An International, Expert-Based Delphi Consensus Document on Controversial Issues about TransCarotid Artery Revascularization (TCAR).

OBJECTIVE: TransCarotid Artery Revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi Consensus document was to attempt to provide some guidance on these topics. METHODS: A 3-Round Delphi Consensus process was performed including 29 experts. The aim of Round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During Round 3, the participants had the opportunity to finalize their vote. RESULTS: Most participants agreed that TCAR can/can probably/possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hours. It was felt that TCAR cannot/should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can/can probably be used for the treatment of restenosis following CEA/TFCAS. Finally, there is a need for a randomized controlled trial to provide better evidence for the unresolved issues. CONCLUSIONS: This Delphi Consensus document attempted to assist the decision-making of physicians/interventionalists/vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and randomized controlled trials should provide more evidence to address the unanswered questions regarding TCAR.

Surgical outcomes for occluded venous thoracic outlet syndrome following transaxillary first rib resection.

OBJECTIVE: Surgical decompression via transaxillary first rib resection (TFRR) is often performed in patients presenting with venous thoracic outlet syndrome (VTOS). We aimed to evaluate the outcomes of TFRR based on chronicity of completely occluded axillosubclavian veins in VTOS. METHODS: We performed a retrospective institutional review of all patients who underwent TFRR for VTOS and had a completely occluded axillosubclavian vein between 2003 and 2022. Patients were categorized into three groups based on the time of inciting VTOS event to TFRR acuity of their venous occlusion: <4 weeks, 4 to 12 weeks, and >12 weeks. We evaluated the association of TFRR timing with 1-year outcomes, including patency and symptomatic improvement. We used the χ2 test to compare baseline characteristics and postoperative outcomes. RESULTS: Overall, 103 patients underwent TFRR for VTOS with a completely occluded axillosubclavian vein (median age, 30.0 years; 42.7% female; 8.8% non-White), of whom 28 had occlusion at <4 weeks, 36 had occlusion at 4 to 12 weeks, and 39 had occlusion at >12 weeks. Postoperative venogram performed 2 to 3 weeks after TFRR demonstrated that 78.6% in the <4 weeks group, 72.2% in the 4- to 12-weeks group, and 61.5% in the >12 weeks group had some degree of recanalization (P = .76). Postoperative balloon angioplasty was successfully performed in 60 patients with stenosed or occluded axillosubclavian vein at the time of postoperative venogram. At the 10- to 14-month follow-up, 79.2% of the <4 weeks group, 73.3% of the 4- to 12-weeks group, and 73.3% of the >12 weeks group had patent axillosubclavian veins based on duplex ultrasound examination (P = .86). Among patients who underwent postoperative balloon angioplasty, 80.0%, 85.0% and 100% in the <4 weeks, 4- to 12-weeks, and >12 weeks groups respectively demonstrated patency at 10 to 14 months (P = .31). Symptomatic improvement was reported in 95.7% in the <4 weeks group, 96.7% in the 4- to 12-weeks group, and 93.5% in the >12 weeks group (P = .84). CONCLUSIONS: TFRR offers excellent postoperative outcomes for patients with symptomatic VTOS, even in cases of completely occluded axillosubclavian veins, regardless of the chronicity of the occlusion. By 14 months, 95.2% of patients experienced symptomatic improvement, and 75% attained venous patency.

Automatic 1-year follow-up appointment creation and reminders can improve long-term follow-up after carotid revascularization.

BACKGROUND: Long-term follow-up (LTFU) following carotid revascularization is important for post-surgical care, stroke risk optimization and post-market surveillance of new technologies. METHODS: We instituted a quality improvement project to improve LTFU rates for carotid revascularizations (primary outcome) by scheduling perioperative and one-year follow-up appointments at time of surgery discharge. A temporal trends analysis (Q1 2019 through Q1 2022), multivariable regression, and interrupted time series (ITS) were performed to compare pre-post intervention LTFU rates. RESULTS: 269 consecutive patients were included (151 pre-intervention, 118 post-intervention; mean 71 â€‹± â€‹12 years-old, 39% female, 77% White). The overall LTFU rate improved (64.9%-78.8%; P â€‹= â€‹0.013) after the intervention. After controlling for patient factors, procedures performed after the intervention were associated with increased odds of being seen for 1-year follow-up (OR: 2.2 95%CI: 1.2-4.0). Quarterly ITS analysis corroborated this relationship (P â€‹= â€‹0.01). CONCLUSIONS: Time-of-surgery appointment creation and automated patient reminders can improve LTFU rates following carotid revascularizations.

