Comparison of limb outcomes between bypass surgery and endovascular therapy in dialysis-dependent and -independent patients with chronic limb-threatening ischemia.

OBJECTIVE: To examine limb salvage (LS) and wound healing in dialysis-dependent and -independent patients with chronic limb-threatening ischemia (CLTI) after infrainguinal bypass surgery or endovascular therapy (EVT). METHODS: We retrospectively analyzed the multi-center data of patients who underwent infrainguinal revascularization for CLTI with Wound, Ischemia, and foot Infection (WIfI) stage 2 to 4 between 2015 and 2020. The primary endpoint was LS. The secondary endpoint included wound healing, amputation-free survival (AFS), periprocedural complications, and 2-year survival. Comparison of these outcomes were made after propensity score matching. RESULTS: We analyzed 252 dialysis-dependent (318 limbs) and 305 dialysis-independent (354 limbs) patients. Propensity score matching extracted 202 pairs with no significant differences in characteristics. The LS rate in bypass surgery was better than that in EVT in dialysis-dependent patients (P < .001). There was no significant difference in the LS rates between bypass surgery and EVT in dialysis-independent patients (P = .168). The wound healing rate of bypass surgery was better than that of EVT both dialysis-dependent and -independent patients with CLTI. The AFS rate of bypass surgery was better than that of EVT in dialysis-dependent patients (P < .001). There was no significant difference in the AFS rates between bypass surgery and EVT in dialysis-independent patients (P = .099). There was no significant difference in the occurrence of Clavien-Dindo ≥ IV and V between bypass surgery and EVT in dialysis-dependent and -independent patients. Age ≥75 years, serum albumin levels <3.5 g/dL, and non-ambulatory status were risk factors for 2-year mortality in dialysis-dependent patients. The 2-year survival rates in dialysis-dependent patients with risk factors of 0, 1, 2, and 3 were 82.5%, 67.1%, 49.5%, and 10.2%, respectively (P < .001). CONCLUSIONS: For LS and wound healing, bypass surgery was preferred for revascularization in dialysis-dependent patients with WIfI stage 2 to 4. Although dialysis dependency was one of the risk factors for 2-year mortality, dialysis-dependent patients, who have 0 to 1 risk factors, may benefit from bypass surgery, as 2-year survival of >50% is expected.

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

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

Influence of inframalleolar modifier P0/P1 on wound healing in bypass surgery vs endovascular therapy in patients with chronic limb-threatening ischemia.

OBJECTIVE: This study aimed to compare the influence of inframalleolar (IM) P0/P1 on wound healing in bypass surgery vs endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI). METHODS: We retrospectively analyzed the multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. IM P represents target artery crossing into foot, with intact pedal arch (P0) and absent or severely diseased pedal arch (P1). The endpoints were wound healing, limb salvage (LS), and postoperative complications. RESULTS: We analyzed 66 and 189 propensity score-matched pairs in the IM P0 and IM P1 cohorts, respectively. In the IM P0 cohort, the 1-year wound healing rates were 94.5% and 85.7% in the bypass surgery and EVT groups, respectively (P = .092), whereas those in the IM P1 cohort were 86.2% and 66.2% in the bypass surgery and EVT groups, respectively (P < .001). In the IM P0 cohort, the 2-year LS rates were 96.7% and 94.1% in the bypass surgery and EVT groups, respectively (P = .625), and those in the IM P1 cohort were 91.8% and 81.5% in the bypass surgery and EVT groups, respectively (P = .004). No significant differences were observed between the bypass surgery and EVT in terms of postoperative complication rates in either the IM P0 or P1 cohorts. CONCLUSIONS: Bypass surgery facilitated better wound healing and LS than EVT in patients with IM P1. Conversely, no differences in wound healing or LS were observed between groups in patients with IM P0. Bypass surgery should be considered a better revascularization strategy than EVT in patients with tissue loss and IM P1 disease.

Validation of JCLIMB, SPINACH, and VQI Calculators for Prediction of Two Year Survival in Patients With Chronic Limb Threatening Ischaemia After Infra-Inguinal Surgical or Endovascular Revascularisation.

