthroplasty rather than repair.

Continue to: It has been suggested...

It has been suggested that the utilization of total joint arthroplasty (TJA) in patients with rheumatoid arthritis (RA) is decreasing over time;¹ however, this observation is largely based upon evidence pertaining to lower extremity TJA.² It remains unknown if these observed trends also hold true for shoulder arthroplasty, whereby the utilization of shoulder arthroplasty in RA patients is not limited to the management of end-stage inflammatory arthropathy. In this study, we used a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. As a secondary objective, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. We hypothesize that the utilization of shoulder arthroplasty in RA patients would be decreasing, but adverse events, length of stay, and hospitalization costs would not differ between patients with and without RA undergoing shoulder arthroplasty.

METHODS

We conducted a retrospective cohort study using the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) from 2002 to 2011.³ The NIS comprises a 20% stratified sample of all hospital discharges in the US. The NIS includes information about patient characteristics (age, sex, insurance status, and medical comorbidities) and hospitalization outcomes (adverse events, costs, and length of stay). The NIS allows identification of hospitalizations according to procedures and diagnoses using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Given the anonymity of this study, it was exempt from Institutional Review Board ethics approval.

Hospitalizations were selected for the study based on ICD-9-CM procedural codes for hemiarthroplasty (81.81), anatomic total shoulder arthroplasty (TSA) (81.80), and reverse TSA (81.88). These patients were then stratified by an ICD-9-CM diagnosis of RA (714.X). We also utilized ICD-9-CM diagnosis codes to determine the presence of rotator cuff pathology at the time of shoulder arthroplasty (726.13, 727.61, 840.4) and to exclude patients with a history of trauma (812.X, 716.11, 733.8X). In a separate analysis, all patients in the NIS database with an ICD-9-CM diagnosis of RA were identified for each calendar year of the study, and a national estimate of RA patients was generated annually to assess overall and individual utilization rates of shoulder arthroplasty in this population (the national estimate served as the denominator).

Preoperative patient data withdrawn from the NIS included age, sex, insurance status, and medical comorbidities. An Elixhauser Comorbidity Index (ECI) was generated for each patient based on the presence of 29 comorbid conditions. The ECI was chosen because of its capacity to accurately predict mortality and represent the patient burden of comorbidities in similar administrative database studies.^4-6

Early adverse events were also chosen based on ICD-9-CM diagnosis codes (Appendix A), and included the following: death, acute kidney injury, cardiac arrest, thromboembolic event, myocardial infarction, peripheral nerve injury, pneumonia, sepsis, stroke, surgical site infection, urinary tract infection, and wound dehiscence. The overall adverse event rate was defined as the occurrence of ≥1 of the above adverse events in a patient.

Appendix A. ICD-9-CM Codes Corresponding to Postoperative Adverse Events

Abbreviation: ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification

Length of stay and total hospital charges were available for each patient. Length of stay represents the number of calendar days a patient stayed in the hospital. All hospital charges were converted to hospitalization costs using the HCUP Cost-to-Charge Ratio Files. All hospitalization costs were adjusted for inflation using the US Bureau of Labor statistics yearly inflation calculator to represent charges in the year 2011, which was the final and most recent year in this study.

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

Statistical analyses were conducted using Stata version 13.1 (StataCorp, LP). All analyses took into account the complex survey design of the NIS. Discharge weights, strata, and cluster variables were included to correctly estimate variance and to produce national estimates from the stratified sample. Pearson’s chi-squared test was used to compare age, sex, ECI, and insurance status between RA and non-RA patients undergoing shoulder arthroplasty.

Bivariate and multivariate logistic regressions were subsequently used to compare the rates of adverse events between RA and non-RA patients undergoing shoulder arthroplasty (non-RA cases were used as the reference). Multivariate linear regressions were used to compare hospital length of stay and hospitalization costs between RA and non-RA patients undergoing shoulder arthroplasty. The multivariate regressions were adjusted for baseline differences in age, sex, ECI, and insurance status. Cochran-Armitage tests for trend were used to assess trends over time. All tests were 2-tailed, and the statistical difference was established at a 2-sided α level of 0.05 (P < .05).

RESULTS

Overall, we identified 332,593 patients who underwent shoulder arthroplasty in the US between 2002 and 2011, of which 17,883 patients (5.4%) had a diagnosis of RA. In comparison with non-RA patients undergoing shoulder arthroplasty, patients with RA at the time of shoulder arthroplasty were significantly younger (65.2 ± 12.5 years vs 68.4 ± 11.0 years, P < .001), included a significantly greater proportion of female patients (76.7% vs 53.8%, P < .001), and included a significantly higher proportion of patients with Medicaid insurance (3.6% vs 2.3%, P < .001). There were no significant differences in the mean ECI between patients with and without a diagnosis of RA (Table 1). As depicted in Table 1, there were significant differences in the utilization of specific shoulder arthroplasty types between patients with and without RA, whereby a significantly greater proportion of RA patients underwent hemiarthroplasty (HA) (31.6% vs 29.3%, P = .002) and reverse TSA (7.7% vs 6.6%, P = .002), whereas a significantly greater proportion of non-RA patients underwent anatomic SA (64.0% vs 60.8%, P = .002).

Over the study period from 2002 to 2011, there was a significant increase in the overall utilization of shoulder arthroplasty in RA patients, as indicated by both the absolute number and the proportion of patients with a diagnosis of RA (P < .001) (Table 2, Figure). More specifically, 0.39% of RA patients underwent shoulder arthroplasty in 2002, as compared with 0.58% of RA patients in 2011 (P < .001) (Table 2). With respect to specific arthroplasty types, there was an exponential rise in the utilization of reverse TSA beginning in 2010 and a corresponding decrease in the rates of both HA and anatomic TSA (Table 2, Figure). In addition to changes in shoulder arthroplasty utilization over time among RA patients, we also observed a significant increase in the number of RA patients undergoing shoulder arthroplasty with a corresponding diagnosis of rotator cuff disease (9.7% in 2002 to 15.2% in 2011, P < .001).

Table 2. The Annual Utilization of Shoulder Arthroplasty Among Patients with a Diagnosis of Rheumatoid Arthritis.

^aRate determined as number of RA patients undergoing shoulder arthroplasty compared to the number of patients with an RA diagnosis in the stated calendar year.

Abbreviations: HA, hemiarthroplasty; RA, rheumatoid arthritis; TSA, total shoulder arthroplasty.

Continue to: Among patients with RA...

Among patients with RA undergoing shoulder arthroplasty, the overall rate of early adverse events was 3.12%, of which the most common early adverse events were urinary tract infections (1.8%), acute kidney injury (0.66%), and pneumonia (0.38%) (Table 3). As compared with patients without a diagnosis of RA undergoing shoulder arthroplasty, there were no significant differences in the overall and individual rates of early adverse events (Table 3).

Table 3. A Comparison of Early Adverse Events, Length of Stay, and Cost Between Patients With and Without Rheumatoid Arthritis (RA) Undergoing Shoulder Arthroplasty

^aReported in days. ^bReported in 2011 US dollars, adjusted for inflation.

The mean length of stay following shoulder arthroplasty in RA patients was 2.4 ± 1.6 days, and the mean hospitalization cost was $14,787 ± $7625 (Table 3). As compared with non-RA patients undergoing shoulder arthroplasty, there were no significant differences in the mean hospitalization costs; however, non-RA patients had a significantly shorter length of stay by 0.1 days (P = .002) (Table 3).

DISCUSSION

In this study, we observed that the utilization of shoulder arthroplasty in patients with RA increased significantly in the decade from 2002 to 2011, largely related to a rise in TSA. Interestingly, we also observed a corresponding rise in the proportion of RA patients undergoing shoulder arthroplasty with a diagnosis of rotator cuff disease, and we believe that this may partly account for the recent increase in the use of the reverse TSA in this patient population. Additionally, we found shoulder arthroplasty in RA patients to be safe in the early postoperative period, with no significant increase in cost as compared with patients undergoing shoulder arthroplasty without a diagnosis of RA. Although we did observe a significant increase in length of stay among RA patients as compared with non-RA patients, the absolute difference was only 0.1 days, and given the aforementioned similarities in cost between RA and non-RA patients, we do not believe this difference to be clinically significant.

