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Hospitalist‐Run Preoperative Clinic
Anesthesiologists typically initiate an assessment in the immediate preoperative period, focused on management of the airway, physiologic parameters, and choice of anesthetic. Given the growing complexity of medical issues in the surgical patient, the preoperative assessment may need to be initiated weeks to months prior to surgery. Early evaluation allows time to implement required interventions, optimize medical conditions, adjust medications, and collaborate with the surgical team.
Most studies of Preoperative clinics are in the Anesthesiology literature.1 Anesthesia‐run Preoperative clinics have demonstrated a reduction in surgical cancellations and length of stay (LOS).2 Auerbach and colleagues found medical consultation to have inconsistent effects on quality of care in surgical patients, but consultations occurred, at the earliest, 1 day prior to surgery.3 A randomized trial, performed at the Pittsburgh Veterans Administration (VA) medical center using an outpatient Internal Medicine Preoperative clinic, demonstrated a shortening of preoperative LOS but no change in total LOS, and increased use of consultants. However, there were reduced numbers of unnecessary admissions, defined as patients who were discharged without having had surgery.4 An analysis of a population‐based administrative database found that voluntary preoperative consultations were associated with a significant, albeit small, increase in mortality. Although this study used a matched cohort, the unmatched cohort that underwent consultation was higher risk; also, selection bias was possible, as the reasons for initial consultation were unknown.5
Historically, the Preoperative clinic at VA Greater Los Angeles Healthcare System (VAGLAHS) was supervised by the Department of Anesthesiology. In July 2004, the Preoperative clinic was restructured with Hospitalist oversight. The Anesthesia staff continued to evaluate all surgical patients, but did so only on the day of surgery, and after the patient was deemed an acceptable risk by the Preoperative clinic.
We undertook this study to measure the institutional impact of the addition of a Hospitalist‐run Preoperative clinic to our standard practice. The VA is an ideal setting, given the closed system with reliable longitudinal data. The VA electronic medical record also allows for comprehensive calculations of clinical covariants and outcomes.
MATERIALS AND METHODS
Setting
VAGLAHS is a tertiary care, academic medical center that serves patients referred from a 110,000 square mile area of Southern California and Southern Nevada. The Preoperative clinic evaluates all outpatients scheduled for inpatient or outpatient noncardiac surgery. Evaluations are performed by mid‐level providers with physician oversight. Patients are seen within 30 days of surgery, with a goal of 2 to 3 weeks prior to the operative date. Two of the 3 mid‐level providers remained after the change in leadership; a third was hired. All were retrained to perform a detailed medical preoperative assessment. Patients awaiting cardiothoracic surgery had their evaluation performed outside the Preoperative clinic by the Cardiology or Pulmonary services during both periods.
With the change in oversight, mid‐level providers were given weekly lectures on medical disease management and preoperative assessment. A syllabus of key articles in perioperative literature was compiled. Evidence‐based protocols were developed to standardize the evaluation. Examples of guidelines include: laboratory and radiological testing guidelines,610 initiation of perioperative beta blockers,11 selection criteria for pulmonary function tests,12 protocols for bridging with low‐molecular‐weight heparin for patients on oral vitamin K antagonists,13 the cardiovascular evaluation based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines,14 as well as adjustment of diabetic medications.
Prior to the change in oversight, patients who required Cardiology evaluations were referred directly to the Cardiology service generally without any prior testing. After institution of the Hospitalist‐run clinic, the mid‐level providers ordered cardiac studies after discussion with the attending to ensure necessity and compliance with ACC/AHA guidelines. Patients were referred to Cardiology only if the results required further evaluation. In addition, entry to the Preoperative clinic was denied to patients awaiting elective surgeries whose hemoglobin A1c percentage was greater than 9%; such patients were referred to their primary care provider. For patients awaiting urgent surgeries, the Preoperative clinic would expedite evaluations in order to honor the surgical date. Providers would document perioperative recommendations for patients anticipated to require an inpatient stay. Occasionally, the patient was deemed too high risk to proceed with surgery, and the case was canceled or delayed after discussion with the patient and surgical team. Once deemed a medically acceptable candidate, the patient was evaluated on the day of surgery by Anesthesia.
Methods
We extracted de‐identified data from Veterans Health Administration (VHA) national databases, and specifically from the Veterans Integrated Service Network (VISN) 22 warehouse. All patients seen in the Preoperative clinic at VAGLAHS, from July 2003 to July 2005, were included. The patients were analyzed in 2 groups: patients seen from July 2003 to June 2004, when the Anesthesia Department staff supervised the Preoperative clinic (Period A); and from July 2004 to June 2005, the first year of the new Hospitalist‐run system (Period B). We collected data on age; gender; American Society of Anesthesia (ASA) score15; perioperative beta blocker use; cardiology studies ordered; and surgical mortality defined as death within the index hospital stay. The length of stay (LOS) was calculated for patients who required an inpatient stay after surgery. As an internal control, we assessed the LOS of the cardiothoracic patients in our facility since this group of patients does not utilize the Preoperative clinic and maintained the same preoperative evaluation process during both time periods. In addition, same‐day surgical cancellations were tracked by the Anesthesia Department, which documents daily operating room utilization and determines whether a cancellation was avoidable.
Statistical Analysis
Differences in demographic, clinical, and preoperative resource utilization characteristics were compared between Periods A and B using chi‐square for categorical variables and t test (or Wilcoxon test) for continuous variables. A subgroup analysis was performed for patients who required an inpatient stay after surgery. The primary outcome was inpatient LOS and the secondary outcome was inpatient death. A mixed‐effects regression model with patient‐level random effects to account for clustering of visits by the same patient was used to assess the impact of certain patient characteristics on inpatient LOS. Covariates included age, gender, time period (A vs B), ASA classification, and perioperative period‐by‐ASA classification interaction. Comparisons of inpatient LOS between periods for different ASA classes were done through model contrasts. Chi‐square test was used to compare the inpatient mortality between periods. A subgroup analysis was performed on postoperative inpatient deaths during the study period using a logistics regression model with age, ASA, and time period. All statistical analyses were performed using SAS Version 9.2 (SAS Institute, Cary, NC).
RESULTS
Table 1 describes the demographics and clinical characteristics of the patients evaluated in the Preoperative clinic. Number of surgeries performed in Periods A and B were 3568 and 3337, respectively, with an average of 1.3 surgeries per patient for both periods. The most common surgical specialties were Ophthalmology, Orthopedics, Urology, and General Surgery. The average ages of patients in Periods A and B were 63.9 and 61.4 years, respectively (P < 0.0001). The patients were predominantly male. ASA classifications were similar in the 2 periods, with over 60% of patients having an ASA score of 3 or higher.
| Period A N (%) | Period B N (%) | P | |
|---|---|---|---|
| |||
| No. of patients | 2658 | 2565 | |
| Total no. of surgeries | 3568 | 3337 | |
| Service | 0.0746 | ||
| Ophthalmology | 756 (21.1) | 637 (19.1) | |
| Urology | 526 (14.7) | 478 (14.3) | |
| Orthopedics | 527 (14.8) | 502 (15.0) | |
| General surgery | 469 (13.1) | 495 (14.8) | |
| ENT | 363 (10.2) | 312 (9.4) | |
| Other | 927 (26.0) | 913 (27.4) | |
| Age, mean (SD) | 63.9 (13.2) | 61.4 (13.5) | <0.0001 |
| Male | 2486 (93.5) | 2335 (93.0) | 0.4100 |
| ASA classification | 0.1836 | ||
| 1. No disturbance | 59 (2.3) | 81 (3.3) | |
| 2. Mild | 896 (35.3) | 864 (35.3) | |
| 3. Severe | 1505 (59.3) | 1425 (58.1) | |
| 4. Life‐threatening or worse | 77 (3.0) | 81 (3.3) | |
| 5. Missing scores | 121 (4.6) | 114 (4.4) | |
Table 2 presents the selected preoperative resource utilization. Less than 3% of patients referred to the Preoperative clinic were referred for Cardiology consultation during both time periods. However, during Period A, some patients required multiple Cardiology referrals resulting in 85 referrals in Period A and 64 referrals in Period B. In contrast, Preoperative clinic providers ordered more cardiac studies in Period B than in Period A (P = 0.012). There was a significant increase in the number of patients on perioperative beta blockers, with 26% in Period A and 33% in Period B (P < 0.0001). Although there was no significant difference in the number of same‐day surgical cancellations between the 2 periods, there was a trend towards a reduction of cancellations for medically avoidable reasons, 34 (8.5%) and 18 (4.9%) cases during Periods A and B, respectively (P = 0.065).
| Period A N (%) | Period B N (%) | P | |
|---|---|---|---|
| |||
| No. of patients | 2658 | 2565 | |
| No. of patients that had at least 1 cardiology referral | 70 (2.6) | 62 (2.4) | 0.660 |
| No. of cardiology referrals | 85 | 64 | |
| Cardiac testing orders | 40 | 88 | 0.012 |
| Nuclear medicine | 20 (50.0) | 58 (65.9) | |
| Nuclear treadmill | 2 (5.0) | 12 (13.6) | |
| ETT | 18 (45.0) | 18 (20.5) | |
| Perioperative beta blocker | 696 (26.2) | 852 (33.2) | <0.0001 |
| Cases canceled day of surgery | |||
| Total | 400 (15.0) | 368 (14.3) | |
| Medical avoidable | 34 (8.5) | 18 (4.9) | 0.065 |
Table 3 describes the clinical characteristics, inpatient LOS, and inpatient mortality for the surgical inpatients assessed in the Preoperative clinic. There were 1101 patients with 1200 inpatient surgeries in Period A, and 1126 patients with 1245 inpatient surgeries in Period B. The mean ages were 63.3 and 61.4 years in Periods A and B, respectively (P = 0.0004). More than 90% of patients were male. Over 62% of patients had ASA scores of 3 or higher in both periods. Both mean and median LOS was reduced in Period B. Results from the mixed‐effects regression model indicated no age and gender effects. ASA classification was significantly associated with LOS (P < 0.0001). There were reductions in LOS from Period A to Period B across all ASA classifications, however, the levels of reduction were different among them (ie, significant interaction effect, P = 0.0005). Patients who were ASA 3 or higher had a significantly shorter LOS in Period B as compared to those in Period A (P < 0.0001).
| Period A | Period B | P | |
|---|---|---|---|
| |||
| No. of patients | 1101 | 1126 | |
| No. of inpatient surgeries | 1200 | 1245 | |
| Age, mean (SD)* | 63.3 (12.7) | 61.4 (12.8) | 0.0004 |
| Male (%) | 1022 (92.8) | 1024 (90.9) | 0.1039 |
| ASA classification | 0.0510 | ||
| 1. No disturbance | 15 (1.36) | 27 (2.40) | |
| 2. Mild | 324 (29.4) | 364 (32.3) | |
| 3. Severe | 710 (64.5) | 697 (61.9) | |
| 4. Life‐threatening | 52 (4.72) | 38 (3.37) | |
| Primary outcome | |||
| In‐patient LOS (days) | |||
| Mean (SD) | 9.87 (25.4) | 5.28 (9.24) | |
| Median (minmax) | 3.0 (1516) | 2.0 (1120) | |
| Mixed‐effects regression | Period AB Estimated difference (SE) | ||
| 1. No disturbance | 1.31 (5.90) | 0.8247 | |
| 2. Mild | 2.52 (1.39) | 0.0717 | |
| 3. Severe | 4.22 (0.96) | <0.0001 | |
| 4. Life‐threatening | 19.7 (3.81) | <0.0001 | |
| Secondary outcome | |||
| Mortality, N (%) | 14 (1.27) | 4 (0.36) | 0.0158 |
| ASA classification | |||
| 3. Severe | 7 (0.99) | 2 (0.29) | |
| 4. Life‐threatening | 7 (13.5) | 2 (5.26) | |
| Logistic regression | Estimated OR (95% CI) | ||
| Period (A vs B) | 3.13 (1.01, 9.73) | 0.0488 | |
| ASA classification (3 vs 4) | 0.06 (0.02, 0.16) | <0.0001 | |
The LOS on the Cardiothoracic services was also evaluated. No significant difference in LOS was observed between the 2 periods (average LOS of 18 days) after adjusting for the patients' age and ASA score.
Inpatient mortality was reduced in Period B, from 14 cases (1.27%) to 4 cases (0.36%) (P = 0.0158). No patients who were ASA 2 or less died. Deaths in each period were evenly split between ASA categories 3 and 4 (Table 3). Subgroup analysis on inpatient deaths showed no age effect, but a significant period effect (odds ratio [OR] = 3.13, 95% confidence interval [CI]: 1.019.73 for Periods A vs B; P = 0.0488) and ASA status effect (OR = 0.06, 95% CI: 0.020.16 for ASA severe vs life‐threatening; P < 0.0001).
DISCUSSION
The addition of a Hospitalist‐run, medical Preoperative clinic was associated with more perioperative beta blocker use, shortened LOS, and lower mortality rates for our veteran patients undergoing noncardiac surgery. Such LOS reduction was not apparent in our internal control of cardiothoracic surgery patients or in the VA National Surgical Quality Improvement Program (NSQIP), a national representative sample of a similar patient population. While median unadjusted LOS in the VA NSQIP did not change over the same time periods, surgical mortality rates decreased, but by a smaller magnitude (15%) than seen in our study. While mortality in our study was reduced, the absolute numbers are relatively small. However, a subgroup analysis accounting for age and ASA score demonstrated a reduction in mortality.
As multiple structure and process changes were made in the Preoperative program, it is not definitively known which specific factor or factors could have affected inpatient surgical care. The Preoperative clinic evaluation was a one‐time consult, but included recommendations for perioperative management, including medication adjustments and infrequent suggestions for perioperative consultation. The decision to follow such recommendations was voluntary on the part of the surgical team. Alternatively, preoperative optimization may have played a role. By performing a multisystem evaluation with evidence‐based protocols, we possibly identified patients that were at increased risk of perioperative harm, and were able to intervene or recommend deferral of the procedure. This could have resulted in better surgical candidate selection with fewer postoperative complications, especially among patients with significant medical comorbidities.
Better patient selection is also suggested by a trend toward fewer same‐day cancellations for medically avoidable reasons during Period B. The distinction between medical versus patient‐related causes and avoidable versus unavoidable causes may be imprecise; however, the same Anesthesia staff assigned the categories over both periods and therefore any possible inconsistencies should have averaged out.
Increased usage of perioperative beta blockers may also have contributed to reduced mortality rates. We anticipated that more patients in Period B would be placed on perioperative beta blockers, given the guidelines in place at the time. More recently, the evidence for perioperative beta blockade has been further refined,16, 17 but during study Periods A and B, it was considered best practice for wider patient populations.
Fewer repeat referrals to Cardiology clinic and more cardiac testing were ordered by the Preoperative clinic providers during Period B. Ordering cardiac studies from Preoperative clinic and referring only when guideline‐driven could have streamlined the evaluation process and prevented the need for repeat referrals. We expect the number of stress tests and Cardiology consultations to have decreased even more in recent years as the 2007 ACC/AHA guidelines further emphasize medical optimization and de‐emphasize cardiac testing and prophylactic revascularization prior to surgery.18
Our results suggest that similar healthcare systems may benefit from adding medical expertise to their preoperative clinical operations. As the LOS reduction was most noticeable in patients with higher ASA scores, the largest impact would likely be with healthcare environments with medically complex patients and variable access to primary care. The shortage of primary care physicians and the increase in chronic disease burden in the US population may cause more patients to present to a surgeon in a nonoptimized condition. Arguably, such clinics could be supervised by any discipline that is familiar with the perioperative literature, chronic disease management, and postoperative inpatient care. Other options include clinics in which Anesthesiologists jointly collaborate with Hospitalists19 or General Internists with expertise in perioperative management.
Our study has many limitations. The VA has a largely male population and an electronic medical record, and thus results are not generalizable. Patients were younger in Period B than in Period A; however, the 2‐ to 3‐year difference might not be clinically significant, and the standard deviation was wide in both groups. This study is a retrospective observational study, and thus we cannot identify the specific processes that could have lead to any associated outcomes. There was no ideal contemporaneous control group, but examination of trends in cardiothoracic surgery at our institution and the national VA database does not reveal changes of this magnitude. Unforeseen biases could have resulted in upcoding of ASA scores by the mid‐level providers. Beta blocker usage was determined by patients prescribed beta blockers perioperatively, and did not exclude those on the medication prior to presentation. However, the significant increase in usage in Period B points to an increase in prescriptions originating from the Preoperative clinic. We do not have a breakdown of postoperative days in the intensive care unit (ICU) or ward settings, or the readmission rates. Thus, a true cost‐effectiveness analysis cannot be done. However, the reduction in postoperative LOS and decline in same‐day cancellations suggests that our institution benefited to some degree. Since the mid‐level providers were present prior to the change from Anesthesia to Hospitalist leadership, the only cost of the intervention was the hiring of a Hospitalist. However, the change freed an Anesthesiologist to work in the operating room or procedure suite. We do not have precise data regarding the number of surgeries delayed or canceled by the Preoperative clinic, but surgical workload was similar between both periods. Hopefully future studies will include richer data to minimize study limitations.
CONCLUSION
The addition of a Hospitalist‐run, medical Preoperative clinic was associated with improvements in perioperative processes and outcomes. Postoperative LOS was reduced in the sickest patients, as was inpatient mortality. Perioperative beta blocker use was increased. Adding Hospitalist expertise to preoperative clinical operations may be a viable model to improve perioperative care.
Acknowledgements
The authors thank Manyee Gee for retrieving much needed data. The authors also thank our staff in the Preoperative clinic for their exceptional hard work and dedication to our veteran patients.
- ,,,,.Value of preoperative clinic visits in identifying issues with potential impact on operating room efficiency.Anesthesiology.2006;105:1254–1259.
