Socioeconomic factors predict successful supervised exercise therapy completion.

OBJECTIVE: Supervised exercise therapy (SET) for patients with intermittent claudication (IC) can lower the risk of progression to chronic limb-threatening ischemia and amputation, while preserving and restoring functional status. Despite supporting evidence, it remains underutilized, and among those who initiate programs, attrition rates are extremely high. We hypothesize that socioeconomic factors may represent significant barriers to SET completion. METHODS: Patients with IC referred to SET at a multi-hospital, single-institution health care system (2018-2022) from a prospectively maintained database were retrospectively analyzed. Our primary endpoint was SET program completion and graduation, defined as completion of 36 sessions. Our secondary endpoints were vascular intervention within 1 year of referral and change in ankle-brachial index (ABI). Baseline demographics were assessed using standard statistical methods. Predictors of SET graduation were analyzed using multivariable logistic regression generating adjusted odds ratios (aORs) with 95% confidence intervals (CIs). Change in ABI was analyzed using t-test between subgroups. Reasons for attrition were tabulated. Patient Health Questionnaire-9 (PHQ-9), metabolic equivalent level, Vascular QOL, Duke Activity Status, and ABI were analyzed using paired t-tests across the entire cohort. RESULTS: Fifty-two patients met inclusion criteria: mean age 67.85 ± 10.69 years, 19 females (36.54%), mean baseline ABI of 0.77 ± 0.16. The co-pays for 100% of patients were fully covered by primary and secondary insurance plans. Twenty-one patients (40.38%) completed SET. On multivariable analysis, residence in a ZIP code with median household income <$47,000 (aOR, 0.10; 95% CI, 0.01-0.76; P = .03) and higher body mass index (aOR, 0.81; 95% CI, 0.67-0.99; P = .04) were significant barriers to SET graduation. There were no differences in ABI change or vascular intervention within 1 year between graduates and non-graduates. Non-graduates reported transportation challenges (25.00%), lack of motivation (20.83%), and illness/functional limitation (20.83%) as primary reasons for SET attrition. Metabolic Equivalent Level (P ≤ .01) and Duke Activity Status scores (P = .04) were significantly greater after participating in a SET program. CONCLUSIONS: Although SET participation improves lower extremity and functionality outcomes, only 40% of referred patients completed therapy in our cohort. Our findings suggest that both socioeconomic and functional factors influence the odds of completing SET programs, indicating a need for holistic pre-referral assessment to facilitate enhanced program accessibility for these populations.

Aortobifemoral bypass vs covered endovascular reconstruction of aortic bifurcation.

BACKGROUND: Covered endovascular reconstruction of aortic bifurcation (CERAB) is increasingly used as a first line-treatment in patients with aortoiliac occlusive disease (AIOD). We sought to compare the outcomes of patients who underwent CERAB compared with the gold standard of aortobifemoral bypass (ABF). METHODS: The Vascular Quality Initiative was queried for patients who underwent ABF or CERAB from 2009 to 2021. Propensity scores were generated using demographics, comorbidities, Rutherford class, and urgency. The two groups were matched using 5-to-1 nearest-neighbor match. Our primary outcomes were 1-year estimates of primary patency, major adverse limb events (MALEs), MALE-free survival, reintervention-free survival, and amputation-free survival. Standard statistical methods were used. RESULTS: A total of 3944 ABF and 281 CERAB cases were identified. Of all patients with AIOD, the proportion of CERAB increased from 0% to 17.9% between 2009 and 2021. Compared with ABF, patients who underwent CERAB were more likely to be older (64.7 vs 60.2; P < .001) and more often had diabetes (40.9% vs 24.1%; P < .001) and end-stage renal disease (1.1% vs 0.3%; P = .03). In the matched analysis (229 CERAB vs 929 ABF), ABF patients had improved MALE-free survival (93.2% [±0.9%] vs 83.2% [±3%]; P < .001) and lower rates of MALE (5.2% [±0.9%] vs 14.1% [±3%]; P < .001), with comparable primary patency rates (98.3% [±0.3%] vs 96.6% [±1%]; P = .6) and amputation-free survival (99.3% [±0.3%] vs 99.4% [±0.6%]; P = .9). Patients in the CERAB group had significantly lower reintervention-free survival (62.5% [±6%] vs 92.9% [±0.9%]; P < .001). Matched analysis also revealed shorter length of stay (1 vs 7 days; P < .001), as well as lower pulmonary (1.2% vs 6.6%; P = .01), renal (1.8% vs 10%; P < .001), and cardiac (1.8% vs 12.8%; P < .001) complications among CERAB patients. CONCLUSIONS: CERAB had lower perioperative morbidity compared with ABF with a similar primary patency 1-year estimates. However, patients who underwent CERAB experienced more major adverse limb events and reinterventions. Although CERAB is an effective treatment for patients with AIOD, further studies are needed to determine the long-term outcomes of CERAB compared with the established durability of ABF and further define the role of CEARB in the treatment of AIOD.

A decade's experience with retrograde open mesenteric stenting for acute mesenteric ischemia.