It has been theorized that the utilization of TJA in RA patients has been decreasing with improvements in medical management; however, this is largely based upon literature pertaining to lower extremity TJA.² On the contrary, past research pertaining to the utilization of shoulder arthroplasty in RA patients has been highly variable. For instance, a Swedish study demonstrated a statistically significant decrease in admissions associated with RA-related upper limb surgery and a stable rate of shoulder arthroplasty between 1998 and 2004.⁷ Similarly, a Finnish study demonstrated that the annual incidence of primary joint arthroplasty in RA patients had declined from 1995 to 2010, with a greater decline for upper-limb arthroplasty as compared with lower-limb arthroplasty.⁸ Despite these European observations, Jain and colleagues⁹ reported an increasing rate of TSA among RA patients in the US between the years 1992 and 2005. In this study, we demonstrate a clear increase in the utilization of shoulder arthroplasty among RA patients between 2002 and 2011. What was most striking about our observation was that the rise in utilization appeared to be driven by an increase in TSA, whereas the utilization of HA decreased over time. This change in practice likely reflects several factors, including the multitude of studies that have demonstrated improved outcomes with anatomic TSA as compared with HA in RA patients.^10-14

Perhaps the most interesting aspect of our data was the recent exponential rise in the utilization of the reverse TSA. Despite improved outcomes following TSA as compared with HA in RA patients, these outcomes all appear to be highly dependent upon the integrity of the rotator cuff.¹⁰ In fact, there is evidence that failure of the rotator cuff could be as high as 75% within 10 years of TSA in patients with RA,¹⁵ which ultimately could jeopardize the long-term durability of the TSA implant in this patient population.¹¹ For this reason, interest in the reverse TSA for the RA patient population has increased since its introduction in the US in 2004;¹⁶ in fact, in RA patients with end-stage inflammatory arthropathy and a damaged rotator cuff, the reverse TSA has demonstrated excellent results.^17-20 Based upon this evidence, it is not surprising that we found an exponential rise in the use of the reverse TSA since 2010, which corresponds to the introduction of an ICD-9 code for this implant.²¹ Prior to 2010, it is likely that many implanted reverse TSAs were coded as TSA, and for this reason, we believe that the observed rise in the utilization of TSA in RA patients prior to 2010 may have been partly fueled by an increase in the use of the reverse TSA. To further support this theory, there was a dramatic decrease in the use of anatomic TSA following 2010, and we believe this was related to increased awareness of the newly introduced reverse TSA code among surgeons.

Another consideration when examining the utilization of shoulder arthroplasty in RA patients is its versatility in managing different disease states, including rotator cuff disease. As has been documented in the literature, outcomes of rotator cuff repair in RA patients are discouraging.²² For this reason, it is reasonable for surgeons and patients with RA to consider alternatives to rotator cuff repair when nonoperative management has failed to provide adequate improvement in symptoms. One alternative may be shoulder arthroplasty, namely the reverse TSA. In this study, we observed a significant increase in the rate of diagnosis of rotator cuff disease among RA patients undergoing shoulder arthroplasty from 2002 to 2011 (9.7% in 2002 to 15.2% in 2011, P < .001), and it is our belief that the simultaneous increase in the diagnosis of rotator cuff disease and use of TSA is not coincidental. More specifically, there is likely an emerging trend among surgeons toward using the reverse TSA to manage rotator cuff tears in the RA population, rather than undertaking a rotator cuff repair that carries a high rate of failure. Going forward, there is a need to not only identify this trend more clearly but to also compare the outcomes between reverse TSA and rotator cuff repair in the management of rotator cuff tears in RA patients.

Continue to: In this study, we observed...

In this study, we observed that RA patients undergoing shoulder arthroplasty were significantly younger than non-RA patients undergoing shoulder arthroplasty. At first, this observation seems to counter recent literature suggesting that the age of patients with inflammatory arthropathy undergoing TJA is increasing over time;¹ however, looking more closely at the data, it becomes clearer that the mean age we report is actually a relative increase as compared with past clinical studies pertaining to RA patients undergoing shoulder arthroplasty (mean ages of 47 years,²³ 55 years,²⁴ 60 years,¹⁰ and 62 years²⁵). On the other hand, the continued existence of an age gap between RA and non-RA patients undergoing shoulder arthroplasty may be the result of several possible phenomena. First, this may reflect issues with patient access to and coverage of expensive biologic antirheumatic medication that would otherwise mitigate disease progression. For instance, the out-of-pocket expense for biologic medication through Medicaid and Medicare is substantial,²⁶ which has direct implications on over two-thirds of our RA cohort. Second, it may be skewed by the proportion of RA patients who have previously been or continue to be poorly managed, enabling disease progression to end-stage arthropathy at a younger age. Ultimately, further investigation is needed to determine the reasons for this continued age disparity.

In comparing RA and non-RA patients undergoing shoulder arthroplasty, we did not find a significant difference in the overall nor the individual rates of early adverse events. This finding appears to be unique, as similar studies pertaining to total knee arthroplasty (TKA) demonstrated a significantly higher incidence of postoperative pneumonia and bleeding requiring transfusion among RA patients as compared with non-RA patients.²⁷ In patients with RA being treated with biologic medication and undergoing shoulder arthroplasty, the frequent concern in the postoperative period is the integrity of the wound and the potential for infection.²⁸ In this study, we did not find a significant difference in the rate of early infection, and although the difference in the rate of early wound dehiscence approached significance, it did not meet the threshold of 0.05 (P = .09). This finding is in keeping with the aforementioned NIS study pertaining to TKA, and we believe that it likely reflects the short duration of follow-up for patients in both studies. Given the nature of the database we utilized, we were only privy to complications that arose during the inpatient hospital stay, and it is likely that the clear majority of patients who develop a postoperative infection or wound dehiscence do so in the postoperative setting following discharge. A second concern regarding postoperative wound complications is the management of biologic medication in the perioperative period, which we cannot determine using this database. Despite all these limitations specific to this database, a past systematic review of reverse TSA in RA patients found a low rate of deep infection after reverse TSA in RA patients (3.3%),¹⁷ which was not higher than that after shoulder arthroplasty performed in non-RA patients.

A final demonstration from this study is that the hospital length of stay was significantly longer for RA patients than non-RA patients undergoing shoulder arthroplasty; however, given that the difference was only 0.1 days, and there was no significant difference in hospitalization cost, we are inclined to believe that statistical significance may not translate into clinical significance in this scenario. Ultimately, we do believe that length of stay is an important consideration in the current healthcare system, and given our finding that shoulder arthroplasty in the RA patient is safe in the early postoperative period, that a prolonged postoperative hospitalization is not warranted on the sole basis of a patient’s history of RA.

As with all studies using data from a search of an administrative database, such as the NIS database, this study has limitations. First, this type of research is limited by the reliability of both diagnosis and procedural coding. Although the NIS database has demonstrated high reliability,³ it is still possible that events may have been miscoded. Second, the tracking period for adverse events is limited to the inpatient hospital stay, which may be too short to detect certain postoperative complications. As such, the rates we report are likely underestimates of the true incidence of these complications, but this is true for both the RA and non-RA populations. Third, the comparisons we draw between RA and non-RA patients are limited to the scope of the NIS database and the available data; as such, we could not draw comparisons between preoperative disease stage, intraoperative findings, and postoperative course following hospital discharge. Lastly, our data are limited to a distinct period between 2002 and 2011 and may not reflect current practice. Ultimately, our findings may underestimate current trends in shoulder arthroplasty utilization among RA patients, particularly for the reverse TSA.

CONCLUSION

In this study, we found that the utilization of shoulder arthroplasty in patients with RA increased significantly from 2002 to 2011, largely related to a rise in the utilization of TSA. Similarly, we observed a rise in the proportion of RA patients undergoing shoulder arthroplasty with a corresponding diagnosis of rotator cuff disease, and we believe the increased utilization of shoulder arthroplasty among RA patients resulted from management of both end-stage inflammatory arthropathy and rotator cuff disease. Although we did not find a significant difference between RA and non-RA patients in the rates of early adverse events and overall hospitalization costs following shoulder arthroplasty, length of stay was significantly longer among RA patients; however, the absolute difference does not appear to be clinically significant.

ABSTRACT

It has been suggested that the utilization of joint arthroplasty in patients with rheumatoid arthritis (RA) is decreasing; however, this observation is largely based upon evidence pertaining to lower-extremity joint arthroplasty. It remains unknown if these observed trends also hold true for shoulder arthroplasty. The purpose of this study is to utilize a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. Secondarily, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and to compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. Using a large population database in the US, we determined the annual rates of shoulder arthroplasty (overall and individual) in RA patients between 2002 and 2011. Early adverse events, length of stay, and hospitalization costs were determined and compared with those of non-RA patients undergoing shoulder arthroplasty. Overall, we identified 332,593 patients who underwent shoulder arthroplasty between 2002 and 2011, of whom 17,883 patients (5.4%) had a diagnosis of RA. Over the study period, there was a significant increase in the utilization of shoulder arthroplasty in RA patients, particularly total shoulder arthroplasty. Over the same period, there was a significant increase in the number of RA patients who underwent shoulder arthroplasty with a diagnosis of rotator cuff disease. There were no significant differences in adverse events or mean hospitalization costs between RA and non-RA patients. Non-RA patients had a significantly shorter length of stay; however, the difference did not appear to be clinically significant. In conclusion, the utilization of shoulder arthroplasty in patients with RA significantly increased from 2002 to 2011, which may partly reflect a trend toward management of rotator cuff disease with arthroplasty rather than repair.

Continue to: It has been suggested...

It has been suggested that the utilization of total joint arthroplasty (TJA) in patients with rheumatoid arthritis (RA) is decreasing over time;¹ however, this observation is largely based upon evidence pertaining to lower extremity TJA.² It remains unknown if these observed trends also hold true for shoulder arthroplasty, whereby the utilization of shoulder arthroplasty in RA patients is not limited to the management of end-stage inflammatory arthropathy. In this study, we used a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. As a secondary objective, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. We hypothesize that the utilization of shoulder arthroplasty in RA patients would be decreasing, but adverse events, length of stay, and hospitalization costs would not differ between patients with and without RA undergoing shoulder arthroplasty.