Transcarotid artery revascularization for carotid pseudoaneurysm and patch degeneration after carotid endarterectomy.

An 86-year-old man with a history of right internal carotid artery occlusion and two remote left carotid endarterectomies presented with a contained posterior rupture of a carotid pseudoaneurysm. The infectious workup was negative. He underwent transcarotid artery revascularization, including external carotid artery coil embolization and exclusion of the carotid aneurysm with a self-expandable stent graft. He was discharged home on postoperative day 1 with his home antiplatelet and anticoagulant therapy. The 3-month postoperative imaging study demonstrated a widely patent carotid stent without an endoleak. Transcarotid artery revascularization is a viable alternative to open repair or transfemoral stenting for carotid artery aneurysms.

Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Reprint of: Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Vascular Surgery In-Training Examination performance following implementation of the Vascular Surgical Council on Resident Education curriculum.

OBJECTIVE: The Vascular Surgery Surgical Council on Resident Education (VSCORE) program is a standardized curriculum intended to prepare Vascular Surgery trainees for the annual Vascular Surgery In-Training Examination (VSITE). This study evaluated the performance of 0+5 and 5+2 Vascular Surgery trainees on the VSITE prior to and following implementation of the VSCORE curriculum. METHODS: VSITE scores, measured as percentage of questions correct, were collected for Vascular Surgery trainees at a United States academic medical center between 2015 and 2022. The VSITE scores were compared for the periods prior to (2015-2021) and following (2022) implementation of the VSCORE curriculum. RESULTS: Fifty-seven VSITE scores were evaluated, including 46 examinations completed prior to and 11 after the implementation of the VSCORE curriculum. The mean VSITE score across all training levels (post-graduate year [PGY] 1-7) increased significantly from 68.4% ± 1.5% prior to implementation of VSCORE curriculum to 76.5% ± 3.1% following implementation (P = .03). Two-way analysis of variance identified pre- and post-VSCORE implementation as a statistically significant categorical variable when residents were stratified into junior (PGY 1-2), senior (PGY 3-5), and fellow (PGY 6-7) training levels (P < .001). The mean change in score between consecutive years also increased following VSCORE implementation (14.1% ± 2.3%) compared with the pre-VSCORE era (5.7% ± 1.7%; P = .002) CONCLUSIONS: The implementation of the VSCORE curriculum at an academic medical center improved VSITE scores across vascular surgery trainees at all levels.

Multidisciplinary approach to decreasing major amputation, improving outcomes, and mitigating disparities in diabetic foot and vascular disease.

Major nontraumatic lower extremity amputation (LEA) is a morbid complication of longstanding or poorly controlled diabetes and/or end-stage peripheral artery disease. Incidence of major LEAs consistently declined during the 1990s and 2000s, but rates have plateaued or increased in many regions during the past decade. Marked racial, ethnic, socioeconomic, and geographic disparities in risk of LEA persist and are related to inequalities in access to care and differential rates of attempted limb preservation. Multidisciplinary diabetic foot care (MDFC) is increasingly recognized as a necessary model for optimal management of patients with diabetic foot and vascular disease. This article reviews the role of MDFC in reducing major LEAs and the specific ways in which MDFC can mitigate disparities in care delivery and limb preservation outcomes. Access to MDFC among vulnerable populations remains a significant barrier to systematic reduction in major LEAs.

Factors associated with successful median arcuate ligament release in an international, multi-institutional cohort.

