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The choice of intervention for treating suprainguinal arterial disease, open bypass vs endovascular intervention, is often tempered by patient age and comorbidities. In the present study, we compared the association of patient age with 1-year major adverse limb events (MALE)-free survival and reintervention-free survival (RFS) rates among patients undergoing intervention for suprainguinal arterial disease.The Vascular Quality Initiative datasets for bypass and peripheral endovascular intervention (PVI; aorta and iliac only) were queried from 2010 to 2017. The patients were divided into two age groups: 60 and ≥60 years at the procedure. Age-stratified propensity matching of patients in bypass and endovascular procedure groups by demographic characteristics, comorbidities, and disease severity was used to identify the analysis samples. The 1-year MALE-free survival and RFS rates were compared using the log-rank test and Kaplan-Meier plots. Proportional hazard Cox regression was used to perform propensity score-adjusted comparisons of MALE-free survival and RFS.A total of 14,301 cases from the Vascular Quality Initiative datasets were included in the present study. Propensity matching led to 3062 cases in the ≥60-year group (1021 bypass; 2041 PVI) and 2548 cases in the 60-year group (1697 bypass; 851 PVI). In the crude comparison of the matched samples, the older patients undergoing bypass had had significantly greater in-hospital (4.6% vs 0.9%; P .001) and 1-year (10.5% vs 7.5%; P = .005) mortality compared with those who had undergone endovascular intervention. The rates of MALE (7.5% vs 14.3%; P .001) and reintervention (6.7% vs 12.7%; P .001) or death were significantly higher for the younger group undergoing PVI than bypass at 1 year. However, the rates of MALE (12.9% vs 14.3%; P = .298) and reintervention (12.7% vs 12.9%; P = .881) or death for were similar both procedures for the older group. Both log-rank analyses and the adjusted propensity score analyses of MALE-free survival and RFS in the two age groups confirmed these findings. The adjusted comparison of outcomes using propensity score matching favored PVI at 1-year survival (hazard ratio, 1.4; 95% confidence interval, 1.1-1.9; P = .003) for the older group but was not different for the younger group (hazard ratio, 0.6; 95% confidence interval, 0.3-1.0; P = .054).Among the patients aged 60 years undergoing intervention for suprainguinal arterial disease, the choice of therapy should be open surgical intervention given the higher risk of reintervention and MALE with endovascular intervention. Endovascular intervention should be favored for patients aged ≥60 years because of reduced perioperative mortality.

Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality.This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes.During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P .001), MACEs (9.6% vs 2.1%; P .001), prolonged LOS (65% vs 28%; P .001), and in-hospital mortality (2.9% vs 0.7%; P .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P .001), female sex (1.3 [1.2-1.4]; P .001), positive stress test result (1.3 [1.2-1.4]; P .001), age 70 to 79 years (1.1 [1.1-1.3]; P .002), age80 years (1.2 [1.1-1.4]; P .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P .01). A history of hypertension was protective (0.9 [0.8-0.9]; P .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality.Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network, a U.S. Food and Drug Administration (FDA)-supported global public-private partnership that seeks to advance the collection and use of real-world data to improve patient outcomes. The VISION CRN began in September 2015 and held its first strategic meeting on September 10, 2018, at the FDA headquarters in Silver Spring, Maryland. VISION is a collaboration of the Vascular Quality Initiative (VQI), the FDA, and other stakeholders. At this annual meeting, leaders from the FDA, VQI, industry representatives, population health researchers, and regulatory science experts gathered to discuss strategic goals and opportunities for VISION. One of the key focus areas for VISION is linkage of VQI registry data to Medicare, longitudinal data sources maintained by various states, and other relevant data sources, as a model for efficient, cost-saving, and effectual evidence generation and appraisal. This would provide the means to expand data collection, assess long-term procedural outcomes across the carotid, lower extremity, aortic, and venous intervention datasets, and execute registry-based trials through the CRN structure in an efficient, cost-effective manner. Looking forward, VISION strives to validate long-term outcome data in the VQI using industry datasets, in hopes of using CRNs to make device regulatory decisions. With the guidance of a steering committee, VISION will provide vascular surgeons, industry, and regulators the appropriate data to improve care for patients with vascular disease.

