Center-level outcomes following elective fenestrated endovascular aortic aneurysm repair in the Vascular Quality Initiative database.

OBJECTIVE: Hospital volume is associated with mortality after open aortic aneurysm repair. Fenestrated and branched endovascular aortic repair (B-FEVAR) has been increasingly used for repair of complex thoracoabdominal and juxtarenal aneurysms, but evidence of a center-volume relationship is limited. We aimed to measure the association of center volume with in-hospital mortality, postoperative outcomes, and 1-year survival following B-FEVAR. METHODS: Patients undergoing elective endovascular thoracoabdominal and complex abdominal aneurysm repair with branch intervention (2014-2021) listed within the national Vascular Quality Initiative Thoracic Endovascular Aortic Repair/Complex EVAR database were analyzed. Centers were grouped into quartiles by mean annual procedure volume. Multivariable regression was used to evaluate the effect of center volume on in-hospital mortality adjusting for baseline and procedural characteristics. Kaplan-Meier estimation, log rank test, and mixed effects Cox regression were used to evaluate 1-year survival. RESULTS: A total of 4302 adult elective F-BEVAR procedures were identified at a total of 163 centers. In-hospital mortality did not differ by hospital volume (quartile [Q]1 = 35/1059 [3.3%]; Q2 = 30/1063 [2.8%]; Q3 = 33/1120 [2.9%]; and Q4 = 44/1060 [4.2%]; P = .308). The high volume group had a higher rate of major complication (Q1 = 14.9%; Q2 = 12.8%; Q3 = 13.3%; and Q4 = 20.1%; adjusted P < .001). Physician-modified grafts were more frequently employed in high-volume centers (Q1 = 4.5%; Q2 = 18.7%; Q3 = 11.3%; and Q4 = 19.2%; P < .001), with a decreased incidence of any endoleak noted at the end of the procedure (Q1 = 34.9%; Q2 = 32.8%; Q3 = 30.0%; and Q4 = 29.0%; P = .003). In the multivariable analysis, in-hospital mortality was not associated with center volume, comparing very low volume to medium- and high-volume centers (odds ratio [95% confidence interval] vs Q4: Q1 = 1.1 [0.6-1.9], Q2 = 0.6 [0.4-1.1], and Q3 = 0.9 [0.5-1.5]; all P > .05). No significant difference was found in 1-year survival between center volume groups. CONCLUSIONS: In-hospital mortality is not associated with procedure volume within centers performing complex endovascular aortic repair. However, complication rates and endoleak may be associated with procedure volume. Long-term outcomes by annualized procedure volume, specifically graft durability and sac expansion, should be investigated.

Current Transthoracic Supra-Aortic Trunk Surgical Reconstruction Has Similar 30-Day Cardiovascular Outcomes Compared to Extra-Anatomic Revascularization but With Higher Morbidity Burden.

BACKGROUND: Operative risk for supra-aortic trunk (SAT) surgical revascularization for occlusive disease, particularly transthoracic reconstruction (TR), remains ill-defined. This study sought to describe and compare 30-day outcomes of TR and extra-anatomic (ER) SAT surgical reconstruction for an occlusive indication across the United States over a contemporary 15-year period. METHODS: Using the National Surgical Quality Improvement Program, TR and ER performed during 2005-2019 were identified. Procedures performed for nonocclusive indications and those concomitant with coronary or valve operations were excluded. Rates of stroke, death, myocardial infarction (MI) and these as composite outcome (S/D/M) were compared. Logistic regression with stabilized inverse probability weighting (IPW) was used to compare groups via average treatment effect (ATE) while adjusting for covariate imbalances. RESULTS: Over the 15-year period, 166 TR and 1,900 ER patients were identified. The majority of ERs were carotid-subclavian bypass (n = 1,344; 70.7%) followed by carotid-carotid bypass (n = 261; 13.7%) and subclavian/carotid transpositions (n = 123; 6.5%). TR consisted of aorto-SAT bypass (n = 120; 72.3%) and endarterectomy (n = 46; 27.7%). The median age was 64 years for TR and 65 years in ER (P = 0.039). Those undergoing TR were more often women (69.0% vs. 56.9%; P = 0.001) and less likely to have undergone previous cardiac surgery (9.2% vs. 20.8%; P = 0.006). TR were also less frequently hypertensive (68.1% vs. 75.4%; P = 0.038) and had statistically lower preoperative creatinine levels (0.86 vs 0.91; P = 0.002). Unadjusted rates of MI (0.6% vs. 1.3%; P = 0.72) and stroke (3.6% vs. 1.9%; P = 0.15) were similar between groups with mortality (3.6% vs. 1.5%; P = 0.05) and S/D/M (6.6% vs. 3.9%; P = 0.10) trending higher with TR. IPWs could be calculated for 1,754 patients (148 TR; 1,606 ER). The estimated probability of S/D/M was 3.8% in the ER group and 6.2% in TR; no difference was seen in ATE (2.4%; 95% confidence interval [CI]: -1.5 to 6.2; P = 0.23). No differences were seen in individual component ATEs (stroke: 3.0% vs. 1.7%; ATE = 1.3%; 95% CI: -3.9 to 1.3; P = 0.32; mortality: 3.8% vs. 1.4%; ATE = 2.4%; 95% CI: -5.6 to 0.7; P = 0.13). Secondary outcomes showed TR patients were more likely to have non-home discharge (18.7% vs. 6.6%; ATE = 12.1%; 95% CI: 5.0-19.2; P < 0.001) and longer lengths of stay (6.1 vs. 4.0; ATE = 2.2 days; 95% CI: 0.9-3.4; P < 0.001). Moreover, TR patients were more likely to require transfusion (22.7% vs. 5.0%; ATE = 17.7%; 95% CI: 10.2-25.2; P < 0.001) and develop sepsis (2.7% vs. 0.2%; ATE = 2.5%; 95% CI: 0.1-5.0; P = 0.04). CONCLUSIONS: Transthoracic and extra-anatomic surgical reconstruction of the SATs for occlusive disease have similar operative cardiovascular risk. However, morbidity tends to be higher with TR due to higher transfusion requirements, sepsis risk, and need for facility stay. These results suggest ER as a first-line approach in those with proper disease anatomy is reasonable with lower morbidity, while TR remains justified in appropriate patients.

