1-year Amputation-free Survival Research Articles

Peripheral Interventional Strategy Assessment (PISA) for Diabetic Foot Ulcer Revascularization: Preliminary Outcomes of a Multidisciplinary Pilot Study.

Digital subtraction angiography (DSA) still represents the gold standard for anatomical arterial mapping and revascularization decision-making in patients with chronic limb-threatening ischemia (CLTI), although DUS (Doppler Ultrasound) remains a primary non-invasive examination tool. The Global Vascular Guidelines established the importance of preoperative arterial mapping to guarantee an adequate in-line flow to the foot. The aim of this study was to evaluate the accuracy of DUS in guiding therapeutic vascular treatments on the basis of Global Vascular Guidelines without the need of a second-level examination. Between January 2022 and June 2022, all consecutive patients with CLTI to be revascularized underwent clinical examination and DUS without further diagnostic examinations. Primary outcomes assessed were technical success, and 30-day mortality. Secondary outcomes were 1-year amputation free survival, and time between evaluation and revascularization. Sixty-eight patients with a mean age of 73.6 ± 8.5 years underwent lower limb revascularization. Technical success was 100%, and the 30-day mortality rate was 2.9%. Mean time between evaluation and revascularization was 29 ± 17 days. One-year amputation free survival was 97.1%. DUS without further diagnostic examinations can accurately assess the status of the vascular tree and foot runoff, providing enough information about target vessels to guide revascularization strategies.

The value of Wound, Ischemia and foot Infection classification in patients undergoing endovascular therapy

ObjectiveThis study aimed to evaluate the correlation between the Society for Vascular Surgery (SVS) Wound, Ischemia and foot infection (WIfI) classification system and clinical outcomes for 1-year limb amputation-free survival (AFS), freedom from reintervention, and wound healing rate in a cohort of patients affected by chronic limb-threatening ischemia treated exclusively by endovascular procedures. MethodsWe analyzed a prospective, consecutive cohort of 203 patients (203 limbs) who underwent infrainguinal endovascular revascularization at a single center between March 2018 and January 2021. These patients were stratified into clinical stages 1 to 4 based on the SVS WIfI classification and categorized into two groups: WIfI 1 to 3 (n = 101 limbs) and WIfI 4 (n = 102 limbs). The SVS objective performance goals of 1-year limb AFS, freedom from reintervention, and wound healing were compared between the groups and assessed using the Kaplan-Meier method. Angiographic lesion characteristics and angioplasty details were compared. ResultsThe average age was 72.4 years (44.3% male, 85.2% had hypertension, 80.3% had diabetes, and 87.7% had tissue loss). There were statistical differences between the groups in 1-year limb AFS Kaplan-Meier rate between WIfI clinical stages 1 to 3 group and WIfI clinical stage 4 group (82% vs 66%, respectively; P < .001), but there was no statistical difference in freedom from reintervention and wound healing rates between the groups (70% vs 64% [P = .62] and 74% vs 79% [P = .90], respectively). Owing to angiographic lesion characteristics, femoropopliteal and infrapopliteal segment distributions were similar between the groups, but there was a statistical difference in target lesion location to tibial vessels (55.4% vs 71.6%, respectively; P = .025). ConclusionsIn this cohort of patients with chronic limb-threatening ischemia, SVS WIfI clinical stage 4 had worse results in the 1-year limb AFS rate, but there was no statistical difference in freedom from reintervention and wound healing rates between the groups.

