2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

The association between frailty and outcomes following ruptured abdominal aortic aneurysm repair.

OBJECTIVE: Endovascular aortic repair (EVAR) is a less invasive method than the more physiologically stressful open surgical repair (OSR) for patients with anatomically appropriate abdominal aortic aneurysms (AAAs). Early postoperative outcomes are associated with both patients; physiologic reserve and the physiologic stresses of the surgical intervention. Among frail patients with reduced physiologic reserve, the stress of an aortic rupture in combination with the stress of an operative repair are less well tolerated, raising the risk of complications and mortality. This study aims to evaluate the difference in association between frailty and outcomes among patients undergoing minimally invasive EVAR and the physiologically more stressful OSR for ruptured AAAs (rAAAs). METHODS: Our retrospective cohort study included adults undergoing rAAA repair in the Vascular Quality Initiative from 2010 to 2022. The validated Risk Analysis Index (RAI) (robust, ≤20; normal, 21-29; frail, 30-39; very frail, ≥40) quantified frailty. The association between the primary outcome of 1-year mortality and frailty status as well as repair type were compared using multivariable Cox models generating adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs). Interaction terms evaluated the association's moderation. RESULTS: We identified 5806 patients (age, 72 ± 9 years; 77% male; EVAR, 65%; robust, 6%; normal, 48%; frail, 36%; very, frail 10%) with a 53% observed 1-year mortality rate following rAAA repair. OSR (aHR, 1.43; 95% CI, 1.19-1.73) was associated with increased 1-year mortality when compared with EVAR. Increasing frailty status (frail aHR, 1.26; 95% CI, 1.00-1.59; very frail aHR, 1.64; 95% CI, 1.26-2.13) was associated with increased 1-year mortality, which was moderated by repair type (P-interaction < .05). OSR was associated with increased 1-year mortality in normal (aHR, 1.49; 95% CI, 1.20-1.87) and frail (aHR, 1.51; 95% CI, 1.20-1.89), but not among robust (aHR, 0.88; 95% CI, 0.59-1.32) and very frail (aHR, 1.29; 95% CI, 0.97-1.72) patients. CONCLUSIONS: Frailty and OSR were associated with increased adjusted risk of 1-year mortality following rAAA repair. Among normal and frail patients, OSR was associated with an increased adjusted risk of 1-year mortality when compared with EVAR. However, there was no difference between OSR and EVAR among robust patients who can well tolerate the stress of OSR and among very frail patients who are unable to withstand the surgical stress from rAAA regardless of repair type.

Outcomes of Women Undergoing Noncardiac Surgery in Veterans Affairs Compared With Non-Veterans Affairs Care Settings.

Importance: Recent legislation facilitates veterans' ability to receive non-Veterans Affairs (VA) surgical care. Although veterans are predominantly male, the number of women receiving care within the VA has nearly doubled to 10% over the past decade and recent data comparing the surgical care of women in VA and non-VA care settings are lacking. Objective: To compare postoperative outcomes among women treated in VA hospitals vs private-sector hospitals. Design, Setting, and Participants: This coarsened exact-matched cohort study across 9 noncardiac specialties in the Veterans Affairs Surgical Quality Improvement Program (VASQIP) and American College of Surgeons National Surgical Quality Improvement Program (NSQIP) took place from January 1, 2016, to December 31, 2019. Multivariable Poisson models with robust standard errors were used to evaluate the association between VA vs private-sector care settings and 30-day mortality. Hospitals participating in American College of Surgeons NSQIP and VASQIP were included. Data analysis was performed in January 2023. Participants included female patients 18 years old or older. Exposures: Surgical care in VA or private-sector hospitals. Main Outcomes and Measures: Postoperative 30-day mortality and failure to rescue (FTR). Results: Among 1 913 033 procedures analyzed, patients in VASQIP were younger (VASQIP: mean age, 49.8 [SD, 13.0] years; NSQIP: mean age, 55.9 [SD, 16.9] years; P < .001) and although most patients in both groups identified as White, there were significantly more Black women in VASQIP compared with NSQIP (29.6% vs 12.7%; P < .001). The mean risk analysis index score was lower in VASQIP (13.9 [SD, 6.4]) compared with NSQIP (16.3 [SD, 7.8]) (P < .001 for both). Patients in the VA were more likely to have a preoperative acute serious condition (2.4% vs 1.8%: P < .001), but cases in NSQIP were more frequently emergent (6.9% vs 2.6%; P < .001). The 30-day mortality, complications, and FTR were 0.2%, 3.2%, and 0.1% in VASQIP (n = 36 762 procedures) as compared with 0.8%, 5.0%, and 0.5% in NSQIP (n = 1 876 271 procedures), respectively (all P < .001). Among 1 763 540 matched women (n = 36 478 procedures in VASQIP; n = 1 727 062 procedures in NSQIP), these rates were 0.3%, 3.7%, and 0.2% in NSQIP and 0.1%, 3.4%, and 0.1% in VASQIP (all P < .01). Relative to private-sector care, VA surgical care was associated with a lower risk of death (adjusted risk ratio [aRR], 0.41; 95% CI, 0.23-0.76). This finding was robust among women undergoing gynecologic surgery, inpatient surgery, and low-physiologic stress procedures. VA surgical care was also associated with lower risk of FTR (aRR, 0.41; 95% CI, 0.18-0.92) for frail or Black women and inpatient and low-physiologic stress procedures. Conclusions and Relevance: Although women comprise the minority of veterans receiving care within the VA, in this study, VA surgical care for women was associated with half the risk of postoperative death and FTR. The VA appears better equipped to meet the unique surgical needs and risk profiles of veterans, regardless of sex and health policy decisions, including funding, should reflect these important outcome differences.

