Clinical impact of fluoropolymer-based drug-eluting stent thrombosis in femoropopliteal artery occlusive lesions.

BACKGROUND: Endovascular treatment (EVT) is recommended for superficial femoral artery (SFA) lesions, and good results have been reported after implantation of drug-eluting stents (DES) for SFA. However, the major concern after implantation is acute thrombosis during the follow-up period, resulting in major amputation and major adverse limb events. In this study, we examined the incidence and outcome of acute thrombosis after DES implantation in the SFA. OBJECTIVES AND METHODS: DES implantation for a femoropopliteal lesion was performed in 288 patients at multiple centers in Japan from 2019 to 2021. A total of 25 patients (8.6%) with DES acute occlusion were analyzed retrospectively. The primary endpoint was amputation-free survival (AFS) after acute occlusion. RESULTS: The median patient age was 77 years, with 48% having diabetes, 40% undergoing maintenance dialysis, and 66% having chronic limb-threatening ischemia (CLTI). The mean time from initial DES implantation to acute occlusion was 153.5 ± 177.6 days, with a median of 104 days. EVT was performed in 18 patients (72%), surgical revascularization in 3 (12%), and conservative treatment in 4 (16%). Two deaths within 30 days were both due to sepsis. No major amputation or major adverse cardiovascular events occurred within 30 days. The 1-year rates of patency and freedom from target lesion revascularization after DES thrombosis were 22.9% and 48.8%, respectively. AFS at 1 year was 55.1%. CONCLUSION: Acute DES occlusion is relatively frequent, and the outcome is poor. Therefore, the indication of DES implantation for a complex SFA lesion may require careful consideration. Further investigation may be needed in DES implantation for a complex SFA lesion.

Effect of gait speed on clinical outcomes after crural and pedal bypass in patients with chronic limb-threatening ischemia.

OBJECTIVES: Many factors affect long-term outcomes after open bypass in patients with chronic limb-threatening ischemia (CLTI). Ambulatory status has been suggested to be associated with clinical outcomes, but there is limited knowledge on the effect of gait speed on outcomes. The purpose of this study is to evaluate the effect of gait speed assessed in a 6-min walk test (6MWT) on outcomes after crural and pedal bypass in patients with CLTI. METHODS: A retrospective analysis was performed in patients with CLTI who underwent a 6MWT at 1 month after crural and pedal bypass at a single center from 2014 to 2021. Comparisons were made between those with high gait speed (HG group, 6-min walk distance (6MWD) > 288 m) and those with low gait speed (LG group, 6MWD ≤288 m). The primary endpoint was survival, and the secondary endpoints were graft patency, limb salvage, wound healing, major adverse cardiovascular events (MACEs), and hospital outcomes. RESULTS: Of 104 patients with CLTI who underwent a 6MWT after crural and pedal bypass, 46 (44%) and 58 (56%) were placed in the HG and LG groups, respectively. The LG group was older (p < .001), had more female subjects (p = .006), and had a higher prevalence of cerebrovascular disease (p = .042) and tissue loss (p = .007). The median follow-up was 36 (22-57) months. The HG group had significantly higher 3-year primary patency (65% vs 42%, p = .013), 3-year secondary patency (87% vs 66%, p = .018), 3-year overall survival (89% vs 58%, p < .001), and 3-year freedom from MACE (79% vs 67%, p = .039). The 3-year limb salvage and 12-month wound healing rates did not differ between the groups. CONCLUSIONS: Gait speed in patients with CLTI after crural and pedal bypass was associated with survival, freedom from MACE, and graft patency but not with limb salvage and wound healing. A detailed study of walking ability in these patients may be needed in the future.

Medium-Term Outcomes of Treatment with a VIABAHN VBX Covered Stent for Aortoiliac Occlusive Lesions in Patients with Peripheral Artery Disease.