OBJECTIVE: This study aimed to evaluate three survival prediction models: the JAPAN Critical Limb Ischaemia Database (JCLIMB), Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischaemia (SPINACH), and Vascular Quality Initiative (VQI) calculators. METHODS: Multicentre data of patients who underwent infrainguinal revascularisation for chronic limb threatening ischaemia between 2018 and 2021 were analysed retrospectively. The prediction models were validated using a calibration plot analysis with the intercept and slope. The discrimination was evaluated using area under the curve (AUC) analysis. The observed two year overall survival (OS) was evaluated by the Kaplan - Meier method. The two year OS predicted by each model at < 50%, 50 - 70%, and > 70% was defined as high, medium, and low risk, respectively. RESULTS: A total of 491 patients who underwent infra-inguinal revascularisation were analysed. The rates of surgical revascularisation, endovascular therapy, and hybrid therapy were 26.5%, 70.1%, and 5.5%, respectively. The average age was 75.6 years, and the percentages of patients with diabetes mellitus and dialysis dependent end stage renal disease were 66.6% and 44.6%, respectively. The tissue loss rate was 85.7%. The intercept and slope were -0.13 and 1.18 for the JCLIMB, 0.11 and 0.82 for the SPINACH, and -0.15 and 1.10 for the VQI. The AUC for the two year OS of JCLIMB, SPINACH, and VQI were 0.758, 0.756, and 0.740, respectively. The observed two year OS rates of low, medium, and high risk using the JCLIMB calculator were 80.1%, 61.1%, and 28.5%, respectively (p < .001), using the SPINACH calculator were 81.0%, 57.0%, and 38.1%, respectively (p < .001), and using the VQI calculator were 77.8%, 45.8%, and 49.6%, respectively (p < .001). CONCLUSION: The JCLIMB, SPINACH, and VQI survival calculation models were useful, although the OS predicted by the VQI model appeared to be lower than the observed OS.

Peak Aortic Valve Jet Velocity is an Independent Predictor of Mortality of Dialysis Patients Undergoing Open Surgery for Chronic Limb Threatening Ischemia.

BACKGROUND: To investigate the impact of peak aortic jet velocity (Vmax) on the prognosis of patients undergoing open surgery for chronic limb threatening ischemia (CLTI). METHODS: Between April 2015 and March 2022, 352 patients underwent infrainguinal open surgery for CLTI. Patients who met the following exclusion criteria were excluded: subsequent infrainguinal surgeries in the registered period, no record of Vmax, history of aortic valve intervention, and Vmax ≥3.0 m/s (moderate or severe aortic valve stenosis). The remaining patients were dichotomized into 2 groups based on their Vmax values. The Youden index calculated from the receiver operating characteristic curve (ROC) was set as the cutoff value. The 2-year overall survival (OS), calculated using the Kaplan-Meier's method, was compared between the 2 groups. A Cox proportional hazards regression analysis was performed using perioperative factors including Vmax to identify independent predictors separately for dialysis and nondialysis patients and the quantitative relationship between Vmax and OS. RESULTS: One hundred and ninety-one patients, including 100 dialysis and 91 nondialysis patients, were included in the analysis. The Youden index was 1.7 m/s. The 2-year OS rates of the group with Vmax >1.7 m/s and with Vmax ≤1.7 m/s were 49% and 76% (P = 0.007), respectively, in the dialysis cohort, while they were 71% and 78% (P = 0.680) in the nondialysis cohort, respectively. Multivariate analysis identified Vmax and ejection fraction as independent predictors in the dialysis cohort and the Barthel Index at admission in the nondialysis cohort. There was a stepwise increase in the risk of death in patients with Vmax of ≥1.5 m/s and a significantly higher risk of death in dialysis patients with Vmax >2.5 m/s. CONCLUSIONS: Vmax was a significant independent predictor of all-cause death within 2 years after open surgery for CLTI in dialysis patients but not in patients managed without dialysis.

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

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

Impact of ambulatory status change on survival in patients with chronic limb-threatening ischemia undergoing infrainguinal surgical or endovascular revascularization.