Preoperative proteinuria is independently associated with mortality after fenestrated endovascular aneurysm repair.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) has become a mainstay in treating complex aortic aneurysms, though baseline patient factors predicting long-term outcomes remain poorly understood. Proteinuria is an early marker for chronic kidney disease and associated with adverse cardiovascular outcomes, but its utility in patients with aortic aneurysms is unknown. We aimed to determine whether preoperative proteinuria impacts long-term survival after FEVAR. METHODS: A single-institution, retrospective review of all elective FEVAR was performed. Preoperative proteinuria was assessed by urinalysis: negative (0-29 mg/dL), 1+ (30-100 mg/dL), 2+ (101-299 mg/dL), and 3+ (≥300 mg/dL). The cohort was stratified by patients with proteinuria (≥30 mg/dL) vs those without (<30 mg/dL). Baseline, perioperative, and long-term outcomes were compared. The primary outcome, all-cause mortality, was evaluated by Kaplan-Meier analysis and independent predictors with Cox proportional hazards modeling. RESULTS: Among 181 patients who underwent standard FEVAR from 2012 to 2022 (mean follow-up 33 months), any proteinuria was noted in 30 patients (16.6%). Patients with proteinuria were more likely to be Black (10.0% vs 1.3%) with a lower estimated glomerular filtration rate (eGFR) (52.7 ± 24.7 vs 67.7 ± 20.5 mL/min/1.73 m2), higher Society for Vascular Surgery comorbidity score (10.9 ± 4.3 vs 8.2 ± 4.7) and calcium channel blocker therapy (50.0% vs 29.1%), and larger maximal aneurysm diameter (67.2 ± 16.9 vs 59.8 ± 9.8 mm) (all P < .05). Thirty-day mortality was higher in the proteinuria group (10.0% vs 1.3%; P = .03). Overall survival at 1 and 5 years was significantly lower for those with proteinuria (71.5% vs 92.3% and 29.5% vs 68.1%; log-rank P < .001). On multivariable analysis, preoperative proteinuria was independently associated with over threefold higher hazard of mortality (hazard ratio [HR]: 3.21, 95% confidence interval [CI]: 1.66-6.20; P < .001), whereas preoperative eGFR was not predictive (HR: 0.99, 95% CI: 0.98-1.01; P = .28). Additional significant predictors included chronic obstructive pulmonary disease (HR: 2.04), older age (HR: 1.05), and larger maximal aneurysm diameter (HR: 1.03; all P < .05). CONCLUSIONS: In our 10-year experience with FEVAR, preoperative proteinuria was observed in 17% of patients and was significantly associated with worse survival. In this cohort, proteinuria was independently associated with all-cause mortality, whereas eGFR was not, suggesting that urinalysis may provide an additional simple metric for risk-stratifying patients before FEVAR.

Comprehensive framework of factors accounting for worse aortic aneurysm outcomes in females: A scoping review.