METHODS

We conducted a retrospective cohort study using the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) from 2002 to 2011.³ The NIS comprises a 20% stratified sample of all hospital discharges in the US. The NIS includes information about patient characteristics (age, sex, insurance status, and medical comorbidities) and hospitalization outcomes (adverse events, costs, and length of stay). The NIS allows identification of hospitalizations according to procedures and diagnoses using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Given the anonymity of this study, it was exempt from Institutional Review Board ethics approval.

Hospitalizations were selected for the study based on ICD-9-CM procedural codes for hemiarthroplasty (81.81), anatomic total shoulder arthroplasty (TSA) (81.80), and reverse TSA (81.88). These patients were then stratified by an ICD-9-CM diagnosis of RA (714.X). We also utilized ICD-9-CM diagnosis codes to determine the presence of rotator cuff pathology at the time of shoulder arthroplasty (726.13, 727.61, 840.4) and to exclude patients with a history of trauma (812.X, 716.11, 733.8X). In a separate analysis, all patients in the NIS database with an ICD-9-CM diagnosis of RA were identified for each calendar year of the study, and a national estimate of RA patients was generated annually to assess overall and individual utilization rates of shoulder arthroplasty in this population (the national estimate served as the denominator).

Preoperative patient data withdrawn from the NIS included age, sex, insurance status, and medical comorbidities. An Elixhauser Comorbidity Index (ECI) was generated for each patient based on the presence of 29 comorbid conditions. The ECI was chosen because of its capacity to accurately predict mortality and represent the patient burden of comorbidities in similar administrative database studies.^4-6

Early adverse events were also chosen based on ICD-9-CM diagnosis codes (Appendix A), and included the following: death, acute kidney injury, cardiac arrest, thromboembolic event, myocardial infarction, peripheral nerve injury, pneumonia, sepsis, stroke, surgical site infection, urinary tract infection, and wound dehiscence. The overall adverse event rate was defined as the occurrence of ≥1 of the above adverse events in a patient.

Appendix A. ICD-9-CM Codes Corresponding to Postoperative Adverse Events

Abbreviation: ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification

Length of stay and total hospital charges were available for each patient. Length of stay represents the number of calendar days a patient stayed in the hospital. All hospital charges were converted to hospitalization costs using the HCUP Cost-to-Charge Ratio Files. All hospitalization costs were adjusted for inflation using the US Bureau of Labor statistics yearly inflation calculator to represent charges in the year 2011, which was the final and most recent year in this study.

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

Statistical analyses were conducted using Stata version 13.1 (StataCorp, LP). All analyses took into account the complex survey design of the NIS. Discharge weights, strata, and cluster variables were included to correctly estimate variance and to produce national estimates from the stratified sample. Pearson’s chi-squared test was used to compare age, sex, ECI, and insurance status between RA and non-RA patients undergoing shoulder arthroplasty.

Bivariate and multivariate logistic regressions were subsequently used to compare the rates of adverse events between RA and non-RA patients undergoing shoulder arthroplasty (non-RA cases were used as the reference). Multivariate linear regressions were used to compare hospital length of stay and hospitalization costs between RA and non-RA patients undergoing shoulder arthroplasty. The multivariate regressions were adjusted for baseline differences in age, sex, ECI, and insurance status. Cochran-Armitage tests for trend were used to assess trends over time. All tests were 2-tailed, and the statistical difference was established at a 2-sided α level of 0.05 (P < .05).

RESULTS

Overall, we identified 332,593 patients who underwent shoulder arthroplasty in the US between 2002 and 2011, of which 17,883 patients (5.4%) had a diagnosis of RA. In comparison with non-RA patients undergoing shoulder arthroplasty, patients with RA at the time of shoulder arthroplasty were significantly younger (65.2 ± 12.5 years vs 68.4 ± 11.0 years, P < .001), included a significantly greater proportion of female patients (76.7% vs 53.8%, P < .001), and included a significantly higher proportion of patients with Medicaid insurance (3.6% vs 2.3%, P < .001). There were no significant differences in the mean ECI between patients with and without a diagnosis of RA (Table 1). As depicted in Table 1, there were significant differences in the utilization of specific shoulder arthroplasty types between patients with and without RA, whereby a significantly greater proportion of RA patients underwent hemiarthroplasty (HA) (31.6% vs 29.3%, P = .002) and reverse TSA (7.7% vs 6.6%, P = .002), whereas a significantly greater proportion of non-RA patients underwent anatomic SA (64.0% vs 60.8%, P = .002).

Over the study period from 2002 to 2011, there was a significant increase in the overall utilization of shoulder arthroplasty in RA patients, as indicated by both the absolute number and the proportion of patients with a diagnosis of RA (P < .001) (Table 2, Figure). More specifically, 0.39% of RA patients underwent shoulder arthroplasty in 2002, as compared with 0.58% of RA patients in 2011 (P < .001) (Table 2). With respect to specific arthroplasty types, there was an exponential rise in the utilization of reverse TSA beginning in 2010 and a corresponding decrease in the rates of both HA and anatomic TSA (Table 2, Figure). In addition to changes in shoulder arthroplasty utilization over time among RA patients, we also observed a significant increase in the number of RA patients undergoing shoulder arthroplasty with a corresponding diagnosis of rotator cuff disease (9.7% in 2002 to 15.2% in 2011, P < .001).

Table 2. The Annual Utilization of Shoulder Arthroplasty Among Patients with a Diagnosis of Rheumatoid Arthritis.

^aRate determined as number of RA patients undergoing shoulder arthroplasty compared to the number of patients with an RA diagnosis in the stated calendar year.

Abbreviations: HA, hemiarthroplasty; RA, rheumatoid arthritis; TSA, total shoulder arthroplasty.

Continue to: Among patients with RA...

Among patients with RA undergoing shoulder arthroplasty, the overall rate of early adverse events was 3.12%, of which the most common early adverse events were urinary tract infections (1.8%), acute kidney injury (0.66%), and pneumonia (0.38%) (Table 3). As compared with patients without a diagnosis of RA undergoing shoulder arthroplasty, there were no significant differences in the overall and individual rates of early adverse events (Table 3).

Table 3. A Comparison of Early Adverse Events, Length of Stay, and Cost Between Patients With and Without Rheumatoid Arthritis (RA) Undergoing Shoulder Arthroplasty

^aReported in days. ^bReported in 2011 US dollars, adjusted for inflation.

The mean length of stay following shoulder arthroplasty in RA patients was 2.4 ± 1.6 days, and the mean hospitalization cost was $14,787 ± $7625 (Table 3). As compared with non-RA patients undergoing shoulder arthroplasty, there were no significant differences in the mean hospitalization costs; however, non-RA patients had a significantly shorter length of stay by 0.1 days (P = .002) (Table 3).

DISCUSSION

In this study, we observed that the utilization of shoulder arthroplasty in patients with RA increased significantly in the decade from 2002 to 2011, largely related to a rise in TSA. Interestingly, we also observed a corresponding rise in the proportion of RA patients undergoing shoulder arthroplasty with a diagnosis of rotator cuff disease, and we believe that this may partly account for the recent increase in the use of the reverse TSA in this patient population. Additionally, we found shoulder arthroplasty in RA patients to be safe in the early postoperative period, with no significant increase in cost as compared with patients undergoing shoulder arthroplasty without a diagnosis of RA. Although we did observe a significant increase in length of stay among RA patients as compared with non-RA patients, the absolute difference was only 0.1 days, and given the aforementioned similarities in cost between RA and non-RA patients, we do not believe this difference to be clinically significant.

It has been theorized that the utilization of TJA in RA patients has been decreasing with improvements in medical management; however, this is largely based upon literature pertaining to lower extremity TJA.² On the contrary, past research pertaining to the utilization of shoulder arthroplasty in RA patients has been highly variable. For instance, a Swedish study demonstrated a statistically significant decrease in admissions associated with RA-related upper limb surgery and a stable rate of shoulder arthroplasty between 1998 and 2004.⁷ Similarly, a Finnish study demonstrated that the annual incidence of primary joint arthroplasty in RA patients had declined from 1995 to 2010, with a greater decline for upper-limb arthroplasty as compared with lower-limb arthroplasty.⁸ Despite these European observations, Jain and colleagues⁹ reported an increasing rate of TSA among RA patients in the US between the years 1992 and 2005. In this study, we demonstrate a clear increase in the utilization of shoulder arthroplasty among RA patients between 2002 and 2011. What was most striking about our observation was that the rise in utilization appeared to be driven by an increase in TSA, whereas the utilization of HA decreased over time. This change in practice likely reflects several factors, including the multitude of studies that have demonstrated improved outcomes with anatomic TSA as compared with HA in RA patients.^10-14

Perhaps the most interesting aspect of our data was the recent exponential rise in the utilization of the reverse TSA. Despite improved outcomes following TSA as compared with HA in RA patients, these outcomes all appear to be highly dependent upon the integrity of the rotator cuff.¹⁰ In fact, there is evidence that failure of the rotator cuff could be as high as 75% within 10 years of TSA in patients with RA,¹⁵ which ultimately could jeopardize the long-term durability of the TSA implant in this patient population.¹¹ For this reason, interest in the reverse TSA for the RA patient population has increased since its introduction in the US in 2004;¹⁶ in fact, in RA patients with end-stage inflammatory arthropathy and a damaged rotator cuff, the reverse TSA has demonstrated excellent results.^17-20 Based upon this evidence, it is not surprising that we found an exponential rise in the use of the reverse TSA since 2010, which corresponds to the introduction of an ICD-9 code for this implant.²¹ Prior to 2010, it is likely that many implanted reverse TSAs were coded as TSA, and for this reason, we believe that the observed rise in the utilization of TSA in RA patients prior to 2010 may have been partly fueled by an increase in the use of the reverse TSA. To further support this theory, there was a dramatic decrease in the use of anatomic TSA following 2010, and we believe this was related to increased awareness of the newly introduced reverse TSA code among surgeons.

