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.

Superficial femoral artery-anterior tibial artery bypass with great saphenous vein grafting via the lateral femoropopliteal route for infection after Viabahn placement.

We report a case involving an elderly man who successfully underwent superficial femoral artery-anterior tibial artery bypass via the lateral femoropopliteal route following development of a stent infection after placement of a small-diameter covered stent for a ruptured superficial femoral artery pseudoaneurysm. This report suggests that appropriate treatment strategies for device infection subsequent to device removal are paramount for the prevention of reinfection and preservation of the affected extremity.

Comparison of Clinical Outcomes in Patients Undergoing Common Femoral Thromboendarterectomy With or Without Patch Angioplasty.

OBJECTIVE: Surgical thromboendarterectomy (TEA) is the standard treatment for an occlusive lesion of the common femoral artery (CFA). However, there is limited knowledge on the need for patch angioplasty in CFA TEA. The objective of this study was to compare the peri-operative and two year results of CFA TEA with or without patch angioplasty. METHODS: A multicentre retrospective observational study was performed at 34 Japanese centres. Comparisons were made between patients undergoing CFA TEA with or without patch angioplasty after propensity score matching (PSM). The primary endpoints were primary patency and freedom from target lesion revascularisation (TLR) of the TEA lesion. The secondary endpoints were hospital outcomes, limb salvage, and overall survival. RESULTS: Between 2018 and 2020, 428 TEA procedures (237 with patch angioplasty and 191 with primary closure) were performed. PSM extracted 151 pairs with no significant intergroup differences in baseline characteristics. Peri-operative death and complications occurred in 0.7% vs. 1.3% (p = 1.0) and 6.0% vs. 6.6% (p = 1.0), respectively. The follow up rate was 96% over a median follow up of 14.9 months (interquartile range 8.3, 24.3). Loss of primary patency occurred in 18 patients. The two year primary patency of patch angioplasty cases was statistically significantly higher than that of primary closure cases (97.0% vs. 89.9%; p = .021). TLR was performed in 14 patients. The two year freedom from TLR in patch angioplasty cases was also statistically significantly higher than in primary closure cases (98.6% vs. 92.9%; p = .003). During follow up, seven limbs required major amputation and 40 patients died. There was no statistically significant difference in limb salvage and survival between the two groups after PSM. CONCLUSIONS: This is the first report to show that patch angioplasty may decrease re-stenosis and target lesion revascularisation of CFA TEA lesions.

Discrimination and learning of temporal input sequences in a cerebellar Purkinje cell model.

Introduction: Temporal information processing is essential for sequential contraction of various muscles with the appropriate timing and amplitude for fast and smooth motor control. These functions depend on dynamics of neural circuits, which consist of simple neurons that accumulate incoming spikes and emit other spikes. However, recent studies indicate that individual neurons can perform complex information processing through the nonlinear dynamics of dendrites with complex shapes and ion channels. Although we have extensive evidence that cerebellar circuits play a vital role in motor control, studies investigating the computational ability of single Purkinje cells are few. Methods: We found, through computer simulations, that a Purkinje cell can discriminate a series of pulses in two directions (from dendrite tip to soma, and from soma to dendrite), as cortical pyramidal cells do. Such direction sensitivity was observed in whatever compartment types of dendrites (spiny, smooth, and main), although they have dierent sets of ion channels. Results: We found that the shortest and longest discriminable sequences lasted for 60 ms (6 pulses with 10 ms interval) and 4,000 ms (20 pulses with 200 ms interval), respectively. and that the ratio of discriminable sequences within the region of the interesting parameter space was, on average, 3.3% (spiny), 3.2% (smooth), and 1.0% (main). For the direction sensitivity, a T-type Ca2+ channel was necessary, in contrast with cortical pyramidal cells that have N-methyl-D-aspartate receptors (NMDARs). Furthermore, we tested whether the stimulus direction can be reversed by learning, specifically by simulated long-term depression, and obtained positive results. Discussion: Our results show that individual Purkinje cells can perform more complex information processing than is conventionally assumed for a single neuron, and suggest that Purkinje cells act as sequence discriminators, a useful role in motor control and learning.

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.

Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck.

