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Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while post-market surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the two sources.Patient-level data from two industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data was matched at the patient-level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention.Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at one year, 82.6% at three years, and 68.1% at five years. Estimates for freedom from reintervention were 90% at one year, 82.4% at three years, and 78.1% at five years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank p=0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at one and five years, respectively (log-rank p=0.13).Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.

Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.

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.

Cirrhosis is a heterogeneous disease that cannot be studied as a single entity and is classified in two main prognostic stages: compensated and decompensated cirrhosis. Portal hypertension, characterized by a pathological increase of the portal pressure and by the formation of portal-systemic collaterals that bypass the liver, is the initial and main consequence of cirrhosis and is responsible for the majority of its complications. A myriad of treatment options exists for appropriately managing the most common complications of portal hypertension, including acute variceal bleeding and refractory ascites. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Nontraumatic aortic disease can be caused by a wide variety of disorders including congenital, inflammatory, infectious, metabolic, neoplastic, and degenerative processes. Imaging examinations such as radiography, ultrasound, echocardiography, catheter-based angiography, CT, MRI, and nuclear medicine examinations are essential for diagnosis, treatment planning, and assessment of therapeutic response. Depending upon the clinical scenario, each of these modalities has strengths and weaknesses. Whenever possible, the selection of a diagnostic imaging examination should be based upon the best available evidence. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. The purpose of this document is to assist physicians select the most appropriate diagnostic imaging examination for nontraumatic aortic diseases.

ImportanceCarotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known.ObjectiveTo compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk.Design, Setting, and ParticipantsThis retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures.ExposuresTranscarotid artery revascularization vs carotid endarterectomy.Main Outcomes and MeasuresThe primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke.ResultsAfter 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, −0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, −0.13% [95% CI, −0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67).Conclusions and RelevanceIn this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

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.

This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest.The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278).The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 - 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 - 1.04) and cohort C (HR 1.10, 95% CI 0.84 - 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 - 1.00; cohort B: HR 0.84, 95% CI 0.67 - 1.06; and cohort C: HR 1.05, 95% CI 0.51 - 2.14).No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings.

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.

Iliofemoral venous thrombosis carries a high risk for pulmonary embolism, recurrent deep vein thrombosis, and post-thrombotic syndrome complicating 30% to 71% of those affected. The clinical scenarios in which iliofemoral venous thrombosis is managed may be diverse, presenting a challenge to identify optimum therapy tailored to each situation. Goals for management include preventing morbidity from venous occlusive disease, and morbidity and mortality from pulmonary embolism. Anticoagulation remains the standard of care for iliofemoral venous thrombosis, although a role for more aggressive therapies with catheter-based interventions or surgery exists in select circumstances. Results from recent prospective trials have improved patient selection guidelines for more aggressive therapies, and have also demonstrated a lack of efficacy for certain conservative therapies. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

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.

ObjectivesGenerating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.Design, setting, and participantsWe invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.Main outcome measuresConsensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.ResultsOf 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.ConclusionsWe have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

ObjectiveTo evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data.DesignObservational surveillance study.Setting282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18).Participants20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models.Main outcome measuresReintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both.ResultsMedian age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017.ConclusionsThe linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

Vascular malformations of the extremities represent a wide spectrum of lesions, broadly divided into high-flow and low-flow categories. High-flow lesions include arteriovenous malformations and arteriovenous fistulas, while the more common low-flow lesions consist of venous and lymphatic malformations. The clinical presentation of vascular malformations is variable and can include extremity pain, discoloration, focal mass, or diffuse extremity enlargement. A vascular murmur can also be present and is more typical of high-flow lesions. While vascular malformations can often be diagnosed or strongly suspected by clinical features alone, imaging is often used to confirm the diagnosis, determine lesion characteristics and extent, and/or plan for treatment. Among the imaging options available, those usually appropriate for initial imaging of suspected vascular malformation are MR angiography without and with intravenous contrast, MRI without and with intravenous contrast, CT angiography with intravenous contrast, or US duplex Doppler. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

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.

A broad range of nonatherosclerotic diseases affect the peripheral arteries. The appropriate initial diagnostic imaging studies vary, depending upon the clinical presentation and suspicion of disease. Accurate vascular imaging relies upon visualization of the vessel lumen, vessel wall, and surrounding soft-tissue structures, with some modalities also offering the ability to characterize blood flow direction and velocity. Furthermore, nonvascular findings are often paramount in supporting a suspected clinical syndrome or guiding surgical management. The scenarios discussed in this document include the initial evaluation of suspected popliteal entrapment syndrome, external iliac artery endofibrosis, lower-extremity inflammatory vasculitides, dissection or connective tissue disease, noninflammatory vascular disease, and vascular trauma. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Abdominal aortic aneurysm (AAA) is defined as aneurysmal dilation of the abdominal aorta to 3 cm or greater. A high degree of morbidity and mortality is associated with AAA rupture, and imaging surveillance plays an essential role in mitigating the risk of rupture. Aneurysm size and growth rate are factors associated with the risk of rupture, thus surveillance imaging studies must be accurate and reproducible to characterize aneurysm size. Ultrasound, CT angiography, and MR angiography provide an accurate and reproducible assessment of size, while radiographs and aortography provide limited evaluation. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Venous thromboembolism (VTE)—deep vein thrombosis and pulmonary embolism—is a common cause of morbidity and mortality. The mainstay of VTE prophylaxis and therapy is anticoagulation. In select patients with VTE, inferior vena cava (IVC) filters are used to prevent pulmonary embolism by trapping emboli as they pass from the lower extremity venous system through the IVC. These guidelines review the indications for placement of IVC filters in acute and chronic VTE, as well as the indications for retrieval of implanted IVC filters. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