OBJECTIVE: Prior research on median arcuate ligament syndrome has been limited to institutional case series, making the optimal approach to median arcuate ligament release (MALR) and resulting outcomes unclear. In the present study, we compared the outcomes of different approaches to MALR and determined the predictors of long-term treatment failure. METHODS: The Vascular Low Frequency Disease Consortium is an international, multi-institutional research consortium. Data on open, laparoscopic, and robotic MALR performed from 2000 to 2020 were gathered. The primary outcome was treatment failure, defined as no improvement in median arcuate ligament syndrome symptoms after MALR or symptom recurrence between MALR and the last clinical follow-up. RESULTS: For 516 patients treated at 24 institutions, open, laparoscopic, and robotic MALR had been performed in 227 (44.0%), 235 (45.5%), and 54 (10.5%) patients, respectively. Perioperative complications (ileus, cardiac, and wound complications; readmissions; unplanned procedures) occurred in 19.2% (open, 30.0%; laparoscopic, 8.9%; robotic, 18.5%; P < .001). The median follow-up was 1.59 years (interquartile range, 0.38-4.35 years). For the 488 patients with follow-up data available, 287 (58.8%) had had full relief, 119 (24.4%) had had partial relief, and 82 (16.8%) had derived no benefit from MALR. The 1- and 3-year freedom from treatment failure for the overall cohort was 63.8% (95% confidence interval [CI], 59.0%-68.3%) and 51.9% (95% CI, 46.1%-57.3%), respectively. The factors associated with an increased hazard of treatment failure on multivariable analysis included robotic MALR (hazard ratio [HR], 1.73; 95% CI, 1.16-2.59; P = .007), a history of gastroparesis (HR, 1.83; 95% CI, 1.09-3.09; P = .023), abdominal cancer (HR, 10.3; 95% CI, 3.06-34.6; P < .001), dysphagia and/or odynophagia (HR, 2.44; 95% CI, 1.27-4.69; P = .008), no relief from a celiac plexus block (HR, 2.18; 95% CI, 1.00-4.72; P = .049), and an increasing number of preoperative pain locations (HR, 1.12 per location; 95% CI, 1.00-1.25; P = .042). The factors associated with a lower hazard included increasing age (HR, 0.99 per increasing year; 95% CI, 0.98-1.0; P = .012) and an increasing number of preoperative diagnostic gastrointestinal studies (HR, 0.84 per study; 95% CI, 0.74-0.96; P = .012) Open and laparoscopic MALR resulted in similar long-term freedom from treatment failure. No radiographic parameters were associated with differences in treatment failure. CONCLUSIONS: No difference was found in long-term failure after open vs laparoscopic MALR; however, open release was associated with higher perioperative morbidity. These results support the use of a preoperative celiac plexus block to aid in patient selection. Operative candidates for MALR should be counseled regarding the factors associated with treatment failure and the relatively high overall rate of treatment failure.

Development and validation of a prediction model for outcomes after transaxillary first rib resection for neurogenic thoracic outlet syndrome following strict Society for Vascular Surgery diagnostic criteria.

OBJECTIVE: Neurogenic thoracic outlet syndrome (NTOS) is the most common form of thoracic outlet syndrome. However, NTOS has remained difficult to diagnose and treat successfully. The purpose of the present study was to generate a predictive clinical calculator for postoperative outcomes after first rib resection (FRR) for NTOS. METHODS: We performed a retrospective review of patients who had undergone FRR for NTOS at a single tertiary care institution between 2016 and 2020. A multivariate stepwise logistic regression analysis was performed to assess the association of the percentage of improvement after FRR with the patient baseline characteristics, pertinent clinical characteristics, and diagnostic criteria set by the Society for Vascular Surgery. The primary outcome was subjective patient improvement after FRR. A prediction risk calculator was developed using backward stepwise multivariate logistic regression coefficients. Bootstrapping was used for internal validation. RESULTS: A total of 208 patients (22.2% male; mean age, 35.8 ± 12.8 years; median follow-up, 44.9 months) had undergone 243 FRRs. Of the 208 patients, 94.7% had had symptoms localized to the supraclavicular area, and 97.6% had had symptoms in the hand. All the patients had had positive symptoms reproduced by the elevated arm stress test and upper limb tension test. Another reasonably likely diagnosis was absent for all the patients. Of the 196 patients who had received a lidocaine injection, 180 (93.3%) had experienced improvement of NTOS symptoms. Of the 95 patients who had received a Botox injection, 82 (74.6%) had experienced improvement of NTOS symptoms. Receiver operating characteristic curve analysis was used to assess the model. The area under the curve for the backward stepwise multivariate logistic regression model was 0.8. The multivariate logistic regression analyses revealed that the significant predictors of worsened clinical outcomes included hand weakness (adjusted odds ratio [aOR], 4.28; 95% confidence interval [CI], 1.04-17.74), increasing age (aOR, 0.93; 95% CI, 0.88-0.99), workers' compensation or litigation case (aOR, 0.09; 95% CI, 0.01-0.82), and symptoms in the dominant hand (aOR, 0.20; 95% CI, 0.05-0.88). CONCLUSIONS: Using retrospective data from a single-institution database, we have developed a prediction calculator with moderate to high predictive ability, as demonstrated by an area under the curve of 0.8. The tool (available at: https://jhhntosriskcalculator.shinyapps.io/NTOS_calc/) is an important adjunct to clinical decision-making that can offer patients and providers realistic and personalized expectations of the postoperative outcome after FRR for NTOS. The findings from the present study have reinforced the diagnostic criteria set by the Society for Vascular Surgery. The calculator could aid physicians in surgical planning, referrals, and counseling patients on whether to proceed with surgery.

