Infrapopliteal Bypass Research Articles

Popliteal-Distal Bypass Affords Better Limb Salvage than Tibial Angioplasty for Chronic Limb-Threatening Ischemia

ObjectiveChronic limb-threatening ischemia (CLTI) due to isolated tibial occlusive disease is treated by either popliteal distal bypass or tibial angioplasty, although there is limited data directly comparing efficacy and outcomes between these two treatment modalities. This study compares 30-day mortality and major adverse limb events following infrapopliteal bypass and tibial angioplasty in patients with CLTI. MethodsPatients who underwent popliteal distal bypass for CLTI were extracted from American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity open database, whereas patient with CLTI who underwent isolated tibial angioplasty were identified in the targeted lower extremity endovascular database. Any case with more proximal angioplasty such as femoral/pop/iliac was excluded. The time interval was 2011-2022. The two groups were comparable in demographics and pre-operative comorbidities were obtained using propensity matching. Mortality, systemic complications, and major adverse limb events were measured. Multivariable logistic regression was used for data analysis. To obtain granular data on the angiographic characteristics of patients undergoing popliteal-distal bypass or tibial angioplasty, The George Washington University institutional data from 2014 to 2019 was used as supplement to the database. ResultsThere were 1,947 and 3,423 cases identified in the bypass and endovascular groups, respectively. After propensity matching for all preoperative variables, 1,747 cases remained in each group. Although bypass was associated with higher major adverse cardiovascular events, pulmonary, renal, and wound complications, bypass had significantly better 30-day limb salvage when compared to tibial angioplasty (major amputation rate 3.32% vs. 6.12%; p<0.01). Institutional data identified 69 patients with CLTI due to isolated tibial occlusive disease; 25 (36.2%) underwent popliteal-distal bypass and 44 (63.8%) underwent tibial angioplasty. Reviewing of angiographic details revealed patients who underwent popliteal-distal bypass had better pedal targets (inframalleolar/pedal score of P0 [24.0% vs 15.9%] or P1 [68.0% vs 61.3%]) than tibial angioplasty patients (inframalleolar/pedal score of P2 [22.7% vs 8.0%]). ConclusionPopliteal-distal bypass was associated with higher morbidity but better limb salvage than endovascular interventions. However, this could be explained by the association with better pedal targets in patients who underwent popliteal-tibial bypass. Prospective studies should be done comparing popliteal distal bypasses and tibial angioplasty in cases with similar pedal targets.

Prosthetic conduits have worse outcomes compared with great saphenous vein conduits in femoropopliteal and infrapopliteal bypass in patients with chronic limb-threatening ischemia

ObjectiveSingle segment great saphenous vein (SSGSV) traditionally has been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some investigators have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable. We sought to evaluate long-term outcomes of infrainguinal bypass based on conduit type for treating chronic limb-threatening ischemia (CLTI). MethodsData from the Best Endovascular vs Best Surgical Therapy of Patients with CLTI multicenter, prospective, randomized controlled trial, comparing infrainguinal bypass with endovascular therapy in patients with CLTI, were evaluated. In this as-treated analysis, we compared outcomes of infrainguinal bypass using prosthetic, alternative autogenous vein (AAV), and cryopreserved vein (Cryo) with SSGSV bypass. Kaplan-Meier and multivariable analyses were performed to examine the associations of conduit type with major adverse limb events (MALE), reinterventions, above-ankle amputations, and all-cause death rates. ResultsIn total, 784 bypasses were analyzed (120 prosthetic, 33 AAV, 21 Cryo, AND 610 SSGSV). For prosthetic and SSGSV, the distribution was 357 femoropopliteal (93 prosthetic and 264 GSV) and 373 infrapopliteal (27 prosthetic and 346 GSV). The mean age for the overall cohort was 67.1 years; 27.4% were female, 29.9% were non-White, and 11.5% were of Hispanic ethnicity. Patients undergoing prosthetic bypass were older (69.2 years vs 66.7 years); more likely to have chronic obstructive pulmonary disease (22.5% vs 14.0%), prior coronary artery bypass grafting (88.9% vs 66.5%), and prior stroke (23.3% vs 14%); but less often were of Hispanic ethnicity (5.8% vs 12.6%) and had diabetes (59.2% vs 71.3%) (P < .05 for all). For femoropopliteal bypass, use of prosthetic conduit was associated with increased major reinterventions at 3 years overall (19.0% vs 11.5%; P = .06) and on risk-adjusted analysis (hazard ratio [HR], 2.13; 95% confidence interval [CI], 1.09-4.2; P = .028). No significant differences in MALE or death, above-ankle amputation, or death were observed. Outcomes were similar for bypasses to above-knee popliteal targets and below-knee popliteal targets. For infrapopliteal bypass, the use of a prosthetic conduit was associated with increased major reintervention (25.3% vs 10.3%; P = .005), death (68.6% vs 34.8%; P < .001), and MALE or death (90.0% vs 48.1%; P < .001) at 3 years. After risk adjustment, infrapopliteal bypass with prosthetic conduit was associated with higher major reintervention (HR, 4.14; 95% CI, 1.36-12.6; P = .012), above-ankle amputation (HR, 4.64; 95% CI, 1.59-13.5; P = .005), death (HR, 2.96; 95% CI, 1.4-6.2; P = .004), and MALE or death (HR, 3.59; 95% CI, 1.64-7.86; P = .001) compared with bypass with SSGSV. Overall, AAV had similar outcomes at 3 years as SSGSV; however, Cryo had significantly higher above-ankle amputation (50.0% vs 12.8%) (HR, 4.2; 95% CI, 1.68-10.5; P = .002), major reintervention (41.9% vs 10.7%) (HR, 3.12; 95% CI, 1.18-8.22; P = .02), and MALE/death (88.8% vs 37.8%) (HR, 2.96; 95% CI, 1.43-6.14; P = .004). ConclusionsThe use of a prosthetic conduit in infrainguinal bypass is associated with inferior outcomes compared with bypass using SSGSV, particularly for bypass to infrapopliteal targets. Cryo grafts were infrequent and also demonstrated inferior outcomes. SSGSV remains the preferred conduit of choice for infrainguinal bypass.

