Earned outcomes correlate with reliability-adjusted surgical mortality after abdominal aortic aneurysm repair and predict future performance.

OBJECTIVE: Cumulative, probability-based metrics are regularly used to measure quality in professional sports, but these methods have not been applied to health care delivery. These techniques have the potential to be particularly useful in describing surgical quality, where case volume is variable and outcomes tend to be dominated by statistical "noise." The established statistical technique used to adjust for differences in case volume is reliability-adjustment, which emphasizes statistical "signal" but has several limitations. We sought to validate a novel measure of surgical quality based on earned outcomes methods (deaths above average [DAA]) against reliability-adjusted mortality rates, using abdominal aortic aneurysm (AAA) repair outcomes to illustrate the measure's performance. METHODS: Earned outcomes methods were used to calculate the outcome of interest for each patient: DAA. Hospital-level DAA was calculated for non-ruptured open AAA repair and endovascular aortic repair (EVAR) in the Vascular Quality Initiative database from 2016 to 2019. DAA for each center is the sum of observed - predicted risk of death for each patient; predicted risk of death was calculated using established multivariable logistic regression modeling. Correlations of DAA with reliability-adjusted mortality rates and procedure volume were determined. Because an accurate quality metric should correlate with future results, outcomes from 2016 to 2017 were used to categorize hospital quality based on: (1) risk-adjusted mortality; (2) risk- and reliability-adjusted mortality; and (3) DAA. The best performing quality metric was determined by comparing the ability of these categories to predict 2018 to 2019 risk-adjusted outcomes. RESULTS: During the study period, 3734 patients underwent open repair (106 hospitals), and 20,680 patients underwent EVAR (183 hospitals). DAA was closely correlated with reliability-adjusted mortality rates for open repair (r = 0.94; P < .001) and EVAR (r = 0.99; P < .001). DAA also correlated with hospital case volume for open repair (r = -.54; P < .001), but not EVAR (r = 0.07; P = .3). In 2016 to 2017, most hospitals had 0% mortality (55% open repair, 57% EVAR), making it impossible to evaluate these hospitals using traditional risk-adjusted mortality rates alone. Further, zero mortality hospitals in 2016 to 2017 did not demonstrate improved outcomes in 2018 to 2019 for open repair (3.8% vs 4.6%; P = .5) or EVAR (0.8% vs 1.0%; P = .2) compared with all other hospitals. In contrast to traditional risk-adjustment, 2016 to 2017 DAA evenly divided centers into quality quartiles that predicted 2018 to 2019 performance with increased mortality rate associated with each decrement in quality quartile (Q1, 3.2%; Q2, 4.0%; Q3, 5.1%; Q4, 6.0%). There was a significantly higher risk of mortality at worst quartile open repair hospitals compared with best quartile hospitals (odds ratio, 2.01; 95% confidence interval, 1.07-3.76; P = .03). Using 2016 to 2019 DAA to define quality, highest quality quartile open repair hospitals had lower median DAA compared with lowest quality quartile hospitals (-1.18 DAA vs +1.32 DAA; P < .001), correlating with lower median reliability-adjusted mortality rates (3.6% vs 5.1%; P < .001). CONCLUSIONS: Adjustment for differences in hospital volume is essential when measuring hospital-level outcomes. Earned outcomes accurately categorize hospital quality and correlate with reliability-adjustment but are easier to calculate and interpret. From 2016 to 2019, highest quality open AAA repair hospitals prevented >40 perioperative deaths compared with the average hospital, and >80 perioperative deaths compared with lowest quality hospitals.

Real-world application of Wound, Ischemia, and foot Infection scores in peripheral arterial disease patients.

OBJECTIVE: The Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system aims to risk stratify patients with chronic limb-threatening ischemia (CLTI), predicting both amputation rates and the need for revascularization. However, real-world use of the system and whether it predicts outcomes accurately after open revascularization and peripheral interventions is unclear. Therefore, we sought to determine the adoption of the WIfI classification system within a contemporary statewide collaborative as well as the impact of patient factor, and WIfI risk assessment on short- and long-term outcomes. METHODS: Using data from a large statewide collaborative, we identified patients with CLTI undergoing open surgical revascularization or peripheral vascular intervention (PVI) between 2016 and 2022. The primary exposure was preoperative clinical WIfI stage. Patients were categorized according to the SVS Lower Extremity Threatened Limb Classification System into clinical WIfI stages 1, 2, 3, or 4. The primary outcomes were 30-day and 1-year amputation and mortality rates. Multivariable logistic regression was performed to estimate the association of WIfI stage on postrevascularization outcomes. RESULTS: In the cohort of 17,417 patients, 83.4% (n = 14,529) had WIfI stage documented. PVIs were performed on 57.6% of patients, and 42.4% underwent an open surgical revascularization. Of the patients, 49.5% were classified as stage 1, 19.3% stage 2, 12.8% stage 3, and 18.3% of patients met stage 4 criteria. Stage 3 and 4 patients had higher rates of diabetes, congestive heart failure, and renal failure, and were less likely to be current or former smokers. One-half of stage 3 patients underwent open surgical revascularization, whereas stage 1 patients were most likely to have received a PVI (64%). As WIfI stage increased from 1 to 4, 1-year mortality increased from 12% to 21% (P < .001), 30-day amputation rates increased from 5% to 38% (P < .001), and 1-year amputation rates increased from 15% to 55% (P < .001). Finally, patients who did not have WIfI scores classified had significantly higher 30-day and 1-year mortality rates, as well as higher 30-day and 1-year amputation rates. CONCLUSIONS: The SVS WIfI clinical stage is significantly associated with 1-year amputation rates in patients with CLTI after lower extremity revascularization. Because nearly 55% of stage 4 patients require a major amputation within 1 year of intervention, this finding study supports use of the WIfI classification system in clinical decision-making for patients with CLTI.