Long-Term Outcomes of Exercise Therapy Versus Revascularization in Patients With Intermittent Claudication.

OBJECTIVE: The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC). BACKGROUND: Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and noninvasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831). RESULTS: A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2-8) per 1000 person-years] and noninvasive treatment [6 (3-10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35-1.69; P =0.51, I2 =0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54-5.26; P =0.36, I2 =0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91-1.74; P =0.16, I2 =0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80-6.16; P <0.00001, I2 =83%). The results were not changed by fixed effect or random-effects models, nor by sensitivity analysis. CONCLUSIONS: Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared with noninvasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of noninvasive treatment for first-line IC therapy is supported.

Operative and long-term outcomes of combined and staged carotid endarterectomy and coronary bypass.

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.54-1.36; P = .51) and mortality (HR, 1.02; 95% CI, 0.76-1.36; P=.91) were similar between groups, but higher risk of MI long-term was seen in those staged (HR, 1.49; 95% CI, 1.07-2.08; P = .02). CONCLUSIONS: In patients undergoing CCAB or staged open revascularization for carotid stenosis and coronary artery disease, the staged approach had an increased risk of postoperative cardiac event, but the short- and long-term rates of stroke and mortality seem to be comparable. Adverse cardiovascular event risk is high between operations when staged and should be a consideration when selecting an approach. Although factors leading to staged sequencing performance need further clarity, CCAB seems to be safe and should be considered an equally reasonable option.

Market competition influences practice patterns in management of patients with intermittent claudication in the vascular quality initiative.

OBJECTIVE: The Society for Vascular Surgery (SVS) clinical practice guidelines recommend best medical therapy (BMT) as first-line therapy before offering revascularization to patients with intermittent claudication (IC). Notably, atherectomy and tibial-level interventions are generally discouraged for management of IC; however, high regional market competition may incentivize physicians to treat patients outside the scope of guideline-directed therapy. Therefore, we sought to determine the association between regional market competition and endovascular treatment of patients with IC. METHODS: We examined patients with IC undergoing index endovascular peripheral vascular interventions (PVI) in the SVS Vascular Quality Initiative from 2010 to 2022. We assigned the Herfindahl-Hirschman Index as a measure of regional market competition and stratified centers into very high competition (VHC), high competition, moderate competition, and low competition cohorts. We defined BMT as preoperative documentation of being on antiplatelet medication, statin, nonsmoking status, and a recorded ankle-brachial index. We used logistic regression to evaluate the association of market competition with patient and procedural characteristics. A sensitivity analysis was performed in patients with isolated femoropopliteal disease matched by the TransAtlantic InterSociety classification of disease severity. RESULTS: There were 24,669 PVIs that met the inclusion criteria. Patients with IC undergoing PVI were more likely to be on BMT when treated in higher market competition centers (odds ratio [OR], 1.07 per increase in competition quartile; 95% confidence interval [CI], 1.04-1.11; P < .0001). The probability of undergoing aortoiliac interventions decreased with increasing competition (OR, 0.84; 95% CI, 0.81-0.87; P < .0001), but there were higher odds of receiving tibial (OR, 1.40; 95% CI, 1.30-1.50; P < .0001) and multilevel interventions in VHC vs low competition centers (femoral + tibial OR, 1.10; 95% CI, 1.03-1.14; P = .001). Stenting decreased as competition increased (OR, 0.89; 95% CI, 0.87-0.92; P < .0001), whereas exposure to atherectomy increased with higher market competition (OR, 1.15; 95% CI, 1.11-1.19; P < .0001). When assessing patients undergoing single-artery femoropopliteal intervention for TransAtlantic InterSociety A or B lesions to account for disease severity, the odds of undergoing either balloon angioplasty (OR, 0.72; 95% CI, 0.625-0.840; P < .0001) or stenting only (OR, 0.84; 95% CI, 0.727-0.966; P < .0001) were lower in VHC centers. Similarly, the likelihood of receiving atherectomy remained significantly higher in VHC centers (OR, 1.6; 95% CI, 1.36-1.84; P < .0001). CONCLUSIONS: High market competition was associated with more procedures among patients with claudication that are not consistent with guideline-directed therapy per the SVS clinical practice guidelines, including atherectomy and tibial-level interventions. This analysis demonstrates the susceptibility of care delivery to regional market competition and signifies a novel and undefined driver of PVI variation among patients with claudication.

Preoperative Spinal Drain Placement is Associated with Reduced Risk of Spinal Cord Ischemia in Patients Undergoing Thoracic Endovascular Aortic Repair for Aortic Dissection.