Factors Associated With 1-year Amputation-free Survival Following Lower Extremity Revascularization in Patients with Chronic Limb-threatening Ischemia: An Analysis of VQI-VISION Database

Factors Associated With 1-year Amputation-free Survival Following Lower Extremity Revascularization in Patients with Chronic Limb-threatening Ischemia: An Analysis of VQI-VISION Database

Characteristics and Outcomes of Patients Undergoing Infrainguinal Bypass in the Endovascular Era

The Society for Vascular Surgery (SVS) developed objective performance goals (OPGs) for lower extremity bypass (LEB) in chronic limb-threatening ischemia (CLTI) based on studies that included patients who were at good risk for open revascularization. In the endovascular era, many LEB patients have had prior interventions, and most would be considered high-risk by the original SVS OPG standards. The goal of this study is to characterize a contemporary patient population undergoing LEB for CLTI and determine if outcomes remain commensurate with the parameters established by the SVS OPG. All patients who underwent LEB for CLTI over a 10-year period (2012-2021) were identified. Patients were stratified into low- and high-risk categories based upon the clinical, conduit, and anatomic parameters used in the SVS OPG. Limb salvage at 1year and amputation-free survival, a composite outcome of major amputation and mortality, at 1 year were compared with the SVS OPG cohort. Primary, assisted, and secondary patency at 1 and 3years were also evaluated using Kaplan-Meier survival analysis. There were 169 LEBs performed for CLTI. One hundred and two (60.36%) males, 101 (59.76%) current or former smokers, 115 (68.05%) with hypertension, 69 (40.83%) with diabetes mellitus, and 40 (23.67%) with coronary artery disease. Median age was 71.84years, and mean follow-up was 2.17years. 65 (38.46%) had a prior ipsilateral endovascular intervention, and 18 (10.65%) were redo bypasses. 21 (12.43%) were deemed clinically high-risk, 44 (26.04%) were high-risk conduits, and 118 (69.82%) had high-risk anatomic factors. Freedom from amputation at 1year was 87.05% in this cohort which was similar to the overall SVS OPG cohort (88.9%). Amputation-free survival at 1year was 77.78%, which was also similar to the overall SVS OPG cohort (76.5%). Primary patency at one and threeyears was 46.84% and 37.59%, assisted patency at one and threeyears was 61.87%and 44.81%, and secondary patency at one and threeyears was 72.13% and 61.16%. The majority of patients undergoing LEB in the endovascular era meet the SVS OPG criteria for high risk. Despite this, the 1-year limb salvage and amputation-free survival in this cohort were equivalent to the SVS OPG LEB cohort. This supports the continued use of LEB for limb salvage in high-risk patients and those who have failed endovascular approaches.

Factors Predicting Outcome in Patients With Critical Limb Ischemia After Multidisciplinary Team Treatment: A 5-Year Single-Center Retrospective Review

Introduction: The global burden of peripheral arterial disease and related critical limb ischemia has been increasing, and with it an increased incidence of limb loss and mortality. Multidisciplinary teams appear to have a beneficial impact on managing these complex patients, but measuring success depends on the outcome chosen. Determining the risk/benefit of intervention can be difficult, and there has been increasing emphasis on using frailty measures to predict the likelihood of morbidity and mortality after vascular interventions. Methods: We performed a retrospective review of patients referred to a multidisciplinary team over a 5-year period who underwent intervention. Data included the modified Frailty Index (mFI), Society for Vascular Surgery (SVS) WIfI wound score (0-2 vs 3), and pedal acceleration time (PAT) post-procedure. Outcomes analyzed were 1-year amputation-free survival (AFS-1), independence, and major complications. Results: There were 81 patients who underwent either open or endovascular revascularization. One-year amputation-free survival was positively correlated with post-procedure PAT (AFS-1 107.3 ± 25.5 vs non-AFS-1 174 ± 93; P = .025) and inversely related to wound score (SVS 3 AFS-1 5/17 [29%] vs SVS 0-2: 46/64 [72%]; P = .025). Independence was linked to wheelchair dependence prior to intervention with 6/16 (38%) patients patients spending more than 50% of their time in a wheelchair being independent versus 56/64 (88%) who were not wheelchair-dependent being independent ( P = .005). An mFI ≥6 was associated with increased incidence of major complications at 1 year (mFI ≥6 11/31 [35%] vs mFI &lt;6 5/50 [10%]; P = .018). Conclusion: One-year amputation-free survival was impacted by post-procedural success as measured by PAT, but negatively impacted by severity of wound at presentation. An mFI ≥6 was associated with greater incidence of complications. These findings may impact decision-making in determining the relative risk/benefit of revascularization in CLI. Vascular technologists can have an important role in development of limb salvage teams.

