Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days.

Importance: As the US population ages, the number of operations performed on elderly patients will likely increase. Frailty predicts postoperative mortality and morbidity more than age alone, thus presenting opportunities to identify the highest-risk surgical patients and improve their outcomes. Objective: To examine the effect of the Frailty Screening Initiative (FSI) on mortality and complications by comparing the surgical outcomes of a cohort of surgical patients treated before and after implementation of the FSI. Design, Setting, and Participants: This single-site, facility-wide, prospective cohort quality improvement project studied all 9153 patients from a level 1b Veterans Affairs medical center who presented for major, elective, noncardiac surgery from October 1, 2007, to July 1, 2014. Interventions: Assessment of preoperative frailty in all patients scheduled for elective surgery began in July 2011. Frailty was assessed with the Risk Analysis Index (RAI), and the records of all frail patients (RAI score, ≥21) were flagged for administrative review by the chief of surgery (or designee) before the scheduled operation. On the basis of this review, clinicians from surgery, anesthesia, critical care, and palliative care were notified of the patient's frailty and associated surgical risks; if indicated, perioperative plans were modified based on team input. Main Outcomes and Measures: Postoperative mortality at 30, 180, and 365 days. Results: From October 1, 2007, to July 1, 2014, a total of 9153 patients underwent surgery (mean [SD] age, 60.3 [13.5] years; female, 653 [7.1%]; and white, 7096 [79.8%]). Overall 30-day mortality decreased from 1.6% (84 of 5275 patients) to 0.7% (26 of 3878 patients, P < .001) after FSI implementation. Improvement was greatest among frail patients (12.2% [24 of 197 patients] to 3.8% [16 of 424 patients], P < .001), although mortality rates also decreased among the robust patients (1.2% [60 of 5078 patients] to 0.3% [10 of 3454 patients], P < .001). The magnitude of improvement among frail patients increased at 180 (23.9% [47 of 197 patients] to 7.7% [30 of 389 patients], P < .001) and 365 days (34.5% [68 of 197 patients] to 11.7% [36 of 309 patients], P < .001). Multivariable models revealed improved survival after FSI implementation, controlling for age, frailty, and predicted mortality (adjusted odds ratio for 180-day survival, 2.87; 95% CI, 1.98-4.16). Conclusions and Relevance: Implementation of the FSI was associated with reduced mortality, suggesting the feasibility of widespread screening of patients preoperatively to identify frailty and the efficacy of system-level initiatives aimed at improving their surgical outcomes. Additional investigation is required to establish a causal connection.

Development and Initial Validation of the Risk Analysis Index for Measuring Frailty in Surgical Populations.

Importance: Growing consensus suggests that frailty-associated risks should inform shared surgical decision making. However, it is not clear how best to screen for frailty in preoperative surgical populations. Objective: To develop and validate the Risk Analysis Index (RAI), a 14-item instrument used to measure surgical frailty. It can be calculated prospectively (RAI-C), using a clinical questionnaire, or retrospectively (RAI-A), using variables from the surgical quality improvement databases (Veterans Affairs or American College of Surgeons National Surgical Quality Improvement Projects). Design, Setting, and Participants: Single-site, prospective cohort from July 2011 to September 2015 at the Veterans Affairs Nebraska-Western Iowa Heath Care System, a Level 1b Veterans Affairs Medical Center. The study included all patients presenting to the medical center for elective surgery. Exposures: We assessed the RAI-C for all patients scheduled for surgery, linking these scores to administrative and quality improvement data to calculate the RAI-A and the modified Frailty Index. Main Outcomes and Measures: Receiver operator characteristics and C statistics for each measure predicting postoperative mortality and morbidity. Results: Of the participants, the mean (SD) age was 60.7 (13.9) years and 249 participants (3.6%) were women. We assessed the RAI-C 10 698 times, from which we linked 6856 unique patients to mortality data. The C statistic predicting 180-day mortality for the RAI-C was 0.772. Of these 6856 unique patients, we linked 2785 to local Veterans Affairs Surgeons National Surgical Quality Improvement Projects data and calculated the C statistic for both the RAI-A (0.823) and RAI-C (0.824), along with the correlation between the 2 scores (r = 0.478; P < .001). Of these 2785 patients, there were sufficient data to calculate the modified Frailty Index for 1021, in which the C statistics were 0.865 (RAI-A), 0.797 (RAI-C), and 0.811 (modified Frailty Index). The correlation between the RAI-A and RAI-C was 0.547, and the correlations of the modified Frailty Index to the RAI-A and RAI-C were 0.301 and 0.269, respectively (all P < .001). A cutoff of RAI-C of at least 21 classified 18.3% patients as "frail" with a sensitivity of 0.50 and specificity of 0.82, whereas the RAI-A was less sensitive (0.25) and more specific (0.97), classifying only 3.7% as "frail." Conclusions and Relevance: The RAI-C and RAI-A represent effective tools for measuring frailty in surgical populations with predictive ability on par with other frailty tools. Moderate correlation between the measures suggests convergent validity. The RAI-C offers the advantage of prospective, preoperative assessment that is proved feasible for large-scale screening in clinical practice. However, further efforts should be directed at determining the optimal components of preoperative frailty assessment.

Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children.

BACKGROUND: Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media. METHODS: We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms. RESULTS: Children who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P=0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P=0.001). The percentage of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment was lower in the 5-day group than in the 10-day group (181 of 227 children [80%] vs. 211 of 233 [91%], P=0.003). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001). CONCLUSIONS: Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).

Outcomes of Aortic Surgery for Abdominal Aortic Graft Infections.

BACKGROUND: Literature on postoperative outcomes following aortic surgery for aortic graft infection (AGI) is limited by relatively small sample sizes, resulting in lack of national benchmarks for quality of care. We report in-hospital outcomes following abdominal aortic surgery for AGI and identify factors associated with postoperative complications using the Nationwide Inpatient Sample (NIS) database. METHODS: Patients who underwent aortic graft resection for AGI were identified from the 2002 to 2008 NIS database, a multicenter database capturing 20% of all US admissions. Multivariable logistic regression analyses were performed. RESULTS: Among 394 patients (men: 73.4%) who underwent abdominal aortic surgery for AGI, 53% of the admissions were emergent/urgent. A significant trend for decreasing number of abdominal aortic surgery for AGIs per year was observed (Pearson r correlation: -.96; P = .0006). Over the same time span, a significant correlation was also seen with decrease in open and increase in endovascular aortic aneurysm repairs in the NIS database. In-hospital rates of overall postoperative morbidity and mortality were 68.3% and 19.8%, respectively. In-hospital rates of postoperative respiratory failure, renal failure, and cardiac arrest were 35.5%, 14.2%, and 8.9%, respectively. Median length of stay was 26 days, with median hospital charges being US$184 162. On multivariable analysis, increase in age per year (odds ratio [OR] 1.07; 95% confidence interval [CI]: 1.03-1.12) was independently associated with postoperative morbidity, while higher hospital volume for this procedure was protective (OR: 0.71; 95% CI: 0.56-0.89). No preoperative factors were independently associated with postoperative mortality. CONCLUSION: Incidence of abdominal aortic surgery for AGI has progressively declined over the span of our study in association with decreased open and increased endovascular aortic aneurysm repairs. Aortic surgery for AGI is associated with very high morbidity and mortality rates along with prolonged lengths of stay and elevated hospital charges. The outcomes of operations for AGI are better in younger patients and higher volume hospitals.

Preoperative frailty Risk Analysis Index to stratify patients undergoing carotid endarterectomy.

