Wound, Ischemia, And Foot Infection Stage Research Articles

Real World Application of WIfI Scores in Peripheral Arterial Disease Patients

The Society for Vascular Surgery wound, ischemia, and foot infection (WIfI) classification system aims to risk stratify patients with chronic limb threatening ischemia (CLTI), predicting both amputation rates and the need for revascularization. However, real-world utilization of the system and whether it accurately predicts outcomes following open revascularization and peripheral interventions is unclear. Therefore, we sought to determine the adoption of the WIfI classification system within a contemporary statewide collaborative as well as the impact of patient factor, and WIfI risk assessment on short- and long-term outcomes. Using data from a large statewide collaborative, we identified patients with CLTI undergoing open surgical revascularization or peripheral vascular intervention (PVI) between 2016 - 2022. The primary exposure was preoperative clinical WIfI stage. Patients were categorized according to the SVS Lower Extremity Threatened Limb Classification System into clinical WIfI stages1, 2, 3, or 4. The primary outcomes were 30-day and 1-year amputation and mortality. Multivariable logistic regression was performed to estimate the association of WIfI stage on post-revascularization outcomes. In the cohort of 17,417 patients, 83.4% (n=14,529) had WIfI stage documented. Peripheral vascular interventions (PVIs) were performed on 57.6% of patients, and 42.4% underwent an open surgical revascularization (OSR). 49.5% of patients were classified as stage 1, 19.3% stage 2, 12.8% stage 3 and 18.3% of patients met stage 4 criteria. Stage 3 and 4 patients had higher rates of diabetes, congestive heart failure, and renal failure, and were less likely to be current or former smokers. One-half of stage 3 patients underwent OSR, while stage 1 patients were most likely to have received a PVI (64%). As WIfI stage increased from 1 to 4, 1-year mortality increased from 12% to 21% (p<0.001), 30-day amputation rates increased from 5% to 38% (p<0.001), and 1-year amputation rates increased from 15% to 55% (p<0.001). Finally, patients who did not have WIfI scores classified had significantly higher 30-day and 1-year mortality, as well as higher 30-day and 1-year amputation rates. The Society for Vascular Surgery WIfI clinical stage is significantly associated with 1-year amputation rates in patients with CLTI following lower extremity revascularization. As nearly 55% of stage 4 patients require a major amputation within one year of intervention, this study supports use of the WIfI classification system in clinical decision making for patients with CLTI.

Predictors of amputation-free survival and wound healing after infrainguinal bypass with alternative conduits

ObjectiveInadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. MethodsA single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. ResultsWithin 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12). ConclusionsIn patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS.

Relevance of BEST-CLI trial endpoints in a tertiary care limb preservation program

ObjectiveMajor adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized trial. The BEST-CLI trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting. MethodsThis is a single-center retrospective study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis). ResultsAmong 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P = .008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot. ConclusionsIn this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass.

Healing rate comparison of revascularized and non-revascularized diabetic foot ulcers with peripheral arterial disease

BackgroundRevascularization is important for the healing of diabetic foot ulcers with peripheral arterial disease because it aids in the restoration of the perfusion function of the leg tissues and can reduce the risk of cardiovascular complications. However, no Indonesian studies have been identified that exclusively discuss the effectiveness of revascularization for patients with this condition. This study aimed to compare the healing rates of diabetic foot ulcers with peripheral arterial disease in patients who received or did not receive revascularization. MethodsThis cohort study included diabetic foot ulcer patients with peripheral arterial disease undergoing treatment at our institution who received or did not receive revascularization based on the wound, ischemia, and foot infection (WIfI) score criteria. Wound healing was considered complete re-epithelialization within six months of the procedure or consistent epithelialization for four consecutive weeks. Patients who required amputation within six months of observation were deemed to have failed therapy. ResultsEach group contained 23 patients. The revascularization group exhibited a healing rate of 78.3 % (18 patients), while the non-revascularization patients had a rate of 26.1 % (6 patients). The wounds of revascularized patients were 14.944 (1.102–202.692) times more likely to heal than those without revascularization (p < 0.01). WIfI stage 2–3 patients showed an 11.926 (1.438–98.883) times increase in the likelihood of wound healing compared to stage 4 WIfI patients. ConclusionThe wound healing rate was higher for revascularized patients than for non-revascularized patients, and the severity of the wound based on WIfI score affected patient wound healing.