BACKGROUND: Spinal cord ischemia (SCI) is a rare but serious complication of Thoracic Endovascular Aortic Repair (TEVAR). Several measures including spinal drain (SD) placement have been proposed to reduce the risk of SCI in TEVARs performed for aneurysms. However, there are no specific large-scale data on potential benefits of SD placement in Stanford Type B aortic dissection (TBAD). We aimed to assess the impact of preoperative SD placement on preventing SCI during TEVARs performed for TBAD. METHODS: We included all TEVAR cases performed for TBAD in Vascular Quality Initiative (VQI) from 2012 to 2021. Patients with connective tissue disease, open conversion, rupture, proximal disease > zone 5, proximal landing zone <2 or SCI on presentation were excluded. One-to-one propensity score matching was used to balance patients on 34 dimensions by the nearest neighbor principle to compare patients based on preoperative SD placement. The primary outcome was SCI. Secondary outcomes included 30-day and 90-day mortality, perioperative complications, and 90-day2intervention. RESULTS: A total of 2,683 TEVARs were performed for TBAD with 1,227 (45.7%) undergoing preoperative SD placement. Propensity matching produced 672 well-matched pairs. In the matched cohort, SD placement was not associated with significant reduction in temporary SCI (3.0% vs. 3.7%, P = 0.45). However, SD placement was associated with significant reduction of the risk of permanent SCI at discharge (1.3% vs. 3.4%, P = 0.012). SD was also associated with lower risk of 30-day mortality (3.7% vs 6.4%, P = 0.025) and shorter length of stay but not 90-day mortality or 90-day reintervention. CONCLUSIONS: Our study suggests that preoperative SD placement in patients undergoing TEVAR for TBAD is beneficial in reducing the risk of permanent SCI without increasing risks of perioperative complications. Further prospective studies are necessary to confirm these findings.

The impact of carotid lesion calcification on outcomes of carotid artery stenting.

OBJECTIVE: The impact of carotid artery lesion calcification on adverse events following carotid artery stenting is not well-studied. Few reports associated heavily calcified lesions with high risk of perioperative stroke following transfemoral carotid artery stenting (TFCAS). With the advent of transcarotid artery revascularization (TCAR), we aimed to compare the outcomes of these two procedures stratified by the degree of lesion calcification. METHODS: Our cohort was derived from the Vascular Quality Initiative database for carotid artery stenting. Patients with missing information on the degree of carotid artery calcification were excluded. Patients were stratified into two groups: >50% (heavy) calcification and ≤50% (no/mild) calcification. The Student t test and the χ2 test were used to compare patients' baseline characteristics and crude outcomes, as appropriate. Clinically relevant and statistically significantly variables on univariable analysis were added to a logistic regression model clustered by center identifier. RESULTS: A total of 11,342 patients were included. Patients with >50% calcification were older, had more comorbidities, and more contralateral occlusion. There were more patients with prior ipsilateral carotid endarterectomy in the ≤50% calcification group. In patients who underwent TCAR, there were no significant differences between those who had >50% vs ≤50% carotid calcification in the odds of in-hospital adverse outcomes. However, in patients with heavy calcification who underwent TFCAS, there was a 50% to 60% increase in the odds of stroke (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.04-2.5; P = .03), stroke/transient ischemic attack (TIA) (OR, 1.6; 95% CI, 1.1-2.3; P = .013), and stroke/death (OR, 1.5; 95% CI, 1.02-2.08; P = .039). Compared with TFCAS in patients with heavy calcification, TCAR was associated with a 40% to 90% reduction in the odds of contralateral stroke (OR, 0.13; 95% CI, 0.04-0.4; P = .001), contralateral stroke/TIA (OR, 0.3; 95% CI, 0.1-0.87; P = .024), any stroke/TIA (OR, 0.6; 95% CI, 0.38-0.91; P = .02), death (OR, 0.3; 95% CI, 0.13-0.72; P = .006), stroke/death (OR, 0.5; 95% CI, 0.32-0.8; P = .004), and stroke/death/myocardial infarction (OR, 0.58; 95% CI, 0.39-0.87; P = .008). There were no significant differences in the odds of stroke and myocardial infarction. CONCLUSIONS: In this retrospective analysis of patients undergoing TFCAS vs TCAR in the Vascular Quality Initiative database, TCAR demonstrated favorable outcomes compared with TFCAS among patients with calcification greater than 50% of the carotid circumference. Advance burden of carotid artery calcification was associated with worse outcomes in patients undergoing TFCAS but not TCAR. These results are consistent with previously demonstrated superiority of flow reversal compared with distal embolic protection devices. Further research is needed to assess long-term outcomes and confirm the durability of TCAR in heavily calcified lesions.

Meta-analysis finds recurrent infection is more common after endovascular than after open repair of infected abdominal aortic aneurysm.

OBJECTIVE: Controversy has continued regarding the use of endovascular aneurysm repair (EVAR) vs open aneurysm repair (OAR) for infected abdominal aortic aneurysms (AAAs). In the present study, we investigated the comparative outcomes of EVAR and OAR for the treatment of infected AAAs. METHODS: We conducted a systematic review and meta-analysis using the MEDLINE and EMBASE databases through May 2021. We included studies that had described both EVAR and OAR for the treatment of infected AAAs. The primary endpoints were the rates of recurrent infection and related rupture and/or death. Perioperative and 1-year mortality and readmissions and reinterventions were also analyzed. RESULTS: Fourteen observational studies describing a total of 1203 patients (EVAR, 359 [29.8%]; OAR, 844 [70.2%]) were eligible for qualitative analysis. The baseline characteristics included diabetes mellitus (33.2%), fever at presentation (71.6%), rupture at diagnosis (26.1%), and positive blood cultures (52.5%). The mean follow-up period ranged from 12 to 40 months. The use of EVAR became more prevalent in recent years (2016-2020, 32.4%) compared with the former period (2010-2015, 13.8%; P < .0001). Fenestrated, branched, or concomitant visceral debranching EVAR was performed in 6.1% of cases. In OAR, surgical debridement was consistently performed, and in situ reconstruction was applied in 82.2% and an omental flap in 51.5%. In nine studies considered for quantitative analysis, the patients' background (EVAR, n = 264; OAR, n = 274) were statistically balanced. The crude rates of recurrent infection and related rupture or death were 13.6% (95% confidence interval [CI], 8.8%-18.5%) and 4.9% (95% CI 1.8%-8.0%), respectively. The pooled analyses depicted significantly higher rates of recurrent infection after EVAR than after OAR (relative risk [RR], 2.42; 95% CI, 1.80-3.27; P < .0001; I2 = 0%). Recurrent infection-related rupture or death (RR, 1.51; 95% CI, 0.70-3.23; P = .29; I2 = 0%), perioperative death (RR, 0.80; 95% CI, 0.39-1.65; P = .55; I2 = 35%), 1-year mortality (hazard ratio, 1.12; 95% CI, 0.97-1.28; P =.13; I2 = 0%), and readmission or reintervention (RR, 1.16; 95% CI, 0.74-1.82; P =.52; I2 = 0%) were not significantly different statistically between the two groups. Funnel plots showed no evidence of publication bias. Sensitivity analyses of leave-one-out meta-analysis confirmed higher rates of recurrent infection after EVAR. CONCLUSIONS: EVAR has become more prevalent as the initial treatment of infected AAAs. Although operative and 1-year survival were similar between OAR and EVAR groups, recurrent infection was more frequent after EVAR. This limitation should be weighed in selecting patients for EVAR in infected AAAs. Postoperative graft and infection surveillance are critical, especially after EVAR.