- ,,, et al.The effect of outpatient perioperative evaluation of hospital inpatients on cancellation of surgery and length of hospital stay.Anesth Analg.2002;94(3):644–649.
- ,,,,,.Opportunity missed: medical consultation, resource use, and quality of care of patients undergoing major surgery.Arch Int Med.2007;167(21):2338–2344.
- ,.Outpatient internal medicine preoperative evaluation: a randomized clinical trial.Med Care.1994;32(5):498–507.
- ,,,,.Outcomes and processes of care related to preoperative medical consultation.Arch Intern Med.2010;170(15):1365–1374.
- .Cost‐effective preoperative evaluation and testing.Chest.1999;115(5):96S–100S.
- ,,.Optimizing postoperative outcomes with efficient preoperative assessment and management.Crit Care Med.2004;32(4):S76–S86.
- .Preoperative laboratory testing: general issues and considerations.Anesthesiol Clin North Am.2004;22(1):13–25.
- .Preoperative medical evaluation of the healthy patient. Available at: http://www.uptodate.com. Accessed July 15, 2004.
- ,.The case against routine preoperative laboratory testing.Med Clin North Am.2003;87(1):7–40.
- ,.Blockers and reduction of cardiac events in noncardiac surgery.JAMA.2002;287:1435–1444.
- .Preoperative pulmonary evaluation.N Engl J Med.1999;340(12):937–944.
- ,,,,,.The pharmacology and management of the vitamin K antagonists. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: evidence‐based guidelines.Chest.2004;126(3 suppl):204S–233S.
- ,,, et al; for theCommittee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery—executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.Circulation.2002;105(10):1257–1267.
- American Society of Anesthesiology House of Delegates.New classification of physical status.Anesthesiology.1963;24:111.
- ,,, et al; for thePOISE Study Group.Effects of extended‐release metoprolol succinate in patients undergoing non‐cardiac surgery (POISE trial): a randomised controlled trial.Lancet.2008;371(9627):1839–1847.
- ,,,,,.Perioperative beta blockers in patients having non‐cardiac surgery: a meta‐analysis.Lancet.2008;372(9654):1962–1976.
- ,,, et al; for theWriting Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.Circulation.2007;116(17):1971–1996.
- ,.Hospitalists and anesthesiologists as perioperative physicians: are their roles complimentary?Proc (Bayl Univ Med Cent).2007;20(2):140–142.
Anesthesiologists typically initiate an assessment in the immediate preoperative period, focused on management of the airway, physiologic parameters, and choice of anesthetic. Given the growing complexity of medical issues in the surgical patient, the preoperative assessment may need to be initiated weeks to months prior to surgery. Early evaluation allows time to implement required interventions, optimize medical conditions, adjust medications, and collaborate with the surgical team.
Most studies of Preoperative clinics are in the Anesthesiology literature.1 Anesthesia‐run Preoperative clinics have demonstrated a reduction in surgical cancellations and length of stay (LOS).2 Auerbach and colleagues found medical consultation to have inconsistent effects on quality of care in surgical patients, but consultations occurred, at the earliest, 1 day prior to surgery.3 A randomized trial, performed at the Pittsburgh Veterans Administration (VA) medical center using an outpatient Internal Medicine Preoperative clinic, demonstrated a shortening of preoperative LOS but no change in total LOS, and increased use of consultants. However, there were reduced numbers of unnecessary admissions, defined as patients who were discharged without having had surgery.4 An analysis of a population‐based administrative database found that voluntary preoperative consultations were associated with a significant, albeit small, increase in mortality. Although this study used a matched cohort, the unmatched cohort that underwent consultation was higher risk; also, selection bias was possible, as the reasons for initial consultation were unknown.5
Historically, the Preoperative clinic at VA Greater Los Angeles Healthcare System (VAGLAHS) was supervised by the Department of Anesthesiology. In July 2004, the Preoperative clinic was restructured with Hospitalist oversight. The Anesthesia staff continued to evaluate all surgical patients, but did so only on the day of surgery, and after the patient was deemed an acceptable risk by the Preoperative clinic.
We undertook this study to measure the institutional impact of the addition of a Hospitalist‐run Preoperative clinic to our standard practice. The VA is an ideal setting, given the closed system with reliable longitudinal data. The VA electronic medical record also allows for comprehensive calculations of clinical covariants and outcomes.
MATERIALS AND METHODS
Setting
VAGLAHS is a tertiary care, academic medical center that serves patients referred from a 110,000 square mile area of Southern California and Southern Nevada. The Preoperative clinic evaluates all outpatients scheduled for inpatient or outpatient noncardiac surgery. Evaluations are performed by mid‐level providers with physician oversight. Patients are seen within 30 days of surgery, with a goal of 2 to 3 weeks prior to the operative date. Two of the 3 mid‐level providers remained after the change in leadership; a third was hired. All were retrained to perform a detailed medical preoperative assessment. Patients awaiting cardiothoracic surgery had their evaluation performed outside the Preoperative clinic by the Cardiology or Pulmonary services during both periods.
With the change in oversight, mid‐level providers were given weekly lectures on medical disease management and preoperative assessment. A syllabus of key articles in perioperative literature was compiled. Evidence‐based protocols were developed to standardize the evaluation. Examples of guidelines include: laboratory and radiological testing guidelines,610 initiation of perioperative beta blockers,11 selection criteria for pulmonary function tests,12 protocols for bridging with low‐molecular‐weight heparin for patients on oral vitamin K antagonists,13 the cardiovascular evaluation based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines,14 as well as adjustment of diabetic medications.
Prior to the change in oversight, patients who required Cardiology evaluations were referred directly to the Cardiology service generally without any prior testing. After institution of the Hospitalist‐run clinic, the mid‐level providers ordered cardiac studies after discussion with the attending to ensure necessity and compliance with ACC/AHA guidelines. Patients were referred to Cardiology only if the results required further evaluation. In addition, entry to the Preoperative clinic was denied to patients awaiting elective surgeries whose hemoglobin A1c percentage was greater than 9%; such patients were referred to their primary care provider. For patients awaiting urgent surgeries, the Preoperative clinic would expedite evaluations in order to honor the surgical date. Providers would document perioperative recommendations for patients anticipated to require an inpatient stay. Occasionally, the patient was deemed too high risk to proceed with surgery, and the case was canceled or delayed after discussion with the patient and surgical team. Once deemed a medically acceptable candidate, the patient was evaluated on the day of surgery by Anesthesia.
Methods
We extracted de‐identified data from Veterans Health Administration (VHA) national databases, and specifically from the Veterans Integrated Service Network (VISN) 22 warehouse. All patients seen in the Preoperative clinic at VAGLAHS, from July 2003 to July 2005, were included. The patients were analyzed in 2 groups: patients seen from July 2003 to June 2004, when the Anesthesia Department staff supervised the Preoperative clinic (Period A); and from July 2004 to June 2005, the first year of the new Hospitalist‐run system (Period B). We collected data on age; gender; American Society of Anesthesia (ASA) score15; perioperative beta blocker use; cardiology studies ordered; and surgical mortality defined as death within the index hospital stay. The length of stay (LOS) was calculated for patients who required an inpatient stay after surgery. As an internal control, we assessed the LOS of the cardiothoracic patients in our facility since this group of patients does not utilize the Preoperative clinic and maintained the same preoperative evaluation process during both time periods. In addition, same‐day surgical cancellations were tracked by the Anesthesia Department, which documents daily operating room utilization and determines whether a cancellation was avoidable.
Statistical Analysis
Differences in demographic, clinical, and preoperative resource utilization characteristics were compared between Periods A and B using chi‐square for categorical variables and t test (or Wilcoxon test) for continuous variables. A subgroup analysis was performed for patients who required an inpatient stay after surgery. The primary outcome was inpatient LOS and the secondary outcome was inpatient death. A mixed‐effects regression model with patient‐level random effects to account for clustering of visits by the same patient was used to assess the impact of certain patient characteristics on inpatient LOS. Covariates included age, gender, time period (A vs B), ASA classification, and perioperative period‐by‐ASA classification interaction. Comparisons of inpatient LOS between periods for different ASA classes were done through model contrasts. Chi‐square test was used to compare the inpatient mortality between periods. A subgroup analysis was performed on postoperative inpatient deaths during the study period using a logistics regression model with age, ASA, and time period. All statistical analyses were performed using SAS Version 9.2 (SAS Institute, Cary, NC).
RESULTS
Table 1 describes the demographics and clinical characteristics of the patients evaluated in the Preoperative clinic. Number of surgeries performed in Periods A and B were 3568 and 3337, respectively, with an average of 1.3 surgeries per patient for both periods. The most common surgical specialties were Ophthalmology, Orthopedics, Urology, and General Surgery. The average ages of patients in Periods A and B were 63.9 and 61.4 years, respectively (P < 0.0001). The patients were predominantly male. ASA classifications were similar in the 2 periods, with over 60% of patients having an ASA score of 3 or higher.
| Period A N (%) | Period B N (%) | P | |
|---|---|---|---|
| |||
| No. of patients | 2658 | 2565 | |
| Total no. of surgeries | 3568 | 3337 | |
| Service | 0.0746 | ||
| Ophthalmology | 756 (21.1) | 637 (19.1) | |
| Urology | 526 (14.7) | 478 (14.3) | |
| Orthopedics | 527 (14.8) | 502 (15.0) | |
| General surgery | 469 (13.1) | 495 (14.8) | |
| ENT | 363 (10.2) | 312 (9.4) | |
| Other | 927 (26.0) | 913 (27.4) | |
| Age, mean (SD) | 63.9 (13.2) | 61.4 (13.5) | <0.0001 |
| Male | 2486 (93.5) | 2335 (93.0) | 0.4100 |
| ASA classification | 0.1836 | ||
| 1. No disturbance | 59 (2.3) | 81 (3.3) | |
| 2. Mild | 896 (35.3) | 864 (35.3) | |
| 3. Severe | 1505 (59.3) | 1425 (58.1) | |
| 4. Life‐threatening or worse | 77 (3.0) | 81 (3.3) | |
| 5. Missing scores | 121 (4.6) | 114 (4.4) | |
Table 2 presents the selected preoperative resource utilization. Less than 3% of patients referred to the Preoperative clinic were referred for Cardiology consultation during both time periods. However, during Period A, some patients required multiple Cardiology referrals resulting in 85 referrals in Period A and 64 referrals in Period B. In contrast, Preoperative clinic providers ordered more cardiac studies in Period B than in Period A (P = 0.012). There was a significant increase in the number of patients on perioperative beta blockers, with 26% in Period A and 33% in Period B (P < 0.0001). Although there was no significant difference in the number of same‐day surgical cancellations between the 2 periods, there was a trend towards a reduction of cancellations for medically avoidable reasons, 34 (8.5%) and 18 (4.9%) cases during Periods A and B, respectively (P = 0.065).
| Period A N (%) | Period B N (%) | P | |
|---|---|---|---|
| |||
| No. of patients | 2658 | 2565 | |
| No. of patients that had at least 1 cardiology referral | 70 (2.6) | 62 (2.4) | 0.660 |
| No. of cardiology referrals | 85 | 64 | |
| Cardiac testing orders | 40 | 88 | 0.012 |
| Nuclear medicine | 20 (50.0) | 58 (65.9) | |
| Nuclear treadmill | 2 (5.0) | 12 (13.6) | |
| ETT | 18 (45.0) | 18 (20.5) | |
| Perioperative beta blocker | 696 (26.2) | 852 (33.2) | <0.0001 |
| Cases canceled day of surgery | |||
| Total | 400 (15.0) | 368 (14.3) | |
| Medical avoidable | 34 (8.5) | 18 (4.9) | 0.065 |
Table 3 describes the clinical characteristics, inpatient LOS, and inpatient mortality for the surgical inpatients assessed in the Preoperative clinic. There were 1101 patients with 1200 inpatient surgeries in Period A, and 1126 patients with 1245 inpatient surgeries in Period B. The mean ages were 63.3 and 61.4 years in Periods A and B, respectively (P = 0.0004). More than 90% of patients were male. Over 62% of patients had ASA scores of 3 or higher in both periods. Both mean and median LOS was reduced in Period B. Results from the mixed‐effects regression model indicated no age and gender effects. ASA classification was significantly associated with LOS (P < 0.0001). There were reductions in LOS from Period A to Period B across all ASA classifications, however, the levels of reduction were different among them (ie, significant interaction effect, P = 0.0005). Patients who were ASA 3 or higher had a significantly shorter LOS in Period B as compared to those in Period A (P < 0.0001).
| Period A | Period B | P | |
|---|---|---|---|
| |||
| No. of patients | 1101 | 1126 | |
| No. of inpatient surgeries | 1200 | 1245 | |
| Age, mean (SD)* | 63.3 (12.7) | 61.4 (12.8) | 0.0004 |
| Male (%) | 1022 (92.8) | 1024 (90.9) | 0.1039 |
| ASA classification | 0.0510 | ||
| 1. No disturbance | 15 (1.36) | 27 (2.40) | |
| 2. Mild | 324 (29.4) | 364 (32.3) | |
| 3. Severe | 710 (64.5) | 697 (61.9) | |
| 4. Life‐threatening | 52 (4.72) | 38 (3.37) | |
| Primary outcome | |||
| In‐patient LOS (days) | |||
| Mean (SD) | 9.87 (25.4) | 5.28 (9.24) | |
| Median (minmax) | 3.0 (1516) | 2.0 (1120) | |
| Mixed‐effects regression | Period AB Estimated difference (SE) | ||
| 1. No disturbance | 1.31 (5.90) | 0.8247 | |
| 2. Mild | 2.52 (1.39) | 0.0717 | |
| 3. Severe | 4.22 (0.96) | <0.0001 | |
| 4. Life‐threatening | 19.7 (3.81) | <0.0001 | |
| Secondary outcome | |||
| Mortality, N (%) | 14 (1.27) | 4 (0.36) | 0.0158 |
| ASA classification | |||
| 3. Severe | 7 (0.99) | 2 (0.29) | |
| 4. Life‐threatening | 7 (13.5) | 2 (5.26) | |
| Logistic regression | Estimated OR (95% CI) | ||
| Period (A vs B) | 3.13 (1.01, 9.73) | 0.0488 | |
| ASA classification (3 vs 4) | 0.06 (0.02, 0.16) | <0.0001 | |
The LOS on the Cardiothoracic services was also evaluated. No significant difference in LOS was observed between the 2 periods (average LOS of 18 days) after adjusting for the patients' age and ASA score.
Inpatient mortality was reduced in Period B, from 14 cases (1.27%) to 4 cases (0.36%) (P = 0.0158). No patients who were ASA 2 or less died. Deaths in each period were evenly split between ASA categories 3 and 4 (Table 3). Subgroup analysis on inpatient deaths showed no age effect, but a significant period effect (odds ratio [OR] = 3.13, 95% confidence interval [CI]: 1.019.73 for Periods A vs B; P = 0.0488) and ASA status effect (OR = 0.06, 95% CI: 0.020.16 for ASA severe vs life‐threatening; P < 0.0001).
DISCUSSION
The addition of a Hospitalist‐run, medical Preoperative clinic was associated with more perioperative beta blocker use, shortened LOS, and lower mortality rates for our veteran patients undergoing noncardiac surgery. Such LOS reduction was not apparent in our internal control of cardiothoracic surgery patients or in the VA National Surgical Quality Improvement Program (NSQIP), a national representative sample of a similar patient population. While median unadjusted LOS in the VA NSQIP did not change over the same time periods, surgical mortality rates decreased, but by a smaller magnitude (15%) than seen in our study. While mortality in our study was reduced, the absolute numbers are relatively small. However, a subgroup analysis accounting for age and ASA score demonstrated a reduction in mortality.
As multiple structure and process changes were made in the Preoperative program, it is not definitively known which specific factor or factors could have affected inpatient surgical care. The Preoperative clinic evaluation was a one‐time consult, but included recommendations for perioperative management, including medication adjustments and infrequent suggestions for perioperative consultation. The decision to follow such recommendations was voluntary on the part of the surgical team. Alternatively, preoperative optimization may have played a role. By performing a multisystem evaluation with evidence‐based protocols, we possibly identified patients that were at increased risk of perioperative harm, and were able to intervene or recommend deferral of the procedure. This could have resulted in better surgical candidate selection with fewer postoperative complications, especially among patients with significant medical comorbidities.
Better patient selection is also suggested by a trend toward fewer same‐day cancellations for medically avoidable reasons during Period B. The distinction between medical versus patient‐related causes and avoidable versus unavoidable causes may be imprecise; however, the same Anesthesia staff assigned the categories over both periods and therefore any possible inconsistencies should have averaged out.
Increased usage of perioperative beta blockers may also have contributed to reduced mortality rates. We anticipated that more patients in Period B would be placed on perioperative beta blockers, given the guidelines in place at the time. More recently, the evidence for perioperative beta blockade has been further refined,16, 17 but during study Periods A and B, it was considered best practice for wider patient populations.
Fewer repeat referrals to Cardiology clinic and more cardiac testing were ordered by the Preoperative clinic providers during Period B. Ordering cardiac studies from Preoperative clinic and referring only when guideline‐driven could have streamlined the evaluation process and prevented the need for repeat referrals. We expect the number of stress tests and Cardiology consultations to have decreased even more in recent years as the 2007 ACC/AHA guidelines further emphasize medical optimization and de‐emphasize cardiac testing and prophylactic revascularization prior to surgery.18
Our results suggest that similar healthcare systems may benefit from adding medical expertise to their preoperative clinical operations. As the LOS reduction was most noticeable in patients with higher ASA scores, the largest impact would likely be with healthcare environments with medically complex patients and variable access to primary care. The shortage of primary care physicians and the increase in chronic disease burden in the US population may cause more patients to present to a surgeon in a nonoptimized condition. Arguably, such clinics could be supervised by any discipline that is familiar with the perioperative literature, chronic disease management, and postoperative inpatient care. Other options include clinics in which Anesthesiologists jointly collaborate with Hospitalists19 or General Internists with expertise in perioperative management.