OBJECTIVE: Retrograde open mesenteric stenting (ROMS) is an alternative to mesenteric bypass in patients with acute mesenteric ischemia (AMI) with variable reported 30-day mortality rates. Large studies evaluating patient outcomes following ROMS are scarce. Our study aims to assess the results of this approach among patients presenting with AMI. METHODS: We reviewed all the patients with AMI who were treated with ROMS (2011-2022). Patient demographics, presentation, operative details, and outcomes were analyzed. Primary end points were in-hospital, 30-day, and 1-year mortality. Kaplan-Meier estimate for 1-year mortality and primary patency loss were generated. Secondary end points included postoperative 30-day complications. RESULTS: Between 2011 and 2022, ROMS was attempted on a total of 42 patients. The median age was 70 ± 15 years and the majority of patients were female. Pain out of proportion to the physical examination was the most common presenting symptom (n = 18, 42.9%) followed by peritonitis (n = 14, 33.4%). All patients underwent preoperative intravenous contrast computed tomography imaging. In situ thrombosis was identified as the etiology of AMI in 36 patients (85.7%). Technical success was achieved in 40 patients (95.2%). Conventional, non-hybrid operating rooms were used for the majority of cases. Revascularization of all 40 patients involved angioplasty and stenting of superior mesenteric artery. A single stent was placed in 35 patients (87.5%) and the reminder had more than one stent. Eighty percent of patients required bowel resection. A second-look laparotomy was required in 34 patients (85.0%). The mean operative time, including both the general surgery and vascular surgery portions of the index procedure, was 192 ± 57 minutes. Sepsis was the most common complication observed within 30 days, occurring in 8 patients (20.0%). In terms of mortality, 13 patients (32.5%) died during their index hospitalization, and 9 died (22.5%) within 30 days. On Kaplan-Meier analysis, the 1-year overall patient survival rate was 58.6%, and the primary patency rate for stents was 51.4%. CONCLUSIONS: ROMS has an excellent technical success rate in management of AMI with lower than traditionally reported mortality rates for AMI. The dual benefits of rapid revascularization and bowel evaluation should make this surgical modality an alternative approach for treatment of AMI.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Carotid Endarterectomy Should Not Be Recommended to End-Stage Kidney Disease Patients with Asymptomatic Carotid Artery Disease.

BACKGROUND: Carotid endarterectomy (CEA) for asymptomatic carotid artery disease is advised for patients with low perioperative stroke risk and life expectancy of 3-5 years. We sought to explore the role of risk stratification and postoperative medical management in identifying appropriate asymptomatic candidates for CEA in the end-stage kidney disease (ESKD) population. METHODS: We identified ESKD patients on dialysis from the United States Renal Data System that underwent CEA (2008-2014) for asymptomatic carotid artery disease. We used the Liu comorbidity index as well as a novel risk prediction model based on Cox proportional hazards model to stratify patients. The primary outcome evaluated was 3-year survival, and Kaplan-Meier methods were used to generate survival estimates. We further conducted a subanalysis of patients with Medicare part D data to determine postoperative usage of the following medications: statins, antiplatelets, and antihypertensives. We evaluated the association of medication utilization and 3-year survival using Kaplan-Meier methods and Cox proportional hazards modeling. RESULTS: We analyzed 1,813 patients meeting inclusion criteria. The population was predominantly older (mean age 70.2 ± 9.1), White (84.8%), and had a high prevalence of cardiovascular comorbidities, such as hypertension (90.7%), diabetes (62.5%), and congestive heart failure (35.4%). Among the entire cohort, 23.0% had a Liu comorbidity index ≤8, 35.0% had index 9-12, and 42.0% had index >12. Increasing Liu comorbidity index was associated with worse survival (P < 0.01); however, even the group with Liu index ≤8 had poor 3-year survival of 58.8% (53.9-63.4). The Cox proportional hazards model identified variables for inclusion in the risk model such as age >80 (adjusted hazard ratio [aHR] = 2.49, 95% confidence interval [CI] [1.87-3.33], P < 0.001), congestive heart failure (aHR = 1.31, 95% CI [1.14-1.51], P < 0.001), and Liu comorbidity index >12(aHR = 1.89, 95% CI [1.56-2.28], P < 0.001). The risk score generated ranged from 0 to 6.5, and patients were divided into 3 groups: score ≤2 (43.4%), 2-4 (41.2%), and >4 (15.4%). Increasing risk score was associated with worse survival (P < 0.01) but even the "low-risk" group had 3-year survival of 58.5% (54.9-61.9). Subanalysis of the 1,249 (68.8% of total) patients with part D data found that statins and calcium channel blocker use was associated with improved survival, although observed rates for patients on drug were still low. CONCLUSIONS: The overall long-term survival of ESKD patients undergoing CEA for asymptomatic carotid artery disease is low. Risk stratification and analysis of postoperative medical management did not identify a subgroup of patients with adequate 3-year survival. Hence, the preventive benefits of CEA are not realized in these patients.

Midterm Outcomes and Predictors of Failure of Lower Extremity Bypass to Para-Malleolar and Pedal Targets.