The CHADS2 score may be a useful predictor of prognosis in chronic limb-threatening ischemia patients after endovascular intervention with and without AF

Abstract Background Chronic limb-threatening ischemia (CLTI) represents the end-stage manifestation of peripheral artery disease. Recently, the Society for Vascular Surgery established the Wound, Ischemia, and foot Infection (WIfI) classification system, focusing on disease severity rather than arterial lesion characteristics. The WIfI clinical stage has been thought to have a prognostic value in CLTI patients. While the CHADS2 score is well known to predicts ischemic stroke/transient ischemic attack in atrial fibrillation (AF) patients, the clinical significance of the CHADS2 score remains unclear in CTLI patients with and without AF. Purpose The purpose of this study was to investigate the patient’s clinical factors including WIfI clinical stage and CHADS2 score, and mortality of CLTI patients undergoing endovascular intervention. Methods This retrospective study investigated 200 consecutive CLTI patients and we individually assessed WIfI clinical stage and CHADS2 score. We then compared mortality after endovascular intervention between a WIfI stage 1, 2 group and a stage 3, 4 group, and investigated association between baseline characteristics and WIfI clinical stage 1, 2 group and a stage 3, 4 group. Results Among 200 patients, 123 patients (62%) showed WIfI stage 1 or 2, and the remaining 77 patients (38%) had WIfI stage 3 or 4. Age was significantly higher in the WIfI stage 3, 4 group [median 75, interquartile range (IQR) 68–82] compared with the WIfI stage 1, 2 group (median 70, IQR 63–79, p=0.004). The rate of AF patients was no difference between WIfI stage 1, 2 group and a stage 3, 4 group (59% vs 41%, p=0.84). CHADS2 score was significantly higher in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (median 3, IQR 2–3 vs. median 2, IQR 1–2, p=0.013). Median duration of follow-up was 966 days (IQR, 540–1268 days). Forty patients (20%) died after endovascular intervention. Incidences of all-cause death were higher in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (27% vs. 15%, p=0.047). Kaplan–Meier analysis showed a significantly lower survival rate in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (p=0.002 by log-rank test). Cox proportional hazard univariate analysis revealed that WIfI stage 3, 4 group [Hazard ratio (HR);2.62, 95% confidence interval (CI):1.39–4.91, p=0.003], CHADS2 score (HR;1.42, 95%CI:1.08–1.82, p=0.008) were correlated to all-cause death. Multivariate analysis using relevant factors from univariate analysis showed WIfI stage 3, 4 group (HR;2.18, 95% CI:1.04–4.16, p=0.031) and CHADS2 score (HR:1.34, 95% CI:1.02–1.73, p=0.019) were significantly associated with all-cause death. A comparison of P-value for interaction of WIfI stage 3, 4 group and CHADS2 score was p=0.17. Conclusion CHADS2 score may be a crucial independent predictor for incidence of all-cause death in CLTI patients undergoing endovascular intervention with and without AF.