Association of Elective Surgical Volume With State Executive Order Curtailing Elective Surgery in Michigan During the COVID-19 Pandemic.

OBJECTIVE: Our objective was to evaluate changes in elective surgical volume in Michigan while an executive order (EO) was in place curtailing elective surgery during the COVID-19 pandemic. SUMMARY BACKGROUND DATA: Many state governors enacted EOs curtailing elective surgery to protect scare resources and generate hospital capacity for patients with COVID-19. Little is known of the effectiveness of an EO on achieving a sustained reduction in elective surgery. METHODS: This retrospective cohort study of data from a statewide claims-based registry in Michigan includes claims from the largest private payer in the state for a representative set of elective operations on adult patients from February 2 through August 1, 2020. We reported trends in surgical volume over the period the EO was in place. Estimated backlogs in elective surgery were calculated using case counts from the same period in 2019. RESULTS: Hospitals achieved a 91.7% reduction in case volume before the EO was introduced. By the time the order was rescinded, hospitals were already performing elective surgery at 60.1% of pre-pandemic case rates. We estimate that a backlog of 6419 operations was created while the EO was in effect. Had hospitals ceased elective surgery during this period, an additional 18% of patients would have experienced a delay in surgical care. CONCLUSIONS: Both the introduction and removal of Michigan's EO lagged behind the observed ramp-down and ramp-up in elective surgical volume. These data suggest that EOs may not effectively modulate surgical care and could also contribute to unnecessary delays in surgical care.

Direct and Indirect Effects of Race and Socioeconomic Deprivation on Outcomes After Lower Extremity Bypass.

OBJECTIVE: To evaluate the potential pathway, through which race and socioeconomic status, as measured by the social deprivation index (SDI), affect outcomes after lower extremity bypass chronic limb-threatening ischemia (CLTI), a marker for delayed presentation. BACKGROUND: Racial and socioeconomic disparities persist in outcomes after lower extremity bypass; however, limited studies have evaluated the role of disease severity as a mediator to potentially explain these outcomes using clinical registry data. METHODS: We captured patients who underwent lower extremity bypass using a statewide quality registry from 2015 to 2021. We used mediation analysis to assess the direct effects of race and high values of SDI (fifth quintile) on our outcome measures: 30-day major adverse cardiac event defined by new myocardial infarction, transient ischemic attack/stroke, or death, and 30-day and 1-year surgical site infection (SSI), amputation and bypass graft occlusion. RESULTS: A total of 7077 patients underwent a lower extremity bypass procedure. Black patients had a higher prevalence of CLTI (80.63% vs 66.37%, P < 0.001). In mediation analysis, there were significant indirect effects where Black patients were more likely to present with CLTI, and thus had increased odds of 30-day amputation [odds ratio (OR): 1.11, 95% CI: 1.068-1.153], 1-year amputation (OR: 1.083, 95% CI: 1.045-1.123) and SSI (OR: 1.052, 95% CI: 1.016-1.089). There were significant indirect effects where patients in the fifth quintile for SDI were more likely to present with CLTI and thus had increased odds of 30-day amputation (OR: 1.065, 95% CI: 1.034-1.098) and SSI (OR: 1.026, 95% CI: 1.006-1.046), and 1-year amputation (OR: 1.068, 95% CI: 1.036-1.101) and SSI (OR: 1.026, 95% CI: 1.006-1.046). CONCLUSIONS: Black patients and socioeconomically disadvantaged patients tended to present with a more advanced disease, CLTI, which in mediation analysis was associated with increased odds of amputation and other complications after lower extremity bypass compared with White patients and those that were not socioeconomically disadvantaged.

Characterizing patient-reported claudication treatment goals to support patient-centered treatment selection and measurement strategies.

OBJECTIVE: Patient-reported outcomes (PRO) have been increasingly emphasized for peripheral artery disease (PAD). Patient-defined treatment goals and expectations, however, are poorly understood and might not be achievable or aligned with guidelines or clinical outcomes. We evaluated the patient-reported treatment goals among patients with claudication and the associations between patient characteristics, goals, and PAD-specific PRO scores. METHODS: Patients with a diagnosis of claudication were prospectively recruited. Patient-defined treatment goals and outcomes related to walking distance, duration, and speed were quantified using multiple-choice survey items. Free-text items were used to identify activities other than walking distance, duration, or speed associated with symptoms and treatment goals. The peripheral artery disease quality of life and walking impairment questionnaire instruments were included as PRO. The treatment goal categories were compared with the PRO percentile scores using 95% confidence intervals (CIs), categorical tests, and logistic regression models. Associations between the patient characteristics and PRO were evaluated using linear and ordinal logistic regression models. RESULTS: A total of 150 patients meeting the inclusion criteria were included in the present study. Of these 150 patients, 144 (96%) viewed the entire survey. Their mean age was 70.0 ± 11.3 years, and 32.9% were women. Most of the respondents had self-reported their race as White (n = 135), followed by Black (n = 3), Asian (n = 2), Native American (n = 2), and other/unknown (n = 2). Two participants self-reported Hispanic ethnicity. The primary treatment goals were an increased walking distance or duration without stopping (62.0%), the ability to perform a specific activity or task (23.0%), an increased walking speed (8.0%), or other/none of the above (7.0%). The specific activities associated with symptoms or goals included outdoor recreation (38.5%), labor-related tasks (30.7%), sports (26.9%), climbing stairs (23.1%), uphill walking (19.2%), and shopping (6%). Among the patients choosing an increased walking distance and duration as the primary goals, 64% had indicated that a distance of ≥0.5 mile (2640 ft) and 59% had indicated a duration of ≥30 minutes would be a minimum increase consistent with meaningful improvement. Increasing age was associated with lower odds of a distance improvement goal of ≥0.5 mile (odds ratio [OR], 0.68 per 5 years; 95% CI, 0.51-0.92; P = .012) or duration improvement goal of ≥30 minutes (OR, 0.76 per 5 years; 95% CI, 0.58-0.99; P = .047). Patient characteristics associated with PAD Quality of Life percentile scores included age, ankle brachial index, and gender. Ankle brachial index was the only patient characteristic associated with the walking impairment questionnaire percentile scores. CONCLUSIONS: Patients define treatment goals according to their desired activities and expectations, which may influence their goals and perceived outcomes. Patients' expectations of minimum increases in walking distance and duration consistent with meaningful improvement exceeded reported minimum important difference criteria for many patients and would not be captured using common clinic-based walking tests. Patient age was associated with both treatment goals and PRO scores, and the related floor and ceiling effects could influence sensitivity to PRO changes for younger and older patients, respectively. Heterogeneity in treatment goals supports consideration of tailored decision-making and outcomes informed by patient characteristics and perspectives.