Infrapopliteal Bypass In Patients On Dialysis: Patency And Survival.

Portugal has one of the highest prevalence of patients on a regular dialysis program. This population has a higher incidence of peripheral arterial disease with higher rates of postoperative morbidity and mortality. Our goal was to compare outcomes between dialysis and non-dialysis patients with chronic limb threatening ischemia (CLTI) submitted to infrapopliteal bypass. A retrospective single-center study of infrapopliteal bypass for CLTI was performed between 2012 and 2019. Patients were divided in two groups based on dialysis status (group 1 incorporated patients on dialysis). Primary end point was 1-year freedom from CLTI. Secondary end points were limb-salvage, survival and primary (PP) and tertiary patency (TP) rates at 3 years of follow-up. A total of 352 infrapopliteal bypasses were performed in 310 patients with CLTI. Fourteen percent of the revascularizations were performed on dialysis patients (48/352). Median age was 73 years (interquartile range - IQR 15) and 74% (259/352) were male. Median follow-up was 26 months (IQR 42). Overall, 92% (325/352) had tissue loss and 44% (154/352) had some degree of infection. The majority of revascularization procedures were performed with vein grafts (61%, 214/352). The 30-day mortality was 4% (11/310), with no difference between groups (p = 0.627). Kaplan-Meier analysis showed no difference between groups regarding freedom from CLTI (76% vs. 79%; HR 0.96, CI 0.65-1.44, p=0.857), limb-salvage (70% vs. 82%; HR 1.40, CI 0.71-2.78, p=0.327) and survival (62% vs. 64%; HR 1.08, CI 0.60-1.94, p=0.799). PP rates were 39% in group 1 and 64% in group 2 (HR 1.71, CI 1.05-2.79, p=0.030). TP rates were not different between groups (57% and 78%; HR 1.79, CI 0.92-3.47, p=0.082). Infrapopliteal bypass for CLTI, on dialysis patients, resulted in lower PP rates. No differences were observed in freedom from CLTI, TP, limb salvage and survival.

Editor's Choice – Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) Prospective Cohort Study and the Generalisability of the BASIL-2 Randomised Controlled Trial

The Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2) randomised controlled trial has shown that, in patients with chronic limb threatening ischaemia (CLTI) who require an infrapopliteal (IP) revascularisation a vein bypass (VB) first revascularisation strategy led to a 35% increased risk of major amputation or death when compared with a best endovascular treatment (BET) first revascularisation strategy. The study aims are to place the BASIL-2 trial within the context of the CLTI patient population as a whole, and to investigate the generalisability of the BASIL-2 outcome data. This was an observational, single centre prospective cohort study. Between 24 June 2014 and 31 July 2018, the BASIL Prospective Cohort Study (PCS) was performed which used BASIL-2 trial case record forms to document the characteristics, initial and subsequent management, and outcomes of 471 consecutive CLTI patients admitted to the vascular centre. Ethical approval was obtained, and all patients provided fully informed written consent. Follow up data were censored on 14 December 2022. Of the 238 patients who required an infrainguinal revascularisation, 75 (32%) had either IP bypass (39 patients) or IP BET (36 patients) outside BASIL-2. Seventeen patients were initially randomised to BASIL-2. A further three patients who did not have an IP revascularisation as their initial management were later randomised in BASIL-2. Therefore, 95/471 (20%) of patients had IP revascularisation (16% outside, 4% inside BASIL-2). Differences in amputation free survival, overall survival, and limb salvage between IP bypass and endovascular revascularisation performed outside BASIL-2 were not subject to hypothesis testing due to the small sample size. Reasons for non-randomisation into the trial were numerous, but often due to anatomical and technical considerations. CLTI patients who required an IP revascularisation procedure and were subsequently randomised into BASIL-2 accounted for a small subset of the CLTI population as a whole. For a wide range of patient, limb, anatomic and operational reasons, most patients in this cohort were deemed unsuitable for randomisation in BASIL-2. The results of BASIL-2 should be interpreted in this context.