BACKGROUND: The frequency of distal lower extremity bypass (LEB) for infrapopliteal critical limb threatening ischemia (IP-CLTI) has significantly decreased. Our goal was to analyze the contemporary outcomes and factors associated with failure of LEB to para-malleolar and pedal targets. METHODS: We queried the Vascular Quality Initiative infrainguinal database from 2003 to 2021 to identify LEB to para-malleolar or pedal/plantar targets. Primary outcomes were graft patency, major adverse limb events [vascular reintervention, above ankle amputation] (MALE), and amputation-free survival at 2 years. Standard statistical methods were utilized. RESULTS: We identified 2331 LEB procedures (1,265 anterior tibial at ankle/dorsalis pedis, 783 posterior tibial at ankle, 283 tarsal/plantar). The prevalence of LEB bypasses to distal targets has significantly decreased from 13.37% of all LEB procedures in 2003-3.51% in 2021 (P < 0.001). The majority of cases presented with tissue loss (81.25. Common postoperative complications included major adverse cardiac events (8.9%) and surgical site infections (3.6%). Major amputations occurred in 16.8% of patients at 1 year. Postoperative mortality at 1 year was 10%. On unadjusted Kaplan-Meier survival analysis at 2 years, primary patency was 50.56% ± 3.6%, MALE was 63.49% ± 3.27%, and amputation-free survival was 71.71% ± 0.98%. In adjusted analyses [adjusted for comorbidities, indication, conduit type, urgency, prior vascular interventions, graft inflow vessel (femoral/popliteal), concomitant inflow procedures, surgeon and center volume] conduits other than great saphenous vein (P < 0.001) were associated with loss of primary patency and increased MALE. High center volume (>5 procedures/year) was associated with improved primary patency (P = 0.015), and lower MALE (P = 0.021) at 2 years. CONCLUSIONS: Despite decreased utilization, open surgical bypass to distal targets at the ankle remains a viable option for treatment of IP-CLTI with acceptable patency and amputation-free survival rates at 2 years. Bypasses to distal targets should be performed at high volume centers to optimize graft patency and limb salvage and minimize reinterventions.

A Comparison of Surgical Techniques and Outcomes for Primary Infected Abdominal Aortic Aneurysms.

BACKGROUND: Primary infected abdominal aortic aneurysms (PIAAAs) are associated with high morbidity and mortality. Three repair approaches include open in-situ repair (OIR), extra-anatomic repair (EAR), and endovascular abdominal aortic aneurysm repair (EVAR). This study is one of the largest single-center case series comparing the outcomes of the different surgical approaches for PIAAA. METHODS: This is a retrospective cohort study of all patients treated surgically for PIAAA between 2000 and 2021. PIAAA diagnosis was defined as the presence of an abdominal aortic aneurysm with evidence of infection on clinical presentation, laboratory markers, radiology, or surgically. Patients with prior aortic surgery were excluded from this study. Basic demographics were compared across the 3 surgical groups using standard statistical methods. Our primary outcomes included mortality at 1 and 5 years. Kaplan-Meier curves were generated and compared using log-rank testing. Multivariate Cox proportional hazards models were created to assess determinants of mortality. RESULTS: A total of 43 patients were included in the full cohort. Patients undergoing EVAR more often had diabetes, end-stage renal disease, and coronary artery disease. EVAR was also more often done in patients with a saccular aneurysm rather than fusiform. (93% vs. 70% in EAR and 42% in OIR; P = 0.015). All-cause mortality rates at 1 year were not significantly different between the 3 groups. Survival at 5 years did show a significant benefit of OIR over EVAR and EAR: OIR had an 8% mortality rate with EAR having a 53% rate and EVAR having the highest (72%) mortality rate at 5 years (P = 0.03). Multivariable Cox regression analysis showed that EVAR (aHR 12.1, (95% CI 1.42 to 103.9), P = 0.02) and EAR (aHR 15.1, (95% CI 1.59 to 143.3), P = 0.0.02) had an increased 5-year mortality risk when compared to OIR. CONCLUSIONS: Repair of primary infected aortic aneurysm is associated with high complication and mortality rates regardless of the approach. In our studied sample, OIR offered an improved long-term survival without added benefits in terms of complication rates. In infected AAA, EVAR should be considered bridging stage between the urgent situation and eventual open repair.

Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device.

OBJECTIVE: We have reported the 5-year results of a pivotal prospective, multicenter study conducted in the United States of a specifically designed iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) for endovascular repair of aortoiliac aneurysms and common iliac artery aneurysms. METHODS: A total of 63 patients (98.4% male; mean age, 70 years) with aortoiliac or common iliac artery aneurysms had undergone implantation of a single IBE device and a bifurcated aortoiliac stent graft. Patients with bilateral common iliac artery aneurysms (n = 22; 34.9%) had undergone either staged occlusion or surgical revascularization of the contralateral internal iliac artery before study enrollment. At 5 years, 36 of the 63 patients had completed the final study follow-up examinations, including clinical examinations (n = 35) and computed tomography (n = 32), with the results evaluated by an independent core laboratory and adverse events adjudicated by a clinical events committee. RESULTS: At 5 years, freedom from all-cause mortality was 85.7% and freedom from aneurysm-related mortality was 100%. The nine deaths that had occurred (range, 132-1898 days) were adjudicated as unrelated to the aneurysm or procedure. Primary patency of the internal and external iliac artery IBE limbs was 95.1% and 100%, respectively. No patients had experienced new-onset buttock claudication on the IBE side or self-reported new-onset erectile dysfunction. The common iliac artery diameter on the IBE side was either unchanged or had decreased by ≥5 mm in 30 of the 31 patients (96.8%) with a baseline (1 month) and 5-year (range, 1641-2006 days) computed tomography scan available. Of the 31 evaluable patients, 9 (29.0%) had had an increase of ≥5 mm in the aortic diameter, 5 of whom had had a concurrent type II endoleak. No type I or type III endoleaks or device migration were identified by the core laboratory. Six patients had undergone eight secondary interventions, including five interventions for a type II endoleak. The freedom from secondary intervention was 90.5%. CONCLUSIONS: The 5-year results of our prospective, multicenter study have confirmed the safety, efficacy, and durability of the IBE device for the treatment of aortoiliac and iliac artery aneurysms. The device effectively prevented common iliac artery aneurysm rupture, maintained the patency of the internal iliac artery, and avoided the complications associated with internal iliac artery sacrifice. Although common iliac artery aneurysm enlargement was rare, abdominal aortic enlargement was more common, suggesting that the outcomes of endovascular aneurysm repair might be different for patients with or without associated common iliac artery aneurysms.

