Long-Term Outcome of Lower Extremity Bypass Surgery in Patients with Chronic Kidney Disease and Critical Limb Ischemia in Germany.

BACKGROUND: The aim of this study is to present short- and long-term outcomes after lower extremity bypass (LEB) surgery in patients with chronic limb-threatening ischemia and chronic kidney disease (CKD), differentiated by peripheral artery disease (PAD) Fontaine stage III and IV. METHODS: Retrospective analysis of anonymized data from a nationwide German health insurance company (AOK). Data from 22,633 patients (14,523 men) who underwent LEB from 2010 to 2015 were analyzed, presenting 18,271 with CKD stage 1/2, 2,483 patients with CKD stage 3, and 1,879 with CKD stage 4/5. RESULTS: Perioperative mortality (60-day mortality) was 7.2% for CKD stage 1/2, 12.4% for CKD stage 3, and 19.8% for CKD stage 4/5. Patients with PAD stage IV had significantly higher perioperative mortality (10.3%) than patients with PAD stage III (4.5%). The perioperative major amputation rate depended significantly on PAD stage IV (odds ratio [OR]: 2.57 confidence interval [CI]: 2.16-3.05, P < 0.001), the LEB level below the knee and crural/pedal (OR: 2.49 CI: 2.14-2.90, P < 0.001), CKD stage 4/5 (OR: 1.28, CI: 1.06-1.54, P = 0.009), and the presence of diabetes mellitus type 2 (OR: 1.19, CI: 1.05-1.36, P = 0.007). Kaplan-Meier estimated long-term survival of up to 9 years after surgery was 31.7% for patients with CKD stage 1 and 2, 14.3% for CKD stage 3, and only 10.1% for CKD stage 4 and 5 (P < 0.001). PAD Fontaine stage IV versus III (hazard ratio: 1.64, CI: 1.56-1.71, P < 0.001), but not bypass level, had an independent adverse influence on long-term survival. CONCLUSION: CKD and PAD stage were equally significant independent predictors of patient survival and major adverse cardiovascular events with higher PAD and CKD stages associated with less favorable long-term outcomes.

Long-term outcomes of great saphenous vein harvest techniques for infrainguinal arterial bypass in a Medicare-matched registry database.

OBJECTIVE: Long-term outcomes for harvesting techniques for great saphenous vein (GSV) and its impact on the outcomes of infrainguinal arterial bypass remains largely unknown. Endoscopic GSV harvesting (EVH) has emerged as a less invasive alternative to conventional open techniques. Using the Vascular Quality initiative Vascular Implant Surveillance & Interventional Outcomes Network (VQI-VISION) database, we compared the long-term outcomes of infrainguinal arterial bypass using open and endoscopic GSV harvest techniques. METHODS: Patients who underwent infrainguinal GSV bypass between 2010 and 2019 were identified in the VQI-VISION Medicare linked database. Long-term outcomes of major/minor amputations, and reinterventions up to 5 years of follow-up were compared between continuous incisions, skip incision, and EVH, with continuous incisions being the reference group. Secondary outcomes included 30- and 90-day readmission, in addition to surgical site infections and patency rates at 6 months to 2 years postoperatively. Survival analysis using Kaplan-Meier curves and Cox regression hazard models were utilized to compare outcomes between groups. To adjust for multiple comparisons between the study groups, a P value of 2.5% was considered significant. RESULTS: Among the 8915 patients included in the study, continuous and skip vein harvest techniques were used in 44.4% and 43.4% of cases each, whereas 12.3% underwent EVH. The utilization of EVH remained relatively stable at around 12% throughout the study period. Compared with GSV harvest using continuous incisions, EVH was associated with higher rates of reintervention at 1 year (46.5% vs 41.3%; adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 1.06-1.41; P = .01]. However, no significant difference was observed between EVH and continuous incisions, and between skip and continuous incisions in terms of long-term reintervention or major and minor amputations on adjusted analysis. Compared with continuous incision vein harvest, both EVH and skip incisions were associated with lower surgical site infection rates within the first 6 months post-bypass (aHR, 0.53; 95% CI, 0.35-0.82 and aHR, 0.68; 95% CI, 0.53-0.87, respectively). Loss of primary, primary-assisted, and secondary patency was higher after EVH compared with continuous incision vein harvest. Among surgeons performing EVH, comparable long-term outcomes were observed regardless of low (<4 cases/year), medium (4-7 cases/year), or high procedural volumes (>7 cases/year). CONCLUSIONS: Despite higher 1-year reintervention rates, EVH for infrainguinal arterial bypass is not associated with a significant difference in long-term reintervention or amputation rates compared with other harvesting techniques. These outcomes are not influenced by procedural volumes for EVH technique.

Descriptive Analysis of Amputation-Free Survival After First Time Infra-Inguinal Bypass Occlusion.

