Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

BACKGROUND AND AIMS: Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. METHODS: This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. RESULTS: Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). CONCLUSIONS: Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Outcomes of Bridging Intravenous Thrombolysis Versus Endovascular Therapy Alone in Late-Window Acute Ischemic Stroke.

BACKGROUND: Studies comparing bridging intravenous thrombolysis (IVT) with direct endovascular therapy (EVT) in patients with acute ischemic stroke who present late are limited. We aimed to compare the clinical outcomes and safety of bridging IVT in patients with acute ischemic stroke due to anterior circulation large vessel occlusion who underwent EVT 6 to 24 hours after time last known well. METHODS: We enrolled patients with anterior circulation large vessel occlusion stroke and a National Institutes of Health Stroke Scale score of ≥6 from 20 centers across 10 countries in the multicenter retrospective CLEAR study (CT for Late Endovascular Reperfusion) between January 2014 and May 2022. We used inverse probability of treatment weighting modeling adjusted for clinical and imaging confounders to compare functional outcomes, reperfusion success, symptomatic intracranial hemorrhage, and mortality between EVT patients with and without prior IVT. RESULTS: Of 5098 patients screened for eligibility, we included 2749 patients, of whom 549 received bridging IVT before EVT. The timing of IVT was not recorded. Witnessed stroke onset and transfer rates were higher in the bridging IVT group (25% versus 12% and 77% versus 55%, respectively, P value for both <0.0001), and time intervals between stroke onset and treatment were shorter (time last known well-start of EVT median 560 minutes [interquartile range, 432-791] versus 724 minutes [interquartile range, 544-912]; P<0.0001). After adjustment for confounders, there was no difference in functional outcome at 3 months (adjusted common odds ratio for modified Rankin Scale shift, 1.03 [95% CI, 0.89-1.19]; P=0.72) or successful reperfusion (adjusted odds ratio, 1.19 [95% CI, 0.81-1.75]; P=0.39). There were no safety concerns associated with bridging IVT versus direct EVT (symptomatic intracranial hemorrhage: adjusted odds ratio, 0.75 [95% CI, 0.38-1.48]; P=0.40; mortality: adjusted odds ratio, 1.14 [95% CI, 0.89-1.46]; P=0.31). Results were unchanged when the analysis was limited to patients who received IVT >6 hours after last known well. CONCLUSIONS: In patients with an anterior circulation large vessel occlusion stroke who underwent EVT 6 to 24 hours from last known well, bridging IVT was not associated with a difference in outcomes compared with direct EVT. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096248.

Combining Early Ischemic Change and Collateral Extent for Functional Outcomes After Endovascular Therapy: An Analysis From AcT Trial.

BACKGROUND: Early ischemic change and collateral extent are colinear with ischemic core volume (ICV). We investigated the relationship between a combined score using the Alberta Stroke Program Early Computed Tomography Score and multiphase computed tomography angiography (mCTA) collateral extent, named mCTA-ACE score, on functional outcomes in endovascular therapy-treated patients. METHODS: We performed a post hoc analysis of a subset of endovascular therapy-treated patients from the Alteplase Compared to Tenecteplase trial which was conducted between December 2019 and January 2022 at 22 centers across Canada. Ten-point mCTA collateral corresponding to M2 to M6 regions of the Alberta Stroke Program Early Computed Tomography Score grid was evaluated as 0 (poor), 1 (moderate), or 2 (normal) and additively combined with the 10-point Alberta Stroke Program Early Computed Tomography Score to produce a 20-point mCTA-ACE score. We investigated the association of mCTA-ACE score with modified Rankin Scale score ≤2 and return to prestroke level of function at 90 to 120 days using mixed-effects logistic regression. In the subset of patients who underwent baseline computed tomography perfusion imaging, we compared the mCTA-ACE score and ICV for outcome prediction. RESULTS: Among 1577 intention-to-treat population in the trial, 368 (23%; 179 men; median age, 73 years) were included, with Alberta Stroke Program Early Computed Tomography Score, mCTA collateral, and combination of both (mCTA-ACE score: median [interquartile range], 8 [7-10], 9 [8-10], and 17 [16-19], respectively). The probability of modified Rankin Scale score ≤2 and return to prestroke level of function increased for each 1-point increase in mCTA-ACE score (odds ratio, 1.16 [95% CI, 1.06-1.28] and 1.22 [95% CI, 1.06-1.40], respectively). Among 173 patients in whom computed tomography perfusion data was assessable, the mCTA-ACE score was inversely correlated with ICV (ρ=-0.46; P<0.01). The mCTA-ACE score was comparable to ICV to predict a modified Rankin Scale score ≤2 and return to prestroke level of function (C statistics 0.71 versus 0.69 and 0.68 versus 0.64, respectively). CONCLUSIONS: The mCTA-ACE score had a significant positive association with functional outcomes after endovascular therapy and had a similar predictive performance as ICV.

