Mid-Term Results of Popliteal-Pedal Inframalleolar Vein Bypasses in Chronic Limb-Threatening Ischemia Patients After Previous Failed Tibial Endovascular Recanalization.

Inframalleolar bypass still preserves its role in the modern endovascular era. Aim of this study was to evaluate the mid-term outcomes of "short" inframalleolar vein bypasses in patients with chronic limb-threatening ischemia (CLTI) after the previously failed tibial endovascular recanalization. Between January 2015 and December 2021,107 CLTI patients in 3 Italian Departments of Vascular Surgery underwent "short" inframalleolar vein bypass after failed tibial endovascular recanalization. Early (30-day) and 3-year outcomes were evaluated in terms of survival, primary patency, primary assisted patency, secondary patency, and amputation-free survival. Univariate analysis of the perioperative factors affecting outcomes were performed by the means of log-rank test. The associations of procedure variables were sought based on a multivariate Cox regression analysis. Distal anastomosis (inframalleolar) was mostly performed on dorsal pedis (64, 59.8%). At 30 days, bypass occlusion was recorded in 5 cases (4.6%). The mean follow-up period was 20.5 ± 17.9 months. The estimated 3-year overall survival was 66.7%. Three-year estimates of primary patency, primary assisted patency, secondary patency, and amputation-free survival were 68.5%, 70.1%, 70.2%, and 76.7%, respectively. Multivariate analysis showed a negative association of insulin treatment with primary patency (HR 4.3, P = 0.04), primary assisted patency (HR 5.1, P = 0.02), and secondary patency (HR 5.1, P = 0.02). The negative association of long-term corticosteroid use was also found with primary patency (HR 7.8, P = 0.005), primary assisted patency (HR 8.7, P = 0.003), secondary patency (HR 8.7, P = 0.003), and amputation-free survival (HR 3.9, P = 0.05). Short" vein bypasses to the foot arteries in CLTI patients yielded good mid-term overall patency and limb salvage rates after a failed tibial endovascular recanalization. Insulin-dependent diabetes mellitus and long-term corticosteroid use seemed to affect the outcomes.

Troisi N ，Stilo F ，Adami D ，De Caridi G ，Montelione N ，Bertagna G ，Barillà C ，Berchiolli R ，Spinelli F ，Benedetto F ... -  《-》

Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.

The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

Giles KA ，Farber A ，Menard MT ，Conte MS ，Nolan BW ，Siracuse JJ ，Strong MB ，Doros G ，Venermo M ，Azene E ，Rosenfield K ，Powell RJ ... -  《-》

The impact of revascularization strategy on clinical failure, hemodynamic failure, and chronic limb-threatening ischemia symptoms in the BEST-CLI Trial.

Menard MT ，Farber A ，Doros G ，McGinigle KL ，Chisci E ，Clavijo LC ，Kayssi A ，Schneider PA ，Hawkins BM ，Dake MD ，Hamza T ，Strong MB ，Rosenfield K ，Conte MS ... -  《-》

Hemoglobin A1c levels are related to patency and adverse limb events in diabetics after revascularization.