COVID-associated acute limb ischemia during the Delta surge and the effect of vaccines.

OBJECTIVE: Hypercoagulability is common in severe acute respiratory syndrome coronavirus 2 and has been associated with arterial thrombosis leading to acute limb ischemia (ALI). Our objective was to determine the outcomes of concurrent coronavirus disease 2019 (COVID-19) infection and ALI, particularly during the Delta variant surge and the impact of vaccination status. METHODS: A retrospective review was performed of patients treated at a single health care system between March 2020 and December 2021 for ALI and recent (<14 days) COVID-19 infection or who developed ALI during hospitalization for the same disease. Patients were grouped by year as well as by pre and post Delta variant emergence in 2021 based on the World Health Organization timeline (January to May vs June to December). Baseline demographics, imaging, interventions, and outcomes were evaluated. A control cohort of all patients with ALI requiring surgical intervention for a 2-year period prior to the pandemic was used for comparison. Primary outcomes were in-hospital mortality and amputation-free survival. Kaplan-Meier survival and Cox proportional hazards analysis were performed. RESULTS: Forty acutely ischemic limbs were identified in 36 patients with COVID-19, the majority during the Delta surge (52.8%) and after the wide availability of vaccines. The rate of COVID-19-associated ALI, although low overall, nearly doubled during the Delta surge (0.37% vs 0.20%; P = .09). Intervention (open or endovascular revascularization vs primary amputation) was performed on 31 limbs in 28 individuals, with the remaining eight treated with systemic anti-coagulation. Postoperative mortality was 48%, and overall mortality was 50%. Major amputation following revascularization was significantly higher with COVID-19 ALI (25% vs 3%; P = .006) compared with the pre-pandemic group. Thirty-day amputation-free survival was significantly lower (log-rank P < .001). COVID-19 infection (adjusted hazard ratio, 6.2; P < .001) and age (hazard ratio, 1.1; P = .006) were associated with 30-day amputation in multivariate analysis. Severity of COVID-19 infection, defined as vasopressor usage, was not associated with post-revascularization amputation. There was a higher incidence of re-thrombosis in the latter half of 2021 with the Delta surge, as reintervention for recurrent ischemia of the same limb was more common than our previous experience (21% vs 0%; P = .55). COVID-19-associated limb ischemia occurred almost exclusively in non-vaccinated patients (92%). CONCLUSIONS: ALI observed with Delta appears more resistant to standard therapy. Unvaccinated status correlated highly with ALI occurrence in the setting of COVID-19 infection. Information of limb loss as a COVID-19 complication among non-vaccinated patients may help to increase compliance.

Midterm Outcomes of Endovascular vs. Medical Therapy for Uncomplicated Type B Aortic Dissection: Meta-Analysis of Reconstructed Time to Event Data.

OBJECTIVE: To evaluate outcomes of thoracic endovascular aortic repair (TEVAR) vs. medical therapy in uncomplicated type B aortic dissections (TBAD). DATA SOURCES: PubMed/MEDLINE, EMBASE, SciELO, LILACS, CENTRAL/CCTR, Google Scholar, and reference lists of relevant articles. REVIEW METHODS: This was a pooled meta-analysis of time to event data extracted from studies published by December 2022 for the following outcomes: all cause mortality, aortic related mortality, and late aortic interventions. Certainty of evidence was evaluated through the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. RESULTS: Ten studies met the eligibility criteria (eight observational; two randomised trials), comprising 17 906 patients (2 332 patients in the TEVAR groups and 15 574 patients in the medical therapy group). Compared with patients who received medical therapy, patients who underwent TEVAR had a statistically significantly lower risk of all cause death (HR 0.79, 95% CI 0.72 - 0.87, p < .001; GRADE certainty: low) and lower risk of aortic related death (HR 0.43, 95% CI 0.30 - 0.62, p < .001; GRADE certainty: low) without statistically significant difference in the risk of late aortic interventions (HR 1.05, 95% CI 0.88 - 1.26, p = .56; GRADE certainty: low). In the subgroup analyses, TEVAR was associated with lower risk of all cause death when randomised controlled trials only were pooled (HR 0.44, 95% CI 0.23 - 0.83, p = .012; GRADE certainty: moderate), younger patients only (HR 0.56, 95% CI 0.47 - 0.67, p < .001; GRADE certainty: low), Western populations only (HR 0.85, 95% CI 0.77 - 0.93, p = .001; GRADE certainty: low) and non-Western populations only (HR 0.47, 95% CI 0.35 - 0.62, p < .001; GRADE certainty: low). For all cause mortality and aortic related mortality, restricted mean survival time was overall 396 days and 398 days longer with TEVAR (p < .001), respectively, which means that TEVAR was associated with lifetime gain. CONCLUSION: TEVAR may be associated with better midterm survival and lower risk of aortic related death in the follow up of patients treated for uncomplicated TBAD compared with medical therapy; however, randomised controlled trials with larger sample sizes and longer follow up are still warranted.