OBJECTIVE: This study aimed to evaluate the influence of change in ambulatory status on the prognosis of patients with chronic limb-threatening ischemia (CLTI) undergoing infrainguinal bypass surgery or endovascular therapy (EVT). METHODS: We retrospectively analyzed data from two vascular centers for patients who underwent revascularization for CLTI between 2015 and 2020. The primary endpoint was overall survival (OS), and the secondary endpoints were changes in ambulatory status and postoperative complications. RESULTS: Throughout the study, 377 patients and 508 limbs were analyzed. In the preoperative nonambulation cohort, the average body mass index (BMI) was lower in the postoperative nonambulatory group than in the postoperative ambulatory group (P < .01). The percentage of cerebrovascular disease (CVD) was higher in the postoperative nonambulatory group than in the postoperative ambulatory group (P = .01). In the preoperative ambulation cohort, the average controlling nutritional status (CONUT) score was higher in the postoperative nonambulatory group than in the postoperative ambulatory group (P < .01). There was no difference in the bypass percentage and the EVT in the preoperative nonambulation (P = .32) and ambulation (P = .70) cohorts. According to the change in ambulatory status before and after revascularization, the 1-year OS rates were 86.8% in the ambulatory → ambulatory group, 81.1% in the nonambulatory → ambulatory group, 54.7% in the nonambulatory → nonambulatory group, and 23.9% in the ambulatory → nonambulatory group (P < .01). On multivariate analysis, increased age (P = .04), higher Wound, Ischemia, and foot Infection stage (P = .02), and increased CONUT score (P < .01) were independent risk factors for the decline in ambulatory status in patients with preoperative ambulation. In patients with preoperative nonambulation, increased BMI (P < .01) and absence of CVD (P = .04) were independent factors related to the improved ambulatory status. The percentages of postoperative complications were 31.0% and 17.0% in the preoperative nonambulation and the preoperative ambulation in the overall cohort (P < .01). Preoperative nonambulatory status (P < .01), CONUT score (P < .01), and bypass surgery (P < .01) were risk factors for postoperative complications. CONCLUSIONS: Improved ambulatory status is associated with better OS in patients with preoperative nonambulatory status after infrainguinal revascularization for CLTI. Although patients with preoperative nonambulatory status have a risk of postoperative complication, some may benefit from revascularization if they have no factors such as low BMI and CVD, improving their ambulatory status.

Treatment outcomes between bypass surgery and endovascular therapy in patients with chronic limb-threatening ischemia classified as bypass-preferred category based on Global Vascular Guidelines.

OBJECTIVE: The aim of this study was to examine outcomes between bypass surgery and endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI), classified as bypass-preferred according to the Global Vascular Guidelines (GVG). METHODS: We retrospectively analyzed the multi-center data of patients who underwent infrainguinal revascularization for CLTI with Wound, Ischemia, and foot Infection (WIfI) Stage 3 to 4 and Global Limb Anatomical Staging System (GLASS) Stage III, which is classified as bypass-preferred category by the GVG between 2015 and 2020. The endpoints were limb salvage and wound healing. RESULTS: We analyzed 301 patients and 339 limbs following 156 bypass surgeries and 183 EVTs. The 2-year limb salvage rates were 92.2% in the bypass surgery group and 76.3% in the EVT group, respectively (P < .01). The 1-year wound healing rates were 86.7% in the bypass surgery group and 67.8% in the EVT group (P < .01). Multivariate analysis shows decreased serum albumin level (P < .01), increased wound grade (P = .04), and EVT (P < .01) were risk factors for major amputation. Decreased serum albumin level (P < .01), increased wound grade (P < .01), GLASS infrapopliteal grade (P = .02), inframalleolar (IM) P grade (P = .01), and EVT (P < .01) were risk factors for impaired wound healing. Subgroup analysis of limb salvage in patients after EVT, decreased serum albumin level (P < .01), increased wound grade (P = .03), increased IM P grade (P = .04), and congestive heart failure (P < .01) were risk factors for major amputation. According to scoring by existence of these risk factors, 2-year limb salvage rates following EVT were 83.0% and 42.8% for the total score of 0 to 2 and of 3 to 4, respectively (P < .01). CONCLUSIONS: Bypass surgery provides better limb salvage and wound healing in patients with WIfI Stage 3 to 4 and GLASS Stage III, which is classified as bypass-preferred category by the GVG. In patients after EVT, serum albumin level, wound grade, IM P grade, and congestive heart failure were related to major amputation. Although bypass surgery may be considered as initial revascularization procedure in patients classified as bypass-preferred category, in case that EVT has to be selected, relatively acceptable outcomes can be expected in patients with less of these risk factors.

