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

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Outcomes and predictors of amputation-free survival in patients undergoing below-knee popliteal-distal bypass.

OBJECTIVE: The infrageniculate popliteal artery is a potential source for inflow in lower extremity bypass surgery in patients with isolated tibial artery disease. The objective of our study was to assess the short- and long-term outcomes of popliteal-distal bypasses using data from the Vascular Quality Initiative (VQI). METHODS: The VQI registry was queried between 2003 and 2021 for patients undergoing surgical revascularizations with the below-knee popliteal artery serving as inflow. Demographics, comorbidities, intraoperative characteristics, and postoperative complications were analyzed. Kaplan-Meier models were used to estimate amputation-free survival, survival, and freedom from amputation. Cox regression analysis was conducted to determine factors associated with major amputation or death. RESULTS: A total of 1884 procedures were analyzed. The mean age of the included patients was 67.7 years. The most frequently observed preoperative comorbidities included insulin-dependent diabetes (52.3%), coronary disease (32.4%), and end-stage renal disease (14.4%). Of all the patients, 670 (35.6%) had a history of ipsilateral endovascular intervention. The procedures were performed for a variety of indications, including tissue loss (84.3%), rest pain (10.9%), and claudication (4.8%). Intraoperatively, the outflow targets were the dorsalis pedis (31.4%), the posterior tibial (24.4%), and the anterior tibial arteries (15.6%). Vein conduit was used in 92.1% of cases. The rate of perioperative myocardial infarction (MI) was 2.4%, and the 30-day mortality was 1.9%. The median length of follow up was 371 days. Amputation-free survival was found to be 85.6% (95% confidence interval [CI], 84.0%-87.2%) at 6 months and 78.6% (95% CI, 76.6%-80.4%) at 12 months. Survival was found to be 93.4% (95% CI, 92.2%-94.5%) at 6 months and 88.6% (95% CI, 87.1%-90.0%) at 12 months. Freedom from amputation was found to be 92.0% (95% CI, 90.7%-93.3%) at 6 months and 89.0% (95% CI, 87.3%-90.4%) at 12 months. Cox regression analysis demonstrated that age greater than 65 years, congestive heart failure, coronary artery disease, and end-stage renal disease were associated with a higher risk of major amputation or death (P < .05). CONCLUSIONS: Below-knee popliteal-distal bypass is a safe and effective approach to treat severe tibial vessel occlusive disease in this challenging patient cohort. Patients exhibited low perioperative complication rates and good amputation-free survival at 1 year.

Long-Term Outcomes of Extra-Anatomic Femoro-Tibial Bypass Reconstructions in Chronic Limb-Threating Ischemia.

(1) Background: While tibial bypass surgery still plays a role in the treatment of patients with chronic limb-threatening ischemia and diabetic foot syndrome; only a few centers have recorded considerable numbers of these conditions. The current study aimed to determine contemporary practice with special focus on the performance of extra-anatomic grafting to the infrapopliteal arteries. (2) Methods: A retrospective, single-center study included patients with tibial bypass grafts from 1 January 2008 to 31 December 2019. Primary endpoints were complication rate, graft patency, amputation, overall survival, and major adverse cardiac (MACE) or limb event (MALE). The cohort was stratified by extra-anatomic vs. anatomic position. (3) Results: A total of 455 patients (31% female) with Rutherford stage 4 (12.5%) and 5/6 (69.5%) were included (thereof, 19.5% had high amputation risk according to the Wound Ischemia Foot Infection score). Autologous reconstruction was performed in 316 cases, and prosthetic reconstruction in 131 cases, with a total of 51 (11.2%) extra-anatomic grafts. Early occlusion rate was 9.0% with an in-hospital overall mortality of 2.8%. The in-hospital rate of MACE was 2.4% and of MALE, 1.5%. After one, three and five years, the primary patency of venous bypasses was 74.5%, 68.6% and 61.7%, respectively. For prosthetic grafts, this was 55.1%, 46.0%, and 38.3%, respectively (p < 0.001). The patency of extra-anatomic prosthetic grafts performed significantly better compared with anatomically positioned prosthetic grafts (log-rank p = 0.008). In multivariate analyses, diabetes (hazard ratio, HR 1.314, CI 1.023−1.688, p = 0.032), coronary artery disease (HR 1.343, CI 1.041−1.732, p = 0.023), and dialysis dependency (HR 2.678, CI 1.687−4.250, p < 0.001) were associated with lower odds of survival (4) Conclusion: In this large, single-center cohort, tibial bypass surgery demonstrated satisfactory results with overall low perioperative complication rates and long-term patency rates of 60% and 38%, respectively. Extra-anatomic bypasses represent a feasible alternative to venous grafts in terms of patency. A tailored, patient-centered approach considering predictors such as diabetes, dialysis dependency, and coronary artery disease along with prediction models may further improve the long-term results in the future.

