Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study.

OBJECTIVE: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. DESIGN: Observational surveillance study. SETTING: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). PARTICIPANTS: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. MAIN OUTCOME MEASURES: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. RESULTS: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. CONCLUSIONS: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

A Vascular Quality Initiative frailty assessment predicts postdischarge mortality in patients undergoing arterial reconstruction.

BACKGROUND: Frailty assessment adds important prognostic information during preoperative decision-making but can be cumbersome to implement into routine clinical care. We developed and tested an abbreviated method of frailty assessment using variables routinely collected by the Vascular Quality Initiative (VQI) registry. METHODS: An abbreviated frailty score (the simple Vascular Quality Initiative-Frailty Score [VQI-FS]) was developed using 11 or fewer VQI variables (hypertension, congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes, chronic obstructive pulmonary disease, renal impairment, anemia, underweight, nonhome residence, and nonambulatory status) that map to recognized frailty domains in the Comprehensive Geriatric Assessment and the literature. Nonemergent cases registered in the VQI from 2010 to 2017 (n = 265,632) in seven registries (carotid endarterectomy, n = 77,111; carotid artery stenting, n = 13,215; endovascular abdominal aortic aneurysm repair, n = 29,607; open abdominal aortic aneurysm repair, n = 7442; infrainguinal bypass, n = 33,128; suprainguinal bypass, n = 10,661; and peripheral vascular intervention, n = 94,468) were analyzed using logistic regression models to determine the predictive power of the VQI-FS for perioperative and longer term (9-month) mortality. Nomograms were created using weighted regression coefficients to assist in individualized frailty assessment and estimation of 9-month mortality. RESULTS: The VQI-FS, using equal weighting of these 11 VQI variables, effectively predicted 9-month mortality with an area under the curve of 0.724 by receiver operating characteristic curve analysis. However, differential weighting of the variables allowed simplification of the model to only seven variables (congestive heart failure, renal impairment, chronic obstructive pulmonary disease, not living at home, not ambulatory, anemia, and underweight status); hypertension, coronary artery disease, peripheral vascular disease, and diabetes had relatively low predictive power. Adding procedure-specific risk further improved performance of the model with a final area under the curve on receiver operating characteristic curve analysis of 0.758. Model calibration was excellent with predicted/observed regression line slope of 0.991 and intercept of 5.449e-04. CONCLUSIONS: A differentially weighted abbreviated VQI-FS using seven variables in addition to procedure-specific risk has strong correlation with 9-month mortality. Nomograms incorporating patient- and procedure-adjusted risk can effectively predict 9-month mortality. Reliable estimates of longer term mortality should assist in preoperative decision-making for vascular procedures that often carry substantial risk of mortality.

An analysis of gender disparities amongst United States medical students, general surgery residents, vascular surgery trainees, and the vascular surgery workforce.

Gender diversity in medicine continues to be a critical topic, and gender diversity within surgical fields remains an overarching challenge. In the following review, we objectively address the data available in terms of training slots for women in general and vascular surgery and within the vascular surgery workforce. Overall, women comprise 36% of active physicians in the 2019 Association of American Medical Colleges data. The number of women in surgical fields is lower representing 22% in general surgery, 9% in neurosurgery, 6% in orthopedic surgery, 17% in plastic surgery, 8% in thoracic surgery, and 15% in vascular surgery. Also notable is the lower academic ranks held by women in surgery. The proportion of women instructors in surgery in 2020 was 61%, assistant professors 30%, associate professors 23%, and full-time professors only 13.5%. There are multiple opportunities across the divisional/institutional/societal domains in which mentorship and sponsorship can promote gender equity and inclusion. Recruitment and retention of women and minorities into the vascular academic and private practices is essential to ensure best patient outcomes and quality of care for our patients. We hope that by shedding light on this topic, there will be greater awareness and improved strategies to address the disparities within institutions.

The Correlation Between Case Total Work Relative Value Unit, Operative Stress, and Patient Frailty: Retrospective Cohort Study.