BACKGROUND: Endovascular treatment (EVT) for aortoiliac (AI) occlusive lesions is now conducted worldwide, but there are challenges in EVT for complex AI lesions. The VIABAHN VBX (W.L. Gore & Associates, Flagstaff, AZ) is a next-generation balloon-expandable covered stent designed for use with complex AI lesions. The purpose of this study is to evaluate the medium-term outcomes of VIABAHN VBX for such lesions. METHODS: Symptomatic patients who underwent EVT with VIABAHN VBX for an AI lesion from 2018 to 2020 at 7 Japanese centers were reviewed retrospectively. The primary endpoints were primary patency and freedom from target lesion revascularization (TLR). RESULTS: A total of 95 EVT procedures with VIABAHN VBX for AI occlusive lesions were performed in 71 patients. The patients had high rates of dyslipidemia (53%) and chronic kidney disease (61%), and 22% had chronic limb-threatening ischemia (CLTI). The Transatlantic Inter-Society Consensus (TASC Ⅱ) class was A in 12 patients (17%), B in 12 (17%), C in 10 (14%), and D in 37 (52%). Severe calcification (360°) of the treated lesion was present in 31 patients (33%). The median procedure time was 84 (49-158) min, with a technical success rate of 100%. The median follow-up period was 36 (32-43) months. The 3-year primary and secondary patency of VIABAHN VBX were 91% and 99%, the 3-year freedom from TLR was 92%, and the 3-year freedom from major adverse limb event (MALE) was 98%. No limbs required major amputation. Lesion severity (TASC Ⅱ C or D) and severe calcification did not affect the primary patency or freedom from TLR. CONCLUSIONS: Medium-term outcomes after EVT with VIABAHN VBX for AI lesions were acceptable regardless of lesion severity and calcification. These results suggest that VIABAHN VBX may be suitable for AI occlusive lesions with severe anatomical complexity and/or severe calcification.

Risk Analysis and Clinical Outcomes in Chronic Limb-threatening Ischemia Patients with Surgical Site Infection after Distal Bypass.

BACKGROUND: A recent randomized control study showed that long-term outcomes after surgical revascularization were superior to those after endovascular treatment for cases with chronic limb-threatening ischemia (CLTI) with an appropriate single-segment great saphenous vein. However, surgical site infection (SSI) in CLTI cases after infrapoplital bypass also resulted in a prolonged hospital stay and poor outcomes, including graft disruption. The aim of the current study was to analyze risk factors for SSI in CLTI patients after distal bypass and to compare outcomes in patients with and without SSI. METHODS: A total of 515 cases that underwent distal bypass at a single center between 2009 and 2022 were analyzed retrospectively. Comparisons were made between patients with and without SSI after distal bypass. The primary end point was limb salvage after distal bypass. RESULTS: Of the 515 cases that underwent distal bypass, 79 (15%) had SSI. The risk factors for SSI were preoperative antibacterial drug use (P = 0.001), pedal bypass (P = 0.001), and prolonged operation time (≥150 min) (P = 0.010). The median hospital stay in SSI cases was longer than that in non-SSI cases (P < 0.001). Of 515 distal bypasses, 7 (1.3%) bypass grafts ruptured postoperatively due to SSI, and of these 7 cases, 6 ruptured during the day, 5 cases occurred within 1 month postoperatively, and 2 patients (29%) are alive without amputation. The mean follow-up period was 34 ± 30 months. During follow-up, 62 limbs (SSI cases, 19; non-SSI cases, 43) required major amputation and there were 234 deaths (SSI cases, 46; non-SSI cases, 188). The 1-, 3-, and 5-year limb salvage rates of 82%, 71%, and 62%, respectively, in SSI cases were significantly lower than those in non-SSI cases (P < 0.001). The 5-year survival rate of 29% in SSI cases showed a tendency to be lower than that in non-SSI cases (P = 0.058). CONCLUSIONS: The limb salvage rate in SSI cases was lower than in non-SSI cases after distal bypass. Graft rupture due to SSI occurred at a rate of 1.3% and resulted in poor outcomes in most cases. SSIs adversely affect outcomes and further study is needed to identify methods to avoid SSI following distal bypass.

Clinical Outcomes of Common Femoral Thromboendarterectomy with Bovine Pericardium Patch Angioplasty.