INTRODUCTION: Occlusion after infra-inguinal bypass surgery for peripheral artery disease is a major complication with potentially devastating consequences. In this descriptive analysis, we sought to describe the natural history and explore factors associated with long-term major amputation-free survival following occlusion of a first-time infra-inguinal bypass. METHODS: Using a prospective database from a tertiary care vascular center, we conducted a retrospective cohort study of all patients with peripheral artery disease who underwent a first-time infra-inguinal bypass and subsequently suffered a graft occlusion (1997-2021). The primary outcome was longitudinal rate of major amputation-free survival after bypass occlusion. Cox proportional hazard models were used to generate hazard ratios (HRs) and 95% confidence intervals (CIs) to explore predictors of outcomes. RESULTS: Of the 1318 first-time infra-inguinal bypass surgeries performed over the study period, 255 bypasses occluded and were included in our analysis. Mean age was 66.7 (12.6) years, 40.4% were female, and indication for index bypass was chronic limb threatening ischemia (CLTI) in 89.8% (n = 229). 48.2% (n = 123) of index bypass conduits used great saphenous vein, 29.0% (n = 74) prosthetic graft, and 22.8% (n = 58) an alternative conduit. Median (interquartile range) time to bypass occlusion was 6.8 (2.3-19.0) months, and patients were followed for median of 4.3 (1.7-8.1) years after bypass occlusion. Following occlusion, 38.04% underwent no revascularization, 32.94% graft salvage procedure, 25.1% new bypass, and 3.92% native artery recanalization. Major amputation-free survival following occlusion was 56.9% (50.6%-62.8%) at 1 y, 37.1% (31%-43.3%) at 5 y, and 17.2% (11.9%-23.2%) at 10 y. In multivariable analysis, factors associated with lower amputation-free survival were older age, female sex, advanced cardiorenal comorbidities, CLTI at index procedure, CLTI at time of occlusion, and distal index bypass outflow. Initial treatment after occlusion with both a new surgical bypass (HR 0.44, CI: 0.29-0.67) or a graft salvage procedure (HR 0.56, CI: 0.38-0.82) showed improved amputation-free survival. One-year rate of major amputation or death were 59.8% (50.0%-69.6%) for those who underwent no revascularization, 37.9% (28.7%-49.0%) for graft salvage, and 26.7% (17.6%-39.5%) for new bypass. CONCLUSIONS: Long-term major amputation-free survival is low after occlusion of a first-time infra-inguinal bypass. While several nonmodifiable risk factors were associated with lower amputation-free survival, treatment after graft occlusion with either a new bypass or a graft salvage procedure may improve longitudinal outcomes.

Longer Operative Time for Lower Extremity Bypass Surgery is Associated With Inferior Outcomes.

INTRODUCTION: This study aims to assess the association of operative time with the postoperative length of stay and unplanned return to the operating room in patients undergoing femoral to below knee popliteal bypasses, stratified by autologous vein graft or polytetrafluoroethylene (PTFE). MATERIALS AND METHODS: A retrospective analysis of vascular quality initiative database (2003-2021). The selected patients were grouped into the following: vein bypass (group I) and PTFE (group II) patients. Each group was further stratified by a median split of operative time (i.e., 210 min for autologous vein and 155 min for PTFE) to study the outcomes. The outcomes were assessed by univariate and multivariate approach. RESULTS: Of the 10,902 patients studied, 3570 (32.7%) were in the autologous vein group, while 7332 (67.3%) were in the PTFE group. Univariate analysis revealed autologous vein and PTFE graft recipients that had increased operative times were associated with a longer mean postoperative length of stay and a higher incidence of all-cause return to the operating room. In PTFE group, patients with prolonged operative times were also found to be associated with higher incidence of major amputation, surgical site infection, and cardiovascular events, along with loss of primary patency within a year. CONCLUSIONS: For patients undergoing femoral to below knee popliteal bypasses using an autologous vein or PTFE, longer operative times were associated with inferior outcomes. Mortality was not found to be associated with prolonged operative time.

Endovascular therapy versus bypass for chronic limb-threatening ischemia in a real-world practice.