Objective The Vascular Quality Initiative (VQI) is the largest registry of vascular surgical procedures and as such is capable of distinguishing small but important differences in outcomes. The goal of this study was to determine the outcomes of carotid endarterectomy (CEA) based on patch type, including bovine pericardium, autogenous vein, polytetrafluoroethylene (PTFE), and Dacron. Methods All primary CEAs performed with primary repair and patching (n = 70,987) within the VQI were retrospectively analyzed. Reoperative CEA and combined CEA and coronary artery bypass were excluded. Rates of any postoperative neurologic event, return to the operating room (bleeding, neurologic event, or wound complication), and restenosis (>50% and >80%) at 1-year follow-up were primary outcomes. Rates were compared by patch type using χ2 and Bonferroni analysis. Multivariate hierarchical logistic regression models were used to predict end points of postoperative neurologic event, return to the operating room, and 1-year restenosis. Results During the period of study, 2003 to 2017, there were 70,987 CEAs entered into the VQI registry. Bovine pericardium was the patch material with the highest frequency of use (n = 51,480), followed by Dacron (n = 12,356), vein (n = 1460), and PTFE (n = 1638). Bovine pericardium, vein, and Dacron had lower rates of postoperative neurologic events compared with PTFE or primary repair. Bovine pericardium had the lowest rate of restenosis at 1 year. By multivariate analysis, bovine pericardium (odds ratio [OR], 0.70; 95% confidence interval [CI], 0.56-0.89) and protamine use (OR, 0.74; 95% CI, 0.60-0.91) were associated with a lower incidence of return to the operating room. The use of Dacron, vein, and PTFE patches was not significantly different from the reference of primary closure. Multivariate analysis of postoperative neurologic events revealed that bovine pericardium (OR, 0.59; CI, 0.48-0.72) and Dacron (OR, 0.56; CI, 0.43-0.72) were associated with lower incidence of stroke or transient ischemic attack, whereas vein and PTFE were no different from primary closure. Bovine pericardium (OR, 0.57; CI, 0.44-0.75), Dacron (OR, 0.70; CI, 0.50-0.98), vein (OR, 0.72; CI, 0.53-0.98), and never smoking (OR, 0.87; CI, 0.78-0.96) were associated with a lower incidence of restenosis at 1 year by multivariate analysis. Conclusions Bovine pericardium has superior outcomes both postoperatively and at 1 year compared with other patch materials. The large volume of patient data contained in the VQI makes it possible to compare outcomes that have small but meaningful differences.

Objective Major adverse event (MAE) rates are used as an outcome measure after surgical procedures. Although MAE rates summarize the occurrences of adverse events, they do not reflect differences in severity of these events. We propose that a measure of complication severity could provide a more accurate assessment about the quality of care. We aimed to analyze and to describe the regional variation in elective endovascular aneurysm repair (EVAR) MAE rates across centers in the Vascular Study Group of New England and to create an index for describing complication severity. Methods Patients undergoing elective EVAR (n = 4731) at 30 Vascular Study Group of New England centers between 2003 and 2016 were studied. The MAE composite end point was defined as the occurrence of any of the following postoperative events: myocardial infarction, dysrhythmia, congestive heart failure, leg ischemia, renal insufficiency, bowel complication, reoperation, surgical site infection, stroke, respiratory complication, and no home discharge. An adjustment factor (complication severity index) was calculated as a ratio of length of stay for complicated to uncomplicated cases. Multivariate logistic regression was used to calculate predicted MAE rates. The observed and predicted MAE rates as well as complication severity index rates were compared among centers and across quintiles of center volume. Results Observed MAE rates varied widely, ranging from 0% to 39%. Multivariate predictors of MAE included abdominal aortic aneurysm diameter >6 cm (odds ratio [OR], 2.1; 95% confidence interval [CI], 2.0-2.3), female sex (OR, 2.0; 95% CI, 1.8-2.2), chronic renal insufficiency (OR, 1.9; 95% CI, 1.7-2.1), age >75 years (OR, 1.9; 95% CI, 1.8-2.1), congestive heart failure (OR, 1.7; 95% CI, 1.5-1.9), chronic obstructive pulmonary disease (OR, 1.5; 95% CI, 1.4-1.6), diabetes (OR, 1.4; 95% CI, 1.1-1.7), positive stress test result (OR, 1.2; 95% CI, 1.1-1.4), preoperative beta blocker (OR, 1.2; 95% CI, 1.1-1.3), and no preoperative statin (OR, 1.2; 95% CI, 1.1-1.3). Predicted MAE rates had little variation (range, 21%-29%). In comparing observed MAE rates and complication severity, there was an inverse relation between the two, suggesting that although certain centers had a greater number of MAEs, the complications were less severe. Conclusions MAE rates after elective EVAR vary widely. However, centers with higher MAE rates tended to have less severe complications, suggesting that observed MAE rates may not be a good measure of outcomes assessment after elective EVARs.