Another consideration when examining the utilization of shoulder arthroplasty in RA patients is its versatility in managing different disease states, including rotator cuff disease. As has been documented in the literature, outcomes of rotator cuff repair in RA patients are discouraging.²² For this reason, it is reasonable for surgeons and patients with RA to consider alternatives to rotator cuff repair when nonoperative management has failed to provide adequate improvement in symptoms. One alternative may be shoulder arthroplasty, namely the reverse TSA. In this study, we observed a significant increase in the rate of diagnosis of rotator cuff disease among RA patients undergoing shoulder arthroplasty from 2002 to 2011 (9.7% in 2002 to 15.2% in 2011, P < .001), and it is our belief that the simultaneous increase in the diagnosis of rotator cuff disease and use of TSA is not coincidental. More specifically, there is likely an emerging trend among surgeons toward using the reverse TSA to manage rotator cuff tears in the RA population, rather than undertaking a rotator cuff repair that carries a high rate of failure. Going forward, there is a need to not only identify this trend more clearly but to also compare the outcomes between reverse TSA and rotator cuff repair in the management of rotator cuff tears in RA patients.

Continue to: In this study, we observed...

In this study, we observed that RA patients undergoing shoulder arthroplasty were significantly younger than non-RA patients undergoing shoulder arthroplasty. At first, this observation seems to counter recent literature suggesting that the age of patients with inflammatory arthropathy undergoing TJA is increasing over time;¹ however, looking more closely at the data, it becomes clearer that the mean age we report is actually a relative increase as compared with past clinical studies pertaining to RA patients undergoing shoulder arthroplasty (mean ages of 47 years,²³ 55 years,²⁴ 60 years,¹⁰ and 62 years²⁵). On the other hand, the continued existence of an age gap between RA and non-RA patients undergoing shoulder arthroplasty may be the result of several possible phenomena. First, this may reflect issues with patient access to and coverage of expensive biologic antirheumatic medication that would otherwise mitigate disease progression. For instance, the out-of-pocket expense for biologic medication through Medicaid and Medicare is substantial,²⁶ which has direct implications on over two-thirds of our RA cohort. Second, it may be skewed by the proportion of RA patients who have previously been or continue to be poorly managed, enabling disease progression to end-stage arthropathy at a younger age. Ultimately, further investigation is needed to determine the reasons for this continued age disparity.

In comparing RA and non-RA patients undergoing shoulder arthroplasty, we did not find a significant difference in the overall nor the individual rates of early adverse events. This finding appears to be unique, as similar studies pertaining to total knee arthroplasty (TKA) demonstrated a significantly higher incidence of postoperative pneumonia and bleeding requiring transfusion among RA patients as compared with non-RA patients.²⁷ In patients with RA being treated with biologic medication and undergoing shoulder arthroplasty, the frequent concern in the postoperative period is the integrity of the wound and the potential for infection.²⁸ In this study, we did not find a significant difference in the rate of early infection, and although the difference in the rate of early wound dehiscence approached significance, it did not meet the threshold of 0.05 (P = .09). This finding is in keeping with the aforementioned NIS study pertaining to TKA, and we believe that it likely reflects the short duration of follow-up for patients in both studies. Given the nature of the database we utilized, we were only privy to complications that arose during the inpatient hospital stay, and it is likely that the clear majority of patients who develop a postoperative infection or wound dehiscence do so in the postoperative setting following discharge. A second concern regarding postoperative wound complications is the management of biologic medication in the perioperative period, which we cannot determine using this database. Despite all these limitations specific to this database, a past systematic review of reverse TSA in RA patients found a low rate of deep infection after reverse TSA in RA patients (3.3%),¹⁷ which was not higher than that after shoulder arthroplasty performed in non-RA patients.

A final demonstration from this study is that the hospital length of stay was significantly longer for RA patients than non-RA patients undergoing shoulder arthroplasty; however, given that the difference was only 0.1 days, and there was no significant difference in hospitalization cost, we are inclined to believe that statistical significance may not translate into clinical significance in this scenario. Ultimately, we do believe that length of stay is an important consideration in the current healthcare system, and given our finding that shoulder arthroplasty in the RA patient is safe in the early postoperative period, that a prolonged postoperative hospitalization is not warranted on the sole basis of a patient’s history of RA.

As with all studies using data from a search of an administrative database, such as the NIS database, this study has limitations. First, this type of research is limited by the reliability of both diagnosis and procedural coding. Although the NIS database has demonstrated high reliability,³ it is still possible that events may have been miscoded. Second, the tracking period for adverse events is limited to the inpatient hospital stay, which may be too short to detect certain postoperative complications. As such, the rates we report are likely underestimates of the true incidence of these complications, but this is true for both the RA and non-RA populations. Third, the comparisons we draw between RA and non-RA patients are limited to the scope of the NIS database and the available data; as such, we could not draw comparisons between preoperative disease stage, intraoperative findings, and postoperative course following hospital discharge. Lastly, our data are limited to a distinct period between 2002 and 2011 and may not reflect current practice. Ultimately, our findings may underestimate current trends in shoulder arthroplasty utilization among RA patients, particularly for the reverse TSA.

CONCLUSION

In this study, we found that the utilization of shoulder arthroplasty in patients with RA increased significantly from 2002 to 2011, largely related to a rise in the utilization of TSA. Similarly, we observed a rise in the proportion of RA patients undergoing shoulder arthroplasty with a corresponding diagnosis of rotator cuff disease, and we believe the increased utilization of shoulder arthroplasty among RA patients resulted from management of both end-stage inflammatory arthropathy and rotator cuff disease. Although we did not find a significant difference between RA and non-RA patients in the rates of early adverse events and overall hospitalization costs following shoulder arthroplasty, length of stay was significantly longer among RA patients; however, the absolute difference does not appear to be clinically significant.

ABSTRACT

It has been suggested that the utilization of joint arthroplasty in patients with rheumatoid arthritis (RA) is decreasing; however, this observation is largely based upon evidence pertaining to lower-extremity joint arthroplasty. It remains unknown if these observed trends also hold true for shoulder arthroplasty. The purpose of this study is to utilize a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. Secondarily, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and to compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. Using a large population database in the US, we determined the annual rates of shoulder arthroplasty (overall and individual) in RA patients between 2002 and 2011. Early adverse events, length of stay, and hospitalization costs were determined and compared with those of non-RA patients undergoing shoulder arthroplasty. Overall, we identified 332,593 patients who underwent shoulder arthroplasty between 2002 and 2011, of whom 17,883 patients (5.4%) had a diagnosis of RA. Over the study period, there was a significant increase in the utilization of shoulder arthroplasty in RA patients, particularly total shoulder arthroplasty. Over the same period, there was a significant increase in the number of RA patients who underwent shoulder arthroplasty with a diagnosis of rotator cuff disease. There were no significant differences in adverse events or mean hospitalization costs between RA and non-RA patients. Non-RA patients had a significantly shorter length of stay; however, the difference did not appear to be clinically significant. In conclusion, the utilization of shoulder arthroplasty in patients with RA significantly increased from 2002 to 2011, which may partly reflect a trend toward management of rotator cuff disease with arthroplasty rather than repair.

Continue to: It has been suggested...

It has been suggested that the utilization of total joint arthroplasty (TJA) in patients with rheumatoid arthritis (RA) is decreasing over time;¹ however, this observation is largely based upon evidence pertaining to lower extremity TJA.² It remains unknown if these observed trends also hold true for shoulder arthroplasty, whereby the utilization of shoulder arthroplasty in RA patients is not limited to the management of end-stage inflammatory arthropathy. In this study, we used a nationally representative population database in the US to identify trends in the utilization of shoulder arthroplasty among patients with RA. As a secondary objective, we sought to determine the rate of early adverse events, length of stay, and hospitalization costs associated with RA patients undergoing shoulder arthroplasty and compare these outcomes to those of patients without a diagnosis of RA undergoing shoulder arthroplasty. We hypothesize that the utilization of shoulder arthroplasty in RA patients would be decreasing, but adverse events, length of stay, and hospitalization costs would not differ between patients with and without RA undergoing shoulder arthroplasty.