OBJECTIVE: The recent Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) study showed that bypass was superior to endovascular therapy (ET) in patients with chronic limb-threatening ischemia (CLTI) deemed suitable for either approach who had an available single-segment great saphenous vein (GSV). However, the superiority of bypass among those lacking GSV was not established. We aimed to examine comparative treatment outcomes from a real-world CLTI population using the Vascular Quality Initiative-Medicare-linked database. METHODS: We queried the Vascular Quality Initiative-Medicare-linked database for patients with CLTI who underwent first-time lower extremity revascularization (2010-2019). We performed two one-to-one propensity score matchings (PSMs): ET vs bypass with GSV (BWGSV) and ET vs bypass with a prosthetic graft (BWPG). The primary outcome was amputation-free survival. Secondary outcomes were freedom from amputation and overall survival (OS). RESULTS: Three cohorts were queried: BWGSV (N = 5279, 14.7%), BWPG (N = 2778, 7.7%), and ET (N = 27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4705 pairs of ET vs BWGSV and 2583 pairs of ET vs BWPG. In the matched cohorts of ET vs BWGSV, ET was associated with greater hazards of death (hazard ratio [HR] = 1.34, 95% confidence interval [CI], 1.25-1.43; P < .001), amputation (HR = 1.30, 95% CI, 1.17-1.44; P < .001), and amputation/death (HR = 1.32, 95% CI, 1.24-1.40; P < .001) up to 4 years. In the matched cohorts of ET vs BWPG, ET was associated with greater hazards of death up to 2 years (HR = 1.11, 95% CI, 1.00-1.22; P = .042) but not amputation or amputation/death. CONCLUSIONS: In this real-world multi-institutional Medicare-linked PSM analysis, we found that BWGSV is superior to ET in terms of OS, freedom from amputation, and amputation-free survival up to 4 years. Moreover, BWPG was superior to ET in terms of OS up to 2 years. Our study confirms the superiority of BWGSV to ET as observed in the BEST-CLI trial.

Clinical factors associated with ultrashort length of stay in patients undergoing lower extremity bypass for peripheral arterial disease.

BACKGROUND: Length of stay (LOS) is a major driver of cost and resource utilization following lower extremity bypass (LEB). However, the variable comorbidity burden and mobility status of LEB patients makes implementing enhanced recovery after surgery pathways challenging. The aim of this study was to use a large national database to identify patient factors associated with ultrashort LOS among patients undergoing LEB for peripheral artery disease. METHODS: All patients undergoing LEB for peripheral artery disease in the National Surgical Quality Improvement Project database from 2011 to 2018 were included. Patients were divided into two groups based on the postoperative length of stay : ultrashort (≤2 days) and standard (>2 days). Thirty-day outcomes were compared using descriptive statistics, and multivariable logistic regression was used to identify patient factors associated with ultrashort LOS. RESULTS: Overall, 17,510 patients were identified who underwent LEB, of which 2678 patients (15.3%) had an ultrashort postoperative LOS (mean, 1.8 days) and 14,832 (84.7%) patients had a standard LOS (mean, 7.1 days). When compared to patients with a standard LOS, patients with an ultrashort LOS were more likely to be admitted from home (95.9% vs 88.0%; P < .001), undergo elective surgery (86.1% vs 59.1%; P < .001), and be active smokers (52.1% vs 40.4%; P < .001). Patients with an ultrashort LOS were also more likely to have claudication as the indication for LEB (53.1% vs 22.5%; P < .001), have a popliteal revascularization target rather than a tibial/pedal target (76.7% vs 55.3%; P < .001), and have a prosthetic conduit (40.0% vs 29.9%; P < .001). There was no significant difference in mortality between the two groups (1.4% vs 1.8%; P = .21); however, patients with an ultrashort LOS had a lower frequency of unplanned readmission (10.7% vs 18.8%; P < .001) and need for major reintervention (1.9% vs 5.6%; P < .001). On multivariable analysis, elective status (odds ratio , 2.66; 95% confidence interval [CI], 2.33-3.04), active smoking (OR, 1.18; 95% CI, 1.07-1.30), and lack of vein harvest (OR, 1.55; 95% CI, 1.41-1.70) were associated with ultrashort LOS. Presence of rest pain (OR, 0.57; 95% CI, 0.51-0.63), tissue loss (OR, 0.30; 95% CI, 0.27-0.34), and totally dependent functional status (OR, 0.54; 95% CI, 0.35-0.84) were associated negatively with an ultrashort LOS. When examining the subgroup of patients who underwent vein harvest, totally dependent (OR, 0.38; 95% CI, 0.19-0.75) and partially dependent (OR, 0.53; 95% CI, 0.32-0.88) functional status were persistently negatively associated with ultrashort LOS. CONCLUSIONS: Ultrashort LOS (≤2 days) after LEB is uncommon but feasible in select patients. Preoperative functional status and mobility are important factors to consider when identifying LEB patients who may be candidates for early discharge.

Alternative vein bypass in octogenarians with chronic limb-threatening ischaemia.