OBJECTIVE: Rapid and objective preoperative assessment of patients undergoing carotid endarterectomy (CEA) remains problematic. Preoperative variables correlate with increased morbidity and mortality, yet no easily implemented tool exists to stratify patients. We determined the relationship between our fully implemented frailty-based bedside Risk Analysis Index (RAI) and complications after CEA. METHODS: Patients undergoing CEA in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2011 were included. Variables of frailty RAI were matched to preoperative NSQIP variables, and outcomes including stroke, mortality, myocardial infarction (MI), and length of stay were analyzed. We further analyzed patients who were symptomatic and asymptomatic before CEA. RESULTS: With use of the NSQIP database, 44,832 patients undergoing CEA were analyzed (17,696 [39.5%] symptomatic; 27,136 [60.5%] asymptomatic). Increasing frailty RAI score correlated with increasing stroke, death, and MI (P < .0001) as well as with length of stay. RAI demonstrated increasing risk of stroke and death on the basis of risk stratification (low risk [0-10], 2.1%; high risk [>10], 5.0%). Among patients undergoing CEA, 88% scored low (<10) on the RAI. In symptomatic patients, the risk of stroke and death for patients with a score of ≤10 is 2.9%, whereas if the RAI score is 11 to 15, it is 5.0%; 16 to 20, 6.9%; and >21, 8.6%. In asymptomatic patients, the risk of stroke and death for patients with a score of ≤10 is 1.6%, whereas if the RAI score is 11 to 15, it is 2.9%; 16 to 20, 5.2%; and >21, 6.2%. CONCLUSIONS: Frailty is a predictor of increased stroke, mortality, MI, and length of stay after CEA. An easily implemented RAI holds the potential to identify a limited subset of patients who are at higher risk for postoperative complications and may not benefit from CEA.

Assessing preoperative frailty utilizing validated geriatric mortality calculators and their association with postoperative hip fracture mortality risk.

INTRODUCTION: End-of-life surgical care is a major concern with a significant number of operations performed within the last year of life; surgery for hip fractures is a prime example. Unfortunately, no simple objective tool exists to assess life expectancy in the postoperative period. The goal of our study was to analyze 2 simple geriatric life expectancy calculators to compare with the current Veterans Affairs Surgical Quality Improvement Program (VASQIP) postoperative 30-day mortality calculator. METHODS: This retrospective study assessed the utility of 3 validated calculators in 47 hip fracture repairs from July 2009 to May 2011. The tools included: 30-day VASQIP mortality calculator, 6-month Minimum Data Set Mortality Risk Index-Revised (MMRI-R), and Four-Year Mortality Index. The VASQIP calculator requires chart review, Current Procedural Terminology (CPT) codes, and laboratory analysis, whereas the mortality risk indices require simple patient questioning if prospective or simple chart review if retrospective. Scoring was performed and mortality risk was compared between survivors and nonsurvivors. RESULTS: A total of 47 hip fractures were repaired during the study period with 37 survivors and 10 nonsurvivors. In all, 7 died within 30 days, 2 died within 6 months, and 1 died greater than 6 months after surgery. The mean age (standard deviation [SD]) of all patients undergoing hip fracture repair was 73.6 (13.3) years. The VASQIP calculator mean (SD) 30-day mortality risk was 10.4% (5.4) for nonsurvivors compared to survivors 4.3% (5.5), P < .003; the MMRI-R mean (SD) mortality risk was 35.8% (15.4) for nonsurvivors compared to survivors 14.7% (9.5), P < .001; the Four-Year Mortality Index mean (SD) mortality risk was 60.9% (16.9) for nonsurvivors compared to survivors 48.9% (24.4), P < .09. CONCLUSION: Overall, the VASQIP 30-day and MMRI-R 6-month mortality calculators showed significant differences in mortality risk between survivors versus nonsurvivors in a population with hip fracture. In contrast, the Four-Year Mortality calculator may not sufficiently discriminate operative risk. The easily obtained MMRI-R has the potential to provide information on short-term postoperative mortality risk.

Surgical palliative care consultations over time in relationship to systemwide frailty screening.