Arterial Recanalization During Interhospital Transfer for Thrombectomy.

BACKGROUND: Patients with acute ischemic stroke harboring a large vessel occlusion admitted to nonendovascular-capable centers often require interhospital transfer for thrombectomy. We evaluated the incidence and predictors of arterial recanalization during transfer, as well as the relationship between interhospital recanalization and clinical outcomes. METHODS: We analyzed data from 2 cohorts of patients with an anterior circulation large vessel occlusion transferred for consideration of thrombectomy to a comprehensive center, with arterial imaging at the referring hospital and on comprehensive stroke center arrival. Interhospital recanalization was determined by comparison of the baseline and posttransfer arterial imaging and was defined as revised arterial occlusive lesion (rAOL) score 2b to 3. Pretransfer variables independently associated with interhospital recanalization were studied using multivariable logistic regression analysis. RESULTS: Of the 520 included patients (Montpellier, France, n=237; Stanford, United States, n=283), 111 (21%) experienced interhospital recanalization (partial [rAOL=2b] in 77% and complete [rAOL=3] in 23%). Pretransfer variables independently associated with recanalization were intravenous thrombolysis (adjusted odds ratio, 6.8 [95% CI, 4.0-11.6]), more distal occlusions (intracranial carotid occlusion as reference: adjusted odds ratio, 2.0 [95% CI, 0.9-4.5] for proximal first segment of the middle cerebral artery, 5.1 [95% CI, 2.3-11.5] for distal first segment of the middle cerebral artery, and 5.0 [95% CI, 2.1-11.8] for second segment of the middle cerebral artery), and smaller clot burden (clot burden score 0-4 as reference: adjusted odds ratio, 3.4 [95% CI, 1.5-7.6] for 5-7 and 5.6 [95% CI, 2.4-12.7] for 8-9). Recanalization on arrival at the comprehensive center was associated with less interhospital infarct growth (rAOL, 0-2a: 11.6 mL; rAOL, 2b: 2.2 mL; rAOL, 3: 0.6 mL; Ptrend<0.001) and greater interhospital National Institutes of Health Stroke Scale score improvement (0 versus -5 versus -6; Ptrend<0.001). Interhospital recanalization was associated with reduced 3-month disability (adjusted common odds ratio, 2.51 [95% CI, 1.68-3.77]) with greater benefit from complete than partial recanalization. CONCLUSIONS: Recanalization is frequently observed during interhospital transfer for thrombectomy and is strongly associated with favorable outcomes, even when partial. Broadening thrombolysis indications in primary centers, and developing therapies that increase recanalization during transfer, will likely improve clinical outcomes.

Randomized Secondary Prevention Trials in Participants With Symptomatic Intracranial Atherosclerotic Stenosis.

Intracranial atherosclerotic stenosis is a prevalent cause of ischemic stroke worldwide. Its association with silent cerebral infarcts and its contribution to cognitive impairment and dementia emphasize the critical need for disease prevention and effective management strategies. Despite extensive research on secondary stroke prevention treatment over the past several decades, intracranial atherosclerotic stenosis continues to exhibit a notably higher recurrent stroke rate compared with other causes. This review focuses on randomized secondary prevention trials involving antithrombotic therapy, endovascular treatment, open surgical therapy, and remote ischemic conditioning. It aims to provide an insightful overview of the major findings from each trial and their implications for future research efforts.

Combined Technique for Internal Carotid Artery Terminus or Middle Cerebral Artery Occlusions in the ASTER2 Trial.

BACKGROUND: The aim of this study was to report the results of a subgroup analysis of the ASTER2 trial (Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion) comparing the safety and efficacy of the combined technique (CoT) and stent retriever as a first-line approach in internal carotid artery (ICA) terminus±M1-middle cerebral artery (M1-MCA) and isolated M1-MCA occlusions. METHODS: Patients enrolled in the ASTER2 trial with ICA terminus±M1-MCA and isolated M1-MCA occlusions were included in this subgroup analysis. The effect of first-line CoT versus stent retriever according to the occlusion site was assessed on angiographic (first-pass effect, expanded Treatment in Cerebral Infarction score ≥2b50, and expanded Treatment in Cerebral Infarction score ≥2c grades at the end of the first-line strategy and at the end of the procedure) and clinicoradiological outcomes (24-hour National Institutes of Health Stroke Scale, ECASS-III [European Cooperative Acute Stroke Study] grades, and 3-month modified Rankin Scale). RESULTS: Three hundred sixty-two patients were included in the postsubgroup analysis according to the occlusion site: 299 were treated for isolated M1-MCA occlusion (150 with first-line CoT) and 63 were treated for ICA terminus±M1-MCA occlusion (30 with first-line CoT). Expanded Treatment in Cerebral Infarction score ≥2b50 (odds ratio, 11.83 [95% CI, 2.32-60.12]) and expanded Treatment in Cerebral Infarction score ≥2c (odds ratio, 4.09 [95% CI, 1.39-11.94]) were significantly higher in first-line CoT compared with first-line stent retriever in patients with ICA terminus±M1-MCA occlusion but not in patients with isolated M1-MCA. CONCLUSIONS: First-line CoT was associated with higher reperfusion grades in patients with ICA terminus±M1-MCA at the end of the procedure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03290885.