Predictability of the Global Limb Anatomic Staging System (GLASS) for Technical and Limb Related Outcomes: A Systematic Review and Meta-Analysis.

OBJECTIVE: The newly proposed Global Limb Anatomic Staging System (GLASS), a categorical staging of infrainguinal artery disease complexity, is expected to correlate with clinical outcomes in patients with chronic limb threatening ischaemia (CLTI). This study aimed to verify the relationship between GLASS stages and clinical outcomes after endovascular treatment (EVT) and bypass surgery (BS). DATA SOURCES: MEDLINE, Web of Science Core Collection, and Google Scholar were searched in consultation with a health sciences librarian through June 2021. REVIEW METHODS: This systematic review and meta-analysis was carried out according to the PRISMA guidelines. All studies comparing the outcomes of patients with CLTI stratified by GLASS staging were eligible. Amputation free survival (AFS), limb salvage rate (LSR), major adverse limb event (MALE), overall survival, immediate technical failure (ITF), and limb based patency (LBP) were analysed. Data were pooled and synthesised with a random effects model. RESULTS: Datasets from seven retrospective cohort studies and one randomised control trial with a total of 2 204 patients (2 483 limbs) were identified. Pooled estimates demonstrated statistical differences between GLASS 1+2 and GLASS 3 in LSR (HR 0.61; 95% CI 0.47 - 0.80, p < .001) and MALE (HR 0.66; 95% CI 0.53 - 0.83, p < .001). After stratification, there were statistical differences in AFS, LSR, and MALE between GLASS 1+2 and GLASS 3 in the EVT subgroup but not in BS. In GLASS 2 and 3, MALE was significantly worse after EVT. In GLASS stages 1, 2, and 3, ITF after EVT was 3.9%, 5.3%, and 27.9%, respectively. LBP after EVT was significantly different between GLASS 1+2 and GLASS 3 (HR 0.83; 95% CI 0.71 - 0.97, p = .020). CONCLUSION: GLASS is predictive of LSR and MALE as well as ITF and LBP after EVT. The current meta-analysis suggests advanced GLASS stages favour BS over EVT.

Smaller size is more suitable for pharmacotherapy among undersized abdominal aortic aneurysm: A systematic review and meta-analysis.

Background: Pharmacotherapy for undersized abdominal aortic aneurysm (AAA) is a clinical unmet need. Randomized controlled trials (RCTs) have failed to show effectiveness despite countless promising data in preclinical studies. We aimed to identify the population with undersized AAAs (30-54 mm) who potentially benefit from pharmacotherapy. Methods: In accordance with the PRISMA statement, we conducted a systematic review and meta-analysis of placebo-controlled RCTs. The primary outcome was mean difference (MD) in annual growth rate (< 0 favors pharmacotherapy), and the secondary outcome was aneurysm-related events (diameters ⩾ 55 mm, ruptures, or referral to surgery). Results: Our search strategy identified eight RCTs (six trials on antibiotics [ABx], two on renin-angiotensin system inhibitors [RAS-I]) with a total of 1325 patients. The mean of baseline diameters ranged from 33.1 mm to 43.1 mm. Neither ABx nor RAS-I showed significant differences in MD. Multivariable random-effects restricted maximum likelihood meta-regression revealed a statistically significant linear relationship between baseline diameter and MD (coefficient 0.15 [95% CI 0.0011, 0.30], p = 0.049) but not for the follow-up period (p = 0.28) and duration of treatment (p = 0.11). In line with this result, ABx with baseline diameter < 40 mm significantly reduced MD (-1.03 mm/year [95% CI -1.64, -0.42], p = 0.001) and a borderline significant difference in aneurysm-related events (HR 0.53 [95% CI 0.28, 1.00], p = 0.05), whereas the other groups ⩾ 40 mm never demonstrated effectiveness. Fixed-effect models did not change the results. No evidence of publication bias was detected. Conclusion: Undersized AAAs < 40 mm can potentially benefit from pharmacotherapy. Future RCTs should consider preferentially including undersized AAA with smaller diameters.

The Effect of Retrograde External Iliac Artery Runoff on Aortofemoral Bypass Limb Patency.