OBJECTIVE: Assess the relationships between case total work relative value units (wRVU), patient frailty, and the physiologic stress of surgical interventions. SUMMARY OF BACKGROUND DATA: Surgeon reimbursement is frequently apportioned by wRVU. These subjective, procedure-specific valuations generated by physician survey estimate the intensity and time for typical patient care services. We hypothesized wRVU would not adequately account for patient-specific factors, such as frailty, that modify the required physician work, regardless of procedural complexity. METHODS: Using National and Veterans Affairs Surgical Quality Improvement Programs (2015-2018), we evaluated the correlation between case total wRVU, patient frailty (risk analysis index) and physiologic surgical stress (operative stress score). RESULTS: Of 4,111,371 (86%) cases, the correlation between total wRVU and operative stress was moderate [ρs = 0.587 (95% confidence interval, 0.586-0.587)], but negligible with frailty ρ = 0.177 (95% confidence interval, 0.176-0.178)]. Very high operative stress procedures [n = 34,047 (1%)] generated a mean total wRVU of 55.1 (standard deviation, 12.9), comprising 7%, 2%, and 1% of thoracic, vascular, and general surgical cases, respectively. Very frail patients [n = 152,535 (4%)] accounted for 9% of thoracic, 9% of vascular, 4% of general, 5% of urologic, and 4% of neurologic surgical cases, generating 21.0 (standard deviation, 12.4) mean total wRVU. Some nonfrail patients undergoing low operative stress procedures [n = 60,128 (2%)] nonetheless generated the highest quintile wRVU; these comprised >15% of plastic, gynecologic, and urologic surgical cases. CONCLUSIONS: Surgeon reimbursement correlates with operative stress but not patient frailty. The total wRVU does not adequately reflect patient-specific factors that increase the physician workload required to render optimal care to complex patients.

Gender Disparity in Surgical Society Leadership and Annual Meeting Programs.

INTRODUCTION: Prior work suggests women surgical role models attract more female medical students into surgical training. We investigate recent trends of women in surgical society leadership and national conference moderator and plenary speaker roles. METHODS: Gender distribution was surveyed at 15 major surgical societies and 14 conferences from 2014 to 2018 using publicly reported data. Roles were categorized as leadership (executive council), moderator, or plenary speaker. Data were cross-checked from online profiles and by contacting societies. Logistic regression with Huber-White clustering by society was utilized to evaluate proportions of women in each role over time and determine associations between the proportion of women in executive leadership, and scientific session moderators and plenary speakers. RESULTS: The proportion of leadership positions held by women increased slightly from 2014 to 2018 (20.6%-26.6%, P = 0.23), as did the proportion of moderators (26.2%-30.6%, P = 0.027) and plenary speakers (26.2%-30.9%, P = 0.058). The proportion of women in each role varied significantly across societies (all P < 0.001): leaders (range 0.0%-52.0%), moderators (12.5%-58.8%), and plenary speakers (11.3%-60.0%). Three patterns of change were observed: eight societies (53.3%) demonstrated increases in representation of women over time, four societies (26.6%) showed stable moderate-to-good gender balance, and three societies (20.0%) had consistent underrepresentation of women. CONCLUSION: There is significant variability in the representation of women at the leadership level of national surgical societies and participating at national surgical conferences as moderators and plenary speakers. Over the past 5 years some societies have achieved advances in gender equity, but many societies still have substantial room for improvement.

Epidemiology of atherosclerotic carotid artery disease.

Atherosclerotic carotid artery disease is a significant cause of stroke in the United States and globally. Its prevalence increases with age and it is more prevalent in men and White and Native-American populations. However, the outcomes related to carotid disease are worse in women and Black patients. Research suggests the disparities exist due to a multitude of factors, including disease pathophysiology, access to care, provider bias, and socioeconomic status. The prevalence of carotid stenosis in the general population is low (3%), and routine screening for carotid stenosis is not recommended in adults. Randomized clinical trials have shown benefits of stroke risk reduction with surgery (carotid endarterectomy or stenting) for symptomatic patients. Management is controversial in asymptomatic patients, as modern medical management has results equivalent to those of surgery and ongoing randomized clinical trials will address this important question. Carotid surgery is not appropriate in asymptomatic patients with limited life expectancy. Future work should explore comprehensive care models for care of patients with carotid disease and assessment of patient-reported outcomes to measure quality of care.