Treatment strategy for splenic artery aneurysms and novel classification based on imaging.

OBJECTIVE: The incidence of splenic artery aneurysms (SAAs) has increased with advances in imaging techniques, necessitating a comprehensive classification to guide treatment strategies. This study aims to propose a novel classification system for SAAs based on aneurysm characteristics and to review treatment outcomes at our center. METHODS: This retrospective study included 113 patients with SAAs admitted to Peking Union Medical College Hospital from January 2019 to December 2023, assessed using computed tomography angiography or digital subtraction angiography. A new classification system was devised based on the aneurysm location, morphology, integrity, and parent artery anatomy. Treatment strategies were determined based on these characteristics, with interventions ranging from endovascular therapy to laparoscopic and open surgery. Patients were followed up after the intervention to assess mortality, complications, reinterventions, and aneurysm-related outcomes. RESULTS: The study cohort of 113 patients with 127 SAAs had a predominance of female patients (63.7%) and a mean age of 52.7 years. The SAAs were classified into five types, with type I being the most common. The intervention techniques varied across types, with sac embolization, covered stent implantation, and artery embolization being the most frequently used. The overall technical success rate was 94.7%, with perioperative complication and reintervention rates of 25.0% and 0.9%, respectively, and no deaths within 30 days after the intervention. The median follow-up duration was 21 months, with overall complications rate of 3.5% and no aneurysm-related complications or deaths. CONCLUSIONS: The proposed classification system effectively guides the selection of treatment strategies for SAAs, incorporating key anatomical and morphological features. This system facilitated high technical success and low complication rates, underscoring the importance of tailored techniques in managing SAAs.

The addition of a leaded arm sleeve to leaded aprons further decreases operator upper outer quadrant chest wall radiation dose during fluoroscopically guided interventions.

OBJECTIVE: Breast cancer most commonly occurs in the upper outer quadrant (UOQ) chest wall (CW). The effectiveness of routine leaded aprons to protect this region of the body in interventionalists during fluoroscopically guided interventions (FGIs) is unknown. Given the high lifetime attributable risks of prolonged occupational exposure to ionizing radiation and the increasing number of practicing female vascular surgeons and interventionalists, we sought to determine if the use of a leaded arm shield would offer additional protection to the lateral CW and axilla in operators compared with routine leaded aprons. METHODS: Effectiveness of leaded sleeves in attenuating radiation dose to the axilla and UOQ was evaluated in clinical practice and simulated scenarios. In the clinical setting, optically stimulated luminescence nanoDot detectors were placed at the UOQ lateral CW position, both over and under a standard leaded apron vest with and without the addition of an antimony/bismuth Enviro-Lite sleeve on two vascular surgeons performing FGIs. In the simulation, nanoDots were similarly placed on an anthropomorphic phantom positioned to represent a primary operator performing right femoral access. Fluorography was performed on 12-inch-thick acrylic scatter phantom at 80 kVp for an exposure of 3 Gy reference air kerma. Experiments were done with and without the sleeve. Paired Wilcoxon and χ2 tests were performed to identify the statistical significance of radiation attenuation. RESULTS: Operator UOQ CW dose was measured during 61 FGIs: 33 cases (54%) with and 28 cases (46%) without the sleeve. Median procedure reference air kerma and fluoroscopy time was 180 mGy (interquartile range [IQR], 85-447 mGy) and 21 minutes (IQR, 11-39 minutes) when the sleeve was worn vs 100 mGy (IQR, 67-270 mGy) and 11 minutes (IQR, 6.3-25 minutes) without the sleeve. Radiation dose to the operator's UOQ was reduced by 96% (IQR, 85%-96%) when the sleeve was present and by 62% (IQR, 44%-82%; P < .001) without the sleeve. In the simulated setting, the sleeve reduced the radiation dose to the UOQ compared with the apron alone (96% vs 67%; P < .001). CONCLUSIONS: Routine leaded aprons do attenuate the majority of UOQ chest wall radiation dose; however, the addition of a lead-equivalent sleeve further significantly reduces this dose. Because this area of the body has a high incidence of cancer formation, additional protection, especially to female interventionalists, seems prudent. Vascular surgeons should consider using a protective sleeve with their personal protective equipment when performing complex fluoroscopically guided procedures.