IMPORTANCE: The need for integrating palliative care into surgical services has been established within the surgical literature. The ability to effectively screen, obtain an appropriately timed consultation, and determine the effect of consultation remains problematic. OBJECTIVE: To examine surgical palliative care consultations over time and their relationship to the initiation and implementation of a systemwide frailty-screening program. DESIGN, SETTING, AND PARTICIPANTS: We reviewed all surgical palliative care consultations performed between January 1, 2006, and August 31, 2013, and abstracted the referring service (medicine/surgery), date of surgery (if any), date of death (if any), and all variables required to calculate a frailty score using the risk analysis index. We examined changes in mortality and referral patterns before and after implementation of the frailty-screening program using multivariable logistic regression. EXPOSURES: Surgical palliative care consultations, including frailty screening. MAIN OUTCOMES AND MEASURES: The primary study outcomes were 30-, 180-, and 360-day mortality. RESULTS: From 2006 to 2013, a total of 310 palliative care consultations were ordered for surgical patients: 160 before initiation of frailty screening (January 1, 2011) and 150 after initiation of the program. The groups had similar demographics, comorbidities, and frailty scores. After initiation, we observed dramatically decreased mortality at 30, 180, and 360 days (21.3% vs 31.9%, 44.0% vs 70.6%, and 66.0% vs 78.8%, respectively; all P < .05). This coincided with an increased rate of palliative care consultations from 32 per year to 56 per year. After initiation of the program, consultations were more likely to be requested by surgeons (56.7% vs 24.4%; P < .05) and were more likely to occur before the index operation (52.0% vs 26.3%; P < .05). Implementation of the screening program was associated with a 33% reduction in 180-day mortality (odds ratio [OR], 0.37; 95% CI, 0.22-0.62; P < .001) even after controlling for age, frailty, and whether the patients had surgery. Modeled mortality was also reduced when the palliative care consultation was ordered by a surgeon (OR, 0.50; CI, 0.30-0.83; P = .007) or ordered before the operation (OR, 0.52; CI, 0.30-0.90; P = .02). CONCLUSIONS AND RELEVANCE: Our data suggest that a systematic frailty-screening program effectively identifies at-risk surgical patients and is associated with a significant reduction in mortality for patients undergoing palliative care consultation. Analysis also suggests that preoperative palliative care consultations ordered by surgeons are associated with reduced mortality rates.

American College of Surgeons Resident Objective Structured Clinical Examination: a national program to assess clinical readiness of entering postgraduate year 1 surgery residents.

OBJECTIVE: This report describes the development, initial implementation, and reliability of American College of Surgeons Resident Objective Structured Clinical Examination (ACS OSCE). BACKGROUND: Variability in clinical knowledge and skills of entering surgery residents has been demonstrated. The ACS OSCE was developed to evaluate and help remediate residents' knowledge and skills in managing patients with life-threatening conditions. METHODS: A task force of surgeons and professional educators developed 10 standardized clinical case stations, evaluation checklists, and rating scales. Standardized patients (SPs) evaluated each resident's clinical skills (history taking, physical examination, communication, and SP-global scores). Residents completed checklists on diagnosis and management. Coefficient alpha and item-total correlations were used, respectively, to assess internal consistency of metrics and station validity. The resident's overall performance for each station was calculated by combining scores of the individual skills. Analysis of variance compared performance across different institutions. RESULTS: A total of 103 postgraduate year 1 residents from 7 institutions completed the OSCE. Reliability coefficients of skills ranged from 0.38 for diagnosis to 0.68 for global scores. For overall performance on individual stations, the reliability coefficients ranged from 0.51 to 0.82. Using total percent correct scores from highly reliable stations (α > 0.8), wide variability in resident performance was demonstrated within and between the 7 institutions. CONCLUSIONS: The ACS OSCE was successfully implemented across diverse institutions. It had moderate reliability and demonstrated variability among entering surgery residents. The ACS OSCE is now available for broader implementation. It should help reduce resident variability and address the requirements of Accreditation Council for Graduate Medical Education for resident supervision.