‘No-Option Chronic Limb-Threatening Ischaemia: What Can We Do To Save Limb?

The aim of this study is to describe the characteristics, the management and the outcome of a series of patients with no-option critical limb ischemia (CLI) treated with a conservative multidisciplinary combined approach including best wound care, NPWT and dermal substitutes. The primary end was limb salvage and 1-year amputation-free survival. The secondary end was mortality and healing time of lesion. Between January 2016 and January 2021, 76 patients with no options CLI were admitted. In 14 patients, there was a failure in distal revascularization with a persistent CLI after the procedure. In 58 patients, revascularization was not feasible. Despite the persistent CLI, a group of patients of this cohort obtained no progression of CLI, complete wound healing treated with surgical debridement or distal amputation and application of NPWT in association with dermal substitute .Any superimposed infection was treated with antimicrobials. Pain was controlled with analgesics. Overall limb was saved in 72 % of the cases. A 1-year survival was 84%.Use of NPWT, dermal substitutes combined with a conservative foot surgery with an approach with minor amputation in patients with no-option CLI may save patient limb and life

WIfI Classification Based Analysis of Risk Factors for Outcomes in Patients with Chronic Limb Threatening Ischaemia after Endovascular Revascularisation Therapy

Evaluating limb status with WIfI classifications and assessing patient risks combined with systemic factors were recommended in patients with chronic limb-threatening ischemic (CLTI). However, there was little application evidence of WIfI in the Chinese population. This study aimed to verify the utilization of the WIfI classification in a China patient population, and further identify local and systemic independent predictors for adverse outcomes of CLTI. A total of 474 patients who underwent endovascular therapy (EVT) for CLTI in a tertiary hospital between July 2017 and September 2020 were included in this retrospective study. The outcomes included 1-year major adverse limb events (MALEs), 1-year all-cause mortality, and 1-year amputation-free survival (AFS). Cox regression was used to analyze the association between risk factors and adverse outcomes. There were 104 (21.9%) all-cause mortalities observed. The MALEs rate was 17.5%, while AFS rate was 71.9%. The multivariate analysis revealed that a BMI < 18.5 kg/㎡ (P = .002), a left ventricular ejection fraction (LVEF) < 50 % (P < .001), and WIfI-Wound Grade (P < .001) were independent risk factors for MALEs, while age ≥ 77 years (P = .031), a BMI < 18.5 kg/㎡ (P < .001), coronary heart disease (P = .040), and WIfI clinical stages (P = .021) were independent risk factors for mortality in CLTI patients. Besides, age ≥ 77 years (P = .003), a BMI < 18.5 kg/㎡ (P < .001), coronary heart disease (P = .012), a LVEF < 50 % (P < .001), WIfI-Wound Grade (P = .004) and WIfI clinical stages (P = .044) were independently associated with a decreased AFS rate. This study confirms the predictive ability of WIfI classification for Chinese CLTI patients who underwent EVT. Wound grade was the most sensitive and important risk factor among the three components of WIfI. In addition, systemic factors should also be considered to ensure a more accurate prognosis prediction and appropriate clinical decision-making in CLTI patients.

Rates of Intervention for Claudication versus Chronic Limb-Threatening Ischemia in Canada and United States