Our study has many limitations. The VA has a largely male population and an electronic medical record, and thus results are not generalizable. Patients were younger in Period B than in Period A; however, the 2‐ to 3‐year difference might not be clinically significant, and the standard deviation was wide in both groups. This study is a retrospective observational study, and thus we cannot identify the specific processes that could have lead to any associated outcomes. There was no ideal contemporaneous control group, but examination of trends in cardiothoracic surgery at our institution and the national VA database does not reveal changes of this magnitude. Unforeseen biases could have resulted in upcoding of ASA scores by the mid‐level providers. Beta blocker usage was determined by patients prescribed beta blockers perioperatively, and did not exclude those on the medication prior to presentation. However, the significant increase in usage in Period B points to an increase in prescriptions originating from the Preoperative clinic. We do not have a breakdown of postoperative days in the intensive care unit (ICU) or ward settings, or the readmission rates. Thus, a true cost‐effectiveness analysis cannot be done. However, the reduction in postoperative LOS and decline in same‐day cancellations suggests that our institution benefited to some degree. Since the mid‐level providers were present prior to the change from Anesthesia to Hospitalist leadership, the only cost of the intervention was the hiring of a Hospitalist. However, the change freed an Anesthesiologist to work in the operating room or procedure suite. We do not have precise data regarding the number of surgeries delayed or canceled by the Preoperative clinic, but surgical workload was similar between both periods. Hopefully future studies will include richer data to minimize study limitations.
CONCLUSION
The addition of a Hospitalist‐run, medical Preoperative clinic was associated with improvements in perioperative processes and outcomes. Postoperative LOS was reduced in the sickest patients, as was inpatient mortality. Perioperative beta blocker use was increased. Adding Hospitalist expertise to preoperative clinical operations may be a viable model to improve perioperative care.
Acknowledgements
The authors thank Manyee Gee for retrieving much needed data. The authors also thank our staff in the Preoperative clinic for their exceptional hard work and dedication to our veteran patients.
Anesthesiologists typically initiate an assessment in the immediate preoperative period, focused on management of the airway, physiologic parameters, and choice of anesthetic. Given the growing complexity of medical issues in the surgical patient, the preoperative assessment may need to be initiated weeks to months prior to surgery. Early evaluation allows time to implement required interventions, optimize medical conditions, adjust medications, and collaborate with the surgical team.
Most studies of Preoperative clinics are in the Anesthesiology literature.1 Anesthesia‐run Preoperative clinics have demonstrated a reduction in surgical cancellations and length of stay (LOS).2 Auerbach and colleagues found medical consultation to have inconsistent effects on quality of care in surgical patients, but consultations occurred, at the earliest, 1 day prior to surgery.3 A randomized trial, performed at the Pittsburgh Veterans Administration (VA) medical center using an outpatient Internal Medicine Preoperative clinic, demonstrated a shortening of preoperative LOS but no change in total LOS, and increased use of consultants. However, there were reduced numbers of unnecessary admissions, defined as patients who were discharged without having had surgery.4 An analysis of a population‐based administrative database found that voluntary preoperative consultations were associated with a significant, albeit small, increase in mortality. Although this study used a matched cohort, the unmatched cohort that underwent consultation was higher risk; also, selection bias was possible, as the reasons for initial consultation were unknown.5
Historically, the Preoperative clinic at VA Greater Los Angeles Healthcare System (VAGLAHS) was supervised by the Department of Anesthesiology. In July 2004, the Preoperative clinic was restructured with Hospitalist oversight. The Anesthesia staff continued to evaluate all surgical patients, but did so only on the day of surgery, and after the patient was deemed an acceptable risk by the Preoperative clinic.
We undertook this study to measure the institutional impact of the addition of a Hospitalist‐run Preoperative clinic to our standard practice. The VA is an ideal setting, given the closed system with reliable longitudinal data. The VA electronic medical record also allows for comprehensive calculations of clinical covariants and outcomes.
MATERIALS AND METHODS
Setting
VAGLAHS is a tertiary care, academic medical center that serves patients referred from a 110,000 square mile area of Southern California and Southern Nevada. The Preoperative clinic evaluates all outpatients scheduled for inpatient or outpatient noncardiac surgery. Evaluations are performed by mid‐level providers with physician oversight. Patients are seen within 30 days of surgery, with a goal of 2 to 3 weeks prior to the operative date. Two of the 3 mid‐level providers remained after the change in leadership; a third was hired. All were retrained to perform a detailed medical preoperative assessment. Patients awaiting cardiothoracic surgery had their evaluation performed outside the Preoperative clinic by the Cardiology or Pulmonary services during both periods.
With the change in oversight, mid‐level providers were given weekly lectures on medical disease management and preoperative assessment. A syllabus of key articles in perioperative literature was compiled. Evidence‐based protocols were developed to standardize the evaluation. Examples of guidelines include: laboratory and radiological testing guidelines,610 initiation of perioperative beta blockers,11 selection criteria for pulmonary function tests,12 protocols for bridging with low‐molecular‐weight heparin for patients on oral vitamin K antagonists,13 the cardiovascular evaluation based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines,14 as well as adjustment of diabetic medications.
Prior to the change in oversight, patients who required Cardiology evaluations were referred directly to the Cardiology service generally without any prior testing. After institution of the Hospitalist‐run clinic, the mid‐level providers ordered cardiac studies after discussion with the attending to ensure necessity and compliance with ACC/AHA guidelines. Patients were referred to Cardiology only if the results required further evaluation. In addition, entry to the Preoperative clinic was denied to patients awaiting elective surgeries whose hemoglobin A1c percentage was greater than 9%; such patients were referred to their primary care provider. For patients awaiting urgent surgeries, the Preoperative clinic would expedite evaluations in order to honor the surgical date. Providers would document perioperative recommendations for patients anticipated to require an inpatient stay. Occasionally, the patient was deemed too high risk to proceed with surgery, and the case was canceled or delayed after discussion with the patient and surgical team. Once deemed a medically acceptable candidate, the patient was evaluated on the day of surgery by Anesthesia.
Methods
We extracted de‐identified data from Veterans Health Administration (VHA) national databases, and specifically from the Veterans Integrated Service Network (VISN) 22 warehouse. All patients seen in the Preoperative clinic at VAGLAHS, from July 2003 to July 2005, were included. The patients were analyzed in 2 groups: patients seen from July 2003 to June 2004, when the Anesthesia Department staff supervised the Preoperative clinic (Period A); and from July 2004 to June 2005, the first year of the new Hospitalist‐run system (Period B). We collected data on age; gender; American Society of Anesthesia (ASA) score15; perioperative beta blocker use; cardiology studies ordered; and surgical mortality defined as death within the index hospital stay. The length of stay (LOS) was calculated for patients who required an inpatient stay after surgery. As an internal control, we assessed the LOS of the cardiothoracic patients in our facility since this group of patients does not utilize the Preoperative clinic and maintained the same preoperative evaluation process during both time periods. In addition, same‐day surgical cancellations were tracked by the Anesthesia Department, which documents daily operating room utilization and determines whether a cancellation was avoidable.
Statistical Analysis
Differences in demographic, clinical, and preoperative resource utilization characteristics were compared between Periods A and B using chi‐square for categorical variables and t test (or Wilcoxon test) for continuous variables. A subgroup analysis was performed for patients who required an inpatient stay after surgery. The primary outcome was inpatient LOS and the secondary outcome was inpatient death. A mixed‐effects regression model with patient‐level random effects to account for clustering of visits by the same patient was used to assess the impact of certain patient characteristics on inpatient LOS. Covariates included age, gender, time period (A vs B), ASA classification, and perioperative period‐by‐ASA classification interaction. Comparisons of inpatient LOS between periods for different ASA classes were done through model contrasts. Chi‐square test was used to compare the inpatient mortality between periods. A subgroup analysis was performed on postoperative inpatient deaths during the study period using a logistics regression model with age, ASA, and time period. All statistical analyses were performed using SAS Version 9.2 (SAS Institute, Cary, NC).
RESULTS
Table 1 describes the demographics and clinical characteristics of the patients evaluated in the Preoperative clinic. Number of surgeries performed in Periods A and B were 3568 and 3337, respectively, with an average of 1.3 surgeries per patient for both periods. The most common surgical specialties were Ophthalmology, Orthopedics, Urology, and General Surgery. The average ages of patients in Periods A and B were 63.9 and 61.4 years, respectively (P < 0.0001). The patients were predominantly male. ASA classifications were similar in the 2 periods, with over 60% of patients having an ASA score of 3 or higher.
| Period A N (%) | Period B N (%) | P | |
|---|---|---|---|
| |||
| No. of patients | 2658 | 2565 | |
| Total no. of surgeries | 3568 | 3337 | |
| Service | 0.0746 | ||
| Ophthalmology | 756 (21.1) | 637 (19.1) | |
| Urology | 526 (14.7) | 478 (14.3) | |
| Orthopedics | 527 (14.8) | 502 (15.0) | |
| General surgery | 469 (13.1) | 495 (14.8) | |
| ENT | 363 (10.2) | 312 (9.4) | |
| Other | 927 (26.0) | 913 (27.4) | |
| Age, mean (SD) | 63.9 (13.2) | 61.4 (13.5) | <0.0001 |
| Male | 2486 (93.5) | 2335 (93.0) | 0.4100 |
| ASA classification | 0.1836 | ||
| 1. No disturbance | 59 (2.3) | 81 (3.3) | |
| 2. Mild | 896 (35.3) | 864 (35.3) | |
| 3. Severe | 1505 (59.3) | 1425 (58.1) | |
| 4. Life‐threatening or worse | 77 (3.0) | 81 (3.3) | |
| 5. Missing scores | 121 (4.6) | 114 (4.4) | |
Table 2 presents the selected preoperative resource utilization. Less than 3% of patients referred to the Preoperative clinic were referred for Cardiology consultation during both time periods. However, during Period A, some patients required multiple Cardiology referrals resulting in 85 referrals in Period A and 64 referrals in Period B. In contrast, Preoperative clinic providers ordered more cardiac studies in Period B than in Period A (P = 0.012). There was a significant increase in the number of patients on perioperative beta blockers, with 26% in Period A and 33% in Period B (P < 0.0001). Although there was no significant difference in the number of same‐day surgical cancellations between the 2 periods, there was a trend towards a reduction of cancellations for medically avoidable reasons, 34 (8.5%) and 18 (4.9%) cases during Periods A and B, respectively (P = 0.065).
| Period A N (%) | Period B N (%) | P | |
|---|---|---|---|
| |||
| No. of patients | 2658 | 2565 | |
| No. of patients that had at least 1 cardiology referral | 70 (2.6) | 62 (2.4) | 0.660 |
| No. of cardiology referrals | 85 | 64 | |
| Cardiac testing orders | 40 | 88 | 0.012 |
| Nuclear medicine | 20 (50.0) | 58 (65.9) | |
| Nuclear treadmill | 2 (5.0) | 12 (13.6) | |
| ETT | 18 (45.0) | 18 (20.5) | |
| Perioperative beta blocker | 696 (26.2) | 852 (33.2) | <0.0001 |
| Cases canceled day of surgery | |||
| Total | 400 (15.0) | 368 (14.3) | |
| Medical avoidable | 34 (8.5) | 18 (4.9) | 0.065 |
Table 3 describes the clinical characteristics, inpatient LOS, and inpatient mortality for the surgical inpatients assessed in the Preoperative clinic. There were 1101 patients with 1200 inpatient surgeries in Period A, and 1126 patients with 1245 inpatient surgeries in Period B. The mean ages were 63.3 and 61.4 years in Periods A and B, respectively (P = 0.0004). More than 90% of patients were male. Over 62% of patients had ASA scores of 3 or higher in both periods. Both mean and median LOS was reduced in Period B. Results from the mixed‐effects regression model indicated no age and gender effects. ASA classification was significantly associated with LOS (P < 0.0001). There were reductions in LOS from Period A to Period B across all ASA classifications, however, the levels of reduction were different among them (ie, significant interaction effect, P = 0.0005). Patients who were ASA 3 or higher had a significantly shorter LOS in Period B as compared to those in Period A (P < 0.0001).
| Period A | Period B | P | |
|---|---|---|---|
| |||
| No. of patients | 1101 | 1126 | |
| No. of inpatient surgeries | 1200 | 1245 | |
| Age, mean (SD)* | 63.3 (12.7) | 61.4 (12.8) | 0.0004 |
| Male (%) | 1022 (92.8) | 1024 (90.9) | 0.1039 |
| ASA classification | 0.0510 | ||
| 1. No disturbance | 15 (1.36) | 27 (2.40) | |
| 2. Mild | 324 (29.4) | 364 (32.3) | |
| 3. Severe | 710 (64.5) | 697 (61.9) | |
| 4. Life‐threatening | 52 (4.72) | 38 (3.37) | |
| Primary outcome | |||
| In‐patient LOS (days) | |||
| Mean (SD) | 9.87 (25.4) | 5.28 (9.24) | |
| Median (minmax) | 3.0 (1516) | 2.0 (1120) | |
| Mixed‐effects regression | Period AB Estimated difference (SE) | ||
| 1. No disturbance | 1.31 (5.90) | 0.8247 | |
| 2. Mild | 2.52 (1.39) | 0.0717 | |
| 3. Severe | 4.22 (0.96) | <0.0001 | |
| 4. Life‐threatening | 19.7 (3.81) | <0.0001 | |
| Secondary outcome | |||
| Mortality, N (%) | 14 (1.27) | 4 (0.36) | 0.0158 |
| ASA classification | |||
| 3. Severe | 7 (0.99) | 2 (0.29) | |
| 4. Life‐threatening | 7 (13.5) | 2 (5.26) | |
| Logistic regression | Estimated OR (95% CI) | ||
| Period (A vs B) | 3.13 (1.01, 9.73) | 0.0488 | |
| ASA classification (3 vs 4) | 0.06 (0.02, 0.16) | <0.0001 | |
The LOS on the Cardiothoracic services was also evaluated. No significant difference in LOS was observed between the 2 periods (average LOS of 18 days) after adjusting for the patients' age and ASA score.
Inpatient mortality was reduced in Period B, from 14 cases (1.27%) to 4 cases (0.36%) (P = 0.0158). No patients who were ASA 2 or less died. Deaths in each period were evenly split between ASA categories 3 and 4 (Table 3). Subgroup analysis on inpatient deaths showed no age effect, but a significant period effect (odds ratio [OR] = 3.13, 95% confidence interval [CI]: 1.019.73 for Periods A vs B; P = 0.0488) and ASA status effect (OR = 0.06, 95% CI: 0.020.16 for ASA severe vs life‐threatening; P < 0.0001).
DISCUSSION
The addition of a Hospitalist‐run, medical Preoperative clinic was associated with more perioperative beta blocker use, shortened LOS, and lower mortality rates for our veteran patients undergoing noncardiac surgery. Such LOS reduction was not apparent in our internal control of cardiothoracic surgery patients or in the VA National Surgical Quality Improvement Program (NSQIP), a national representative sample of a similar patient population. While median unadjusted LOS in the VA NSQIP did not change over the same time periods, surgical mortality rates decreased, but by a smaller magnitude (15%) than seen in our study. While mortality in our study was reduced, the absolute numbers are relatively small. However, a subgroup analysis accounting for age and ASA score demonstrated a reduction in mortality.
As multiple structure and process changes were made in the Preoperative program, it is not definitively known which specific factor or factors could have affected inpatient surgical care. The Preoperative clinic evaluation was a one‐time consult, but included recommendations for perioperative management, including medication adjustments and infrequent suggestions for perioperative consultation. The decision to follow such recommendations was voluntary on the part of the surgical team. Alternatively, preoperative optimization may have played a role. By performing a multisystem evaluation with evidence‐based protocols, we possibly identified patients that were at increased risk of perioperative harm, and were able to intervene or recommend deferral of the procedure. This could have resulted in better surgical candidate selection with fewer postoperative complications, especially among patients with significant medical comorbidities.
Better patient selection is also suggested by a trend toward fewer same‐day cancellations for medically avoidable reasons during Period B. The distinction between medical versus patient‐related causes and avoidable versus unavoidable causes may be imprecise; however, the same Anesthesia staff assigned the categories over both periods and therefore any possible inconsistencies should have averaged out.
Increased usage of perioperative beta blockers may also have contributed to reduced mortality rates. We anticipated that more patients in Period B would be placed on perioperative beta blockers, given the guidelines in place at the time. More recently, the evidence for perioperative beta blockade has been further refined,16, 17 but during study Periods A and B, it was considered best practice for wider patient populations.
Fewer repeat referrals to Cardiology clinic and more cardiac testing were ordered by the Preoperative clinic providers during Period B. Ordering cardiac studies from Preoperative clinic and referring only when guideline‐driven could have streamlined the evaluation process and prevented the need for repeat referrals. We expect the number of stress tests and Cardiology consultations to have decreased even more in recent years as the 2007 ACC/AHA guidelines further emphasize medical optimization and de‐emphasize cardiac testing and prophylactic revascularization prior to surgery.18
Our results suggest that similar healthcare systems may benefit from adding medical expertise to their preoperative clinical operations. As the LOS reduction was most noticeable in patients with higher ASA scores, the largest impact would likely be with healthcare environments with medically complex patients and variable access to primary care. The shortage of primary care physicians and the increase in chronic disease burden in the US population may cause more patients to present to a surgeon in a nonoptimized condition. Arguably, such clinics could be supervised by any discipline that is familiar with the perioperative literature, chronic disease management, and postoperative inpatient care. Other options include clinics in which Anesthesiologists jointly collaborate with Hospitalists19 or General Internists with expertise in perioperative management.