Importance of Flow Waveform and Flow Volume as Prognostic Indicators for the Patency of Infra-Inguinal Autologous Vein Bypass.

OBJECTIVE: To investigate the association of the intra-operative flow waveform and the flow volume with graft prognosis of the infra-inguinal vein bypass. METHODS: This was a retrospective study of intra-operative flowmetry performed for infra-inguinal autologous vein bypass between 2011 and 2020. Flow waveforms were classified as type 0 - IV according to the Kyushu University (KU) classification. The patients (n = 340) were divided into three groups based on the flow waveform predicting the graft patency: type 0/I (long patency), type II (no early occlusion but late occlusion possible), and type III/IV (early occlusion). The graft occlusion rates of popliteal artery bypass (PAB) and infrapopliteal artery bypass (IPAB) within 30 days of surgery were compared between type 0/I + II and type III/IV groups, while the midterm graft patency rates were compared between type 0/I and type II groups. Additionally, a multivariate analysis was performed to identify independent risk factors for early and late graft occlusion. RESULTS: The early graft occlusion rates of type 0/I + II and type III/IV groups were 3.9% and 0%, respectively, (p = 1.0) for PAB, and 5.3% and 46.2%, respectively, (p < .001) for IPAB. The two year primary patency rates of type 0/I and type II groups were 91% and 75%, respectively, (p = .030) for PAB, and 58% and 63%, respectively, (p = .72) for IPAB. Independent risk factors for early occlusion were none in PAB and flow waveform (type IV) in IPAB. Independent risk factors for patency loss in PAB were flow waveform (type II), end stage renal disease, and dual antiplatelet use, and those in IPAB were older age, women, lower flow volume, and iterative bypass. CONCLUSION: Intra-operative flowmetry is useful for predicting the graft prognosis in infra-inguinal vein bypass and this is dependent on the distal target artery.

Use of the 11-Item Modified Frailty Index to Determine Accurate Prognosis and Revascularization Strategy in Patients Undergoing Vascular Bypass Surgery for Intermittent Claudication.

BACKGROUND: In cases of intermittent claudication (IC) where traditionally noninvasive management yields unsatisfactory results, revascularization strategy in IC patients is generally decided based on anatomical considerations and the availability of a saphenous vein graft. Life expectancy should also be considered. This study aimed to investigate the relationship between the 11-item modified frailty index (mFI-11) and the overall survival (OS) in patients with IC who underwent vascular bypass surgery to facilitate revascularization strategy selection. METHODS: We reviewed the records of 144 consecutive patients (153 lower limbs) who underwent infrainguinal bypass for IC between 2011 and 2020. Patients were divided into 2 groups based on their mFI-11 score: high frailty (H), mFI score >0.3; and low frailty (L), mFI score ≤0.3. The OS was compared among the 2 groups. Rates of graft patency and freedom from major adverse limb event (ffMALE) were also determined and compared. RESULTS: Five-year OS in the L and H groups was 92% and 55% (P < 0.001). Multivariate analysis showed that mFI, age, and end-stage renal disease were independent predictors of OS. Five-year rates of primary and secondary patency and ffMALE for vein grafts were 81%, 91%, and 94%, respectively; those for prosthetic grafts were 65%, 80%, and 84%, respectively; the differences were not significant. CONCLUSIONS: The mFI-11 was a helpful tool in predicting OS for patients with IC who underwent vascular bypass surgery. Those with H should not undergo open revascularization; however, for IC patients who have either not responded to a regimen of exercise and medication, or have specifically requested a more aggressive approach, obtaining a good score in frailty assessment is useful in determining whether or not bypass surgery would be a viable option.

Risk Factors for Major Amputation in Chronic Limb-Threatening Ischemia Patients Classified as Wound, Ischemia, and Foot Infection Stage 4 following Infrainguinal Revascularization.