Previous studies have demonstrated important geographic variations in peripheral artery disease (PAD) management despite existing guidelines. We assessed differences in patient characteristics, procedural technique, and outcomes for PAD interventions in Canada versus United States. The Vascular Quality Initiative (VQI) was used to identify all patients who underwent endovascular intervention or surgical bypass for PAD between 2010 and 2019 in Canada and United States. Independent t-test and chi-square test were performed to assess differences between countries in terms of demographic, clinical, and procedural characteristics. The primary outcome was the percentage of interventions performed for claudication versus chronic limb-threatening ischemia (CLTI). Perioperative outcomes were in-hospital mortality and index limb amputation. The long-term outcome was 1-year amputation-free survival. Univariate/multivariate logistic regression and Cox proportional hazards analysis were performed to investigate associations between region and outcomes. A total of 246,770 US patients and 3,467 Canadian patients underwent revascularization for PAD during the study period. There was a higher proportion of endovascular interventions in the US (75.9% vs. 69.2%, OR 1.41 [95% CI 1.31-1.51], P< 0.001). American patients were younger with more comorbidities, including hypertension, diabetes, and coronary artery disease. The percentage of interventions performed for claudication was significantly higher in the US (42.3% vs. 35.7%, OR 1.31 [95% CI 1.22-1.44], P< 0.001). This persisted after controlling for demographic, clinical, and procedural characteristics (adjusted OR 1.05 [95% CI 1.01-1.10], P=0.02). Perioperative outcomes were similar between countries after adjustment for baseline differences: in-hospital mortality (adjusted OR 1.07 [95% CI 0.69-1.62], P= 0.75) and index limb amputation (adjusted OR 0.67 [95% CI 0.43-1.07], P= 0.09). However, 1-year amputation-free survival was higher in the US (84.1% vs. 71.0%, HR 1.61 [95% CI 1.47-1.76], P< 0.001). Multivariable Cox proportional hazards analysis demonstrated that the factor most strongly associated with index limb amputation or death at 1-year was intervention for CLTI (HR 1.56 [95% CI 1.54-1.58], P< 0.001). There are significant variations in PAD management between US and Canada. In particular, a higher proportion of interventions are performed for claudication rather than CLTI in the US compared to Canada. This is an important contributor to the higher 1-year amputation-free survival rate in US patients. Reasons for these differences should be assessed by future studies and evidence-based care may be standardized by targeted quality improvement projects.

Rheopheresis for severe peripheral arterial disease in hemodialysis patients: A clinical series.

Rheopheresis is a double-filtration plasmapheresis that removes high-molecular-weight molecules from the plasma and thereby lowers blood viscosity. This treatment has been proposed in hemodialysis (HD) patients for chronic limb-threatening ischemia (CLTI), but very few studies have evaluated the usefulness of this technique. To assess 1-year amputation-free survival (AFS) of HD patients suffering from CLTI treated by rheopheresis. We conducted a retrospective study of 28 consecutive HD patients treated by rheopheresis in three French dialysis centers between 1 February 2017 and 30 April 2019 in two indications resulting from CLTI, namely chronic ulceration or recent minor amputation with delayed healing. One-year AFS rate reached 53.6 (-19.8; +16.3)%. One-year overall survival rate reached 67.9 (-20.5; +13.1)%. Main causes of death were infections and related to palliative care implying reduction or withdrawal of regular dialysis treatment. Hypotension episodes were the main rheopheresis adverse events with a prevalence rate of 13.5%. Rheopheresis sessions significantly reduced fibrinogen, C-reactive protein, α2-macroglobulin, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, IgM, and estimated plasma viscosity (P < .0001). Rheopheresis may improve clinical outcomes of CLTI in HD patients. The assessment of rheopheresis effectiveness needs to be confirmed by a multicenter randomized controlled trial, such as the ongoing project in France (RHEO-PAD, NCT: 03975946).

The Impact of Anemia on One-Year Amputation-Free Survival in Patients Undergoing Revascularization for Chronic Limb-Threatening Ischemia: A Retrospective Cohort Study

