Objective: The Best Endovascular vs best Surgical Therapy in Patients with Chronic Limb-threatening Ischemia (CLTI) (BEST-CLI) trial was a multi-specialty trial that compared endovascular therapy with open surgery in patients with CLTI. We evaluated differences in endovascular practice patterns and outcomes among participating specialties.
Methods: All patients who underwent endovascular therapy performed by interventional cardiologists (ICs), interventional radiologists (IRs), and vascular surgeons (VSs) who met credentialing criteria in the trial were included in the analysis. Between-specialty group differences in demographics and practice patterns were evaluated using analysis of variance. The primary endpoint was major adverse limb events (MALE) and death (MALE-death); subcomponents of major revascularization, above-ankle amputation, and death were also examined.
Results: VSs treated the majority of the patients in the endovascular arm of BEST-CLI and more frequently treated patients of African-American descent and those with grade 3 limb ischemia (P = .016). ICs more frequently treated patients of Hispanic ethnicity, and utilized P2Y12 inhibitors (P = .005), clopidogrel (P = .021), and dual antiplatelet therapy (P = .002) compared with IRs and VSs. ICs also more often treated tibial arteries (P = .007), and utilized atherectomy (P < .001), drug-coated balloon angioplasty (P < .001), and drug-eluting stents (P < .001). There was no difference in endovascular technical failure between the groups. Over the course of follow-up, IRs had a lower incidence of MALE-death compared with ICs (IC vs IR: rate ratio [RR], 2.34; 95% confidence interval [CI], 1.45-3.77; P = .0005) and VS (IR vs VS: RR, 0.54; 95% CI, 0.37-0.77; P = .0007). This was largely driven by a lower incidence of death (IC vs IR: RR, 3.16; 95% CI, 1.80-45.55; P < .0001; IR vs VS: RR, 0.44; 95% CI, 0.28-0.70; P = .0005) and major revascularization (IC vs IR: RR, 1.56; 95% CI, 0.67-3.63; P = .30; IR vs VS: RR, 0.55; 95% CI, 0.32-0.96; P = .034). There was no difference in above-ankle amputation between the groups (IC vs IR: RR, 1.55; 95% CI, 0.74-3.22; P = .24; IC vs VS: RR, 1.12; 95% CI, 0.60-2.07; P = .72, IR vs VS: RR, 0.72; 95% CI, 0.42-1.24; P = .24).
Conclusions: Significant differences in practice patterns were seen between ICs, IRs, and VSs in BEST-CLI. The majority of patients were enrolled by VSs. There was significant differences in severity of patient CLTI at presentation. Although IRs had a lower incidence of MALE-death, death, and major revascularization compared with ICs and VSs, there was no difference in major amputation between the specialties.
Objective: The aim of this study was to assess the 24-month clinical outcome of endovascular therapy (EVT) for femoropopliteal (FP) lesions in patients with lifestyle-limiting claudication in a current real-world setting.
Methods: We retrospectively analyzed data from a clinical database formed by TALENT (Impact Of Tibial Run Off On Clinical Outcome Of Endovascular Therapy In Femoropopliteal Lesions), a prospective, multicenter patient registry. We selected 980 patients (1010 limbs) with symptomatic intermittent claudication (IC) undergoing FP intervention from the TALENT registry between December 1, 2020, and May 1, 2023. The observational end points included the incidence of clinically driven target lesion revascularization (CD-TLR), major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), all-cause of mortality, progression to chronic limb threatening ischemia (CLTI), and changes in self-reported quality-of-life (QOL) measures (Vascular Quality of Life 25). Prognostic predictors for MALE, MACE, CD-TLR, and progression to CLTI were elucidated by Cox proportional hazard regression analysis.