Contemporary Practices and Complications of Surgery for Thoracic Outlet Syndrome in the United States.

BACKGROUND: Thoracic outlet syndrome (TOS) surgery is relatively rare and controversial, given the challenges in diagnosis as well as wide variation in symptomatic and functional recovery. Our aims were to measure trends in utilization of TOS surgery, complications, and mortality rates in a nationally representative cohort and compare higher versus lower volume centers. METHODS: The National Inpatient Sample was queried using International Classification of Diseases, Ninth Revision, codes for rib resection and scalenectomy paired with axillo-subclavian aneurysm (arterial [aTOS]), subclavian deep vein thrombosis (venous [vTOS]), or brachial plexus lesions (neurogenic [nTOS]). Basic descriptive statistics, nonparametric tests for trend, and multivariable hierarchical regression models with random intercept for center were used to compare outcomes for TOS types, trends over time, and higher and lower volume hospitals, respectively. RESULTS: There were 3,547 TOS operations (for an estimated 18,210 TOS operations nationally) performed between 2010 and 2015 (89.2% nTOS, 9.9% vTOS, and 0.9% aTOS) with annual case volume increasing significantly over time (P = 0.03). Higher volume centers (≥10 cases per year) represented 5.2% of hospitals and 37.0% of cases, and these centers achieved significantly lower overall major complication (defined as neurologic injury, arterial or venous injury, vascular graft complication, pneumothorax, hemorrhage/hematoma, or lymphatic leak) rates (adjusted odds ratio [OR] 0.71 [95% confidence interval 0.52-0.98]; P = 0.04], but no difference in neurologic complications such as brachial plexus injury (aOR 0.69 [0.20-2.43]; P = 0.56) or vascular injuries/graft complications (aOR 0.71 [0.0.33-1.54]; P = 0.39). Overall mortality was 0.6%, neurologic injury was rare (0.3%), and the proportion of patients experiencing complications decreased over time (P = 0.03). However, vTOS and aTOS had >2.5 times the odds of major complication compared with nTOS (OR 2.68 [1.88-3.82] and aOR 4.26 [1.78-10.17]; P < 0.001), and ∼10 times the odds of a vascular complication (aOR 10.37 [5.33-20.19] and aOR 12.93 [3.54-47.37]; P < 0.001], respectively. As the number of complications decreased, average hospital charges also significantly decreased over time (P < 0.001). Total hospital charges were on average higher when surgery was performed in lower volume centers (<10 cases per year) compared with higher volume centers (mean $65,634 [standard deviation 98,796] vs. $45,850 [59,285]; P < 0.001). CONCLUSIONS: The annual number of TOS operations has increased in the United States from 2010 to 2015, whereas complications and average hospital charges have decreased. Mortality and neurologic injury remain rare. Higher volume centers delivered higher value care: less or similar operative morbidity with lower total hospital charges.

Managing central venous access during a health care crisis.