METHODS

We conducted a retrospective cohort study using the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) from 2002 to 2011.³ The NIS comprises a 20% stratified sample of all hospital discharges in the US. The NIS includes information about patient characteristics (age, sex, insurance status, and medical comorbidities) and hospitalization outcomes (adverse events, costs, and length of stay). The NIS allows identification of hospitalizations according to procedures and diagnoses using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Given the anonymity of this study, it was exempt from Institutional Review Board ethics approval.

Hospitalizations were selected for the study based on ICD-9-CM procedural codes for hemiarthroplasty (81.81), anatomic total shoulder arthroplasty (TSA) (81.80), and reverse TSA (81.88). These patients were then stratified by an ICD-9-CM diagnosis of RA (714.X). We also utilized ICD-9-CM diagnosis codes to determine the presence of rotator cuff pathology at the time of shoulder arthroplasty (726.13, 727.61, 840.4) and to exclude patients with a history of trauma (812.X, 716.11, 733.8X). In a separate analysis, all patients in the NIS database with an ICD-9-CM diagnosis of RA were identified for each calendar year of the study, and a national estimate of RA patients was generated annually to assess overall and individual utilization rates of shoulder arthroplasty in this population (the national estimate served as the denominator).

Preoperative patient data withdrawn from the NIS included age, sex, insurance status, and medical comorbidities. An Elixhauser Comorbidity Index (ECI) was generated for each patient based on the presence of 29 comorbid conditions. The ECI was chosen because of its capacity to accurately predict mortality and represent the patient burden of comorbidities in similar administrative database studies.^4-6

Early adverse events were also chosen based on ICD-9-CM diagnosis codes (Appendix A), and included the following: death, acute kidney injury, cardiac arrest, thromboembolic event, myocardial infarction, peripheral nerve injury, pneumonia, sepsis, stroke, surgical site infection, urinary tract infection, and wound dehiscence. The overall adverse event rate was defined as the occurrence of ≥1 of the above adverse events in a patient.

Appendix A. ICD-9-CM Codes Corresponding to Postoperative Adverse Events

Abbreviation: ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification

Length of stay and total hospital charges were available for each patient. Length of stay represents the number of calendar days a patient stayed in the hospital. All hospital charges were converted to hospitalization costs using the HCUP Cost-to-Charge Ratio Files. All hospitalization costs were adjusted for inflation using the US Bureau of Labor statistics yearly inflation calculator to represent charges in the year 2011, which was the final and most recent year in this study.

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

Statistical analyses were conducted using Stata version 13.1 (StataCorp, LP). All analyses took into account the complex survey design of the NIS. Discharge weights, strata, and cluster variables were included to correctly estimate variance and to produce national estimates from the stratified sample. Pearson’s chi-squared test was used to compare age, sex, ECI, and insurance status between RA and non-RA patients undergoing shoulder arthroplasty.

Bivariate and multivariate logistic regressions were subsequently used to compare the rates of adverse events between RA and non-RA patients undergoing shoulder arthroplasty (non-RA cases were used as the reference). Multivariate linear regressions were used to compare hospital length of stay and hospitalization costs between RA and non-RA patients undergoing shoulder arthroplasty. The multivariate regressions were adjusted for baseline differences in age, sex, ECI, and insurance status. Cochran-Armitage tests for trend were used to assess trends over time. All tests were 2-tailed, and the statistical difference was established at a 2-sided α level of 0.05 (P < .05).

RESULTS

Overall, we identified 332,593 patients who underwent shoulder arthroplasty in the US between 2002 and 2011, of which 17,883 patients (5.4%) had a diagnosis of RA. In comparison with non-RA patients undergoing shoulder arthroplasty, patients with RA at the time of shoulder arthroplasty were significantly younger (65.2 ± 12.5 years vs 68.4 ± 11.0 years, P < .001), included a significantly greater proportion of female patients (76.7% vs 53.8%, P < .001), and included a significantly higher proportion of patients with Medicaid insurance (3.6% vs 2.3%, P < .001). There were no significant differences in the mean ECI between patients with and without a diagnosis of RA (Table 1). As depicted in Table 1, there were significant differences in the utilization of specific shoulder arthroplasty types between patients with and without RA, whereby a significantly greater proportion of RA patients underwent hemiarthroplasty (HA) (31.6% vs 29.3%, P = .002) and reverse TSA (7.7% vs 6.6%, P = .002), whereas a significantly greater proportion of non-RA patients underwent anatomic SA (64.0% vs 60.8%, P = .002).

Over the study period from 2002 to 2011, there was a significant increase in the overall utilization of shoulder arthroplasty in RA patients, as indicated by both the absolute number and the proportion of patients with a diagnosis of RA (P < .001) (Table 2, Figure). More specifically, 0.39% of RA patients underwent shoulder arthroplasty in 2002, as compared with 0.58% of RA patients in 2011 (P < .001) (Table 2). With respect to specific arthroplasty types, there was an exponential rise in the utilization of reverse TSA beginning in 2010 and a corresponding decrease in the rates of both HA and anatomic TSA (Table 2, Figure). In addition to changes in shoulder arthroplasty utilization over time among RA patients, we also observed a significant increase in the number of RA patients undergoing shoulder arthroplasty with a corresponding diagnosis of rotator cuff disease (9.7% in 2002 to 15.2% in 2011, P < .001).

Table 2. The Annual Utilization of Shoulder Arthroplasty Among Patients with a Diagnosis of Rheumatoid Arthritis.

^aRate determined as number of RA patients undergoing shoulder arthroplasty compared to the number of patients with an RA diagnosis in the stated calendar year.

Abbreviations: HA, hemiarthroplasty; RA, rheumatoid arthritis; TSA, total shoulder arthroplasty.

Continue to: Among patients with RA...

Among patients with RA undergoing shoulder arthroplasty, the overall rate of early adverse events was 3.12%, of which the most common early adverse events were urinary tract infections (1.8%), acute kidney injury (0.66%), and pneumonia (0.38%) (Table 3). As compared with patients without a diagnosis of RA undergoing shoulder arthroplasty, there were no significant differences in the overall and individual rates of early adverse events (Table 3).

Table 3. A Comparison of Early Adverse Events, Length of Stay, and Cost Between Patients With and Without Rheumatoid Arthritis (RA) Undergoing Shoulder Arthroplasty

^aReported in days. ^bReported in 2011 US dollars, adjusted for inflation.

The mean length of stay following shoulder arthroplasty in RA patients was 2.4 ± 1.6 days, and the mean hospitalization cost was $14,787 ± $7625 (Table 3). As compared with non-RA patients undergoing shoulder arthroplasty, there were no significant differences in the mean hospitalization costs; however, non-RA patients had a significantly shorter length of stay by 0.1 days (P = .002) (Table 3).

DISCUSSION

In this study, we observed that the utilization of shoulder arthroplasty in patients with RA increased significantly in the decade from 2002 to 2011, largely related to a rise in TSA. Interestingly, we also observed a corresponding rise in the proportion of RA patients undergoing shoulder arthroplasty with a diagnosis of rotator cuff disease, and we believe that this may partly account for the recent increase in the use of the reverse TSA in this patient population. Additionally, we found shoulder arthroplasty in RA patients to be safe in the early postoperative period, with no significant increase in cost as compared with patients undergoing shoulder arthroplasty without a diagnosis of RA. Although we did observe a significant increase in length of stay among RA patients as compared with non-RA patients, the absolute difference was only 0.1 days, and given the aforementioned similarities in cost between RA and non-RA patients, we do not believe this difference to be clinically significant.

It has been theorized that the utilization of TJA in RA patients has been decreasing with improvements in medical management; however, this is largely based upon literature pertaining to lower extremity TJA.² On the contrary, past research pertaining to the utilization of shoulder arthroplasty in RA patients has been highly variable. For instance, a Swedish study demonstrated a statistically significant decrease in admissions associated with RA-related upper limb surgery and a stable rate of shoulder arthroplasty between 1998 and 2004.⁷ Similarly, a Finnish study demonstrated that the annual incidence of primary joint arthroplasty in RA patients had declined from 1995 to 2010, with a greater decline for upper-limb arthroplasty as compared with lower-limb arthroplasty.⁸ Despite these European observations, Jain and colleagues⁹ reported an increasing rate of TSA among RA patients in the US between the years 1992 and 2005. In this study, we demonstrate a clear increase in the utilization of shoulder arthroplasty among RA patients between 2002 and 2011. What was most striking about our observation was that the rise in utilization appeared to be driven by an increase in TSA, whereas the utilization of HA decreased over time. This change in practice likely reflects several factors, including the multitude of studies that have demonstrated improved outcomes with anatomic TSA as compared with HA in RA patients.^10-14

Perhaps the most interesting aspect of our data was the recent exponential rise in the utilization of the reverse TSA. Despite improved outcomes following TSA as compared with HA in RA patients, these outcomes all appear to be highly dependent upon the integrity of the rotator cuff.¹⁰ In fact, there is evidence that failure of the rotator cuff could be as high as 75% within 10 years of TSA in patients with RA,¹⁵ which ultimately could jeopardize the long-term durability of the TSA implant in this patient population.¹¹ For this reason, interest in the reverse TSA for the RA patient population has increased since its introduction in the US in 2004;¹⁶ in fact, in RA patients with end-stage inflammatory arthropathy and a damaged rotator cuff, the reverse TSA has demonstrated excellent results.^17-20 Based upon this evidence, it is not surprising that we found an exponential rise in the use of the reverse TSA since 2010, which corresponds to the introduction of an ICD-9 code for this implant.²¹ Prior to 2010, it is likely that many implanted reverse TSAs were coded as TSA, and for this reason, we believe that the observed rise in the utilization of TSA in RA patients prior to 2010 may have been partly fueled by an increase in the use of the reverse TSA. To further support this theory, there was a dramatic decrease in the use of anatomic TSA following 2010, and we believe this was related to increased awareness of the newly introduced reverse TSA code among surgeons.