Increased Regional Market Competition is Associated with a Lower Threshold for Revascularization in Asymptomatic Carotid Artery Stenosis.

BACKGROUND: Revascularization practices with respect to asymptomatic carotid stenosis (ACAS) are known to vary widely among proceduralists. In addition, regional market competition has been previously shown to drive more aggressive practices in a number of surgical procedures. The aim of our study was to examine the association of regional market competition with revascularization thresholds for ACAS. METHODS: All patients undergoing carotid revascularization in the Vascular Quality Initiative carotid endarterectomy and stenting databases (2016-2020) were included. High-grade carotid stenosis was defined as ≥80%. We calculated the Herfindahl-Hirschman Index (HHI; a measure of physician market competition) for each U.S region as defined by the U.S Department of Health and Human Services. Logistic regression was used to examine the association of degree of carotid stenosis at revascularization with HHI stratified by symptomatology, adjusting for age, sex, race, insurance, and revascularization modality. RESULTS: Of 92,243 carotid interventions, 57,094 (61.9%) were performed for ACAS and 35,149 (38.1%) were performed for symptomatic carotid stenosis (SCAS). ACAS patients undergoing revascularization for moderate-grade stenosis were significantly less likely to be aspirin (85.6% vs. 86.3%), clopidogrel (41.3% vs. 45.1%), dual anti-platelet therapy (35.9% vs. 39.2%) and systemic anticoagulants (10.9 vs. 11.7%) compared to high-grade stenosis (all P < 0.05). Multivariable analysis demonstrated that decreased local market competition was independently associated with a lower odds of revascularization for moderate versus high-grade ACAS (odds ratio OR: 0.99 per 10 point increase in HHI, 95% confidence interval CI: 0.98-0.99). There was no association of local market competition with degree of carotid stenosis at time of revascularization among patients with SCAS (OR: 1.00 per 10 point increase in HHI, 95% CI: 0.99-1.00). Among ACAS patients, patients with moderate-grade stenosis had a higher odds ratio of in-hospital stroke or death compared to patients with high-grade stenosis (OR: 1.22, 95% CI 1.03-1.45). This association was not redemonstrated in the SCAS group (OR: 0.92, 95% CI: 0.80-1.06). CONCLUSIONS: Increased local market competition is associated with a lower threshold for revascularization of ACAS. There is no association between regional market competition and revascularization threshold for SCAS. These findings, combined with the significantly increased risk of perioperative stroke/death among moderate-grade ACAS patients, suggest that competition among proceduralists may result in a higher tolerance for increased operative risk in patients who might otherwise be reasonable candidates for surveillance.

Drug-Eluting Stents are Associated with Superior Mid-Term Outcomes for the Treatment of Infrainguinal Bypass Graft Stenoses.

