Learning curve of transfemoral carotid artery stenting in the Vascular Quality Initiative registry.

OBJECTIVE: With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data. METHODS: We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians. RESULTS: We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. CONCLUSIONS: In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.

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

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

Predictors of prolonged length of stay after elective carotid revascularization.

OBJECTIVE: Postoperative day-one discharge is used as a quality-of-care indicator after carotid revascularization. This study identifies predictors of prolonged length of stay (pLOS), defined as a postprocedural LOS of >1 day, after elective carotid revascularization. METHODS: Patients undergoing carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TFCAS) in the Vascular Quality Initiative between 2016 and 2022 were included in this analysis. Multivariable logistic regression analysis was used to identify predictors of pLOS, defined as a postprocedural LOS of >1 day, after each procedure. RESULTS: A total of 118,625 elective cases were included. pLOS was observed in nearly 23.2% of patients undergoing carotid revascularization. Major adverse events, including neurological, cardiac, infectious, and bleeding complications, occurred in 5.2% of patients and were the most significant contributor to pLOS after the three procedures. Age, female sex, non-White race, insurance status, high comorbidity index, prior ipsilateral CEA, non-ambulatory status, symptomatic presentation, surgeries occurring on Friday, and postoperative hypo- or hypertension were significantly associated with pLOS across all three procedures. For CEA, additional predictors included contralateral carotid artery occlusion, preoperative use of dual antiplatelets and anticoagulation, low physician volume (<11 cases/year), and drain use. For TCAR, preoperative anticoagulation use, low physician case volume (<6 cases/year), no protamine use, and post-stent dilatation intraoperatively were associated with pLOS. One-year analysis showed a significant association between pLOS and increased mortality for all three procedures; CEA (hazard ratio [HR],1.64; 95% confidence interval [CI], 1.49-1.82), TCAR (HR,1.56; 95% CI, 1.35-1.80), and TFCAS (HR, 1.33; 95%CI, 1.08-1.64) (all P < .05). CONCLUSIONS: A postoperative LOS of more than 1 day is not uncommon after carotid revascularization. Procedure-related complications are the most common drivers of pLOS. Identifying patients who are risk for pLOS highlights quality improvement strategies that can optimize short and 1-year outcomes of patients undergoing carotid revascularization.

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy.

OBJECTIVE: This study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. METHODS: Utilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. RESULTS: A total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). CONCLUSIONS: Although tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

Device regulation and surveillance in vascular care: Challenges and opportunities.

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

Vascular Quality Initiative assessment of compliance with Society for Vascular Surgery clinical practice guidelines on the management of extracranial cerebrovascular disease.

OBJECTIVES: Compliance with Society for Vascular Surgery (SVS) clinical practice guidelines (CPGs) is associated with improved outcomes for the treatment of abdominal aortic aneurysm, but this has not been assessed for carotid artery disease. The Vascular Quality Initiative (VQI) registry was used to examine compliance with the SVS CPGs for the management of extracranial cerebrovascular disease and its impact on outcomes. METHODS: The 2021 SVS extracranial cerebrovascular disease CPGs were reviewed for evaluation by VQI data. Compliance rates by the center and provider were calculated, and the impact of compliance on outcomes was assessed using logistic regression with inverse probability-weighted risk adjustment for each CPG recommendation, allowing for clustering by the center. Our primary outcome was a composite end point of in-hospital stroke/death. As a secondary analysis, compliance with the 2021 SVS carotid implementation document recommendations and associated outcomes were also assessed. RESULTS: Of the 11 carotid CPG recommendations, 4 (36%) could be evaluated using VQI registry data. Median center-specific CPG compliance ranged from 38% to 95%, and median provider-specific compliance ranged from 36% to 100%. After adjustment, compliance with 2 of the recommendations was associated with lower rates of in-hospital stroke/death: first, the use of best medical therapy (antiplatelet and statin therapy) in low/standard surgical risk patients undergoing carotid endarterectomy for >70% asymptomatic stenosis (event rate in compliant vs noncompliant cases 0.59% vs 1.3%; adjusted odds ratio: 0.44, 95% confidence interval: 0.29-0.66); and second, carotid endarterectomy over transfemoral carotid artery stenting in low/standard surgical risk patients with >50% symptomatic stenosis (1.9% vs 3.4%; adjusted odds ratio: 0.55, 95% confidence interval: 0.43-0.71). Of the 132 implementation document recommendations, only 10 (7.6%) could be assessed using VQI data, with median center- and provider-specific compliance rates ranging from 67% to 100%. The impact of compliance on outcomes could only be assessed for 6 (4.5%) of these recommendations, and compliance with all 6 recommendations was associated with lower stroke/death. CONCLUSIONS: Few SVS recommendations could be assessed in the VQI because of incongruity between the recommendations and the VQI data variables collected. Although guideline compliance was extremely variable among VQI centers and providers, compliance with most of these recommendations was associated with improved outcomes after carotid revascularization. This finding confirms the value of guideline compliance, which should be encouraged for centers and providers. Optimization of VQI data to promote evaluation of guideline compliance and distribution of these findings to VQI centers and providers will help facilitate quality improvement efforts in the care of vascular patients.