Another consideration when examining the utilization of shoulder arthroplasty in RA patients is its versatility in managing different disease states, including rotator cuff disease. As has been documented in the literature, outcomes of rotator cuff repair in RA patients are discouraging.²² For this reason, it is reasonable for surgeons and patients with RA to consider alternatives to rotator cuff repair when nonoperative management has failed to provide adequate improvement in symptoms. One alternative may be shoulder arthroplasty, namely the reverse TSA. In this study, we observed a significant increase in the rate of diagnosis of rotator cuff disease among RA patients undergoing shoulder arthroplasty from 2002 to 2011 (9.7% in 2002 to 15.2% in 2011, P < .001), and it is our belief that the simultaneous increase in the diagnosis of rotator cuff disease and use of TSA is not coincidental. More specifically, there is likely an emerging trend among surgeons toward using the reverse TSA to manage rotator cuff tears in the RA population, rather than undertaking a rotator cuff repair that carries a high rate of failure. Going forward, there is a need to not only identify this trend more clearly but to also compare the outcomes between reverse TSA and rotator cuff repair in the management of rotator cuff tears in RA patients.

Continue to: In this study, we observed...

In this study, we observed that RA patients undergoing shoulder arthroplasty were significantly younger than non-RA patients undergoing shoulder arthroplasty. At first, this observation seems to counter recent literature suggesting that the age of patients with inflammatory arthropathy undergoing TJA is increasing over time;¹ however, looking more closely at the data, it becomes clearer that the mean age we report is actually a relative increase as compared with past clinical studies pertaining to RA patients undergoing shoulder arthroplasty (mean ages of 47 years,²³ 55 years,²⁴ 60 years,¹⁰ and 62 years²⁵). On the other hand, the continued existence of an age gap between RA and non-RA patients undergoing shoulder arthroplasty may be the result of several possible phenomena. First, this may reflect issues with patient access to and coverage of expensive biologic antirheumatic medication that would otherwise mitigate disease progression. For instance, the out-of-pocket expense for biologic medication through Medicaid and Medicare is substantial,²⁶ which has direct implications on over two-thirds of our RA cohort. Second, it may be skewed by the proportion of RA patients who have previously been or continue to be poorly managed, enabling disease progression to end-stage arthropathy at a younger age. Ultimately, further investigation is needed to determine the reasons for this continued age disparity.

In comparing RA and non-RA patients undergoing shoulder arthroplasty, we did not find a significant difference in the overall nor the individual rates of early adverse events. This finding appears to be unique, as similar studies pertaining to total knee arthroplasty (TKA) demonstrated a significantly higher incidence of postoperative pneumonia and bleeding requiring transfusion among RA patients as compared with non-RA patients.²⁷ In patients with RA being treated with biologic medication and undergoing shoulder arthroplasty, the frequent concern in the postoperative period is the integrity of the wound and the potential for infection.²⁸ In this study, we did not find a significant difference in the rate of early infection, and although the difference in the rate of early wound dehiscence approached significance, it did not meet the threshold of 0.05 (P = .09). This finding is in keeping with the aforementioned NIS study pertaining to TKA, and we believe that it likely reflects the short duration of follow-up for patients in both studies. Given the nature of the database we utilized, we were only privy to complications that arose during the inpatient hospital stay, and it is likely that the clear majority of patients who develop a postoperative infection or wound dehiscence do so in the postoperative setting following discharge. A second concern regarding postoperative wound complications is the management of biologic medication in the perioperative period, which we cannot determine using this database. Despite all these limitations specific to this database, a past systematic review of reverse TSA in RA patients found a low rate of deep infection after reverse TSA in RA patients (3.3%),¹⁷ which was not higher than that after shoulder arthroplasty performed in non-RA patients.

A final demonstration from this study is that the hospital length of stay was significantly longer for RA patients than non-RA patients undergoing shoulder arthroplasty; however, given that the difference was only 0.1 days, and there was no significant difference in hospitalization cost, we are inclined to believe that statistical significance may not translate into clinical significance in this scenario. Ultimately, we do believe that length of stay is an important consideration in the current healthcare system, and given our finding that shoulder arthroplasty in the RA patient is safe in the early postoperative period, that a prolonged postoperative hospitalization is not warranted on the sole basis of a patient’s history of RA.

As with all studies using data from a search of an administrative database, such as the NIS database, this study has limitations. First, this type of research is limited by the reliability of both diagnosis and procedural coding. Although the NIS database has demonstrated high reliability,³ it is still possible that events may have been miscoded. Second, the tracking period for adverse events is limited to the inpatient hospital stay, which may be too short to detect certain postoperative complications. As such, the rates we report are likely underestimates of the true incidence of these complications, but this is true for both the RA and non-RA populations. Third, the comparisons we draw between RA and non-RA patients are limited to the scope of the NIS database and the available data; as such, we could not draw comparisons between preoperative disease stage, intraoperative findings, and postoperative course following hospital discharge. Lastly, our data are limited to a distinct period between 2002 and 2011 and may not reflect current practice. Ultimately, our findings may underestimate current trends in shoulder arthroplasty utilization among RA patients, particularly for the reverse TSA.

CONCLUSION

In this study, we found that the utilization of shoulder arthroplasty in patients with RA increased significantly from 2002 to 2011, largely related to a rise in the utilization of TSA. Similarly, we observed a rise in the proportion of RA patients undergoing shoulder arthroplasty with a corresponding diagnosis of rotator cuff disease, and we believe the increased utilization of shoulder arthroplasty among RA patients resulted from management of both end-stage inflammatory arthropathy and rotator cuff disease. Although we did not find a significant difference between RA and non-RA patients in the rates of early adverse events and overall hospitalization costs following shoulder arthroplasty, length of stay was significantly longer among RA patients; however, the absolute difference does not appear to be clinically significant.

SEATTLE – The overall regression rate of Barrett’s esophagus topped 70% after magnetic lower esophageal sphincter (LES) augmentation in 67 patients at the University of Southern California, Los Angeles.

The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.

Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”

Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.

Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.

The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.

“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.

Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.

At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.

Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.

Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).

There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.

Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.

The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m², but BMI ranged as high as 44.3.

Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.

Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).

About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.

Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.

The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
 

[email protected]

SOURCE: Alicuben E et al. WCE 2018, Abstract S095.

SEATTLE – The overall regression rate of Barrett’s esophagus topped 70% after magnetic lower esophageal sphincter (LES) augmentation in 67 patients at the University of Southern California, Los Angeles.

The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.

Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”

Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.

Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.

The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.

“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.

Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.

At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.

Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.

Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).

There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.

Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.

The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m², but BMI ranged as high as 44.3.

Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.

Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).

About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.

Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.

The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
 

[email protected]

SOURCE: Alicuben E et al. WCE 2018, Abstract S095.

SEATTLE – The overall regression rate of Barrett’s esophagus topped 70% after magnetic lower esophageal sphincter (LES) augmentation in 67 patients at the University of Southern California, Los Angeles.

The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.

Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”

Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.

Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.

The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.

“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.

Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.

At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.

Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.

Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).

There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.

Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.

The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m², but BMI ranged as high as 44.3.

Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.

Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).

About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.

Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.

The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
 

[email protected]

SOURCE: Alicuben E et al. WCE 2018, Abstract S095.

Adults with mild to moderate Parkinson’s disease showed reductions in free serum alpha-synuclein levels without notable side effects after intravenous treatment with a monoclonal antibody known as PRX002.

“Pathologically, PD [Parkinson’s disease] is typically associated with an accumulation of aggregated alpha-synuclein protein in the central nervous system and the peripheral nervous system,” making alpha-synuclein a target for treatment in preclinical studies, wrote Joseph Jankovic, MD, of Baylor College of Medicine, Houston, and his colleagues.

Kuo Chun Hung/Thinkstock

SOURCE: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.

Adults with mild to moderate Parkinson’s disease showed reductions in free serum alpha-synuclein levels without notable side effects after intravenous treatment with a monoclonal antibody known as PRX002.

“Pathologically, PD [Parkinson’s disease] is typically associated with an accumulation of aggregated alpha-synuclein protein in the central nervous system and the peripheral nervous system,” making alpha-synuclein a target for treatment in preclinical studies, wrote Joseph Jankovic, MD, of Baylor College of Medicine, Houston, and his colleagues.