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.

Impact of the endovascular revolution on vascular training through analysis of national data case reports.

BACKGROUND: In the last couple of decades, there has been a shift in use of endovascular procedures in vascular surgery. We aim to examine the impact of this endovascular shift on vascular trainees, determine whether the surgical experiences of trainees in the integrated residency and fellowship program changed over time, and identify differences between the two training paradigms. METHODS: Data were extracted from the Accreditation Council for Graduate Medical Education National Data Case Logs for the vascular surgery fellowship (1999-2021) and integrated residency (2012-2021) programs. Every procedure was categorized as open or endovascular, then designated into the following subcategories: thoracic aneurysm repairs, cerebrovascular, abdominal aneurysm repairs, venous, vascular access, peripheral arterial disease, visceral, or miscellaneous. We compared the prevalence of open and endovascular cases in the fellowship and integrated residency using data from overlapping years (2012-2021). In addition, we compared the mean number of cases per trainee per year within designated time intervals. The vascular surgery fellowship was grouped into three intervals: 1999 to 2006, 2006 to 2013, and 2013 to 2021; the integrated vascular surgery residency was grouped into two intervals: 2012 to 2017 and 2017 to 2021. Data were standardized to represent the average number of cases per trainee per year. RESULTS: Within the fellowship, we found a 362.37% increase in endovascular procedures (mean, 56.80 ± 32.57 vs 262.63 ± 9.91; P < .001), although there was only a 32.47% increase in open procedures (220.19 ± 4.55 vs 291.68 ± 8.20) between the first and last time intervals. There was a decrease in abdominal aneurysm repair (24.46 ± 7.30 vs 13.85 ± 0.58; P < .001) and visceral (6.41 ± 0.44 vs 5.80 ± 0.42; P = .039) open procedures. For the integrated residency, there was an increase in open procedures by 8.52% (352.18 ± 8.23 vs 382.20 ± 5.84; P < .001). Residents had greater total, open, and endovascular procedures per year than fellows (all P < .001). Chief residents had approximately one-half as many cases as vascular fellows per year. Fellows performed more open abdominal aneurysm repair (14.04 ± 0.80 vs 12.40 ± 1.32; P = .007) and visceral (5.83 ± 0.41 vs 4.88 ± 0.46; P > .001) procedures than residents. Overall, 52% to 53% of cases performed by trainees per year were open procedures in both the fellowship and integrated residency (288.56 ± 12.10 vs 261.27 ± 10.13, 365.52 ± 17.23 vs 319.58 ± 6.62; both P < .001). Within the subcategories, only cerebrovascular, vascular access, and miscellaneous had more open procedures performed per trainee. CONCLUSIONS: Vascular surgery training has incorporated new endovascular techniques and technologies while maintaining operative training in open procedures. Despite changes in vascular surgery training, trainees are still performing more open procedures than endovascular procedures per year. However, there are evolving deficits in specific types of procedures.

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, and overall survival. METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation, given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic. RESULTS: Eight studies were included in the review after full text screening. A total of 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions; the aortic sac was opened in 96.1% of cases; in 93.3% of cases, ligation/suture of one or more culprit arteries were performed; and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2 = 24.9%) and 13.4% (I2 = 54.3%), respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2 = 83.2%), and the rate of reinterventions was 7% (I2 = 50.1%); the semi-conversion failure rate was 5.5% (I2 = 54.1%), and the overall survival was 84.6% (I2 = 33.3%). CONCLUSIONS: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures, and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross-clamping is not ideal.

Comparison of total percutaneous in situ microneedle puncture and chimney technique for left subclavian artery fenestration in thoracic endovascular aortic repair for type B aortic dissection.