BACKGROUND: Superficial femoral artery and profunda patency has been shown to affect aortofemoral bypass (AFB) limb patency. However, the effect of retrograde flow through the external iliac artery (EIA) is unknown and is the subject of this analysis. METHODS: Institutional AFB data from 2000 to 2017 were gathered, excluding that where Superficial femoral artery /EIA patency could not be determined. The cohort was divided into limbs with and without EIA occlusion; primary outcome was limb-based primary patency. Kaplan-Meier estimated patency; cox proportional-hazards model evaluated EIA patency while controlling for other factors. RESULTS: Over the study period, there were AFB 557 limbs in 281 patients. Of the 435 AFB limbs in 220 patients that met inclusion criteria and were included in the analysis, 162 had EIA occlusion and 273 had a patent EIA. Mean age was 69.6 ± 9.0. EIA occlusions were more common in male patients (59.9% vs. 44.6%; P = 0.001), patients with CAD (43.8% vs. 34.1%; P = 0.042), COPD (34.6% vs. 20.5%; P = 0.001), and CHF (14.8% vs. 5.9%; P = 0.002). Limbs with EIA occlusions more often underwent end-to-side proximal anastomosis (40.7% vs. 24.2%; P < 0.001) and simultaneous infrainguinal bypass (7.4% vs. 0.7%; P < 0.001). Median clinical follow-up was 4.4 years (IQR: 1.6-8.4). Five-year primary patency was 83.1% (95% CI: 74.5-90.0%) for EIA occlusion limbs and 85.9% (95% CI: 80.2-90.0%) with patent EIA limbs (P = 0.96). While controlling for other factors, EIA stenosis or occlusion did not affect primary patency. For patients with a proximal occlusion (occluded aorta, occluded common iliac, or end-to-end proximal anastomosis) and occluded SFA (N = 73), EIA occlusion had a HR of 1.92 for loss of patency, but this was not statistically significant. CONCLUSIONS: EIA patency did not influence primary patency in the overall cohort Further investigation on the topic in specific patient subgroups is warranted to determine the effect of EIA patency.

Preliminary Experience With the Human Acellular Vessel: A Descriptive Case Series Detailing Early Use of a Bioengineered Blood Vessel for Arterial Repair.

BACKGROUND: An infection-resistant, immediately available conduit for trauma and urgent vascular reconstruction remains a critical need for successful limb salvage. While autologous vein remains the gold standard, vein-limited patients and size mismatch are common issues. The Human Acellular Vessel (HAV) (Humacyte, Inc., Durham, NC) is a bioengineered conduit with off-the-shelf availability and resistance to infection, ideal characteristics for patients with challenging revascularization scenarios. This report describes HAV implantation in patients with complex limb-threatening ischemia and limited conduit options who may have otherwise faced limb loss. METHODS: The Food and Drug Administration (FDA) expanded-access program was used to allow urgent implantation of the HAV for arterial reconstruction. Electronic medical records were reviewed with extraction of relevant data including patient demographics, surgical implantation, patency, infectious complications, and mortality. RESULTS: The HAV was implanted in 8 patients requiring vascular reconstruction. Graft or soft tissue infection was present in 2 patients. One patient with severe penetrating pelvic injury had 4 HAV placed to repair bilateral external iliac artery and vein injuries. There was 1 technical failure due to poor outflow, 2 patients died unrelated to HAV use, and 5 lower extremity bypasses maintained patency at an average of 11.4 months (range: 4-20 months). No HAV infectious complications were identified. CONCLUSIONS: This report is the first United States series describing early outcomes using the HAV under the FDA expanded-access program for urgent vascular reconstruction. The HAV demonstrates resistance to infection, reliable patency, and offers surgeons an immediate option when confronted with complex revascularization scenarios. Assessment of long-term outcomes will be important for future studies.

Outcomes of open and endovascular infra-inguinal revascularization are poor in young patients with atherosclerotic peripheral artery disease but do not differ between genders.

OBJECTIVES: The effect of gender on the outcomes of revascularization procedures in young patients with premature atherosclerotic peripheral arterial disease (PAD) is not known. The objective of this study was to compare short-term and long-term outcomes between young males and females undergoing infra-inguinal revascularization procedures. METHODS: We examined postoperative outcomes of male and female PAD patients under the age of 55 who underwent infra-inguinal revascularization procedures at a single tertiary institution from 2011 to 2019. Primary outcomes included 30-day morbidity, patency of the revascularization procedures, and major adverse limb events (MALE). Secondary outcomes included survival, amputation rate, reintervention rate, improvement of ankle-brachial index (ABI), and number of reinterventions. RESULTS: Eighty-one infra-inguinal revascularization procedures (46 endovascular and 35 open procedures) were reviewed including 45 procedures in 37 males and 36 procedures in 31 females. Fifty-three (65.4%) of the procedures were performed in patients with chronic limb-threatening ischemia symptoms. The rest were treated for life-disabling claudication. The female patients were younger, had higher body mass index, and were more likely to have diabetes, hyperlipidemia, or chronic obstructive pulmonary disease in comparison to males. Thirty-day major adverse cardiovascular event was 0.0% and MALE was 16.0%. Mean follow-up was 806.2 days. At 1 year, primary patency was 34.4 ± 6.2%, primary assisted patency was 52.7 ± 6.5%, secondary patency was 61.8 ± 6.3%, and MALE-free rate was 47.0 ± 6.4%. For secondary outcomes at 1 year, amputation-free rate was 92.5 ± 3.2%, reintervention-free rate was 50.2 ± 6.4%, and survival was 96.2 ± 2.6%. By the end of the study, overall mortality rate was 14.8% and major amputation rate was 13.6%. No major differences were observed between males and females among these outcomes. A smaller improvement in ABI after revascularization was noted in females compared to males (female 0.2 ± 0.2 vs male 0.4 ± 0.2, p = .04). Among patients who required reintervention, females required a higher number of reinterventions than males (female 1.7 ± 2.5 vs male 0.8 ± 1.1, p = .03). CONCLUSIONS: There were no significant differences in short-term and long-term outcomes between males and females under the age of 55 after infra-inguinal revascularization. Poor patency, high MALE rate, and high mid-term mortality, and amputation rates after revascularization in young PAD patients highlight the need for improved strategies to treat premature PAD.

Simultaneous treatment of common carotid lesions increases the risk of stroke and death after carotid artery stenting.