BACKGROUND: The purpose of the study is to evaluate the efficacy of thromboendarterectomy (TEA) for common femoral occlusive disease using bovine pericardium patch angioplasty. METHODS: The subjects were patients who underwent TEA for common femoral occlusive disease with bovine pericardium patch angioplasty from October 2020 to August 2021. The study had a prospective, multicenter, and observational design. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, amputation-free survival (AFS), postoperative wound complication, hospital death within 30 days, and major adverse cardiovascular events (MACE) within 30 days. RESULTS: Forty-seven TEA procedures with a bovine patch were performed in 42 patients (34 males; median age, 78 years; diabetes mellitus, 57%; end-stage renal disease with hemodialysis, 19%). Clinical presentations were intermittent claudication (68%) and critical limb-threatening ischemia (32%). Sixteen (34%) limbs underwent TEA alone and 31 (66%) underwent a combined procedure. Surgical site infection (SSI) occurred in 4 limbs (9%) and lymphatic fistulas in 3 limbs (6%). One limb with SSI required surgical debridement 19 days after the procedure, and 1 limb (2%) without postoperative wound complications required additional treatment due to acute bleeding. Hospital death within 30 days occurred in 1 case due to panperitonitis. There was no MACE within 30 days. Claudication was improved in all cases. Postoperative ABI of 0.92 [0.72-1.00] was significantly higher than the preoperative value (P < 0.001). The median follow-up period was 10 months [9-13 months]. One limb (2%) required additional endovascular therapy due to stenosis at the endarterectomy site at 5 months postoperatively. Primary and secondary patencies were 98% and 100% at 12 months, respectively, and the AFS rate was 90% at 12 months. CONCLUSIONS: Common femoral TEA with bovine pericardium patch angioplasty has satisfactory clinical outcomes.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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±30 months. 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 6 months and 85% at 12 months, 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). CONCLUSIONS: 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.

Limb outcomes based on limb severity and anatomic complexity following infrapopliteal vein bypass for Japanese patients with chronic limb-threatening ischemia.

OBJECTIVE: The 2019 Global Vascular Guidelines recommend a suitable initial revascularization method with reference to limb severity (wound, ischemia, and foot infection [WIfI] stage) and anatomic complexity (Global Limb Anatomical Staging System [GLASS] stage). However, limb outcomes after revascularization among WIfI and GLASS stages have not been investigated fully after infrapopliteal vein bypass. The purpose of this study was to assess the four Global Vascular Guideline-recommended limb outcomes after infrapopliteal vein bypass in cases with different WIfI and GLASS stages. METHODS: Patients who underwent infrapopliteal vein bypass for chronic limb-threatening ischemia at a single center were analyzed retrospectively. Medium-term limb outcomes were compared among WIfI and GLASS stages. The primary end points were limb salvage rate and major to minor amputation ratio, and the secondary end points were wound healing rate and wound healing time. RESULTS: A total of 353 infrapopliteal vein bypasses were performed in 284 patients with tissue loss (male, 193 patients; median age, 77 years; diabetes, 71%; hemodialysis, 41%). A total of 111 limbs (31%) required only minor amputation and 38 limbs (11%) required major amputation. The major to minor amputation ratio was 0.34 with no significant differences among WIfI stages or GLASS stages. The 3-year limb salvage rate was 87%. This rate was significantly lower in WIfI stage 4 than in stage 2 (P = .049), but did not differ significantly among GLASS stages. The 12-month wound healing rate was 86%. This rate was also significantly lower in WIfI stage 4 than in stages 2 and 3 (both P < .001), but did not differ significantly among GLASS stages. The median wound healing time was 55 days (range, 32-110 days), and was significantly longer in WIfI stage 4 compared with stages 2 (P = .001) and 3 (P < .001), but showed no significant differences among GLASS stages. CONCLUSIONS: The limb salvage rate, wound healing rate, and wound healing time were associated with limb severity (WIfI stage), but not with anatomic complexity (GLASS stage). These findings suggest that an appropriate preoperative strategy and careful perioperative management are important for patients with greater limb severity.

Effectiveness of Unsupervised Exercise Therapy After Endovascular Treatment for an Iliac Occlusive Lesion.