Racial Disparities in Treatment Indications and Outcomes for Limb Ischemia.

BACKGROUND: Studies suggest that the Affordable Care Act (ACA) of 2014 has improved access to vascular care and vascular outcomes among patients suffering from peripheral arterial disease (PAD). We sought to examine the racial disparities that exist in patients with PAD who have undergone lower extremity bypass (LEB) or a peripheral vascular intervention (PVI) using the Vascular Quality initiative (VQI) database. METHODS: The VQI infrainguinal and PVI datasets were queried for patients receiving elective and urgent LEB or PVI between 2016, 2 years after ACA implementation, and in 2021. Patients undergoing interventions urgently/emergently or for aneurysm were excluded. The primary outcome was major adverse limb event (MALE-defined as any vascular reintervention or above-ankle amputation) free survival at 1 year. Standard statistical methods were utilized as appropriate. RESULTS: A total of 17,455 LEB and 87,475 PVIs were included in this analysis. Black persons present at a younger age when compared to non-Hispanic White persons (NHW) and are more likely to have diabetes, hypertension, end-stage renal disease (ESRD), and higher rates of prior amputation. Black persons are more likely to present with chronic limb-threatening ischemia (CLTI) rather than claudication, and in a more urgent setting. Postoperative outcomes show higher rates of major amputations among racial minorities, specifically Black persons for both LEB (1.8% vs. 0.8% P < 0.001) and PVI (20.8% vs. 16.8% P < 0.001). Black persons are at higher risk of 1-year MALE for LEB (36.7% vs. 29.9% P < 0.001) and PVI (31.0% vs. 21.7%; P < 0.001). Even after adjusting for confounding variables, Black persons have a higher risk of 1-year MALE for LEB, with an adjusted hazard ratio (aHR) of 1.15 (95% CI [1.05-1.26], P = 0.003) and PVI (aHR 1.18 95% CI [1.12-1.24], P < 0.001). Other major determinates of 1-year MALE on multivariate Cox regression included CLTI (LEB aHR 1.57 95% CI [1.43-1.72], P < 0.001; PVI aHR 2.29 95% CI [2.20-2.39], P < 0.001) and history of prior amputation (LEB aHR 1.35 95% CI [1.17-1.56], P < 0.001; PVI aHR 1.5 95% CI [1.4-1.6], P < 0.001). CONCLUSIONS: Compared to NHW persons, Black persons present with more advanced vascular disease regardless of the operative indication. Black persons are also at significantly higher risk of 1-year MALE. Despite some advances in more accessible care through the ACA of 2014, our observations suggest that Black persons still have significantly worse outcomes due to variety of variables that need further investigation.

Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials.

BACKGROUND: Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. METHODS: RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30 months after the completion date, the date the final participant was examined, allowing time for publication. RESULTS: Of 108 RCT (n = 37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR = 0.18, (95% CI 0.05-0.71), P = 0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. CONCLUSIONS: Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.

Carotid endarterectomy remains cost-effective for the surgical management of carotid stenosis.

OBJECTIVE: Transcarotid arterial revascularization (TCAR) has gained popularity as an alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS), potentially combining the benefits of a minimally invasive approach with a lower risk of procedural stroke compared with TFCAS. Emerging evidence shows TCAR to have excellent perioperative outcomes. However, the cost-effectiveness of TCAR is not well-understood. METHODS: Incorporating data from Carotid Revascularization Endarterectomy vs Stenting Trial (CREST), the Vascular Quality Initiative Surveillance Project, and local cost data, we compared the cost-effectiveness of these three treatment modalities (TFCAS, CEA, and TCAR) for both symptomatic and asymptomatic carotid stenosis using a Markov state-transition model to quantify lifetime costs in United States dollars and effectiveness in quality-adjusted life-years (QALYs). We accounted for perioperative stroke and myocardial infarction, as well as long-term risks of stroke and restenosis. Based on CREST, we assumed a start age of 69 years and a cost-effectiveness acceptability threshold of $100,000/QALYs gained. Sensitivity analyses were performed. RESULTS: In the base-case scenario, TCAR cost $160,642/QALY gained compared with CEA, greater than the frequently cited $100,000/QALY gained threshold. TFCAS was more expensive and less effective than other strategies, largely due to a greater periprocedural stroke risk. In one-way sensitivity analysis, if TCAR stroke risk was <0.9% (base-case risk, 1.4%), than it was economically favorable compared with CEA at its current procedural cost. Alternatively, if TCAR procedural costs were reduced by approximately $2000 (base-case cost, $15,182), it would also become economically favorable. In a probabilistic sensitivity analysis, varying all parameters simultaneously over distributions, CEA was favored in 80% of model iterations at $100,000/QALY, with TCAR favored in 19%. CONCLUSIONS: At current cost and outcomes, TCAR does not meet a traditional cost-effectiveness threshold to replace CEA as the primary treatment modality for carotid stenosis. TFCAS is the least cost-effective strategy for carotid revascularization. Given these observations, TCAR should be limited to select patients, specifically those at high physiologic and anatomic risk from CEA. However, TCAR can become cost-effective if its cost is reduced. Given the current outcomes and cost, CEA remains the most cost-effective treatment for carotid revascularization.

