Revascularization For Chronic Limb-threatening Ischemia Research Articles

Validity of the Global Vascular Guidelines in Predicting Outcomes in a Comprehensive Wound Care Program

Recent Global Vascular Guidelines (GVG) recommend selecting an endovascular vs open surgical approach to lower-extremity revascularization for chronic limb-threatening ischemia (CLTI) based upon the Global Limb Anatomic Staging System (GLASS) and Wound, Ischemia, and Foot Infection (WIfI) staging system. We reviewed the utility of GVG-recommended revascularization strategies in predicting patient outcomes in our comprehensive wound care program.

Relationship Between Global Limb Anatomic Staging System and Clinical Outcomes After Infrapopliteal Revascularization for Chronic Limb Threatening Ischemia

The Global Vascular Guidelines' “Global Limb Anatomic Staging System” (GLASS) was designed to provide an angiography-based anatomic classification of peripheral vascular disease and to guide revascularization strategies. Our study uses GLASS to evaluate outcomes after open and endovascular isolated infrapopliteal revascularization for chronic limb-threatening ischemia.

The Vascular Quality Initiative Chronic Limb-Threatening Ischemia Mortality Prediction Model Underestimates Mortality After Infrainguinal Revascularization

Perioperative mortality remains high in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). To facilitate decision-making, a mortality prediction model derived from the Vascular Quality Initiative (VQI) database has stratified patients into low, medium, and high risk, defined as a 30-day and 2-year mortality of ≤3% and ≤30%, 3%-5% or 50%-70%, and ≥5% or ≥50%, respectively. The purpose of this study was to compare expected mortality derived from this model with observed outcomes using a contemporary database from a tertiary center.

Impact of homocysteine levels on mortality risk in patients with chronic limb-threatening ischemia undergoing revascularization

The current study aimed to reveal the clinical impact of plasma homocysteine levels in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization. This was a sub-analysis of a prospective multicenter registry of CLTI patients, named the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH) study. The current analysis included 192 non-dialysis-dependent CLTI patients who underwent revascularization for CLTI, and whose plasma homocysteine levels at baseline were available. The association of clinical characteristics with homocysteine levels was evaluated with the linear regression model. The association of homocysteine levels with the mortality risk was investigated using the Cox proportional hazards regression model. Cystatin C-based estimated glomerular filtration rate (eGFR) was independently associated with log-transformed homocysteine levels; the adjusted standardized regression coefficient (95% confidence interval) was − 0.432 (− 0.657 to − 0.253; P < 0.001). Homocysteine levels were significantly associated with the mortality risk in the univariate model (P = 0.017); the unadjusted hazard ratio was 1.71 (1.13–2.50) per twofold increase. The association was significantly attenuated when adjusted for cystatin C-based eGFR (P < 0.001); the hazard ratio adjusted for cystatin C-based eGFR was 1.28 (0.80–1.90; P = 0.29). An apparent association of homocysteine levels with an increased risk of mortality could be explained by renal dysfunction. Future studies will be needed to validate the current findings.

Diabetes mellitus was not associated with lower amputation-free survival after open revascularization for chronic limb-threatening ischemia - A nationwide propensity score adjusted analysis.

The risk of major amputation is higher after urgently planned endovascular therapy for chronic limb-threatening ischemia (CLTI) in patients with diabetes mellitus (DM). The aim of this nationwide cohort study was to compare outcomes between patients with and without DM following urgently planned open revascularization for CLTI from 2010 to 2014. Out of 1537 individuals registered in the Swedish Vascular Registry, 569 were registered in the National Diabetes Register. A propensity score adjusted Cox regression analysis was conducted to compare outcome between the groups with and without DM. Median follow-up was 4.3 years and 4.5 years for patients with and without DM, respectively. Patients with DM more often had foot ulcers (p = 0.034) and had undergone more previous amputations (p = 0.001) at baseline. No differences in mortality, cardiovascular death, major adverse cardiovascular events (MACE), or major amputation were observed between groups. The incidence rate of stroke was 70% higher (95% CI: 1.11–2.59; p = 0.0137) and the incidence rate of acute myocardial infarction (AMI) 39% higher (95% CI: 1.00–1.92; p = 0.0472) among patients with DM in comparison to those without. Open vascular surgery remains a first-line option for a substantial number of patients with CLTI, especially for limb salvage in patients with DM. The higher incidence rates of stroke and AMI among patients with DM following open vascular surgery for infrainguinal CLTI require specific consideration preoperatively with the aim of optimizing medical treatment to improve cardiovascular outcome postoperatively.