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. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. RESULTS: The mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. CONCLUSIONS: In this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Regional variation in patient selection, practice patterns, and outcomes based on techniques for carotid artery revascularization in the Vascular Quality Initiative.

OBJECTIVE: Significant regional variation is known with multiple surgical procedures. This study describes regional variation in carotid revascularization within the Vascular Quality Initiative (VQI). METHODS: Data from the VQI carotid endarterectomy (CEA) and carotid artery stenting (CAS) databases from 2016 to 2021 were used. Nineteen geographic VQI regions were divided into three tertiles based on the average annual volume of carotid procedures performed per region (low-volume: 956 cases [range, 144-1382]; medium-volume: 1533 cases [range, 1432-1589]; and high-volume: 1845 cases [range, 1642-2059]). Patients' characteristics, indications for carotid revascularization, practice patterns, and outcomes (perioperative and 1-year stroke/death) of different revascularization techniques were compared between these regional groups. Regression models that adjust for known risk factors and allow for random effects at the center level were used. RESULTS: CEA was the most common revascularization procedure (>60%) across all regional groups. Significant regional variation was observed in the practice of CEA such as variability in the use of shunting, drain placement, stump pressure and electroencephalogram monitoring, intraoperative protamine, and patch angioplasty. For transfemoral CAS, high-volume regions had a higher proportion of asymptomatic patients with <80% stenosis (30.5% vs 27.8%) in addition to higher use of local/regional anesthesia (80.4% vs 76.2%), protamine (16.1% vs 11.8%), and completion angiography (81.6% vs 77.6%) during transfemoral carotid artery stenting (TF-CAS) compared with low-volume regions. For transcarotid artery revascularization (TCAR), high-volume regions were less likely to intervene on asymptomatic patients with <80% stenosis (32.2% vs 35.8%) than low-volume regions. They also had a higher proportion of urgent/emergent procedures (13.6% vs 10.4%) and were more likely to use general anesthesia (92.0% vs 82.1%), completion angiography (67.3% vs 63.0%), and poststent ballooning (48.4% vs 36.8%). For each carotid revascularization technique, no significant differences were noted in perioperative and 1-year outcomes between low-, medium-, and high-volume regions. Finally, there were no significant differences in outcomes between TCAR and CEA across the different regional groups. In all regional groups, TCAR was associated with a 40% reduction in perioperative and 1-year stroke/death compared with TF-CAS. CONCLUSIONS: Despite significant variation in clinical practices for the management of carotid disease, no regional variation exists in the overall outcomes of carotid interventions. TCAR and CEA continue to show superior outcomes to TF-CAS across all VQI regional groups.

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group.

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease.

PURPOSE: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database. MATERIALS AND METHODS: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival. RESULTS: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69-0.79]; P <.05, and HR, 0.89 [95% CI, 0.77-1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76-0.87]; P =.02, and HR, 0.77 [95% CI, 0.67-0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. CONCLUSIONS: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.

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). RESULTS: 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). CONCLUSION: 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.

Using the Evaluating Devices Using Claims and RegisTry Data (EDUCATe) Plan within the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) to Analyze the Long-Term Outcomes following Endovascular Aortic Aneurysm Repair.