Anemia is potentially associated with increased morbidity and mortality following vascular surgery procedures. This study investigated whether peri-procedural anemia is associated with reduced 1-year amputation-free survival (AFS) in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). A retrospective analysis of patients diagnosed with CLTI between February 2018-February 2019, who subsequently underwent revascularization, was conducted. Hemoglobin concentration measured at index assessment was recorded and stratified by WHO criteria. Subsequent peri-procedural red blood cell transfusions (RBC) were also recorded. The primary outcome was 1-year AFS. Kaplan Meier survival analysis and Cox's proportional hazard modelling were conducted to assess the effect of anemia and peri-procedure transfusion on outcomes. 283 patients were analyzed, of which 148 (52.3%) were anemic. 53 patients (18.7%) underwent RBC transfusion. Patients with anemia had a significantly lower 1-year AFS (64.2% vs. 78.5%, P=0.009). A significant difference in 1-year AFS was also observed based upon anemia severity (P=0.008) and for patients who received RBC transfusion (45.3% vs 77.0%, P < 0.001). On multivariable analysis, moderately severe anemia was independently associated with increased risk of major amputation/death (aHR 1.90, 95% CI 1.06-3.38, P=0.030). After adjusting for severity of baseline anemia, peri-procedural RBC transfusion was associated with a significant increase in the combined risk of major amputation/death (aHR 3.15, 95% CI 1.91-5.20, P < 0.001). Moderately severe peri-procedural anemia and subsequent RBC transfusion are independently associated with reduced 1-year AFS in patients undergoing revascularization for CLTI. Future work should focus on investigating alternative measures to managing anemia in this cohort.

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

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

The Relationship Between Obesity and Amputation-free Survival in Patients Undergoing Lower-limb Revascularisation for Chronic Limb-threatening Ischaemia: A Retrospective Cohort Study

The obesity paradox is a well-documented phenomenon in cardiovascular disease, however it remains poorly understood. We aimed to investigate the relationship between body mass (as measured by body mass index [BMI]) and 1-year amputation-free survival (AFS) for patients undergoing lower limb revascularisation for chronic limb-threatening ischaemia (CLTI). A retrospective analysis was undertaken of all consecutive patients undergoing lower limb revascularisation for CLTI at the Leicester Vascular Institute between February 2018-19. Baseline demographics and outcomes were collected using electronic records. BMI was stratified using the World Health Organization criteria. One-year AFS (composite of major amputation/death) was the primary outcome. Kaplan-Meier survival analysis and adjusted Cox's proportional hazard models were used to compare groups to patients of normal mass. One-hundred and ninety patients were included. Overall, no difference was identified in 1-year AFS across all groups (pooled P=0.335). Compared to patients with normal BMI (n=66), obese patients (n=43) had a significantly lower adjusted combined risk of amputation/death (aHR 0.39, 95% CI 0.16-0.92, P=0.032), however no significant differences were observed for overweight (aHR 0.89, 95% CI 0.47-1.70, P=0.741), morbidly obese (aHR 1.15, 95% CI 0.41-3.20, P=0.797) and underweight individuals (aHR 1.86, 95% CI 0.56-6.20, P=0.314). In the context of CLTI, obesity is potentially associated with favourable amputation-free survival at 1 year, compared to normal body mass. The results of this study support the notion of an obesity paradox existing within CLTI and question whether current guidance on weight management requires a more patient-specific approach.

Impact of Longer Hemodialysis Vintage with Higher Serum Phosphorus Level on Clinical Outcomes in Patients with Chronic Limb-Threatening Ischemia Presenting Tissue Loss after Endovascular Therapy.

Aims: Hemodialysis vintage and serum phosphorus levels adversely affect outcomes in patients on hemodialysis. Whether these factors have a similar prognostic impact on patients who are on hemodialysis and have chronic limb-threatening ischemia (CLTI) has not been systematically studied. We aimed to explore the risk factors, including hemodialysis vintage and serum phosphorus levels, on clinical outcomes after endovascular therapy (EVT) in hemodialysis patients with CLTI. Methods: The current study rerospectively analyzed 374 hemodialysis patients with CLTI presenting with ischemic tissue loss (age: 72.3±9.0 years, male: 73.3%, diabetes mellitus: 68.2%, Rutherford 5: 75.9%, 6: 24.1%, WIfI stage 4: 50.0%) primarily treated with EVT between April 2007 and December 2016. The primary outcome measure was 1-year amputation-free survival (AFS), while the secondary outcome measure was 1-year wound healing. Predictors for each outcome were evaluated by Cox proportional hazards model. Results: Multivariate analysis significantly associated longer hemodialysis vintages with higher serum phosphorus levels (hazard ratio [HR], 0.599; 95% confidence interval [CI], 0.394-0.910; p =0.016) with 1-year AFS. Longer vintages for hemodialysis with higher serum phosphorus levels were marginally, but not significantly, associated with 1-year wound healing. (HR, 0.684; 95% CI, 0.467–1.000; p =0.050). Conclusion: Longer hemodialysis vintages with higher serum phosphorus levels adversely affect outcomes after EVT for hemodialysis patients with CLTI presenting with ischemic tissue loss.