Hospital-based delays to revascularization increase risk of postoperative mortality and short bowel syndrome in acute mesenteric ischemia.

OBJECTIVE: Acute mesenteric ischemia (AMI) is a surgical emergency for which delays in treatment have been closely associated with high morbidity and mortality. Although the duration of ischemia as a determinant of outcomes for AMI is well known, the objective of this study was to identify hospital-based determinants of delayed revascularization and their effects on postoperative morbidity and mortality in AMI. METHODS: All patients who underwent any surgery for AMI from a multi-center hospital system between 2010 and 2020 were divided into two groups based on timeliness of mesenteric revascularization after presentation. Early revascularization (ER) was defined as having both vascular consultation ≤12 hours of presentation and vascular surgery performed at the patient's initial operation. Delayed revascularization (DR) was defined as having either delays to vascular consultation or vascular surgery. A retrospective review of demographic and postoperative data was performed. The effect of DR on major postoperative outcomes, including 30-day and 2-year mortality, total length of bowel resection, and development of short bowel syndrome, were analyzed. Effects of delayed vascular consultation alone, delayed vascular surgery alone, no revascularization during admission, and admitting service on outcomes were also examined on subgroup analyses. RESULTS: A total of 212 patients were analyzed. Ninety-nine patients received ER, whereas the remaining 113 patients experienced a DR after hospital presentation. Among the DR group, 55 patients (25.9%) had delayed vascular consultation, whereas vascular surgery was deferred until after the initial operation in 37 patients (17.4%). Fifty-one patients (24.0%) were never revascularized during admission. DR was a significant predictor of 30-day (odds ratio [OR], 2.09; 95% confidence interval [CI], 1.4-4.9; P = .03) and 2-year mortality (hazard ratio, 1.55, 95% CI, 1.0-2.3; P = .04). DR was also independently associated with increased bowel resection length (OR, 7.47; P < .01) and postoperative short bowel syndrome (OR, 2.4; P = .03) on multivariate analyses. When examined separately on subgroup analysis, both delayed vascular consultation (OR, 3.38; P = .03) and vascular surgery (OR, 4.31; P < .01) independently increased risk of 30-day mortality. Hospital discharge after AMI without mesenteric revascularization was associated with increased risk of short bowel syndrome (OR, 2.94; P < .01) and late mortality (hazard ratio, 1.60; P = .04). CONCLUSIONS: Delayed vascular consultation and vascular surgery are both significant hospital-based determinants of postoperative mortality and short bowel syndrome in patients with AMI. Timing-based management protocols that emphasize routine evaluation by a vascular surgeon and early, definitive mesenteric revascularization should be established and widely adopted for all patients with clinically suspected AMI at presentation.

Endovascular repair of abdominal and thoracoabdominal aneurysms using chimneys and periscopes is associated with poor outcomes.

OBJECTIVE: Chimneys and periscopes are often used to treat pararenal or thoracoabdominal aneurysms de novo or after failed open or endovascular repair. We sought to describe our institutional experience, given their limited success and questionable long-term outcomes. METHODS: We retrospectively reviewed the electronic records for patients treated with chimneys/periscopes from 1997 through 2020. Baseline characteristics, procedural details, periprocedural complications, reinterventions, and midterm outcomes were collected. RESULTS: Fifty-eight patients (86 vessels) were treated; the median follow-up was 32 months (range, 0.03-104 months). There were 36% (n = 21) juxta-renal, 2% (n = 1) para-visceral, and 21% (n = 12) thoracoabdominal aneurysms, and 41% (n = 24) had pararenal failure of prior endovascular aneurysm repair (n = 17) or open repair (n = 7). Stent configuration for the majority of the 86 vessels (n = 80; 93%) treated were chimney configuration (n = 6 periscopes; 7%). The most common stent graft utilized was Viabahn, and 8.1% (n = 7) were reinforced with a bare metal stent. Although the majority of the cases were elective, 36.2% (n = 21) of the cases were urgent/emergent. At the conclusion of the initial procedure, 16 of 58 patients had an endoleak (gutter, 50% [8/16]; type Ia, 25% [4/16]; and type II, 25% [4/16]). On follow-up, 14 of 58 patients developed one or more endoleaks, with the most common endoleaks being a gutter endoleak (35% [7/20]). Other endoleaks observed included 30% (6/20) type III, 15% (3/20) type Ia, 15% (3/20) type Ib, and 5% (1/20) type II. Eleven of 58 patients underwent interventions for one or more endoleak (gutter, 33% [5/15]; type Ib, 20% [3/15]; type II, 7% [1/15]; and type III, 40% [6/15]). Twelve of 58 patients returned to the operating room for one or more procedures during the index hospitalization (five laparotomies, three dialysis access, three acute limb ischemia, and four chimney/periscope interventions). Ten of 58 patients underwent angioplasty/stenting for chimney/periscope compression or occlusion during the follow-up period. Survival was 61.3% at 1 year by Kaplan-Meier analysis (75% for elective, 37% for urgent/emergent) (aneurysm-related death, 22%). Cox hazard modeling showed that aneurysm diameter (hazard ratio, 1.03; 95% confidence interval, 1.004-1.05; P = .02) and urgent/emergent interventions (hazard ratio, 3.6; 95% confidence interval, 1.33-9.74; P = .01) were predictors of mortality. CONCLUSIONS: Endovascular repair of aortic aneurysms with chimneys/periscopes is associated with poor outcomes, including limited technical success and aneurysm exclusion, as well as high morbidity and mortality, with a high rate of reinterventions both in the immediate postoperative period and on follow-up. They should be used only when other surgical or endovascular options are not possible.