BACKGROUND: Tandem carotid artery lesions that involve simultaneous internal carotid artery (ICA) and common carotid artery (CCA) stenoses present a complex clinical problem. Some studies have shown that the addition of a retrograde proximal intervention to treat a CCA lesion during a carotid endarterectomy (CEA) increases the risk of stroke and death. However, the stroke and death risks associated with a totally endovascular approach to tandem lesions is unknown and is the subject of this study. METHODS: Vascular Study Group of New England data for the years 2005 to 2020 were queried for carotid artery stenting (CAS) procedures. Emergent and bilateral procedures, procedures for indications other than atherosclerosis, patients with prior ipsilateral CAS, ICA lesions with stenosis of less than 50%, and transcarotid procedures were excluded. The cohort was divided into tandem and isolated lesion groups. The primary outcome was the composite of stroke and death. Predictors of stroke or death were determined with multivariable logistic regression. RESULTS: There were 2016 carotid arteries stented in 1950 patients-1881 (96%) with isolated lesions and 135 (4%) with tandem lesions. The mean patient age was 69.6 ± 9.0 years. Tandem lesions were more likely to be present in women (50.4% vs 33.0%; P < .001) and in patients with a prior carotid endarterectomy (45.9% vs 35.4%; P = .014). Other covariates were similar between the groups. Symptomatic lesions accounted for 42.3% of cases (isolated, 42.2% vs tandem, 43.0%; P = .86). Arteries in the tandem group more often required multiple stents to treat the ICA lesion (9.6% vs 5.2%; P = .027). ICA neuroprotection had similar outcomes in both groups (tandem: success 94.1%, failure 3.7%; isolated: success 96.3%, failure 1.8%; P = .29). The tandem group experienced a higher 30-day mortality (2.2% vs 0.6%; P = .039), more perioperative neurologic events (stroke or transient ischemic attack) (8.1% vs 2.0%; P < .001), and a higher incidence of stroke or death (5.9% vs 1.9%; P = .002). Predictors of the primary outcome in the multivariable model included treatment of tandem lesions (odds ratio [OR], 3.10; 95% confidence interval [CI], 1.39-6.89; P = .006), symptomatic lesions (OR, 2.24; 95% CI, 1.21-4.17; P = .010), chronic obstructive pulmonary disease (OR, 2.14; 95% CI, 1.17-3.92; P = .014), general anesthesia (OR, 3.34; 95% CI, 1.35-8.26; P = .009), and advancing age (OR, 1.05 per year; 95% CI, 1.01-1.09; P = .006). CONCLUSIONS: The addition of endovascular treatment of tandem CCA lesions with CAS is associated with a three-fold increase in perioperative stroke and death and should be avoided if possible.

Addition of common carotid intervention increases the risk of stroke and death after carotid artery stenting for asymptomatic patients.

BACKGROUND: A recent review of Vascular Study Group of New England data suggested that simultaneous endovascular treatment of tandem carotid lesions (TCAL: common carotid artery + internal carotid artery) is associated with a fourfold increase in perioperative neurologic events and death. However, given the small cohort, the effect of symptomatic status could not be evaluated. This study sought to determine the risk of simultaneous TCAL stenting in cohorts stratified by symptom status. METHODS: Vascular Quality Initiative data (2005-2020) were queried for carotid stenting procedures (CAS). Emergent and bilateral procedures, patients with prior ipsilateral CAS, internal carotid artery lesions with stenosis <50%, and hybrid transcarotid procedures were excluded. The cohort was stratified by symptomatic status. The primary outcome was the composite of perioperative stroke and death. Predictors of stroke/death were determined with multivariable logistic regression for symptomatic and asymptomatic patients with TCAL forced into the models. RESULTS: There were 18,886 carotid arteries stented (18,441 patients): 18,077 (96%) with isolated carotid artery lesions and 809 (4%) with TCAL. Mean age was 70.0 ± 9.7. Symptomatic lesions were present in 58.9% of cases (isolated carotid artery lesions: 59.1% vs TCAL: 52.5%; P < .001). More TCAL arteries had a prior carotid endarterectomy (38.3% vs 23.8%; P < .001). TCAL had a higher perioperative stroke/death (3.4% vs 1.8%; P = .026) for asymptomatic lesions, but not symptomatic lesions (4.5% vs 3.7%; P = .41). TCAL were independently associated with stroke/death in asymptomatic patients (odds ratio, 1.85; 95% confidence interval, 1.03-3.33; P = .039) but not symptomatic patients (odds ratio, 1.22; 95% confidence interval, 0.76-1.97; P = .42). CONCLUSIONS: The addition of endovascular treatment of common carotid artery lesions with CAS is associated with almost double the risk of perioperative stroke/death in asymptomatic patients and should be avoided if possible. Treatment of TCAL is not associated with an increased risk of stroke/death for symptomatic lesions.

Society for Vascular Surgery femoral runoff score is associated with limb-based patency after aortofemoral bypass.