Results: A total of 1010 targeted limbs in 980 patients with IC treated with EVT were included in this study. The median follow-up time was 24 months (interquartile range, 24-36 months). At the 24-month follow-up, the cumulative incidence of CD-TLR was 7.15% (95% confidence interval [CI], 5.45%-8.85%), whereas progression to CLTI occurred in only 2.20% of limbs (95% CI, 1.18%-3.22%). Incidence of MALE and MACE were 7.59% (95% CI, 5.85%-9.34%) and 2.04% (95% CI, 1.10%-2.98%), respectively. The all-cause of mortality rate was 5.85% (95% CI, 4.29%-7.41%) and VascuQOL scores showed sustained improvement throughout the follow-up period (3.17 ± 0.84 vs 5.71 ± 1.19; P < .001). Cox regression analysis identified chronic renal insufficiency (CRI) (defined as a glomerular filtration rate of <30 mL/min/1.73 m2), Trans-Atlantic Inter-Society Consensus Document (TASC) II C/D FP lesions, and a history of previous lower extremity intervention as independent risk factors for CD-TLR. Female sex, TASC II C/D FP lesions, and poor pedal runoff (pedal runoff score = 2-3) were identified as independent risk factors for progression to CLTI within 24 months. CRI and TASC II C/D FP lesions were independent risk factors for MALEs. CRI and chronic obstructive pulmonary disease were independent risk factors for MACEs within 24 months.
Conclusions: The 24-month clinical outcomes of EVT for FP lesions in patients with lifestyle-limiting IC demonstrated acceptable results, with sustained enhancements in health-related QOL.
Background: Subclavian artery trauma is relatively rare and may result from blunt or penetrating mechanisms. We aimed to evaluate short- and long-term outcomes in patients with traumatic subclavian injuries treated with endovascular repair.
Methods: We performed a systematic review and single-arm meta-analysis following the PRISMA guidelines. We included retrospective studies involving endovascular repair for traumatic subclavian injury. We pooled means and proportions using inverse variance and logit transformations and assessed heterogeneity with I statistics. Subgroup analysis based on mechanism of injury (penetrating vs blunt) was performed.
Results: We included 13 studies comprising 1105 patients. The pooled early mortality rate was 7%, late mortality was 2%, amputation 3%, and compartment syndrome 5%. The mean length of stay was 10.31 days, and the mean operative time was 112.03 minutes. Thrombosis occurred in 13% of patients, with 7% requiring reintervention. Stenosis was reported in 11%, with 9% undergoing reintervention. Endoleak was observed in 10% of cases, and 7% required reintervention. Penetrating injuries were associated with lower early mortality (P = .0869) and shorter length of stay (P = .0206), with no significant differences in other outcomes.
Conclusions: This meta-analysis showed low postoperative complication rates after endovascular repair of subclavian artery trauma. Despite adequate follow-up times, further studies are needed owing to the rarity of the condition and variability in trauma center practices.
Background: Intermittent claudication (IC) interventions are predicated on safety, durability, and long-term expected benefit. Patients with end-stage renal disease (ESRD) have a higher risk of complications after many surgical procedures and have lower overall survival. Our goal was to assess perioperative and 1-year outcomes of IC interventions in patients with ESRD.
Methods: The Vascular Quality Initiative was queried from 2010 to 2020 for peripheral vascular interventions (PVI) and infrainguinal bypasses (IIBs) for IC. Demographics, comorbidities, procedural details, and outcomes were analyzed in patients with and without ESRD.