OBJECTIVE: During the COVID-19 pandemic, central venous access line teams were implemented at many hospitals throughout the world to provide access for critically ill patients. The objective of this study was to describe the structure, practice patterns, and outcomes of these vascular access teams during the COVID-19 pandemic. METHODS: We conducted a cross-sectional, self-reported study of central venous access line teams in hospitals afflicted with the COVID-19 pandemic. To participate in the study, hospitals were required to meet one of the following criteria: development of a formal plan for a central venous access line team during the pandemic; implementation of a central venous access line team during the pandemic; placement of central venous access by a designated practice group during the pandemic as part of routine clinical practice; or management of an iatrogenic complication related to central venous access in a patient with COVID-19. RESULTS: Participants from 60 hospitals in 13 countries contributed data to the study. Central venous line teams were most commonly composed of vascular surgery and general surgery attending physicians and trainees. Twenty sites had 2657 lines placed by their central venous access line team or designated practice group. During that time, there were 11 (0.4%) iatrogenic complications associated with central venous access procedures performed by the line team or group at those 20 sites. Triple lumen catheters, Cordis (Santa Clara, Calif) catheters, and nontunneled hemodialysis catheters were the most common types of central venous lines placed by the teams. Eight (14%) sites reported experience in placing central venous lines in prone, ventilated patients with COVID-19. A dedicated line cart was used by 35 (59%) of the hospitals. Less than 50% (24 [41%]) of the participating sites reported managing thrombosed central lines in COVID-19 patients. Twenty-three of the sites managed 48 iatrogenic complications in patients with COVID-19 (including complications caused by providers outside of the line team or designated practice group). CONCLUSIONS: Implementation of a dedicated central venous access line team during a pandemic or other health care crisis is a way by which physicians trained in central venous access can contribute their expertise to a stressed health care system. A line team composed of physicians with vascular skill sets provides relief to resource-constrained intensive care unit, ward, and emergency medicine teams with a low rate of iatrogenic complications relative to historical reports. We recommend that a plan for central venous access line team implementation be in place for future health care crises.

Validation of the Risk Analysis Index for Evaluating Frailty in Ambulatory Patients.

BACKGROUND: Frailty is a marker of dependency, disability, hospitalization, and mortality in community-dwelling older adults. However, existing tools for measuring frailty are too cumbersome for rapid point-of-care assessment. The Risk Analysis Index (RAI) of frailty is validated in surgical populations, but its performance outside surgical populations is unknown. OBJECTIVE: Validate the RAI in ambulatory patients. DESIGN, SETTING, AND PARTICIPANTS: Observational cohort study of outpatient surgical clinics within the University of Pittsburgh Medical Center Healthcare System between July 1, 2016, and December 31, 2016. Frailty was assessed using the RAI. Current Procedural Terminology codes following RAI assessment identified patients with and without minor office-based procedures (eg, joint injection, laryngoscopy). MAIN OUTCOMES AND MEASURES: All-cause 1-year mortality, assessed by stratified Cox proportional hazard models. RESULTS: Of 28,059 patients, 13,861 were matched to a minor, office-based procedure and 14,198 did not undergo any procedure. The mean (SD) age was 56.7 (17.2) years; women constituted 15,797 (56.3%) of the cohort. Median time (interquartile range 25th-75th percentile) to measure RAI was 30 (22-47) seconds. Mortality among the frail was two to five times that of patients with normal RAI scores. For example, the hazard ratio for frail ambulatory patients without a minor procedure was 3.69 (95% confidence interval [CI] = 2.51-5.41), corresponding to 30-, 180-, and 365-day mortality rates of 2.9%, 11.2%, and 17.4%, respectively, compared to 0.3%, 2.3%, and 4.0% among patients with normal RAI scores. Discrimination of mortality (overall, and censored at 30, 180, and 365 days) was excellent, ranging from c = 0.838 (95% CI = 0.773-0.902) for 30-day mortality after minor procedures to c = 0.909 (95% CI = 0.855-0.964) without a procedure. CONCLUSION: RAI is a valid, easily administered tool for point-of-care frailty assessment in ambulatory populations that may help clinicians and patients make better informed decisions about care choices-especially among patients considered high risk with a potentially limited life span. J Am Geriatr Soc 68:1818-1824, 2020.

Frailty as measured by the Risk Analysis Index is associated with long-term death after carotid endarterectomy.