OBJECTIVE: Exercise therapy has acceptable outcomes for patients with intermittent claudication (IC), but there are few reports on the results of continuous unsupervised exercise therapy after endovascular treatment (EVT) for an iliac lesion. The aim of this study is to analyze the long-term outcomes of unsupervised exercise therapy for patients after EVT. MATERIAL AND METHODS: A retrospective analysis was performed in 76 patients (93 limbs) with IC who underwent iliac EVT from 2012 to 2020 at our hospital. Maintenance of unsupervised exercise therapy was evaluated at 6 months after EVT. Long-term outcomes such as primary patency, clinically driven target lesion revascularization (CD-TLR), survival, and major adverse cardiovascular events (MACE) were compared between patients who continued (cET group) or discontinued (dET group) unsupervised exercise therapy. RESULTS: A total of 28 patients (37%) continued unsupervised exercise therapy until 6 months after EVT for an iliac lesion. There were no differences in patient background and procedural details between the cET and dET groups. The follow-up rate was 96% in a median follow-up period of 35 [25 - 42] months. The mean exercise time in the cET group was 52 ± 18 minutes daily, with a mean frequency of 5.8 ± 1.1 days per week. The median step count in the cET group was 5559 ± 2908 steps daily. At 3 years, the cET group had significantly higher rates for primary patency (97% vs 71%, P = .002), and freedom from CD-TLR (97% vs 79%, P = .007); and a tendency for higher survival (100% vs 94%, P = .074), and higher freedom from MACE (89% vs 73%, P = .12). CONCLUSION: The findings of this study suggested superior long-term outcomes, including primary patency, freedom from CD-TLR, survival, and freedom from MACE, in patients who maintained continuous unsupervised exercise therapy after EVT.

Effectiveness of the Vascular Quality Initiative Chronic Limb-Threatening Ischemia Mortality Prediction Model in Patents with Distal Bypass.

BACKGROUND: The purpose of this study is to evaluate the effectiveness of mortality prediction using the Vascular Quality Initiative (VQI) chronic limb-threatening ischemia (CLTI) model in patients with distal bypass. METHODS: Patients who underwent distal bypass for CLTI from 2009 to 2020 at a single center were retrospectively reviewed. Distal bypass was defined as any bypass with a distal anastomosis to the posterior tibial, anterior tibial, dorsalis pedis, plantar, or peroneal artery. Baseline characteristics, operative details, hospital outcomes, and medium-term outcomes were compared among patients with a low-, medium-, and high-risk of mortality based on a VQI CLTI calculation. The primary endpoints were survival and limb salvage. RESULTS: A total of 287 distal bypasses were performed in 230 patients (153 males; median age, 74 years; diabetes mellitus, 70%; end-stage renal disease [ESRD] with hemodialysis, 38%). These patients were stratified into 153 (66%) low-, 35 (15%) medium-, and 42 (18%) high-risk cases based on the VQI CLTI model. There were two hospital deaths (1%) within 30 days. During a mean follow-up period of 33 ± 29 months, 105 patients died and 26 limbs (9%) required major amputation. The 2-year survival rate of 81% in the low-risk group was significantly higher than those of 41% in the medium-risk group and 46% in the high-risk group (both P < 0.001). The 2-year survival rates did not differ significantly between the medium- and high-risk groups (P = 0.81). The 2-year limb salvage rate of 93% in the low-risk group was significantly higher than those of 81% in the medium-risk (P = 0.023) and those of 87% in the high-risk (P = 0.039) groups. There were no significant differences in graft patency and wound healing among the three groups. CONCLUSIONS: These results suggest that distal bypass is optimal treatment for patients with a low VQI-predicted risk of mortality. However, the lower limb salvage and higher mortality rates at 2 years suggest that the decision-making for VQI medium- and high-risk patients may be carefully considered.

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines.

OBJECTIVE: The Global Vascular Guidelines (GVGs) recommend initial revascularization (bypass or endovascular therapy) for chronic limb-threatening ischemia (CLTI) based on anatomical complexity and limb severity. This decision is made based on a prediction of the outcomes after endovascular intervention. This study was performed to evaluate outcomes after distal bypass in cases recommended for GVG bypass. METHODS: A total of 239 distal bypasses for CLTI were evaluated in 195 patients with a GVG bypass recommendation treated between 2009 and 2020 at a single center in Japan. Comparisons were made between crural and pedal bypass cases. RESULTS: The 195 patients (median age, 77 years; 67% male) underwent 133 crural bypasses (106 patients; 54%) and 106 pedal bypasses (89 patients; 46%). Hemodialysis was more common in pedal cases than in crural cases (P = .03). Hospital deaths occurred in two cases (1%) within 30 days. The whole cohort has a follow-up rate of 96% over a mean of 28 ± 26 months, with 3-year limb salvage rates of 87% and 3-year primary, assisted primary, and secondary patency rates of 40%, 65%, and 67%, all without significant differences between crural and pedal cases. The 1-year wound healing rate was 88% and tended to be higher in crural cases than in pedal cases (P = .068). The 3-year survival rate was 52% in the cohort and did not differ significantly between crural and pedal cases. CONCLUSIONS: Patients with CLTI with a GVG bypass recommendation had acceptable limb salvage, graft patency, wound healing, and survival after distal bypass, regardless of the bypass method. These findings indicate that a GVG bypass recommendation as an initial revascularization method is valid in the real world.