The Global Anatomic Staging System Does Not Predict Limb Based Patency of Tibial Endovascular Interventions

Anatomic grading systems have historically been poor predictors of patency after endovascular tibial interventions. The Global Vascular Guidelines proposed a new Global Anatomic Staging System (GLASS) to estimate one-year limb-based patency (LBP). The purpose of this study was to determine the association of GLASS with LBP following endovascular tibial interventions. We included all patients presenting to our multidisciplinary diabetic limb preservation service between 01/2012 and 8/2020 who underwent first-time endovascular tibial revascularization for chronic limb-threatening ischemia. Diagnostic angiograms were reviewed to define the preferred target artery pathway and assign a GLASS stage to each treated limb. One-year LBP was calculated and compared across GLASS stages using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models. We performed tibial revascularization in 96 limbs (5.2% rest pain, 56.3% ulcer, 37.5% gangrene), including isolated tibial interventions in 61.5% and tibial + femoropopliteal interventions in 38.5%. 15.6% of limbs were GLASS stage 1, 28.1% were GLASS stage 2, and 56.3% were GLASS stage 3. Overall, one-year LBP was 43.2 ± 6.3%, and did not differ significantly across GLASS stages (P = 0.42). The hazard ratio for failed LBP was 1.94 (95% CI 0.70-5.41) for GLASS stage 2 and 1.49 (95% CI 0.56-3.94) for GLASS stage 3 limbs (versus GLASS stage 1). When analyzed excluding the calcium modifier, LBP remained similar across GLASS stages (P = 0.72). Major amputation was uncommon, occurring in 9.3 ± 3.4% of limbs at one year, and did not significantly differ by GLASS stage (P = 0.98). The Global Anatomic Staging System did not predict limb-based patency following tibial endovascular interventions. Given the low major amputation rates in this cohort, anatomic complexity should not preclude endovascular limb salvage efforts below the knee.

Frequency of limb salvage after infra-inguinal bypass for chronic limb-threatening ischaemia in diabetics: A retrospective study.

A study was conducted to assess the number of limbs salvaged among diabetic patients with chronic limb-threatening ischaemia after infra-inguinal bypass surgeries at a low- to middle-income country (LMIC) hospital. It was a retrospective chart review of diabetic patients who underwent infra-inguinal bypass for lower leg revascularisation for chronic limb-threatening ischaemia at the Section of Vascular Surgery, Aga Khan University Hospital, Karachi (Pakistan) from January 2008 till April 2019. Diabetic patients with chronic limb-threatening ischaemia had a salvage rate of 90.5%(29/32) after infra-inguinal bypass surgery in our set up which is comparable to those described in the literature.

Clinical Impact of Measures for Frailty Severity in Poor-Risk Patients Undergoing Revascularization for Chronic Limb-Threatening Ischemia.

Aim: This study aimed to demonstrate the clinical impact of various frailty-related aspects in poor-risk patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). Methods: We analyzed a clinical database of a prospective multicenter observational study. A total of 562 CLTI patients who required assistance for their daily lives and were candidates for revascularization were included. We examined various measures of frailty severity, including activities of daily living (ADL)/mobility, physical performance, nutritional status, cognitive function, and cardiac function at baseline (before revascularization). Data on inflammatory markers at baseline and ADL/mobility before CLTI onset were also collected. Results: The patients were aged 77±10 years, 65% were non-ambulatory, and 38% were categorized as mild dementia or severer. The correlation coefficients between the frailty measures ranged from 0.00 to 0.91. The random forest analysis for one-year mortality risk showed that these frailty-related measures, as well as age and inflammatory markers, had a relatively high variable importance compared with comorbidities and limb severity. Conclusion: The correlations between measures of frailty severity were not always strong but rather widely varied in CLTI patients who required assistance for their daily lives and were candidates for revascularization. Measures of frailty severity, as well as age and inflammatory markers, had a relatively large predictive impact on one-year mortality risk compared with comorbidities and limb severity in the population.