This manuscript describes the abrupt pivot of VQI physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures in response to the pandemic. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020 to discern pandemic impact. Approximately three fourths (74%) of physicians adopted a restrictive operating policy for urgent and emergent cases only, yet one half considered ‘time sensitive’ elective cases as urgent. Data manager case entry was affected by both low case volume and staffing due to re-assignment or furlough. A seven-fold reduction in arterial VQI case volume entry was noted in 1st Quarter of 2020 when compared to same period in 2019. The downstream consequences of delaying vascular procedures for carotid, aortic, vascular access and chronic limb ischemia remain undetermined. Further ramifications of a pandemic shutdown will likely be amplified if resumption of elective vascular care extends beyond a short window of time., Article Highlights Type of Research: SVS PSO survey of clinical practice effects due to coronavirus, Covid-19 pandemic. Retrospective review of VQI arterial registry volume between 1st Quarter of 2019 and 2020. Key Findings: Seventy four percent of respondents restricted operating policy to urgent and emergent procedures because of the pandemic. One half of surgeons reported doing ‘time sensitive’ elective procedures despite policy shift including large AAA repair. A seven-fold reduction in VQI arterial registry procedure volume was noted in 1st Quarter of 2020 when compared to same period in 2019, with Data Manager re-assignment/furlough and case volume decline contributing. Take home Message: VQI arterial case volume activity and registry data entry was sharply reduced during the initial phase of the Covid-19 pandemic as many vascular surgeons adopted a restrictive policy on elective vascular procedures.

Transcarotid artery revascularization (TCAR) using a flow-reversal neuroprotection system has gained popularity for the endovascular treatment of carotid artery atherosclerotic disease owing to its lower risk of stroke or death compared with transfemoral carotid artery stenting. However, specific risk factors associated with stroke or death complications after TCAR have yet to be defined.All patients undergoing TCAR for the treatment of asymptomatic or symptomatic atherosclerotic carotid disease were identified between September 2016 and September 2019 in the Vascular Quality Initiative TCAR Surveillance Project. Our primary outcome was 30-day stroke or death. We created a risk model for 30-day stroke or death using multivariable fractional polynomials and internally validated the model using bootstrapping.During the study period 7633 patients underwent TCAR, of which 4089 (53.6%) were treated for symptomatic and 3544 (46.4%) for asymptomatic disease. The average age of patients undergoing TCAR was 73.3 ± 9.1 years and 63.7% were male. Stroke or death events within 30 days of the index operation occurred in 153 patients (2.0%). Factors independently associated with a higher odds of 30-day stroke or death included the severity of presenting stroke symptoms (cortical transient ischemic attack, odds ratio [OR], 2.17 [95% confidence interval (CI), 1.21-3.90; P = .009]; stroke, OR, 3.30; 95% CI, 2.25-4.85; P .001), advancing age (OR, 1.03 per year; 95% CI, 1.01-1.06; P = .003), and history of unstable angina or myocardial infarction within the past 6 months (OR, 2.20; 95% CI, 1.29-3.77; P = .004), moderate or severe congestive heart failure (OR, 2.44; 95% CI, 1.31-4.55; P = .005), chronic obstructive pulmonary disease (on medications, OR, 1.61 [95% CI, 1.06-2.43; P = .024]; on home oxygen, OR, 2.52 [95% CI, 1.44-4.41; P = .001]), and prior ipsilateral carotid endarterectomy (OR, 1.56; 95% CI, 1.09-2.25; P = .016), whereas preoperative P2YThis Vascular Quality Initiative TCAR risk score calculator can be used to estimate the risk of stroke or death within 30 days of the procedure. Because TCAR is commonly used to treat patients with high surgical risk for carotid endarterectomy, this risk score will help to guide treatment decisions in patients being considered for TCAR.

Background The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. Methods The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. Results Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. Conclusions The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance

Recent studies have found that transcarotid artery revascularization (TCAR) is associated with lower risk of stroke or death compared with transfemoral carotid artery stenting but higher risk of bleeding complications, presumably associated with the need for an incision. Heparin anticoagulation is universally used during TCAR, so protamine use may reduce bleeding complications. However, the safety and effectiveness of protamine use in TCAR are unknown. We therefore evaluated the impact of protamine use on perioperative outcomes after TCAR in the Vascular Quality Initiative TCAR Surveillance Project.We performed a retrospective review of patients undergoing TCAR in the Vascular Quality Initiative TCAR Surveillance Project from September 2016 to April 2019. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary efficacy end point was access site bleeding complications, and the primary safety end point was in-hospital stroke or death. Secondary end points included the individual end points of stroke, death, transient ischemic attack, myocardial infarction, congestive heart failure exacerbation, and hemodynamic instability.Of the 5144 patients undergoing TCAR, all patients received heparin and 4072 (79%) patients received protamine. We identified 944 matched pairs of patients who did and did not receive protamine. Protamine use was associated with a significantly lower risk of bleeding complications (2.8% vs 8.3%; relative risk [RR], 0.33; 95% confidence interval [CI], 0.21-0.52; P .001), including bleeding that resulted in interventional treatment (1.0% vs 3.6%; RR, 0.26; 95% CI, 0.13-0.54; P .001) and in blood transfusion (1.2% vs 3.9%; RR, 0.30; 95% CI, 0.15-0.58; P .001). There were no statistically significant differences in in-hospital stroke or death for patients who received protamine and those who did not (1.6% vs 2.2%; RR, 0.71; 95% CI, 0.37-1.39; P = .32); however, there was a trend toward lower risk of stroke for patients who received protamine (1.1% vs 2.0%; RR, 0.53; 95% CI, 0.24-1.13; P = .09). There were also no statistically significant differences in the rates of transient ischemic attack (0.4% vs 1.1%; RR, 0.40; 95% CI, 0.13-1.28; P = .11), myocardial infarction (0.4% vs 0.8%; RR, 0.50; 95% CI, 0.15-1.66; P = .25), heart failure exacerbation (0.4% vs 0.3%; RR, 1.33; 95% CI, 0.30-5.96; P = .71), or postoperative hypotensive hemodynamic instability (16% vs 15%; RR, 1.06; 95% CI, 0.83-1.35; P = .50) with protamine use.Protamine can be safely used in TCAR to reduce the risk of perioperative bleeding complications without increasing the risk of thrombotic events.