Impact of tibial bypass conduit on long-term amputation-free survival and primary patency in the Vascular Quality Initiative.

OBJECTIVE: Much research remains focused on tibial bypass conduit selection. We sought to describe long-term amputation-free survival (AFS) and primary patency (PP) of patients undergoing tibial bypass by conduit type and configuration across several permutations in the Society for Vascular Surgery Vascular Quality Initiative. METHODS: Patients in the Vascular Quality Initiative registry undergoing elective first-time femoral- or popliteal-to-tibial bypass for occlusive disease involving rest pain or tissue loss were identified. Prior ipsilateral infrainguinal bypass or concomitant procedures were excluded. Outcomes of interest included patient AFS at 22 months and PP at 1 year (defined as freedom from revision, thrombectomy, or graft occlusion). RESULTS: A total of 4192 bypasses were identified. The majority utilized great saphenous vein (GSV) (76.2%), followed by polytetrafluoroethylene (10.6%), nonautologous biologic (6.5%), composite (3.3%), arm vein (2.8%), and small saphenous vein (0.6%). Compared with all prosthetic and composite bypasses, vein grafts had the best AFS (76.4%; P < .0001) and PP (68.1%; P = .041). Of the single segment vein conduits, GSV bypasses had the best PP (69.1%) and arm vein the worst (60.2%). AFS and PP were similar between single-segment GSV orientations. Single-segment GSV bypasses exhibited better PP than multiple segment bypasses (69.1% vs 54.6%; P = .0016). PP was significantly better for polytetrafluoroethylene compared with nonautologous biologic (68.4% vs 51.2%; P = .0039). PP did not significantly differ between vein cuff for prosthetic bypass compared with no vein cuff (69.1% vs 59.7%; P = .091). PP was not significantly different between single-segment GSV and prosthetic grafts with vein cuff (69.1% vs 69.1%; P = .51). There were no significant differences in AFS comparing arm vein, prosthetic bypass with vein cuff, or composite grafts (67.2% vs 63.8% vs 59.3%; P = .092), as well as in PP (60.2% vs 69.1% vs 54.8%; P = .14). CONCLUSIONS: Single-segment vein bypass was only marginally the most optimal conduit. Surprisingly, there may be more equipoise among conduit types, particularly in the absence of adequate GSV. Prosthetic grafts overall may not be as disadvantaged in the long term as initially thought, especially when compared with arm vein, as prosthetic bypass with vein cuff did not significantly differ in PP. Similarly, a composite conduit may not impact long-term outcomes. These data suggest that conduit choice may not impact outcomes to the degree previously thought and that other factors may have a greater impact than presumed, especially in conduit limited situations.

Protamine sulfate use during tibial bypass does not appear to increase thrombotic events or affect short-term graft patency.

OBJECTIVES: While the use of protamine sulfate as a heparin reversal agent has been extensively reviewed in patients undergoing carotid endarterectomy and coronary artery bypass grafting, there is a lack of literature on protamine's effects on lower extremity bypasses. The purpose of this study was to determine the risk of protamine sulfate dosing after tibial bypass on thrombotic or bleeding events, including early bypass failure. METHODS: We performed a retrospective review of our institutional database for patients undergoing primary distal peripheral bypass from January 2009 through December 2015 (contralateral bypass was considered to be a new primary bypass). Primary endpoints include composite thrombotic events (myocardial infarction, stroke, amputation at 30 days and patency less than 30 days) and composite bleeding events (bleeding or transfusion). RESULTS: A total of 152 tibial or peroneal bypasses in 136 patients with critical limb ischemia were identified. Of these, 78 (57.4%) patients received protamine sulfate intraoperatively and 58 (42.6%) did not. There were no differences in composite thrombotic or hemorrhagic outcomes. Protamine use had no effect on the rates of perioperative MI (9.0% versus 3.5%, p = 0.20), stroke (1.3% versus 1.7%, p = 0.83), or perioperative mortality (5.1% versus 3.5%, p = 0.64). There was no significant difference in composite post-operative bleeding events (20.7% versus 14.1%, p = 0.31) or composite thrombotic events (17.2% versus 18.0%, p = 0.91). Patients who received protamine undergoing bypass with non-autogenous conduit had significantly higher-recorded median operative blood loss (250 mL versus 150 mL, p = 0.0097) and median procedure lengths (265 min versus 201 min, p = 0.0229). No difference in 30-day amputation-free survival was noted (91.0% versus 91.4%, p = 0.94). Follow-up Kaplan-Meier estimation did not demonstrate a difference in 30-day patency (91.7% versus 88.5%, p = 0.52). CONCLUSIONS: Heparin reversal with protamine sulfate after tibial or peroneal bypass grafting is not associated with higher cardiovascular morbidity, bypass thrombosis, amputation, or mortality. Additionally, there was no statistically significant difference in post-operative bleeding or thrombosis complications for patients who did not receive protamine, although the findings are suggestive of a potential difference in a more adequately powered study. Our results suggest that protamine sulfate is safe for intraoperative use without increased risk of thrombotic complications or early tibial bypass graft failure.