Association Between Wearable Device–Based Measures of Physical Frailty and Major Adverse Events Following Lower Extremity Revascularization

Physical frailty is a key risk factor associated with higher rates of major adverse events (MAEs) after surgery. Assessing physical frailty is often challenging among patients with chronic limb-threatening ischemia (CLTI) who are often unable to perform gait-based assessments because of the presence of plantar wounds. To test a frailty meter (FM) that does not rely on gait to determine the risk of occurrence of MAEs after revascularization for patients with CLTI. This cohort study included 184 consecutively recruited patients with CLTI at 2 tertiary care centers. After 32 individuals were excluded, 152 participants were included in the study. Data collection was conducted between May 2018 and June 2019. Physical frailty measurement within 1 week before limb revascularization and incidence of MAEs for as long as 1 month after surgery. The FM works by quantifying weakness, slowness, rigidity, and exhaustion during a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. The FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of physical frailty. Of 152 eligible participants (mean [SD] age, 67.0 [11.8] years; 59 [38.8%] women), 119 (78.2%) were unable to perform the gait test, while all could perform the FM test. Overall, 53 (34.9%), 58 (38.1%), and 41 (27.0%) were classified as robust (FI <0.20), prefrail (FI ≥0.20 to <0.35), or frail (FI ≥0.35), respectively. Within 30 days after surgery, 24 (15.7%) developed MAEs, either major adverse cardiovascular events (MACE; 8 [5.2%]) or major adverse limb events (MALE; 16 [10.5%]). Baseline demographic characteristics were not significantly different between frailty groups. In contrast, the FI was approximately 30% higher in the group that developed MAEs (mean [SD] score, 0.36 [0.14]) than those who were MAE free (mean [SD] score, 0.26 [0.13]; P = .001), with observed MAE rates of 4 patients (7.5%), 7 patients (12.1%), and 13 patients (31.7%) in the robust, prefrail and frail groups, respectively (P = .004). The FI distinguished individuals who developed MACE and MALE from those who were MAE free (MACE: mean [SD] FI score, 0.38 [0.16]; P = .03; MALE: mean [SD] FI score, 0.35 [0.13]; P = .004) after adjusting by body mass index. In this cohort study, measuring physical frailty using a wrist-worn sensor during a short upper extremity test was a practical method for stratifying the risk of MAEs following revascularization for CLTI when the administration of gait-based tests is often challenging.

Abstract 13208: Pedal Arterial Calcification Score Correlates With Risk of Death and Major Adverse Cardiovascular Event in Patients With Chronic Limb Threatening Ischemia

Introduction: Peripheral arterial disease is associated with cardiovascular morbidity and mortality, and the burden of PAD can be used to reclassify risk within CVD models. We describe a novel, practical score for quantifying peripheral arterial calcification based on plain x-ray films of the foot (MAC). We hypothesize that high MAC score is associated with risk of death and major adverse cardiovascular events (MACE; defined as MI, coronary intervention, CVA, TIA) in patients with chronic limb-threatening ischemia (CLTI). Methods: This is a single-institution retrospective study of 275 patients who underwent infrainguinal revascularization for CLTI between 1/2011 and 7/2019. MAC scores were calculated by a single blinded reviewer using two-view plain foot radiographs. Each patient was assigned a score of 0-5, with 1 point each for calcifications &gt; 2 cm in the dorsalis pedis, plantar and metatarsal arteries, and &gt; 1 cm in the hallux and non-hallux digital arteries. Results: The distribution of MAC scores was 0 (45%), 1 (4.7%), 2 (8.4%), 3 (18%), 4 (12%) and 5 (11%). MAC scores were trichotomized [mild (0-2), moderate (3-4), severe (5)] and higher scores were associated with male sex, DM, ESRD, and history of smoking. Median follow-up was 620 days (IQR 263-1494). Higher MAC score was significantly associated with MACE (p=0.01) and all-cause mortality (p=0.03), and was predictive of worse MACE-free survival (MACEFS; p=0.01; Figure 1 ). In a Cox Proportional Hazards model for MACEFS that included age; ESRD; CAD; history of CVA or TIA; Society for Vascular Surgery Wound, Ischemia and foot Infection (WIfI) stage; and MAC; the most severe MAC score (HR 1.8 [1.01-3.4] for MAC 5, p=0.04) was significantly associated with worse MACEFS. Conclusions: The MAC score is an independent predictor of MACE-free survival in patients with CLTI. It is a simple, quick and inexpensive tool that has the potential to stratify patients at highest risk of long-term cardiovascular complications.