Impact of impaired ambulatory capacity on the outcomes of peripheral vascular interventions among patients with chronic limb-threating ischemia

ObjectiveDespite prior literature recommending against limb salvage in patients with poor functional status such as nonambulatory patients with chronic limb-threatening ischemia (CLTI), peripheral endovascular interventions continue to be carried out in this group of patients. Clinical outcomes following these interventions are, however, not well-characterized. MethodsA retrospective review was conducted on all patients treated for CLTI in the Vascular Quality Initiative from September 2016 to December 2019. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression analyses were used as appropriate to study outcomes. The primary outcomes were 30-day mortality and 1-year amputation-free survival. The secondary outcomes were in-hospital death, postoperative complications, 1-year freedom from major amputation, and 2-year survival. ResultsOf the 49,807 patients studied, 28,469 (57.2%) were ambulatory, 15,148 (31.0%) were ambulatory with assistance, 5395 (10.8%) were wheelchair bound, and 525 (1.1%) were bedridden. There was a 2-fold increase in the odds of 30-day death in patients who were ambulatory with assistance (odds ratio [OR], 2.03; 95% confidence interval [CI], 1.77-2.34; P < .001) and wheelchair-bound patients (OR, 2.09; 95% CI, 1.74-2.51; P < .001), and a more than 6-fold increase in bedridden patients (OR, 6.28; 95% CI, 4.55-8.65; P < .001) compared with ambulatory patients. There was a significantly higher odds of postoperative complications in patients who were ambulatory with assistance or bedridden, but no difference with wheelchair-bound patients. Among ambulatory patients, the risks of major amputation and death within 1 year were only 10% and 12%, respectively, whereas that of bedridden patients were as high as 30% and 38%, respectively. A stepwise decrease in amputation-free survival from 81% with full ambulatory capacity to less than 50% (47.7%) in bedridden patients was observed. The risk of major amputation or death within 1 year was 35% higher for ambulatory with assistance (hazard ratio [HR], 1.35; 95% CI, 1.26-1.44; P < .001), 65% higher for wheelchair-bound (HR, 1.65; 95% CI, 1.51-1.79; P < .001) and 2.6-fold higher for bedridden (HR, 2.64; 95% CI, 2.17-3.21; P < .001) compared with ambulatory. A similar association was seen for 1-year freedom from major amputation and 2-year survival. ConclusionsAmbulatory impairment in patients with CLTI is associated with a significant increase in 30-day mortality and significant decrease in amputation-free survival after peripheral endovascular intervention. Bedridden patients had a 6-fold increase in the 30-day death rate, whereas their amputation-free survival dropped to less than 50% at 1 year. These risks should be considered during shared decision-making regarding management options for nonambulatory patients with CLTI.

Abstract 13331: Impact of Longer Hemodialysis Vintage With Higher Serum Phosphorus Level on Clinical Outcomes in Patients With Chronic Limb-threatening Ischemia