Ten-year experience with use of cryopreserved allografts for redo infrapopliteal bypass.

The aim of this study is to report the early and late outcomes of cryopreserved saphenous vein (CSV) in redo infrainguinal bypass and to investigate possible predictors of primary patency loss. All patients who underwent a redo bypass for critical limb ischemia from January 2010 to December 2020 were reviewed. Early and late complications were analyzed and included. The endpoints of the study were all cause mortality, major limb amputation, and primary patency (PP). Data were collected from 95 patients. Among the entire cohort, 16 (16.8%) patients received a cryopreserved vessel bypass with anastomosis in the popliteal artery and 79 (83.2%) patients had cryopreserved vessel bypasses with distal anastomosis in tibial vessels. Median duration of follow-up was 73months; during this, period estimated survival at 5years was 80.5 ± 4% (95% CI, 78.0-91.2) and estimates of freedom from limb amputation was 90.3 ± 3.2% (95% CI, 87.3-98.1). Overall, the estimated primary patency of the bypass was 43.7 ± 6.7% (95% CI, 30.2-51.4). On multivariable analysis, intraprocedural tibial vessel angioplasty (HR = 2.3, p = 0.01), distal anastomosis in tibial vessels (HR = 3.6, p = 0.36), and the use of a composite graft (HR = 2.4, p = 0.01) were independently associated with loss of PP. The use of CSV in redo bypass is an effective strategy in salvaging threatened lower extremities and in preventing or delaying limb amputation. Our results confirm that further attempts at revascularization are generally appropriate, even in technically changing patients.

The effects of high quality team medicine on outcomes of chronic limb-threatening ischemia patients with infrapopliteal bypass.

A team approach for treatment of patients with CLTI is used worldwide. However, the quality of team medicine is a concern. The Global Vascular Guidelines provide recommendations for high quality team medicine, but there is limited knowledge of the significance of team quality in CLTI treatment. The objective of this study is to evaluate the effects of team quality on clinical outcomes after infrapopliteal bypass. A retrospective analysis was performed in 337 patients who underwent 414 infrapopliteal bypasses under a team medicine approach at a single center between 2009 and 2021. In 2017, team medicine was reorganized for improvement of quality. Comparisons were made between before (Group 1; 160 patients, 195 limbs) and after (Group 2; 177 patients, 219 limbs) reorganization. The primary endpoints were limb salvage and wound healing after infrapopliteal bypass. The patients included 227 males (67%) and had a median age of 76 [68-83]years. Diabetes mellitus was present in 67% and end-stage renal disease with hemodialysis in 37%. The follow-up rate was 96% in a mean follow-up period of 31±30months. The 3-year limb salvage rate was significantly lower in Group 1 (before reorganization) than in Group 2 (after reorganization) (84% vs 95%, p = .001). The wound healing rates in the whole cohort were 72% at 6months and 85% at 12months, with no significant differences between the groups. In multivariate analysis, the risk factors for major amputation were treatment before reorganization (HR 2.68; p = .017), hemodialysis (HR 2.27; p = .017), and non-ambulatory status (HR 2.63; p = .005). A reorganized team approach with the goal of higher quality was independently associated with reduced major amputation for patients with CLTI treated with infrapopliteal bypass. This result indicates the importance of a high quality team approach for success of this treatment.

A national analysis of vascular surgery resident operative experience in peripheral artery disease