An Evaluation of Pre-Operative Nutritional Assessment Methods in Patients with Chronic Limb Threatening Ischaemia Having Distal Bypass.

OBJECTIVE: The purpose of this study was to evaluate the influence of pre-operative nutritional status on long term outcomes of patients with chronic limb threatening ischaemia (CLTI) after distal bypass. METHODS: Patients who underwent distal bypass for CLTI from 2011 to 2020 at a single centre were reviewed retrospectively in Japan. Comparisons were made between patients with malnutrition and normal nutrition, as diagnosed by four nutritional assessments: Controlling Nutritional Status (CONUT), Geriatric Nutritional Risk Index (GNRI), Glasgow Prognostic Score (GPS), and Prognostic Nutritional Index (PNI). The primary endpoint was survival, and the secondary endpoints were graft patency, limb salvage, and wound healing. RESULTS: A total of 314 distal bypasses were performed in 249 patients (169 males; median age, 76 years; diabetes mellitus, 70%; and end stage renal disease with haemodialysis, 40%). Malnutrition was observed in 103 patients (41%) evaluated by CONUT, 129 (52%) by GNRI, 76 (31%) by GPS, and 114 (46%) by PNI. The survival rates in the study cohort were 81% at one year, 55% at three years, and 47% at five years. Malnutrition in all assessments was statistically significantly associated with reduced survival rate (CONUT, p < .001; GNRI, p = .002; GPS, p < .001; PNI, p < .001). In multivariable analysis, CONUT was the best predictor of mortality (p = .014). Malnutrition did not affect graft patency and limb salvage, but malnutrition based on CONUT, GNRI, and GPS was statistically significantly associated with reduced wound healing (CONUT, p = .002; GNRI, p = .006; GPS, p = .011). In multivariable analysis, CONUT tended to be the best predictor of wound healing (p = .061). CONCLUSION: Malnutrition in patients with CLTI with distal bypass was associated with overall mortality and incomplete wound healing. CONUT assessment was most effective for prediction of survival and wound healing. Distal bypass for CLTI patients with malnutrition may be suboptimal, and endovascular treatment may be recommended as an initial revascularisation method.

Efficacy and Safety of Ultrasound-Guided Repeat Access and Repeat Closure With an ExoSeal Vascular Closure System in Patients With Peripheral Arterial Disease.

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of ultrasound-guided repeat access and repeat closure with an ExoSeal vascular closure system. METHODS: A total of 123 endovascular therapy (EVT) procedures were performed in 59 patients (65 limbs) with ultrasound-guided repeat access and repeat implantation of an ExoSeal vascular closure system between January 2019 and March 2021. The procedural details and postprocedural outcomes of EVT with repeat access and use of ExoSeal (RE group) were compared with those of EVT with initial use of ExoSeal (IE group) in the same patients. In a subgroup analysis, these outcomes were also compared in early repeat (within 3 months) and late repeat (over 3 months) cases. RESULTS: The technical success rate of ultrasound-guided access in the RE group was 100%. The procedural success rate of EVT and deployment success rate of ExoSeal in the RE group were 93% and 94%, respectively, which were not significantly different to those in the IE group. Access site complications in the RE group occurred in 2 cases (2%), again with no significant difference with the IE group. The median puncture, procedural, and hemostasis times in the RE group were 3 [2-5], 36.5 [29-54], and 7 [5-10] min, respectively, which were not significantly longer than those in the IE group. In the RE group, early and late repeat closure was performed in 66 (54%) and 57 (46%) cases, respectively, and there were no significant differences in the technical success of ultrasound-guided access, procedural success of EVT, deployment success of ExoSeal, and access site complication rates in these cases. CONCLUSIONS: Ultrasound-guided access facilitated higher technical success of repeat access and fewer access site complications in EVT with repeat use of ExoSeal, regardless of the interval between procedures.

Prognostic Significance of Preoperative Functional Independence Measure (FIM) on Long-Term Outcomes in Patients with Chronic Limb-Threatening Ischemia (CLTI).