Outcomes of operative and nonoperative management of blunt thoracic aortic injury.

OBJECTIVE: Although the current guidelines for the management of blunt traumatic aortic injury (BTAI) have recommended intervention for grade 2 injuries or higher, a national trend has occurred for aggressive endovascular treatment of low-grade BTAIs. Little is known about the natural history of grade 1 and 2 injuries treated nonoperatively. We hypothesized that most of these low-grade injuries would remain stable with nonoperative management. METHODS: We performed a review of BTAIs at a large referral level 1 trauma center from 2004 to 2020. The injuries were graded using a standard 1 to 4 scale. The outcomes of the nonoperative and thoracic endovascular aortic repair (TEVAR) management strategies were compared, including post-trauma morbidity, mortality, reinterventions, and lesion stability. RESULTS: A total of 176 patients with BTAIs and sufficient imaging studies and follow-up data available were identified during the study period, including 36 with grade 1, 24 with grade 2, 115 with grade 3, and 1 with a grade 4 injury. Of these 176 patients, 112 had undergone TEVAR and 64 had been treated nonoperatively. Most of the patients (90.2%) who had undergone TEVAR had had grade 3 injuries. Nonoperative management was performed for 97.2% of the grade 1 injuries and 62.5% of the grade 2 injuries. Endovascular reintervention after TEVAR was rare (2.7%). The rates of post-trauma morbidity within 30 days (stroke, 3.6% vs 3.1%; myocardial infarction/arrhythmia, 8.9% vs 1.6%; respiratory failure, 31.2% vs 28.1%; acute kidney injury, 9.8% vs 12.5%; urinary tract infection, 2.7% vs 4.8%; gastrointestinal bleeding, 3.6% vs 0.0%; pulmonary embolism, 10.9% vs 4.5%) and 1-year mortality after discharge (1.8% vs 3.1%) were comparable between the operative and nonoperative groups. The median follow-up was 1501 days (interquartile range [IQR], 475.6-2804 days) for the TEVAR group and 1170.5 days (IQR, 317-2173 days) for the nonoperative group. No lesion progression had occurred in the patients with low-grade (grade 1-2) injuries managed nonoperatively. Resolution of grade 1 and 2 injury had occurred in 20% of the patients at 30 days, which had improved to 44% at long-term follow-up. Fourteen patients with grade 3 injuries (12.2% of the grade 3 injuries in our series) were also observed and did not require future intervention. These patients had generally had smaller pseudoaneurysms with minimal periaortic hematoma. None of these 14 patients had experienced progression or rupture during follow-up (median, 454.5 days; IQR, 81-1199 days) using computed tomography. CONCLUSIONS: Nonoperative management of low-grade BTAIs did not result in long-term aortic complications or the need for reintervention. We found that grade 3 injuries with smaller pseudoaneurysms and minimal periaortic hematoma can be safely observed if the patients can be appropriately followed up. Thus, the indications for treatment of select grade 3 injuries merit further consideration.

Contemporary management of acute and chronic mesenteric ischemia: 10-year experience from a multihospital healthcare system.

OBJECTIVE: Endovascular and hybrid methods have been increasingly used to treat mesenteric ischemia. However, the long-term outcomes and risk of symptom recurrence remain unknown. The objective of the present study was to define the predictors of postoperative morbidity, mortality, and patency loss for acute mesenteric ischemia (AMI) and chronic mesenteric ischemia (CMI). METHODS: The inpatient and follow-up records for all patients who had undergone revascularization for AMI and CMI from 2010 to 2020 at a multicenter hospital system were reviewed. Patency and mortality were evaluated with Cox regression, visualized with Kaplan-Meier curves, and compared using log-rank testing. Patency was further evaluated using Fine-Gray regression with death as a competing risk. The postoperative major adverse events (MAE) and 30-day mortality were evaluated with logistic regression. RESULTS: A total of 407 patients were included, 148 with AMI and 259 with CMI. For the AMI group, the 30-day mortality was 31%. Open surgery was associated with lower rates of bowel resection (odds ratio [OR], 0.23; 95% confidence interval [CI], 0.13-0.61). The etiology of AMI also did not change the outcomes (OR, 1.30; 95% CI, 0.77-2.19). Adjusted analyses indicated that a history of diabetes (OR, 2.77; 95% CI, 1.37-5.61) and sepsis on presentation (OR, 2.32; 95% CI, 1.18-4.58) were independently associated with an increased risk of 30-day MAE. In the CMI group, open surgery and chronic kidney disease were associated with a higher incidence of MAE (OR, 3.03; 95% CI, 1.14-8.05; OR, 2.37; 95% CI, 1.31-4.31). In contrast, chronic kidney disease (OR, 3.02; 95% CI, 1.10-8.37) and inpatient status before revascularization (OR, 2.78; 95% CI, 1.01-7.61) were associated with increased 30-day mortality. For the CMI group, the endovascular cohort had experienced greater rates of symptom recurrence (29% vs 13%) with a faster onset (endovascular, 64 days; vs bypass, 338 days). CONCLUSIONS: AMI remains a morbid disease despite the evolving revascularization techniques. An open approach should remain the reference standard because it reduces the likelihood of bowel resection. For CMI, endovascular interventions have improved the postoperative morbidity but have also resulted in early symptom recurrence and reintervention. An endovascular-first approach should be the standard of care for CMI with close surveillance.