BackgroundEndovascular and hybrid interventions have played an increasingly prominent role in the treatment of peripheral arterial disease (PAD) in the past decade. This shift has prompted concerns about the adequacy of open surgical training for current surgical residents. Moreover, the recent Best Surgical Therapy in Patients With Critical Limb Ischemia trial has further emphasized the importance of open surgical techniques in the treatment of peripheral arterial disease. The purpose of this study was to examine national temporal trends in peripheral operative volume among integrated vascular surgery residents. MethodsData was obtained from the Accreditation Council for Graduate Medical Education national data reports for integrated vascular surgery residents. Case volumes for surgeon chief or surgeon junior cases were collected from academic years 2012 to 2013 and 2021 to 2022. Trends in case-mix and volume were evaluated using linear regression analysis. ResultsThe mean total vascular operative volume increased from 851.2 to 914.3 cases among graduating chief residents, with an annual growth of 8.5 ± 1.7 cases/year (R2 = 0.77; P < .0001). Major vascular case volume also increased at a rate of 5.7 ± 1.2 cases/year (R2 = 0.74; P < .001). Among operative categories, peripheral cases were the most frequent (n = 232.2 [26.6%]) and demonstrated the greatest annual growth (+8.0 ± 0.8 cases/year, R2 = 0.93; P < .001). No changes were seen in volume of open peripheral cases, including suprainguinal bypass (+0.1 ± 0.2 cases/year; R2 = 0.08; P = .40) or femoropopliteal bypass procedures (−0.1 ± 0.2 cases/year; R2 = 0.17; P = .20). Infrapopliteal bypass (+0.4 ± 0.1 cases/year; R2 = 0.48; P = .006), iliac/femoral endarterectomy (+1.3 ± 0.2 cases/year; R2 = 0.82; P < .001), and leg thromboembolectomy (+0.4 ± 0.1 cases/year; R2 = 0.64; P < .001) all demonstrated annual growth. For endovascular peripheral cases, aortoiliac revascularization (+3.4 ± 0.3 cases/year; R2 = 0.94; P < .001), femoropopliteal revascularization (+5.4 ± 0.2 cases/year; R2 = 0.98; P < .001), and tibioperoneal revascularization (+2.0 ± 0.2 cases/year; R2 = 0.92; P < .001) all increased in volume. Lower extremity amputations, including above-knee amputation (+0.6 ± 0.2 cases/year; R2 = 0.65; P < .001) and below-knee amputation (+0.9 ± 0.2 cases/year; R2 = 0.72; P < .001) also demonstrated an increase in volume. ConclusionsCurrent graduating residents have higher open and endovascular case volumes for peripheral artery disease on a national level, despite the increasing popularity of endovascular techniques. Further studies are needed to identify how these trends may impact current vascular surgery milestones. These trends may also influence the rising interest in competency-based training programs.

Heparin-Bonded Expanded Polytetrafluoroethylene Is a Solution for Infrapopliteal Revascularization in the Absence of an Adequate Autologous Vein Graft

To analyze the outcomes of heparin-bonded expanded polytetrafluoroethylene (HePTFE) graft as an alternative conduit in infrapopliteal revascularization of chronic limb-threatening ischemia (CLTI) in the absence of an autologous vein conduit. A single-center retrospective analysis of patients with CLTI submitted to infrapopliteal bypasses with autologous vein graft (VEIN group) or HePTFE graft (HePTFE group) was implemented. Primary end points were freedom from CLTI at 12months and recurrence of CLTI at 3years. Secondary end points included freedom from major amputation, amputation-free survival (AFS), survival, and primary (PP) and secondary patency (SP) rates at 3years of follow-up. A total of 348 limbs submitted to infrapopliteal bypasses, 214 with venous graft and 134 with HePTFE graft, were followed-up for a median of 25months. Most patients of the HePTFE group were male (69%), with a median age of 76years (interquartile range [IQR] 15). Fifty-nine percent of the limbs of the HePTFE group had Wound grade ≥2, being 46% of them infected. Eighty-eight percent were GLASS stage III. Freedom from CLTI was not significantly different between HePTFE and VEIN groups (75% vs. 84%, adjusted hazard ratio [aHR] 0.88, confidence interval [CI] 0.66-1.18, P=0.401). Recurrence of CLTI was higher in the HePTFE group (42% vs.18% at 3years; aHR 2.82, CI 1.59-5.00, P<0.001). The VEIN group achieved higher rates of freedom from major amputation (87% vs.69% at 3years; aHR 2.21, CI 1.31-3.75, P=0.003) and AFS (59% vs. 37% at 3years; aHR 1.39, CI 1.02-1.88, P=0.036), but no significance in survival (aHR 1.10, CI 0.72-1.66, P=0.667). Patency rates were inferior in the HePTFE group, with 2-year PP and SP rates of 52% vs. 74%, and 76% vs. 90%, respectively (PP: aHR 1.70, CI 1.11-2.59, P=0.014; SP: aHR 2.51, CI 1.42-4.42, P=0.001). Infrapopliteal bypass with autologous vein graft is the gold standard to treat CLTI limbs. HePTFE graft should be regarded as an alternative for complex infrapopliteal revascularization when lacking an autologous vein conduct.