Development of a risk index for prediction of mortality after open aortic aneurysm repair.

OBJECTIVE: Open infrarenal abdominal aortic aneurysm (oAAA) repair is associated with significant morbidity and mortality. Although there has been a shift toward endovascular repair, many patients continue to undergo an open repair due to anatomic considerations. Tools currently existing for estimation of periprocedural risk in patients undergoing open aortic surgery have certain limitations. The objective of this study was to develop a risk index to estimate the risk of 30-day perioperative mortality after elective oAAA repair. METHODS: Patients who underwent elective oAAA repair (n = 2845) were identified from the American College of Surgeons' 2007 to 2009 National Surgical Quality Improvement Program (NSQIP), a prospective database maintained at >250 centers. Univariable and multivariable analyses were performed to evaluate risk factors associated with 30-day mortality after oAAA repair and a risk index was developed. RESULTS: The 30-day mortality after oAAA repair was 3.3%. Multivariable analysis identified six preoperative predictors of mortality, and a risk index was created by assigning weighted points to each predictor using the ß-coefficients from the regression analysis. The predictors included dyspnea (at rest: 8 points; on moderate exertion: 2 points; none: 0 points), history of peripheral arterial disease requiring revascularization or amputation (3 points), age >65 years (3 points), preoperative creatinine >1.5 mg/dL (2 points), female gender (2 points), and platelets <150,000/mm(3) or >350,000/mm(3) (2 points). Patients were classified as low (<7%), intermediate (7%-15%), and high (>15%) risk for 30-day mortality based on a total point score of <8, 8 to 11, and >11, respectively. There were 2508 patients (88.2%) patients in the low-risk category, 278 (9.8%) in the intermediate-risk category, and 59 (2.1%) in the high-risk category. CONCLUSIONS: This risk index has excellent predictive ability for mortality after oAAA repair and awaits validation in subsequent studies. It is anticipated to aid patients and surgeons in informed patient consent, preoperative risk assessment, and optimization.

Preoperative anemia is an independent predictor of postoperative mortality and adverse cardiac events in elderly patients undergoing elective vascular operations.

OBJECTIVE: The objective of this study was to assess the impact of preoperative anemia (hematocrit <39%) on postoperative 30-day mortality and adverse cardiac events in patients 65 years or older undergoing elective vascular procedures. BACKGROUND: Preoperative anemia is associated with adverse outcomes after cardiac surgery, but its association with postoperative outcomes after open and endovascular procedures is not well established. Elderly patients have a decreased tolerance to anemia and are at high risk for complications after vascular procedures. METHODS: Patients (N = 31,857) were identified from the American College of Surgeons' 2007-2009 National Surgical Quality Improvement Program-a prospective, multicenter (>250) database maintained across the United States. The primary and secondary outcomes of interest were 30-day mortality and a composite end point of death or cardiac event (cardiac arrest or myocardial infarction), respectively. RESULTS: Forty-seven percent of the study population was anemic. Anemic patients had a postoperative mortality and cardiac event rate of 2.4% and 2.3% in contrast to the 1.2% and 1.2%, respectively, in patients with hematocrit within the normal range (P < 0.0001). On multivariate analysis, we found a 4.2% (95% confidence interval, 1.9-6.5) increase in the adjusted risk of 30-day postoperative mortality for every percentage point of hematocrit decrease from the normal range. CONCLUSIONS: The presence and degree of preoperative anemia are independently associated with 30-day death and adverse cardiac events in patients 65 years or older undergoing elective open and endovascular procedures. Identification and treatment of anemia should be important components of preoperative care for patients undergoing vascular operations.

In-hospital and postdischarge venous thromboembolism after vascular surgery.