BackgroundPoststent ballooning/angioplasty (post-SB) have been shown to increase the risk of stroke risk after transfemoral carotid artery stenting. With the advancement of transcarotid artery revascularization (TCAR) with dynamic cerebral blood flow reversal, we aimed to study the impact of post-SB during TCAR.MethodsPatients undergoing TCAR in the Vascular Quality Initiative between September 2016 and May 2019 were included and were divided into three groups: those who received prestent deployment angioplasty only (pre-SB, reference group), those who received poststent deployment ballooning only (post-SB), and those who received both prestent and poststent deployment ballooning (prepost-SB). Patients who did not receive any angioplasty during their procedure (n= 367 [6.7%]) were excluded because these represent a different group of patients with less complex lesions than those requiring angioplasty. Primary outcome was in-hospital stroke or death. Analysis was performed using univariable and multivariable logistic regression models.ResultsOf 5161 patients undergoing TCAR, 34.7% had pre-SB only, 25% had post-SB only, and 40.3% had both (prepost-SB). No differences in the rates of in-hospital and 30-day stroke, death, and stroke/death were observed among the three groups; in-hospital stroke/death in the pre-SB group was 1.4% (n= 25), post-SB 1.2% (n= 16), and prepost-SB 1.4% (n= 29; P= .92). However, patients undergoing post-SB and prepost-SB had higher rates of in-hospital transient ischemic attacks (TIA) (post-SB, 0.9%; prepost-SB, 1% vs pre-SB, 0.2%, P< .01) and postprocedural hypotension (16.6% and 16.8% vs 13.1%, respectively; P< .001). Post-SB also had longer operative times, as well as flow reversal and fluoroscopy times. On multivariable analysis, no association was seen between post-SB and the primary outcome of in-hospital stroke/death (post-SB odds ratio [OR], 0.88; 95% confidence interval [CI], 0.44-1.73; prepost-SB OR, 0.98; 95% CI, 0.57-1.70). Similarly, no significant differences were noted in terms of postprocedural hemodynamic instability and 30-day outcomes. However, post-SB and prepost-SB were associated with four times the odds of in-hospital TIA compared with pre-SB alone (post-SB OR, 4.24 [95% CI, 1.51-11.8]; prepost-SB OR, 4.76 [95% CI, 1.53-14.79]; P= .01). Symptomatic patients had higher rates of in-hospital stroke/death compared with their asymptomatic counterparts; however, there was no significant interaction between symptomatic status and ballooning in predicting the primary outcome.ConclusionsPost-SB was used in 65.3% of TCAR patients. This maneuver seems to be safe without an increase in the odds of postoperative in-hospital stroke/death. However, the increased rates of TIA associated with post-SB requires further investigation.

ObjectiveThe current recommendations are to perform carotid endarterectomy within 2weeks of symptoms for maximum long-term stroke prevention, although urgent carotid endarterectomy within 48hours has been associated with increased perioperative stroke. With the development and rapid adoption of transcarotid artery revascularization (TCAR), we decided to study the effect of timing on the outcomes after TCAR.MethodsThe Vascular Quality Initiative database was searched for symptomatic patients who had undergone TCAR from September 2016 to November 2019. These patients were stratified by the interval to TCAR after symptom onset: urgent, within 48hours; early, 3 to 14days; and late, >14days. The primary outcome was the in-hospital rate of combined stroke and death (stroke/death), evaluated using logistic regression analysis. The secondary outcome was the 1-year rate of recurrent ipsilateral stroke and mortality, evaluated using Kaplan-Meier survival analysis.ResultsA total of 2608 symptomatic patients who had undergone TCAR were included. The timing was urgent for 144 patients (5.52%), early for 928 patients (35.58%), and late for 1536 patients (58.90%). Patients undergoing urgent intervention had an increased risk of in-hospital stroke/death, which was driven primarily by an increased risk of stroke. No differences were seen for in-hospital death. On adjusted analysis, urgent intervention resulted in a threefold increased risk of stroke (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.2; P= .01) and a threefold increased risk of stroke/death (OR, 2.9; 95% CI, 1.3-6.4; P= .01) compared with late intervention. Patients undergoing early intervention had comparable risks of stroke (OR, 1.3; 95% CI, 0.7-2.3; P= .40) and stroke/death (OR, 1.2; 95% CI, 0.7-2.1; P= .48) compared with late intervention. On subset analysis, the type of presenting symptoms was an effect modifier. Patients presenting with stroke and those presenting with transient ischemic attack or amaurosis fugax both had an increased risk of stroke/death when undergoing urgent compared with late TCAR (OR, 2.7; 95% CI, 1.1-6.6; P= .04; and OR, 4.1; 95% CI, 1.1-15.0; P= .03, respectively). However only patients presenting with transient ischemic attack or amaurosis fugax had experienced an increased risk of stroke with urgent compared with late TCAR (OR, 5.0; 95% CI, 1.4-17.5; P< .01). At 1year of follow-up, no differences were seen in the incidence of recurrent ipsilateral stroke (urgent, 0.7%; early, 0.2%; late, 0.1%; P= .13) or postdischarge mortality (urgent, 0.7%; early, 1.6%; late, 1.8%; P= .71).ConclusionsWe found that TCAR had a reduced incidence of stroke when performed 48hours after symptom onset. Urgent TCAR within 48hours of the onset of stroke was associated with a threefold increased risk of in-hospital stroke/death, with no added benefit for ≤1year after intervention. Further studies are needed on long-term outcomes of TCAR stratified by the timing of the procedure.