BACKGROUND: Octogenarians are regarded as one of the frailest patient groups among the chronic limb-threatening ischaemia population with high perioperative morbidity and mortality rates. As a result, alternative vein bypass surgery in the absence of sufficient great saphenous vein is often not considered as a potential treatment option. The aim of this study was to compare the results of octogenarians undergoing alternative vein bypass surgery due to chronic limb-threatening ischaemia to younger patients. METHODS: A single-centre retrospective analysis of patients undergoing bypass surgery for chronic limb-threatening ischaemia with alternative autologous vein grafts between 1997 and 2018 was performed. Patients aged over 80 years were compared with those under 80 years. Graft patency rates were assessed and a risk factor analysis for limb loss was performed. RESULTS: In total, 592 patients underwent bypass surgery during the study interval. Twenty-one per cent (n = 126) of patients were 80 years or older. At 4 years, primary, primary-assisted and secondary patency as well as limb salvage rates were not significantly different between the two groups (46% versus 50%, 60% versus 66%, 69% versus 72%, 72% versus 77%, for octogenarians versus non-octogenarians respectively). Major amputations were performed in 27 (21%) octogenarians and 91 (20%) non-octogenarians (P = 0.190). No higher 30-day and long-term mortality rates nor morbidity rates were detected in the octogenarian group with a median follow-up time of 27 (interquartile range 12-56) months. Minor amputation, the reason for alternative vein grafts, as well as the profunda femoris artery as proximal origin of the bypass were risk factors for limb loss in the postoperative course. CONCLUSION: Alternative vein bypass surgery in octogenarians with chronic limb-threatening ischaemia is safe and effective in terms of patency rates, limb salvage and survival compared with younger patients in the absence of sufficient great saphenous vein. Age alone should not be a deterrent from performing bypass surgery.

Midterm Outcomes and Predictors of Failure of Lower Extremity Bypass to Para-Malleolar and Pedal Targets.

BACKGROUND: The frequency of distal lower extremity bypass (LEB) for infrapopliteal critical limb threatening ischemia (IP-CLTI) has significantly decreased. Our goal was to analyze the contemporary outcomes and factors associated with failure of LEB to para-malleolar and pedal targets. METHODS: We queried the Vascular Quality Initiative infrainguinal database from 2003 to 2021 to identify LEB to para-malleolar or pedal/plantar targets. Primary outcomes were graft patency, major adverse limb events [vascular reintervention, above ankle amputation] (MALE), and amputation-free survival at 2 years. Standard statistical methods were utilized. RESULTS: We identified 2331 LEB procedures (1,265 anterior tibial at ankle/dorsalis pedis, 783 posterior tibial at ankle, 283 tarsal/plantar). The prevalence of LEB bypasses to distal targets has significantly decreased from 13.37% of all LEB procedures in 2003-3.51% in 2021 (P < 0.001). The majority of cases presented with tissue loss (81.25. Common postoperative complications included major adverse cardiac events (8.9%) and surgical site infections (3.6%). Major amputations occurred in 16.8% of patients at 1 year. Postoperative mortality at 1 year was 10%. On unadjusted Kaplan-Meier survival analysis at 2 years, primary patency was 50.56% ± 3.6%, MALE was 63.49% ± 3.27%, and amputation-free survival was 71.71% ± 0.98%. In adjusted analyses [adjusted for comorbidities, indication, conduit type, urgency, prior vascular interventions, graft inflow vessel (femoral/popliteal), concomitant inflow procedures, surgeon and center volume] conduits other than great saphenous vein (P < 0.001) were associated with loss of primary patency and increased MALE. High center volume (>5 procedures/year) was associated with improved primary patency (P = 0.015), and lower MALE (P = 0.021) at 2 years. CONCLUSIONS: Despite decreased utilization, open surgical bypass to distal targets at the ankle remains a viable option for treatment of IP-CLTI with acceptable patency and amputation-free survival rates at 2 years. Bypasses to distal targets should be performed at high volume centers to optimize graft patency and limb salvage and minimize reinterventions.

Treatment Outcomes in Octogenarians with Chronic Limb-Threatening Ischemia after Infrainguinal Bypass Surgery or Endovascular Therapy.