OBJECTIVE: The role of carotid endarterectomy (CEA) continues to be debated in the age of optimal medical therapy, particularly for patients with limited life expectancy. The Risk Analysis Index (RAI) measures frailty, a syndrome of decreased physiologic reserve, which increases vulnerability to adverse outcomes. The RAI better predicts surgical complications, nonhome discharge, and death than age or comorbidities alone. We sought to measure the association of frailty, as measured by the RAI, with postoperative in-hospital stroke, long-term stroke, and long-term survival after CEA. We also sought to determine how postoperative stroke interacts with frailty to alter survival trajectory after CEA. METHODS: We queried the Vascular Quality Initiative CEA procedure and long-term data sets (2003-2017) for elective CEAs with complete RAI case information. For all analyses, the cohort was divided into asymptomatic and symptomatic carotid stenosis. Scoring was defined as not frail (RAI <30), frail (RAI 30-34), and very frail (RAI ≥35). Mortality information through December 2017 was obtained from the Social Security Death Index. Multivariable models (logistic and Cox proportional hazards regressions) were used to study the association of frail and very frail patients with the outcomes of interest. In a post hoc analysis, we created Kaplan-Meier curves to analyze patient mortality after CEA as well as after postoperative stroke. RESULTS: Of the 42,869 included patients, 17,092 (39.9%) were female, and 38,395 (89.6%) were white. There were 25,673 (59.9%) patients assigned to the asymptomatic stenosis group and 17,196 (40.1%) patients in the symptomatic stenosis group. Frailty was not associated with perioperative or long-term postoperative stroke. The risk of long-term mortality was significantly higher for frail (hazard ratio, 1.9 [1.7-2.3]) and very frail (hazard ratio, 3.1 [2.6-3.7]) asymptomatic patients; symptomatic frail and very frail patients also had a two to three times increased risk of long-term mortality. Frail and very frail patients had two to three times the risk for long-term mortality compared with patients who were not frail. Postoperative stroke negatively affected the mortality trajectory for all patients in the cohort, regardless of frailty status. CONCLUSIONS: RAI score is not associated with postoperative stroke; however, frail and very frail status is associated with decreased long-term survival in an incremental fashion based on increasing RAI. RAI assessment should be considered in the preoperative decision-making for patients undergoing CEA to ensure long-term survival and optimal surgical outcomes vs medical management.

Association of peripheral artery disease with life-space mobility restriction and mortality in community-dwelling older adults.

OBJECTIVE: Symptomatic peripheral artery disease (PAD) impairs walking, but data on the impact of PAD on community mobility is limited. Life-space mobility measures the distance, frequency, and assistance needed as older adults move through geographic areas extending from their bedroom (life-space mobility score: 0) to beyond their town (life-space mobility score: 120). We evaluated the association of PAD with longitudinal life-space mobility trajectory. METHODS: Participants were part of the University of Alabama at Birmingham Study of Aging, a longitudinal study of community-dwelling older adults who were observed from 2001 to 2009. We limited our analysis to those who survived at least 6 months (N = 981). PAD was based on self-report with verification by physician report and hospital records. Our primary outcome was life-space mobility score assessed every 6 months. A multilevel change model (mixed model) was used to determine the association between PAD and life-space mobility trajectory during a median 7.9 years of follow-up. RESULTS: Participants had a mean age of 75.7 (standard deviation, 6.7) years; 50.5% were female, and 50.4% were African American. PAD prevalence was 10.1%, and 57.1% of participants with PAD died. In participants with both PAD and life-space restriction, defined as life-space mobility score <60, we observed the highest mortality (73.1%). In a multivariable adjusted mixed effects model, participants with PAD had a more rapid decline in life-space mobility by -1.1 (95% confidence interval [CI], -1.9 to -0.24) points per year compared with those without PAD. At 5-year follow-up, model-adjusted mean life-space mobility was 48.1 (95% CI, 43.5-52.7) and 52.4 (95% CI, 50.9-53.8) among those with and without PAD, respectively, corresponding to a restriction in independent life-space mobility at the level of one's neighborhood. CONCLUSIONS: Life-space mobility is a novel patient-centered measure of community mobility, and PAD is associated with significant life-space mobility decline among community-dwelling older adults. Further study is needed to mechanistically confirm these findings and to determine whether better recognition and treatment of PAD alter the trajectory of life-space mobility.