BACKGROUND: To evaluate limb salvage outcomes and risk factors for major amputation in chronic limb-threatening ischemia (CLTI) patients classified as stage 4 per the wound, ischemia, and foot infection (WIfI) classification following infrainguinal revascularization. METHODS: We retrospectively analyzed multicenter data of patients who had undergone infrainguinal revascularization for CLTI between 2015 and 2020. The endpoint was secondary major amputation defined as an above- or below-knee amputation following infrainguinal revascularization. RESULTS: We analyzed 243 patients with CLTI and 267 limbs. Bypass surgery was performed in 14 (25.5%) and 120 (56.6%) limbs from the secondary major amputation and limb salvage groups, respectively (P < 0.01). Endovascular therapy (EVT) was performed in 41 limbs (74.5%) in the secondary major amputation group and 92 limbs (43.4%) in the limb salvage group (P < 0.01). The average serum albumin levels were 3.0 ± 0.6 and 3.4 ± 0.5 g/dL in the secondary major amputation and limb salvage groups, respectively (P < 0.01). The percentage of congestive heart failure (CHF) was 36.4% and 14.2% in secondary major amputation and limb salvage groups, respectively (P < 0.01). The number of limbs with infra-malleolar (IM) P0, P1, and P2 were 4 (7.3%), 37 (67.3%), and 14 (25.5%), respectively, in the secondary major amputation group and 58 (27.4%), 140 (66.0%), and 14 (6.6%), respectively, in the limb salvage group (P < 0.01). Limb salvage rates at 1 year were 91.0% and 68.6% in the bypass and EVT groups, respectively (P < 0.01). Limb salvage rates at 1 year in patients with IM P0, P1, and P2 were 91.8%, 79.9%, and 53.1%, respectively (P < 0.01). Multivariate analysis revealed that serum albumin level [hazard ratio (HR), 0.56; 95% confidence interval (CI), 0.36-0.89; P = 0.01], hypertension (HR, 0.39; 95% CI, 0.21-0.75; P < 0.01), CHF (HR, 2.10; 95% CI, 1.09-4.05; P = 0.03), wound grade (HR, 1.72; 95% CI, 1.03-2.88; P = 0.04), IM P (HR, 2.08; 95% CI, 1.27-3.42; P < 0.01), and EVT (HR, 3.31; 95% CI, 1.77-6.18; P < 0.01) as independent risk factors for secondary major amputation being required. CONCLUSIONS: Among CLTI patients with WIfI stage 4, the limb salvage rate was poor in those with IM P1-2 following infrainguinal EVT. Low serum albumin levels, CHF, high wound grade, IM P1-2, and EVT were independent risk factors for CLTI patients requiring major amputation.

Bypass Surgery Provides Better Outcomes Compared with Endovascular Therapy in Patients with Chronic Limb-Threatening Ischemia Classified as Indeterminate Category According to the Global Vascular Guidelines.

BACKGROUND: The present study aimed to determine the preferred initial revascularization procedure between bypass surgery and endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI) categorized as indeterminate according to the Global Vascular Guidelines (GVG). METHODS: We retrospectively analyzed the multicenter data of patients who underwent infrainguinal revascularization for CLTI categorized as indeterminate according to the GVG between 2015 and 2020. The end point was the composite of relief from rest pain, wound healing, major amputation, reintervention, or death. RESULTS: A total of 255 patients with CLTI and 289 limbs were analyzed. Of the 289 limbs, 110 (38.1%) and 179 (61.9%) underwent bypass surgery and EVT, respectively. The 2-year event-free survival rates with respect to the composite end point were 63.4% and 28.7% in the bypass and EVT groups, respectively (P < 0.01). Multivariate analysis revealed that increased age (P = 0.03); decreased serum albumin level (P = 0.02); decreased body mass index (P = 0.02); dialysis-dependent end-stage renal disease (P < 0.01); increased Wound, Ischemia, and foot Infection (WIfI) stage (P < 0.01); Global Limb Anatomic Staging System (GLASS) III (P = 0.04); increased inframalleolar grade (P < 0.01); and EVT (P < 0.01) were independent risk factors for the composite end point. In the WIfI-GLASS 2-III and 4-II subgroups, bypass surgery was superior to EVT with regard to 2-year event-free survival (P < 0.01). CONCLUSIONS: Bypass surgery is superior to EVT in terms of the composite end point in patients classified as indeterminate according to the GVG. Bypass surgery should be considered an initial revascularization procedure, especially in the WIfI-GLASS 2-III and 4-II subgroups.