Impact of Cannabis Use on Outcomes after Lower Extremity Bypass.

BACKGROUND: Cannabis is one of the most commonly used substances in the United States, with national use on the rise. However, there is a paucity of data regarding the effects of cannabis and surgical outcomes. The aim of this study was to assess the association of cannabis use on postoperative outcomes after lower extremity bypass. METHODS: We queried a large statewide registry from 2014 to 2021 to assess patients who underwent lower extremity bypass procedures. Data were gathered regarding cannabis use and the association with postoperative outcomes at 30 days and 1 year. RESULTS: A total of 11,013 patients were identified. Ninety-one percent of patients (10,024) reported no cannabis use, whereas 9.0% (989) reported cannabis use in the past month. Compared with noncannabis users, patients using cannabis had higher opioid use at discharge (odds ratio [OR]: 1.56, 95% confidence interval [CI]: 1.28-1.90), decreased bypass patency at 30 days (OR: 0.52, 95% CI: 0.36-0.78) and 1 year (OR: 0.64, 95% CI 0.47-0.86), and an increased amputation rate at 1 year (OR: 1.25, 95% CI: 1.02-1.52) after lower extremity bypass. CONCLUSIONS: This study shows that cannabis use in vascular surgical patients was associated with decreased graft patency, increased amputation, and increased opioid use after lower extremity bypass procedures. Although future studies are needed, the present study provides novel data that can be used to counsel patients undergoing vascular surgery.

A Novel Preoperative Risk Assessment Tool to Identify Patients at Risk of Contrast-Associated Acute Kidney Injury After Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Contrast-associated acute kidney injury (CA-AKI) after endovascular abdominal aortic aneurysm repair (EVAR) is associated with mortality and morbidity. Risk stratification remains a vital component of preoperative evaluation. We sought to generate and validate a preprocedure CA-AKI risk stratification tool for elective EVAR patients. METHODS: We queried the Blue Cross Blue Shield of Michigan Cardiovascular Consortium database for elective EVAR patients and excluded those on dialysis, with a history of renal transplant, death during procedure, and without creatinine measures. Association with CA-AKI (rise in creatinine > 0.5 mg/dL) was tested using mixed-effects logistic regression. Variables associated with CA-AKI were used to generate a predictive model via a single classification tree. The variables selected by the classification tree were then validated by fitting a mixed-effects logistic regression model into the Vascular Quality Initiative dataset. RESULTS: Our derivation cohort included 7,043 patients, 3.5% of whom developed CA-AKI. After multivariate analysis, age (odds ratio [OR] 1.021, 95% confidence interval [CI] 1.004-1.040), female sex (OR 1.393, CI 1.012-1.916), glomerular filtration rate (GFR) < 30 mL/min (OR 5.068, CI 3.255-7.891), current smoking (OR 1.942, CI 1.067-3.535), chronic obstructive pulmonary disease (OR 1.402, CI 1.066-1.843), maximum abdominal aortic aneurysm (AAA) diameter (OR 1.018, CI 1.006-1.029), and presence of iliac artery aneurysm (OR 1.352, CI 1.007-1.816) were associated with increased odds of CA-AKI. Our risk prediction calculator demonstrated that patients with a GFR < 30 mL/min, females, and patients with a maximum AAA diameter of > 6.9 cm are at a higher risk of CA-AKI after EVAR. Using the Vascular Quality Initiative dataset (N = 62,986), we found that GFR < 30 mL/min (OR 4.668, CI 4.007-5.85), female sex (OR 1.352, CI 1.213-1.507), and maximum AAA diameter > 6.9 cm (OR 1.824, CI 1.212-1.506) were associated with an increased risk of CA-AKI after EVAR. CONCLUSIONS: Herein, we present a simple and novel risk assessment tool that can be used preoperatively to identify patients at risk of CA-AKI after EVAR. Patients with a GFR < 30 mL/min, maximum AAA diameter > 6.9 cm, and females who are undergoing EVAR may be at risk for CA-AKI after EVAR. Prospective studies are needed to determine the efficacy of our model.