Our study has many limitations. The VA has a largely male population and an electronic medical record, and thus results are not generalizable. Patients were younger in Period B than in Period A; however, the 2‐ to 3‐year difference might not be clinically significant, and the standard deviation was wide in both groups. This study is a retrospective observational study, and thus we cannot identify the specific processes that could have lead to any associated outcomes. There was no ideal contemporaneous control group, but examination of trends in cardiothoracic surgery at our institution and the national VA database does not reveal changes of this magnitude. Unforeseen biases could have resulted in upcoding of ASA scores by the mid‐level providers. Beta blocker usage was determined by patients prescribed beta blockers perioperatively, and did not exclude those on the medication prior to presentation. However, the significant increase in usage in Period B points to an increase in prescriptions originating from the Preoperative clinic. We do not have a breakdown of postoperative days in the intensive care unit (ICU) or ward settings, or the readmission rates. Thus, a true cost‐effectiveness analysis cannot be done. However, the reduction in postoperative LOS and decline in same‐day cancellations suggests that our institution benefited to some degree. Since the mid‐level providers were present prior to the change from Anesthesia to Hospitalist leadership, the only cost of the intervention was the hiring of a Hospitalist. However, the change freed an Anesthesiologist to work in the operating room or procedure suite. We do not have precise data regarding the number of surgeries delayed or canceled by the Preoperative clinic, but surgical workload was similar between both periods. Hopefully future studies will include richer data to minimize study limitations.
CONCLUSION
The addition of a Hospitalist‐run, medical Preoperative clinic was associated with improvements in perioperative processes and outcomes. Postoperative LOS was reduced in the sickest patients, as was inpatient mortality. Perioperative beta blocker use was increased. Adding Hospitalist expertise to preoperative clinical operations may be a viable model to improve perioperative care.
Acknowledgements
The authors thank Manyee Gee for retrieving much needed data. The authors also thank our staff in the Preoperative clinic for their exceptional hard work and dedication to our veteran patients.
- ,,,,.Value of preoperative clinic visits in identifying issues with potential impact on operating room efficiency.Anesthesiology.2006;105:1254–1259.
- ,,, et al.The effect of outpatient perioperative evaluation of hospital inpatients on cancellation of surgery and length of hospital stay.Anesth Analg.2002;94(3):644–649.
- ,,,,,.Opportunity missed: medical consultation, resource use, and quality of care of patients undergoing major surgery.Arch Int Med.2007;167(21):2338–2344.
- ,.Outpatient internal medicine preoperative evaluation: a randomized clinical trial.Med Care.1994;32(5):498–507.
- ,,,,.Outcomes and processes of care related to preoperative medical consultation.Arch Intern Med.2010;170(15):1365–1374.
- .Cost‐effective preoperative evaluation and testing.Chest.1999;115(5):96S–100S.
- ,,.Optimizing postoperative outcomes with efficient preoperative assessment and management.Crit Care Med.2004;32(4):S76–S86.
- .Preoperative laboratory testing: general issues and considerations.Anesthesiol Clin North Am.2004;22(1):13–25.
- .Preoperative medical evaluation of the healthy patient. Available at: http://www.uptodate.com. Accessed July 15, 2004.
- ,.The case against routine preoperative laboratory testing.Med Clin North Am.2003;87(1):7–40.
- ,.Blockers and reduction of cardiac events in noncardiac surgery.JAMA.2002;287:1435–1444.
- .Preoperative pulmonary evaluation.N Engl J Med.1999;340(12):937–944.
- ,,,,,.The pharmacology and management of the vitamin K antagonists. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: evidence‐based guidelines.Chest.2004;126(3 suppl):204S–233S.
- ,,, et al; for theCommittee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery—executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.Circulation.2002;105(10):1257–1267.
- American Society of Anesthesiology House of Delegates.New classification of physical status.Anesthesiology.1963;24:111.
- ,,, et al; for thePOISE Study Group.Effects of extended‐release metoprolol succinate in patients undergoing non‐cardiac surgery (POISE trial): a randomised controlled trial.Lancet.2008;371(9627):1839–1847.
- ,,,,,.Perioperative beta blockers in patients having non‐cardiac surgery: a meta‐analysis.Lancet.2008;372(9654):1962–1976.
- ,,, et al; for theWriting Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.Circulation.2007;116(17):1971–1996.
- ,.Hospitalists and anesthesiologists as perioperative physicians: are their roles complimentary?Proc (Bayl Univ Med Cent).2007;20(2):140–142.
- ,,,,.Value of preoperative clinic visits in identifying issues with potential impact on operating room efficiency.Anesthesiology.2006;105:1254–1259.
- ,,, et al.The effect of outpatient perioperative evaluation of hospital inpatients on cancellation of surgery and length of hospital stay.Anesth Analg.2002;94(3):644–649.
- ,,,,,.Opportunity missed: medical consultation, resource use, and quality of care of patients undergoing major surgery.Arch Int Med.2007;167(21):2338–2344.
- ,.Outpatient internal medicine preoperative evaluation: a randomized clinical trial.Med Care.1994;32(5):498–507.
- ,,,,.Outcomes and processes of care related to preoperative medical consultation.Arch Intern Med.2010;170(15):1365–1374.
- .Cost‐effective preoperative evaluation and testing.Chest.1999;115(5):96S–100S.
- ,,.Optimizing postoperative outcomes with efficient preoperative assessment and management.Crit Care Med.2004;32(4):S76–S86.
- .Preoperative laboratory testing: general issues and considerations.Anesthesiol Clin North Am.2004;22(1):13–25.
- .Preoperative medical evaluation of the healthy patient. Available at: http://www.uptodate.com. Accessed July 15, 2004.
- ,.The case against routine preoperative laboratory testing.Med Clin North Am.2003;87(1):7–40.
- ,.Blockers and reduction of cardiac events in noncardiac surgery.JAMA.2002;287:1435–1444.
- .Preoperative pulmonary evaluation.N Engl J Med.1999;340(12):937–944.
- ,,,,,.The pharmacology and management of the vitamin K antagonists. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: evidence‐based guidelines.Chest.2004;126(3 suppl):204S–233S.
- ,,, et al; for theCommittee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery—executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.Circulation.2002;105(10):1257–1267.
- American Society of Anesthesiology House of Delegates.New classification of physical status.Anesthesiology.1963;24:111.
- ,,, et al; for thePOISE Study Group.Effects of extended‐release metoprolol succinate in patients undergoing non‐cardiac surgery (POISE trial): a randomised controlled trial.Lancet.2008;371(9627):1839–1847.
- ,,,,,.Perioperative beta blockers in patients having non‐cardiac surgery: a meta‐analysis.Lancet.2008;372(9654):1962–1976.
- ,,, et al; for theWriting Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.Circulation.2007;116(17):1971–1996.
- ,.Hospitalists and anesthesiologists as perioperative physicians: are their roles complimentary?Proc (Bayl Univ Med Cent).2007;20(2):140–142.
Copyright © 2012 Society of Hospital Medicine
FDA approves 3rd-generation TKI for CML
The FDA has approved bosutinib (Bosulif), an Abl and Src kinase inhibitor, to treat patients with relapsed or refractory chronic myelogenous leukemia (CML).
Bosutinib is intended for use in patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive CML who have failed therapy with first-generation and second-generation tyrosine kinase inhibitors (TKIs).
The recommended dose of bosutinib is 500 mg, taken once daily with food.
“[Bosutinib] is an important new addition to the CML treatment landscape,” said Jorge E. Cortes, MD, of MD Anderson Cancer Center in Houston.
“Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”
Dr Cortes was a lead investigator of the industry-sponsored study that led to bosutinib’s approval. The phase 1/2 trial included 546 adult patients who had chronic, accelerated, or blast phase CML.
Efficacy data
Patients were evaluable for efficacy if they had received at least one bosutinib dose and had a valid baseline efficacy assessment. Of the 546 patients enrolled, 503 were evaluable for efficacy.
Among the patients in chronic phase, 266 received prior treatment with imatinib only, and 108 received prior treatment with imatinib followed by dasatinib and/or nilotinib. There were 129 evaluable patients with advanced phase CML who were previously treated with at least one TKI.
The efficacy endpoints for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24 and the duration of MCyR. The efficacy endpoints for patients with accelerated phase or blast phase CML were the rates of complete hematologic response (CHR) and overall hematologic response (OHR) by week 48.
In patients with chronic phase CML who received prior therapy with one TKI, 90 patients (33.8%) achieved an MCyR at week 24. Among the chronic phase CML patients who received prior therapy with more than one TKI, 29 (26.9%) achieved an MCyR by week 24.
Of the patients with chronic phase CML who had been treated with one prior TKI, 53.4% achieved an MCyR at any time during the trial. And 52.8% had a response lasting at least 18 months.
For the 32.4% of patients with chronic phase CML treated with more than one TKI who achieved an MCyR at any time, 51.4% had a response lasting at least 9 months.
In patients with accelerated phase CML who received at least one prior TKI, 21 (30.4%) achieved a CHR by week 48. And 38 patients (55.1%) achieved an OHR.
In the blast phase population, 9 patients (15%) achieved a CHR by week 48. And 17 patients (28.3%) achieved an OHR.
Safety data
The researchers evaluated bosutinib’s safety in all 546 patients. Of these patients, 287 had chronic phase CML, were previously treated with a single TKI, and had a median bosutinib treatment duration of 24 months.
There were 119 patients who had chronic phase CML, were previously treated with more than one TKI, and had a median bosutinib treatment duration of 9 months.
There were also 76 patients with accelerated phase CML and 64 patients with blast phase CML. In these patients, the median treatment duration was 10 months and 3 months, respectively.
The most common adverse events observed in more than 20% of all patients were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.
The most common grade 3 to 4 adverse events observed in more than 10% of patients were thrombocytopenia, anemia, and neutropenia. Other serious adverse events included anaphylactic shock, myelosuppression, gastrointestinal toxicity, fluid retention, hepatoxicity, and rash.
Bosutinib is marketed as Bosulif by Pfizer. For more information on bosutinib, see the package insert. ![]()
The FDA has approved bosutinib (Bosulif), an Abl and Src kinase inhibitor, to treat patients with relapsed or refractory chronic myelogenous leukemia (CML).
Bosutinib is intended for use in patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive CML who have failed therapy with first-generation and second-generation tyrosine kinase inhibitors (TKIs).
The recommended dose of bosutinib is 500 mg, taken once daily with food.
“[Bosutinib] is an important new addition to the CML treatment landscape,” said Jorge E. Cortes, MD, of MD Anderson Cancer Center in Houston.
“Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”
Dr Cortes was a lead investigator of the industry-sponsored study that led to bosutinib’s approval. The phase 1/2 trial included 546 adult patients who had chronic, accelerated, or blast phase CML.
Efficacy data
Patients were evaluable for efficacy if they had received at least one bosutinib dose and had a valid baseline efficacy assessment. Of the 546 patients enrolled, 503 were evaluable for efficacy.
Among the patients in chronic phase, 266 received prior treatment with imatinib only, and 108 received prior treatment with imatinib followed by dasatinib and/or nilotinib. There were 129 evaluable patients with advanced phase CML who were previously treated with at least one TKI.
The efficacy endpoints for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24 and the duration of MCyR. The efficacy endpoints for patients with accelerated phase or blast phase CML were the rates of complete hematologic response (CHR) and overall hematologic response (OHR) by week 48.
In patients with chronic phase CML who received prior therapy with one TKI, 90 patients (33.8%) achieved an MCyR at week 24. Among the chronic phase CML patients who received prior therapy with more than one TKI, 29 (26.9%) achieved an MCyR by week 24.
Of the patients with chronic phase CML who had been treated with one prior TKI, 53.4% achieved an MCyR at any time during the trial. And 52.8% had a response lasting at least 18 months.
For the 32.4% of patients with chronic phase CML treated with more than one TKI who achieved an MCyR at any time, 51.4% had a response lasting at least 9 months.
In patients with accelerated phase CML who received at least one prior TKI, 21 (30.4%) achieved a CHR by week 48. And 38 patients (55.1%) achieved an OHR.
In the blast phase population, 9 patients (15%) achieved a CHR by week 48. And 17 patients (28.3%) achieved an OHR.
Safety data
The researchers evaluated bosutinib’s safety in all 546 patients. Of these patients, 287 had chronic phase CML, were previously treated with a single TKI, and had a median bosutinib treatment duration of 24 months.
There were 119 patients who had chronic phase CML, were previously treated with more than one TKI, and had a median bosutinib treatment duration of 9 months.
There were also 76 patients with accelerated phase CML and 64 patients with blast phase CML. In these patients, the median treatment duration was 10 months and 3 months, respectively.
The most common adverse events observed in more than 20% of all patients were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.
The most common grade 3 to 4 adverse events observed in more than 10% of patients were thrombocytopenia, anemia, and neutropenia. Other serious adverse events included anaphylactic shock, myelosuppression, gastrointestinal toxicity, fluid retention, hepatoxicity, and rash.
Bosutinib is marketed as Bosulif by Pfizer. For more information on bosutinib, see the package insert. ![]()
The FDA has approved bosutinib (Bosulif), an Abl and Src kinase inhibitor, to treat patients with relapsed or refractory chronic myelogenous leukemia (CML).
Bosutinib is intended for use in patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive CML who have failed therapy with first-generation and second-generation tyrosine kinase inhibitors (TKIs).
The recommended dose of bosutinib is 500 mg, taken once daily with food.
“[Bosutinib] is an important new addition to the CML treatment landscape,” said Jorge E. Cortes, MD, of MD Anderson Cancer Center in Houston.
“Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”
Dr Cortes was a lead investigator of the industry-sponsored study that led to bosutinib’s approval. The phase 1/2 trial included 546 adult patients who had chronic, accelerated, or blast phase CML.
Efficacy data
Patients were evaluable for efficacy if they had received at least one bosutinib dose and had a valid baseline efficacy assessment. Of the 546 patients enrolled, 503 were evaluable for efficacy.
Among the patients in chronic phase, 266 received prior treatment with imatinib only, and 108 received prior treatment with imatinib followed by dasatinib and/or nilotinib. There were 129 evaluable patients with advanced phase CML who were previously treated with at least one TKI.
The efficacy endpoints for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24 and the duration of MCyR. The efficacy endpoints for patients with accelerated phase or blast phase CML were the rates of complete hematologic response (CHR) and overall hematologic response (OHR) by week 48.
In patients with chronic phase CML who received prior therapy with one TKI, 90 patients (33.8%) achieved an MCyR at week 24. Among the chronic phase CML patients who received prior therapy with more than one TKI, 29 (26.9%) achieved an MCyR by week 24.
Of the patients with chronic phase CML who had been treated with one prior TKI, 53.4% achieved an MCyR at any time during the trial. And 52.8% had a response lasting at least 18 months.
For the 32.4% of patients with chronic phase CML treated with more than one TKI who achieved an MCyR at any time, 51.4% had a response lasting at least 9 months.
In patients with accelerated phase CML who received at least one prior TKI, 21 (30.4%) achieved a CHR by week 48. And 38 patients (55.1%) achieved an OHR.
In the blast phase population, 9 patients (15%) achieved a CHR by week 48. And 17 patients (28.3%) achieved an OHR.
Safety data
The researchers evaluated bosutinib’s safety in all 546 patients. Of these patients, 287 had chronic phase CML, were previously treated with a single TKI, and had a median bosutinib treatment duration of 24 months.
There were 119 patients who had chronic phase CML, were previously treated with more than one TKI, and had a median bosutinib treatment duration of 9 months.
There were also 76 patients with accelerated phase CML and 64 patients with blast phase CML. In these patients, the median treatment duration was 10 months and 3 months, respectively.
The most common adverse events observed in more than 20% of all patients were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.
The most common grade 3 to 4 adverse events observed in more than 10% of patients were thrombocytopenia, anemia, and neutropenia. Other serious adverse events included anaphylactic shock, myelosuppression, gastrointestinal toxicity, fluid retention, hepatoxicity, and rash.
Bosutinib is marketed as Bosulif by Pfizer. For more information on bosutinib, see the package insert. ![]()
Attention: New Resident Medical Editors Wanted! (copy 1)
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: October 15, 2012
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: October 15, 2012
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: October 15, 2012
Attention: New Resident Medical Editors Wanted! (copy 1)
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: October 15, 2012
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: October 15, 2012
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: October 15, 2012
Attention: New Resident Medical Editors Wanted!
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: November 15, 2012
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: November 15, 2012
Thoracic Surgery News is seeking 2 new resident associate medical editors for a 1-year appointment for our publication. To apply, you should be a resident in a field of thoracic surgery and willing to review and potentially comment upon articles for our monthly Residents’ Corner section.
In addition, resident medical editors are expected to work with the other editors to contribute 4 to 6 short articles throughout the appointment year, whether it is case studies by themselves or solicited from other thoracic surgeons, news or opinion pieces on resident issues, or summaries of resident-oriented sessions at meetings they attend.
Please send a CV and cover letter indicating your interest to [email protected] Deadline: November 15, 2012
PMI After Hip Fracture Surgery
Perioperative myocardial infarction (PMI) often remains unrecognized with higher mortality in the aged.13 Perioperative ischemic symptoms are often masked by analgesia, sedation, and transient and subtle electrocardiographic (ECG) changes. Postoperative troponin measurement is not routinely done for PMI diagnosis. Hip fracture surgery is the most common non‐cardiac surgical procedure in the elderly, with limited data on clinical presentation of PMI.46 Moreover, the elderly are significantly underrepresented in clinical studies.7 We therefore examined the clinical presentation of PMI and its outcomes among elderly patients admitted for hip fracture repair.