Racial and Sex Disparities in Catheter Use and Dialysis Access in the United States Medicare Population.

BACKGROUND: Despite efforts to increase arteriovenous fistula and graft use, 80% of patients in the United States start hemodialysis on a central venous catheter (CVC). METHODS: To better understand in incident hemodialysis patients how sex and race/ethnicity are associated with time on a central venous catheter and transition to an arteriovenous fistula and graft, our observational cohort study analyzed US Renal Data System data for patients with incident ESKD aged ≥66 years who started hemodialysis on a CVC in July 2010 through 2013. RESULTS: At 1 year, 32.7% of 74,194 patients transitioned to an arteriovenous fistula, 10.8% transitioned to an arteriovenous graft, 32.1% stayed on a CVC, and 24.5% died. Women spent a significantly longer time on a CVC than men. Compared with white patients, patients who were black, Hispanic, or of another racial/ethnicity minority spent significantly more days on a CVC. In competing risk regression, women were significantly less likely than men to transition to a fistula and more likely to transition to a graft. Compared with white patients, blacks were significantly less likely to transition to a fistula but more likely to transition to a graft, Hispanics were significantly more likely to transition to a fistula, and other races/ethnicities were significantly more likely to transition to either a fistula or a graft. CONCLUSIONS: Female patients spend a longer time on a CVC and are less likely to transition to permanent access. Compared with white patients, minorities also spend longer time on a CVC, but are more likely to eventually transition to permanent access. Strategies to speed transition to permanent access should target groups that currently lag in this area.

Assessment of the Risk Analysis Index for Prediction of Mortality, Major Complications, and Length of Stay in Patients who Underwent Vascular Surgery.

BACKGROUND: Frailty is a risk factor for adverse postoperative outcomes. We aimed to test the performance of a prospectively validated frailty measure, the Risk Analysis Index (RAI) in patients who underwent vascular surgery and delineate the additive impact of procedure complexity on surgical outcomes. METHODS: We queried the 2007-2013 American College of Surgeons National Surgical Quality Improvement Program database to identify 6 major elective vascular procedure categories (carotid revascularization, abdominal aortic aneurysm [AAA] repair, suprainguinal revascularization, infrainguinal revascularization, thoracic aortic aneurysm [TAA] repair, and thoracoabdominal aortic aneurysm [TAAA] repair). We trained and tested logistic regression models for 30-day mortality, major complications, and prolonged length of stay (LOS). The first model, "RAI," used the RAI alone; "RAI-Procedure (RAI-P)" included procedure category (e.g., AAA repair) and procedure approach (e.g., endovascular); "RAI-Procedure Complexity (RAI-PC)" added outpatient versus inpatient surgery, general anesthesia use, work relative value units (RVUs), and operative time. RESULTS: The RAI model was a good predictor of mortality for vascular procedures overall (C-statistic: 0.72). The C-statistic increased with the RAI-P (0.78), which further improved minimally, with the RAI-PC (0.79). When stratified by procedure category, the RAI predicted mortality well for infrainguinal (0.79) and suprainguinal (0.74) procedures, moderately well for AAA repairs (0.69) and carotid revascularizations (0.70), and poorly for TAAs (0.62) and TAAAs (0.54). For carotid, infrainguinal, and suprainguinal procedures, procedure complexity (RAI-PC) had little impact on model discrimination for mortality, did improve discrimination for AAAs (0.84), TAAs (0.73), and TAAAs (0.80). Although the RAI model was not a good predictor for major complications or LOS, discrimination improved for both with the RAI-PC model. CONCLUSIONS: Frailty as measured by the RAI was a good predictor of mortality overall after vascular surgery procedures. Although the RAI was not a strong predictor of major complications or prolonged LOS, the models improved with the addition of procedure characteristics like procedure category and approach.