OBJECTIVE: Despite advancements, aortofemoral bypass (AFB) remains the most durable option for aortoiliac occlusive disease. Although runoff has been shown to be associated with AFB patency, the association of the Society for Vascular Surgery (SVS) thigh runoff scoring system with patency has not been assessed. The aim of the present study was to evaluate the association between the SVS runoff scoring system and limb-based primary patency after AFB. METHODS: Institutional data for patients undergoing AFB with preoperative runoff imaging available from 2000 to 2017 were queried. Runoff scores were assigned according to the presence of occlusive disease in the superficial femoral artery and profunda femoris artery (minimum, 1; maximum, 10) as described by the 1997 SVS reporting standards for lower extremity ischemia. Limb-based patency was the primary endpoint. Kaplan-Meier analysis was used to compare the long-term limb-based patency and freedom from reintervention between limbs with runoff scores ≥6 and those with runoff scores <6. Propensity score-weighted Cox proportional hazards modeling was used to evaluate the association between a runoff score of ≥6 and primary patency loss, controlling for other factors associated with primary patency. RESULTS: In 161 patients, 316 limbs had undergone revascularization. The mean patient age was 66.7 ± 11.3 years, and 51.6% were women. Most limbs had undergone revascularization for claudication (56.5%). Most (89.4%) had TransAtlantic InterSociety Consensus class D lesions, 27.3% had required suprarenal or higher clamping, and 11.2% had undergone concomitant mesenteric intervention. A femoral outflow adjunct and concurrent lower extremity bypass was required in 41.8% and 2.9% of limbs, respectively. Those with a runoff score of ≥6 had experienced greater rates of 30-day myocardial infarction (11% vs 1%; P = .005), respiratory failure (11% vs 1%; P = .005), and mortality (8% vs 0%; P ≤ .006). The median follow-up period was 4.0 years (interquartile range, 6.5 years). The 1-, 3-, and 5-year primary patency was 94.6% (95% confidence interval [CI], 91.9%-97.3%), 89.2% (95% CI, 85.4%-93.2%), and 81.4% (95% CI, 76.0%-87.1%), respectively. The 5-year primary-assisted patency, secondary patency, and freedom from reintervention were 84.9% (95% CI, 79.7%-90.5%), 91.7% (95% CI, 87.3%-96.3%), and 83.3% (95% CI, 78.3%-88.7%), respectively. Patients with a runoff score of ≥6 had lower primary (log-rank P < .01), primary-assisted (P < .01), and secondary patency (P = .01). The factors associated with the loss of primary patency included a high runoff score (runoff score of ≥6: hazard ratio [HR], 4.1; 95% CI, 2.1-8.0; P < .01), simultaneous mesenteric endarterectomy (HR, 13.5; 95% CI, 1.9-97.8; P = .01), and chronic kidney disease (HR, 4.6; 95% CI, 1.5-14.6; P = .01). Increasing age (HR, 0.94 per year; 95% CI, 0.91-0.97; P < .01) and hyperlipidemia (HR, 0.44; 95% CI, 0.23-0.85; P = .01) were protective. CONCLUSIONS: The SVS femoral runoff score is an important factor associated with long-term AFB limb patency. Scores of ≥6 portend for worse limb outcomes and a greater incidence of operative complications. The SVS score can be determined from preoperative axial imaging studies and serve as a guide in decision-making and operative planning.

Chronic mesenteric ischemia: Clinical practice guidelines from the Society for Vascular Surgery.

BACKGROUND: Chronic mesenteric ischemia (CMI) results from the inability to achieve adequate postprandial intestinal blood flow, usually from atherosclerotic occlusive disease at the origins of the mesenteric vessels. Patients typically present with postprandial pain, food fear, and weight loss, although they can present with acute mesenteric ischemia and bowel infarction. The diagnosis requires a combination of the appropriate clinical symptoms and significant mesenteric artery occlusive disease, although it is often delayed given the spectrum of gastrointestinal disorders associated with abdominal pain and weight loss. The treatment goals include relieving the presenting symptoms, preventing progression to acute mesenteric ischemia, and improving overall quality of life. These practice guidelines were developed to provide the best possible evidence for the diagnosis and treatment of patients with CMI from atherosclerosis. METHODS: The Society for Vascular Surgery established a committee composed of vascular surgeons and individuals experienced with evidence-based reviews. The committee focused on six specific areas, including the diagnostic evaluation, indications for treatment, choice of treatment, perioperative evaluation, endovascular/open revascularization, and surveillance/remediation. A formal systematic review was performed by the evidence team to identify the optimal technique for revascularization. Specific practice recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation system based on review of literature, the strength of the data, and consensus. RESULTS: Patients with symptoms consistent with CMI should undergo an expedited workup, including a computed tomography arteriogram, to exclude other potential causes. The diagnosis is supported by significant arterial occlusive disease in the mesenteric vessels, particularly the superior mesenteric artery. Treatment requires revascularization with the primary target being the superior mesenteric artery. Endovascular revascularization with a balloon-expandable covered intraluminal stent is the recommended initial treatment with open repair reserved for select younger patients and those who are not endovascular candidates. Long-term follow-up and surveillance are recommended after revascularization and for asymptomatic patients with severe mesenteric occlusive disease. Patient with recurrent symptoms after revascularization owing to recurrent stenoses should be treated with an endovascular-first approach, similar to the de novo lesion. CONCLUSIONS: These practice guidelines were developed based on the best available evidence. They should help to optimize the care of patients with CMI. Multiple areas for future research were identified.

The long-term implications of access complications during endovascular aneurysm repair.

BACKGROUND: Access issues are one of the most common complications of endovascular aneurysm repair (EVAR). However, contemporary rates as well as risk factors for complications and the subsequent impact of access complications on mortality are poorly described. METHODS: We studied all EVAR for intact abdominal aortic aneurysms without prior aortic surgery in the Vascular Quality Initiative between 2011 and 2018. We studied factors associated with access complications (thrombosis, embolus, wound infection, hematoma, and conversion to cutdown), as well as the interaction with female sex and the impact on survival using multilevel logistic regression and propensity weighting. Multiple imputation was used for missing data. RESULTS: There were 33,951 EVAR during the study period (91% elective, 9% symptomatic); most cases (70%) involved an attempt at percutaneous access on at least one side, with 30% bilateral cutdowns and 0.1% iliac conduits. There were 1553 patients (4.6%) who experienced at least one access complication. Access complications were almost twice as common in female patients (7.5% vs 3.9%; P < .001). The factors associated with access complications included female sex (odds ratio [OR], 2.7; 95% confidence interval [CI], 2.0-3.6; P < .001), age (OR, 1.05 per 5 years; 95% CI, 1.02-1.1; P < .01), aortouni-iliac device (OR, 1.6; 95% CI, 1.1-2.3; P < .01), smoking (OR, 1.4; 95% CI, 1.1-1.7; P < .01), body mass index of less than 16 (OR, 1.8; 95% CI, 1.3-2.5; P = .001), dual antiplatelet therapy (1.3; 95% CI, 1.02-1.6 P = .03), prior infrainguinal bypass (OR, 1.8; 95% CI, 1.3-2.7; P < .01), and beta blocker use (OR, 1.2; 95% CI, 1.03-1.4; P = .02). Conversion from percutaneous access to open cutdown was associated with higher rates of complications than planned open cutdown (8.6% vs 2.9%; P < .001). In propensity-weighted analysis, percutaneous access was associated with significantly lower odds of access complications in women (OR, 0.6; 95% CI, 0.4-0.96; P = .03). Patients who experienced an access complication had more than four times the odds of perioperative death (OR, 4.2; 95% CI, 2.5-7.1; P < .001), and a 60% higher risk of long-term mortality (hazard ratio, 1.6; 95% CI, 1.2-2.1; P = .001). In addition to death, patients with access site complications had higher rates of other major complications, including reoperation during the index hospitalization (19% vs 1.2%; P < .001), myocardial infarction (3.5% vs 0.7%; P < .001), stroke (0.8% vs 0.2%; P < .001), acute kidney injury (12% vs 3%; P < .001), and reintubation (5.7% vs 0.8%). CONCLUSIONS: Although access complications are infrequent in the current era, they are associated with both perioperative and long-term morbidity and mortality. Female patients in particular are at high risk of access complications, but may benefit from percutaneous access.