OBJECTIVE: To compare the outcomes of totally percutaneous in situ microneedle puncture for left subclavian artery (LSA) fenestration (ISMF) and chimney technique in type B aortic dissection (TBAD) during thoracic endovascular aortic repair (TEVAR). MATERIALS AND METHODS: Data on patients who underwent either chimney-TEVAR (n = 89) or ISMF-TEVAR (n = 113) from October 2018 to April 2022 were analyzed retrospectively. The primary outcomes were mortality and major complications at 30 days and during follow-up. RESULTS: The technical success rate was 84.3% in the chimney group and 93.8% in the ISMF group (p = 0.027). The incidence of immediate endoleakage was significantly higher in the chimney than ISMF group (15.7% vs 6.2%, respectively; p = 0.027). The 1- and 3-year survival rates in the chimney and ISMF groups were 98.9% ± 1.1% vs 98.1% ± 0.9% and 86.5% ± 6.3% vs 92.6% ± 4.1%, respectively (log-rank p = 0.715). The 3-year rate of cumulative freedom from branch occlusion in the chimney and ISMF group was 95.4% ± 2.3% vs 100%, respectively (log-rank p = 0.023). CONCLUSION: Both ISMF-TEVAR and chimney-TEVAR achieved satisfactory short- and mid-term outcomes for the preservation of the LSA in patients with TBAD. ISMF-TEVAR appears to offer better clinical outcomes with higher patency and lower reintervention rates. However, ISMF-TEVAR had longer operation times with higher procedure expenses. CLINICAL RELEVANCE STATEMENT: When LSA revascularization is required during TEVAR, in situ, fenestration, and chimney techniques are all safe and effective methods; in situ, fenestration-TEVAR appears to offer better clinical outcomes, but takes longer and is more complicated. KEY POINTS: LSA revascularization during TEVAR reduces post-operative complication rates. Both in situ ISMF-TEVAR and chimney-TEVAR are safe and effective techniques for the preservation of the LSA during TEVAR. The chimney technique is associated with a higher incidence of endoleakage and branch occlusion, but ISMF-TEVAR is a more complicated and expensive technique.

Real-World Vein Mapping Practice Patterns Before Endovascular Treatment of Limb Ischemia.

INTRODUCTION: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial results suggest that in patients with chronic limb-threatening ischemia (CLTI) and adequate single-segment great saphenous vein (SSGSV) by preoperative duplex ultrasonography, a surgical-first treatment strategy is superior to an endovascular-first strategy. However, the utilization of vein mapping prior to endovascular-first revascularization for CLTI in actual clinical practice is not known. METHODS: Data from a multicenter clinical data warehouse (2008-2019) were linked to Medicare claims data for patients undergoing endovascular-first treatment of infra-inguinal CLTI. Only patients who would have otherwise been eligible for enrollment in BEST-CLI were included. Adequate SSGSV was defined as healthy vein >3.0 mm in diameter from the groin through the knee. Logistic regression was used to estimate associations between preprocedure characteristics and vein mapping. Survival methods were used to estimate the risk of major adverse limb events and death. RESULTS: A total of 142 candidates for either surgical or endovascular treatment underwent endovascular-first management of CLTI. Ultrasound assessment for SSGSV was not performed in 76% of patients prior to endovascular-first revascularization. Of those who underwent preprocedure vein mapping, 44% had adequate SSGSV for bypass. Within one year postprocedure, 12.0% (95% confidence interval 7.4-18.0%) of patients underwent open surgical bypass and 54.7% (95% confidence interval 45.3-62.4%) experienced a major adverse limb event or death. CONCLUSIONS: In a real-world cohort of BEST-CLI-eligible patients undergoing endovascular-first intervention for infra-inguinal CLTI, three-quarters of patients had no preprocedure ultrasound assessment of great saphenous vein conduit. Practice patterns for vein conduit assessment in the real-world warrant reconsideration in the context of BEST-CLI trial results.

Paradigm Shift of Interventional Strategies and Outcomes for Acute Limb Ischemia Post-Pandemic.

PURPOSE: We performed a large-scale comparison of patients treated for acute limb ischemia (ALI) in the pre-COVID (2017-2019) and COVID (2020-2022) eras to evaluate changes in interventional strategies and compare factors associated with adverse outcomes. We sought to characterize patient outcomes in an evolving ALI treatment algorithm in response to pandemic-associated presentation delays and rapid technological advancements in mechanical thrombectomy (MT). METHODS: Using the TriNetX global research network, we conducted a multicenter query across 80 health care organizations (HCOs) spanning 4 countries for patients treated for ALI. Propensity score matching was performed to account for comorbidities. Risk of adverse outcomes within 30 days was calculated for each era, including re-intervention (RI30), major/minor amputation, and death. Patients were then stratified by initial intervention: open revascularization (OR), MT, or catheter-directed thrombolysis and adjunctive endovascular procedures alone (CDT/EP). Risk of adverse outcomes was compared between treatment groups of the same era. RESULTS: After propensity score matching, the pre-COVID era and COVID era cohorts included 7344 patients each. COVID era patients experienced a statistically significant higher risk of 30-day mortality (RR=1.211, p=0.027). Mechanical thrombectomy interventions were performed more frequently in the COVID era (RR=1.314, p<0.0001). Comparing outcomes between treatment groups, MT patients required RI30 more than OR patients (pre-COVID: RR=2.074, p=0.006; COVID: RR=1.600, p=0.025). Open revascularization patients had higher 30-day mortality (pre-COVID: RR=2.368, p<0.0001; COVID: RR=2.013, p<0.0001) and major amputations (pre-COVID: RR=2.432, p<0.0001; COVID: RR=2.176, p<0.0001) than CDT/EP. Pre-COVID CDT/EP patients were at higher risk for RI30 (RR=1.449, p=0.005) and minor amputations (RR=1.500, p=0.010) than OR. The MT group had higher major amputation rates than CDT/EP (pre-COVID: RR=2.043, p=0.019; COVID: RR=1.914, p=0.007). COVID-era MT patients had greater 30-day mortality (RR=1.706, p=0.031) and RI30 (RR=1.544, p=0.029) than CDT/EP. CONCLUSION: Significant shifts toward an MT-based approach have been observed in the last 3 years. Although MT required more RI30 than OR, there was no associated consequence of mortality and limb salvage. The increased mortality seen among COVID-era patients could be explained by delayed presentation, as well as poorly understood pro-thrombogenic or pro-inflammatory mechanisms related to the first waves of COVID. More research is necessary to determine an optimal treatment algorithm. CLINICAL IMPACT: Comorbid risk factors and severity of ischemia must be carefully considered before selecting an interventional strategy to prevent adverse outcomes and maximize limb salvage. Open revascularization strategies are associated with increased mortality and limb loss compared to less-invasive thrombolytic therapy alone. Mechanical thrombectomy (MT)-based approaches have been increasingly used in the last 3 years. Patients receiving MT are more likely to require reintervention within 30 days.