Sex-based outcome studies have consistently documented worse results for females undergoing care for abdominal aortic aneurysms. This review explores the underlying factors that account for worse outcomes in the females sex. A scoping review of studies reporting sex-based disparities on abdominal aortic aneurysms was performed. The review was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for scoping reviews. Factors that account for worse outcomes in the females sex were identified, grouped into themes, and analyzed. Key findings of each study are reported and a comprehensive framework of these factors is presented. A total of 35 studies were identified as critical in highlighting sex-based disparities in care of patients with aortic aneurysms. We identified the following 10 interrelated themes in the chain of aneurysm care that account for differential outcomes in females: natural history, risk factors, pathobiology, biomechanics, screening, morphology, device design and adherence to instructions for use, technique, trial enrollment, and social determinants. Factors accounting for worse outcomes in the care of females with aortic aneurysms were identified and described. Some factors are immediately actionable, such as screening criteria, whereas device design improvement will require further research and development. This comprehensive framework of factors affecting care of aneurysms in females should serve as a blueprint to develop education, outreach, and future research efforts to improve outcomes in females.

Artificial intelligence in clinical workflow processes in vascular surgery and beyond.

In the past decade, artificial intelligence (AI)-based applications have exploded in health care. In cardiovascular disease, and vascular surgery specifically, AI tools such as machine learning, natural language processing, and deep neural networks have been applied to automatically detect underdiagnosed diseases, such as peripheral artery disease, abdominal aortic aneurysms, and atherosclerotic cardiovascular disease. In addition to disease detection and risk stratification, AI has been used to identify guideline-concordant statin therapy use and reasons for nonuse, which has important implications for population-based cardiovascular disease health. Although many studies highlight the potential applications of AI, few address true clinical workflow implementation of available AI-based tools. Specific examples, such as determination of optimal statin treatment based on individual patient risk factors and enhancement of intraoperative fluoroscopy and ultrasound imaging, demonstrate the potential promise of AI integration into clinical workflow. Many challenges to AI implementation in health care remain, including data interoperability, model bias and generalizability, prospective evaluation, privacy and security, and regulation. Multidisciplinary and multi-institutional collaboration, as well as adopting a framework for integration, will be critical for the successful implementation of AI tools into clinical practice.

A Retrospective Cohort Study to Evaluate Adding Biomarkers to the Risk Analysis Index of Frailty.

INTRODUCTION: The Risk Analysis Index (RAI) is a frailty assessment tool associated with adverse postoperative outcomes including 180 and 365-d mortality. However, the RAI has been criticized for only containing subjective inputs rather than including more objective components such as biomarkers. METHODS: We conducted a retrospective cohort study to assess the benefit of adding common biomarkers to the RAI using the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database. RAI plus body mass index (BMI), creatinine, hematocrit, and albumin were evaluated as individual and composite variables on 180-d postoperative mortality. RESULTS: Among 480,731 noncardiac cases in VASQIP from 2010 to 2014, 324,320 (67%) met our inclusion criteria. Frail patients (RAI ≥30) made up to 13.0% of the sample. RAI demonstrated strong discrimination for 180-d mortality (c = 0.839 [0.836-0.843]). Discrimination significantly improved with the addition of Hematocrit (c = 0.862 [0.859-0.865]) and albumin (c = 0.870 [0.866-0.873]), but not for body mass index (BMI) or creatinine. However, calibration plots demonstrate that the improvement was primarily at high RAI values where the model overpredicts observed mortality. CONCLUSIONS: While RAI's ability to predict the risk of 180-d postoperative mortality improves with the addition of certain biomarkers, this only observed in patients classified as very frail (RAI >49). Because very frail patients have significantly elevated observed and predicted mortality, the improved discrimination is likely of limited clinical utility for a frailty screening tool.

Sex differences in outcomes among adults undergoing abdominal aortic aneurysm repair.