Impact of cilostazol on prevention of late failure of autologous vein grafts.

OBJECTIVES: The effectiveness of postoperative medication for the prevention of late graft failure is controversial. We conducted the present study to investigate whether cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass for chronic limb-threatening ischemia (CLTI). METHODS: From April 1994 to March 2022, we performed 590 de novo infrainguinal bypass procedures using autologous vein grafts (AVGs) in three hospitals. The bypass grafts were classified according to the postoperative prescription of cilostazol. The loss of graft patency and major adverse limb events (MALEs) were set as endpoints. Patients who died within 30 days and grafts that lost primary patency within 30 days after surgery were excluded. Data up to 3 years were analyzed. The cumulative primary patency (PP), assisted primary patency (AP), secondary patency (SP), and freedom from MALE (ffMALE) rates were calculated by the Kaplan-Meier method and compared between the cilostazol group and the non-cilostazol group. After a propensity score matching, same statistical analyses were performed. In addition, a Cox proportional hazards regression analysis that included preoperative factors, intraoperative factors, and postoperative medications was performed to identify whether cilostazol is an independent predictor for the outcomes. RESULTS: A total of 523 AVGs met inclusion criteria. Kaplan-Meier curves showed that the cilostazol group was superior to the non-cilostazol group in all outcomes, while the cilostazol group was superior to the non-cilostazol group in AP and SP after a propensity score matching. A multivariable analysis showed that non-use of cilostazol was identified as an independent predictor for loss of AP, SP, and ffMALE. CONCLUSIONS: Cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass.

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.

Prediction Models for Two Year Overall Survival and Amputation Free Survival After Revascularisation for Chronic Limb Threatening Ischaemia.

OBJECTIVE: The aim of this study was to create prediction models for two year overall survival (OS) and amputation free survival (AFS) after revascularisation in patients with chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective analysis of prospectively collected multicentre registry data (JAPAN Critical Limb Ischaemia Database; JCLIMB). Data from 3 505 unique patients with CLTI who had undergone revascularisation from 2013 to 2017 were extracted from the JCLIMB for the analysis. The cohort was randomly divided into development (2 861 patients) and validation cohorts (644 patients). In the development cohort, multivariable risk models were constructed to predict two year OS and AFS using Cox proportional hazard regression analysis. These models were applied to the validation cohort and their performances were evaluated using Harrell's C index and calibration plots. RESULTS: Kaplan-Meier estimates of two year OS and AFS post-revascularisation in the whole cohort were 69% and 62%, respectively. Strong predictors for OS consisted of age, activity, malignant neoplasm, chronic kidney disease (CKD), congestive heart failure (CHF), geriatric nutritional risk index (GNRI), and sex. Strong predictors for AFS included age, activity, malignant neoplasm, CKD, CHF, GNRI, body temperature, white blood cells, urgent revascularisation procedure, and sex. Prediction models for two year OS and AFS showed good discrimination with Harrell's C indexes of 0.73 (95% confidence interval [CI] 0.69 - 0.77) and 0.72 (95% CI 0.68 - 0.76), respectively CONCLUSION: Prediction models for two year OS and AFS post-revascularisation in patients with CLTI were created. They can assist in determining treatment strategies and serve as risk adjustment modalities for quality benchmarking for revascularisation in patients with CLTI at each facility.