Evaluating the Effectiveness and Clinical Outcomes of Endovascular Aneurysm Repair-First Approach for Ruptured Abdominal Aortic Aneurysm in Japan.

PURPOSE: To verify the validity of an endovascular aneurysm repair (EVAR)-first strategy for treating patients with ruptured abdominal aortic aneurysm (rAAA) in Japan. MATERIALS AND METHODS: This study was conducted on 2 groups of patients with rAAA who underwent surgical treatment at 3 hospitals in the Kanagawa Prefecture, Japan, between January 2007 and September 2016. The open surgical treatment group comprised patients with rAAA who underwent open surgical treatment before January 2012; their data were retrospectively collected from their medical records. The EVAR-first strategy group comprised patients with rAAA who underwent treatment based on the Shonan rAAA protocol (SRAP; the standard protocol-based EVAR-first strategy) in or after February 2012; their data were collected prospectively. The short- and long-term treatment outcomes of both groups were compared. In addition, a risk score-based sensitivity analysis (one-to-one matching) was conducted on both groups using a caliper with 0.2 standard deviations of the score. RESULTS: Of the 163 patients with rAAA, the open surgical and EVAR-first strategy groups comprised 53 and 110 patients, respectively (EVAR: 91.8%, open repair: 8.2%). The 30-day postoperative mortality rate differed significantly, being 42% for the open surgery group and 25% for the EVAR-first strategy group (odds ratio: 0.44, 95% confidence interval: 0.20-0.97). The postoperative survival rates at 6 months, 1 year, and 3 years were 66%, 48%, and 58% for the EVAR-first group, respectively, and 51%, 66%, and 48% for the open surgery group, respectively (p=0.072). In a matched cohort analysis (n=50), the 30-day postoperative mortality rate was 22% for the EVAR-first group and 44% for the open surgery group (odds ratio: 0.35, 95% confidence interval: 0.14-0.90). The postoperative survival rates at 6 months, 1 year, and 3 years were 76%, 76%, and 63% for the EVAR-first group, respectively, and 48%, 45%, and 45% for the open surgery group, respectively (p=0.003). CONCLUSION: The SRAP-based EVAR-first strategy for rAAA yielded significantly better treatment outcomes than the open surgical strategy. These findings suggest that EVAR should be considered the primary treatment option for rAAA, given its potential to reduce early mortality rates. CLINICAL IMPACT: Multicenter retrospective analysis of prospectively collected registry data was done to compare treatment outcomes of two groups of ruptured abdominal aortic aneurysm patients open surgery and endovascular-aneurysm-repair (EVAR)-first strategy (Shonan ruptured abdominal aortic aneurysm protocol). EVAR-first group showed better outcomes: lower 30-day mortality (25% vs. 42%), higher survival rates at 6 months, 1 year, and 3 years. Take home Message: The study supports the use of the EVAR-first strategy with the Shonan Protocol for treating ruptured abdominal aortic aneurysms in Japan, showing improved outcomes, reduced 30-day postoperative mortality, and better long-term survival rates compared to the conventional approach.

The influence of embolization of internal carotid artery aneurysms on arterial tortuosity: a prospective cohort study.