Impact of the Timing of Foot Tissue Resection on Outcomes in Patients Undergoing Revascularization for Chronic Limb-Threatening Ischemia.

The objective of this study is to describe utilization of revascularization and tissue resection in patients with chronic limb-threatening ischemia (CLTI) and determine whether the timing of resection impacts outcomes. Revascularizations for CLTI were queried (ACS-NSQIP 2011-2015). Outcomes included 30-day major adverse limb events (MALE), major adverse cardiac events (MACE), length of stay (LOS), operative time, 30-day readmissions, and wound infections. Groups included revascularization alone, revascularization/tissue resection during the same procedure (concurrent), or revascularization/delayed tissue resection (delayed). Resections were debridement or transmetatarsal amputations. Multivariate logistic regression determined risk-adjusted effects of tissue resection on outcomes. There was no difference in overall 30-day MACE or MALE between groups (P = .70 and P = .35, respectively). Length of stay (6.1 days revascularization alone vs 7.8 days concurrent vs 8.7 days delayed, P < .0001) was longer in patients who underwent any tissue resection. Highest 30-day readmission and operative time was the concurrent group (P = .02 and P < .0001, respectively). Wound infection was highest in the delayed group (1.4% revascularization alone vs 1.3% concurrent vs 6.2% delayed, P < .0001). After risk adjustment, timing of resection did not impact LOS for concurrent and delayed groups compared to revascularization alone (both P < .0001). Debridement and minor amputations can be done concurrently in patients undergoing revascularization for CLTI.

Lower Extremity Revascularization for Chronic Limb-Threatening Ischemia among Patients at the Extremes of Age

Patients with chronic limb-threatening ischemia (CLTI) at the extremes of age are thought to have distinct risk factor profiles and poor outcomes after lower extremity revascularization (LER). The aim of this study is to examine the relationships among age, risk factor profiles, and outcomes of LER in patients with CLTI in a large database focusing on the extreme age groups. Patients undergoing LER for CLTI in the Vascular Quality Initiative suprainguinal bypass, infrainguinal bypass, and peripheral vascular intervention files were reviewed through 2019. Patients were stratified into 3 groups: premature peripheral artery disease (PAD) (≤50years old), 51-84years old, and elderly (≥85 years old). Trends in major amputation and mortality by age group were analyzed. There were 156,513 patients who underwent LER for CLTI. Of these, 9,063 (5.79%) patients had premature PAD, 131,694 (84.14%) patients were 51-84years old, and 15,756 (10.07%) were elderly. Patients with premature PAD were more likely to have insulin-dependent diabetes, be dialysis-dependent, and be active smokers compared to patients 51-84years old and the elderly. Elderly patients were more likely to undergo an endovascular procedure for tissue loss compared to younger groups. Perioperative and 1-year major amputation rates were highest among patients with premature PAD and decreased with increasing age (P<0.001), while perioperative and 1-year mortality increased with age (P<0.001). On multivariable analysis, premature PAD was associated with an increased risk of major amputation (odds ratio, OR=1.41 [1.22-1.62]), while elderly age was associated with decreased odds of major amputation compared to patients 51-84years old (OR=0.61 [0.51-0.73]). Patients at the extremes of age have significantly different outcomes after LER for CLTI. Although mortality increases with age, the risk of major amputation decreases. Patients with premature PAD constitute a group of patients with a high risk of perioperative and 1-year major amputation.

Discrepancy in Outcomes after Revascularization for Chronic Limb-Threatening Ischemia Warrants Separate Reporting of Rest Pain and Tissue Loss