Assessment of Determinants of Value in Carotid Endarterectomy.

BACKGROUND: Over 150,000 carotid endarterectomies (CEA) are performed annually worldwide, accounting for $900 million in the United States alone. How cost/spending and quality are related is not well understood but remain essential components in maximizing value. We sought to identify determinants of variability in hospital 90-day episode value for CEA. METHODS: Medicare and private-payer admissions for CEA from January 2, 2014 to August 28, 2020 were linked to retrospective clinical registry data for hospitals in Michigan performing vascular surgery. Hospital-specific, risk-adjusted, 30-day composite complications (defined as reoperation, new neurologic deficit, myocardial infarction, additional procedure including CEA or carotid artery stenting, readmission, or mortality) and 30-day risk-adjusted, price-standardized total episode payments were used to categorize hospitals into low or high value by defining the intersection between complications and spending. RESULTS: A total of 6,595 patients across 39 hospitals were identified across both datasets. Patients at low-value hospitals had a higher rate of 30-day composite complications (17.9% vs. 10.1%, P < 0.001) driven by a significantly higher rate of reoperation (3.0% vs. 1.4%, P = 0.016), readmission (10.7% vs. 6.2%, P = 0.012), new neurologic deficit (4.6% vs. 2.3%, P = 0.017), and mortality (1.6% vs. 0.6%, P < 0.049). Mean total episode payments were $19,635 at low-value hospitals compared to $15,709 at high-value hospitals driven by index hospitalization ($10,800 vs. $9,587, P = 0.002), professional ($3,421 vs. $2,827, P < 0.001), readmission ($3,011 vs. $1,826, P < 0.001), and post-acute care payments ($2,335 vs. $1,486, P < 0.001). Findings were similar when only including patients who did not suffer a complication. CONCLUSIONS: There is tremendous variation in both quality and payments across hospitals included for CEA. Importantly, costs were higher at low-value hospitals independent of postoperative complication. There appears to be little to no relationship between total episode spending and surgical quality, suggesting that improvements in value may be possible by decreasing total episode cost without affecting surgical outcomes.

Low to Moderate Risk Non-orthopedic Surgical Patients Do Not Benefit From VTE Chemoprophylaxis.

This retrospective cohort study analyzes venous thromboembolism (VTE) incidence, morbidity, and mortality amongst postsurgical patients with and without VTE chemoprophylaxis within a quality collaborative. Postoperative thromboprophylaxis was broadly applied, yet was associated with no decrease in VTE, without affecting transfusion or mortality. Predictors of breakthrough VTE development despite evidence-based thromboprophylaxis are identified. OBJECTIVE: We hypothesized that a high rate of prescription of VTE chemoprophylaxis would be associated with decreased VTE incidence and mortality. SUMMARY BACKGROUND DATA: Recommendations for VTE prevention in surgical patients include chemoprophylaxis based upon preoperative risk stratification. METHODS: This retrospective cohort study analyzed VTE incidence, morbidity, and mortality amongst postsurgical patients with and without VTE chemoprophylaxis between April 2013 and September 2017 from 63 hospitals within the Michigan Surgical Quality Collaborative. A VTE risk assessment survey was distributed to providers. Bivariate and multivariate comparisons were made, as well as using propensity score matched cohorts to determine if VTE chemoprophylaxis was associated with decreased VTE events. Hospitals were compared using risk-reliability adjusted VTE prophylaxis and postoperative VTE event rates. RESULTS: Within the registry, 80% of practitioners reported performing formal VTE risk assessment. Amongst 32,856 operations, there were 480 (1.46%) postoperative VTE, and an overall mortality of 609 (1.85%) patients. Using a propensity matched cohort, we found that rates of VTE were similar in those receiving unfractionated heparin or low molecular weight heparin compared to those not receiving chemoprophylaxis (1.22 vs 1.13%, P = 0.57). When stratified further by VTE risk scoring, even the highest risk patients did not have an associated lower VTE rate (3.68 vs 4.22% P = 0.092). Postoperative transfusion (8.28 vs 7.50%, P = 0.057) and mortality (2.00% vs 1.62%, P = 0.064) rates were similar amongst those receiving and those not receiving chemoprophylaxis. No correlation was found between postoperative VTE chemoprophylaxis application and hospital specific risk adjusted postoperative VTE rates. CONCLUSIONS: In modern day postsurgical care, VTE remains a significant occurrence, despite wide adoption of VTE risk assessment. Although postoperative VTE chemoprophylaxis was broadly applied, after adjusting for confounders, no reduction in VTE was observed in at-risk surgical patients.

Reliability of hospital-level mortality in abdominal aortic aneurysm repair.