BACKGROUND: The purpose of this study was to evaluate the effect of preoperative motor and cognitive activities of daily living (ADL) on long-term outcomes of patients with chronic limb-threatening ischemia (CLTI) after distal bypass. METHODS: A retrospective review was performed for patients who underwent distal bypass for CLTI from 2013 to 2019 at multiple centers in Japan. Comparisons were made among patients with high and low motor and cognitive ADL based on the functional independence measure (FIM). The primary endpoint was limb salvage and the secondary endpoints were survival, amputation free survival (AFS), major adverse limb events (MALE), readmission, and wound healing. RESULTS: A total of 226 distal bypasses were performed in 185 patients (169 males; median age, 76 years; diabetes mellitus, 70%; end-stage renal disease with hemodialysis, 40%). The patients were divided into high (n = 93, 50%) and low (n = 92, 50%) FIM-motor cases, and high (n = 157, 85%) and low (n = 28, 15%) FIM-cognitive cases. FIM-motor (high vs. low) and FIM-cognitive (high vs. low) were not significantly associated with limb salvage, freedom from MALE, freedom from readmission, and wound healing. The 1- and 3-year survival rates were significantly lower in low FIM-motor cases (93% vs. 70% at 1 year, 73% vs. 46% at 3 years, P = 0.0011); and in low FIM-cognitive cases (87% vs. 50% at 1 year, 63% vs. 45% at 3 years, P < 0.001). The 1- and 3-year AFS rates were significantly lower in low FIM-motor cases (92% vs. 67% at 1 year, 69% vs. 44% at 3 years, P < 0.001); and in low FIM-cognitive cases (85% vs. 49% at 1 year, 59% vs. 44% at 3 years, P < 0.001). In multivariate analysis, independent risk factors for survival were hemodialysis (HR = 2.17; 95% confidence interval (CI), 1.23-3.83; P = .0078), low FIM-cognitive (HR = 3.45; 95% CI, 1.78-6.71; P < 0.001), and ejection fraction (HR = 0.98; 95% CI, 0.95-0.99; P = 0.019). CONCLUSIONS: FIM-motor and FIM-cognitive were predictive factors for long-term survival and AFS of CLTI patients after distal bypass, but had no influence on limb salvage, MALE, readmission, and wound healing. These results suggest that the motor and cognitive status of ADL should be assessed using FIM before distal bypass for patients with CLTI.

Prognostic Significance of Intraoperative Graft Flow in Distal Bypass on Long-Term Outcomes in Patients with Chronic Limb-Threatening Ischemia.

BACKGROUND: The aim of the study was to determine the prognostic significance of measurement of graft flow on the patency of distal bypass. METHODS: A retrospective analysis was performed for 208 distal bypasses (208 limbs, 170 patients) with a single segment great saphenous vein conducted in a nonreversed manner from January 2009 to December 2019 in Japan. Patient backgrounds, operative details (including intraoperative mean graft flow), hospital outcomes, and long-term outcomes were evaluated. The primary endpoints were the primary, assisted primary, and secondary patency of the distal bypass graft and the secondary endpoints were limb salvage and wound healing. RESULTS: The median intraoperative graft flow was 18 [10-30] mL/min. The follow-up rate was 98% in a mean follow-up period of 31 ± 26 months. Primary, assisted primary, and secondary patency in the cohort were 51%, 72%, and 73% at 1 year, and 39%, 59%, and 61% at 3 years, respectively. In multivariate analysis, the independent risk factors for primary patency were low graft flow (P = 0.0022) and female sex (P = 0.0016), and those for secondary patency were also low graft flow (P = 0.0025) and female sex (P < .001). The cut-offs for graft flow predicting primary and secondary patency were both 16 mL/min. The limb salvage rate was 94% at 1 year and 89% at 3 years; and the wound healing rates were 55%, 71% and 84% at 3, 6, and 12 months, respectively. Limb salvage and wound healing were not significantly associated with intraoperative graft flow. CONCLUSIONS: Intraoperative graft flow was an independent predictor for graft patency in distal bypass, but had no influence on limb salvage and wound healing. The cut-off value for the mean graft flow predicting primary and secondary patency was 16 mL/min.

Does the Global Limb Anatomic Staging System Inframalleolar Modifier Influence Long Term Outcomes of Chronic Limb Threatening Ischaemia after Distal Bypass?