Chronic limb-threatening ischemia (CLTI) manifests as rest pain (RP) and tissue loss (TL). Outcomes of lower extremity revascularization (LER) for CLTI have traditionally been evaluated as a single entity and compared with claudication. We hypothesize that patients presenting with TL have worse short-term outcomes after LER, compared to patients with RP. The National Inpatient Sample was reviewed between 2009 and 2013. All patients undergoing LER for TL and RP were identified. Patient characteristics, Charlson Comorbidity Index (CCI), length of stay, rates of inpatient major amputation, and mortality after LER were noted. Multivariable regression analysis was performed to identify predictors of inpatient mortality and major amputation between the 2 groups. A total of 218,628 patients underwent LER (RP=76,108, TL=142,519). Patients with TL were more likely to undergo endovascular LER (RP=31.3% vs. TL=48.7%; P<0.001). Patients with TL had higher comorbidities as suggested by increased likelihood of having CCI ≥3 (RP=22.9% vs. TL=40.3%; P<0.001). The mean costs were significantly higher in the TL group (RP=$23,795 vs. TL=$31,470; P<0.001). There was a significantly higher rate of major amputation (RP=1.3% vs. TL=6.6%; P<0.001) and inpatient mortality (RP=0.9% vs. TL=1.9%; P<0.001) after LER for TL. On multivariable analysis, TL was independently associated with increased major amputation (odds ratio [OR] 4.93, 95% confidence interval [CI] 4.18-5.81) and increased mortality (OR 1.42, 95% CI 1.16-1.74) compared to RP. There is significant discrepancy in outcomes of LER for TL and RP. TL is independently associated with major amputation and inpatient mortality. Outcomes of LER for TL and RP should be reported separately for better benchmarking.

Living in a Food Desert is Associated with 30-day Readmission after Revascularization for Chronic Limb-Threatening Ischemia

Living in a food desert has been associated with increased cardiovascular risk; however, its impact on vascular surgery outcomes is unknown. This study hypothesized that living in a food desert would be associated with increased postoperative complications in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). This was a single-center retrospective analysis of open and endovascular infrainguinal revascularization for CLTI between April 2013 and December 2015. A food desert was defined using the US Department of Agriculture's Food Access Research Atlas. Bivariate analyses were performed appropriate to the data. Binary logistic regression was performed assessing the association of food desert status with 30-day postoperative complications. In total, 152 cases were included, of which 17% (n=26) resided in food deserts. Patients in the food desert cohort were less likely to be low income (27% vs. 54%, P=0.01). Living in a food desert was associated with increased 30-day readmission [(39% vs. 20%, P=0.04), unadjusted OR: 2.5 (CI: 1.0-6.2)]. FD cases also had a higher proportion of wound complications [12 (46%) vs. 28 (22%), P=0.01)]. The overall wound complication rate was 27% with the majority being due to infections (63%). On multivariable analysis, food desert status remained associated with increased odds of 30-day readmission (OR: 2.7, CI: 1.2-8.4, P=0.047). Reasons for readmission in the food desert group were all due to wound complications (100% vs. 72%, P=0.08). Living in a food desert was associated with nearly three times the odds of 30-day readmission after lower extremity revascularization for CLTI. This increase in readmission may be explained through increased wound complications. These findings support considering access to healthy food as a potential modifiable risk factor for adverse outcomes, particularly in CLTI revascularization.

Increased Reintervention After Infrainguinal Revascularization for Chronic Limb-Threatening Ischemia in Women

The objective of this study was to determine if there are gender-based differences in major adverse limb events after revascularization for chronic limb-threatening ischemia (CLTI) and to identify potential associated factors. This was a single-center retrospective analysis of 151 patients who underwent infrainguinal revascularization for CLTI between April 2013 and December 2015. Only the first revascularized limb was included in patients with bilateral CLTI. Demographic data and clinical outcomes were collected using electronic medical records. The mean age was 68.1±12.1years, and 55 of 151 (36%) were women. Women were less likely to carry a diagnosis of hyperlipidemia (60% vs. 83%; P=0.003), less likely to be on a statin medication (58% vs. 81%; P=0.004), and less likely to undergo an infrapopliteal revascularization (60% vs. 77%; P=0.04) compared with men. There were no differences between genders with regard to the Society for Vascular Surgery Wound Ischemia and Foot Infection stage at presentation or utilization of open versus endovascular intervention. During the median follow-up time of 678days (interquartile range, 167-1277days), 48 of 151 patients (32%) underwent reintervention on the threatened limb and 23 of 151 patients (15%) underwent major amputation. Women were more likely than men to need reintervention (P=0.02). There was no difference between genders for major amputation (P=0.48) or overall survival (P=0.65). In a multivariable Cox proportional hazards model for reintervention that included gender, preoperative body mass index, hyperlipidemia, preoperative anticoagulation, and ischemia score ≥2 (all P<0.20 in univariate analysis), female gender (hazard ratio [HR], 1.96 [1.10-3.54]; P=0.02) and hyperlipidemia (HR, 2.32 [1.07-5.03]; P=0.03) were significantly associated with increased rates of reintervention. Women undergoing lower extremity revascularization for CLTI were more likely to require reintervention compared with men but had similar rates of limb preservation. Further study is required to understand potential causative factors to improve treatment outcomes in women.