Poor glycemic control in the perioperative period has been reported to be associated with early and late major adverse limb events (MALEs). However, these studies were mostly from large databases or lacked long-term outcomes. We examined the long-term effects of high hemoglobin A1c (HbA1c) level on patency, MALE, limb salvage (LS) and survival after lower extremity revascularization procedures in patients with diabetes. Patients with diabetes who underwent revascularization for Rutherford class 3 to 6 ischemia between May 2002 and December 2018 were identified. Patients with an HbA1c of ≤7% were compared with those with an HbA1c of >7% for patency, MALE, survival, LS, and amputation-free survival. Of 706 patients, 699 had HbA1c data (775 limbs), with 311 (357 limbs) in the HbA1c ≤7% and 388 (418 limbs) in the HbA1c >7% groups. Patients with an HbA1c of >7% were younger (69.9 ± 10.2 years vs 71.7 ± 9.5 years; P = .011), had higher lipid levels, insulin use (70% vs 49%; P < .01), American Society of Anesthesiologists classification of 4, and had a lower prevalence of chronic kidney disease (32% v s41%; P = .023). Patients with an HbA1c of >7% were more likely to present with chronic limb-threatening ischemia (CLTI) (79% vs 72%; P = .019) and undergo infrapopliteal interventions (49% vs 42%; P = .005), with no difference in anatomical complexity (TransAtlantic Inter Society Consensus class C/D, 75% vs 77%; P = .72) or type of revascularization (24% vs 18% open, 66% vs 70% endovascular, 10% vs 12% hybrid; P = .236). Patency and freedom from MALE were significantly lower in patients with an HbA1c of >7% for infrainguinal revascularizations, whereas amputation-free survival and overall survival were similar. In patients with chronic limb-threatening ischemia, LS rates at 5 years were significantly lower in patients undergoing open revascularization (HbA1c > 7%: 64% ± 6% vs HbA1c < 7%:86% ± 5%; P = .020), whereas it was similar after endovascular interventions (HbA1c > 7%:79% ± 4% vs HbA1c < 7%:77% ± 3%; P = .631). Seventy patients with an HbA1c of >7% lost limbs vs 38 patients with an HbA1c of ≤7% (P = .007). In multivariate analysis, HbA1c was associated significantly with primary patency. HbA1c, insulin use, level of intervention, and angiotensin-converting enzyme inhibitor use were associated with MALE. A perioperative HbA1c of >7% is associated with poorer patency rates and increased MALE, especially at the infrainguinal level revascularization in patients with diabetes, with no significant impact on survival. LS is impacted after open, but not after endovascular revascularization.

Oh K ，Repasky A ，Nader ND ，Rivero M ，Montross B ，Khan SZ ，Harris L ，Dryjski M ，Dosluoglu HH ... -  《-》

National trends and outcomes of pedal bypass surgery.

The technical demands associated with pedal bypass (PB) surgery place it at risk of underutilization and may be limiting its widespread adoption as a valuable revascularization modality. This study aims to evaluate trends in PB performance, assess its outcomes, and compare its results between high- and low-volume centers. All patients receiving a PB between 2003 and 2023 were identified in the Vascular Quality Initiative (VQI) infrainguinal bypass (IIB) module. The ratio of PB to total IIB performed was calculated for each year and trended over the study period. Centers performing PB were categorized according to their annual PB volume into tertiles of low-volume centers (LVC, <2 PB/year), medium-volume centers (MVC, 2-4 PB/year), and high-volume centers (HVC, >4 PB/year) for comparison. Patient characteristics and outcomes were compared using the χ2 or Fisher exact test as appropriate for categorical variables and the analysis of variance test or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between center volume and the primary outcomes of primary patency, primary-assisted patency, secondary patency, reintervention, amputation, and major adverse limb events (MALE), defined as the composite outcome of amputation and/or reintervention. A total of 3466 patients received a PB during the study period. The ratio of PB to IIB dropped from 14% to 4% between 2003 and 2023. Primary, primary-assisted, and secondary patency rates were 65%, 76%, and 80%, respectively, and limb salvage rate was 83% at 1 year. Nineteen percent of centers performing IIBs in the VQI did not perform any PBs during the study period. Of the 246 centers performing PBs, 78% were LVC, 15% were MVC, and only 7% were HVC. On Cox regression analysis, HVCs were associated with a lower risk of primary patency loss (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.95; P = .010), reintervention (HR, 0.75; 95% CI, 0.60-0.95; P = .016), amputation (HR, 0.77; 95% CI, 0.61-0.98; P = .034), and MALE (HR, 0.78; 95% CI, 0.66-0.93; P = .005) compared with LVCs. No difference in secondary patency between high- and low-volume centers was observed (P = .680). The utilization of PB operations experienced a four-fold decrease over the past 20 years, despite favorable patency and limb salvage outcomes. Centers with a higher operative volume in PB achieve better outcomes than LVCs, and accordingly, patients with extensive tibioperoneal disease may benefit from evaluation at centers with documented expertise in PB before resorting to an alternative revascularization modality or a major limb amputation.

Chamseddine H ，Shepard A ，Nypaver T ，Weaver M ，Boules T ，Kavousi Y ，Onofrey K ，Peshkepija A ，Hoballah J ，Kabbani L ... -  《-》