Recalibration and External Validation of the Risk Analysis Index: A Surgical Frailty Assessment Tool.

OBJECTIVE AND BACKGROUND: The Risk Analysis Index (RAI) predicts 30-, 180-, and 365-day mortality based on variables constitutive of frailty. Initially validated, in a single-center Veteran hospital, we sought to improve model performance by recalibrating the RAI in a large, veteran surgical registry, and to externally validate it in both a national surgical registry and a cohort of surgical patients for whom RAI was measured prospectively before surgery. METHODS: The RAI was recalibrated among development and confirmation samples within the Veterans Affairs Surgical Quality Improvement Program (VASQIP; 2010-2014; N = 480,731) including major, elective noncardiac surgery patients to create the revised RAI (RAI-rev), comparing discrimination and calibration. The model was tested externally in the American College of Surgeons National Surgical Quality Improvement Program dataset (NSQIP; 2005-2014; N = 1,391,785), and in a prospectively collected cohort from the Nebraska Western Iowa Health Care System VA (NWIHCS; N = 6,856). RESULTS: Recalibrating the RAI significantly improved discrimination for 30-day [c = 0.84-0.86], 180-day [c = 0.81-0.84], and 365-day mortality [c = 0.78-0.82] (P < 0.001 for all) in VASQIP. The RAI-rev also had markedly better calibration (median absolute difference between observed and predicted 180-day mortality: decreased from 8.45% to 1.23%). RAI-rev was highly predictive of 30-day mortality (c = 0.87) in external validation with excellent calibration (median absolute difference between observed and predicted 30-day mortality: 0.6%). The discrimination was highly robust in men (c = 0.85) and women (c = 0.89). Discrimination also improved in the prospectively measured cohort from NWIHCS for 180-day mortality [c = 0.77 to 0.80] (P < 0.001). CONCLUSIONS: The RAI-rev has improved discrimination and calibration as a frailty-screening tool in surgical patients. It has robust external validity in men and women across a wide range of surgical settings and available for immediate implementation for risk assessment and counseling in preoperative patients.

Variation in center-level frailty burden and the impact of frailty on long-term survival in patients undergoing elective repair for abdominal aortic aneurysms.

OBJECTIVE: Frailty is increasingly recognized as a key determinant in predicting postoperative outcomes. Centers that see more frail patients may not be captured in risk adjustment, potentially accounting for poorer outcomes in hospital comparisons. We aimed to (1) determine the effect of frailty on long-term mortality in patients undergoing elective abdominal aortic aneurysm (AAA) repair and (2) evaluate the variability in frailty burden among centers in the Vascular Quality Initiative (VQI) database. METHODS: Patients undergoing elective open and endovascular AAA repair (2003-2017) were identified, and those with complete data on component variables of the VQI-derived Risk Analysis Index (VQI-RAI) and centers with ≥10 AAA repairs were included. VQI-RAI characteristics are sex, age, body mass index, renal failure, congestive heart failure, dyspnea, preoperative ambulation, and functional status. Frailty was defined as VQI-RAI ≥35 based on prior work in surgical patients using other quality improvement databases. This corresponds to the top 12% of patients at risk in the VQI. Center-level VQI-RAI differences were assessed by analysis of variance test. Relationships between frailty and survival were compared by Kaplan-Meier analysis and the log-rank test for open and endovascular procedures. Multivariable hierarchical Cox proportional hazards regression models were calculated with random intercepts for center, controlling for frailty, race, insurance, AAA diameter, procedure type, AAA case mix, and year. RESULTS: A total of 15,803 patients from 185 centers were included. Mean VQI-RAI scores were 27.6 (standard deviation, 5.9; range, 4-56) and varied significantly across centers (F = 2.41, P < .001). The percentage of frail patients per center ranged from 0% to 40.0%. In multivariable analysis, frailty was independently associated with long-term mortality (hazard ratio, 2.88; 95% confidence interval, 2.6-3.2) after accounting for covariates and center-level variance. Open AAA repair was not associated with long-term mortality after adjusting for frailty (hazard ratio, 0.98; 95% confidence interval, 0.86-1.13). There was a statistically significant difference in the percentage of frail patients compared with nonfrail patients who were discharged to a rehabilitation facility or nursing home after both open (40.5% vs 17.8%; P < .0001) and endovascular repair (17.7% vs 4.6%; P < .0001). CONCLUSIONS: There is considerable variability of preoperative frailty among VQI centers performing elective AAA repair. Adjusting for center-level variation, frailty but not procedure type had a significant association with long-term mortality; however, frailty and procedure type were both associated with nonhome discharge. Routine measurement of frailty preoperatively by centers to identify high-risk patients may help mitigate procedural and long-term outcomes and improve shared decision-making regarding AAA repair.