BACKGROUND: We previously demonstrated that everolimus drug-eluting stents (eDES) have reasonable short-term patency for the treatment of infrainguinal bypass stenoses. The aim of this study is to compare mid-term outcomes of eDES, plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and drug-coated balloon (DCB) interventions for failing infrainguinal bypasses. METHODS: We conducted a retrospective review of patients with infrainguinal bypass stenoses treated by endovascular intervention (August 2010-August 2021). The primary outcome was primary patency (PP). Secondary outcomes were primary-assisted patency (PAP), secondary patency (SP), limb salvage (LS), and mortality. Outcomes were compared by treatment using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models adjusting for baseline differences between groups. RESULTS: Seventy-two consecutive patients with 152 discrete infrainguinal bypass graft stenoses were identified. Mean age was 65.1 ± 10.6 years, 55.6% were male, and 48.6% were Black. In total, 81.9% of patients were originally treated for chronic limb-threatening ischemia, and 57.2% of distal anastomoses were to tibial or pedal targets. Of 152 lesions, 44.1% (n = 67) were treated with PTA, 17.8% (n = 27) with PCB, 20.4% (n = 31) with DCB, and 17.8% (n = 27) with eDES. Median follow-up was 28.5 months (interquartile range 11.5-51.9). There was no difference in bypass configuration, conduit choice, or stenosis location (proximal anastomosis, mid-bypass, distal anastomosis) between groups. At 24 months postintervention, PP was significantly better for eDES (72.9%, 95% confidence interval [CI] 49.8-85.6), followed by PCB (55.9%, 95% CI 34.2-72.9), PTA (34.4%, 95% CI 21.7-47.4), and DCB (33.6%, 95% CI 14.5-53.9) (P = 0.03). PAP, LS, and mortality did not significantly differ between modalities (P > 0.05). After risk adjustment, eDES was associated with the lowest risk of PP loss (hazard ratio versus PTA 0.15, 95% CI 0.05-0.47). CONCLUSIONS: eDES is associated with superior 24-month patency rates compared to other endovascular technologies, and should be considered a primary therapy modality for the treatment of infrainguinal bypass graft stenoses.

Association of carotid revascularization approach with perioperative outcomes based on symptom status and degree of stenosis among octogenarians.

OBJECTIVE: Age ≥80 years is known to be an independent risk factor for periprocedural stroke after transfemoral carotid artery stenting (TF-CAS) but not after carotid endarterectomy (CEA). The objective of the present study was to compare the perioperative outcomes for CEA, TF-CAS, and transcarotid artery revascularization (TCAR) among octogenarian patients (aged ≥80 years) overall and stratified by symptom status and degree of stenosis. METHODS: All patients aged ≥80 years with 50% to 99% carotid artery stenosis who had undergone CEA, TF-CAS, or TCAR in the Vascular Quality Initiative (2005-2020) were included. We compared the perioperative (30-day) incidence of ipsilateral stroke or death for CEA vs TF-CAS vs TCAR using analysis of variance and multivariable logistic regression models. The results were confirmed in a sensitivity analysis stratified by symptom status and degree of stenosis. RESULTS: Overall, 28,571 carotid revascularization procedures were performed in patients aged ≥80 years: CEA, n = 20,912 (73.2%), TF-CAS, n = 3628 (12.7%), and TCAR, n = 4031 (14.1%). The median age was 83 years (interquartile range, 81.0-86.0 years); 49.8% of the patients were symptomatic (51.9% CEA, 46.2% TF-CAS, 42.4% TCAR); and 60.7% had high-grade stenosis (59.0% CEA, 65.2% TF-CAS, 65.4% TCAR). Perioperative stroke/death occurred most frequently following TF-CAS (6.6%), followed by TCAR (3.1%) and CEA (2.5%; P < .001). After adjusting for baseline differences between groups, the odds ratio (OR) for stroke/death was greater for TF-CAS vs CEA (adjusted OR [aOR], 3.35; 95% confidence interval [CI], 2.65-4.23), followed by TCAR vs CEA (aOR 1.49, 95% CI 1.18-1.87). The risk of perioperative stroke/death remained significantly greater for TF-CAS compared with CEA regardless of symptom status and degree of stenosis (P < .05 for all). In contrast, the risk of stroke/death was higher for TCAR vs CEA for asymptomatic patients (aOR, 2.04; 95% CI, 1.41-2.94) and those with high-grade stenosis (aOR, 1.49; 95% CI, 1.11-2.05) but similar for patients with symptomatic and moderate-grade disease (P > .05 for both). The risk of myocardial infarction was lower with TCAR (aOR, 0.59; 95% CI, 0.40-0.87) and TF-CAS (aOR, 0.56; 95% CI, 0.40-0.87) compared with CEA overall. CONCLUSIONS: Overall, TCAR and CEA can be safely offered to older adults, in particular, symptomatic patients and those with moderate-grade stenosis. TF-CAS should be avoided in older patients when possible.

Transcarotid artery revascularization is associated with similar outcomes to carotid endarterectomy regardless of patient risk status.