OBJECTIVE: The purpose of this study was to evaluate the influence of inframalleolar disease (Global Limb Anatomic Staging System Inframalleolar [GLASS IM] modifier) on long term outcomes of patients with chronic limb threatening ischaemia (CLTI) after distal bypass. METHODS: Patients who underwent distal bypass for CLTI from January 2012 to December 2019 at a single centre were reviewed retrospectively. Comparisons including baseline characteristics, procedural details, and long term outcomes were made between patients with an intact pedal arch (GLASS IM modifier P0), an absent or severely diseased pedal arch (P1), and no target artery crossing the ankle into the foot (P2), diagnosed by pre- and intra-operative high quality angiography. The primary endpoint was limb salvage. The secondary endpoints were graft patency and wound healing. RESULTS: A total of 254 distal bypasses were performed in 206 patients (139 males; median age, 76 years). The GLASS IM modifier was P0 in 80 (32%) limbs, P1 in 127 (50%), and P2 in 47 (18%). During the follow up period, 22 limbs (9%) required major amputation. The limb salvage rates at three years in P0, P1, and P2 cases were 94%, 89%, and 93%, respectively, with no significant differences among the modifiers. The primary patencies at three years in P0, P1, and P2 cases were 49%, 38% and 24%, respectively. The primary patency in P2 cases was significantly lower than that in P0 cases (p < .050). The respective wound healing rates at 12 months were 97%, 93%, and 79%, and again the wound healing rate in P2 cases was significantly lower than those in other cases (p < .050). CONCLUSION: Long term outcomes including patency, limb salvage, and wound healing after distal bypass for CLTI patients with an infrapopliteal lesion were acceptable in cases in each GLASS IM modifier.

Rupture of Abdominal Aortic Aneurysm Caused by Combined Type IIIb and Type Ia Endoleak with the Endurant II Endograft: A Case Report.

We report a case of combined types IIIb and Ia endoleak that developed 6 years after endovascular aneurysm repair (EVAR) with the Endurant II® endograft for abdominal aortic aneurysm (AAA). The patient presented with post-EVAR AAA rupture and underwent emergency open repair. We observed types IIIb and Ia endoleak and successfully performed felt banding to preserve the stent graft. Type IIIb endoleak with the Endurant® endograft is rare, and treatments have not been fully established. We summarized the case reports regarding type IIIb endoleak with the Endurant® endograft and mainly discussed the treatments.

Effectiveness of combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass: A paradigm shift in surgical open bypass for chronic limb-threatening ischemia.

OBJECTIVES: The purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia. METHODS: The records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients' background, operative details, and long-term outcomes were analyzed. RESULTS: Fifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery-popliteal lesion was "A" in 8 (15%) patients, "B" in 14 (27%) patients, "C" in 24 (46%) patients, and "D" in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months. CONCLUSIONS: Combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

Effectiveness of continuous unsupervised exercise therapy after above-knee femoropopliteal bypass.

OBJECTIVE: Exercise therapy has acceptable outcomes for patients with intermittent claudication, although few reports exist regarding the results of continuous exercise therapy after surgical reconstruction for intermittent claudication. This study aimed to analyze the long-term outcomes of unsupervised exercise therapy for patients after above-knee femoropopliteal bypass. MATERIAL AND METHODS: We retrospectively analyzed 69 patients (69 limbs, 69 grafts) who underwent above-knee femoropopliteal bypass from April 2009 to March 2018 in our hospital. At six months after above-knee femoropopliteal bypass, we evaluated the maintenance of unsupervised exercise therapy. Patients who continued unsupervised exercise therapy or discontinued unsupervised exercise therapy were assessed via 1:1 propensity matching. Long-term outcomes such as patency, survival, and major adverse cardiovascular events were compared between the groups after matching. We also analyzed the maintaining rate of unsupervised exercise therapy in a study cohort. RESULTS: Twenty-nine (42%) patients continued unsupervised exercise therapy until six months after above-knee femoropopliteal bypass. The discontinued unsupervised exercise therapy had higher proportions of female sex (p = 0.015) and cerebrovascular disease (p = 0.025) than did the continued unsupervised exercise therapy. The mean follow-up period was 65 ± 36 months. After propensity matching, the rates of the following factors were significantly higher in the continued unsupervised exercise therapy than in the discontinued unsupervised exercise therapy: primary patency (97% vs. 61%, p = 0.0041), secondary patency (100% vs. 69%, p = 0.0021), and freedom from major adverse cardiovascular events (61% vs. 24%, p = 0.0071) at five years. Both groups had a similar survival rate. The maintaining rate of unsupervised exercise therapy in the study cohort was 44% at six months, 41% at one year, 36% at three years, 25% at five years, and 25% at seven years. CONCLUSION: The findings of this study suggested superior long-term outcomes, including graft patency and freedom from major adverse cardiovascular events, with unsupervised exercise therapy after open bypass than with the usual therapy. Unsupervised exercise therapy may be recommended for the patients after open bypass.