Background Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy. Methods A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey. Results The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234). Conclusions In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.

Society for Vascular Surgery practice guidelines recommend 1- and 12-month follow-up with computed tomography imaging for the year after endovascular aneurysm repair (EVAR). We describe the incidence, risk factors, and outcomes of EVAR patients who are lost to follow-up (LTF).All patients undergoing elective EVAR in the Vascular Quality Initiative (VQI) data set (January 2003-December 2015) were stratified according to long-term follow-up method (in-person vs phone call vs LTF). Mortality was captured for all patients by linkage with the Social Security Death Index. Univariable statistics, Kaplan-Meier estimated survival curves, and Cox proportional hazard modeling were used to compare groups. Coarsened exact matching analysis was then performed to refine the association between LTF and risk of post-EVAR death.During the study period, 11,309 patients underwent elective EVAR (78% in-person follow-up, 11% phone call follow-up, 11% LTF). On univariable analysis, LTF patients had larger baseline aneurysms, higher American Society of Anesthesiologists scores, more comorbidities, and worse baseline functional status compared to patients with in-person or phone call follow-up (P ≤ .05). Procedural factors (contrast material volume, blood transfusions, postoperative vasopressor use) were higher in the LTF group, as was the incidence of postoperative complications (P ≤ .05). Accordingly, LTF patients had longer postoperative lengths of stay and were less frequently discharged to home (P .001). Five-year survival was lower for LTF vs phone call follow-up vs in-person follow-up (62% vs 68% vs 84%; P .001). On multivariable analysis correcting for baseline differences between groups, there was a significantly higher risk of death for both the LTF group (hazard ratio, 6.45; 95% confidence interval, 4.89-8.51) and phone call follow-up group (hazard ratio, 3.48; 95% confidence interval, 2.66-4.57) compared with patients who followed up in person (P .001). After coarsened exact matching on 30 preoperative and perioperative variables, 5-year survival after EVAR for LTF vs phone call follow-up vs in-person follow-up was 84.9% vs 84.8% vs 91.9%, respectively (log-rank, P .001). Notably, patients with phone call follow-up had a lower prevalence of documented postoperative imaging compared with patients with in-person follow-up (56.1% vs 85.1%; P .001).EVAR patients with more comorbidities and a higher incidence of in-hospital complications tend to be more frequently LTF and ultimately have worse survival outcomes. In-person follow-up is associated with better post-EVAR survival and a higher rate of postoperative imaging. Phone follow-up confers a mortality risk equivalent to lack of follow-up, possibly as a result of inadequate postoperative imaging. Surgeons should stress the importance of office-based postoperative follow-up to all EVAR patients, particularly those with poor baseline health and functional status and more complicated perioperative courses.