BACKGROUND: This study aimed to analyze the clinical outcomes after revascularization for chronic limb-threatening ischemia (CLTI) in patients aged ≥ 80 years and < 80 years. METHODS: We retrospectively analyzed multicenter data of 789 patients who underwent infrainguinal revascularization for CLTI between 2015 and 2021. The end points were 2-year overall survival (OS), amputation-free survival (AFS), limb salvage (LS), and postoperative complications. RESULTS: A total of 90 patients aged ≥ 80 years and 200 patients aged < 80 years underwent bypass surgery (BSX), and 205 patients aged ≥ 80 years and 294 patients aged < 80 years underwent endovascular therapy (EVT). Before the propensity score matching, multivariate analyses showed that age ≥ 80 years, lower body mass index and serum albumin levels, nonambulatory status, and end-stage renal disease were independent risk factors for 2-year mortality in the BSX and EVT groups. After propensity score matching, the 2-year OS was better in the < 80 years cohort than in the ≥ 80 years cohort in both the BSX and EVT groups (P = 0.018 and P = 0.035, respectively). There was no difference in the 2-year LS rates between the < 80 years and the ≥ 80 years cohorts in both the BSX and EVT groups (P = 0.621 and P = 0.287, respectively). According to the number of risk factors, except for age ≥ 80 years, there was no difference in the 2-year AFS rates between the < 80 years and ≥ 80 years cohorts for the BSX and EVT groups with 0-1 risk factor (P = 0.957 and P = 0.655, respectively). However, the 2-year AFS rate was poor, especially in the ≥ 80 years cohort in the BSX with 2-4 risk factors (P = 0.015). The Clavien-Dindo ≥ IV complication rates tended to be higher in the ≥ 80 years cohort than in the < 80 years cohort only in the BSX with 2-4 risk factors (P = 0.056). CONCLUSIONS: Patients with CLTI aged ≥ 80 years had poorer OS than those aged < 80 years. However, there was no difference in LS between the ≥ 80 years and < 80 years cohorts in both the BSX and EVT groups. Although age ≥ 80 years was associated with poorer OS, patients with 0-1 risk factor may benefit from revascularization, including BSX, because no difference was observed in AFS or Clavien-Dindo ≥ IV complications.

Comparison of mortality and amputation after lower extremity bypass versus peripheral vascular intervention in patients with chronic limb-threatening ischemia and comorbid chronic kidney disease.

OBJECTIVE: Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. METHODS: Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS: Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS: Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.

The obesity paradox exists for perioperative complications and mortality following lower extremity arterial bypass surgery.

OBJECTIVE: The obesity paradox refers to a phenomenon by which obese individuals experience lower risk of mortality and even protective associations from chronic disease sequelae when compared with the non-obese and underweight population. Prior literature has demonstrated an obesity paradox after cardiac and other surgical procedures. However, the relationship between body mass index (BMI) and perioperative complications for patients undergoing major open lower extremity arterial revascularization is unclear. METHODS: We queried the Vascular Quality Initiative for individuals receiving unilateral infrainguinal bypass between 2003 and 2020. We used multivariable logistic regression to assess the relationship of BMI categories (underweight [<18.5 kg/m2], non-obese [18.5-24.9 kg/m2], overweight [25-29.9 kg/m2], Class 1 obesity [30-34.9 kg/m2], Class 2 obesity [35-39.9 kg/m2], and Class 3 obesity [>40 kg/m2]) with 30-day mortality, surgical site infection, and adverse cardiovascular events. We adjusted the models for key patient demographics, comorbidities, and technical and perioperative characteristics. RESULTS: From 2003 to 2020, 60,588 arterial bypass procedures met inclusion criteria for analysis. Upon multivariable logistic regression with the non-obese category as the reference group, odds of 30-day mortality were significantly decreased among the overweight (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.53-0.78), Class 1 obese (OR, 0.65; 95% CI, 0.52-0.81), Class 2 obese (OR, 0.66; 95% CI, 0.48-0.90), and Class 3 obese (OR, 0.61; 95% CI, 0.39-0.97) patient categories. Conversely, odds of 30-day mortality were increased in the underweight patient group (OR, 1.58; 95% CI, 1.16-2.13). Furthermore, a BMI-dependent positive association was present, with odds of surgical site infections with patients in Class 3 obesity having the highest odds (OR, 2.10; 95% CI, 1.60-2.76). Finally, among the adverse cardiovascular event outcomes assessed, only myocardial infarction (MI) demonstrated decreased odds among overweight (OR, 0.82; 95% CI, 0.71-0.96), Class 1 obese (OR, 0.78; 95% CI, 0.65-0.93), and Class 2 obese (OR, 0.66; 95% CI, 0.51-0.86) patient populations. Odds of MI among the underweight and Class 3 obesity groups were not significant. CONCLUSIONS: The obesity paradox is evident in patients undergoing lower extremity bypass procedures, particularly with odds of 30-day mortality and MI. Our findings suggest that having higher BMI (overweight and Class 1-3 obesity) is not associated with increased mortality and should not be interpreted as a contraindication for lower extremity arterial bypass surgery. However, these patients should be under vigilant surveillance for surgical site infections. Finally, patients that are underweight have a significantly increased odds of 30-day mortality and may be more suitable candidates for endovascular therapy.