METHODS
Study Population
A population‐based, retrospective, case‐control study was conducted of all residents in Olmsted County, Minnesota undergoing surgery for hip fracture repair from January 1, 1988 through December 31, 2002. Primary indication for the surgery was proximal femur (femoral neck or subtrochanteric) fracture. Patients who were <65 years old, had a pathological hip fracture, multiple injuries or fractures, surgery >72 hours after injury (due to higher mortality with delayed surgery),8 nonsurgical management of hip fracture repair, or incomplete data were excluded. All patients provided prior authorization to use their medical records for research, per institutional protocols.9
Criteria for Perioperative Myocardial Infarction and Death
We utilized the universal definition of acute myocardial infarction10 to define PMI within the first 7 days following hip fracture surgery. We included creatine kinase‐MB fraction (CK‐MB) as the biomarker for 1988July 2000, and troponin as the biomarker for August 20002002. Mortality was defined as death from any cause within the first year following hip fracture repair. Deaths were identified through the National Death Index.
Statistical Analysis
For each case of PMI, we identified 2 control patients who were selected at random from the non‐PMI patient population. These controls were matched to cases based on age at the time of surgery (5 years) and gender in 1:2 ratios. Baseline characteristics across PMI and non‐PMI groups were compared using the Kruskal‐Wallis test (for continuous data) and the chi‐square or Fisher's exact tests (for categorical data). Mean values were utilized in place of the missing values for the following variables: preoperative troponin (missing values 88 [17.5%]), CK‐MB (8 [1.6%]), troponin (21 [5.4%]), and postoperative hemoglobin (17 [3.4%]). Univariate predictors of PMI with P 0.2 baseline characteristics were entered into a multivariate, conditional, logistic regression analysis. Rates of outcomes were calculated using the Kaplan‐Meier method, and by a landmark survival curve for those with and without PMI. Cox proportional hazards analysis was utilized for survival analysis at 30 days and 1 year. All statistical tests were 2‐sided, and P values <0.05 were considered significant. All analyses were performed using SAS for UNIX (version 9.1.3; SAS Institute, Inc, Cary, NC).
RESULTS
In the cohort of 1212 with hip fracture surgeries, 167 (13.8%) cases of PMI occurred in the first 7 days, of which 153 (92%) occurred within the first 48 hours. A total of 334 controls were matched with 167 cases of PMI. Table 1 summarizes the demographic characteristics of the study participants. Of the patients with PMI, 25.2% experienced symptoms of ischemia; 7% reported chest pain, and 12% reported dyspnea. Only 22.8% of patients with PMI had ECG changes consistent with ischemia. ST elevation MI was present in 7.2% patients. PMI patients had a lower mean hemoglobin compared to the patients without PMI (8.9 mg/dL vs 9.4 mg/dL, P < 0.001). Median length of stay (LOS) in the hospital was higher among patients who experienced PMI (11.6 vs 7.4 days, P < 0.001). Overall in‐hospital mortality was 5.6%. There were 24 deaths (14.4%) in the PMI group compared to 4 (1.2%) in‐hospital deaths in patients without PMI (P < 0.001). A total of 473 (94%) patients survived to discharge. At 30‐day follow‐up, there were 29 (17.4%) deaths in the PMI group and 14 (4.2%) deaths in non‐PMI group. During the follow‐up for 1 year, there were 143 (29%) deaths: PMI 66 (39.5%) and 77 (23%) non‐PMI group (P < 0.01).
| Characteristics, n (%) | Patients With PMI | Patients Without PMI | P Value* |
|---|---|---|---|
| (N = 167) | (N = 334) | ||
| |||
| Age mean SD | 85.3 7.4 | 85.2 7.1 | 0.5 |
| Weight (kg) mean SD | 59.98 16.7 | 59.80 13.9 | 0.5 |
| Women | 127 (76.4) | 254 (76) | 0.5 |
| Any symptom of ischemia, n (%) | |||
| Chest/arm pain | 11 (7) | 4 (1) | 0.002 |
| Dyspnea | 20 (12) | 14 (4) | 0.001 |
| Nausea/vomiting | 8 (5) | 6 (2) | 0.08 |
| Diaphoresis | 1 (1) | 1 (0.3) | 1.0 |
| PND | 3 (2) | 1 (0.3) | 0.3 |
| ECG changes, n (%) | |||
| ST‐segment elevation MI | 12 (7.2) | 0 | 0.01 |
| New ECG changes consistent with ischemia | 38 (22.8) | 1(0.3) | 0.01 |
| Biochemical evidence of ischemia, n (%) | |||
| CK‐MB | 147 (88) | 20 (6) | 0.01 |
| Troponin | 52 (33) | 9 (3) | 0.001 |
| Laboratory markers | |||
| Hemoglobin gm/dL mean (SD) | 8.9 1.0 | 9.4 1.2 | 0.001 |
| Postoperative anemia (<8.0 gm/dL), n (%) | 22 (13.2) | 37 (11.1) | 0.5 |
| Length of stay (days), mean SD | 11.6 7.7 | 7.4 6.4 | 0.001 |
| In‐hospital outcome | <0.001 | ||
| Dead | 24 (14.4) | 4 (1.2) | |
| Alive | 143 (85.6) | 330 (98.8) | |
| 30‐Day outcome | <0.001 | ||
| Dead | 29 (17.4) | 14 (4.2) | |
| Alive | 138 (82.6) | 320 (95.8) | |
| 1‐Year outcome | <0.001 | ||
| Dead | 66 (39.5) | 77 (23) | |
| Alive | 101 (60.4) | 257 (77) | |
Table 2 describes the risk factors associated with PMI in‐hospital, 30‐day, and 1‐year mortality. Risk factors for PMI were coronary artery disease (CAD) (odds ratio [OR], 3.5; confidence interval [CI], 2.25.6), and serum creatinine >2 mg/dL (OR, 2.4; CI, 1.34.4). Risk factors for in‐hospital mortality were age 8589 (OR, 5.3; CI, 1.617.7), age 90 (OR, 8.9; CI, 2.630.8), PMI (OR 15.1; CI, 4.648.8), male gender (OR 5.8; CI, 2.215.2), dyspnea (OR 5.4; CI, 1.816.9), and hemoglobin <8.0 gm/dL (OR, 3.5; CI, 1.29.9). PMI was a strong predictor for 30‐day mortality (hazard ratio [HR], 4.3; CI, 2.18.9). Risk factors for 1‐year mortality were: age 90 (HR, 2.0; CI, 1.43.1), male gender (HR, 2.1; CI, 1.53.0), and PMI (HR, 1.9; CI, 1.42.7). Figures 1 and 2 describe the Kaplan‐Meier survival curves for patients with and without PMI.


| Unadjusted OR (95% CI) | Adjusted OR (95% CI) | P Value | |
|---|---|---|---|
| |||
| Perioperative myocardial infarction | |||
| Coronary artery disease | 3.0 (2.14.5) | 3.5 (2.25.6) | <0.001 |
| Serum creatinine >2.0 mg/dL | 2.7 (1.64.8) | 2.4 (1.34.4) | 0.003 |
| In‐hospital mortality | |||
| Age 8589 | 1.7 (0.83.7) | 5.3 (1.617.7) | 0.01 |
| Age 90 | 2.2 (1.04.8) | 8.9 (2.630.8) | <0.001 |
| Male gender | 3.0 (1.46.4) | 5.8 (2.215.2) | <0.001 |
| Postoperative anemia (<8.0 gm/dL) | 4.2 (1.710.0) | 3.5 (1.29.9) | 0.02 |
| Perioperative myocardial infarction | 14.0 (5.248.0) | 15.1 (4.649.0) | <0.001 |
| 30‐Day mortality | |||
| Perioperative myocardial infarction | 4.1 (2.27.8) | 4.3 (2.18.9) | <0.001 |
| 1‐Year mortality | |||
| Age 8589 | 1.3 (0.81.9) | 1.6 (1.02.4) | <0.03 |
| Age 90 | 1.9 (1.32.9) | 2.0 (1.43.1) | 0.001 |
| Male gender | 1.9 (1.32.6) | 2.1 (1.53.0) | <0.001 |
| Dementia | 2.5 (1.83.6) | 2.7 (1.93.8) | <0.001 |
| Perioperative myocardial infarction | 2.0 (1.52.8) | 1.9 (1.42.7) | 0.001 |
DISCUSSION
We report the high incidence of PMI (13.8%) in the cohort of 1212 elderly patients (mean age 85 years) undergoing hip fracture surgery. Most PMI events (92%) occurred within the first 48 hours of surgery. Most of the events (75%) were asymptomatic. Elderly patients with PMI had an increased hospital LOS by 4.2 days, with high in‐hospital mortality (13.8%), 30‐day mortality (17.4%), and 1‐year mortality (39.5%).
Most of the PMI patients were identified with cardiac biomarkers on the basis of universal definition of MI within the first 48 hours. Although universal definition of MI does not define PMI as a separate type, PMI shares common pathophysiological pathways of Type 1 MI (primary coronary event) and Type 2 MI (myocardial oxygen supplydemand imbalance). Postoperative tachycardia, hemodynamic instability, anemia, and hypoxemia may initiate pathways causing more Type 2 MI. Our study highlights the continued need for active surveillance of clinical symptoms, postoperative ECG monitoring for STT changes, and utilizing cardiac troponin in older postoperative patients to improve diagnostic accuracy of PMI.
The current study has higher asymptomatic PMI events when compared to a study of Devereaux et al.11 The current study had an older population undergoing urgent hip fracture surgery, with a higher burden of CAD (60%) and renal failure (20%) with serum creatinine >2 gm/dL (see Supporting Information, Appendix 1, in the online version of this article). Older age and a higher burden of these risk factors may explain the higher incidence of PMI in the current study. Perioperative liberal use of analgesics in hip fracture surgery may explain more asymptomatic patients.
In light of the recently published FOCUS12 trial, an important finding from our study is that postoperative anemia among elderly (<8.0 gm/dL) is associated with a 3.5‐fold increased in‐hospital mortality. It is critical to maintain perioperative hemoglobin above 8.0 gm/dL in very elderly patients, due to asymptomatic presentation of PMI.
In the current study, PMI is associated with a 15‐fold increased risk of in‐hospital death and a 4.3‐fold increased risk of 30‐day mortality in the elderly. Advanced age (85 years) is a well known strong predictor of initial hospital admission and death in elderly patients after outpatient surgery.13 Furthermore, the odds for an in‐hospital death increase by 70% for each 10‐year increase in age.14 Therefore, early detection of silent PMI among at‐risk elderly patients by cardiac biomarkers may help in optimization of cardiac pharmacotherapy known to decrease short‐ and long‐term mortality.
There are limitations inherent to the retrospective design and methodology. Data collection was done through the year 2002. CK was used for the period that spans from 1988 to mid‐2000. Troponin was used from 2000 to 2002. Statin use was not analyzed for lack of significant data. Limited use of beta‐blockers (15%) and angiotensin‐converting‐enzyme (ACE) inhibitors (25%) may also contribute to higher events (see Supporting Information, Appendix 1, in the online version of this article).
CONCLUSIONS
Elderly patients have a higher incidence of PMI and mortality after hip fracture surgery than what guidelines indicate. The majority of the elderly patients with PMI did not experience ischemic symptoms and required cardiac biomarkers for diagnosis. The results of our study support the measurement of troponin in postoperative elderly patients for the diagnosis of PMI to implement in‐hospital preventive strategies to reduce PMI‐associated mortality.
Acknowledgements
The authors gratefully acknowledge the assistance of Ms Dawn Bergen in drafting and editing the manuscript.
Disclosures: This research was supported by funding from AHA grant 03‐30103N‐04, Rochester Epidemiology Project (grant RO1‐AR30582 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases). The project was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1 RR024150. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
- , , , et al. Impact of age on perioperative complications and length of stay in patients undergoing noncardiac surgery. Ann Intern Med. 2001;134(8):637–643.
- , , , et al. Meta‐analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010;152(6):380–390.
- , , , et al. Body mass index (BMI) and risk of noncardiac postoperative medical complications in elderly hip fracture patients: a population‐based study. J Hosp Med. 2009;4(8):E1–E9.
- . History of the Rochester Epidemiology Project. Mayo Clin Proc. 1996;71(3):266–274.
- , , , . Incidence and mortality of hip fractures in the United States. JAMA. 2009;302(14):1573–1579.
- , , , et al. Body mass index and risk of adverse cardiac events in elderly patients with hip fracture: a population‐based study. J Am Geriatr Soc. 2009;57(3):419–426.
- , , , et al. Acute coronary care in the elderly, part I. Non‐ST‐segment‐elevation acute coronary syndromes: a scientific statement for healthcare professionals from the American Heart Association Council on Clinical Cardiology: in collaboration with the Society of Geriatric Cardiology. Circulation. 2007;115(19):2549–2569.
- , . Hip fracture mortality. A prospective, multifactorial study to predict and minimize death risk. Clin Orthop Relat Res. 1992;280:214–222.
- , , , et al. ACC/AHA/ACP‐ASIM guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol. 1999;33(7):2092–2190.
- , , ; for the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007;50(22):2173–2195.
- , , , et al. Characteristics and short‐term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery. Ann Intern Med. 2011;154(8):523–528.
- , , , et al. Liberal or restrictive transfusion in high‐risk patients after hip surgery. N Engl J Med. 2011;365(26):2453–2462.
- , , , . Inpatient hospital admission and death after outpatient surgery in elderly patients: importance of patient and system characteristics and location of care. Arch Surg. 2004;139(1):67–72.
- , , , et al. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med. 2003;163(19):2345–2353.
Perioperative myocardial infarction (PMI) often remains unrecognized with higher mortality in the aged.13 Perioperative ischemic symptoms are often masked by analgesia, sedation, and transient and subtle electrocardiographic (ECG) changes. Postoperative troponin measurement is not routinely done for PMI diagnosis. Hip fracture surgery is the most common non‐cardiac surgical procedure in the elderly, with limited data on clinical presentation of PMI.46 Moreover, the elderly are significantly underrepresented in clinical studies.7 We therefore examined the clinical presentation of PMI and its outcomes among elderly patients admitted for hip fracture repair.
METHODS
Study Population
A population‐based, retrospective, case‐control study was conducted of all residents in Olmsted County, Minnesota undergoing surgery for hip fracture repair from January 1, 1988 through December 31, 2002. Primary indication for the surgery was proximal femur (femoral neck or subtrochanteric) fracture. Patients who were <65 years old, had a pathological hip fracture, multiple injuries or fractures, surgery >72 hours after injury (due to higher mortality with delayed surgery),8 nonsurgical management of hip fracture repair, or incomplete data were excluded. All patients provided prior authorization to use their medical records for research, per institutional protocols.9
Criteria for Perioperative Myocardial Infarction and Death
We utilized the universal definition of acute myocardial infarction10 to define PMI within the first 7 days following hip fracture surgery. We included creatine kinase‐MB fraction (CK‐MB) as the biomarker for 1988July 2000, and troponin as the biomarker for August 20002002. Mortality was defined as death from any cause within the first year following hip fracture repair. Deaths were identified through the National Death Index.
Statistical Analysis
For each case of PMI, we identified 2 control patients who were selected at random from the non‐PMI patient population. These controls were matched to cases based on age at the time of surgery (5 years) and gender in 1:2 ratios. Baseline characteristics across PMI and non‐PMI groups were compared using the Kruskal‐Wallis test (for continuous data) and the chi‐square or Fisher's exact tests (for categorical data). Mean values were utilized in place of the missing values for the following variables: preoperative troponin (missing values 88 [17.5%]), CK‐MB (8 [1.6%]), troponin (21 [5.4%]), and postoperative hemoglobin (17 [3.4%]). Univariate predictors of PMI with P 0.2 baseline characteristics were entered into a multivariate, conditional, logistic regression analysis. Rates of outcomes were calculated using the Kaplan‐Meier method, and by a landmark survival curve for those with and without PMI. Cox proportional hazards analysis was utilized for survival analysis at 30 days and 1 year. All statistical tests were 2‐sided, and P values <0.05 were considered significant. All analyses were performed using SAS for UNIX (version 9.1.3; SAS Institute, Inc, Cary, NC).