OBJECTIVE: The relationship between volume and surgical outcomes has been shown for a variety of surgical procedures. The effects in abdominal aortic aneurysm repair have continued to be debated. Reliability adjustment has been used as a method to remove statistical noise from hospital-level outcomes. However, its impact on aortic aneurysm repair is not well understood. METHODS: We used prospectively collected data from the Vascular Quality Initiative to identify all patients who had undergone abdominal aortic aneurysm repair from 2003 to 2019. We first calculated the hospital-level risk-adjusted 30-day mortality rates. We subsequently used hierarchical logistic regression modeling to adjust for measurement reliability using empirical Bayes techniques. The effect of volume on risk- and reliability-adjusted mortality rates was then assessed using linear regression. RESULTS: Between 2003 and 2019, 67,073 abdominal aortic aneurysms were repaired, of which 11,601 (17.3%) were repaired with an open approach. The median annual volume was 7.4 (interquartile range, 3.0-13.3) for open repairs and 35.4 (interquartile range, 18.8-59.8) for endovascular repairs. Of the 223 hospitals that had performed open repairs during the study period, only 11 (4.9%) had performed ≥15 open repairs annually, and the risk-adjusted mortality rates varied from 0% to 75% across all centers. After reliability adjustment, the variability of the risk-adjusted mortality rates had decreased significantly to 1.3% to 8.2%. The endovascular repair risk-adjusted mortality rate variability had decreased from 0% to 14.3% to 0.3% to 2.8% after reliability adjustment. A decreasing trend in mortality was found with increasing an annual case volume for open repair with each additional annual case associated with a 0.012% decrease in mortality (P = .05); however, the relationship was not significant for endovascular repair (P = .793). CONCLUSIONS: We found that most hospitals do not perform a sufficient number of annual cases to generate a reliable center-specific mortality rate for open aneurysm repair. Center-specific mortality rates for low-volume centers should be viewed with caution, because a substantial proportion of the variation for these outcomes will be statistical noise rather than true center-level differences in the quality of care.

A statewide quality improvement collaborative significantly improves quality metric adherence and physician engagement in vascular surgery.

BACKGROUND: Quality improvement national registries provide structured, clinically relevant outcome and process-of-care data to practitioners-with regional meetings to disseminate best practices. However, whether a quality improvement collaborative affects processes of care is less clear. We examined the effects of a statewide hospital collaborative on the adherence rates to best practice guidelines in vascular surgery. METHODS: A large statewide retrospective quality improvement database was reviewed for 2013 to 2019. Hospitals participating in the quality improvement collaborative were required to submit adherence and outcomes data and meet semiannually. They received an incentive through a pay for participation model. The aggregate adherence rates among all hospitals were calculated and compared. RESULTS: A total of 39 hospitals participated in the collaborative, with attendance of surgeon champions at face-to-face meetings of >85%. Statewide, the hospital systems improved every year of participation in the collaborative across most "best practice" domains, including adherence to preoperative skin preparation recommendations (odds ratio [OR], 1.83; 95% confidence interval [CI], 1.76-1.79; P < .001), intraoperative antibiotic redosing (OR, 1.09; 95% CI, 1.02-1.17; P = .018), statin use at discharge for appropriate patients (OR, 1.18; 95% CI, 1.16-1.2; P < .001), and reducing transfusions for asymptomatic patients with hemoglobin >8 mg/dL (OR, 0.66; 95% CI, 0.66-0.66; P < .001). The use of antiplatelet therapy at discharge remained high and did not change significantly during the study period. Teaching hospital and urban or rural status did not affect adherence. The adherence rates exceeded the professional society mean rates for guideline adherence. CONCLUSIONS: The use of a statewide hospital collaborative with incentivized semiannual meetings resulted in significant improvements in adherence to "best practice" guidelines across a large, heterogeneous group of hospitals.

Outcomes of axillofemoral bypass for intermittent claudication.

OBJECTIVE: Although endovascular therapy is often the first-line option for medically refractory intermittent claudication (IC) caused by aortofemoral disease, suprainguinal bypass is often performed. Although this will often be aortofemoral bypass (AoFB), axillofemoral bypass (AxFB) is still sometimes performed despite limited data evaluating its utility in the management of IC. Our goal was to assess the safety and durability of AxFB performed for IC. METHODS: The Vascular Quality Initiative (2009-2019) was queried for suprainguinal bypass performed for IC. Univariable and multivariable analyses were used to compare the perioperative and 1-year outcomes between AxFB and a comparison cohort of AoFB. RESULTS: We identified 3261 suprainguinal bypasses performed for IC: 436 AxFBs and 2825 AoFBs. The mean age was 61.4 ± 9.1 years, 58.8% of the patients were men, and 59.7% currently smoked. Patients undergoing AxFB, compared with AoFB, were more often older, male, never smokers and ambulated with assistance (P < .001 for all). They had more often had hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, and end-stage renal disease and had more often undergone previous outflow peripheral endovascular interventions and previous inflow or outflow bypass. The AxFBs, compared with the AoFBs, were more often unifemoral (P < .05). Patients who had undergone AxFB, compared with AoFB, had had a shorter postoperative length of stay (median, 4 vs 6 days) and fewer perioperative pulmonary (3% vs 7.9%) and renal (5.5% vs 9.9%) complications but had required more perioperative ipsilateral major amputations (0.9% vs 0.04%; P < .05 for all). No significant differences were found in the incidence of perioperative myocardial infarction (2.8% vs 2.7%), stroke (0.7% vs 1.1%), or death (1.8% vs 1.7%). At 1 year, the Kaplan-Meier analysis demonstrated that the AxFB cohort, compared with the AoFB cohort, had had higher rates of death (7.3% vs 3.6%; P = .002), graft occlusion or death (14.3% vs 7.2%; P = .001), ipsilateral major amputation or death (12.5% vs 5.6%; P < .001), and reintervention, amputation, or death (19% vs 8.6%; P < .001). On multivariable analysis, AxFB was independently associated with an increased risk of 1-year reintervention, amputation, or death (hazard ratio, 1.6; 95% confidence interval, 1.03-2.4; P = .04). CONCLUSIONS: The results from the present retrospective analysis suggest that long-term complications were more frequent in patients who had undergone AxFB compared with AoFB, although patients treated with AxFB had had a greater risk with more comorbidities. Because AxFB was associated with significant perioperative morbidity, mortality, and long-term complications, serious consideration should be given before its use to treat IC.