BACKGROUND: Carotid artery stenting (CAS), including both transfemoral carotid artery stenting (TFCAS) and transcarotid artery revascularization (TCAR), reimbursement has been limited to high-risk patients by the Centers for Medicare & Medicaid Services (CMS) since 2005. We aimed to assess the association of CMS high-risk status with perioperative outcomes for carotid endarterectomy (CEA), TFCAS, and TCAR. METHODS: We performed a retrospective review of all Vascular Quality Initiative patients who underwent carotid revascularization between 2015 and 2020. Patients were stratified by whether they met CMS CAS criteria, and univariable and multivariable logistic regression analyses were performed to assess the association of procedure type (CEA, TFCAS, TCAR) with perioperative outcomes. RESULTS: Of 124,531 individuals who underwent carotid revascularization procedures, 91,687 (73.6%) underwent CEA, 17,247 (13.9%) underwent TFCAS, and 15,597 (12.5%) underwent TCAR. Among patients who met the CMS CAS criteria (ie, high-risk patients), the incidence of perioperative stroke was 2.7% for CEA, 3.4% for TFCAS, and 2.4% for TCAR (P < .001). Among standard-risk patients, the incidence of perioperative stroke was 1.7% for CEA, 2.7% for TFCAS, and 1.8% for TCAR (P < .001). After adjusting for baseline demographic and clinical characteristics, the odds of perioperative stroke were lower for TCAR versus CEA in high-risk patients (adjusted odds ratio [aOR], 0.82; 95% confidence interval [CI], 0.68-0.99) and similar in standard-risk patients (aOR, 1.05; 95% CI, 0.84, 1.31). In contrast, the adjusted odds of perioperative stroke were higher for TFCAS versus CEA in high-risk patients (aOR, 1.23; 95% CI, 1.03-1.46) and standard-risk patients (aOR, 1.60; 95% CI, 1.37-1.86). In both populations, TFCAS and TCAR patients had significantly lower odds of myocardial infarction than CEA patients (both P < .001). CONCLUSIONS: The perioperative risks associated with CEA, TFCAS, and TCAR in high-risk patients support the current CMS criteria, although the risks associated with each revascularization approach in standard-risk patients suggest that distinguishing TCAR from TFCAS may be warranted.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

Patient-centered clinical success after lower extremity revascularization for complex diabetic foot wounds treated in a multidisciplinary setting.

OBJECTIVE: Physician-oriented outcomes, such as patency and amputation-free survival (AFS), have traditionally been markers of success after lower extremity revascularization. Previous studies have defined clinical success based on a composite of patient-centered outcomes and have shown this outcome to be achieved in less than 50% of patients, far lower than standard physician-oriented outcomes. The purpose of this study is to evaluate clinical success after lower extremity bypass (LEB) or peripheral vascular intervention (PVI) for tissue loss in diabetic patients treated in a multidisciplinary setting to better understand what factors are associated with success from a patient's perspective. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service from July 2012 to January 2020 were enrolled in a prospective database. Patients who underwent either LEB or PVI for ulcer or gangrene were included in the analysis. Clinical success was defined as the composite outcome of secondary patency to the point of wound healing, limb salvage for 1 year, maintenance of ambulatory status for 1 year, and survival for 6 months. Secondary outcomes included 1-year wound healing, patency, and AFS. RESULTS: A total of 134 revascularizations were performed in 131 patients, including 91 (68%) PVI and 43 (32%) LEB. Patients were more frequently male (64%) and black (61%), and 16% were dialysis-dependent. All patients had tissue loss (53% ulcer, 47% gangrene). There were 5 (3.7%) wound, ischemia, and foot infection stage 1, 6 (6.0%) stage 2, 29 (22%) stage 3, and 92 (69%) stage 4 limbs at the time of revascularization. Overall, 76.9% of patients preserved secondary patency to the point of wound healing, 92.5% had limb salvage for 1 year, 90.3% had maintenance of ambulatory status for 1 year, and 96.3% survived for 6 months. The clinical success composite outcome was achieved in 71.6% of patients and was not statistically different between those undergoing PVI vs LEB (69.2% vs 76.7%, P = .37). Secondary patency, limb salvage, and AFS at 1 year were 80.8% ± 3.6%, 91.8% ± 2.3%, and 83.3% ± 3.1%, respectively. Wound healing at 1 year was 84.3% ± 3.4%. The only covariate associated with clinical failure on multivariable analysis was increased age (odds ratio, 0.95; 95% confidence interval, 0.91-0.99; P = .008). CONCLUSIONS: Among diabetic patients presenting with tissue loss, the composite outcome of patient-centered clinical success is lower than traditional physician-centered outcomes after lower extremity revascularization, mostly due to low rates of secondary patency to the point of wound healing. In the current study, clinical failure was only associated with older age and was no different after PVI compared with LEB.