Results: There were 83,698 PVIs (2% ESRD and 98% non-ESRD) and 10,935 IIBs (1.2% ESRD and 98.8% non-ESRD) performed for IC. For PVI, ESRD patients more often underwent femoropopliteal (65.1% vs 59.5%) and infrapopliteal (26.5% vs 10.1%), and less often iliac interventions (32.1% vs 46.4%) (all P < .001). There were no differences in access site complications; however, ESRD patients had higher 30-day mortality (2.2% vs 0.4%; P < .001). At 1 year, ESRD patients less often ambulated independently (74.3% vs 90.4%; P < .001). On Kaplan-Meier analysis, patient with ESRD had lower 1-year freedom from reintervention/major amputation/death (62.8% vs 86.7%), major amputation/death (67.8% vs 93.9%), and survival (81.7% vs 96.6%) (all P < .001). On multivariable analysis, ESRD was associated with reintervention/major amputation/death (hazard ratio [HR], 2.46; 95% confidence interval [CI], 2.1-2.8; P < .001), major amputation/death (HR, 3.72; 95% CI, 3.1-4.4; P < .001), and death (HR, 3.8; 95% CI, 3.2-4.58; P < .001). For IIB, ESRD patients more often had an infrapopliteal target (33.3% vs 20%; P < .001) and similar great saphenous vein use (43.9% vs 50.3%; P = .33). ESRD patients had more cardiac complications (8.7% vs 3.2%; P = .001) with a similar risk of 30-day mortality (1.6 % vs 0.5%; P = .11). At 1 year, ESRD patients less often ambulated independently (66.7% vs 88.5%; P = .006). On Kaplan-Meier analysis, ESRD patients had lower 1-year freedom from reintervention/major amputation/death (66.7% vs 81.3%), major amputation/death (70.3% vs 93.7%), and survival (81.6% vs 96.3%) (all P < .001). On multivariable analysis, ESRD was associated with reintervention/major amputation/death (HR, 1.72; 95% CI, 1.04-2.87; P = .034), major amputation/death (HR, 2.87,95% CI 1.59-5.15; P = .001), and death (HR, 3.58; 95% CI, 1.86-6.9; P < .001).
Conclusions: Patients with ESRD have higher perioperative morbidity and long-term ambulatory impairment, limb loss, and mortality. The risks/benefit profile should be carefully assessed, and noninvasive interventions should be maximized in this population.
Background: Median arcuate ligament syndrome is a rare condition involving compression of the celiac artery and/or celiac plexus by the median arcuate ligament, often causing chronic gastrointestinal symptoms. Surgical decompression via median arcuate ligament release (MALR) is the definitive treatment; however, the optimal approach remains debated.
Study design: We retrospectively reviewed 271 patients who underwent MALR (120 open, 151 laparoscopic) at our institution between 2001 and 2024.
Results: Patients in the laparoscopic group more frequently completed diagnostic evaluations including dynamic duplex ultrasound scanning (76.8% vs 57.5%, P < .001), provocative mesenteric angiography (35.8% vs 11.7%, P < .001), and celiac plexus block (74.2% vs 46.7%, P < .001). Conversion to open surgery occurred in 4.6% of laparoscopic cases. Intraoperative interventions were more common in open cases (17.5% vs 2.0%, P < .001). The open group experienced higher rates of postoperative ileus (17.5% vs 2.0%, P < .001) and longer hospital stays (4.6 ± 1.7 vs 1.7 ± 1.3 days, P < .001). However, open MALR was associated with greater improvement in pain (84.2% vs 71.5%, P = .014) and nausea (89.7% vs 78.5%, P = .034). A multivariable logistic regression for nausea improvement demonstrated a significant inverse association with body mass index, indicating that higher body mass index was associated with lower odds of symptom improvement (odds ratio: 0.87 per 1 kg/m2 increase; 95% confidence interval: 0.80-0.95; P = .0015).
Conclusions: Both open and laparoscopic MALR provide symptom relief in patients with median arcuate ligament syndrome. Open surgery showed a trend toward greater improvement in pain and nausea (particularly nausea) but at the cost of higher morbidity, highlighting the need for careful patient-specific approach selection.
Objective: Although numerous endovascular technologies are available for lower extremity arterial disease (LEAD), a lack of direct, comparative evidence complicates optimal device selection. We conducted a network meta-analysis of randomized controlled trials (RCTs) to establish an evidence-based framework for device selection across distinct clinical-anatomical subgroups.
Methods: Following the PRISMA guidelines (PROSPERO: CRD42024629620), major databases were searched for RCTs comparing nine endovascular treatments for LEAD. The analysis was stratified into four subgroups based on lesion location and clinical severity (intermittent claudication [IC] vs critical limb ischemia [CLI]). Primary outcomes were primary patency, target lesion revascularization, major amputation, and all-cause mortality. We performed a random effects network meta-analysis with sensitivity analyses to assess for multiple comparisons.