Operative volume has been used as a marker of quality. Research from previous decades has suggested minimum open abdominal aortic aneurysm (AAA) repair volume requirements for surgeons of 9 to 13 open AAA repairs annually and for hospitals of 18 open AAA repairs annually to purportedly achieve acceptable results. Given concerns regarding the decreased frequency of open repairs in the endovascular era, we examined the association of surgeon and hospital volume with the 30- and 90-day mortality in the Vascular Quality Initiative (VQI) registry.Patients who had undergone elective open AAA repair from 2013 to 2018 were identified in the VQI registry. We performed a cross-sectional evaluation of the association between the average hospital and surgeon volume and 30-day postoperative mortality using a hierarchical Bayesian model. Cross-level interactions were permitted, and random surgeon- and hospital-level intercepts were used to account for clustering. The mortality results were adjusted by standardizing to the observed distribution of relevant covariates in the overall cohort. The outcomes were compared to the Society for Vascular Surgery guidelines recommended criteria of 5% perioperative mortality.A total of 3078 patients had undergone elective open AAA repair by 520 surgeons at 128 hospitals. The 30- and 90-day risks of postoperative mortality were 4.1% (n = 126) and 5.4% (n = 166), respectively. The mean surgeon volume and hospital volume both correlated inversely with the 30-day mortality. Averaged across all patients and hospitals, we found a 96% probability that surgeons who performed an average of four or more repairs per year achieved 5% 30-day mortality. Substantial interplay was present between surgeon volume and hospital volume. For example, at lower volume hospitals performing an average of five repairs annually, 5% 30-day mortality would be expected 69% of the time for surgeons performing an average of three operations annually. In contrast, at higher volume hospitals performing an average of 40 repairs annually, a 5% 30-day mortality would be expected 96% of the time for surgeons performing an average of three operations annually. As hospital volume increased, a diminishing difference occurred in 30-day mortality between lower and higher volume surgeons. Likewise, as surgeon volume increased, a diminishing difference was found in 30-day mortality between the lower and higher volume hospitals.Surgeons and hospitals in the VQI registry achieved mortality outcomes of 5% (Society for Vascular Surgery guidelines), with an average surgeon volume that was substantially lower compared with previous reports. Furthermore, when considering the development of minimal surgeon volume guidelines, it is important to contextualize the outcomes within the hospital volumes.

Professional societies publish clinical practice guidelines to provide evidence-based recommendations to improve care and to reduce practice variation. However, the degree of compliance with the guidelines and its impact on outcomes have not been well defined. This study used the Vascular Quality Initiative (VQI) abdominal aortic aneurysm (AAA) registries to determine current compliance with and impact of recent Society for Vascular Surgery (SVS) AAA guidelines.Recommendations from the SVS AAA guidelines were reviewed and assessed as to whether they could be evaluated with current VQI data sets. The degree of compliance with these individual recommendations was calculated by center and correlated with clinical outcomes. Data were analyzed by univariate analysis and mixed effects multivariable logistic regression. Statistical significance was measured at P .05.Of the 111 SVS recommendations, 10 could be evaluated using VQI registries. The mean center-specific compliance rate ranged from 40% (smoking cessation 2 weeks before open AAA [OAAA] repair) to 99% (preservation of flow to one internal iliac artery during endovascular aneurysm repair [EVAR]). Some recommendations were associated with improved outcomes (eg, cell salvage for OAAA repair and antibiotic prophylaxis), whereas others were not (eg, EVAR at a center with10 cases per year or door-to-intervention time 90 minutes for ruptured AAA). With multivariable analysis, compliance with preservation of flow to the internal iliac artery decreased major adverse cardiac events in EVAR and marginally decreased in-hospital and 1-year mortality in OAAA repair. Antibiotic administration decreased surgical site infection, major adverse cardiac events, and in-hospital mortality and marginally decreased respiratory complications and 1-year mortality in EVAR. Cell salvage for OAAA repair decreased 1-year mortality. Tobacco cessation before EVAR or OAAA repair decreased respiratory complications and 1-year mortality.The VQI registry is a valuable tool that can be used to measure compliance with SVS AAA guidelines. Compliance with recommendations was associated with improved outcomes and should be encouraged for providers. Participation in the VQI registry provides an objective assessment of performance and compliance with guidelines. VQI provider and center reports may be used as a focus for quality improvement efforts.

Previous data showed superior outcomes of carotid endarterectomy (CEA) compared with transfemoral carotid artery stenting (TFCAS) in elderly patients because of an increased stroke risk in TFCAS-treated patients. Transcarotid artery revascularization (TCAR) with flow reversal was developed to mitigate the maneuvers at highest risk for causing stroke during TFCAS, such as manipulation of a diseased aortic arch and crossing of the carotid lesion before deployment of an embolic protection device. This study aimed to compare the association between age and outcomes after TCAR, TFCAS, and CEA.All patients undergoing carotid procedures in the Society for Vascular Surgery Vascular Quality Initiative database between 2015 and November 2018 were included. Patients were divided into three different age groups (≤70 years, 71-79 years, and ≥80 years). In-hospital outcomes after TCAR vs TFCAS and after TCAR vs CEA were compared in each age group by introducing an interaction term between treatment type and age in the logistic regression analysis after adjustment for patients' preoperative characteristics.The study cohort included 3152 TCAR, 10,381 TFCAS, and 61,650 CEA cases. The absolute and adjusted in-hospital outcomes after TCAR did not change across the different age groups. The rates of in-hospital stroke/death after TCAR were 1.4% in patients ≤70 years vs 1.9% in patients 71 to 79 years and 1.5% in patients ≥80 years (P = .55). Comparison of TCAR to CEA across different age groups showed no significant differences in outcomes, and no interaction was noted between treatment and age in predicting in-hospital stroke/death (P = .80). In contrast, TCAR was associated with a 72% reduction in stroke risk (4.7% vs 1%; odds ratio [OR], 0.28; 95% confidence interval [CI], 0.12-0.65; P .01), 65% reduction in risk of stroke/death (4.6% vs 1.5%; OR, 0.35; 95% CI, 0.20-0.62; P .001), and 76% reduction in the risk of stroke/death/myocardial infarction (5.3% vs 2.5%; OR, 0.24; 95% CI, 0.12-0.47; P .001) compared with TFCAS in patients ≥80 years. Moreover, compared with TCAR, the odds of stroke/death after TFCAS doubled at 77 years (OR, 2.0; 95% CI, 1.4-3.0; P .01) and tripled at 90 years (OR, 3.0; 95% CI, 1.6-5.8; P .01; P value for the interaction = .08).TCAR is a relatively safe procedure regardless of the patient's age. The advantages of TCAR become more pronounced in elderly patients, with significant reductions in in-hospital stroke compared with TFCAS in patients ≥77 years old, independent of symptomatic status and other medical comorbidities. These findings suggest that TCAR should be preferred to TFCAS in elderly patients who are at high surgical risk.