RESULTS
In the cohort of 1212 with hip fracture surgeries, 167 (13.8%) cases of PMI occurred in the first 7 days, of which 153 (92%) occurred within the first 48 hours. A total of 334 controls were matched with 167 cases of PMI. Table 1 summarizes the demographic characteristics of the study participants. Of the patients with PMI, 25.2% experienced symptoms of ischemia; 7% reported chest pain, and 12% reported dyspnea. Only 22.8% of patients with PMI had ECG changes consistent with ischemia. ST elevation MI was present in 7.2% patients. PMI patients had a lower mean hemoglobin compared to the patients without PMI (8.9 mg/dL vs 9.4 mg/dL, P < 0.001). Median length of stay (LOS) in the hospital was higher among patients who experienced PMI (11.6 vs 7.4 days, P < 0.001). Overall in‐hospital mortality was 5.6%. There were 24 deaths (14.4%) in the PMI group compared to 4 (1.2%) in‐hospital deaths in patients without PMI (P < 0.001). A total of 473 (94%) patients survived to discharge. At 30‐day follow‐up, there were 29 (17.4%) deaths in the PMI group and 14 (4.2%) deaths in non‐PMI group. During the follow‐up for 1 year, there were 143 (29%) deaths: PMI 66 (39.5%) and 77 (23%) non‐PMI group (P < 0.01).
| Characteristics, n (%) | Patients With PMI | Patients Without PMI | P Value* |
|---|---|---|---|
| (N = 167) | (N = 334) | ||
| |||
| Age mean SD | 85.3 7.4 | 85.2 7.1 | 0.5 |
| Weight (kg) mean SD | 59.98 16.7 | 59.80 13.9 | 0.5 |
| Women | 127 (76.4) | 254 (76) | 0.5 |
| Any symptom of ischemia, n (%) | |||
| Chest/arm pain | 11 (7) | 4 (1) | 0.002 |
| Dyspnea | 20 (12) | 14 (4) | 0.001 |
| Nausea/vomiting | 8 (5) | 6 (2) | 0.08 |
| Diaphoresis | 1 (1) | 1 (0.3) | 1.0 |
| PND | 3 (2) | 1 (0.3) | 0.3 |
| ECG changes, n (%) | |||
| ST‐segment elevation MI | 12 (7.2) | 0 | 0.01 |
| New ECG changes consistent with ischemia | 38 (22.8) | 1(0.3) | 0.01 |
| Biochemical evidence of ischemia, n (%) | |||
| CK‐MB | 147 (88) | 20 (6) | 0.01 |
| Troponin | 52 (33) | 9 (3) | 0.001 |
| Laboratory markers | |||
| Hemoglobin gm/dL mean (SD) | 8.9 1.0 | 9.4 1.2 | 0.001 |
| Postoperative anemia (<8.0 gm/dL), n (%) | 22 (13.2) | 37 (11.1) | 0.5 |
| Length of stay (days), mean SD | 11.6 7.7 | 7.4 6.4 | 0.001 |
| In‐hospital outcome | <0.001 | ||
| Dead | 24 (14.4) | 4 (1.2) | |
| Alive | 143 (85.6) | 330 (98.8) | |
| 30‐Day outcome | <0.001 | ||
| Dead | 29 (17.4) | 14 (4.2) | |
| Alive | 138 (82.6) | 320 (95.8) | |
| 1‐Year outcome | <0.001 | ||
| Dead | 66 (39.5) | 77 (23) | |
| Alive | 101 (60.4) | 257 (77) | |
Table 2 describes the risk factors associated with PMI in‐hospital, 30‐day, and 1‐year mortality. Risk factors for PMI were coronary artery disease (CAD) (odds ratio [OR], 3.5; confidence interval [CI], 2.25.6), and serum creatinine >2 mg/dL (OR, 2.4; CI, 1.34.4). Risk factors for in‐hospital mortality were age 8589 (OR, 5.3; CI, 1.617.7), age 90 (OR, 8.9; CI, 2.630.8), PMI (OR 15.1; CI, 4.648.8), male gender (OR 5.8; CI, 2.215.2), dyspnea (OR 5.4; CI, 1.816.9), and hemoglobin <8.0 gm/dL (OR, 3.5; CI, 1.29.9). PMI was a strong predictor for 30‐day mortality (hazard ratio [HR], 4.3; CI, 2.18.9). Risk factors for 1‐year mortality were: age 90 (HR, 2.0; CI, 1.43.1), male gender (HR, 2.1; CI, 1.53.0), and PMI (HR, 1.9; CI, 1.42.7). Figures 1 and 2 describe the Kaplan‐Meier survival curves for patients with and without PMI.


| Unadjusted OR (95% CI) | Adjusted OR (95% CI) | P Value | |
|---|---|---|---|
| |||
| Perioperative myocardial infarction | |||
| Coronary artery disease | 3.0 (2.14.5) | 3.5 (2.25.6) | <0.001 |
| Serum creatinine >2.0 mg/dL | 2.7 (1.64.8) | 2.4 (1.34.4) | 0.003 |
| In‐hospital mortality | |||
| Age 8589 | 1.7 (0.83.7) | 5.3 (1.617.7) | 0.01 |
| Age 90 | 2.2 (1.04.8) | 8.9 (2.630.8) | <0.001 |
| Male gender | 3.0 (1.46.4) | 5.8 (2.215.2) | <0.001 |
| Postoperative anemia (<8.0 gm/dL) | 4.2 (1.710.0) | 3.5 (1.29.9) | 0.02 |
| Perioperative myocardial infarction | 14.0 (5.248.0) | 15.1 (4.649.0) | <0.001 |
| 30‐Day mortality | |||
| Perioperative myocardial infarction | 4.1 (2.27.8) | 4.3 (2.18.9) | <0.001 |
| 1‐Year mortality | |||
| Age 8589 | 1.3 (0.81.9) | 1.6 (1.02.4) | <0.03 |
| Age 90 | 1.9 (1.32.9) | 2.0 (1.43.1) | 0.001 |
| Male gender | 1.9 (1.32.6) | 2.1 (1.53.0) | <0.001 |
| Dementia | 2.5 (1.83.6) | 2.7 (1.93.8) | <0.001 |
| Perioperative myocardial infarction | 2.0 (1.52.8) | 1.9 (1.42.7) | 0.001 |
DISCUSSION
We report the high incidence of PMI (13.8%) in the cohort of 1212 elderly patients (mean age 85 years) undergoing hip fracture surgery. Most PMI events (92%) occurred within the first 48 hours of surgery. Most of the events (75%) were asymptomatic. Elderly patients with PMI had an increased hospital LOS by 4.2 days, with high in‐hospital mortality (13.8%), 30‐day mortality (17.4%), and 1‐year mortality (39.5%).
Most of the PMI patients were identified with cardiac biomarkers on the basis of universal definition of MI within the first 48 hours. Although universal definition of MI does not define PMI as a separate type, PMI shares common pathophysiological pathways of Type 1 MI (primary coronary event) and Type 2 MI (myocardial oxygen supplydemand imbalance). Postoperative tachycardia, hemodynamic instability, anemia, and hypoxemia may initiate pathways causing more Type 2 MI. Our study highlights the continued need for active surveillance of clinical symptoms, postoperative ECG monitoring for STT changes, and utilizing cardiac troponin in older postoperative patients to improve diagnostic accuracy of PMI.
The current study has higher asymptomatic PMI events when compared to a study of Devereaux et al.11 The current study had an older population undergoing urgent hip fracture surgery, with a higher burden of CAD (60%) and renal failure (20%) with serum creatinine >2 gm/dL (see Supporting Information, Appendix 1, in the online version of this article). Older age and a higher burden of these risk factors may explain the higher incidence of PMI in the current study. Perioperative liberal use of analgesics in hip fracture surgery may explain more asymptomatic patients.
In light of the recently published FOCUS12 trial, an important finding from our study is that postoperative anemia among elderly (<8.0 gm/dL) is associated with a 3.5‐fold increased in‐hospital mortality. It is critical to maintain perioperative hemoglobin above 8.0 gm/dL in very elderly patients, due to asymptomatic presentation of PMI.
In the current study, PMI is associated with a 15‐fold increased risk of in‐hospital death and a 4.3‐fold increased risk of 30‐day mortality in the elderly. Advanced age (85 years) is a well known strong predictor of initial hospital admission and death in elderly patients after outpatient surgery.13 Furthermore, the odds for an in‐hospital death increase by 70% for each 10‐year increase in age.14 Therefore, early detection of silent PMI among at‐risk elderly patients by cardiac biomarkers may help in optimization of cardiac pharmacotherapy known to decrease short‐ and long‐term mortality.
There are limitations inherent to the retrospective design and methodology. Data collection was done through the year 2002. CK was used for the period that spans from 1988 to mid‐2000. Troponin was used from 2000 to 2002. Statin use was not analyzed for lack of significant data. Limited use of beta‐blockers (15%) and angiotensin‐converting‐enzyme (ACE) inhibitors (25%) may also contribute to higher events (see Supporting Information, Appendix 1, in the online version of this article).
CONCLUSIONS
Elderly patients have a higher incidence of PMI and mortality after hip fracture surgery than what guidelines indicate. The majority of the elderly patients with PMI did not experience ischemic symptoms and required cardiac biomarkers for diagnosis. The results of our study support the measurement of troponin in postoperative elderly patients for the diagnosis of PMI to implement in‐hospital preventive strategies to reduce PMI‐associated mortality.
Acknowledgements
The authors gratefully acknowledge the assistance of Ms Dawn Bergen in drafting and editing the manuscript.
Disclosures: This research was supported by funding from AHA grant 03‐30103N‐04, Rochester Epidemiology Project (grant RO1‐AR30582 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases). The project was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1 RR024150. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Perioperative myocardial infarction (PMI) often remains unrecognized with higher mortality in the aged.13 Perioperative ischemic symptoms are often masked by analgesia, sedation, and transient and subtle electrocardiographic (ECG) changes. Postoperative troponin measurement is not routinely done for PMI diagnosis. Hip fracture surgery is the most common non‐cardiac surgical procedure in the elderly, with limited data on clinical presentation of PMI.46 Moreover, the elderly are significantly underrepresented in clinical studies.7 We therefore examined the clinical presentation of PMI and its outcomes among elderly patients admitted for hip fracture repair.
METHODS
Study Population
A population‐based, retrospective, case‐control study was conducted of all residents in Olmsted County, Minnesota undergoing surgery for hip fracture repair from January 1, 1988 through December 31, 2002. Primary indication for the surgery was proximal femur (femoral neck or subtrochanteric) fracture. Patients who were <65 years old, had a pathological hip fracture, multiple injuries or fractures, surgery >72 hours after injury (due to higher mortality with delayed surgery),8 nonsurgical management of hip fracture repair, or incomplete data were excluded. All patients provided prior authorization to use their medical records for research, per institutional protocols.9
Criteria for Perioperative Myocardial Infarction and Death
We utilized the universal definition of acute myocardial infarction10 to define PMI within the first 7 days following hip fracture surgery. We included creatine kinase‐MB fraction (CK‐MB) as the biomarker for 1988July 2000, and troponin as the biomarker for August 20002002. Mortality was defined as death from any cause within the first year following hip fracture repair. Deaths were identified through the National Death Index.
Statistical Analysis
For each case of PMI, we identified 2 control patients who were selected at random from the non‐PMI patient population. These controls were matched to cases based on age at the time of surgery (5 years) and gender in 1:2 ratios. Baseline characteristics across PMI and non‐PMI groups were compared using the Kruskal‐Wallis test (for continuous data) and the chi‐square or Fisher's exact tests (for categorical data). Mean values were utilized in place of the missing values for the following variables: preoperative troponin (missing values 88 [17.5%]), CK‐MB (8 [1.6%]), troponin (21 [5.4%]), and postoperative hemoglobin (17 [3.4%]). Univariate predictors of PMI with P 0.2 baseline characteristics were entered into a multivariate, conditional, logistic regression analysis. Rates of outcomes were calculated using the Kaplan‐Meier method, and by a landmark survival curve for those with and without PMI. Cox proportional hazards analysis was utilized for survival analysis at 30 days and 1 year. All statistical tests were 2‐sided, and P values <0.05 were considered significant. All analyses were performed using SAS for UNIX (version 9.1.3; SAS Institute, Inc, Cary, NC).
RESULTS
In the cohort of 1212 with hip fracture surgeries, 167 (13.8%) cases of PMI occurred in the first 7 days, of which 153 (92%) occurred within the first 48 hours. A total of 334 controls were matched with 167 cases of PMI. Table 1 summarizes the demographic characteristics of the study participants. Of the patients with PMI, 25.2% experienced symptoms of ischemia; 7% reported chest pain, and 12% reported dyspnea. Only 22.8% of patients with PMI had ECG changes consistent with ischemia. ST elevation MI was present in 7.2% patients. PMI patients had a lower mean hemoglobin compared to the patients without PMI (8.9 mg/dL vs 9.4 mg/dL, P < 0.001). Median length of stay (LOS) in the hospital was higher among patients who experienced PMI (11.6 vs 7.4 days, P < 0.001). Overall in‐hospital mortality was 5.6%. There were 24 deaths (14.4%) in the PMI group compared to 4 (1.2%) in‐hospital deaths in patients without PMI (P < 0.001). A total of 473 (94%) patients survived to discharge. At 30‐day follow‐up, there were 29 (17.4%) deaths in the PMI group and 14 (4.2%) deaths in non‐PMI group. During the follow‐up for 1 year, there were 143 (29%) deaths: PMI 66 (39.5%) and 77 (23%) non‐PMI group (P < 0.01).
| Characteristics, n (%) | Patients With PMI | Patients Without PMI | P Value* |
|---|---|---|---|
| (N = 167) | (N = 334) | ||
| |||
| Age mean SD | 85.3 7.4 | 85.2 7.1 | 0.5 |
| Weight (kg) mean SD | 59.98 16.7 | 59.80 13.9 | 0.5 |
| Women | 127 (76.4) | 254 (76) | 0.5 |
| Any symptom of ischemia, n (%) | |||
| Chest/arm pain | 11 (7) | 4 (1) | 0.002 |
| Dyspnea | 20 (12) | 14 (4) | 0.001 |
| Nausea/vomiting | 8 (5) | 6 (2) | 0.08 |
| Diaphoresis | 1 (1) | 1 (0.3) | 1.0 |
| PND | 3 (2) | 1 (0.3) | 0.3 |
| ECG changes, n (%) | |||
| ST‐segment elevation MI | 12 (7.2) | 0 | 0.01 |
| New ECG changes consistent with ischemia | 38 (22.8) | 1(0.3) | 0.01 |
| Biochemical evidence of ischemia, n (%) | |||
| CK‐MB | 147 (88) | 20 (6) | 0.01 |
| Troponin | 52 (33) | 9 (3) | 0.001 |
| Laboratory markers | |||
| Hemoglobin gm/dL mean (SD) | 8.9 1.0 | 9.4 1.2 | 0.001 |
| Postoperative anemia (<8.0 gm/dL), n (%) | 22 (13.2) | 37 (11.1) | 0.5 |
| Length of stay (days), mean SD | 11.6 7.7 | 7.4 6.4 | 0.001 |
| In‐hospital outcome | <0.001 | ||
| Dead | 24 (14.4) | 4 (1.2) | |
| Alive | 143 (85.6) | 330 (98.8) | |
| 30‐Day outcome | <0.001 | ||
| Dead | 29 (17.4) | 14 (4.2) | |
| Alive | 138 (82.6) | 320 (95.8) | |
| 1‐Year outcome | <0.001 | ||
| Dead | 66 (39.5) | 77 (23) | |
| Alive | 101 (60.4) | 257 (77) | |
Table 2 describes the risk factors associated with PMI in‐hospital, 30‐day, and 1‐year mortality. Risk factors for PMI were coronary artery disease (CAD) (odds ratio [OR], 3.5; confidence interval [CI], 2.25.6), and serum creatinine >2 mg/dL (OR, 2.4; CI, 1.34.4). Risk factors for in‐hospital mortality were age 8589 (OR, 5.3; CI, 1.617.7), age 90 (OR, 8.9; CI, 2.630.8), PMI (OR 15.1; CI, 4.648.8), male gender (OR 5.8; CI, 2.215.2), dyspnea (OR 5.4; CI, 1.816.9), and hemoglobin <8.0 gm/dL (OR, 3.5; CI, 1.29.9). PMI was a strong predictor for 30‐day mortality (hazard ratio [HR], 4.3; CI, 2.18.9). Risk factors for 1‐year mortality were: age 90 (HR, 2.0; CI, 1.43.1), male gender (HR, 2.1; CI, 1.53.0), and PMI (HR, 1.9; CI, 1.42.7). Figures 1 and 2 describe the Kaplan‐Meier survival curves for patients with and without PMI.


| Unadjusted OR (95% CI) | Adjusted OR (95% CI) | P Value | |
|---|---|---|---|
| |||
| Perioperative myocardial infarction | |||
| Coronary artery disease | 3.0 (2.14.5) | 3.5 (2.25.6) | <0.001 |
| Serum creatinine >2.0 mg/dL | 2.7 (1.64.8) | 2.4 (1.34.4) | 0.003 |
| In‐hospital mortality | |||
| Age 8589 | 1.7 (0.83.7) | 5.3 (1.617.7) | 0.01 |
| Age 90 | 2.2 (1.04.8) | 8.9 (2.630.8) | <0.001 |
| Male gender | 3.0 (1.46.4) | 5.8 (2.215.2) | <0.001 |
| Postoperative anemia (<8.0 gm/dL) | 4.2 (1.710.0) | 3.5 (1.29.9) | 0.02 |
| Perioperative myocardial infarction | 14.0 (5.248.0) | 15.1 (4.649.0) | <0.001 |
| 30‐Day mortality | |||
| Perioperative myocardial infarction | 4.1 (2.27.8) | 4.3 (2.18.9) | <0.001 |
| 1‐Year mortality | |||
| Age 8589 | 1.3 (0.81.9) | 1.6 (1.02.4) | <0.03 |
| Age 90 | 1.9 (1.32.9) | 2.0 (1.43.1) | 0.001 |
| Male gender | 1.9 (1.32.6) | 2.1 (1.53.0) | <0.001 |
| Dementia | 2.5 (1.83.6) | 2.7 (1.93.8) | <0.001 |
| Perioperative myocardial infarction | 2.0 (1.52.8) | 1.9 (1.42.7) | 0.001 |
DISCUSSION
We report the high incidence of PMI (13.8%) in the cohort of 1212 elderly patients (mean age 85 years) undergoing hip fracture surgery. Most PMI events (92%) occurred within the first 48 hours of surgery. Most of the events (75%) were asymptomatic. Elderly patients with PMI had an increased hospital LOS by 4.2 days, with high in‐hospital mortality (13.8%), 30‐day mortality (17.4%), and 1‐year mortality (39.5%).
Most of the PMI patients were identified with cardiac biomarkers on the basis of universal definition of MI within the first 48 hours. Although universal definition of MI does not define PMI as a separate type, PMI shares common pathophysiological pathways of Type 1 MI (primary coronary event) and Type 2 MI (myocardial oxygen supplydemand imbalance). Postoperative tachycardia, hemodynamic instability, anemia, and hypoxemia may initiate pathways causing more Type 2 MI. Our study highlights the continued need for active surveillance of clinical symptoms, postoperative ECG monitoring for STT changes, and utilizing cardiac troponin in older postoperative patients to improve diagnostic accuracy of PMI.