Abstract 13060: Nutritional Status is Associated With Cardiac Death in Patients With Chronic Limb-Threatening Ischemia Undergoing Endovascular Intervention

Introduction: Chronic limb-threatening ischemia (CLTI) represents the end-stage manifestation of peripheral artery disease. The Wound, Ischemia, and foot Infection (WIfI) clinical stage has been thought to have a prognostic value in patients with CLTI. Research Questions: The relationship between cardiac death in patients with CLTI undergoing endovascular intervention (EVT) and malnutrition is unknown. Methods: This retrospective study investigated 200 consecutive patients with CLTI and we individually assessed WIfI clinical stage and nutritional status assessed using Geriatric Nutritional Risk Index (GNRI). We then compared cardiac death after EVT between a WIfI stage 1, 2 group and a stage 3, 4 group, and investigated association between baseline characteristics. Results: In 200 consecutive patients, 123 patients (62%) showed WIfI stage 1 or 2, and the remaining 77 patients (38%) had WIfI stage 3 or 4. Age was significantly higher in the WIfI stage 3, 4 group [median 75, interquartile range (IQR) 68-82] compared with the WIfI stage 1, 2 group (median 70, IQR 63-79, p=0.004). GNRI was significantly lower in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (median 88, IQR 80-97 vs. median 103, IQR 94-111, p&lt;0.001). Median duration of follow-up was 966 days (IQR, 540-1268 days). Incidences of all-cause and cardiac deaths were higher in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (27% vs. 15%, p = 0.047 and 12% vs. 3%, p = 0.040, respectively). Kaplan-Meier analysis showed a significantly lower survival rate in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (p=0.002 by log-rank test). Cox proportional hazard univariate analysis revealed that WIfI stage 3, 4 group [Hazard ratio (HR); 4.22, 95% confidence interval (CI): 1.29-13.72, p = 0.012], GNRI (HR;0.93, 95%CI:0.87-0.97, p=0.002), Hemodialysis (HR;4,67, 95%CI:1.28-16.96, p=0.010), Statin (HR;4,52, 95%CI:1.00-20.43, p=0.022), LVEF (HR;0.96, 95%CI:0.92-0.99, p=0.045) were correlated to cardiac death. Multivariate analysis models adjusted for relevant factors showed GNRI (HR;0.93, 95% CI:0.86-0.99, p=0.019) was significantly associated with cardiac death. Conclusion: GNRI may be a crucial independent predictor for cardiac death in patients with CLTI undergoing EVT.

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

ObjectiveTo 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). MethodsWe 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. ResultsWe 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). ConclusionsFor 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.

Relationship of the Wound, Ischemia, and Foot Infection Stage With Frailty, Disability, and Quality of Life at Baseline, and 1-year Outcomes in All-comers With Chronic Limb-threatening Ischemia