The outcomes of carotid revascularization in patients with contralateral carotid artery occlusion (CCO) are controversial. CCO has been defined by the Centers for Medicare and Medicaid Services as a high-risk criterion and is used as an indication for transfemoral carotid artery stenting. With the promising outcomes associated with transcarotid artery revascularization (TCAR), we aimed to study the perioperative outcomes of TCAR in patients with CCO and to assess the feasibility of TCAR in these high-risk patients.All patients in the Vascular Quality Initiative database who underwent TCAR with flow reversal between September 2016 and May 2019 were included. Patients with trauma, dissection, or more than two treated lesions were excluded. Univariable and multivariable logistic analyses were used to compare the primary outcome of in-hospital stroke or death after TCAR in patients with CCO and those without CCO (patent and 99% stenosis). Secondary outcomes included intraoperative neurologic changes and the individual outcomes of in-hospital stroke, death, and myocardial infarction as well as 30-day mortality.A total of 5485 TCAR cases were included, of which 593 (10.8%) had CCO. In patients with CCO, mean flow reversal time was shorter (10.1 ± 6.7 minutes vs 11.1 ± 7.8 minutes; P .01); intraoperative neurologic changes occurred in 1% of these patients compared with 0.7% of those with patent contralateral carotid arteries (P = .43). On univariable analysis, no significant difference in in-hospital stroke or death was shown between patients with and patients without CCO (1.7% vs 1.5%; P = .65). Similarly, no significant differences were noted between the groups in terms of in-hospital death (0.7% vs 0.4%; P = .27), stroke (1.7% vs 1.2%; P = .32), and stroke/death/myocardial infarction (2.2% vs 1.8%; P = .53) as well as 30-day mortality (0.8% vs 0.6%; P = .55). The results remained statistically nonsignificant after adjustment for baseline differences between the groups; the adjusted odds ratio (OR) of in-hospital stroke/death in patients with CCO compared with those with patent contralateral carotid arteries was not significant (OR, 1.39; 95% confidence interval, 0.65-3.0; P = .40). In symptomatic patients presenting with prior stroke, CCO was associated with significantly higher odds of stroke or death (OR, 4.63; 95% confidence interval, 1.39-15.4; P = .01) compared with no CCO. On the other hand, in asymptomatic patients, no significant difference in outcomes was observed between the groups.In this analysis, TCAR seems to be safe in patients with CCO. Caution should be taken in symptomatic patients with CCO and a history of prior stroke as they might have worse outcomes compared with patients with patent contralateral carotid arteries. Studies with larger sample size and longer follow-up are needed to assess the perioperative and long-term outcomes of TCAR in patients with CCO in comparison to other procedures.

ObjectiveTranscarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarterectomy (CEA) are needed to confirm the safety of TCAR outside of highly selected patients and providers.MethodsWe compared in-hospital outcomes of patients undergoing TCAR and CEA from January 2016 to March 2018 using the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project registry and the Society for Vascular Surgery Vascular Quality Initiative CEA database, respectively. The primary outcome was a composite of in-hospital stroke and death.ResultsA total of 1182 patients underwent TCAR compared with 10,797 patients who underwent CEA. Patients undergoing TCAR were older (median age, 74 vs 71years; P< .001) and more likely to be symptomatic (32% vs 27%; P< .001); they also had more medical comorbidities, including coronary artery disease (55% vs 28%; P< .001), chronic heart failure (20% vs 11%; P1day (27% vs 30%; P=.046). On adjusted analysis, there was no difference in terms of stroke/death (odds ratio, 1.3; 95% confidence interval, 0.8-2.2; P= .28), stroke/death/MI (odds ratio, 1.4; 95% confidence interval, 0.9-2.1, P= .18), or the individual outcomes.ConclusionsDespite a substantially higher medical risk in patients undergoing TCAR, in-hospital stroke/death rates were similar between TCAR and CEA. Further comparative studies with larger samples sizes and longer follow-up will be needed to establish the role of TCAR in extracranial carotid disease management.