Background: Although hemodialysis vintage and serum phosphorus level adversely impact on outcomes in the field of general population on hemodialysis, it has not systematically studied whether these have similar prognostic impacts on clinical outcomes in population with chronic limb-threatening ischemia (CLTI). Methods: The current study retrospectively analyzed 374 hemodialysis patients with CLTI presenting ischemic tissue loss (age: 72.3±9.0 years, male: 73.3%, diabetes mellitus: 39.6%, Rutherford 5: 75.9%, 6: 24.1%, WIFI stage 4: 50.0%) primarily treated with endovascular therapy (EVT) between April 2007 and December 2016. Primary outcome measure was 1-year amputation-free survival (AFS), while secondary outcome measure was 1-year wound healing. Predictors for each outcome were evaluated by Cox proportional hazards model. Result: One-year rate of AFS and wound healing rate were 70.5±2.5%, and 57.1±3.0%, respectively. Multivariate analysis demonstrated that body mass index (hazard ratio [HR], 0.918; 95% confidence interval [CI], 0.859-0.981; p=0.012), non-ambulatory status (HR, 1.887; 95% CI, 1.222-2.913; p=0.004), lower serum albumin level (HR, 0.591; 95% CI, 0.414-0.844; p=0.004), WIfI stage 4 (HR, 1.782; 95% CI, 1.156-2.748; p=0.009) and longer vintages for hemodialysis with higher serum phosphorus levels (HR, 1.670; 95% CI, 1.099-2.537; p=0.016) were significantly associated with 1-year AFS (Figure), while WIfI stage 4 (HR, 0.713; 95% CI, 0.519-0.979; p=0.037) was associated and longer vintages for hemodialysis with higher serum phosphorus levels was close to significant association (HR, 0.684; 95% CI, 0.467-1.000; p=0.050) with 1-year wound healing. Conclusion: Longer hemodialysis vintage with higher serum phosphorus level would adversely affect clinical outcomes after EVT for hemodialysis patients with CLTI presenting ischemic tissue loss.

Abstract 14286: Significance of Nutritional Status in Patients With Chronic Limb Threatening Ischemia

Introduction: The nutrition status plays a key role in the pathogenesis of frailty, and is strongly associated with the prognosis of patients with chronic limb-threatening ischemia (CLTI). The Geriatric Nutritional Risk Index (GNRI) is a widely used, simple, and well established nutritional status screening method. The association between the GNRI and wound healing in patients with CLTI has not been established. Hypothesis: We assessed the hypothesis that GNRI is associated with wound healing in patients with CLTI. Methods: We conducted a single-center retrospective analysis for 172 consecutive CLTI patients who were admitted to our hospital from August 2017 to April 2019 (age 70±14 years; men 62.2%). The GNRI on admission was calculated as follows: [14.89 х albumin (g/dL)] + [41.7 х (bodyweight/ideal body weight)]. According to the GNRI values, 4 grades of nutrition-related risk are defined as major risk (GNRI:&lt;82), moderate risk (GNRI: 82 to &lt;92), low risk (GNRI: 92 to 98), and no risk (GNRI: &gt;98). The amputation-free survival (AFS) and the cumulative wound healing rate are calculated by the log-rank test. The receiver operating characteristic curve was used to obtain a cutoff value for wound heal. Cox proportional hazards regression analysis was performed to explore the independent association between the GNRI and wound heal. Results: The follow-up period was 12±6.7 months. The 1-year AFS in no risk, low risk, moderate risk, and major risk groups were 90%, 74%, 66%, and 62%, respectively ( P =0.045). GNRI was significantly associated with WIfI wound score (W1, 95±8.8; W2, 87±8.0; W3, 84±9.3, P &lt;0.001). The 1-year cumulative wound healing rate in no risk, low risk, moderate risk, and major risk groups were 56%, 45%, 37%, and 32%, respectively ( P =0.036). GNRI=95 was selected as cutoff value with maximum discriminative power for wound healing (sensitivity 70%, specificity 60%; Area under the curve, 0.67; 95% confidence interval, 0.59-0.76). GNRI&gt;95 was an independent predictor of wound healing (Hazard ratio, 1.9; 95% confidence interval, 1.0-3.7; P =0.046). Conclusions: The GNRI was significantly associated with AFS and wound healing in patients with CLTI. GNRI=95 is a novel cutoff value to predict wound healing during follow-up.

Nonambulatory Patients With Chronic Limb-threatening Ischemia Have Worse One-year Amputation-Free Survival After Peripheral Endovascular Intervention Compared to Ambulatory Patients

Despite prior literature recommending against limb salvage in nonambulatory patients, peripheral endovascular interventions (PVI) continue to be carried out in this group of patients with chronic limb-threatening ischemia (CLTI) for various reasons. Clinical outcomes following these interventions are however not well-characterized. We aimed to compare in-hospital outcomes and 1-year amputation-free survival between ambulatory and nonambulatory patients with CLTI who underwent PVI.