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.

In response to the pandemic, an abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures occurred. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020. Approximately three-fourths (74%) of physicians adopted restrictive operating policies for urgent and emergent cases only, whereas one-half proceeded with "time sensitive" elective cases as urgent. Data manager case entry was negatively affected by both low case volumes and staffing due to reassignment or furlough. Venous registry volumes were reduced fivefold in the first quarter of 2020 compared with a similar period in 2019. The consequences of delaying vascular procedures for ambulatory venous practice remain unknown with increased morbidity likely. Challenges to determine venous thromboembolism mortality impact exist given difficulty in verifying "in home and extended care facility" deaths. Further ramifications of a pandemic shutdown will likely be amplified if postponement of elective vascular care extends beyond a short window of time. It will be important to monitor disease progression and case severity as a result of policy shifts adopted locally in response to pandemic surges.

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.

BackgroundReal-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.ObjectivesTo determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.MethodsWe compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers.ResultsWe analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%–71%) were also realized compared with industry-based estimates.ConclusionsThe use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.

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

Background: To compare mortality after treatment of superficial femoral-popliteal artery disease with paclitaxel and nonpaclitaxel devices using a multicenter vascular registry. Methods: Patients (N=8376) undergoing endovascular treatment of superficial femoral-popliteal artery disease in the Society for Vascular Surgery Vascular Quality Initiative were studied from October 2016 to December 2017. One-year mortality was compared between 3 groups; plain balloon angioplasty (N=2104) versus paclitaxel-coated balloon angioplasty (N=3543), bare-metal stenting (N= 2045) versus paclitaxel-eluting stents (N=684), and combined paclitaxel versus nonpaclitaxel devices. Mortality rates with hazard ratios (HR) and 95% CI were compared in unadjusted and propensity-matched cohorts and illustrated by Kaplan-Meier analysis with subgroup analysis for intermittent claudication, chronic limb-threatening ischemia, and secondary interventions. Results: In propensity-matched analyses, mortality was similar after plain balloon angioplasty (12.6%) and paclitaxel-coated balloon angioplasty (9.6%; HR=0.84 [95% CI, 0.66–1.06], P =0.14). In propensity-matched groups, mortality was similar after bare-metal stenting (9.8%) and paclitaxel-eluting stenting (8.8%; HR=0.93 [95% CI, 0.62–1.41], P =0.75). In the combined, matched analysis mortality was significantly lower in the paclitaxel device group (8.5%) compared with the nonpaclitaxel device group (11.5%; HR=0.82 [95% CI, 0.68–0.98], P =0.03). Secondary interventions were similar after nonpaclitaxel (N=1113/4149, 26.8%) and paclitaxel device use (N=1113/4227, 26.3%). For intermittent claudication, mortality was lower after paclitaxel device use (1.6%) compared with nonpaclitaxel devices (4.4%; adjusted HR=0.59 [95% CI, 0.39–0.89], P =0.01). For chronic limb-threatening ischemia, the mortality difference was not significant; paclitaxel (12.8%) versus nonpaclitaxel devices (15.5%; adjusted HR=0.85 [95% CI, 0.72–1.00], P =0.05). Conclusions: At 1 year, mortality was similar if not lower after treatment of femoral-popliteal occlusive disease with paclitaxel versus nonpaclitaxel devices. This work highlights the potential use of the Society for Vascular Surgery Vascular Quality Initiative for surveillance of the safety of new peripheral arterial devices.

Enhanced recovery after surgery (ERAS) pathways have been beneficial for many surgical specialties, but these coordinated care pathways have yet to be developed for patients undergoing vascular operations. Vascular surgery patients present specific challenges due to their advanced age, frailty, and multiple comorbidities as well as the highly invasive operations that are sometimes required. This combination of factors results in complex management strategies, increased utilization of healthcare resources, and high rates of postoperative complications leading to prolonged hospitalizations, chronic pain, rehabilitation needs, and frequent hospital readmissions. ERAS, with its aim of delivering high-quality perioperative care and accelerating recovery, appears well-suited to address the needs of this demanding population.

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.