PURPOSE: To compare quantitative tortuosity descriptors of Internal Carotid Artery (ICA) on aneurysmal and non-aneurysmal side before and after embolization of aneurysm and to determine possible factors associated with its change. MATERIAL AND METHODS: An analysis of 52 patients with intracranial aneurysm, treated with endovascular procedure, was performed. Based on their Digital Subtraction Angiography images, obtained prior to the procedure and after first follow-up examination, tortuosity of ICA, both on the side of embolization and on the other side was analysed. For each patient tortuosity descriptors were calculated: Relative Length, Sum of Angle Metrics, Triangular Index, Product of Angle Distance, and Inflection Count Metric. To represent changes in tortuosity, for each descriptor delta value (Δ) was defined as value of the descriptor prior to embolization - value of the descriptor on follow-up examination. RESULTS: In the follow-up We found no statistically significant changes in tortuosity on non-embolized side. On the embolized side SOAM (2.89±0.92 vs. 2.38±0.94;p<0.001), PAD (5.01±1.83 vs. 3.95±1.72 ;p<0.001) and ICM (12.18±4.55 vs. 9.76±4.04 vs.;p = 0.006) was significantly higher after embolization than before embolization. Mean ΔRelative Length (-0.02 [-0.045--0.002] vs. -0.01 [-0.02-0.003];p - 0.003),ΔProduct of Angle Distance (0.84 [0.30 - 1.82] vs. 0.10 [-0.001 - 1.10];p<0.001) and ΔInflection Count Metric (2.05 [0.42 - 3.50] vs. 0.27 [0.02 - 2.16];p = 0.004) were significantly higher on the embolized side. CONCLUSION: Following study showed that embolization may increase the tortuosity of ICA.

Development and Testing of Step, Error, and Event Frameworks to Evaluate Technical Performance in Peripheral Endovascular Interventions.

OBJECTIVE: Tools for endovascular performance assessment are necessary in competency based education. This study aimed to develop and test a detailed analysis tool to assess steps, errors, and events in peripheral endovascular interventions (PVI). METHODS: A modified Delphi consensus was used to identify steps, errors, and events in iliac-femoral-popliteal endovascular interventions. International experts in vascular surgery, interventional radiology, cardiology, and angiology were identified, based on their scientific track record. In an initial open ended survey round, experts volunteered a comprehensive list of steps, errors, and events. The items were then rated on a five point Likert scale until consensus was reached with a pre-defined threshold (Cronbach's alpha > 0.7) and > 70% expert agreement. An experienced endovascular surgeon applied the finalised frameworks on 10 previously videorecorded elective PVI cases. RESULTS: The expert consensus panel was formed by 28 of 98 invited proceduralists, consisting of three angiologists, seven interventional radiologists, five cardiologists, and 13 vascular surgeons, with 29% from North America and 71% from Europe. The Delphi process was completed after three rounds (Cronbach's alpha; αsteps = 0.79; αerrors = 0.90; αevents = 0.90), with 15, 26, and 18 items included in the final step (73 - 100% agreement), error (73 - 100% agreement), and event (73 - 100% agreement) frameworks, respectively. The median rating time per case was 4.3 hours (interquartile range [IQR] 3.2, 5 hours). A median of 55 steps (IQR 40, 67), 27 errors (IQR 21, 49), and two events (IQR 1, 6) were identified per case. CONCLUSION: An evaluation tool for the procedural steps, errors, and events in iliac-femoral-popliteal endovascular procedures was developed through a modified Delphi consensus and applied to recorded intra-operative data to identify hazardous steps, common errors, and events. Procedural mastery may be promoted by using the frameworks to provide endovascular proceduralists with detailed technical performance feedback.

Patient Factors Influencing Prescription of Antithrombotic Medication After Lower Limb Endovascular Intervention.

OBJECTIVE: There is significant practice variation in the use of antithrombotic therapy after endovascular intervention for lower limb peripheral arterial disease, with differences in medication choice and duration. Prescriber decision making is complex, and patient factors have been shown to substantially contribute to prescribing variation. To determine the influence of patient factors on antithrombotic prescribing, a discrete choice experiment was distributed to vascular surgeons and trainees across Australia and Aotearoa New Zealand. METHODS: After pilot testing, the discrete choice experiment questionnaire was distributed to 300 vascular surgeons and trainee members of the Australian and New Zealand Society for Vascular Surgery. Multinomial logistic regression models were used to analyse patient factors that had the most influence on decisions to prescribe a second antithrombotic agent, and the preferred choice of antithrombotic (clopidogrel 75 mg daily or rivaroxaban 2.5 mg twice daily) in addition to aspirin 100 mg daily. The odds ratio (OR) with 95% confidence interval (CI) reported preference strength. RESULTS: A total of 44 questionnaires were completed between September and October 2023, reaching the 15% targeted response rate. Prescribing a second antithrombotic was more likely after femoropopliteal stenting compared with angioplasty (OR 1.89, 95% CI 1.20 - 2.13), and in chronic limb threatening ischaemia compared with intermittent claudication (OR 1.58, 95% CI 1.20 - 2.13). Most respondents preferred clopidogrel over rivaroxaban (62%), with over a third of respondents exclusively prescribing clopidogrel. Patients with stents (OR 1.77, 95% CI 1.32 - 2.37) or moderate bleeding risk (OR 1.38, 95% CI 0.97 - 1.84) were more likely to receive clopidogrel than rivaroxaban. CONCLUSION: This study demonstrates that vascular surgeons primarily prioritise antithrombotic prescribing decisions by procedure type. Clopidogrel is more likely to be prescribed than rivaroxaban as a second agent in combination with aspirin, especially after stenting. Knowing these clinician preferences can target implementation strategies towards supporting decision making in subgroups of patients according to individual risk profiles.