Vascular Surgery Trainees' Experience with Open Lower Extremity Revascularization in an Era of Endovascular-First Therapy

The impact of the adoption of endovascular-first therapies for lower extremity revascularization on vascular trainees’ experience with open bypass is not known. We sought to determine trends in open versus endovascular lower extremity revascularization case volumes among graduating vascular fellows (5+2) and integrated vascular residents (0+5). We reviewed the Accreditation Council for Graduate Medical Education 2012-2021 case log data for graduating vascular surgery fellows (5+2) and integrated residents (0+5). We retrieved the mean number of femoropopliteal and infrapopliteal revascularization procedures carried out by each trainee group, both open and endovascular. The means were plotted against time. A Mann Kendall test was conducted to detect trends in the average number of cases performed by vascular graduates. Between 2012 and 2021, integrated vascular residents graduated with an average of 21.9 femoropopliteal and 22.5 infrapopliteal bypasses which were 4.4 ± 1.4 and 3.0 ± 1.9 more than vascular surgery fellows, respectively. For both trainee groups, the mean number of open procedures—femoropopliteal or infrapopliteal—was consistent over the course of the years with no statistically significant trend observed (Figs 1 and 2). Integrated vascular residents graduated with an average of 47.9 femoropopliteal and 22.7 infrapopliteal endovascular procedures, which were 6.2 ± 2.9 and 3.1 ± 1.7 more than vascular surgery fellows, respectively. We observed a statistically significant increase in the mean number of femoropopliteal and infrapopliteal endovascular procedures in this time period –in both trainee groups. The mean number of femoropopliteal endovascular cases increased by 105.5% (31.1 to 63.9; P < .001) for integrated residents and 110.3% (26.2 to 55.1; P < .001) for vascular fellows. Likewise, the mean number of infrapopliteal endovascular cases increased by 120.3% (14.3 to 31.5; P < .001) for integrated residents and 94.1% (13.6 to 26.4; P < .001) for vascular fellows. The overall case volume of femoropopliteal and infrapopliteal procedures, combining open and endovascular techniques, increased for both trainee groups, which is mainly due a significant increase in peripheral vascular intervention volume. The total case volume of lower extremity revascularization has increased for all vascular trainees but graduates of integrated residency programs have a more robust experience. Despite a significant rise in endovascular case volume, however, the average number of open bypass procedures performed by graduating vascular surgery trainees is not affected and has remained stable.Fig 2Trends in open infrapopliteal bypass revascularization.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Outcomes of Infrapopliteal Bypass for Chronic Limb-Threatening Ischemia are Worse in Renal Transplant Patients than in Hemodialysis-Dependent Patients

Comparisons of distal bypass outcomes between hemodialysis-dependent (HD) and renal transplant (RT) patients have been reported, but the influences of immunosuppressive therapy on the outcomes remain unclear because of the limited number of RT patients who underwent distal bypass or cohort heterogenicity. We compared outcomes of distal bypass for chronic limb-threatening ischemia (CLTI) with homogenous ischemic limb pathology. Between January 2014 and December 2019, we performed 334 infrapopliteal bypass procedures using vein grafts for 275 consecutive CLTI patients with tissue loss. Among them, there were 130 HD patients (47.3%) (163 limbs) and 11 RT patients (4%) (15 limbs), and 30-day mortality, 5-year primary and secondary patency (PP and SP), limb salvage (LS), amputation-free survival rates, and wound healing (WH) status were compared between the HD and RT patient groups. Nine HD patients died within 30days after surgery (7%), whereas no deaths were observed among the RT patients. Five-year PP and SP rates in the RT group 39% and 41%, which were significantly worse compared to 64% and 82% in the HD group (P<0.01). Unsuccessful rate of revision surgery including hemodynamically failed grafts after revision reached over 80% in the RT group, which was technically unfeasible pathology for graft salvage (vs. 3% in the HD group), and WH, and LS rates were significantly worse in the RT group. In comparison with HD patients, RT patients showed a lower LS rate for CLTI. The lower LS rate was associated with a lower SP rate, which was caused by disease progression of distal arteries in the foot.

Predictors of infrapopliteal vein bypass graft revision in patients with chronic limb-threatening ischemia.

Surgical revascularization is the standard treatment for chronic limb-threatening ischemia (CLTI). However, some patients may require reintervention. The Global Anatomic Staging System (GLASS), which evaluates the complexity of infrainguinal lesions, was proposed. This study aimed to identify predictors for graft revision and evaluate whether GLASS impacts vein graft revision. Between 2011 and 2018, CLTI patients who underwent de novo infrapopliteal bypass using autogenous veins were retrospectively analyzed. To assess anatomic complexity with GLASS, femoropopliteal, infrapopliteal, and inframalleolar/pedal (IM) disease grades were determined. The outcomes of patients with or without graft revision were compared. Cox regression analysis was performed. Thirty-six of the 80 patients underwent reintervention for graft revision. Compared to the non-graft revision group, the graft revision group exhibited significantly higher rates of GLASS stage III (66% vs 81%, p = 0.046) and grade P2 IM disease (25% vs 58%, p = 0.009). Multivariate analysis revealed that IM grade P2 (hazard ratio [HR], 3.35; 95% confidence interval [CI], 1.66-6.75; p = 0.001) and spliced vein grafts (HR, 3.18; 95% CI, 1.43-7.06; p = 0.005) were significantly associated with graft revision. This study demonstrated that IM grade P2 and spliced vein grafts were predictors of graft revision. The GLASS stratification of IM disease grade may be useful in optimizing treatment for CLTI.