OBJECTIVE: Although the differences in short-term outcomes between male and female patients in abdominal aortic aneurysm (AAA) repair have been well studied, it remains unclear if these sex disparities extend to other long-term adverse outcomes after AAA repair, such as reintervention and late rupture. METHODS: We performed a retrospective cohort study of 13,007 patients who underwent either endovascular (EVAR) or open AAA repair (OAR) between 2003 and 2015 using data from the Vascular Quality Initiative registries. Eligible patients were linked to fee-for-service Medicare claims to identify late outcomes of rupture and aneurysm-specific reintervention. RESULTS: The mean age of our cohort was 76 ± 6.7 years, 22% were female, 94% were White, and 77% underwent EVAR. The 10-year rupture incidence was slightly higher for women at 4.8 per 1000 person-years, vs 3.9 for men, but this difference was not statistically significant after risk adjustment (hazard ratio [HR] = 1.13, 95% confidence interval [CI]: 0.74-1.73). Likewise, we found no sex difference in reintervention rates (5.1 vs 4.8 in women per 1000 person-years) even after risk adjustment (HR = 0.95, 95% CI: 0.83-1.09). Regression models suggest effect modification by repair type for reintervention, where women who underwent index EVAR had a higher risk of reintervention than men (HR = 1.08, 95% CI: 0.93-1.26), whereas women who underwent OAR were at a lower risk of reintervention than men (HR = 0.79, 95% CI: 0.58-1.08); however, neither effect reached statistical significance within each subgroup. In addition, we found that the risk of reintervention for women vs men varied by clinical presentation, where women were less likely to undergo reintervention after an elective or symptomatic AAA repair but were more likely to undergo reintervention after a repair for AAA rupture (HR = 1.70, 95% CI: 1.05-2.75). CONCLUSIONS: Male and female patients who underwent AAA repair had similar rates of reintervention and late aneurysm rupture in the 10 years after their procedure. However, our findings suggest that repair type and clinical presentation may affect the role of sex in clinical outcomes and warrant further exploration in these subgroups.

Simplifying Hospital Quality Comparisons for Vascular Surgery Using Center-Level Frailty Burden Rather Than Comorbidities.

BACKGROUND: Failure to rescue (FtR), or inpatient death following complication, is a publicly reported hospital quality measure. Previous work has demonstrated significant variation in the proportion of frail patients across hospitals. However, frailty is not incorporated into risk-adjustment algorithms for hospital quality comparisons and risk adjustment is made by comorbidity scores. Our aim was to assess the impact of frailty on FtR quality measurement and as a means of risk adjustment. METHODS: Patients undergoing open or endovascular aneurysm repair or lower extremity bypass in the Vascular Quality Initiative (VQI) at centers performing ≥ 25 vascular procedures annually (2003-2019) were included. Multivariable logistic regression evaluated in-hospital death using scaled hierarchical modeling clustering at the center level. Center FtR observed/expected ratios were compared with expected values adjusted for either standard comorbidity profiles or frailty as measured by the VQI Risk Analysis Index. Centers were divided into quartiles using VQI-linked American Hospital Association data to describe the hospital characteristics of centers whose ranks changed. RESULTS: A total of 63,143 patients (213 centers) were included; 1,630 patients (2.58%) were classified as FtR. After accounting for center-level variability, frailty was associated with FtR [scaled odds ratio 1.9 (1.8-2.0), P < 0.001]. The comorbidity-centric and frailty-based models performed similarly in predicting FtR with C-statistics of 0.85 (0.84-0.86) and 0.82 (0.82-0.84), respectively. Overall changes in ranking based on observed/expected ratios were not statistically significant (P = 0.48). High and low performing centers had similar ranking using comorbidity-centric and frailty-based methods; however, centers in the middle of the performance spectrum saw more variability in ranking alterations. Forty nine (23%) of hospitals improved their ranking by five or more positions when using frailty versus comorbidity risk adjustment. The centers in Quartile 4, those who performed the highest number of vascular procedures annually, experience on average a significant improvement in hospital ranking when frailty was used for risk adjustment, whereas centers performing the fewest number of vascular procedures and the lowest proportion of vascular surgery cases annually (Quartile 1) saw a significant worsening of ranking position (all P < 0.05). However, total number of surgical procedures annually, total hospital beds, for-profit status, and teaching hospital status were not significantly associated with changes in rank. CONCLUSIONS: A simple frailty-adjusted model has similar predictive abilities as a comorbidity-focused model for predicting a common quality metric that influences reimbursement. In addition to distilling the risk-adjustment algorithm to a few variables, frailty can be assessed preoperatively to develop quality improvement efforts for rescuing frail patients. Centers treating a greater proportion of frail patients and those who perform higher volumes of vascular surgery benefit from a risk adjustment strategy based on frailty.

Evaluation of Lower Extremity Calcium Score as a Measure of Peripheral Arterial Disease Burden and Amputation Risk.