Health Related Quality of Life Over Time After Revascularisation in Patients With Chronic Limb Threatening Ischaemia.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) decreases life expectancy and impairs health related quality of life (HR-QOL). Revascularisation is needed to relieve ischaemia and salvage limbs. Although a major goal of CLTI treatment is maintaining QOL, little information is available about changes of HR-QOL over time after revascularisation. HR-QOL with survival after revascularisation for CLTI was assessed. METHODS: The clinical database of the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH), a prospective multicentre observational study, was analysed. Outcome measures were disease specific QOL per the Vascular Quality of Life (VascuQOL) questionnaire and the Short Form (SF) 36 evaluated generic QOL, which were assessed at baseline and three, 12, 24, and 36 months. The outcome measure was change of QOL from baseline. The minimally important difference (half a standard deviation from baseline) was used as the cut off point for improved, worsened, and unchanged QOL. RESULTS: Overall QOL was improved in 61% of patients for the VascuQOL and approximately 40% for the SF-36 component summaries at three months. However, these proportion gradually decreased to 21% - 31% at three years. In contrast, the proportion of deceased patients gradually increased over the three year follow up. Multivariable analysis revealed that pre-operative non-ambulatory status was inversely associated with improved QOL for the three month VascuQOL and SF-36 mental component summary, and surgical reconstruction was positively associated with these measurements. Advanced age and renal failure were inversely associated with improved QOL for the SF-36 mental component summary and VascuQOL at one to three years. CONCLUSION: Revascularisation improved QOL. However, patients with non-ambulatory status exhibited a negative association with improved QOL at three months, and advanced age and renal failure limited benefits one to three years after revascularisation. Accumulating QOL data will be essential for post-revascularisation QOL estimation. Pre-operative assessment, including estimated QOL, is important in shared decision making for patient oriented outcomes in the treatment of CLTI patients.

Preoperative nutritional status is independently associated with wound healing in patients undergoing open surgery for ischemic tissue loss.

OBJECTIVES: The aim of this study was to determine the relationship between preoperative nutritional status and wound healing in patients undergoing surgical reconstruction for ischemic tissue loss. METHODS: The preoperative nutritional status of patients who underwent surgical reconstruction for ischemic tissue loss for the years 2011-2018 was retrospectively estimated using the Controlling Nutritional Status (CONUT) score. Patients were allocated to two groups: Group I, normal nutrition or mild malnutrition (CONUT score ≤4), and Group II, moderate-to-severe malnutrition (CONUT score ≥5). Wound healing was set as the primary endpoint and major amputation and death as the secondary endpoints. The wound healing, limb salvage, and overall survival rates were calculated after two years using the Kaplan-Meier method, and Cox proportional hazards regression analysis was performed to determine which variables were independently associated with these outcomes. RESULTS: Forty-eight patients with missing values for the CONUT score were excluded. A total of 174 limbs in 147 patients were studied (Group I: 115 limbs in 100 patients; Group II: 59 limbs in 47 patients). The mean duration of the study was 519 ± 270 days. The Kaplan-Meier curves showed that wound healing in Group I was superior to that in Group II (Group I vs. II: two-year wound healing, 97% vs. 79%; time to 50% wound healing, 83 vs. 150 days, p < 0.001), and multivariate analysis showed that the CONUT score was an independent predictor of wound healing (hazard ratio, 0.63; 95% confidence interval, 0.41-0.98; p = 0.038). CONCLUSIONS: Patients with better preoperative nutritional status are more likely to experience wound healing earlier than those with excessive malnutrition.

Preoperative Nutritional Status is an Independent Predictor of the Long-Term Outcome in Patients Undergoing Open Bypass for Critical Limb Ischemia.

INTRODUCTION: The nutritional status before treatment has been reported to be significantly associated with the prognosis of patients with various diseases. The aim of this study was to examine whether or not this applies to patients undergoing open bypass for critical limb ischemia (CLI). METHODS: The preoperative nutritional status of patients who underwent de novo infrainguinal bypass for CLI from January 2000 to December 2017 was retrospectively evaluated using the geriatric nutritional risk index (GNRI) and controlling nutritional status (CONUT) score. Patients were divided into 4 groups based on the GNRI or CONUT score; group I, normal nutrition; group II, mild malnutrition; group III, moderate malnutrition, and group IV, severe malnutrition. The amputation-free survival (AFS), overall survival (OS), and limb salvage (LS) rates up to 5 years were calculated by Kaplan-Meier method and a Cox proportional hazard regression analysis was performed to elucidate whether or not the nutritional indices were independently associated with these outcomes. RESULTS: A total of 373 patients were included. The median observation term was 969 days. There were significant differences in the AFS and OS of the 4 groups divided based on the GNRI and CONUT score. The 2- and 5-year AFS rates of groups I, II, III, and IV, divided based on the GNRI, were 81% and 56%, 72% and 48%, 56% and 27%, and 56% and 12%, respectively (P < 0.001), while those based on the CONUT score were 75% and 55%, 72% and 41%, 50% and 6%, and 30% and 30%, respectively (P < 0.001). The GNRI (groups III + IV) was an independent predictor of AFS (Hazard ratio [HR], 1.85; 95% confidence interval [CI], 1.27-2.69; P < 0.001) and OS (HR, 2.26; 95% CI, 1.50-3.41; P < 0.001), while the CONUT score (groups III + IV) was also an independent predictor of AFS (HR, 1.68; 95% CI, 1.13-2.49; P = 0.011) and OS (HR, 1.64; 95% CI, 1.07-2.49; P = 0.024). However, neither nutritional index was an independent predictor of LS. CONCLUSIONS: The preoperative nutritional status, as measured by the GNRI or CONUT score, was significantly associated with AFS and OS in patients undergoing infrainguinal bypass for CLI.