Femoropopliteal Bypasses with Varicose Great Saphenous Vein.

The great saphenous vein is the conduit of choice for femoropopliteal or infrapopliteal bypass, but it is traditionally recommended that varicose vein grafts (VVGs) should not be used for bypass conduits owing to the risk of immediate rupture or long-term aneurysmal change. Herein, we report two cases of femoropopliteal bypass with VVGs. They achieved primary patency without aneurysmal formation after 32 and 17 months. Therefore, VVGs without morphologically conspicuous abnormalities are worth considering for usage as a vein graft.

Clinical outcomes in patients with infrapopliteal arterial occlusive disease treated by lower extremity bypass surgery: a comparison of atherosclerosis and thromboangiitis obliterans.

Surgical bypasses are commonly utilized for the treatment of infrapopliteal arterial occlusive disease resulting from atherosclerosis (ASO) and thromboangiitis obliterans (TAO), especially when endovascular procedures fail. The aim of this study is to compare the in-hospital and follow-up outcomes of ASO and TAO patients treated with infrapopliteal bypass surgery. A total of 32 infrapopliteal bypasses were analyzed in 18 TAO patients and 14 ASO patients. Preoperative and postoperative arterial Doppler ultrasonography was performed in all patients. The ankle-brachial index (ABI) was calculated preoperatively and postoperatively in all cases. All patients were followed-up for at least one year and clinical outcomes were recorded. Within 1-7 days postoperatively, 4 grafts in TAO patients occluded; nevertheless, 1 graft occlusion occurred in ASO patients. Patency rates at in-hospital were 77.8% and 92.9% in TAO and ASO patients, respectively. In 27 patients with successful infrapopliteal bypass, ABIs and crural peak arterial flow velocities significantly increased at 1-7 days postoperatively. During the period of follow-up, 6 graft occlusions occurred in TAO patients, and one ASO patient died of myocardial infarction. Patency rates at follow-up were 44.5% and 85.7% in TAO and ASO patients. For TAO patients with graft failure, ABIs at follow-up did not statistically differ from those postoperatively; however, they were significantly higher than those preoperatively. Infrapopliteal bypass surgery is a feasible and effective procedure for ASO and TAO patients. Patency rates are lower in TAO than those in ASO during the in-hospital and follow-up period. However, TAO patients had the ischemic symptom relief and the improvement in ABI despite graft occlusion one year postoperatively.

Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia

ObjectiveAlthough the current guidelines have recommended single antiplatelet therapy (SAPT) for patients undergoing revascularization for chronic limb-threatening ischemia (CLTI), antithrombotic management has varied by patient and provider. Our aim was to examine the effects of different postoperative antithrombotic regimens on 3-year clinical outcomes after infrapopliteal bypass for CLTI. MethodsWe identified patients who had undergone infrapopliteal bypass for CLTI in the Vascular Quality Initiative (VQI) registry from 2003 to 2017 with linkage to Medicare claims for long-term outcomes. We divided the patients into three cohorts according to the discharge antithrombotic regimen: SAPT (aspirin or clopidogrel), dual antiplatelet therapy (DAPT; aspirin and clopidogrel), or anticoagulation (AC) plus any antiplatelet (AP) agent. To reduce selection bias, we restricted the analysis cohorts to patients treated by providers who discharged >50% of patients with each antithrombotic regimen. Our primary outcome was 3-year major adverse limb events (MALE; major amputation or reintervention). The secondary outcomes included 3-year major amputation, reintervention, and mortality. We used Kaplan-Meier and Cox regression analyses to assess these outcomes stratified by antithrombotic regimen and adjusted for demographic, comorbid, clinical, and operative differences between the treatment groups with clustering at the center level. ResultsAmong 1812 patients (median follow-up, >2 years), 693 (38%) were discharged with SAPT, 544 (30%) with DAPT, and 575 (32%) with AC+AP. At 3 years, the MALE rates were 75% with DAPT, 74% with AC+AP, and 68% with SAPT. In adjusted analyses with SAPT as the reference group, no differences were found in 3-year MALE with DAPT (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.85-1.3; P = .71) or AC+AP (aHR, 1.1; 95% CI, 0.96-1.3; P = .14). Across the treatment groups, we also found no differences in the individual end points of 3-year major amputation (DAPT: aHR, 0.98; 95% CI, 0.72-1.3; AC+AP: aHR, 1.3; 95% CI, 0.96-1.7), reintervention (DAPT: aHR, 1.0; 95% CI, 0.84-1.3; AC+AP: aHR, 1.1; 95% CI, 0.96-1.3), or mortality (DAPT: aHR, 1.1; 95% CI, 0.88-1.4; AC+AP: aHR, 0.95; 95% CI, 0.74-1.2). In a sensitivity analysis evaluating patients treated by providers who discharged >60%, >70%, or >80% of patients with these regimens, the association between antithrombotic regimen and MALE was unchanged. ConclusionsCompared with SAPT, DAPT and anticoagulation therapy were not associated with improved outcomes among Medicare beneficiaries who had undergone infrapopliteal bypass for CLTI at VQI participating centers. These findings support current guidelines recommending SAPT after lower extremity bypass and suggest that the routine use of DAPT or anticoagulation therapy might not provide clinical benefit in this high-risk, elderly population. However, further evaluation of the risks and benefits of various antithrombotic regimens in relevant subgroups is warranted.