Editor's Choice - Management of Lower Extremity Venous Outflow Obstruction: Results of an International Delphi Consensus.

OBJECTIVE: The endovascular treatment of venous obstruction has expanded significantly in recent years. Best practices for optimal patient outcomes are not well established and the evidence base is poor. The purpose of this study was to obtain consensus on management criteria for patients with lower extremity venous outflow obstruction. METHODS: The study was conducted as a two round Delphi consensus. Statements addressed imaging, symptoms and other baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow and outflow assessment, successful procedural outcomes, post-procedure therapies and stent surveillance, and clinical success factors. Statements were prepared by six expert physicians (round 1, 40 statements) and an expanded panel of 24 physicians (round 2, 80 statements) and sent to a pre-identified group of venous experts who met qualifying criteria. A 9 point Likert scale was used and consensus was defined as ≥ 70% of respondents rating a statement between 7 and 9 (agreement) or between 1 and 3 (disagreement). Round 1 results were used to guide rewording and splitting compound statements for greater clarity in round 2. RESULTS: In round 1, 75 of 110 (68%) experts responded, and 91 of 121 (75%) experts responded in round 2. Round 1 achieved consensus in 32/40 (80%) statements. Consensus was not reached in the treatment algorithm section. Round 2 achieved consensus in 50/80 (62.5%). Statements reaching consensus were imaging (2/3, 66%), symptoms and other baseline measures (12/24, 50%), differential diagnosis (2/8, 25%), treatment algorithm (10/17, 59%), indications for stenting (10/10, 100%), inflow and outflow assessment (2/2, 100%), procedural outcomes (2/2, 100%), post-procedure therapies and stent surveillance, (5/7, 71%), and clinical success factors (5/7, 71%). CONCLUSION: This study demonstrated that considerable consensus was achieved between venous experts on the optimal management of lower extremity venous outflow obstruction. There were multiple domains where consensus is lacking, highlighting important areas for further investigation and research.

Peri-operative Mortality and Morbidity of Complex Abdominal Aortic Aneurysms Repair in Switzerland: A Swissvasc Report.

OBJECTIVE: Complex abdominal aortic aneurysms (cAAA) pose a clinical challenge. The aim of this study was to assess the 30 day mortality and morbidity for open aneurysm repair (OAR) and fenestrated/branched endovascular aortic repair (F/BEVAR), and the effect of hospital volume in patients with asymptomatic cAAA in Switzerland. METHODS: Retrospective, cohort study using data from Switzerland's national registry for vascular surgery, Swissvasc, including patients treated from 1 January 2019 to 31 December 2022. All patients with asymptomatic, true, non-infected cAAA were identified. Primary outcome was 30 day mortality and morbidity reported using the Clavien-Dindo classification. Outcomes were compared between OAR and F/BEVAR after propensity score weighting. RESULTS: Of the 461 patients identified, 333 underwent OAR and 128 underwent F/BEVAR for cAAA. At 30 days, overall mortality rate was 3.3% after OAR and 3.1% after F/BEVAR (p = .76). Propensity scores weighted analysis indicated similar morbidity rates for both approaches: F/BEVAR (OR 0.69, 95% CI 0.45 - 1.05, p = .055); intestinal ischaemia (1.8% after OAR, 3.1% after F/BEVAR, p = .47) and renal failure requiring dialysis (1.5% after OAR, 5.5% after F/BEVAR, p = .024) were associated with highest morbidity and mortality. Treatment specific complications with high morbidity were abdominal compartment syndrome and lower limb compartment syndrome following F/BEVAR. Overall treatment volume was low for most of the hospitals treating cAAA in Switzerland; outliers with increased mortality were identified among low volume hospitals. CONCLUSION: Comparable 30 day mortality and morbidity rates were found between OAR and F/BEVAR for cAAA in Switzerland; lack of centralisation was also highlighted. Organ specific complications driving mortality were renal failure, intestinal ischaemia, and limb ischaemia, specifically after F/BEVAR. Treatment in specialised high volume centres, alongside efforts to reduce peri procedural kidney injury and mesenteric ischaemia, offers potential to lower morbidity and mortality in elective cAAA treatment.