Impact of COVID-19 on the Society for Vascular Surgery Vascular Quality Initiative Venous Procedure Registries (Varicose Vein and Inferior Vena Cava Filter)

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

Effects of Timing on In-hospital and One-year Outcomes after TransCarotid Artery Revascularization.

OBJECTIVE: Current recommendations are to perform carotid endarterectomy (CEA) within two weeks of symptoms due to superior long-term stroke prevention, although urgent CEA within 48-hours has been associated with increased perioperative stroke. With the development and rapid adoption of TransCarotid Artery Revascularization (TCAR), we aim to study the impact of timing on outcomes after TCAR. METHODS: Symptomatic patients undergoing TCAR in the Vascular Quality Initiative between September 2016 and November 2019 were stratified by time to procedure: urgent (TCAR within 48-hours), early (TCAR between 3-14 days after symptoms), and late (TCAR greater than 14 days after symptoms). Primary outcome was in-hospital rates of stroke/death and evaluated using logistic regression. Secondary outcome was one-year rate of recurrent ipsilateral stroke and mortality, analyzed using Kaplan Meier Survival Analysis. RESULTS: A total of 2608 symptomatic patients undergoing TCAR were included: 144 urgent (5.52%), 928 early (35.58%), and 1536 (58.90%) late. Patients undergoing urgent intervention had increased risk of in-hospital stroke/death that was driven primarily by increased risk of stroke. No differences were seen in in-hospital death. On adjusted analysis, urgent intervention had a 3-fold increased odds of stroke [OR:2.8, 95%CI:1.3-6.2, p=0.01] and a 3-fold increased odds of stroke/death [OR:2.9, 95%CI:1.3-6.4, p=0.01] when compared to late intervention. Patients undergoing early intervention had comparable risks of stroke [OR:1.3, 95%CI:0.7-2.3, p=0.40] and stroke/death [OR:1.2, 9%CI:0.7-2.1, p=0.48] when compared to late intervention. On subset analysis, the type of presenting symptoms was an effect modifier. Both patients presenting with stroke and patients presenting with transient ischemic attacks (TIA) or amaurosis fugax (AF) had increased risk of stroke/death when undergoing urgent compared to late TCAR: [OR:2.7, 95%CI:1.1-6.6, p=0.04] and [OR:4.1, 95%CI:1.1-15.0, p=0.03] respectively. However only patients presenting with TIA or AF had experienced increased risk of stroke when undergoing urgent compared to late TCAR: [OR:5.0, 95%CI:1.4-17.5, p CONCLUSION: TCAR has a reduced incidence of stroke when performed 48-hours after onset of symptoms. Urgent TCAR within 48 hours of onset of stroke is associated with a three-fold increased risk of in-hospital stroke/death with no added benefit up to one year after the intervention. Further studies are needed on long-term outcomes of TCAR stratified by timing of the procedure

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

This article is made available for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.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

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

ObjectiveThe 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.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 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.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 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).ConclusionsWe 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

The impact of age on in-hospital outcomes after transcarotid artery revascularization, transfemoral carotid artery stenting, and carotid endarterectomy.

OBJECTIVE: Previous data showed superior outcomes of carotid endarterectomy (CEA) compared with transfemoral carotid artery stenting (TFCAS) in elderly patients because of an increased stroke risk in TFCAS-treated patients. Transcarotid artery revascularization (TCAR) with flow reversal was developed to mitigate the maneuvers at highest risk for causing stroke during TFCAS, such as manipulation of a diseased aortic arch and crossing of the carotid lesion before deployment of an embolic protection device. This study aimed to compare the association between age and outcomes after TCAR, TFCAS, and CEA. METHODS: All patients undergoing carotid procedures in the Society for Vascular Surgery Vascular Quality Initiative database between 2015 and November 2018 were included. Patients were divided into three different age groups (≤70 years, 71-79 years, and ≥80 years). In-hospital outcomes after TCAR vs TFCAS and after TCAR vs CEA were compared in each age group by introducing an interaction term between treatment type and age in the logistic regression analysis after adjustment for patients\u27 preoperative characteristics. RESULTS: The study cohort included 3152 TCAR, 10,381 TFCAS, and 61,650 CEA cases. The absolute and adjusted in-hospital outcomes after TCAR did not change across the different age groups. The rates of in-hospital stroke/death after TCAR were 1.4% in patients ≤70 years vs 1.9% in patients 71 to 79 years and 1.5% in patients ≥80 years (P = .55). Comparison of TCAR to CEA across different age groups showed no significant differences in outcomes, and no interaction was noted between treatment and age in predicting in-hospital stroke/death (P = .80). In contrast, TCAR was associated with a 72% reduction in stroke risk (4.7% vs 1%; odds ratio [OR], 0.28; 95% confidence interval [CI], 0.12-0.65; P \u3c .01), 65% reduction in risk of stroke/death (4.6% vs 1.5%; OR, 0.35; 95% CI, 0.20-0.62; P \u3c .001), and 76% reduction in the risk of stroke/death/myocardial infarction (5.3% vs 2.5%; OR, 0.24; 95% CI, 0.12-0.47; P \u3c .001) compared with TFCAS in patients ≥80 years. Moreover, compared with TCAR, the odds of stroke/death after TFCAS doubled at 77 years (OR, 2.0; 95% CI, 1.4-3.0; P \u3c .01) and tripled at 90 years (OR, 3.0; 95% CI, 1.6-5.8; P \u3c .01; P value for the interaction = .08). CONCLUSIONS: TCAR is a relatively safe procedure regardless of the patient\u27s age. The advantages of TCAR become more pronounced in elderly patients, with significant reductions in in-hospital stroke compared with TFCAS in patients ≥77 years old, independent of symptomatic status and other medical comorbidities. These findings suggest that TCAR should be preferred to TFCAS in elderly patients who are at high surgical risk

Real-world study of mortality after the Use of Paclitaxel-coated Devices in Peripheral Vascular Intervention

OBJECTIVES: To examine outcomes after peripheral vascular intervention (PVI) with paclitaxel-coated devices (PCD) and non-PCD and evaluate heterogeneity of treatment effect in populations of interest. DESIGN: Observational cohort study. METHODS: We included patients undergoing percutaneous transluminal angioplasty and/or stent placement during 1/10/2015-31/12/2018 in the Vascular Quality Initiative Registry linked to Medicare claims. We 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/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 lower mortality (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 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; B: HR=0.84, 95% CI 0.67-1.06; C: HR=1.05, 95% CI 0.51-2.14). CONCLUSIONS: We did not find increased patient mortality or major amputation 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. Our analysis and results from three cohorts intended to mirror the cohorts of prior studies provide robust and niche real-world evidence on PCD safety and help understand and reconcile previously discrepant findings

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 (\u3e1 day), and in-hospital mortality. Patients\u27 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 \u3c .001), MACEs (9.6% vs 2.1%; P \u3c .001), prolonged LOS (65% vs 28%; P \u3c .001), and in-hospital mortality (2.9% vs 0.7%; P \u3c .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 \u3c .001), female sex (1.3 [1.2-1.4]; P \u3c .001), positive stress test result (1.3 [1.2-1.4]; P \u3c .001), age 70 to 79 years (1.1 [1.1-1.3]; P \u3c .002), age \u3e80 years (1.2 [1.1-1.4]; P \u3c .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P \u3c .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P \u3c .01). A history of hypertension was protective (0.9 [0.8-0.9]; P \u3c .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