Effect of Escalating Antithrombotic Therapy on Lower Extremity Outcomes After Infrapopliteal Bypass for Chronic Limb Threatening Ischemia

Although the current guidelines recommend single antiplatelet therapy (SAPT) for patients undergoing revascularization for chronic limb threatening ischemia (CLTI), antithrombotic management varies by patient and provider. We examined the effects of different antithrombotic regimens on major amputation and reintervention after infrapopliteal bypass for CLTI.

Impact of chronic kidney disease on the outcomes of infrapopliteal venous, and heparin-bonded expanded polytetrafluoroethylene bypass surgeries: A retrospective cohort study.

The aim of this study was to analyze the results of infrapopliteal venous and prosthetic bypass surgeries for patients with chronic limb-threatening ischemia (CLTI) and moderate to severe chronic kidney disease (CKD). All consecutive patients undergoing infrapopliteal bypass surgeries at two academic vascular centers between March 2002 and November 2018 were included in this retrospective study. During this timeframe, infrapopliteal grafts were performed for 487 patients. Of these patients, 160 (32.9%; group 1) had normal renal function, 248 (50.9%; group 2) had moderate CKD, and 79 (16.2%; group 3) had severe CKD according to the Kidney Disease Improving Global Outcomes guidelines. After 5 years' follow-up, the primary patency rate was 46.0% and the secondary patency rate was 54.9% without statistical significance noted between the CKD groups. Limb salvage (65.3%, p = 0.024) and long-term survival (19.6%, p < 0.001) were considerably lower in patients with severe CKD. In subgroup analysis, vein grafts had significantly better long-term patency rates compared to prosthetic grafts, regardless of CKD group. However, in patients with severe CKD, patency rates of vein and heparin-bonded expanded polytetrafluoroethylene (HePTFE) grafts were comparable at the 1-year mark. Our study shows that autologous vein grafts remain the first choice for infrapopliteal bypass surgeries in patients with CKD. HePTFE grafts showed good short-term results in patients with severe CKD. Given the short life expectancy of these high-risk patients, prosthetic HePTFE grafts may be reasonable in this population if a suitable vein is absent.

Comparison of Operative Risks and Benefits of Spliced Vein vs Prosthetic Conduits for Infrapopliteal Bypass

In the absence of adequate continuous segment of saphenous vein for infrapopliteal bypasses, early patency of prosthetic bypasses has been disappointing. Whether the performance of infrapopliteal bypasses can be improved if performed using spliced vein (SpV) grafts remains unclear. Our study investigates 30-day limb-related outcomes of SpV and prosthetic grafts for infrapopliteal (to tibial or peroneal arteries) bypasses.

Technical Success and Mid-Term Outcomes of Endovascular Revascularization of Tibio-Peroneal Trunk Lesions.

Tibio-peroneal trunk (TPT) lesions are usually categorized as ‘complex’ in anatomical classifications, which leads to the perception that endovascular therapy (EVT) will be challenging and the outcome most likely poor. This multicenter, retrospective cohort study investigates the efficacy of the EVT of TPT lesions in patients with chronic limb threatening ischemia (CLTI) or an infrapopliteal bypass at risk. The primary endpoint was limb-salvage. The secondary outcomes were technical success, freedom from clinically driven target lesion revascularization (CD-TLR), overall survival, and amputation-free survival. A total of 107 TPT lesions were treated in 101 patients. At 3 years, the limb-salvage rate was 76.4% (95% CI 66.0–86.8%). Technical success was achieved in 96.3% of cases. The freedom from CD-TLR, amputation-free survival, and overall survival at 3 years were 53.0% (95% CI 38.1–67.9%), 33.6% (95% CI 23.0–44.2%), and 47.7% (95% CI 36.1–59.3%), respectively. Reintervention significantly increased the hazard ratio for amputation by 7.65 (95% CI 2.50–23.44, p < 0.001). Our results show that the EVT of both isolated and complex TPT lesions is associated with high technical success and acceptable limb-salvage rates, with reintervention being a major risk factor for amputation. Moreover, mid-term mortality rate was relatively high. In future revisions of the anatomical grading scales, the classification of TPT lesions as highly complex should be reconsidered.