The current study has higher asymptomatic PMI events when compared to a study of Devereaux et al.11 The current study had an older population undergoing urgent hip fracture surgery, with a higher burden of CAD (60%) and renal failure (20%) with serum creatinine >2 gm/dL (see Supporting Information, Appendix 1, in the online version of this article). Older age and a higher burden of these risk factors may explain the higher incidence of PMI in the current study. Perioperative liberal use of analgesics in hip fracture surgery may explain more asymptomatic patients.
In light of the recently published FOCUS12 trial, an important finding from our study is that postoperative anemia among elderly (<8.0 gm/dL) is associated with a 3.5‐fold increased in‐hospital mortality. It is critical to maintain perioperative hemoglobin above 8.0 gm/dL in very elderly patients, due to asymptomatic presentation of PMI.
In the current study, PMI is associated with a 15‐fold increased risk of in‐hospital death and a 4.3‐fold increased risk of 30‐day mortality in the elderly. Advanced age (85 years) is a well known strong predictor of initial hospital admission and death in elderly patients after outpatient surgery.13 Furthermore, the odds for an in‐hospital death increase by 70% for each 10‐year increase in age.14 Therefore, early detection of silent PMI among at‐risk elderly patients by cardiac biomarkers may help in optimization of cardiac pharmacotherapy known to decrease short‐ and long‐term mortality.
There are limitations inherent to the retrospective design and methodology. Data collection was done through the year 2002. CK was used for the period that spans from 1988 to mid‐2000. Troponin was used from 2000 to 2002. Statin use was not analyzed for lack of significant data. Limited use of beta‐blockers (15%) and angiotensin‐converting‐enzyme (ACE) inhibitors (25%) may also contribute to higher events (see Supporting Information, Appendix 1, in the online version of this article).
CONCLUSIONS
Elderly patients have a higher incidence of PMI and mortality after hip fracture surgery than what guidelines indicate. The majority of the elderly patients with PMI did not experience ischemic symptoms and required cardiac biomarkers for diagnosis. The results of our study support the measurement of troponin in postoperative elderly patients for the diagnosis of PMI to implement in‐hospital preventive strategies to reduce PMI‐associated mortality.
Acknowledgements
The authors gratefully acknowledge the assistance of Ms Dawn Bergen in drafting and editing the manuscript.
Disclosures: This research was supported by funding from AHA grant 03‐30103N‐04, Rochester Epidemiology Project (grant RO1‐AR30582 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases). The project was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1 RR024150. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
- , , , et al. Impact of age on perioperative complications and length of stay in patients undergoing noncardiac surgery. Ann Intern Med. 2001;134(8):637–643.
- , , , et al. Meta‐analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010;152(6):380–390.
- , , , et al. Body mass index (BMI) and risk of noncardiac postoperative medical complications in elderly hip fracture patients: a population‐based study. J Hosp Med. 2009;4(8):E1–E9.
- . History of the Rochester Epidemiology Project. Mayo Clin Proc. 1996;71(3):266–274.
- , , , . Incidence and mortality of hip fractures in the United States. JAMA. 2009;302(14):1573–1579.
- , , , et al. Body mass index and risk of adverse cardiac events in elderly patients with hip fracture: a population‐based study. J Am Geriatr Soc. 2009;57(3):419–426.
- , , , et al. Acute coronary care in the elderly, part I. Non‐ST‐segment‐elevation acute coronary syndromes: a scientific statement for healthcare professionals from the American Heart Association Council on Clinical Cardiology: in collaboration with the Society of Geriatric Cardiology. Circulation. 2007;115(19):2549–2569.
- , . Hip fracture mortality. A prospective, multifactorial study to predict and minimize death risk. Clin Orthop Relat Res. 1992;280:214–222.
- , , , et al. ACC/AHA/ACP‐ASIM guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol. 1999;33(7):2092–2190.
- , , ; for the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007;50(22):2173–2195.
- , , , et al. Characteristics and short‐term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery. Ann Intern Med. 2011;154(8):523–528.
- , , , et al. Liberal or restrictive transfusion in high‐risk patients after hip surgery. N Engl J Med. 2011;365(26):2453–2462.
- , , , . Inpatient hospital admission and death after outpatient surgery in elderly patients: importance of patient and system characteristics and location of care. Arch Surg. 2004;139(1):67–72.
- , , , et al. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med. 2003;163(19):2345–2353.
- , , , et al. Impact of age on perioperative complications and length of stay in patients undergoing noncardiac surgery. Ann Intern Med. 2001;134(8):637–643.
- , , , et al. Meta‐analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010;152(6):380–390.
- , , , et al. Body mass index (BMI) and risk of noncardiac postoperative medical complications in elderly hip fracture patients: a population‐based study. J Hosp Med. 2009;4(8):E1–E9.
- . History of the Rochester Epidemiology Project. Mayo Clin Proc. 1996;71(3):266–274.
- , , , . Incidence and mortality of hip fractures in the United States. JAMA. 2009;302(14):1573–1579.
- , , , et al. Body mass index and risk of adverse cardiac events in elderly patients with hip fracture: a population‐based study. J Am Geriatr Soc. 2009;57(3):419–426.
- , , , et al. Acute coronary care in the elderly, part I. Non‐ST‐segment‐elevation acute coronary syndromes: a scientific statement for healthcare professionals from the American Heart Association Council on Clinical Cardiology: in collaboration with the Society of Geriatric Cardiology. Circulation. 2007;115(19):2549–2569.
- , . Hip fracture mortality. A prospective, multifactorial study to predict and minimize death risk. Clin Orthop Relat Res. 1992;280:214–222.
- , , , et al. ACC/AHA/ACP‐ASIM guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol. 1999;33(7):2092–2190.
- , , ; for the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007;50(22):2173–2195.
- , , , et al. Characteristics and short‐term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery. Ann Intern Med. 2011;154(8):523–528.
- , , , et al. Liberal or restrictive transfusion in high‐risk patients after hip surgery. N Engl J Med. 2011;365(26):2453–2462.
- , , , . Inpatient hospital admission and death after outpatient surgery in elderly patients: importance of patient and system characteristics and location of care. Arch Surg. 2004;139(1):67–72.
- , , , et al. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med. 2003;163(19):2345–2353.
Ask-Tell-Ask: Simple Technique Can Help Hospitalists Communicate Difficult Messages
Sometimes a hospitalist is put in the difficult position of communicating information that involves bad news—for instance, a poor prognosis to a patient or clarifying treatment options and goals for care to a family member of a patient with an advanced illness. A workshop at HM12 offered a technique that hospitalists can use to convey such difficult messages.
“Ask-Tell-Ask” is a back-and-forth cycle between the patient and health professional that addresses four essential components: the patient’s perspective, information that needs to be delivered, response to the patient’s emotions, and recommendations by the professional.
—Kristen Schaefer, MD, palliative-care physician, Brigham and Women’s Hospital, Boston
“In the setting of an advanced illness, the patient’s perspective needs to be more fully explored so that we can figure out what information they need and want,” says Kristen Schaefer, MD, a palliative-care physician and director of residency education at Brigham and Women’s Hospital in Boston who spoke at an HM12 workshop. “That communication needs to be multidirectional to promote shared decision-making. All of these communication techniques are based on a better understanding of the patient’s perspective, but with Ask-Tell-Ask, you are clarifying their emotional response to illness, their values and personal goals in life, and how they cope with setbacks.”
Physicians should always start in an open-ended way, asking questions and listening to the response, Dr. Schaefer explains. “Then you can tailor the information you provide to what they have told you. There’s always emotional content around these issues, and you need to clarify that emotion,” she says. “If there is a big emotion in the room, and it hasn’t been addressed, it doesn’t matter what you teach the patient. You’ll never get to the underlying problems.”
Another effective technique, Dr. Schaefer says, is the judicious use of silence. She says healthcare providers can learn to listen more, talk less, and always start with the patient’s perspective as the basis for communication.
“It makes for more satisfying work—and it’s also more effective,” she says.
Larry Beresford is a freelance writer in Oakland, Calif.
Sometimes a hospitalist is put in the difficult position of communicating information that involves bad news—for instance, a poor prognosis to a patient or clarifying treatment options and goals for care to a family member of a patient with an advanced illness. A workshop at HM12 offered a technique that hospitalists can use to convey such difficult messages.
“Ask-Tell-Ask” is a back-and-forth cycle between the patient and health professional that addresses four essential components: the patient’s perspective, information that needs to be delivered, response to the patient’s emotions, and recommendations by the professional.
—Kristen Schaefer, MD, palliative-care physician, Brigham and Women’s Hospital, Boston
“In the setting of an advanced illness, the patient’s perspective needs to be more fully explored so that we can figure out what information they need and want,” says Kristen Schaefer, MD, a palliative-care physician and director of residency education at Brigham and Women’s Hospital in Boston who spoke at an HM12 workshop. “That communication needs to be multidirectional to promote shared decision-making. All of these communication techniques are based on a better understanding of the patient’s perspective, but with Ask-Tell-Ask, you are clarifying their emotional response to illness, their values and personal goals in life, and how they cope with setbacks.”
Physicians should always start in an open-ended way, asking questions and listening to the response, Dr. Schaefer explains. “Then you can tailor the information you provide to what they have told you. There’s always emotional content around these issues, and you need to clarify that emotion,” she says. “If there is a big emotion in the room, and it hasn’t been addressed, it doesn’t matter what you teach the patient. You’ll never get to the underlying problems.”
Another effective technique, Dr. Schaefer says, is the judicious use of silence. She says healthcare providers can learn to listen more, talk less, and always start with the patient’s perspective as the basis for communication.
“It makes for more satisfying work—and it’s also more effective,” she says.
Larry Beresford is a freelance writer in Oakland, Calif.
Sometimes a hospitalist is put in the difficult position of communicating information that involves bad news—for instance, a poor prognosis to a patient or clarifying treatment options and goals for care to a family member of a patient with an advanced illness. A workshop at HM12 offered a technique that hospitalists can use to convey such difficult messages.
“Ask-Tell-Ask” is a back-and-forth cycle between the patient and health professional that addresses four essential components: the patient’s perspective, information that needs to be delivered, response to the patient’s emotions, and recommendations by the professional.
—Kristen Schaefer, MD, palliative-care physician, Brigham and Women’s Hospital, Boston
“In the setting of an advanced illness, the patient’s perspective needs to be more fully explored so that we can figure out what information they need and want,” says Kristen Schaefer, MD, a palliative-care physician and director of residency education at Brigham and Women’s Hospital in Boston who spoke at an HM12 workshop. “That communication needs to be multidirectional to promote shared decision-making. All of these communication techniques are based on a better understanding of the patient’s perspective, but with Ask-Tell-Ask, you are clarifying their emotional response to illness, their values and personal goals in life, and how they cope with setbacks.”
Physicians should always start in an open-ended way, asking questions and listening to the response, Dr. Schaefer explains. “Then you can tailor the information you provide to what they have told you. There’s always emotional content around these issues, and you need to clarify that emotion,” she says. “If there is a big emotion in the room, and it hasn’t been addressed, it doesn’t matter what you teach the patient. You’ll never get to the underlying problems.”
Another effective technique, Dr. Schaefer says, is the judicious use of silence. She says healthcare providers can learn to listen more, talk less, and always start with the patient’s perspective as the basis for communication.
“It makes for more satisfying work—and it’s also more effective,” she says.
Larry Beresford is a freelance writer in Oakland, Calif.
Huber the Tuber
Recently, I had an office visit from a lovely 80-year-old woman, born and raised in Providence, R.I., whose past medical history included pulmonary tuberculosis for which she was sent to a sanatorium – 50 years ago.
Her TB had nothing to do with why she had come to see me. By and large, this is a really healthy patient whose only complaint was a 2-month history of right shoulder pain that turned out to be caused by rotator cuff tendonitis. But I lingered with her, and we chatted for awhile. She used to work at Veterans Affairs, processing claims and grievances so she was familiar with medical terminology and was in general a joy to talk with. And I was captivated by the progress in medicine that she represented.
Now, by the time I went to medical school, we were no longer sending patients to sanatoria. The word was as abstract a concept to me as, say, injecting intramuscular gold to treat rheumatic diseases. By the time I was in training, everyone in the developing world got a BCG vaccine, which prevents severe complications from TB but does not prevent infections. As long as I have been a physician, we have understood transmission well, have known about four-drug regimens, and were aware of drug-resistant TB (I am still floored when I read about XDR-TB, with the X being short for "extensively.")
Needless to say I was fascinated by her story.
When she was originally diagnosed more than half a century ago, this woman did not have the usual symptoms that we associate with active pulmonary tuberculosis. She had not had a cough and certainly did not have "wasting." She simply tripped one day and in doing so coughed up some blood. She was found to have disease in both apices and, subsequently, she spent 14 months in a local sanatorium. She remembers being treated with "PAS and streptomycin" (PAS being p-aminosalicylic acid), and "lots of fresh air."
Although tuberculosis is rare in the USA today, it was "so rampant that cautionary visual messages appeared in myriad public places, from offices to restrooms," according to the National Library of Medicine. "Huber the Tuber" was a mascot developed by TB patient and physician Harry Wilmer (1917-2005). In the educational pamphlet, Huber rides respiratory droplets along with his cohort "Nasty von Sputum, Rusty the Bloodyvitch, and Huey the Long Tuber." That final appellation is supposedly a reference to Sen. Huey Long, according to the NLM. (Can we still anthropomorphize bacteria into corrupt government officials?)
The discovery of Mycobacterium tuberculosis by German bacteriologist Dr. Robert Koch in 1882 led to a revolution of isolating patients, which in turn led to a decrease in transmission. In 1905, the American Sanatorium Association was formed – it still exists today as the American Thoracic Society! When the association started, there were 106 sanatoria in the United States, which provided 9,107 beds for patients. At its peak in 1954, there were 108,457 beds worsening (Am. J. Respir. Crit. Care Med. 2004:169;118-6). From a patient’s journal during time spent in a sanatorium in 1944, we know that there were only two rules for sanatorium residents:
1. Absolute and utter rest of mind and body – no bath, no movement except to toilet once a day, no sitting up except propped by pillows and semireclining, no deep breath. Lead the life of a log, in fact. Don’t try, therefore, to sew, knit, or write, except as occasional relief from reading and sleeping.
2. Eat nourishing food and have plenty of fresh air.
Not everyone got antibiotic treatment, unless their chest x-rays showed worsening. Some patients were treated with an induced pneumothorax, according to the women’s journal. Why this would be is not clear to me.
Then, in 1952, isoniazid was developed, and that was the start of the end of the sanatorium.
In our daily lives, we focus on individual patients, but history informs the current practice of medicine. How wonderful that we can now treat many illnesses that were once considered uniformly fatal. How fortunate are we to call this our profession, one that provides an unambiguous good.
Dr. Chan practices rheumatology in Pawtucket, R.I.
Recently, I had an office visit from a lovely 80-year-old woman, born and raised in Providence, R.I., whose past medical history included pulmonary tuberculosis for which she was sent to a sanatorium – 50 years ago.
Her TB had nothing to do with why she had come to see me. By and large, this is a really healthy patient whose only complaint was a 2-month history of right shoulder pain that turned out to be caused by rotator cuff tendonitis. But I lingered with her, and we chatted for awhile. She used to work at Veterans Affairs, processing claims and grievances so she was familiar with medical terminology and was in general a joy to talk with. And I was captivated by the progress in medicine that she represented.
Now, by the time I went to medical school, we were no longer sending patients to sanatoria. The word was as abstract a concept to me as, say, injecting intramuscular gold to treat rheumatic diseases. By the time I was in training, everyone in the developing world got a BCG vaccine, which prevents severe complications from TB but does not prevent infections. As long as I have been a physician, we have understood transmission well, have known about four-drug regimens, and were aware of drug-resistant TB (I am still floored when I read about XDR-TB, with the X being short for "extensively.")
Needless to say I was fascinated by her story.
When she was originally diagnosed more than half a century ago, this woman did not have the usual symptoms that we associate with active pulmonary tuberculosis. She had not had a cough and certainly did not have "wasting." She simply tripped one day and in doing so coughed up some blood. She was found to have disease in both apices and, subsequently, she spent 14 months in a local sanatorium. She remembers being treated with "PAS and streptomycin" (PAS being p-aminosalicylic acid), and "lots of fresh air."
Although tuberculosis is rare in the USA today, it was "so rampant that cautionary visual messages appeared in myriad public places, from offices to restrooms," according to the National Library of Medicine. "Huber the Tuber" was a mascot developed by TB patient and physician Harry Wilmer (1917-2005). In the educational pamphlet, Huber rides respiratory droplets along with his cohort "Nasty von Sputum, Rusty the Bloodyvitch, and Huey the Long Tuber." That final appellation is supposedly a reference to Sen. Huey Long, according to the NLM. (Can we still anthropomorphize bacteria into corrupt government officials?)
The discovery of Mycobacterium tuberculosis by German bacteriologist Dr. Robert Koch in 1882 led to a revolution of isolating patients, which in turn led to a decrease in transmission. In 1905, the American Sanatorium Association was formed – it still exists today as the American Thoracic Society! When the association started, there were 106 sanatoria in the United States, which provided 9,107 beds for patients. At its peak in 1954, there were 108,457 beds worsening (Am. J. Respir. Crit. Care Med. 2004:169;118-6). From a patient’s journal during time spent in a sanatorium in 1944, we know that there were only two rules for sanatorium residents:
1. Absolute and utter rest of mind and body – no bath, no movement except to toilet once a day, no sitting up except propped by pillows and semireclining, no deep breath. Lead the life of a log, in fact. Don’t try, therefore, to sew, knit, or write, except as occasional relief from reading and sleeping.
2. Eat nourishing food and have plenty of fresh air.
Not everyone got antibiotic treatment, unless their chest x-rays showed worsening. Some patients were treated with an induced pneumothorax, according to the women’s journal. Why this would be is not clear to me.