Popliteal-to-Distal Extreme Bypass in Endovascular Era.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is characterized by rest pain and tissue loss, with an annual mortality rate of 20% and amputation rate of 40%, if not treated. Open bypass surgery is recommended in CLTI, depending on the availability of good quality venous material, outflow artery patency, and surgical expertise. The aim of the study is to analyze primary patency, limb salvage, and survival rate in patients undergoing popliteal-to-distal bypass. METHODS: All consecutive patients who underwent popliteal-to-distal bypass surgery between January 2016 and December 2021 were enrolled in the study. Primary outcomes were primary patency, limb salvage, and overall survival. Secondary outcomes included amputation-free survival and secondary patency. RESULTS: Forty-nine patients were included during the study. Technical success was achieved in 100% of cases. Target outflow artery was in 27% (n. 13) of cases the anterior tibial artery, in 27% (n. 13) the dorsalis pedis, in 2% (n. 1) the peroneal artery, in 30% (n. 15) the retromalleolar tibial artery, in 10% (n. 5) the medial plantar artery, and in 4% (n. 2) the tarsal artery. Two-year primary patency was 85% ± 5. Secondary patency rates were 86% ± 3 at 2 years. The overall survival was 81% ± 6 at 2 years, the amputation-free survival was 70% ± 9, and the limb salvage rate was 81% ± 6. CONCLUSIONS: Popliteal-to-distal bypass requires high technical expertise to be performed. When a good autologous vein and adequate outflow artery are present, they can be feasible with good patency rates and overall survival.

Long-Term Outcomes of Anatomical and Extra-Anatomical Bypass for the Treatment of Unilateral Iliac Artery Lesions a Systematic Review Aggregated Data and Individual Participant Data Meta-Analysis.

BACKGROUND: We investigated the long-term safety and efficacy of anatomical and extra-anatomical bypass for the treatment of unilateral iliac artery disease. METHODS: A systematic search on PubMed, Scopus and Web of science for articles published by June 2023 was performed. We implemented a 2-stage individual participant data meta-analysis and pooled survival probabilities using the multivariate methodology of DerSimonian and Laird. The primary endpoint was primary patency at 5 and 10 years of follow-up. RESULTS: Ten studies encompassing 1,907 patients were included. The 5- and 10-year pooled patency rates for anatomical bypass were 83.27% (95% confidence interval (CI): 69.99-99.07) and 77.30% (95% CI: 60.32-99.04), respectively, with a mean primary patency time representing the duration individuals remained event-free for 10.08 years (95% CI: 8.05-10.97). The 5- and 10-year pooled primary patency estimates for extra-anatomical bypass were 77.02% (95% CI: 66.79-88.80) and 68.54% (95% CI: 53.32-88.09), respectively, with a mean primary patency time of 9.25 years, (95% CI: 7.21-9.68). Upon 2-stage individual participant data meta-analysis, anatomical bypass displayed a decreased risk for loss of primary patency compared to extra-anatomical bypass, hazard ratio 0.51 (95% CI: 0.30-0.85). The 5- and 10-year secondary patency estimates for anatomical bypass were 96.83% (95% CI: 90.28-100) and 96.13% (95% CI: 88.72-100), respectively. The 5- and 10-year secondary patency estimates for extra-anatomical bypass were 91.39% (95% CI: 84.32-99.04) and 85.05% (95% CI: 74.43-97.18), respectively, with non-statistically significant difference between the 2 groups. The 5- and 10-year survival for patients undergoing anatomical bypass were 67.99% (95% CI: 53.84-85.85) and 41.09% (95% CI: 25.36-66.57), respectively. The 5- and 10-year survival for extra-anatomical bypass were 70.67% (95% CI: 56.76-87.98) and 34.85% (95% CI: 19.76-61.44), respectively. The mean survival time was 6.92 years (95% CI: 5.56-7.89) for the anatomical and 6.78 years (95% CI: 5.31-7.63) for the extra-anatomical groups. The pooled overall 30-day mortality was 2.32% (95% CI: 1.12-3.87) with metaregression analysis displaying a negative association between the year of publication and mortality (ß =-0.0065, P < 0.01). Further analysis displayed a 30-day mortality of 1.29% (95% CI: 0.56-2.26) versus 4.02% (95% CI: 1.78-7.03), (P = 0.02) for studies published after and before the year 2000. Non-statistically significant differences were identified between the 2 groups concerning long-term and 30-day mortality outcomes. CONCLUSIONS: While we have demonstrated favorable long-term primary and secondary patency outcomes for both surgical techniques, anatomical bypass exhibited a reduced risk of primary patency loss potentially reflecting its inherent capacity to circumvent the anticipated disease progression in the distal aorta and the contralateral donor artery. The reduction in perioperative mortality observed in our review, coupled with the anachronistic demographic characteristics and inclusion criteria presented in the existing literature, underscores the imperative necessity for contemporary research.

Infra-inguinal bypass surgery vs endovascular revascularization for chronic limb-threatening ischemia in average- and high-risk patients.