Background Patients undergoing vascular operations face high rates of intraoperative and postoperative complications and delayed return to baseline. Enhanced recovery after surgery (ERAS), with its aim of delivering high-quality perioperative care and accelerating recovery, appears well suited to address the needs of this population. Methods In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we performed a systematic review to characterize the use and effectiveness of ERAS in all types of vascular and endovascular operations. We queried MEDLINE (through PubMed), Embase, Web of Science, Scopus, ProQuest Dissertations and Theses Global, Cochrane Central Register of Controlled Trials, Prospero, and Google Scholar. Two reviewers independently completed screening, review, and quality assessment. Eligible articles described the use of ERAS pathways for vascular operations from January 1, 1997, through December 7, 2017. Details regarding patients' demographics and use of the ERAS pathway or selected ERAS components were extracted. When available, results including perioperative morbidity, mortality, and in-hospital length of stay were collected. The studies with control groups that evaluated ERAS-like pathways were meta-analyzed using random-effects meta-analysis. Results In the final analysis, 19 studies were included: four randomized controlled trials and 15 observational studies. By Let Evidence Guide Every New Decision (LEGEND) criteria, the two good-quality studies are randomized controlled trials that evaluated a specific part of an ERAS pathway. All other studies were considered poor quality. Meta-analysis of the five studies describing ERAS-like pathways demonstrated a reduction in length of stay by 3.5 days (P = .0012). Conclusions Based on systematic review, the use of ERAS pathways in vascular surgery is limited, and existing evidence of their feasibility and effectiveness is low quality. There is minimal poor- to moderate-quality evidence describing the use of ERAS pathways in open aortic operations. There is scarce, poor-quality evidence related to ERAS pathways in lower extremity operations and no published evidence related to ERAS pathways in endovascular operations. Although the risk of bias is high in most of the studies done to date, all of them observed improvements in length of stay, postoperative diet, and ambulation. It is reasonable to consider the implementation of ERAS pathways in the care of vascular surgery patients, specifically those undergoing open aortic operations, but many of the details will be based on limited data and extrapolation from other surgical specialties until further research is done.

Patch angioplasty has been shown to decrease rates of restenosis after carotid endarterectomy (CEA). In 2003, the Vascular Study Group of New England (VSGNE) implemented its first quality initiative aimed at increasing the rates of patch closure after CEA. This study reports the effects of that initiative on the rate of patch closure in the VSGNE and also postoperative and 1-year CEA outcomes.Patients undergoing CEA (N = 14,636) within the VSGNE between 2003 and 2014 were studied. Rates of in-hospital postoperative events (death, ipsilateral stroke or transient ischemic attack [TIA], and return to the operating room for bleeding) and events during 1 year of follow-up (stroke or TIA and restenosis70% or occlusion) were compared by repair type-patch closure, primary closure, or eversion. One-year follow-up events were also compared over time and by annualized surgeon volume.During the 12 years studied, patch use increased from 71% to 91% (P .001). There was no difference in postoperative death or ipsilateral stroke or TIA between the repair types. However, there was a statistically lower rate of return to the operating room for bleeding (P .001), 1-year stroke or TIA (P .003), and 1-year restenosis or occlusion (P .001) with patch closure. Overall, the rates of 1-year stroke or TIA and restenosis decreased over time in the VSGNE. The initiative affected patch closure rates and outcomes of high-volume surgeons (47 CEAs/y) the most. High-volume surgeons increased patch use from 50% to 90% and decreased their restenosis rates from 9.0% to 1.2% and 1-year stroke or TIA from 4.9% to 1.9% (P .001).The VSGNE carotid patch quality initiative successfully increased the rates of CEA patch closure. During the same time, there has been a decrease in postoperative bleeding requiring reoperation and 1-year ipsilateral neurologic events and restenosis or occlusion.

Objective The aim of this review was to provide an up-to-date summarization of available Food and Drug Administration-approved vascular closure devices (VCDs) and to analyze current evidence comparing individual devices with one another and with manual compression (MC). The review includes indications for use, advantages and disadvantages, safety and efficacy, and outcomes. Methods A review of literature available on VCDs was conducted using PubMed and MEDLINE. Only clinical trials published within the last 10 years evaluating the efficacy of different VCDs with access obtained through common femoral artery or vein were included. All literature included in this review was published in English and used human participants. Results The search strategy yielded 34 relevant articles. These studies included procedures ranging from diagnostic catheterizations to percutaneous endovascular aneurysm repair. There is considerable heterogeneity in the studies, with a wide variety of definitions and different outcome measures. The review demonstrated that VCDs provided improvement in the patients' comfort and satisfaction as well as in the time to hemostasis and ambulation. Most studies are underpowered to show differences, but even after meta-analysis or Cochrane review, complication rates as well as safety and efficacy between devices and MC remained comparable. Conclusions VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture.