Impact of the Geriatric Nutritional Risk Index on the Long-Term Outcomes of Patients Undergoing Open Bypass for Intermittent Claudication.

BACKGROUND: Nutritional status has been reported to be a predictor of the outcomes of critical limb ischemia. However, there have been no reports of the association between nutritional status and the prognosis of patients with intermittent claudication (IC). The aim of this study was to examine whether or not the geriatric nutritional risk index (GNRI) is independently associated with the long-term outcomes of elderly patients following open bypass for IC.Methods and Results:The preoperative nutritional status of patients aged ≥65 years undergoing infrainguinal bypass for IC between 1991 and 2017 was retrospectively evaluated using the GNRI. Patients were divided into 3 groups based on the GNRI: Group I (normal nutritional risk), GNRI >98; Group II (low nutritional risk), GNRI 92 to ≤98; Group III (moderate to high nutritional risk), GNRI <92. The amputation-free survival (AFS), overall survival, and freedom from cardiovascular death up to 5 years were calculated by Kaplan-Meier method and a multivariate analysis was performed to detect independent predictors of each outcome. Group I showed superior outcomes to Group III for each of the 3 outcomes and the multivariate analysis showed that GNRI was an independent predictor of AFS. CONCLUSIONS: The GNRI was independently associated with the AFS of elderly patients who underwent open bypass for IC.

Impact of Low Activity of Daily Living on the Prognosis of Patients with Critical Limb Ischemia and Sarcopenia.

BACKGROUND: We aimed to investigate the impact of low activity of daily living (ADL) on the long-term outcomes after infrainguinal bypass surgery in patients with critical limb ischemia (CLI) and sarcopenia. METHODS: In this multicenter retrospective cohort study, 110 patients with CLI who underwent infrainguinal bypass between April 2011 and September 2016 were divided into 4 groups according to the presence or absence of sarcopenia before surgery and ADL at discharge (Normal group: absence of sarcopenia and normal ADL [Barthel Index ≥60]; Low ADL alone group: absence of sarcopenia and abnormal ADL [Barthel Index <60]; Sarcopenia alone group: presence of sarcopenia and normal ADL; Sarcopenia and low ADL group: presence of sarcopenia and abnormal ADL). Three-year overall survival (OS) and amputation-free survival (AFS) were compared among the 4 groups using the Kaplan-Meier method, and Cox proportional hazards models were used to assess the unadjusted and adjusted associations between patient characteristics and 3-year OS and AFS. RESULTS: The Sarcopenia and low ADL group was significantly inferior to the other 3 groups in 3-year OS (versus Normal group, P < 0.001; versus Low ADL alone group, P = 0.005; versus Sarcopenia alone group, P = 0.022) and was significantly inferior to the Normal group and Sarcopenia alone group in 3-year AFS (P < 0.001 and P = 0.027, respectively). In the multivariable analysis, after adjustment for age, sex, ischemic heart disease, and hemodialysis, the presence of both sarcopenia and low ADL was a significant predictor of 3-year OS (hazard ratio [HR] 5.99, 95% confidence interval [CI] 1.92-18.69, P = 0.002) and AFS (HR 3.63, 95% CI 1.27-10.39, P = 0.016). CONCLUSIONS: Low ADL at discharge was a significant predictor of 3-year OS and AFS in patients with CLI and sarcopenia, while either sarcopenia alone or low ADL alone did not significantly affect outcomes.