OBJECTIVE: This study aimed to evaluate treatment outcomes after bypass surgery or endovascular therapy (EVT) in average- and high-risk patients with chronic limb-threatening ischemia (CLTI). METHODS: We retrospectively analyzed multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. A high-risk patient was defined as one with estimated 30-day mortality rate ≥5% or 2-year survival rate ≤50%, as determined by the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) calculator. The amputation-free survival (AFS), limb salvage (LS), wound healing, and 30-day mortality were compared separately for the average- and high-risk patients between the bypass and EVT with propensity score matching. RESULTS: We analyzed 239 and 31 propensity score-matched pairs in the average- and high-risk patients with CLTI. In the average-risk patients, the 2-year AFS and LS rates were 78.1% and 94.4% in the bypass group and 63.0% and 87.7% in the EVT group (P < .001 and P = .007), respectively. The 1-year wound healing rates were 88.6% in the bypass group and 76.8% in the EVT group, respectively (P < .001). The 30-day mortality was 0.8% in the bypass surgery and 0.8% in the EVT group (P = .996). In the high-risk patients, there was no differences in the AFS, LS, and wound healing between the groups (P = .591, P = .148, and P = .074). The 30-day mortality was 3.2% in the bypass group and 3.2% in the EVT group (P = .991). CONCLUSIONS: Bypass surgery is superior to EVT with respect to the AFS, LS, and wound healing in the average-risk patients. EVT is a feasible first-line treatment strategy for high-risk patients with CLTI undergoing revascularization, based on the lack of significant differences in the 2-year AFS rate, between the bypass surgery and EVT cohorts.

Predictors of amputation-free survival and wound healing after infrainguinal bypass with alternative conduits.

OBJECTIVE: Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. METHODS: A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. RESULTS: Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12). CONCLUSIONS: In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS.

Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial.

OBJECTIVES: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints. METHODS: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models. RESULTS: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial. CONCLUSIONS: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.

Contemporary outcomes of concomitant suprainguinal bypass with infrainguinal revascularization procedures in patients with chronic limb-threatening ischemia.

OBJECTIVE: Combined suprainguinal and infrainguinal revascularization is sometimes necessary in the treatment of patients with chronic limb-threatening ischemia (CLTI). However, data on outcomes of concomitant revascularization procedures are lacking. We studied the outcomes of patients with CLTI who underwent suprainguinal bypass (SIB) alone, SIB with concomitant infrainguinal bypass (IIB), and SIB with concomitant infrainguinal peripheral endovascular intervention (IIPVI). METHODS: We reviewed all patients in the Vascular Quality Initiative with CLTI who underwent SIB from January 2010 to June 2020. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression were used to analyze outcomes. Outcomes were 30-day mortality, perioperative myocardial infarction, perioperative major amputation, 1-year amputation-free survival, and 5-year survival. RESULTS: Of 8037 patients included, 81.3% (n = 6537) underwent SIB alone, 9.7% (n = 783) underwent SIB+IIB, and 8.9% (n = 717) underwent SIB+IIPVI. The indication for surgery was rest pain in 5040 (62.5%) and tissue loss in 3031 (37.6%). There were no significant differences in 30-day mortality and perioperative myocardial infarction rates. However, there was 2.8-fold increased odds of perioperative major amputation in both SIB+IIPVI (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.30-5.88; P = .008) and SIB+IIB (OR, 2.79; 95% CI, 1.38-5.54; P = .004) among patients with rest pain as compared with SIB alone. Comparing SIB+IIPVI with SIB alone, there were no significant differences in 1-year freedom from amputation and amputation-free survival. SIB+IIPVI was associated with a 27% increased risk of 5-year mortality (hazard ratio [HR], 1.27; 95% CI, 1.03-1.55; P = .035). Compared with SIB alone, SIB+IIB was associated with 97% increased risk of 1-year major amputation among patients with rest pain (HR, 1.97; 95% CI, 1.06-3.69; P = .033), but a 47% decreased risk of 1-year major amputation or death for patients with tissue loss (HR, 0.53; 95% CI, 0.37-0.78; P = .001). SIB+IIPVI, compared with SIB+IIB, was associated with a two-fold increased risk of 1-year major amputation or death (HR, 2.04; 95% CI, 1.04-2.23), P = .003) and a 52% increased risk of 5-year mortality (HR,1.52; 95% CI, 1.04-2.24; P = .032) among patients with tissue loss. CONCLUSIONS: This study shows that SIB with concomitant infrainguinal revascularization in patients with rest pain is associated with an increased risk of amputation, whereas SIB+IIB in patients with tissue loss is associated with decreased risk of amputation or death. SIB+IIB outperformed SIB+IIPVI in patients with tissue loss. SIB with infrainguinal revascularization should be limited in patients with rest pain in line with current guidelines, but SIB+IIB may be preferred in patients with tissue loss.

Impact of Perioperative Blood Transfusion in Anemic Patients Undergoing Infra Inguinal Bypass.

OBJECTIVE: Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients. METHODS: All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL. RESULTS: Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001). CONCLUSIONS: For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings.

