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

Objective: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population.

Methods: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease.

Objective: The Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry.

Methods: A single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019.

Editor's Choice - Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.

Objective: 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.

Methods: 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).

Underutilization of medical management of peripheral artery disease among patients with claudication undergoing lower extremity bypass.

Objective: First-line treatment of peripheral artery disease (PAD) involves medical therapy and lifestyle modification. Multiple professional organizations such as the Society for Vascular Surgery and the American Heart Association/American College of Cardiology make Class I recommendations for medical management including antiplatelet, statin, antihypertensive, and cilostazol medications, as well as lifestyle therapy including exercise and smoking cessation. Although evidence supports up-front medical and lifestyle management prior to surgical intervention, it is unclear how well this occurs in contemporary clinical practice.

Changes in the Long-term Risk of Adverse Outcomes in Patients Treated With Open vs Endovascular Abdominal Aortic Aneurysm Repair.

This comparative effectiveness research study assesses the mortality and reintervention rates associated with 2 devices used for abdominal aortic aneurysm repair.

Impact of a regional smoking cessation intervention for vascular surgery patients.

Objective: Tobacco use is common among vascular surgery patients and negatively impacts outcomes and longevity. In the second quarter of 2018, a statewide vascular quality collaborative launched an initiative across its 35 participating hospitals to promote smoking cessation at the time of surgery. This intervention was based on the Vascular Physician Offer and Report (VAPOR) trial and consisted of 3 components: brief physician-delivered advice, referral to telephone-based counseling, and nicotine replacement therapy.

Vascular Quality Initiative risk score for 30-day stroke or death following transcarotid artery revascularization.

Objective: 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.

Methods: 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.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

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.

TransCarotid Revascularization With Dynamic Flow Reversal Versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Project.

Objective: To compare the outcomes of TCAR with flow reversal to the gold standard CEA using data from the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project.

Summary Of Background Data: TCAR is a novel minimally invasive procedure for carotid revascularization in high-risk patients that is associated with significantly lower stroke rates compared with carotid artery stenting via the transfemoral approach.

Methods: Patients in the United States and Canada who underwent TCAR and CEA for carotid artery stenosis (2016-2019) were included.

Practice patterns in the use of completion imaging after carotid endarterectomy.

Background: The use of intraoperative completion imaging (completion carotid duplex ultrasound or angiography) to confirm the technical adequacy of carotid endarterectomy (CEA) remains a matter of controversy. The purpose of this study was to describe vascular surgeons' practice patterns in the use of completion imaging after CEA and to study the association between completion imaging and postoperative stroke/death and high-grade restenosis (>70%).

Methods: Patients who underwent CEA without concomitant procedures in the Vascular Quality Initiative database between 2003 and 2018 were included.

Protamine use in transcarotid artery revascularization is associated with lower risk of bleeding complications without higher risk of thromboembolic events.

Objective: 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.

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis.

Objective: Recent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described.

Methods: We performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019.

Predictors of midterm high-grade restenosis after carotid revascularization in a multicenter national database.

Background: Restenosis after carotid revascularization is clinically challenging. Several studies have looked into the management of recurrent restenosis; however, studies looking into factors associated with restenosis are limited. This study evaluated the predictors of restenosis after carotid artery stenting (CAS) and carotid endarterectomy (CEA) using a large national database.

Mortality After Paclitaxel Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery in the Vascular Quality Initiative.

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.

Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting With Stroke or Death Among Patients With Carotid Artery Stenosis.

Importance: Several trials have observed higher rates of perioperative stroke following transfemoral carotid artery stenting compared with carotid endarterectomy. Transcarotid artery revascularization with flow reversal was recently introduced for carotid stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral carotid artery stenting, are not well characterized.

Learning Curve for Surgeons Adopting Transcarotid Artery Revascularization Based on the Vascular Quality Initiative-Transcarotid Artery Revascularization Surveillance Project.

Background: Transcarotid artery revascularization (TCAR) with flow reversal was recently introduced as a novel technique for carotid artery stenting (CAS). We examined the learning curve of surgeons adopting TCAR based on data from the Vascular Quality Initiative (VQI-TCAR Surveillance Project; TSP).

Study Design: We identified all patients in the TSP who underwent TCAR from September 2016 to December 2018.

In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative.

Objective: Transcarotid 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.

Methods: We 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.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

Objective: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.

Methods: Under the auspices of the U.

Registry Assessment of Peripheral Interventional Devices (RAPID) - Registry Assessment of Peripheral Interventional Devices Core Data Elements.

Background: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.