Significance of Recovery of Limb Function After Surgical Revascularization in Chronic Limb-Threatening Ischemia

Wound healing and ambulation could be pivotal goals in treatment of chronic limb-threatening ischemia (CLTI). To show the impact these limb functions have on the patient’s prognosis, the wound-free ambulation (WFA) rate was evaluated as a new end point. Based on clinical outcomes of 187 patients (225 limbs) who underwent surgical revascularization for CLTI between January 2012 and December 2017 in a single center (74% diabetes and 50% dialysis), WFA, which was the end point to complete wound healing and achievement of ambulation after revascularization, was assessed. Significance of WFA in patients’ prognosis and factors associated with WFA were analyzed by the Cox proportional hazards model. WFA rate reached 52% at 3 months and 65% at 6 months after surgery. Wound, Ischemia, and foot Infection (WIfI) clinical stage did not alter patients’ survival rate in this series; however, WFA clearly stratified patients’ prognosis in CLTI. There was significant difference in 2-year survival rate between patients who achieved WFA and patients who did not (73% and 40%; P < .01). In particular, WFA was the strongest factor associated with postoperative patients’ prognosis. Multivariate analysis demonstrated four statistically significant predictors of WFA: heart failure (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.32-0.70), low nutrition (serum albumin concentration <3.0 g/dL; HR, 0.64; 95% CI, 0.42-0.98), limb severity expressed by WIfI classification (HR, 0.16; 95% CI, 0.09-0.26), and loss of ambulation on CLTI onset (HR, 0.25; 95% CI, 0.16-0.40). Thus, WFA was a comprehensive factor including these multiple factors associated with patients’ survival rate in CLTI. Limb function expressed by WFA was related to postoperative patients’ prognosis after revascularization. Recovery of limb function after revascularization might be an important end point to extend a life prognosis of CLTI patients.

Limb-Based Patency After Surgical vs Endovascular Revascularization in Patients with Chronic Limb-Threatening Ischemia

Purpose: To determine whether limb-based patency (LBP) after infrainguinal revascularization for chronic limb-threatening ischemia (CLTI) is similar between bypass surgery and endovascular therapy (EVT). Materials and Methods: The database for the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study was interrogated to identify 130 patients (mean age 73±8 years; 94 men) who underwent bypass surgery and 271 patients (mean age 74±10 years; 178 men) who underwent EVT alone. Skin perfusion pressure (SPP) and the ankle-brachial index (ABI) were measured before the procedure and at 0, 1, and 3 months after revascularization. The outcome measure was hemodynamically evaluated LBP (SPP ≥10 mm Hg or ABI ≥0.1) maintained over the first 3 months after treatment. Any reintervention or major amputation was regarded as loss of LBP. The associations between the revascularization strategy (bypass vs EVT) and between the preoperative characteristics and the study outcome (ie, SPP- or ABI-based LBP), were determined using generalized linear mixed models with a logit link function. Patency rates are presented with the 95% confidence interval (CI). Results: The bypass surgery group had a higher stage of limb severity (WIfI) and anatomic complexity (GLASS) than the EVT group, whereas the EVT group had a higher prevalence of heart failure. Both SPP- and ABI-based LBP rates were higher in the bypass group than in the EVT group. SPP-based LBP rates at 3 months were 73.8% (95% CI 63.4% to 84.2%) in the bypass group and 46.2% (95% CI 38.5% to 53.8%) in the EVT group; the corresponding ABI-based LBP rates were 71.5% (95% CI 61.8% to 81.2%) and 44.0% (95% CI 37.3% to 50.7%). Conclusion: LBP is an important concept in the new global vascular guidelines for assessing the anatomic and hemodynamic status of CLTI patients. The present study found that LBP was significantly lower in the EVT group vs the bypass surgery group.