Female Gender is a Predictor of Lower Iliac Vein Stenting Patency Rates.

BACKGROUND: Iliac venous stenting (IVS) for thrombotic and nonthrombotic venous disease is increasingly used as evidence of the safety, efficacy and durability of these interventions increases. Female gender has been implicated as a predictor of failure in arterial endovascular interventions. We hypothesize that female gender could be predictive of patency rates of iliac vein stenting. METHODS: Consecutive patients who underwent IVS for thrombotic or nonthrombotic venous disease at our institution from 2007 until 2019 were identified and divided into groups based on gender. Operative notes, venograms, and the electronic health record were then queried to obtain operative details, co-morbid conditions, postoperative outcomes and stent patency. Study outcome was long term patency rate. The data was analyzed using chi-square, logistic regression, and Kaplan-Meier analysis as appropriate. RESULTS: A total of 200 consecutive patients (231 limbs) were identified in our retrospective analysis, with a mean age of 48.8 ± 17.3, and BMI of 31.6 ± 8.6. Of those, 119 (59.5%) patients, (131 [56.8%] limbs) were female. Comparisons between the gender groups revealed no difference in age, BMI, or preoperative comorbidities. There was no difference in type of venous disease between male (85% thrombotic, 15% nonthrombotic) and female (84% thrombotic, 16% nonthrombotic), P= 0.830. The male cohort was more likely to present with leg ulceration (17% vs. 4.6%, P = 0.002), and the female cohort was more likely to present with leg edema (98.5% vs. 93.0%, P= 0.03). The male cohort had a higher rate of caval (48% vs. 33.6%, P= 0.027) and infrainguinal stent extension. (11% vs. 6.9%, P= 0.02). Females had a higher rate of left sided stenting (80.9% vs. 66/0%, P= 0.010). There was no difference in the median stent diameter used between the cohorts. Primary patency at 5 years was significantly higher for the male cohort (94.1% vs. 74.4%, P= 0.01) On adjusted multivariable cox regression female gender was a predictor of loss of primary patency within 5 years (HR, 4.04; P= 0.007). CONCLUSIONS: In this single center retrospective analysis of IVS, male patients were found to have better primary stent patency compared to female.

Cost-effectiveness analysis of immediate access arteriovenous grafts versus standard grafts for hemodialysis.

OBJECTIVE: Immediate-access arteriovenous grafts (IAAVGs), or early cannulation arteriovenous grafts (AVGs), are more expensive than standard grafts (sAVGs) but can be used immediately after placement, reducing the need for a tunneled dialysis catheter (TDC). We hypothesized that a decrease in TDC-related complications would make IAAVGs a cost-effective alternative to sAVGs. METHODS: We constructed a Markov state-transition model in which patients initially received either an IAAVG or an sAVG and a TDC until graft usability; patients were followed through multiple subsequent access procedures for a 60-month time horizon. The model simulated mortality and typical graft- and TDC-related complications, with parameter estimates including probabilities, costs, and utilities derived from previous literature. A key parameter was median time to TDC removal after graft placement, which was studied under both real-world (7 days for IAAVG and 70 days for sAVG) and ideal (no TDC placed with IAAVG and 1 month for sAVG) conditions. Costs were based on current Medicare reimbursement rates and reflect a payer perspective. Both microsimulation (10,000 trials) and probabilistic sensitivity analysis (10,000 samples) were performed. The willingness-to-pay threshold was set at $100,000 per quality-adjusted life-year (QALY). RESULTS: IAAVG placement is a dominant strategy under both real-world ($1201.16 less expensive and 0.03 QALY more effective) and ideal ($1457.97 less expensive and 0.03 QALY more effective) conditions. Under real-world parameters, the result was most sensitive to the time to TDC removal; IAAVGs are cost-effective if a TDC is maintained for ≥23 days after sAVG placement. The mean catheter time was lower with IAAVG (3.9 vs 8.7 months; P < .0001), as was the mean number of access-related infections (0.55 vs 0.74; P < .0001). Median survival in the model was 29 months. Overall mortality was similar between groups (76.3% vs 76.7% at 5 years; P = .33), but access-related mortality trended toward improvement with IAAVG (6.1% vs 6.8% at 5 years; P = .052). CONCLUSIONS: The Markov decision analysis model supported our hypothesis that IAAVGs come with added initial cost but are ultimately cost-saving and more effective. This apparent benefit is due to our prediction that a decreased number of catheter days per patient would lead to a decreased number of access-related infections.

The Society for Vascular Surgery clinical practice guidelines on the management of visceral aneurysms.

These Society for Vascular Surgery Clinical Practice Guidelines describe the care of patients with aneurysms of the visceral arteries. They include evidence-based size thresholds for repair of aneurysms of the renal arteries, splenic artery, celiac artery, and hepatic artery, among others. Specific open surgical and endovascular repair strategies are also discussed. They also describe specific circumstances in which aneurysms may be repaired at smaller sizes than these size thresholds, including in women of childbearing age and false aneurysms. These Guidelines offer important recommendations for the care of patients with aneurysms of the visceral arteries and long-awaited guidance for clinicians who treat these patients.