Results: A total of 82 RCTs involving 12,796 patients were included. For femoropopliteal lesions in IC, a time-dependent hierarchy was observed: atherectomy combined with drug-coated balloon (DCB) excelled in short-term (6-month) patency, while covered stents (CS) and drug-eluting stents (DES) were superior at 24 and 36 months, respectively. For iliac lesions in IC, CS showed higher patency rates than bare metal stent (BMS) and balloon angioplasty (BA) at 12 months. In infrapopliteal CLI, drug-eluting technologies (DES and DCB) were superior for both patency and target lesion revascularization at 12 months, with DES associated with a lower 12-month major amputation rate compared with DCB (odds ratio, 0.41; 95% confidence interval [CI], 0.18-0.94). For femoropopliteal CLI, time-to-event analysis revealed that BA resulted in lower primary patency compared with both BMS (hazard ratio, 0.44; 95% CI, 0.21-0.92) and DCB (hazard ratio, 0.69; 95% CI, 0.49-0.98) over a 12- to 24-month period. Across all comparisons, no significant differences in all-cause mortality were found. A sensitivity analysis using 99% CIs confirmed the robustness of most findings, but the superiority of CS in iliac lesions and the amputation benefit of DES over DCB became nonsignificant, warranting caution.
Conclusions: Endovascular device selection for LEAD should be tailored to the clinical-anatomical context. For IC, CS trends toward being the preferred option for iliac lesions, whereas a dynamic hierarchy of devices exists for femoropopliteal disease, balancing long-term patency against reintervention risk. For CLI, drug-eluting technologies are paramount for infrapopliteal disease, with DES showing a potential but not robust 12-month advantage in limb salvage. For femoropopliteal CLI, evidence suggests that both stenting (BMS) and drug-eluting technologies (DCB) offer superior patency over 12 to 24 months compared with BA alone.
Objective: Crawford extent III thoracoabdominal aortic aneurysm (TAAA) repairs, which extend from the lower descending thoracic aorta (below the sixth rib) into the abdomen, may be perceived as less morbid than extent II TAAA repairs that begin near the left subclavian artery. In contemporary repair, there is a relatively high risk. We aimed to identify predictors of major complications after open extent III TAAA repair and explore differences between men and women.
Methods: In this retrospective study, 732 patients (median age, 69 years; quartile 1-quartile 3, 61-74 years) who underwent extent III repair between 1990 and 2021 were stratified by sex (306 women [41.8%] and 426 men [58.2%]). Statistical models identified independent predictors of operative mortality and adverse events (comprising operative death or persistent stroke, paraplegia, paraparesis, or renal failure). Inverse probability of treatment weighting analysis was done to eliminate baseline differences between groups when the primary outcomes were assessed. Competing risk analyses compared relative rates of survival and freedom from repair failure between men and women.
Results: Operative mortality was 8.7% (women 10.8% vs men 7.3%; P = .1), and adverse events occurred in 16.8% of patients (women 20.6% vs men 14.1%; P = .02). Predictors of operative mortality were female sex, a larger maximal aortic diameter, chronic kidney disease, chronic symptoms, longer cross-clamp time, and more packed red blood cell units transfused. Independent predictors of adverse events were female sex, chronic kidney disease, longer cross-clamp time, branch vessel stenting, and more packed red blood cell units transfused. Elective operation predicted better operative survival and fewer adverse events than urgent or emergency repairs. Weighted analysis (inverse probability of treatment weighting adjustment) showed that female sex was independently predictive of adverse events (odds ratio, 1.75; 95% confidence interval, 1.09-2.80; P = .02). Women and men did not differ significantly in late survival (P = .3) or freedom from repair failure (P > .9).
Conclusions: Open extent III repair remains a durable approach for TAAA repair but carries a notable risk of operative mortality and adverse events. Female sex independently predicts adverse events after weighting; however, long-term survival is comparable between men and women. These insights into the extent III repair patient population could be used to revise treatment guidelines and, thus, to improve patient outcomes.
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