Contemporary incidence, outcomes, and survival associated with endovascular aortic aneurysm repair conversion to open repair among Medicare beneficiaries.

OBJECTIVE: The widespread application of endovascular abdominal aortic aneurysm repair (EVAR) has ushered in an era of requisite postoperative surveillance and the potential need for reintervention. The national prevalence and results of EVAR conversion to open repair, however, remain poorly defined. The purpose of this analysis was to define the incidence of open conversion and its associated outcomes. METHODS: The SVS Vascular Quality Initiative EVAR registry linked to Medicare claims via Vascular Implants Surveillance and Interventional Outcomes Network was queried for open conversions after initial EVAR procedures from 2003 to 2016. Cumulative conversion incidence within up to 5 years after EVAR and outcomes after open intervention were determined. Multivariable logistic regressions were used to identify independent predictors of conversion and mortality. RESULTS: Among 15,937 EVAR patients, 309 (1.9%) underwent an open conversion: 43% (n = 132) early (<30 days) and 57% (n = 177) late (>30 days). The longitudinally observed rate of conversion was constant over time, as well as by geographic region. Independent predictors of conversion included female sex (hazard ratio [HR], 1.49; P < .001), aneurysm diameter or more than 6.0 cm at the time of index EVAR (HR, 1.74; P < .001), nonelective repair (compared with elective presentation: HR, 1.72; P < .001), and aortouni-iliac repairs (HR, 2.19; P < .001). In contrast, adjunctive operative procedures such as endo-anchors or cuff extensions (HR, 0.62; P = .06) were protective against long-term conversion. Both early (HR, 1.6; P < .001) and late (HR, 1.26; P = .07) open conversions were associated with significant 30-day (total cohort, 15%) and 1-year mortality (total cohort, 25%). Patients undergoing open conversion experienced high rates of 30-day readmission (42%) and cardiac (45%), renal (32%), and pulmonary (30%) complications. CONCLUSIONS: This large, registry-based analysis is among the first to document the incidence and outcomes for open conversion after EVAR in a national cohort with long-term follow-up. Importantly, women, patients with large aneurysms, and complex anatomy, as well as urgent or emergent EVARs are at an increased risk for open conversion. It seems that more conversions are performed in the early postoperative period, despite perceptions that conversion is a delayed phenomenon. In all instances, conversion is associated with significant morbidity and mortality and highlights the importance of appropriate patient selection at the time of index EVAR.

Society for Vascular Surgery appropriate use criteria for management of intermittent claudication.

The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Endovascular surgery is not protective against new persistent opioid use development compared to open vascular surgery.

OBJECTIVE: Endovascular techniques continue to be increasingly utilized to treat vascular disease, but the effect of these minimally invasive techniques on opioid use following surgery is not known. METHODS: Using Medicare data, we identified opioid-naive patients undergoing vascular procedures between 2009 and 2017. We selected patients ≥65 years old with continuous enrollment 12 months before and 6 months after surgery and had no additional operations. We defined new persistent opioid use (NPOU) as one or more opioid prescription fills both between 4-90 and 91-180 days postoperatively. Multivariable regression was performed for risk adjustment, and frequencies of NPOU were estimated between endovascular and open techniques to compare surgical approach. RESULTS: A total of 77,767 patients were identified, with 2.6% of all patients developing new persistent use. In addition to the identification of several risk factors for new persistent use, patients undergoing endovascular carotid or vertebral interventions were found to have higher adjusted frequencies of persistent use compared to those undergoing open interventions (3.0% vs. 1.8%, p < 0.001) as did those undergoing endovenous compared to open vein procedures (2.2%, vs. 1.6%, p = 0.019). We found no difference for peripheral vascular or aortic/iliac procedures. CONCLUSIONS: Patients undergoing vascular surgery are at high risk for new persistent use. Undergoing endovascular carotid or venous surgery was associated with an increased risk of NPOU, whereas no differences were found between endovascular and open approaches for peripheral arterial or aortic disease.

Non-high-density lipoprotein cholesterol and treatment targets in vascular surgery patients.

INTRODUCTION: Low-density lipoprotein cholesterol (LDL) is a known contributing factor to atherosclerotic cardiovascular disease (ASCVD) and a primary therapeutic target for medical management of ASCVD. Non-high-density lipoprotein cholesterol (non-HDL) has recently been identified as a secondary therapeutic target but is not yet widely used in vascular surgery patients. We sought to assess if vascular surgery patients were undertreated per non-HDL therapeutic guidelines. METHODS: This was an observational study that used a single-center database to identify a cohort of adult patients who received care from a vascular surgery provider from 01/2001 to 07/2021. ICD-9/10-CM codes were used to identify patients with a medical history of hyperlipidemia (HLD), coronary artery disease (CAD), cerebrovascular occlusive disease (CVOD), peripheral artery disease (PAD), hypertension (HTN), or diabetes mellitus (DM). Patient smoking status and medications were also identified. Lab values were obtained from the first and last patient encounter within our system. Primary outcomes were serum concentrations of LDL and non-HDL, with therapeutic thresholds defined as 70 mg/dL and 100 mg/dL, respectively. RESULTS: The cohort included 2465 patients. At first encounter, average age was 59.3 years old, 21.4% were on statins, 8.4% were on a high-intensity statin, 25.7% were diagnosed with HLD, 5.2% with CAD, 15.3% with PAD, 26.3% with DM, 18.6% with HTN, and 2.1% with CVOD. At final encounter, mean age was 64.8 years, 23.5% were on statins with 10.1% on high-intensity statin. Diagnoses frequency did not change at final encounter. At first encounter, nearly two-thirds of patients were not at an LDL <70 mg/dL (62.3%) or non-HDL <100 mg/dL (66.0%) with improvement at final encounter to 45.2 and 40.5% of patients not at these LDL or non-HDL treatment thresholds, respectively. Patients on statins exhibited similar trends with 51.1 and 50.1% of patients not at LDL or non-HDL treatment thresholds at first encounter and 39.9 and 35.4% not at LDL or non-HDL treatment thresholds at last encounter. Importantly, 6.9% of patients were at LDL but not non-HDL treatment thresholds. DISCUSSION: Among vascular surgery patients, over half did not meet non-HDL targets. These results suggest that we may be vastly under-performing adequate medical optimization with only about one-fourth of patients on a statin at their final encounter and approximately one-tenth of patients being treated with a high-intensity statin. With recent evidence supporting non-HDL as a valuable measurement for atherosclerotic risk, there is potential to optimize medical management beyond current high-intensity statin therapy. Further investigation is needed regarding the risk of adverse events between patients treated with these varied therapeutic targets.