Long-Term Results of Distal Bypass for Intermittent Claudication.

BACKGROUND: Distal bypass (DB) is the optimal treatment for patients with critical limb ischemia (CLI). However, effectiveness of DB for patients with intermittent claudication (IC) remains uncertain. This study aimed to analyze long-term results of DB for IC patients (IC-DB) compared with those of DB for CLI patients (CLI-DB). METHODS: Patients undergoing DB from January 2009 to July 2018 at a single institution were retrospectively reviewed. Operative details, primary and secondary patency, amputation free survival rate (AFS), and long-term exercise capacity using Barthel index were analyzed. RESULTS: Out of 302 DB (245 patients), 49 IC-DB were performed in 43 patients: 38 males, mean age 70.3 ± 8.0 years, diabetes mellitus 51%, chronic renal failure with hemodialysis 7%. The Great saphenous vein was used in 47 limbs, the small saphenous vein in 1, and the arm vein in 1. These grafts were bypassed in a non-reversed fashion for 35 limbs, in an in-situ fashion in 9, and in a reversed fashion in 5. The mean operative time was 173 min. The mean follow-up was 25 ± 26 months. Primary and secondary patency of IC-DB was 79% and 94% at 1 year, 71% and 90% at 3 years, 65% and 90% at 5 years, which were significantly higher than those of CLI-DB (primary patency: P = .007, secondary patency: P = .025). AFS of IC-DB and CLI-DB was 100% and 77% at 1 year, 93% and 52% at 3 years, and 90% and 43% at 5 years (IC-DB vs. CLI-DB, p < .0001). Barthel index of IC-DB unchanged at discharge (median 100) and at the last visit (median 100), showing daily activity was maintained adequately. CONCLUSIONS: DB could offer a promising approach for patients with IC because of durable graft patency, acceptable AFS, and maintenance of daily activity.

Long Term Outcomes of Endovascular Therapy for Failing Distal Bypass Vein Grafts.

OBJECTIVE: Although distal bypass using vein has been established with acceptable outcomes for chronic limb threatening ischaemia (CLTI), the major issue affecting long term outcomes is vein graft disease. This study aimed to analyse the peri-procedural results and long term outcomes of endovascular therapy (EVT) for failing vein grafts after distal bypass. METHODS: A retrospective analysis of 113 failing vein grafts (94 patients, 113 limbs) after distal bypass between 2009 and 2019 at the study hospital. RESULTS: The mean age was 74 ± 9 years and 72% of the patients were men. Of the 113 grafts, 54 grafts (48%) were detected in asymptomatic patients, 41 grafts (36%) in patients with recurrent ulcer or gangrene, and 18 grafts (16%) in patients with rest pain. The failing grafts were treated by low pressure long inflation balloon angioplasty with a mean balloon size of 3.0 ± 0.8 mm. The mean procedural time was 60 ± 29 min and procedural success was 98% (111 grafts). During the mean follow up period of 34 months, EVT was performed a median frequency of two times (range 1-11 times). The primary and assisted primary patency of the EVT revised grafts were 41% and 80% at one year, 34% and 68% at three years, 31% and 58% at five years, respectively. Of 41 limbs with recurrent ulcer or gangrene, the wound healed in 34 limbs (85%). The complete healing rate was 71% at three months and 84% at 12 months. Eight patients required major amputation, and the freedom from major amputation rate was 96% at one year and 80% at five years. CONCLUSION: Long term outcomes including patency, wound healing rate, and amputation free survival after EVT for failing vein grafts were acceptable. EVT could be a viable alternative to surgical revascularisation in patients with a failing distal bypass graft for CLTI.