The long-term fate of renal and visceral vessel reconstruction after open thoracoabdominal aortic aneurysm repair.

OBJECTIVES: In the ever-advancing era of endovascular thoracoabdominal aneurysm (TAAA) repair, understanding long-term patency of renovisceral reconstructions after open TAAA repair provides important benchmarks. METHODS: Institutional open TAAA repair patient data were queried. Patients dying during index admission or with incomplete operative detail were excluded. Visceral and renal reconstructions were categorized as bypass, incorporation into a proximal or distal beveled aortic anastomosis, inclusion button, Carrel patch, or hybrid stent along with endarterectomy/stent adjuncts. Axial imaging or angiography determined long-term patency. Vessel event was defined as new occlusion or reintervention after repair. Overall time-to-event analysis was performed as well as separate analyses for each vessel (celiac, superior mesenteric artery [SMA], right renal, left renal) by reconstruction type utilizing Kaplan-Meier methods. Log-rank testing was employed to compare reconstructive strategies. RESULTS: Over 28 years, 604 repairs (type I, 106 [18%]; type II, 73 [12%]; type III, 195 [32%]; and type IV, 230 [38%]) were identified. Follow-up (median, 500 days) was available in 410/570 (72%) celiac, 406/573 (71%) SMA, 379/532 (71.2%) right renal, and 370/515 (72%) left renal reconstructions. There were five celiac, one SMA, eight right renal, and 10 left renal events. No type of reconstruction or adjunct was significantly associated with event. Overall 5-year patency of all renal/visceral reconstructions was 94% (95% confidence interval, 90%-96%). Estimated 5-year patency of the celiac, SMA, left renal, and right renal were similar, and were 99%, 100%, 97%, and 96%, respectively (P = .09). CONCLUSIONS: Visceral and renal long-term patency after open TAAA repair is excellent regardless of reconstructive technique. No differences are appreciated even when target vessel disease is addressed at the time of reconstruction. These findings continue to substantiate the effective long-term durability of open TAAA repair and are particularly germane to the ongoing evolution of endovascular strategies.

Comparison of 30 Day Stroke and Death in Hybrid Intervention and Open Surgical Reconstruction for the Treatment of Tandem Carotid Bifurcation and Supra-aortic Trunk Disease.

OBJECTIVE: The optimal approach for the treatment of tandem carotid bifurcation and supra-aortic trunk (SAT) disease remains controversial. The hybrid technique of carotid endarterectomy (CEA) with ipsilateral proximal endovascular intervention (IPE) has provided an attractive alternative to CEA with open SAT reconstruction (SATr). However, no studies have compared cohorts treated by these two approaches. METHODS: Using the National Surgical Quality Improvement Program (2005-2017), patients who underwent CEA + IPE and CEA + SATr were identified. Non-occlusive indications were excluded. Primary outcomes included 30 day stroke, death, and their composite (stroke and/or death [SD]). Univariable and logistic regression analyses were performed. RESULTS: In total, 372 patients were identified: 319 CEA + SATr and 53 CEA + IPE. SATr included 19 (5.9%) aorta to carotid bypasses, 22 (6.9%) carotid subclavian transpositions, 96 (30.1%) carotid carotid bypasses, 179 (56.1%) carotid subclavian bypasses, and three (0.9%) SAT endarterectomies. The mean age was 69 ± 10 years. The majority were men (53%), white (85%), and had a history of hypertension (84%). There were no demographic differences between the operative cohorts except that those having CEA + SATr were more likely to have hypertension (86% vs. 74%; p = .031). CEA + SATr had longer operative times and longer hospital length of stay. There were no differences in outcomes between the cohorts: stroke (CEA + SATr 4.1% vs. CEA + IPE 3.8%; p = .92), death (1.6% vs. 0%; p = .36), or SD (5.3% vs. 3.8%; p = .63). After risk adjustment, predictors of SD included symptomatic status (odds ratio [OR] 3.9, 95% confidence interval [CI] 1.1-13.5; p = .034), congestive heart failure (OR 16.5, 95% CI 2.0-136; p = .011), and return to the operating room (OR 8.5, 95% CI 2.3-30.8; p = .001). Operative method was not predictive (p = .63). CONCLUSION: Outcomes following CEA + SATr and CEA + IPE are similar. Although proposed as a safer, less invasive alternative, the hybrid approach did not reduce the risk of operative stroke or death relative to open reconstruction for the treatment of occlusive, tandem carotid/SAT disease. Based upon lesion and patient factors, both may be considered management options in select patients.