OBJECTIVE: Recent single-center reports demonstrate a high (up to 10%) incidence of postoperative venous thromboembolism (VTE) after major vascular surgery. Moreover, vascular patients rarely receive prolonged prophylaxis despite evidence that it reduces thromboembolic events after discharge. This study used a national, prospective, multicenter database to define the incidence of overall and postdischarge VTE after major vascular operations and assess risk factors associated with VTE development. METHODS: Patients with VTE who underwent elective vascular procedures (n = 45,548) were identified from the 2007-2009 National Surgical Quality Improvement Program (NSQIP) database. The vascular procedures included carotid endarterectomy (CEA; n = 20,785), open thoracoabdominal aortic aneurysm (TAAA) repair (n = 361), thoracic endovascular aortic repair (TEVAR; n = 732), open abdominal aortic (OAA) surgery (n = 6195), endovascular aneurysm repair (EVAR; n = 7361), and infrainguinal bypass graft (BPG; n = 10,114). Univariable and multivariable analyses were performed to ascertain risk factors associated with VTE. RESULTS: VTE was diagnosed in 187 patients (1.3 %) who underwent aortic surgery, with TAAA repair having the highest rate of VTE (4.2%), followed by TEVAR (2.2%), OAA surgery (1.7%), and EVAR (0.7%). In this subgroup, pulmonary embolisms (PE) were diagnosed in 52 (0.4%) and deep venous thrombosis (DVT) in 144 (1%). VTE rates were 1.0% and 0.2% for patients who underwent a BPG or CEA, respectively. Forty-one percent of all VTEs were diagnosed after discharge. The median (interquartile range) number of days from surgery to PE and DVT were 10 (5-15) and 10 (4-18), respectively. On multivariable analyses, type of surgical procedure, totally dependent functional status, disseminated cancer, postoperative organ space infection, postoperative cerebrovascular accident, failure to wean from ventilator ≤48 hours, and return to the operating room were significantly associated with development of VTE. In those experiencing a DVT or PE, overall mortality increased from 1.5% to 6.2% and from 1.5% to 5.7% respectively (P < .05 for both). CONCLUSIONS: Postoperative VTE is associated with the type of vascular procedure and is highest after operations in the chest and abdomen/pelvis. About 40% of VTE events in elective vascular surgery patients were diagnosed after discharge, and the presence of VTE was associated with a quadrupled mortality rate. Future studies should evaluate the benefit of DVT screening and postdischarge VTE prophylaxis in high-risk patients.

Development and validation of a risk calculator for prediction of mortality after infrainguinal bypass surgery.

OBJECTIVE: For peripheral arterial disease, infrainguinal bypass grafting (BPG) carries a higher perioperative risk compared with peripheral endovascular procedures. The choice between the open and endovascular therapies is to an extent dependent on the expected periprocedural risk associated with each. Tools for estimating the periprocedural risk in patients undergoing BPG have not been reported in the literature. The objective of this study was to develop and validate a calculator to estimate the risk of perioperative mortality ≤30 days of elective BPG. METHODS: We identified 9556 patients (63.9% men) who underwent elective BPG from the 2007 to 2009 National Surgical Quality Improvement Program data sets. Multivariable logistic regression analysis was performed to identify risk factors associated with 30-day perioperative mortality. Bootstrapping was used for internal validation. The risk factors were subsequently used to develop a risk calculator. RESULTS: Patients had a median age of 68 years. The 30-day mortality rate was 1.8% (n = 170). Multivariable logistic regression analysis identified seven preoperative predictors of 30-day mortality: increasing age, systemic inflammatory response syndrome, chronic corticosteroid use, chronic obstructive pulmonary disease, dependent functional status, dialysis dependence, and lower extremity rest pain. Bootstrapping was used for internal validation. The model demonstrated excellent discrimination (C statistic, 0.81; bias-corrected C statistic, 0.81) and calibration. The validated risk model was used to develop an interactive risk calculator using the logistic regression equation. CONCLUSIONS: The validated risk calculator has excellent predictive ability for 30-day mortality in a patient after an elective BPG. It is anticipated to aid in surgical decision making, informed patient consent, preoperative optimization, and consequently, risk reduction.