Kuo Chun Hung/Thinkstock

SOURCE: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.

Adults with mild to moderate Parkinson’s disease showed reductions in free serum alpha-synuclein levels without notable side effects after intravenous treatment with a monoclonal antibody known as PRX002.

“Pathologically, PD [Parkinson’s disease] is typically associated with an accumulation of aggregated alpha-synuclein protein in the central nervous system and the peripheral nervous system,” making alpha-synuclein a target for treatment in preclinical studies, wrote Joseph Jankovic, MD, of Baylor College of Medicine, Houston, and his colleagues.

Kuo Chun Hung/Thinkstock

SOURCE: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.

AMSTERDAM – Patients treated with a tumor necrosis factor inhibitor for any indication had their mortality rate cut by about one third, compared with the general population, in a combined analysis of safety findings from 78 trials that involved nearly 30,000 patients.

This first indication that treatment with a tumor necrosis factor inhibitor (TNFi) significantly cut overall mortality only became apparent because of the very large number of patients and patient-years of treatment analyzed, and is likely a real effect – not an artifact – that’s probably linked in part to the anti-inflammatory effect from treatment and its favorable impact on cardiovascular disease events, Gerd R. Burmester, MD, said at the European Congress of Rheumatology.

The cut in overall mortality might also partially result from a “healthy cohort effect,” in which patients enrolled in trials pay more attention to their diet and other aspects of a healthy lifestyle, compared with the general population. But Dr. Burmester cited the recent results from the CANTOS trial that showed treatment with the anti-inflammatory drug canakinumab (Ilaris) was linked with a significant 12% relative reduction in cardiovascular death, myocardial infarction, and stroke (New Engl J Med. 2017 Sept 21;377[12]:1119-31).

“It may be that the anticytokine effect of TNFi works the same way as canakinumab,” Dr. Burmester said in an interview.

The results also confirmed previous reports, based on trial data from fewer numbers of TNFi-treated patients, of low rates of serious infections and malignancies, said Dr. Burmester, professor and director of the department of rheumatology and clinical immunology at Charité Medical University in Berlin.

The data he presented came from both randomized trials and open-label studies of adalimumab (Humira) conducted in several countries worldwide through the end of 2016. The various studies enrolled a total of 29,987 patients treated with adalimumab for 56,951 patient-years who had any of 11 different diseases, including rheumatologic, gastrointestinal, and dermatologic diseases. The most common condition treated in the studies was rheumatoid arthritis (in 33 of the 78 studies), followed by psoriasis (13 studies), and Crohn’s disease (11 studies).

The studies included 9,363 patients treated for at least 2 years, and 4,003 patients treated for at least 5 years. The median duration of adalimumab exposure was 0.7 years and the maximum exposure was just over 12 years.

The overall rate of serious infections in treated patients was 3.7 per 100 patient-years. The most common serious infections were pneumonia, at a rate of 0.6 per 100 patient-years, followed by cellulitis, at a rate of 0.2 per 100 patient-years. Active tuberculosis infections also occurred at a rate of 0.2 per 100 patient-years. Malignancies occurred at a rate of 0.6 per 100 patient-years. These rates were similar to those reported by Dr. Burmester and his associates in 2013 using data from a small pool of patients – 23,458 – enrolled in 71 studies of adalimumab (Ann Rheum Dis. 2013 Apr;72[4]:517-24).

In the current study, Dr. Burmester and his coauthors analyzed the observed mortality rate of the adalimumab-treated patients against the mortality rates for the general populations in the various countries in which the studies were run, based on World Health Organization statistics for the period 1997-2006, and adjusted so that the age and sex of the comparison general populations matched the age and sex of the treated patients. This analysis showed an overall, statistically significant mortality reduction in patients receiving adalimumab of 35%, which was consistent in both the subgroups of men and women.

The observed mortality reduction linked with TNFi treatment is likely a class effect, Dr. Burmester said, although similar analyses have not been conducted using data from patients treated with other TNFis. So far, he has been unsuccessful in getting similar, large-scale trial data from manufacturers of other TNFis that he has approached, but Dr. Burmester said he hopes to eventually receive these data so that he can perform an even larger analysis.

The study was sponsored by AbbVie, the company that markets adalimumab (Humira). Dr. Burmester has been a consultant to and speaker on behalf of AbbVie, as well as for Bristol Myers Squibb, Merk, Pfizer, Roche, and UCB.

[email protected]

SOURCE: Burmester GR et al. Ann Rheum Dis. 2018;77(Suppl 2):165. Abstract OP0233.

AMSTERDAM – Patients treated with a tumor necrosis factor inhibitor for any indication had their mortality rate cut by about one third, compared with the general population, in a combined analysis of safety findings from 78 trials that involved nearly 30,000 patients.

This first indication that treatment with a tumor necrosis factor inhibitor (TNFi) significantly cut overall mortality only became apparent because of the very large number of patients and patient-years of treatment analyzed, and is likely a real effect – not an artifact – that’s probably linked in part to the anti-inflammatory effect from treatment and its favorable impact on cardiovascular disease events, Gerd R. Burmester, MD, said at the European Congress of Rheumatology.

The cut in overall mortality might also partially result from a “healthy cohort effect,” in which patients enrolled in trials pay more attention to their diet and other aspects of a healthy lifestyle, compared with the general population. But Dr. Burmester cited the recent results from the CANTOS trial that showed treatment with the anti-inflammatory drug canakinumab (Ilaris) was linked with a significant 12% relative reduction in cardiovascular death, myocardial infarction, and stroke (New Engl J Med. 2017 Sept 21;377[12]:1119-31).

“It may be that the anticytokine effect of TNFi works the same way as canakinumab,” Dr. Burmester said in an interview.

The results also confirmed previous reports, based on trial data from fewer numbers of TNFi-treated patients, of low rates of serious infections and malignancies, said Dr. Burmester, professor and director of the department of rheumatology and clinical immunology at Charité Medical University in Berlin.

The data he presented came from both randomized trials and open-label studies of adalimumab (Humira) conducted in several countries worldwide through the end of 2016. The various studies enrolled a total of 29,987 patients treated with adalimumab for 56,951 patient-years who had any of 11 different diseases, including rheumatologic, gastrointestinal, and dermatologic diseases. The most common condition treated in the studies was rheumatoid arthritis (in 33 of the 78 studies), followed by psoriasis (13 studies), and Crohn’s disease (11 studies).

The studies included 9,363 patients treated for at least 2 years, and 4,003 patients treated for at least 5 years. The median duration of adalimumab exposure was 0.7 years and the maximum exposure was just over 12 years.

The overall rate of serious infections in treated patients was 3.7 per 100 patient-years. The most common serious infections were pneumonia, at a rate of 0.6 per 100 patient-years, followed by cellulitis, at a rate of 0.2 per 100 patient-years. Active tuberculosis infections also occurred at a rate of 0.2 per 100 patient-years. Malignancies occurred at a rate of 0.6 per 100 patient-years. These rates were similar to those reported by Dr. Burmester and his associates in 2013 using data from a small pool of patients – 23,458 – enrolled in 71 studies of adalimumab (Ann Rheum Dis. 2013 Apr;72[4]:517-24).

In the current study, Dr. Burmester and his coauthors analyzed the observed mortality rate of the adalimumab-treated patients against the mortality rates for the general populations in the various countries in which the studies were run, based on World Health Organization statistics for the period 1997-2006, and adjusted so that the age and sex of the comparison general populations matched the age and sex of the treated patients. This analysis showed an overall, statistically significant mortality reduction in patients receiving adalimumab of 35%, which was consistent in both the subgroups of men and women.

The observed mortality reduction linked with TNFi treatment is likely a class effect, Dr. Burmester said, although similar analyses have not been conducted using data from patients treated with other TNFis. So far, he has been unsuccessful in getting similar, large-scale trial data from manufacturers of other TNFis that he has approached, but Dr. Burmester said he hopes to eventually receive these data so that he can perform an even larger analysis.

The study was sponsored by AbbVie, the company that markets adalimumab (Humira). Dr. Burmester has been a consultant to and speaker on behalf of AbbVie, as well as for Bristol Myers Squibb, Merk, Pfizer, Roche, and UCB.

[email protected]

SOURCE: Burmester GR et al. Ann Rheum Dis. 2018;77(Suppl 2):165. Abstract OP0233.

AMSTERDAM – Patients treated with a tumor necrosis factor inhibitor for any indication had their mortality rate cut by about one third, compared with the general population, in a combined analysis of safety findings from 78 trials that involved nearly 30,000 patients.

This first indication that treatment with a tumor necrosis factor inhibitor (TNFi) significantly cut overall mortality only became apparent because of the very large number of patients and patient-years of treatment analyzed, and is likely a real effect – not an artifact – that’s probably linked in part to the anti-inflammatory effect from treatment and its favorable impact on cardiovascular disease events, Gerd R. Burmester, MD, said at the European Congress of Rheumatology.