Modeling the elective vascular surgery recovery after coronavirus disease 2019: Implications for moving forward.

OBJECTIVE: The delays in elective surgery caused by the coronavirus disease 2019 (COVID-19) pandemic have resulted in a substantial backlog of cases. In the present study, we sought to determine the estimated time to recovery for vascular surgery procedures delayed by the COVID-19 pandemic in a regional health system. METHODS: Using data from a 35-hospital regional vascular surgical collaborative consisting of all hospitals performing vascular surgery in the state of Michigan, we estimated the number of delayed surgical cases for adults undergoing carotid endarterectomy, carotid stenting, endovascular and open abdominal aortic aneurysm repair, and lower extremity bypass. We used seasonal autoregressive integrated moving average models to predict the surgical volume in the absence of the COVID-19 pandemic and historical data to predict the elective surgical recovery time. RESULTS: The median statewide monthly vascular surgical volume for the study period was 439 procedures, with a maximum statewide monthly case volume of 519 procedures. For the month of April 2020, the elective vascular surgery procedural volume decreased by ∼90%. Significant variability was seen in the estimated hospital capacity and estimated number of backlogged cases, with the recovery of elective cases estimated to require ∼8 months. If hospitals across the collaborative were to share the burden of backlogged cases, the recovery could be shortened to ∼3 months. CONCLUSIONS: In the present study of vascular surgical volume in a regional health collaborative, elective surgical procedures decreased by 90%, resulting in a backlog of >700 cases. The recovery time if all hospitals in the collaborative were to share the burden of backlogged cases would be reduced from 8 months to 3 months, underscoring the necessity of regional and statewide policies to minimize patient harm by delays in recovery for elective surgery.

Thoracic endovascular aortic repair for symptomatic penetrating aortic ulcers and intramural hematomas is associated with poor outcomes.

BACKGROUND: The natural history of penetrating aortic ulcers (PAUs) and intramural hematomas (IMHs) of the aorta has not been well described. Although repair is warranted for rupture, unremitting chest pain, or growth, no threshold has been established for treating those found incidentally. Thoracic endovascular aortic repair (TEVAR) offers an attractive approach for treating these pathologic entities. However, the periprocedural and postoperative outcomes have not been well defined. METHODS: Patients aged ≥18 years identified in the Vascular Quality Initiative database who had undergone TEVAR for PAUs and/or IMHs from January 2011 to February 2020 were included. We identified 1042 patients, of whom 809 had follow-up data available. The patient demographics and comorbidities were analyzed to identify the risk factors for major adverse events (MAEs) and postoperative and late mortality. RESULTS: The cohort was 54.8% female, and 69.9% were former smokers, with a mean age of 71.1 years. Comorbidities were prevalent, with 57.8% classified as having American Society of Anesthesiologists class 4. Of the 1042 patients, 89.8% had hypertension, 28.3% chronic obstructive pulmonary disease, 17.9% coronary artery disease, and 12.2% congestive heart failure. Patients were predominately symptomatic (74%), and 44.5% had undergone nonelective repair. The MAE incidence was 17%. The independent predictors of MAEs were a history of coronary artery disease, nonwhite race, emergent procedural indication, ruptured presentation, and deployment of two or more endografts. In-hospital mortality was 4.3%. Of the index hospitalization mortalities, 73% were treatment related. For the 809 patients with follow-up (mean, 25.1 ± 19 months), the all-cause mortality was 10.6%. The predictors of late mortality during follow-up included age >70 years, ruptured presentation, and a history of chronic obstructive pulmonary disease and end-stage renal disease. A subset analysis comparing symptomatic (74%) vs asymptomatic (26%) patients demonstrated that the former were frequently women (58.2% vs 45.3%; P < .001), with a greater incidence of MAEs (20.6% vs 6.9%; P < .001), including higher in-hospital reintervention rates (5.9% vs 1.5%; P = .002) and mortality (5.6% vs 0.7%; log-rank P = .015), and a prolonged length of stay (6.9 vs 3.7 days; P < .0001), despite similar procedural risks. During follow-up, late mortality was greater in the symptomatic cohort (12.2% vs 6.5%; log-rank P = .025), with all treatment-related mortalities limited to the symptomatic group. CONCLUSIONS: We found significantly greater morbidity and mortality in symptomatic patients undergoing repair compared with asymptomatic patients, despite similar baseline characteristics. Asymptomatic patients treated with TEVAR had no treatment-related mortality during follow-up, with the overall prognosis largely dependent on preexisting comorbidities. These findings, in conjunction with increasing evidence highlighting the risk of disease progression and attendant morbidity associated with these aortic entities, suggest a need for natural history studies and definitive guidelines on the elective repair of IMHs and PAUs.