BACKGROUND: The ankle-brachial pressure index (ABI) and toe-brachial pressure index (TBI) are commonly used diagnostic tools for peripheral artery disease (PAD) that are unreliable in the presence of calcified vessels. In this study, we aimed to demonstrate the utility of the lower extremity calcium score (LECS) in addition to ABI and TBI in measuring disease burden and predicting the risk of amputation in patients with PAD. METHODS: Patients who were evaluated in the vascular surgery clinic at Emory University for PAD and who underwent noncontrast computed tomography of the aorta and lower extremities were included in the study. Aortoiliac, femoral-popliteal, and tibial calcium scores were measured using the Agatston method. ABI and TBI that were obtained within 6 months of the computed tomography scan were noted and divided into categories of PAD severity. Associations between ABI, TBI, and LECS of each anatomic segment were evaluated. Univariate and multivariate ordinal regression analyses were performed to predict the outcome of amputation. Receiver operating characteristic analysis was performed to compare LECS with other variables in its ability to predict amputation. RESULTS: Fifty patients included in the study cohort were divided into LECS quartiles, with 12-13 patients in each quartile. The highest quartile tended to be older (P = 0.016), had a higher percentage of diabetics (P = 0.034), and had a higher frequency of major amputations (P = 0.004) compared to the other quartiles. Patients in the highest quartile of tibial calcium score were more likely to have stage 3 chronic kidney disease (CKD) or greater (P = 0.011) and also had a higher frequency of amputation (P < 0.005) and mortality (P = 0.041). We found no significant association between each anatomic LECS and ABI/TBI categories. On univariate analysis, CKD (Odds Ratio [OR] 12.92 (95% CI 2.01 to 82.83), P = 0.007), diabetes mellitus (OR 5.47 (95% CI 1.27 to 23.64), P = 0.023), tibial calcium score (OR 6.62 (95% CI 1.79 to 24.54), P = 0.005), and total bilateral calcium score (OR 6.32 (95% CI 1.18 to 33.78), P = 0.031) were associated with increased risk of amputation. On multivariate stepwise ordinal regression, TBI and tibial calcium score were identified as important predictors of amputation, with hyperlipidemia and CKD increasing the overall prediction of the model. On Receiver operating characteristic analysis, the addition of the tibial calcium score (area under the curve 0.94, standard error 0.048) significantly improved the prediction of amputation compared to hyperlipidemia, CKD, and TBI alone (area under the curve 0.82, standard error 0.071, P = 0.022). CONCLUSIONS: The addition of tibial calcium score to other known PAD risk factors may improve the prediction of amputation in patients with PAD.

A framework for perioperative care for lower extremity vascular bypasses: A Consensus Statement by the Enhanced Recovery after Surgery (ERAS®) Society and Society for Vascular Surgery.

The Society for Vascular Surgery and the Enhanced Recovery After Surgery (ERAS) Society formally collaborated and elected an international, multi-disciplinary panel of experts to review the literature and provide evidence-based suggestions for coordinated perioperative care for patients undergoing infrainguinal bypass surgery for peripheral artery disease. Structured around the ERAS core elements, 26 suggestions were made and organized into preadmission, preoperative, intraoperative, and postoperative sections.

Racial, ethnic, and socioeconomic inequities in amputation risk for patients with peripheral artery disease and diabetes.

Peripheral artery disease and diabetes are highly prevalent diseases and the leading cause of limb loss. Despite advances in medical and surgical techniques, there are stark differences in delivery and outcomes of lower extremity amputation among populations when stratified by race, ethnicity, and socioeconomic status. We reviewed studies from the last 2 decades (1999-2022) to provide a comprehensive assessment of the current impact of disparities on the risk for, and management of, lower extremity amputation and offer action items that can optimize health outcomes.

Transfusion trigger after operations in high cardiac risk patients (TOP) trial protocol. Protocol for a multicenter randomized controlled transfusion strategy trial.

BACKGROUND: There is substantial uncertainty regarding the effects of restrictive postoperative transfusion among patients who have underlying cardiovascular disease. The TOP Trial's objective is to compare adverse outcomes between liberal and restrictive transfusion strategies in patients undergoing vascular and general surgery operations, and with a high risk of postoperative cardiac events. METHODS: A two-arm, single-blinded, randomized controlled superiority trial will be used across 15 Veterans Affairs hospitals with expected enrollment of 1520 participants. Postoperative transfusions in the liberal arm commence when Hb is <10 g/ dL and continue until Hb is greater than or equal to 10 g/dL. In the restrictive arm, transfusions begin when Hb is <7 g/dL and continue until Hb is greater than or equal to 7 g/dL. Study duration is estimated to be 5 years including a 3-month start-up period and 4 years of recruitment. Each randomized participant will be followed for 90 days after randomization with a mortality assessment at 1 year. RESULTS: The primary outcome is a composite endpoint of all-cause mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or stroke occurring up to 90-days after randomization. Events rates will be compared between restrictive and liberal transfusion groups. CONCLUSIONS: The TOP Trial is uniquely positioned to provide high quality evidence comparing transfusion strategies among patients with high cardiac risk. Results will clarify the effect of postoperative transfusion strategies on adverse outcomes and inform postoperative management algorithms. TRIAL REGISTRATION: http://clinicaltrials.gov identifier: NCT03229941.