Performing lower extremity bypass (LEB) in actively smoking claudicants remains controversial. Whereas some surgeons advocate a strict nonoperative approach to active smokers, citing perceived inferior outcomes, others will proceed with surgical bypass if the patient is anatomically suited and medical management has failed. The purpose of this study was to determine the impact of active smoking on LEB outcomes among claudicants.All patients undergoing infrainguinal LEB for claudication in the Vascular Study Group of New England from 2003 to 2016 were analyzed. Smoking was defined as active tobacco use within 1 month of surgery. End points included in-hospital outcomes; long-term primary, assisted primary, and secondary patency; and mortality. Univariate, Cox multivariable, and Kaplan-Meier methods were used to determine the impact of smoking. Propensity score matching was performed to control for intergroup differences.Of 1789 LEBs, 971 (54%) were performed in nonsmokers and 818 (46%) in smokers. The follow-up rate was 87% at a mean of 382 days (standard error, ±6.8 days). Smokers were younger (60 vs 68 years; P .001) and were less likely to have multiple comorbidities, including hypertension, coronary artery disease, congestive heart failure, diabetes, and chronic renal insufficiency (P ≤ .05); they were more likely to have an above-knee popliteal bypass target (52% vs 43%; P = .001). Smokers also had lower rates of postoperative major cardiac events (2.4% vs 5.3%; P = .002) and perioperative blood transfusion (5.6% vs 11%; P .001) compared with nonsmokers, but there was no difference in respiratory complications, wound complications, or mortality. At 2-year follow-up, smokers demonstrated inferior primary patency (48% vs 61%; P = .03) and assisted primary patency (59% vs 74%; P = .01), with comparable rates of secondary patency and overall mortality. Propensity matching yielded two similar groups (n = 450 for each). Propensity-matched smokers had significantly decreased 2-year primary patency (43% vs 58%; P = .02), assisted primary patency (54% vs 71%; P = .03), and 10-year survival (69% vs 76%; P .01). Cox multivariable analysis confirmed that smoking was an independent predictor of diminished primary patency (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.0-1.6; P = .03), assisted primary patency (HR, 1.4; 95% CI, 1.1-1.8; P = .004), and overall survival (HR, 1.3; 95% CI, 1.1-1.5; P .001).Despite the fact that smokers are younger and have fewer comorbidities than nonsmokers, active smoking at the time of LEB for claudication is associated with decreased long-term patency and decreased overall survival. Surgeons should consider smoking an important risk factor for worse LEB outcomes in smokers compared with nonsmokers.

Objective Lower extremity bypass (LEB) operations have high rates of surgical site infections (SSI). Phenylephrine is a commonly used vasoconstrictor which may reduce skin blood flow and increase the likelihood of SSI in these patients. We studied the potential effect of phenylephrine infusion during LEB surgery on SSI. Methods LEB cases and their demographic data were identified through the Vascular Quality Initiative registry. SSI in this population was identified using the hospital epidemiology surveillance database. Phenylephrine use in this population was identified through chart review. Results We identified 699 patients who underwent LEB; 82 (11.7%) developed an SSI, and 244 of 698 (35.0%) were treated with phenylephrine infusion. In bivariate analysis, higher body mass index (28.8 kg/m 2 vs 27.3 kg/m 2 ; P = .034), diabetes (14.6% vs 9.4%; P = .035), hypertension (12.6% vs 4.7%; P = .038), groin incision (13.2 vs 5.4%; P = .013) and longer procedure times (17.1% for >220 minutes and 8.9% for ≤220 minutes; P = .003) were associated with higher rates of SSI. Whereas phenylephrine infusion exhibited a trend toward a higher rate (14.8% vs 9.9%; P = .057). In the logistic regression model, diabetes (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.0-3.2; P = .032), total procedure time (OR, 1.85; 95% CI, 1.1-3.1; P = .026) and vertical groin incision (OR, 2.6; 95% CI, 1.1-6.5; P = .035) were independent predictors of increased SSI rates, whereas body mass index (OR, 1.04; 95% CI, 0.99-1.08; P = .09), hypertension (OR, 2.5; 95% CI, 0.6-10.9; P = .22), and phenylephrine infusion (OR, 1.08; 95% CI, 0.63-1.85; P = .78) were not independent predictors of increased SSI rates. Conclusions Phenylephrine infusion did not increase the risk of SSI in patients who underwent LEB.