Competing Risk Analysis of the Impact of Pedal Arch Status and Angiosome-Targeted Revascularization in Chronic Limb-Threatening Ischemia

In the context of chronic limb-threatening ischemia, the prognostic impact of angiosome-targeted revascularization and of the status of the pedal arch are debated. This series includes 580 patients who underwent endovascular (n=407) and surgical revascularization (n=173) of the infrapopliteal arteries for chronic limb-threatening ischemia associated with foot ulcer or gangrene. The risk of major amputation after infrapopliteal revascularization was assessed by a competing risk approach. A subanalysis was made separately for patients who underwent endovascular or open surgical revascularization. At 2years, survival was 65.1% and leg salvage was 76.1%. Multivariable competing risk analysis showed that C-reactive protein ≥10mg/dL, diabetes, rheumatoid arthritis, increased number of affected angiosomes, and the incomplete or total absence of pedal arch compared with complete pedal arch (CPA) were independent predictors of major amputation after infrapopliteal revascularization. Multivariable analysis showed increasing risk estimates of major amputation in patients with incomplete (subdistribution hazard ratio [SHR], 2.131; 95% confidence interval [95% CI], 1.282-3.543) and no visualized pedal arch (SHR, 3.022; 95% CI, 1.553-5.883) compared with CPA. Pedal arch was important even if angiosome-targeted revascularization was achieved: Angiosome-directed revascularization in presence of CPA had a lower risk of major amputation (adjusted SHR, 0.463; 95% CI, 0.240-0.894) compared with angiosome-directed revascularization without CPA. In the subanalysis, among patients who underwent endovascular revascularization, CPA (SHR, 0.509; 95% CI, 0.286-0.905) and angiosome-targeted revascularization (SHR, 0.613; 95% CI, 0.394-0.956) were associated with a lower risk of major amputation. Competing risk analysis showed that a patent pedal arch had significant impact on leg salvage and that the subset of patients undergoing endovascular procedure may most benefit of an angiosome-targeted revascularization.

Amputation-free survival, limb symptom alleviation, and reintervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia

BackgroundThe optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study, we investigated outcomes after open and endovascular revascularization in the femoropopliteal segment for CLTI. MethodsBetween March 2011 and January 2015, there were 190 patients presenting with CLTI with the principal target lesion in the superficial femoral or popliteal segment who underwent endovascular intervention (n = 117) or bypass surgery (n = 73) and were observed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were observed for 2 years. The primary end point was amputation-free survival (AFS) assessed with Kaplan-Meier estimates; secondary end points included CLTI symptom alleviation rates and reintervention rates. A Cox proportional hazards regression model was used to investigate risk factors for amputation and death. ResultsAFS at 2 years was 59% in the endovascular group and 76% in the bypass group (P = .020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis, the observed difference in AFS between the groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (hazard ratio, 2.38; 95% confidence interval, 1.14-4.96). At 2 years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% vs 45%; P = .009). The proportions of patients who underwent reintervention within 2 years were similar in the two groups (38% vs 39%; P = .90), but repeated reinterventions were more frequent in the bypass group. ConclusionsAt 2 years, bypass surgery was associated with higher AFS than endovascular intervention, a finding that could not be explained only by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both 1 year and 2 years after revascularization. Reinterventions to maintain patency were equally common after bypass and endovascular intervention.

The Association of Preoperative Characteristics with Reintervention Risk in Patients Undergoing Revascularization for Chronic Limb-Threatening Ischemia.

Aim: To investigate the associations between preoperative characteristics and the risk of reintervention in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI) in a contemporary real-world setting.Methods: We retrospectively analyzed data from a clinical database formed by the Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study, which was a multicenter, prospective, observational study. The study population was composed of 520 CLTI patients with the wound, ischemia, and foot infection (WIfI) classes I-3 with resting pain or classes I-2/3 with ulcers/gangrene. Of the 520 patients, 192 had surgical reconstruction planned, whereas 328 had endovascular therapy (EVT) alone planned at the time of registration. The current analysis was conducted to explore the associations between preoperative characteristics and the risk of reintervention.Results: A total of 452 participants (87%) completed the 3-year follow-up regarding reintervention. The competing risk analysis estimated that the three-year cumulative incidence rates for reintervention and reintervention-free deaths were 44.0% and 28.7%, respectively. No preoperative characteristics had a significant interaction effect with EVT versus surgical reconstruction. The risk analysis identified the following independent risk factors for reintervention: 1) EVT instead of bypass reconstruction, 2) renal dysfunction, 3) history of revascularization after CLTI onset (i.e., requirement of redo revascularization for CLTI), and 4) bilateral CLTI. Patients with more than one of these risk factors had an increased risk of reintervention.Conclusions: The current study identified preoperative characteristics associated with an increased risk of reintervention. No preoperative characteristics had any significant interactions with EVT or surgical reconstruction.