A Systematic Review of the Recruitment and Outcome Reporting by Sex and Race/Ethnicity in Stent Device Development Trials for Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Women and racial/ethnic minority groups have been shown to experience poor outcomes after endovascular aortic aneurysm repair (EVAR). One potential reason is the rare inclusion of these populations in initial phases of device development. The objective of this systematic review is to understand enrollment and outcome reporting by sex and race/ethnicity in industry-funded EVAR device development trials. METHODS: MEDLINE, PubMed, and Embase were searched from inception to January 2022 without language restrictions using the following terminology: "stent", "graft", "endograft", "device", and "abdominal aortic aneurysm" (AAA). CLINICALTRIALS: gov was also searched from inception to January 2022 for "AAA." Two independent reviewers screened and extracted data. All phase I-III and postmarket evaluation trials that included patients ≥18 years of age, who underwent EVAR were assessed. Participation-to-prevalence ratios (PPRs) were calculated to estimate representation of participants by sex and race/ethnicity in trials compared with their share of disease burden. RESULTS: Among the 4,780 retrieved articles, 55 industry-funded trials met inclusion criteria for this review. A total of 51 trials (93%) reported enrollment by sex/gender, and only 7 trials (13%) reported enrollment by race/ethnicity of the participants. A median of 19 (interquartile range [IQR]: 4.5, 51) women participants were recruited compared to 171 (IQR: 57, 311.5) men, and 17 (IQR: 7.5, 21.5) racial/minority patients were recruited compared to 241 (IQR: 123, 463.5) White participants. Women represent 16.6% of the disease population, and the median PPR is 0.62 (IQR: 0.42, 0.88), which has remained constant over time (Figure 1). None of the device trials reported outcomes based on sex/gender or race/ethnicity. CONCLUSIONS: This systematic review highlights the disparities in recruitment and outcome reporting based on sex and race/ethnicity in EVAR device development trials. While most trials may be underpowered to study these differences, recent registry studies show differential outcomes based on sex and race/ethnicity of vascular patients. Therefore, it is imperative to include and report outcomes in these participants, starting from the initial device development phases to improve generalizability of device-use and understand sources of variation in device performance.

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.

Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.

Importance: Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair. Objective: To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive. Design, Setting, and Participants: In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021. Interventions: Presurgical consultation using a decision aid vs usual care. Main Outcomes and Measures: The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios. Results: Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70). Conclusions and Relevance: Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT03115346.

Patient Perspectives on Recovery and Information Needs After Surgery: A Qualitative Study of Veterans.

INTRODUCTION: Little is known about patients' postoperative emotional and social functioning and preferences for recovery settings. This qualitative study explores patients' perspectives on factors influencing postoperative recovery, including the proportion of time recovering at home (home time) and unmet information needs. METHODS: Semistructured interviews were conducted between September and December 2020 with veteran patients aged 65 y or older who underwent surgery at a single hospital. A purposeful sampling strategy was used to identify patients with a broad representation of major operations and various amounts of home time. One-hour interviews were audio-recorded, transcribed verbatim, and anonymized for analysis. A rigorous team-based in-depth thematic analysis was performed. Validation techniques to enhance the quality and credibility of the study included triangulation, independent coding, and search for disconfirming evidence. RESULTS: Twelve patients were interviewed (11 [91.7%] males; mean (standard deviation) age, 72.3 [4.8] y). Five factors that influenced the recovery process emerged: (1) professional support services, (2) informal caregiver support, (3) environment for recovery, (4) individual traits, and (5) physical and functional impairments. The analysis also elucidated four unmet information needs regarding recovery: (1) personalized and detailed information, (2) anticipated recovery time, (3) possible complications, and (4) comprehensive information about discharge location options. CONCLUSIONS: The study demonstrated that patients recovering from surgery require wide-ranging levels of support to meet their unique needs and preferences. Patients value easy-to-understand and personalized information about recovery from providers. These findings may be helpful to develop strategies that better support patients in their postoperative recovery and post-acute care transition pathways.