Comparison of Surgeon Assessment to Frailty Measurement in Abdominal Aortic Aneurysm Repair.

BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) allows us to intervene on patients otherwise considered poor candidates for open repair. Despite its importance in determining operative approach, no comparison has been made between the subjective "eyeball test" and an objective measurement of preoperative frailty for EVAR patients. MATERIALS AND METHODS: Patients undergoing elective EVAR were identified in the Vascular Quality Initiative (VQI) database (2003-2017). Patients were classified "unfit" based on a surgeon-reported variable. Frailty was defined using the VQI-derived Risk Analysis Index, which includes sex, age, BMI, renal failure, congestive heart failure, dyspnea, preoperative ambulation, and functional status. The association between fitness and/or frailty and adverse outcomes was determined by logistic regression. RESULTS: A total of 11,694 patients undergoing elective EVAR were included of which only 18.1% were "unfit," whereas 34.6% were "frail" and overall 43.6% "unfit or frail." Patients deemed "unfit" or "frail" had significantly increased odds of mortality, complications, and nonhome discharge (P < 0.001), and both frailty and unfitness generated negative predictive values for these outcomes greater than 93%. In adjusted logistic regression, the addition of objective frailty significantly improved model performance in predicting nonhome discharge (C-statistic 0.65 versus 0.71, P < 0.001) and complications (0.59 versus 0.61, P = 0.01), but similarly predicted mortality (0.74 versus 0.73, P = 0.99). CONCLUSIONS: Preoperative frailty assessment provides a useful objective measure of risk stratification as an adjunct to a physician's clinical intuition. The addition of frailty expands the pool of high-risk patients who are more likely to experience adverse postoperative events after elective EVAR and may benefit from uniquely tailored perioperative interventions.

Race and Socioeconomic Status Independently Affect Risk of Major Amputation in Peripheral Artery Disease.

BACKGROUND: Black race has been shown to be a risk factor for amputation in peripheral artery disease (PAD); however, race has been argued to be a marker for socioeconomic status (SES) rather than true disparity. The aim of this study is to study the impact of race and SES on amputation risk in PAD patients. METHODS AND RESULTS: Patients with incident PAD in the national Veterans Affairs Corporate Data Warehouse were identified from 2003 to 2014 (N=155 647). The exposures were race and SES (measured by median income in residential ZIP codes). The outcome was incident major amputation. Black veterans were significantly more likely to live in low-SES neighborhoods and to present with advanced PAD. Black patients had a higher amputation risk in each SES stratum compared with white patients. In Cox models (adjusting for covariates), black race was associated with a 37% higher amputation risk compared with white race (hazard ratio: 1.37; 95% confidence interval, 1.30-1.45), whereas low SES was independently predictive of increased risk of amputation (hazard ratio: 1.12; 95% confidence interval, 1.06-1.17) and showed no evidence of interaction with race. In predicted amputation risk analysis, black race and low SES continued to be significant risk factors for amputation regardless of PAD presentation. CONCLUSIONS: Black race significantly increases the risk of amputation within the same SES stratum compared with white race and has an independent effect on limb loss after controlling for comorbidities, severity of PAD at presentation, and use of medications.

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.