Comparison of Clinical Outcomes in Patients Selected for Infra-Popliteal Bypass or Plain Balloon Angioplasty for Chronic Limb Threatening Ischemia Between 2009 and 2013.

Introduction:A published subgroup analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial suggests that, in patients with chronic limb threatening ischemia (CLTI) due to infra-popliteal (IP) disease, clinical outcomes are better following vein bypass surgery (BS) than after plain balloon angioplasty (PBA). The aim of the present study is to determine if clinical outcomes following IP revascularization in our unit are concordant with those found in BASIL-1.Methods:We analyzed prospectively gathered data pertaining to 137 consecutive CLTI patients undergoing IP PBA or BS between 2009 and 2013. We compared 30-day morbidity and mortality, days in hospital (index admission and out to 12-months), amputation free survival (AFS), overall survival (OS), limb salvage (LS), and freedom from arterial re-intervention (FFR). Patient outcomes were censored on 1 February 2017, providing a minimum 3 years follow-up.Results:Patients undergoing BS (73/137, 47%) tended to be younger, have less comorbidity, and were more likely to be on best medical therapy (BMT). BS patients spent more days in hospital during the index admission (median 9 vs 5, p = .003), but not out to 12 months (median 15 vs 13, NS). BS patients suffered more 30-day morbidity (36% vs 10%, p < .001), mainly due to infective complications, but not mortality (3.1% vs 6.8%, NS). AFS (p = .001) and OS (p < .001), but not LS or FFR, were better after BS.Conclusions:CLTI patients selected for revascularization by means of IP BS had better long-term outcomes in terms of AFS and OS, but not FFR or LS. Although we await the results of the BASIL-2 trial, current data support the BASIL-1 sub-group analysis which suggests that patients requiring revascularization for IP disease should have BS where possible and that PBA should usually be reserved for patients who are not suitable for BS.

Different inflammatory cytokines release after open and endovascular reconstructions influences wound healing.

Prodromal signs of a non-healing wound after revascularisation, which might be strictly linked with impending failure of vascular reconstructions, are associated with an inflammatory response mediated by several circulating adhesion molecules, extracellular endopeptidases, and cytokines. The aim of our study was to investigate the role of selected plasma biomarkers in the prediction of both wound healing and failure of infrapopliteal vein graft or percutaneous trans-luminal angioplasty (PTA) with selective stent positioning of the superficial femoral artery (SFA) in a population affected with critical limb ischaemia. A total of 68 patients who underwent either surgical or endovascular revascularisation of the inferior limb with autologous saphenous vein infrapopliteal bypass or PTA and selective stenting of the SFA were enrolled in our study. Patients were divided into two groups according to treatment: 41 patients were included in Group 1 (open surgery) and 27 in Group 2 (endovascular procedure). Plasma and blood samples were collected on the morning of surgery and every 6 months thereafter for up to 2 years of follow-up or until an occlusion occurred of either the vein bypass graft or the vessel treated endovascularly. Fifteen age-matched healthy male volunteers were considered a reference for biological parameters. Vascular cell adhesion molecule 1 [VCAM-1]/CD106, inter-cellular adhesion molecule-1 [ICAM-1]/CD54), interleukin-1 (IL-1), interleukin-6 (IL-6), tumour necrosis factor alpha (TNF-α), and metalloproteinases (MMP)-2 and -9 plasma levels were measured with enzyme-linked immunosorbent assay (ELISA) kits. The mean observed time to heal of 54 wounds was 13 ± 4 months, with no statistically significant differences among the groups. The healing failure of the remaining wounds was strictly related to an unsuccessful open (n = 12) or endovascular (n = 8) treatment. The 2-year primary patency rate was 65% (SE = .09) in Group 1 and 52% (SE = .1) in Group 2. When compared with mean concentration values of Group 1, VCAM-1 and ICAM-1 were always significantly higher during follow-up in patients of Group 2 (P < .05). Furthermore, in the same group, IL-6 and tumour necrosis factor alpha (TNF-α) were found to be significantly higher at 6- and 12-month (P < .05) when compared with surgically treated patients. Cox regression analysis showed that elevated plasma levels of VCAM-1, ICAM-1, IL-6, and TNF-α during follow up were strongly related to impaired wound healing and/or revascularisation failure (P < .05). Elevated plasma levels of inflammatory markers VCAM-1, ICAM-1, IL-6, and TNF-α may be related to the failure of wound healing and revascularisation procedures. Interestingly, we have observed that endovascular treatments cause a higher level of these inflammation biomarkers when compared with a vein graft, although wound-healing and patency and limb salvage rates are not influenced.