219-OR: Comparison of the Impact of Autologous Cell Therapy and Conservative Treatment on Chronic Limb-Threatening Ischemia in Patients with Diabetic Foot: A Randomized Controlled Trial

Background: Autologous cell-therapy (ACT) is a new treatment method for patients with diabetes and no-option chronic limb-threatening ischemia (NO-CLTI). We aimed to assess the impact of ACT on CLTI in comparison with standard treatment (ST) in a randomized controlled trial. Methods: Forty diabetic patients with NO-CLTI were randomized to receive either cell therapy (n=20) or standard conservative therapy (n=16); 4 patients dropped out of the study. After 3 months, those in the ST group were switched to ACT (cell therapy crossover). The effect on ischemia and diabetic foot was assessed by changes in transcutaneous oxygen pressure (TcPO2) and the number of healed patients at 3 months. Amputation rates and amputation-free survival (AFS) were assessed at 3 months and then during 12-month follow-up. Results: TcPO2 increased significantly in the ACT group after 1 and 3 months (both p&amp;lt;0.001) whereas TcPO2 in the control group remained unchanged (NS). After the crossover to cell therapy in patients of the ST group, we observed a significant increase in TcPO2 at 1 and 3 months after the injection of ACT (p=0.036 and p&amp;lt;0.001, respectively). We also observed significantly more healed patients at 3 months in the ACT group compared to the ST group (p=0.01). The rates of major amputation and AFS at 3 months were not significantly different between the ACT and ST groups (both NS). In Kaplan-Meier estimate, patients treated initially by ACT showed a trend towards higher AFS rates compared to those treated initially by ST who received ACT after the 3-month delay, but without a significant difference (65 vs. 43.8%). Conclusions: Our study showed that ACT in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing when compared to standard conservative therapy, without influencing amputation rates and with a trend to higher 1-year AFS in comparison with delayed ACT treatment in ST group. Disclosure M. Dubsky: None. R. Bem: None. A. Nemcova: None. J. Husáková: None. V. Fejfarova: None. A. Jirkovska: None. K. Sutoris: None. Funding Ministry of Health of the Czech Republic (16-27262A, 00023001)

Outcome of rectus femoris muscle flaps for groin coverage after vascular surgery

ObjectiveThe aim of this retrospective cohort study was to investigate the outcome of rectus femoris muscle flaps (RFFs) for deep groin wound complications in vascular surgery patients and to compare the outcome with a cohort of sartorius muscle flaps (SMFs) because the RFF is a promising alternative technique for groin coverage. MethodsAll RFFs and SMFs performed by vascular surgeons in a regional collaboration in The Southern Netherlands were retrospectively reviewed. Primary outcomes were muscle flap survival, overall and secondary graft salvage, and limb salvage. Secondary outcomes were 30-day groin wound complications and mortality, donor site and vascular complications, 1-year amputation-free survival, overall patient survival, impaired knee extensor function, and length of hospital stay. ResultsA total of 96 RFFs were performed in 88 patients (mean age, 68 years; 67% male) and compared with a cohort of 30 SMFs in 28 patients (mean age, 64 years; 77% male). At a mean follow-up of 29 months and 23 months, respectively, comparable flap survival (94% vs 90%), secondary graft salvage (80% vs 92%), and limb salvage (89% vs 90%) rates were found. The 30-day mortality rates were 12% and 17%, respectively, and the 1-year amputation-free survival was comparable between treatment groups (71% vs 68%). ConclusionsThis study presents a large series of RFFs for deep groin wound complications after vascular surgery. We demonstrate that muscle flap coverage using the rectus femoris muscle by vascular surgeons is an effective way to manage complex groin wound infections in a challenging group of patients, achieving similarly good results as the SMF.

Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia.

We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days (P = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.