Contemporary Use of the Femoropopliteal Vein in Vascular Reconstructions.

INTRODUCTION: Current practice patterns favor endovascular treatment, resulting in fewer open procedures. When needed, greater saphenous vein and/or prosthetic conduits are considered the first choice for open vascular bypass. However, there is a cohort of patients in which these conduits are either not available or not suitable to address the surgical requirements. One alternative is to use femoropopliteal vein (FPV), an often-overlooked conduit. We report on the contemporary use of FPV in a tertiary vascular institution. METHODS: All patients who underwent FPV harvest, as defined by CPT code 35572, between 2005 and 2019 were identified. Patient demographics (sex, age, baseline laboratory values, medical co-morbidities), indication for use of FPV, complications specific to vein harvest, operative details, post-operative course, and outcomes were recorded. RESULTS: Ninety patients had harvest of FPV for creation of 123 conduits. In this study, a conduit was defined as a segment of vein used to perfuse a distinctly separate vascular bed. We identified four cohorts in which FPV was used: aorto-iliac reconstruction in 38 patients for infected graft (19), occlusive disease (8), aortitis (5), mycotic aneurysm (5), and malignancy (1); peripheral artery revascularization in 26 patients for ilio-femoral reconstruction (15), femoropopliteal reconstruction (4), upper extremity/cerebrovascular reconstruction (6), and coronary bypass (1); mesenteric revascularization in 20 patients for acute or acute on chronic ischemia (12), chronic ischemia (7) or aneurysm (1); and dialysis access in 6 patients. There was a high incidence of pre-existing comorbid conditions in all groups, but most notably those patients who underwent aorto-iliac reconstruction. Harvest-related or conduit-related complications included compartment syndrome, graft-associated hemorrhage, surgical site infection, and lymphatic complications. Primary graft patency at 3 years was 83% ± 4% (aorto-iliac), 83% ± 6% (peripheral), 100% (mesenteric), and 23% ± 19% (dialysis access, P < 0.001). CONCLUSIONS: While use of FPV has potential significant harvest-related, conduit-related, or systemic complications, FPV is useful for a variety of needs, almost universally available, and durable. In the current era where endovascular approach is the focus, FPV should not be forgotten as a potential conduit that can be used for a variety of vascular reconstruction indications.

Outcomes of bypass and endovascular interventions for advanced femoropopliteal disease in patients with premature peripheral artery disease.

OBJECTIVE: Patients with premature peripheral artery disease (PAD), defined as age ≤50 years at presentation, have had poor outcomes with open and endovascular lower extremity revascularization. It is unclear whether either strategy is associated with better outcomes because comparative studies have been limited to case series in this patient population. The aim of the present study was to compare the outcomes of patients with premature PAD who had undergone bypass or endovascular revascularization for advanced femoropopliteal disease. Our hypothesis was that open bypass would provide superior long-term outcomes compared with endovascular intervention for patients with premature advanced femoropopliteal PAD. METHODS: All the patients with premature PAD who had undergone isolated femoropopliteal lower extremity revascularization and included in the Vascular Quality Initiative infrainguinal bypass and peripheral vascular intervention files were reviewed from 2003 through 2019. Propensity score matching (1:1) was performed between patients who had undergone femoropopliteal bypass and endovascular interventions for isolated femoropopliteal Trans-Atlantic Classification System C or D lesions. The 1-year outcomes, including reintervention, patency, major amputation, and mortality, were analyzed. RESULTS: Of the 2538 included patients, 902 had undergone isolated femoropopliteal endovascular intervention and 1636 had undergone femoropopliteal bypass. The endovascular intervention group were more likely to have diabetes (68.9% vs 54.0%; P < .001), coronary artery disease (31.0% vs 23.0%; P < .001), renal failure requiring dialysis (14.2% vs 7.2%; P < .001), and claudication (45.1% vs 36.6%; P < .001) compared with the bypass group. After propensity score matching, 466 patients were in each group with no significant differences in the baseline characteristics. Perioperative morbidity was higher with femoropopliteal bypass compared with endovascular intervention (12.0% vs 7.9%; P = .038); however, the rates of major amputation and mortality were not different. At 1 year, patients who had undergone femoropopliteal bypass were less likely to require reintervention (17.0% vs 25.2%; P = .012). However, no differences were found in major amputation (7.7% vs 7.9%; P = .928) or mortality (5.2% vs 5.2%; P = 1.00). Propensity score matching was also performed between femoropopliteal bypass with the great saphenous vein and isolated femoropopliteal endovascular interventions, and the outcomes were similar. CONCLUSIONS: For patients with premature PAD and advanced femoropopliteal disease, bypass surgery decreased the reintervention rate at 1 year but was associated with increased perioperative morbidity and hospital length of stay compared with endovascular therapy. No differences were found in major amputation or mortality between the two strategies.