In-hospital and one-year outcomes are similar for women and men following transcarotid artery revascularization in symptomatic and asymptomatic patients.

OBJECTIVE: In randomized controlled trials and retrospective series, women have higher rates of periprocedural stroke and death following carotid endarterectomy and transfemoral carotid artery stenting compared with men. We sought to compare outcomes by sex following transcarotid artery revascularization (TCAR) among patients in the Vascular Quality Initiative (VQI). METHODS: We reviewed all patients in the VQI who underwent TCAR from 2017 to 2020. We stratified the analysis by symptom status. The primary outcome was in-hospital stroke/death, and secondary outcomes were in-hospital stroke and death and 1-year stroke/death, stroke, and death. We used multivariable logistic and Cox regression models to assess the association of sex with in-hospital and 1-year outcomes after adjusting for preoperative and intraoperative characteristics. RESULTS: We identified 15,851 patients who underwent TCAR, of whom 7391 (47%) were symptomatic (2708 or 37% female) and 8460 (53%) were asymptomatic (3097 or 37% female). Women were less frequently considered anatomic high risk than men in both groups (symptomatic: 43% vs 46%; P = .004; asymptomatic: 44% vs 48%; P = .004). Among symptomatic patients, women more often had severe ≥70% stenosis (89% vs 87%; P = .02). There were no differences in in-hospital death, stroke, or stroke/death for women vs men following TCAR among symptomatic or asymptomatic patients (all P > .05). After adjusting for baseline differences between groups, female sex was not associated with in-hospital stroke/death in either symptomatic (odds ratio, 1.05; 95% confidence interval, 0.72-1.56) or asymptomatic (odds ratio, 0.93; 95% confidence interval, 0.53-1.63) patients undergoing TCAR. There were also no differences in 1-year stroke, death, or stroke/death risk for women compared with men with and without symptoms on unadjusted or adjusted analyses (P > .05). CONCLUSIONS: We found no sex differences in in-hospital or 1-year stroke/death following TCAR, regardless of symptom status. TCAR appears to be as safe of a surgical procedure for women as for men in patients with both symptomatic and asymptomatic carotid artery disease.

Use of Intravascular Ultrasound During First-Time Femoropopliteal Peripheral Vascular Interventions Among Medicare Beneficiaries.

BACKGROUND: Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI. METHODS: We included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS. RESULTS: We identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons. CONCLUSIONS: Wide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians.

Racial Disparities Associated With Reinterventions After Elective Endovascular Aortic Aneurysm Repair.

BACKGROUND: There are substantial racial and socioeconomic disparities underlying endovascular abdominal aortic aneurysm repair (EVAR) in the United States. To date, race-based variations in reinterventions following elective EVAR have not been studied. Here, we aim to examine racial disparities associated with reinterventions following elective EVAR in a real-world cohort. MATERIALS AND METHODS: We used the Vascular Quality Initiative EVAR dataset to identify all patients undergoing elective EVAR between January 2009 and December 2018 in the United States. We compared the association of race with reinterventions after EVAR and all-cause mortality using Welch two-sample t-tests, multivariate logistic regression, and Cox proportional hazards analyses adjusting for baseline differences between groups. RESULTS: At median follow-up of 1.1 ± 1.1 y (1.3 ± 1.4 y Black, 1.1 ± 1.1 y White; P = 0.02), a total of 1,164 of 42,481 patients (2.7%) underwent reintervention after elective EVAR, including 2.7% (n = 1,096) White versus 3.2% (n = 68) Black (P = 0.21). Black patients requiring reintervention were more frequently female, more frequently current or former smokers, and less frequently insured by Medicare/Medicaid (P < 0.05). After adjusting for baseline differences, the risk of reintervention after elective EVAR was significantly lower for Black versus White patients (HR 0.74, 95% CI 0.55-0.99; P = 0.04). All-cause mortality was comparable between groups (HR 0.81, 95% CI 0.33-2.00, P = 0.65). CONCLUSIONS: There are significant differences between Black and White patients in the risk of reintervention after elective EVAR in the United States. The etiology of this difference deserves investigation.