PURPOSE: To evaluate the efficacy of the Active Seal technology employed in the AFX endovascular aortic aneurysm system (AFX), during endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysms (AAAs) having a conical proximal neck. MATERIALS AND METHODS: A retrospective analysis of the EVAR for AAA with a conical proximal neck using the AFX was performed at 17 Japanese hospitals between January 2016 and August 2020. The conical proximal neck was defined as a cone-shaped proximal neck, with more than 10% diameter increase within a 15 mm length at the proximal landing zone. All anatomical analyses were performed in the core laboratory, and cases with parallel walls within the proximal neck adequate for the landing zone were excluded from the study. RESULTS: This study included 53 patients, but only 39 patients (mean age, 76.6 ± 6.7 years; 87.0% males; mean aneurysm diameter, 52.0 ± 8.0 mm) were analyzed after being characterized as having a pure conical neck by the core laboratory. The mean proximal neck diameters at the lower renal artery and proximal edge of the aneurysm were 20.0 ± 2.9 mm and 27.5 ± 4.9 mm, respectively. The mean proximal neck length was 21.5 ± 6.0 mm. Instructions for use violations other than the conical neck were observed in 15 patients (38.5%). The VELA cuff was used in all cases; however, additional proximal cuff was required in 9 more cases (23.1%). The Active Seal technology was able to significantly extend the proximal sealing zone from 21.5 ± 6.0 to 26.0 ± 12.2 mm (p = .047). Thirty-six patients completed the 12-month follow-up (one patient was lost to follow-up, and 2 patients died from causes unrelated to the aneurysm), and there were no type-1a and 3 endoleaks with only one reintervention (2.6%) related to type 1b endoleak in the 12-month period. Furthermore, there was no significant enlargement of the proximal neck diameter at 12 months (at 1 month: 20.6 ± 3.4 mm and at 12 months: 21.3 ± 3.8 mm; p = .420). CONCLUSION: The Active Seal technology of the AFX significantly extended the proximal seal zone and no type-1a endoleak and proximal neck dilation was observed in patients with conical proximal neck at 12 months.

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.

Drug Eluting Versus Covered Stent for Femoropopliteal Artery Lesions: Results of the ULTIMATE Study.

OBJECTIVE: Stent grafts (SG) and drug eluting stents (DES) have emerged to combat intimal hyperplasia. It remains unclear which type of stent yields superior outcomes in femoropopliteal (FP) arterial lesions. This study compared the clinical data between the VIABAHN SG and the Eluvia DES two years after endovascular treatment. METHODS: In this retrospective multicentre study, 504 cases with a lesion length > 10 cm treated either with SG or DES were analysed. Ankle brachial index (ABI) measurements were conducted before and after the endovascular procedure, and every three months thereafter. When the ABI dropped ≥ 0.15 compared with the baseline value, a duplex ultrasound was conducted to check stent patency. The outcome measures were stent patency rates, freedom from target lesion revascularisation (TLR), stent thrombosis, and acute limb ischaemia (ALI) accompanying loss of patency rates. Propensity score matching (PSM) was performed to adjust for confounding baseline characteristics. RESULTS: PSM extracted 219 limbs in the SG group and 109 limbs in the DES group. Compared with the SG group, the DES group had statistically significantly higher rates of freedom from TLR (86.0 ± 4.2% vs. 73.1 ± 4.8%, p = .040), and ALI accompanying loss of patency (98.9 ± 1.1% vs. 93.5 ± 1.8%, p = .029) at two years. Primary patency (75.9 ± 5.9% vs. 69.5 ± 5.9%, p = .087) and freedom from stent thrombosis (90.4 ± 3.3% vs. 81.2% ± 3.0%, p = .11) were not statistically significantly different. For lesions ≤ 15 cm, primary patency in the DES group was statistically significantly better than the SG group. CONCLUSION: FP lesions treated with Eluvia DES had a higher primary patency rate in lesions ≤ 15 cm, freedom from clinically driven TLR and ALI accompanying loss of patency than the VIABAHN SG.

Comparison of clinical outcomes, including the wound healing rate, between inframalleolar bypass to the pedal artery and that to the pedal branch artery in the modern endovascular era.

OBJECTIVE: Inframalleolar (IM) bypass has been reported to demonstrate acceptable patency and limb salvage in patients with chronic limb-threatening ischemia. However, wound healing after IM bypass and comparisons between pedal artery (PA) bypass and pedal branch artery (PBA) bypass are lacking. METHODS: We reviewed prospectively collected data from 208 consecutive patients after IM bypass performed over a period of 6 years. Patients were divided into two groups based on the distal anastomotic artery: the PA group (dorsal pedis artery or common plantar artery) and the PBA group (medial tarsal, lateral tarsal, medial plantar, and lateral plantar artery). The primary outcome was wound healing, and secondary outcomes included loss of patency and limb and life prognosis. RESULTS: Of the 208 patients, 174 (74%) had PA bypass, whereas 34 (16%) had PBA bypass. Patients in the PBA group were significantly younger than those in the PA group (69 ± 7 vs 73 ± 9; P = .03). Although early (30-day) graft failure was more common in the PBA group, late clinical outcomes, including the wound healing rate (79% in the PA group and 84% in the PBA group; P = .74), were similar between the two groups. The Global Limb Anatomic Staging System IM grade (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.58-0.93; P = .006); wound, ischemia, and foot infection wound grade (HR, 0.67; 95% CI, 0.51-0.89; P < .01); and wound, ischemia, and foot infection foot infection grade (HR, 0.79; 95% CI, 0.65-0.96; P = .02) were independent predictors of wound healing. CONCLUSIONS: The current study revealed that wound healing in patients after PBA bypass was acceptable and comparable with that after PA bypass. In the modern era, including a high prevalence of infrapopliteal angioplasty, our results could provide useful information to clinicians in actual clinical settings. Moreover, PBA bypass may be an alternative revascularization procedure to avoid major amputation when the PA is occluded, such as in the global vascular guideline IM P2 grade. Prospective multicenter larger studies are warranted to confirm the findings of this study and to compare PBA bypass and IM endovascular treatment in patients with anatomical no-option chronic limb-threatening ischemia.

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.