BACKGROUND: Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket 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 2 sources. METHODS: Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. RESULTS: 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 1 year, 82.6% at 3 years, and 68.1% at 5 years. Estimates for freedom from reintervention were 90% at 1 year, 82.4% at 3 years, and 78.1% at 5 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 1 and 5 years, respectively (log-rank P = 0.13). CONCLUSIONS: 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.

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. Propensity scores were calculated based on baseline clinical variables and used to match patients in the 2 treatment groups (n = 6384 each). The primary endpoint was the combined outcome of perioperative stroke and/or death. RESULTS: No significant differences were observed between TCAR and CEA in terms of in-hospital stroke/death [TCAR, 1.6% vs CEA, 1.6%, RR (95% CI): 1.01 (0.77-1.33), P = 0.945], stroke [1.4% vs 1.4%, RR (95% CI): 1.02 (0.76-1.37), P = 0.881], or death [0.4% vs 0.3%, RR (95% CI): 1.14 (0.64-2.02), P = 0.662]. Compared to CEA, TCAR was associated with lower rates of in-hospital myocardial infarction [0.5% vs 0.9%, RR (95% CI): 0.53 (0.35-0.83), P = 0.005], cranial nerve injury [0.4% vs 2.7%, RR (95% CI): 0.14 (0.08-0.23), P < 0.001], and post-procedural hypertension [13% vs 18.8%, RR (95% CI): 0.69 (0.63-0.76), P < 0.001]. They were also less likely to stay in the hospital for more than 1 day [26.4% vs 30.1%, RR (95% CI): 0.88 (0.82-0.94), P < 0.001]. No significant interaction was observed between procedure and symptomatic status in predicting postoperative outcomes. At 1 year, the incidence of ipsilateral stroke or death was similar between the 2 groups [HR (95% CI): 1.09 (0.87-1.36), P = 0.44]. CONCLUSIONS: This propensity-score matched analysis demonstrated significant reduction in the risk of postoperative myocardial infarction and cranial nerve injury after TCAR compared to CEA, with no differences in the rates of stroke/death.

Outcomes of transcarotid artery revascularization with dynamic flow reversal in patients with contralateral carotid artery occlusion.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Effects of timing on in-hospital and one-year outcomes after transcarotid artery revascularization.

OBJECTIVE: The current recommendations are to perform carotid endarterectomy within 2 weeks of symptoms for maximum long-term stroke prevention, although urgent carotid endarterectomy within 48 hours 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. METHODS: The 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 48 hours; early, 3 to 14 days; and late, >14 days. 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. RESULTS: A 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 1 year 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). CONCLUSIONS: We found that TCAR had a reduced incidence of stroke when performed 48 hours after symptom onset. Urgent TCAR within 48 hours of the onset of stroke was associated with a threefold increased risk of in-hospital stroke/death, with no added benefit for ≤1 year after intervention. Further studies are needed on long-term outcomes of TCAR stratified by the timing of the procedure.

Effects of coronavirus disease 2019 on the Society for Vascular Surgery Vascular Quality Initiative arterial procedure registry.

In the present report, we have described the abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures in response to the coronavirus disease 2019 (COVID-19) pandemic. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020 to discern the effects of the COVID-19 pandemic. Approximately three fourths of physicians (74%) had adopted a restrictive operating policy for urgent and emergent cases only. However, one half had considered "time sensitive" elective cases as urgent. Data manager case entry was affected by both low case volumes and low staffing resulting from reassignment or furlough. A sevenfold reduction in arterial Vascular Quality Initiative case volume entry was noted in the first quarter of 2020 compared with the same period in 2019. The downstream consequences of delaying vascular procedures for carotid artery stenosis, aortic aneurysm repair, vascular access, and chronic limb ischemia remain undetermined. Further ramifications of the COVID-19 pandemic shutdown will likely be amplified if resumption of elective vascular care is delayed beyond a short window of time.

A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision.

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.

Poststent ballooning during transcarotid artery revascularization.

BACKGROUND: Poststent 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. METHODS: Patients 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. RESULTS: Of 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. CONCLUSIONS: Post-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.

Younger patients have worse outcomes after peripheral endovascular interventions for suprainguinal arterial occlusive disease.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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), age >80 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. CONCLUSIONS: 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.