Diagnosis and surgical treatment of a persistent sciatic artery aneurysm. / Diagnostika i khirurgicheskoe lechenie anevrizmy atipichnoi sedalishchnoi arterii.

The persistent sciatic artery is situated superficially in the gluteal region wherein it can be traumatized in normal daily activities: during a prolonged sitting position or while attempting to sit down. This leads to an early atherosclerotic lesion of the sciatic artery, to the development of aneurysmatic dilatation, and damage to the arterial wall. The present article describes a 72-year-old female patient presenting with a persistent sciatic artery of the left leg and a PSA aneurysm which consequently resulted in critical ischaemia of her left lower limb. This abnormality was detected during an examination and the woman was subjected to the operation of internal iliac-posterior tibial bypass grafting using an autologous vein with ligation of the sciatic artery. The bypass graft has been functioning for 5 months, with no events of critical ischaemia.

[Choice of reconstructive operation in lesions of femoropopliteotibial segment and dubious outflow pathways]. / Vybor rekonstruktivnoi operatsii pri porazheniiakh arterii bedrenno-podkolenno-bertsovogo segmenta i somnitel'nykh putiakh ottoka.

We analysed the results of surgical treatment of 40 patients with lower limb critical ischaemia induced by atherosclerotic lesion of arteries of the femoropopliteotibial segment with dubious outflow pathways. The patients were divided into two groups of 20 each. Group One patients underwent autovenous femoropopliteal or tibial bypass grafting below the fissure of the knee joint and Group Two patients were subjected to profundoplasty with closure of the arteriotomic opening with an autovenous patch. The outflow pathway index in Group One amounted to 7.5±0.09 and in Group Two to 7.45±0.08. Our findings suggest that the use of profundoplasty as reconstructive operation in patients with dubious outflow pathways is pathogenetically substantiated, because it makes it possible to decrease the rate of early postoperative complications by 20% and that of late bypass thromboses by 25%, as well as to increase the level of the physical component of health by 12.1% and that of mental health by 3.2%. A conclusion drawn is that performing profundoplasty in this cohort of patients is appropriate and effective.

Long-Term Results of Femorotibial Polytetrafluoroethylene Bypass with a Distal Vein Cuff for Critical Limb Ischemia.

Objective: Although autologous veins are the first-choice conduit for femorotibial artery bypass, if there are no appropriate autologous veins, we perform femorotibial artery bypass using polytetrafluoroethylene (PTFE) with a distal vein cuff for patients with critical limb ischemia (CLI). This study examined the long-term outcomes of femorotibial artery bypass using PTFE with a Miller's cuff. Materials and Methods: Using prospectively collected data for 444 distal bypasses, a retrospective analysis was conducted for 32 femorotibial PTFE bypasses with a Miller's cuff (PTFE-Miller's cuff) performed for patients with CLI from April 1994 to December 2016. Results: Primary and secondary patency rates of PTFE-Miller's cuff at 3 years were 35.8% and 51.2%, respectively. Limb salvage rate of PTFE-Miller's cuff at 3 years was 71.0%. Conclusion: Although the patency rate was low and failed to yield satisfactory results, the limb salvage rate remained relatively high. Femorotibial PTFE bypass with a Miller's cuff was a useful technique of limb salvage for patients with CLI in whom an appropriate autologous vein could not be used.

Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training.

OBJECTIVE: Endovascular aneurysm repair has led to a significant reduction in vascular trainee experience in the surgical treatment of aortic aneurysms. We sought to evaluate whether the vascular training paradigm or the "endovascular first" approach to lower extremity vascular disease has had a similar effect on trainee experience with infrapopliteal endovascular therapy and vein bypass. METHODS: Deidentified data were provided by the Vascular Surgery Board on the number of procedures performed by each 2014 fellowship and residency (0 + 5) graduate during training. Data were analyzed using parametric and nonparametric methods, where appropriate. RESULTS: Of 125 trainees (109 fellows, 16 residents), 33 (27%) performed 10 or fewer infrapopliteal vein bypasses and 37 (29%) performed 10 or fewer infrapopliteal endovascular procedures during their training. Eleven trainees (9%) performed 10 or fewer of both procedures. There was a positive correlation between number of infrapopliteal vein bypass and endovascular procedures performed (r = 0.19; P = .03). There was no difference between fellows and residents in the mean number of bypass operations performed during training (17.3 vs 19.1; P = .50; range, 0-53). However, residents performed more infrapopliteal endovascular procedures than fellows did (median, 29 vs 16; P = .03; range, 0-128). CONCLUSIONS: More than one in four graduates of both training paradigms finish with a low number of infrapopliteal bypasses and endovascular interventions. The number of these procedures needed for proficiency is not known. Vascular surgery training programs should critically evaluate the number of infrapopliteal procedures required to achieve proficiency.