The cut in overall mortality might also partially result from a “healthy cohort effect,” in which patients enrolled in trials pay more attention to their diet and other aspects of a healthy lifestyle, compared with the general population. But Dr. Burmester cited the recent results from the CANTOS trial that showed treatment with the anti-inflammatory drug canakinumab (Ilaris) was linked with a significant 12% relative reduction in cardiovascular death, myocardial infarction, and stroke (New Engl J Med. 2017 Sept 21;377[12]:1119-31).

“It may be that the anticytokine effect of TNFi works the same way as canakinumab,” Dr. Burmester said in an interview.

The results also confirmed previous reports, based on trial data from fewer numbers of TNFi-treated patients, of low rates of serious infections and malignancies, said Dr. Burmester, professor and director of the department of rheumatology and clinical immunology at Charité Medical University in Berlin.

The data he presented came from both randomized trials and open-label studies of adalimumab (Humira) conducted in several countries worldwide through the end of 2016. The various studies enrolled a total of 29,987 patients treated with adalimumab for 56,951 patient-years who had any of 11 different diseases, including rheumatologic, gastrointestinal, and dermatologic diseases. The most common condition treated in the studies was rheumatoid arthritis (in 33 of the 78 studies), followed by psoriasis (13 studies), and Crohn’s disease (11 studies).

The studies included 9,363 patients treated for at least 2 years, and 4,003 patients treated for at least 5 years. The median duration of adalimumab exposure was 0.7 years and the maximum exposure was just over 12 years.

The overall rate of serious infections in treated patients was 3.7 per 100 patient-years. The most common serious infections were pneumonia, at a rate of 0.6 per 100 patient-years, followed by cellulitis, at a rate of 0.2 per 100 patient-years. Active tuberculosis infections also occurred at a rate of 0.2 per 100 patient-years. Malignancies occurred at a rate of 0.6 per 100 patient-years. These rates were similar to those reported by Dr. Burmester and his associates in 2013 using data from a small pool of patients – 23,458 – enrolled in 71 studies of adalimumab (Ann Rheum Dis. 2013 Apr;72[4]:517-24).

In the current study, Dr. Burmester and his coauthors analyzed the observed mortality rate of the adalimumab-treated patients against the mortality rates for the general populations in the various countries in which the studies were run, based on World Health Organization statistics for the period 1997-2006, and adjusted so that the age and sex of the comparison general populations matched the age and sex of the treated patients. This analysis showed an overall, statistically significant mortality reduction in patients receiving adalimumab of 35%, which was consistent in both the subgroups of men and women.

The observed mortality reduction linked with TNFi treatment is likely a class effect, Dr. Burmester said, although similar analyses have not been conducted using data from patients treated with other TNFis. So far, he has been unsuccessful in getting similar, large-scale trial data from manufacturers of other TNFis that he has approached, but Dr. Burmester said he hopes to eventually receive these data so that he can perform an even larger analysis.

The study was sponsored by AbbVie, the company that markets adalimumab (Humira). Dr. Burmester has been a consultant to and speaker on behalf of AbbVie, as well as for Bristol Myers Squibb, Merk, Pfizer, Roche, and UCB.

[email protected]

SOURCE: Burmester GR et al. Ann Rheum Dis. 2018;77(Suppl 2):165. Abstract OP0233.

SAN DIEGO – Reserve soldiers who have never been deployed are just as likely to have poor outcomes related to mental health and substance use as their peers who have been deployed, results from a novel survey suggest.

“We tend to focus on screening and intervention efforts for soldiers who have been deployed and who have experienced combat, but we should also focus our intervention and screening efforts on soldiers who have never been deployed,” lead study author Rachel A. Hoopsick, MPH, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “Both are at risk for substance use and mental illness.”

Doug Brunk/MDedge News

Ms. Hoopsick reported results from 121 never-deployed, male soldiers who completed the survey at baseline and at a 1-year follow-up. Their mean age was 30 years, 76% were non-Hispanic white, and 84% had at least some college education. In addition, the soldiers had served a mean of 5.5 years, had a mean of 0.6 military friends in the social network, and had a mean marital satisfaction score of 114 out of 158 possible points.

On responses to the Non-Deployment Emotions Questionnaire, 65% of nondeployed soldiers felt guilt, 56% felt decreased value within his unit, 50% felt decreased camaraderie within his unit, and 50% felt decreased connectedness within his unit for having never been deployed. “We did anticipate that some of these soldiers were going to have poor outcomes related to their nondeployment emotions, but it was surprising to see how many of the soldiers did express having negative emotions related to having never been deployed,” Ms. Hoopsick said. After the researchers controlled for years of military service, the number of military friends in the soldier’s social network, and marital satisfaction, more negative nondeployment emotions were associated with a greater likelihood of alcohol problems (adjusted risk ratio, 1.06), frequent heavy drinking (ARR, 1.03), and current nonmedical use of prescription drugs (ARR, 1.21).

She acknowledged certain limitations of the study, including its cross-sectional nature. “It would be interesting to have additional longitudinal studies looking at their outcomes over time,” she said.

The National Institute on Drug Abuse provided funding to Ms. Hoopsick’s mentor and coauthor, Gregory G. Homish, PhD, and the study received additional funding from the National Center for Advancing Translational Sciences and the Health Resources and Services Administration.

[email protected]

SAN DIEGO – Reserve soldiers who have never been deployed are just as likely to have poor outcomes related to mental health and substance use as their peers who have been deployed, results from a novel survey suggest.

“We tend to focus on screening and intervention efforts for soldiers who have been deployed and who have experienced combat, but we should also focus our intervention and screening efforts on soldiers who have never been deployed,” lead study author Rachel A. Hoopsick, MPH, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “Both are at risk for substance use and mental illness.”

Doug Brunk/MDedge News

Ms. Hoopsick reported results from 121 never-deployed, male soldiers who completed the survey at baseline and at a 1-year follow-up. Their mean age was 30 years, 76% were non-Hispanic white, and 84% had at least some college education. In addition, the soldiers had served a mean of 5.5 years, had a mean of 0.6 military friends in the social network, and had a mean marital satisfaction score of 114 out of 158 possible points.

On responses to the Non-Deployment Emotions Questionnaire, 65% of nondeployed soldiers felt guilt, 56% felt decreased value within his unit, 50% felt decreased camaraderie within his unit, and 50% felt decreased connectedness within his unit for having never been deployed. “We did anticipate that some of these soldiers were going to have poor outcomes related to their nondeployment emotions, but it was surprising to see how many of the soldiers did express having negative emotions related to having never been deployed,” Ms. Hoopsick said. After the researchers controlled for years of military service, the number of military friends in the soldier’s social network, and marital satisfaction, more negative nondeployment emotions were associated with a greater likelihood of alcohol problems (adjusted risk ratio, 1.06), frequent heavy drinking (ARR, 1.03), and current nonmedical use of prescription drugs (ARR, 1.21).

She acknowledged certain limitations of the study, including its cross-sectional nature. “It would be interesting to have additional longitudinal studies looking at their outcomes over time,” she said.

The National Institute on Drug Abuse provided funding to Ms. Hoopsick’s mentor and coauthor, Gregory G. Homish, PhD, and the study received additional funding from the National Center for Advancing Translational Sciences and the Health Resources and Services Administration.

[email protected]

SAN DIEGO – Reserve soldiers who have never been deployed are just as likely to have poor outcomes related to mental health and substance use as their peers who have been deployed, results from a novel survey suggest.

“We tend to focus on screening and intervention efforts for soldiers who have been deployed and who have experienced combat, but we should also focus our intervention and screening efforts on soldiers who have never been deployed,” lead study author Rachel A. Hoopsick, MPH, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “Both are at risk for substance use and mental illness.”

Doug Brunk/MDedge News

Ms. Hoopsick reported results from 121 never-deployed, male soldiers who completed the survey at baseline and at a 1-year follow-up. Their mean age was 30 years, 76% were non-Hispanic white, and 84% had at least some college education. In addition, the soldiers had served a mean of 5.5 years, had a mean of 0.6 military friends in the social network, and had a mean marital satisfaction score of 114 out of 158 possible points.

On responses to the Non-Deployment Emotions Questionnaire, 65% of nondeployed soldiers felt guilt, 56% felt decreased value within his unit, 50% felt decreased camaraderie within his unit, and 50% felt decreased connectedness within his unit for having never been deployed. “We did anticipate that some of these soldiers were going to have poor outcomes related to their nondeployment emotions, but it was surprising to see how many of the soldiers did express having negative emotions related to having never been deployed,” Ms. Hoopsick said. After the researchers controlled for years of military service, the number of military friends in the soldier’s social network, and marital satisfaction, more negative nondeployment emotions were associated with a greater likelihood of alcohol problems (adjusted risk ratio, 1.06), frequent heavy drinking (ARR, 1.03), and current nonmedical use of prescription drugs (ARR, 1.21).

She acknowledged certain limitations of the study, including its cross-sectional nature. “It would be interesting to have additional longitudinal studies looking at their outcomes over time,” she said.

The National Institute on Drug Abuse provided funding to Ms. Hoopsick’s mentor and coauthor, Gregory G. Homish, PhD, and the study received additional funding from the National Center for Advancing Translational Sciences and the Health Resources and Services Administration.

[email protected]

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

[email protected]

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

[email protected]

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

[email protected]

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

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The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.