Then, in 1952, isoniazid was developed, and that was the start of the end of the sanatorium.
In our daily lives, we focus on individual patients, but history informs the current practice of medicine. How wonderful that we can now treat many illnesses that were once considered uniformly fatal. How fortunate are we to call this our profession, one that provides an unambiguous good.
Dr. Chan practices rheumatology in Pawtucket, R.I.
Recently, I had an office visit from a lovely 80-year-old woman, born and raised in Providence, R.I., whose past medical history included pulmonary tuberculosis for which she was sent to a sanatorium – 50 years ago.
Her TB had nothing to do with why she had come to see me. By and large, this is a really healthy patient whose only complaint was a 2-month history of right shoulder pain that turned out to be caused by rotator cuff tendonitis. But I lingered with her, and we chatted for awhile. She used to work at Veterans Affairs, processing claims and grievances so she was familiar with medical terminology and was in general a joy to talk with. And I was captivated by the progress in medicine that she represented.
Now, by the time I went to medical school, we were no longer sending patients to sanatoria. The word was as abstract a concept to me as, say, injecting intramuscular gold to treat rheumatic diseases. By the time I was in training, everyone in the developing world got a BCG vaccine, which prevents severe complications from TB but does not prevent infections. As long as I have been a physician, we have understood transmission well, have known about four-drug regimens, and were aware of drug-resistant TB (I am still floored when I read about XDR-TB, with the X being short for "extensively.")
Needless to say I was fascinated by her story.
When she was originally diagnosed more than half a century ago, this woman did not have the usual symptoms that we associate with active pulmonary tuberculosis. She had not had a cough and certainly did not have "wasting." She simply tripped one day and in doing so coughed up some blood. She was found to have disease in both apices and, subsequently, she spent 14 months in a local sanatorium. She remembers being treated with "PAS and streptomycin" (PAS being p-aminosalicylic acid), and "lots of fresh air."
Although tuberculosis is rare in the USA today, it was "so rampant that cautionary visual messages appeared in myriad public places, from offices to restrooms," according to the National Library of Medicine. "Huber the Tuber" was a mascot developed by TB patient and physician Harry Wilmer (1917-2005). In the educational pamphlet, Huber rides respiratory droplets along with his cohort "Nasty von Sputum, Rusty the Bloodyvitch, and Huey the Long Tuber." That final appellation is supposedly a reference to Sen. Huey Long, according to the NLM. (Can we still anthropomorphize bacteria into corrupt government officials?)
The discovery of Mycobacterium tuberculosis by German bacteriologist Dr. Robert Koch in 1882 led to a revolution of isolating patients, which in turn led to a decrease in transmission. In 1905, the American Sanatorium Association was formed – it still exists today as the American Thoracic Society! When the association started, there were 106 sanatoria in the United States, which provided 9,107 beds for patients. At its peak in 1954, there were 108,457 beds worsening (Am. J. Respir. Crit. Care Med. 2004:169;118-6). From a patient’s journal during time spent in a sanatorium in 1944, we know that there were only two rules for sanatorium residents:
1. Absolute and utter rest of mind and body – no bath, no movement except to toilet once a day, no sitting up except propped by pillows and semireclining, no deep breath. Lead the life of a log, in fact. Don’t try, therefore, to sew, knit, or write, except as occasional relief from reading and sleeping.
2. Eat nourishing food and have plenty of fresh air.
Not everyone got antibiotic treatment, unless their chest x-rays showed worsening. Some patients were treated with an induced pneumothorax, according to the women’s journal. Why this would be is not clear to me.
Then, in 1952, isoniazid was developed, and that was the start of the end of the sanatorium.
In our daily lives, we focus on individual patients, but history informs the current practice of medicine. How wonderful that we can now treat many illnesses that were once considered uniformly fatal. How fortunate are we to call this our profession, one that provides an unambiguous good.
Dr. Chan practices rheumatology in Pawtucket, R.I.
Hospitalists Play Integral Roles in HHS-Funded Innovation Projects
In May and June, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius in May and June announced 107 healthcare innovations grants to improve coordination of care and reduce costs. The grants, a provision of the Affordable Care Act (ACA), range from $1 million to $30 million. HHS anticipates that the projects will reduce healthcare spending by $254 million over the next three years and provide "new ideas on how to deliver better health, improved care, and lower costs to people enrolled in Medicare, Medicaid and [the] Children's Health Insurance Program (CHIP)."
Hospitalists played key roles in planning and developing several of the projects. Common themes include coordination and integration of services, promotion of community collaborations, integrating behavioral and physical care, and the use of telemedicine—many of the same approaches utilized by SHM's Project BOOST and other national initiatives for preventing unnecessary readmissions.
In Atlanta, Emory University's Center for Critical Care received a $10.7 million grant to deploy 40 nurse practitioners (NPs) and physician assistants (PAs) trained in critical care to underserved and rural ICUs in Georgia. In many of the targeted hospitals, hospitalists manage patients in the ICU, but this program brings an additional layer of staffing and expertise to the care, allowing patients to stay in their beds rather than having to be transferred, says Daniel Owens, MBA, the center’s director of operations and senior administrator of the division of hospital medicine at Emory.
The project will bring NPs and PAs from participating hospitals to Emory for an intensive, six-month, critical-care residency. "If they don't have these folks, we'll help to identify staff for the jobs," he adds.
At Vanderbilt University Medical Center in Nashville, Tenn., a $2.4 million project to reduce rehospitalizations for a high-risk geriatric patients aims to close the gaps in care transitions between hospital, outpatient, post-acute, and extended-care settings, says Vanderbilt hospitalist Eduard Vasilevskis, MD. The project will employ transition advocates or coordinators in the hospital to improve communication at both ends, with evidence-based protocols to improve discharge planning. Long-term care providers will be offered Web-based training and video conferencing.
"The goal is to break the cycle of rehospitalization," says Dr. Vasilevskis, "but if patients need to come back to the hospital, there will be someone involved in their care who is familiar with the settings where they’ve come from."
Beth Israel Deaconess Medical Center (BIDMC) in Boston received $4.9 million for its Post-Acute Care Transitions program (PACT), which links the hospital to six affiliated primary care practices using a bundle of post-acute care interventions, care-transition specialists, and dedicated clinical pharmacists. Nurses remain in contact with patients by telephone for 30 days post-hospital discharge and coordinate the services of extended-care facilities and visiting nurses. Pharmacists perform in-hospital medication reconciliation and patient education, says hospitalist Lauren Doctoroff, MD, FHM. She and Julius Yang, MD, BIDMC medical director of inpatient quality, helped develop the pilot program, which began in August 2011.
"These care-transitions specialists offer us an added level of patient support and a different level of integration focused on risk assessment of such issues as social supports and problems with medical compliance, which can be used by the inpatient team to come up with the most rational and ideal discharge plan," Dr. Doctoroff says. "One of my colleagues said to me, ‘I feel so much better knowing there is this added level of support for patients after discharge.'"
The HHS grants reflect an important recognition that what happens to patients following discharge partly reflects what happens in the hospital but also depends on collaborations with post-acute providers, Dr. Doctoroff says.
"Hospitalists can't do everything, but they need their eye out of the hospital on post-acute providers in order to deliver the best care," she adds.
In May and June, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius in May and June announced 107 healthcare innovations grants to improve coordination of care and reduce costs. The grants, a provision of the Affordable Care Act (ACA), range from $1 million to $30 million. HHS anticipates that the projects will reduce healthcare spending by $254 million over the next three years and provide "new ideas on how to deliver better health, improved care, and lower costs to people enrolled in Medicare, Medicaid and [the] Children's Health Insurance Program (CHIP)."
Hospitalists played key roles in planning and developing several of the projects. Common themes include coordination and integration of services, promotion of community collaborations, integrating behavioral and physical care, and the use of telemedicine—many of the same approaches utilized by SHM's Project BOOST and other national initiatives for preventing unnecessary readmissions.
In Atlanta, Emory University's Center for Critical Care received a $10.7 million grant to deploy 40 nurse practitioners (NPs) and physician assistants (PAs) trained in critical care to underserved and rural ICUs in Georgia. In many of the targeted hospitals, hospitalists manage patients in the ICU, but this program brings an additional layer of staffing and expertise to the care, allowing patients to stay in their beds rather than having to be transferred, says Daniel Owens, MBA, the center’s director of operations and senior administrator of the division of hospital medicine at Emory.
The project will bring NPs and PAs from participating hospitals to Emory for an intensive, six-month, critical-care residency. "If they don't have these folks, we'll help to identify staff for the jobs," he adds.
At Vanderbilt University Medical Center in Nashville, Tenn., a $2.4 million project to reduce rehospitalizations for a high-risk geriatric patients aims to close the gaps in care transitions between hospital, outpatient, post-acute, and extended-care settings, says Vanderbilt hospitalist Eduard Vasilevskis, MD. The project will employ transition advocates or coordinators in the hospital to improve communication at both ends, with evidence-based protocols to improve discharge planning. Long-term care providers will be offered Web-based training and video conferencing.
"The goal is to break the cycle of rehospitalization," says Dr. Vasilevskis, "but if patients need to come back to the hospital, there will be someone involved in their care who is familiar with the settings where they’ve come from."
Beth Israel Deaconess Medical Center (BIDMC) in Boston received $4.9 million for its Post-Acute Care Transitions program (PACT), which links the hospital to six affiliated primary care practices using a bundle of post-acute care interventions, care-transition specialists, and dedicated clinical pharmacists. Nurses remain in contact with patients by telephone for 30 days post-hospital discharge and coordinate the services of extended-care facilities and visiting nurses. Pharmacists perform in-hospital medication reconciliation and patient education, says hospitalist Lauren Doctoroff, MD, FHM. She and Julius Yang, MD, BIDMC medical director of inpatient quality, helped develop the pilot program, which began in August 2011.
"These care-transitions specialists offer us an added level of patient support and a different level of integration focused on risk assessment of such issues as social supports and problems with medical compliance, which can be used by the inpatient team to come up with the most rational and ideal discharge plan," Dr. Doctoroff says. "One of my colleagues said to me, ‘I feel so much better knowing there is this added level of support for patients after discharge.'"
The HHS grants reflect an important recognition that what happens to patients following discharge partly reflects what happens in the hospital but also depends on collaborations with post-acute providers, Dr. Doctoroff says.
"Hospitalists can't do everything, but they need their eye out of the hospital on post-acute providers in order to deliver the best care," she adds.
In May and June, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius in May and June announced 107 healthcare innovations grants to improve coordination of care and reduce costs. The grants, a provision of the Affordable Care Act (ACA), range from $1 million to $30 million. HHS anticipates that the projects will reduce healthcare spending by $254 million over the next three years and provide "new ideas on how to deliver better health, improved care, and lower costs to people enrolled in Medicare, Medicaid and [the] Children's Health Insurance Program (CHIP)."
Hospitalists played key roles in planning and developing several of the projects. Common themes include coordination and integration of services, promotion of community collaborations, integrating behavioral and physical care, and the use of telemedicine—many of the same approaches utilized by SHM's Project BOOST and other national initiatives for preventing unnecessary readmissions.
In Atlanta, Emory University's Center for Critical Care received a $10.7 million grant to deploy 40 nurse practitioners (NPs) and physician assistants (PAs) trained in critical care to underserved and rural ICUs in Georgia. In many of the targeted hospitals, hospitalists manage patients in the ICU, but this program brings an additional layer of staffing and expertise to the care, allowing patients to stay in their beds rather than having to be transferred, says Daniel Owens, MBA, the center’s director of operations and senior administrator of the division of hospital medicine at Emory.
The project will bring NPs and PAs from participating hospitals to Emory for an intensive, six-month, critical-care residency. "If they don't have these folks, we'll help to identify staff for the jobs," he adds.
At Vanderbilt University Medical Center in Nashville, Tenn., a $2.4 million project to reduce rehospitalizations for a high-risk geriatric patients aims to close the gaps in care transitions between hospital, outpatient, post-acute, and extended-care settings, says Vanderbilt hospitalist Eduard Vasilevskis, MD. The project will employ transition advocates or coordinators in the hospital to improve communication at both ends, with evidence-based protocols to improve discharge planning. Long-term care providers will be offered Web-based training and video conferencing.
"The goal is to break the cycle of rehospitalization," says Dr. Vasilevskis, "but if patients need to come back to the hospital, there will be someone involved in their care who is familiar with the settings where they’ve come from."
Beth Israel Deaconess Medical Center (BIDMC) in Boston received $4.9 million for its Post-Acute Care Transitions program (PACT), which links the hospital to six affiliated primary care practices using a bundle of post-acute care interventions, care-transition specialists, and dedicated clinical pharmacists. Nurses remain in contact with patients by telephone for 30 days post-hospital discharge and coordinate the services of extended-care facilities and visiting nurses. Pharmacists perform in-hospital medication reconciliation and patient education, says hospitalist Lauren Doctoroff, MD, FHM. She and Julius Yang, MD, BIDMC medical director of inpatient quality, helped develop the pilot program, which began in August 2011.
"These care-transitions specialists offer us an added level of patient support and a different level of integration focused on risk assessment of such issues as social supports and problems with medical compliance, which can be used by the inpatient team to come up with the most rational and ideal discharge plan," Dr. Doctoroff says. "One of my colleagues said to me, ‘I feel so much better knowing there is this added level of support for patients after discharge.'"
The HHS grants reflect an important recognition that what happens to patients following discharge partly reflects what happens in the hospital but also depends on collaborations with post-acute providers, Dr. Doctoroff says.
"Hospitalists can't do everything, but they need their eye out of the hospital on post-acute providers in order to deliver the best care," she adds.
ITL: Physician Reviews of HM-Relevant Research
Clinical question: Does treatment with drotrecogin alfa (activated) reduce mortality in patients with septic shock?
Background: Recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), was approved for the treatment of patients with severe sepsis in 2001 on the basis of the Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study. Since approval, conflicting reports about its efficacy have surfaced.
Study design: Double-blind, randomized-controlled trial.
Setting: Multicenter, multinational trial.
Synopsis: This trial enrolled 1,697 patients with septic shock to receive either DrotAA or placebo. At 28 days, 223 of 846 patients (26.4%) in the DrotAA group and 202 of 834 (24.2%) in the placebo group had died (relative risk in the DrotAA group, 1.09; 95% confidence interval, 0.92 to 1.28; P=0.31). At 90 days, there was still no significant difference in mortality. Mortality was also unchanged in patients with severe protein C deficiency at baseline. This lack of mortality benefit with either therapy persisted across all predefined subgroups in this study.
The incidence of non-serious bleeding was more common among patients who received DrotAA than among those in the placebo group (8.6% vs. 4.8%, P=0.002), but the incidence of serious bleeding events was similar in both groups. This study was appropriately powered after adjusting the sample size when aggregate mortality was found to be lower than anticipated.
Bottom line: DrotAA does not significantly reduce mortality at 28 or 90 days in patients with septic shock.
Citation: Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012;366:2055-2064.
Read more of our physician reviews of recent, HM-relevant literature.
Clinical question: Does treatment with drotrecogin alfa (activated) reduce mortality in patients with septic shock?
Background: Recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), was approved for the treatment of patients with severe sepsis in 2001 on the basis of the Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study. Since approval, conflicting reports about its efficacy have surfaced.
Study design: Double-blind, randomized-controlled trial.
Setting: Multicenter, multinational trial.
Synopsis: This trial enrolled 1,697 patients with septic shock to receive either DrotAA or placebo. At 28 days, 223 of 846 patients (26.4%) in the DrotAA group and 202 of 834 (24.2%) in the placebo group had died (relative risk in the DrotAA group, 1.09; 95% confidence interval, 0.92 to 1.28; P=0.31). At 90 days, there was still no significant difference in mortality. Mortality was also unchanged in patients with severe protein C deficiency at baseline. This lack of mortality benefit with either therapy persisted across all predefined subgroups in this study.
The incidence of non-serious bleeding was more common among patients who received DrotAA than among those in the placebo group (8.6% vs. 4.8%, P=0.002), but the incidence of serious bleeding events was similar in both groups. This study was appropriately powered after adjusting the sample size when aggregate mortality was found to be lower than anticipated.
Bottom line: DrotAA does not significantly reduce mortality at 28 or 90 days in patients with septic shock.
Citation: Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012;366:2055-2064.
Read more of our physician reviews of recent, HM-relevant literature.
Clinical question: Does treatment with drotrecogin alfa (activated) reduce mortality in patients with septic shock?
Background: Recombinant human activated protein C, or drotrecogin alfa (activated) (DrotAA), was approved for the treatment of patients with severe sepsis in 2001 on the basis of the Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study. Since approval, conflicting reports about its efficacy have surfaced.
Study design: Double-blind, randomized-controlled trial.
Setting: Multicenter, multinational trial.
Synopsis: This trial enrolled 1,697 patients with septic shock to receive either DrotAA or placebo. At 28 days, 223 of 846 patients (26.4%) in the DrotAA group and 202 of 834 (24.2%) in the placebo group had died (relative risk in the DrotAA group, 1.09; 95% confidence interval, 0.92 to 1.28; P=0.31). At 90 days, there was still no significant difference in mortality. Mortality was also unchanged in patients with severe protein C deficiency at baseline. This lack of mortality benefit with either therapy persisted across all predefined subgroups in this study.
The incidence of non-serious bleeding was more common among patients who received DrotAA than among those in the placebo group (8.6% vs. 4.8%, P=0.002), but the incidence of serious bleeding events was similar in both groups. This study was appropriately powered after adjusting the sample size when aggregate mortality was found to be lower than anticipated.
Bottom line: DrotAA does not significantly reduce mortality at 28 or 90 days in patients with septic shock.
Citation: Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012;366:2055-2064.