Tibial bypass in patients with intermittent claudication is associated with poor outcomes.

OBJECTIVE: Given that intermittent claudication (IC) rarely progresses to chronic limb-threatening ischemia and limb loss, safety and durability of elective interventions for IC are essential. Whether patients with IC benefit from tibial intervention is controversial, and data supporting its utility are limited. Despite endovascular therapy expansion, surgical bypass is still commonly performed. We sought to assess outcomes of bypass to tibial arteries for IC. METHODS: The Vascular Quality Initiative (2003-2018) was queried for infrainguinal bypasses performed for IC. Perioperative and 1-year outcomes were compared between bypasses constructed to tibial and popliteal arteries. RESULTS: Of 5347 infrainguinal bypasses, 1173 (22%) and 4184 (78%) were tibial and popliteal bypasses, respectively. Overall, mean age was 65 ± 10 years, and patients were often men (72%) and current smokers (42%). Tibial bypasses commonly targeted posterior tibial (40%), tibioperoneal trunk (23%), and anterior tibial (19%) arteries. Great saphenous vein was more often used for tibial bypass than for popliteal bypass (78% vs 54%; P < .001). Patients undergoing tibial compared with popliteal bypass more often had impaired ambulation and prior ipsilateral bypasses and were less often taking antiplatelets and statins (all P < .05). In the perioperative period, tibial bypass patients had longer postoperative length of stay (4.5 ± 3.5 vs 3.5 ± 2.8 days), more pulmonary complications (1.3% vs 0.6%), and higher return to the operating room (7% vs 4%; all P < .05). Perioperative myocardial infarction (1.2% vs 0.8%; P = .19), stroke (0.4% vs 0.4%; P = .91), and mortality (0.3 vs 0.3%; P = .86) rates were similar between the cohorts. At 1 year, tibial compared with popliteal bypasses exhibited lower freedom from occlusion/death (81% vs 89%; P < .001), ipsilateral major amputation/death (90% vs 94%; P < .001), and reintervention/amputation/death (73% vs 80%; P < .001), but patient survival was similar (96% vs 97%; P = .07). On multivariable analysis, tibial compared with popliteal bypass was independently associated with increased occlusion/death (hazard ratio [HR], 1.65; 95% confidence interval [CI], 1.28-2.11; P < .001), major ipsilateral amputation/death (HR, 1.6; 95% CI, 1.12-2.19; P = .003), and ipsilateral reintervention/amputation/death (HR, 1.51; 95% CI, 1.28-1.79; P < .001), with similar patient survival. CONCLUSIONS: In patients with IC, tibial bypass was associated with poor outcomes, including major amputation. Surgeons should exhaust nonoperative therapies and present realistic outcome expectations to their patients before offering such intervention.

Fenestrated repair improves perioperative outcomes but lacks a hospital volume association for complex abdominal aortic aneurysms.

BACKGROUND: Complex abdominal aortic aneurysms (AAAs) have traditionally been treated with an open surgical repair (OSR). During the past decade, fenestrated endovascular aneurysm repair (FEVAR) has emerged as a viable option. Hospital procedural volume to outcome relationship for OSR of complex AAAs has been well established, but the impact of procedural volume on FEVAR outcomes remains undefined. This study investigated the outcomes of OSR and FEVAR for the treatment of complex AAAs and examined the hospital volume-outcome relationship for these procedures. METHODS: A retrospective review of a statewide vascular surgery registry was queried for all patients between 2012 and 2018 who underwent elective repair of a juxtarenal/pararenal AAA with FEVAR or OSR. The primary outcomes were 30-day mortality, myocardial infarction, and new dialysis. Secondary end points included postoperative pneumonia, renal dysfunction (creatine concentration increase of >2 mg/dL from preoperative baseline), major bleeding, early procedural complications, length of stay, and need for reintervention. To evaluate procedural volume-outcomes relationship, hospitals were stratified into low- and high-volume aortic centers based on a FEVAR annual procedural volume. To account for baseline differences, we calculated propensity scores and employed inverse probability of treatment weighting in comparing outcomes between treatment groups. RESULTS: A total of 589 patients underwent FEVAR (n = 186) or OSR (n = 403) for a complex AAA. After adjustment, OSR was associated with higher rates of 30-day mortality (10.7% vs 2.9%; P < .001) and need for dialysis (11.3% vs 1.8; P < .001). Postoperative pneumonia (6.8% vs 0.3%; P < .001) and need for transfusion (39.4% vs 10.4%; P < .001) were also significantly higher in the OSR cohort. The median length of stay for OSR and FEVAR was 9 days and 3 days, respectively. For those who underwent FEVAR, endoleaks were present in 12.1% of patients at 30 days and 6.1% of patients at 1 year, with the majority being type II. With a median follow-up period of 331 days (229-378 days), 1% of FEVAR patients required a secondary procedure, and there were no FEVAR conversions to an open aortic repair. Hospitals were divided into low- and high-volume aortic centers based on their annual FEVAR volume of complex AAAs. After adjustment, hospital FEVAR procedural volume was not associated with 30-day mortality or myocardial infarction. CONCLUSIONS: FEVAR was associated with lower perioperative morbidity and mortality compared with OSR for the management of complex AAAs. Procedural FEVAR volume outcome analysis suggests limited differences in 30-day morbidity, although long-term durability warrants further research.