The wound, ischemia, and foot infection (WIfI) classification system has been widely adopted in chronic limb-threatening ischemia (CLTI) management, but validation has predominantly been among patients undergoing revascularization. This study aimed to investigate the association of WIfI stage with baseline frailty, disability, and quality of life (QoL), in addition to 1-year major amputation and survival, in all-comers with CLTI. Single-center prospective cohort study (NCT04027244) of patients aged ≥18 with CLTI, between May 2019 and March 2022. Frailty (clinical frailty scale), disability (Barthel index), and QoL (vascular QoL questionnaire; EQ-5D-5L) assessments were performed at baseline. Interim analysis of 1-year outcomes was performed in January 2023. Amputation incidence was calculated for WIfI stages, and individual WIfI score combinations with five or more patients, and presented as percentages with 95% confidence intervals (CI) (Agresti-Coull method). Associations of WIfI stage with 1-year major amputation was investigated using Fine-Gray competing risk analysis (death as competing risk), reported as subdistribution hazard ratios (HR) with 95% sCI. Associations of WIfI stage with one-year mortality was investigated using Cox regression and reported as HR with 95% CI. A total of 434 patients were included. Fifty-two patients (12.0%) classified as WIfI stage 1, 112 (25.8%) stage 2, 107 (24.7%) stage 3, 92 (21.2%) stage 4, and 71 (16.4%) had incomplete WIfI scores. Increasing WIfI stage was associated with increasing prevalence and severity of frailty (P = .002) and greater disability (P < .001). QoL scores were similar for each WIfI stage (Table I). Major amputation incidence at one-year was 2% (95% CI, 0%-11%) for WIfI stage 1, 7% (95% CI, 3%-14%) stage 2, 8% (95% CI, 4%-15%) stage 3, 21% (95% CI, 14%-30%) stage 4, and 14% (95% CI, 9%–26%) in those with incomplete WIfI scores. Amputation incidence for individual WIfI scores was largely consistent with stage classification (Table II). Increasing WIfI stage was independently associated with one-year major amputation (subdistribution HR, 2.00; 95% CI, 1.34-3.00; P = .001). Increasing WIfI stage was also associated with 1-year mortality (HR, 1.31; 95% CI, 1.02-1.68; P = .031), with frailty (clinical frailty scale score ≥5) (HR, 2.48; 95% CI, 1.33-4.61; P = .004) and nonoperative management (HR, 5.35; 95% CI, 2.98-9.59; P < .001) the strongest predictors of mortality at 1 year. WIfI classification is predictive of major amputation at one-year in patients with CLTI, but frailty status is a better predictor of mortality. Although WIfI classification is associated with both frailty and disability, it is not associated with QoL at baseline.Table IBaseline assessment scores and management strategy by WIfI stageStage 1 (n = 52)Stage 2 (n = 112)Stage 3 (n = 107)Stage 4 (n = 92)Missing (n = 71)P valueFrailty status.002 No frailty (CFS 1-3)8 (15)16 (14)10 (9)6 (7)5 (7.) Vulnerable (CFS 4)22 (42)50 (45)40 (37)20 (22)20 (28) Mild/moderate (CFS 5-6)20 (38)44 (39)52 (49)55 (60)41 (58) Severe frailty (CFS 7-9)2 (4)2 (2)5 (5)11 (12)5 (7)Barthel index20 (18-20)19 (17-20)19 (16-20)17 (15-20)18 (15-20)<.001HADS Anxiety score4.5 (2-10)7 (3-11)5 (3-9)6 (3-9)6 (3-12).414 Depression score5 (3-8)5 (3.5-9.0)5 (3-10)6 (4-10)7 (3-10).423VascuQoL score3.3 ± 1.52.8 ± 1.12.9 ± 1.13.1 ± 1.23.1 ± 1.2.143EQ-5D-5L EQ-5D value0.557 ± 0.2410.480 ± 0.2740.456 ± 0.2510.462 ± 0.2550.418 ± 0.296.237 EQ VAS55.5 ± 22.050.8 ± 23.153.6 ± 24.156.4 ± 21.847.1 ± 21.6.319Initial management<.001 Endovascular21 (40)53 (47)44 (41)40 (43)27 (38) Open/hybrid7 (13)33 (29)27 (25)15 (16)22 (31) Major amputation0 (0)0 (0)2 (2)9 (10)2 (3) Minor amputation1 (2)2 (2)3 (3)10 (11)9 (13) Nonoperative23 (44)24 (21)31 (29)18 (20)11 (15)CFS, Clinical frailty scale; HADS, Hospital Anxiety and Depression Scale; VAS, visual analogue scale; VascuQoL, Vascular Quality of Life Questionnaire.Data are presented as number (%), mean ± standard deviation, or median (interquartile range) unless otherwise stated. P values in bold are statistically significant.aData presented as. Open table in a new tab Table IIOne-year major amputation rates of individual WIfI score combinationWoundIschemia – 0Ischemia – 1Ischemia – 2Ischemia – 30––––0 (0) [0-21]–––1 (5) [0-26]–––3 (5) [1-15]–––10 (0) [0-34]–––1 (5) [0-25]2 (20) [5-52]––1 (4) [0-23]1 (14) [1-53]––1 (2) [0-13]4 (19) [7-41]––2––0 (0) [0-49]–0 (0) [0-40]0 (0) [0-32]2 (15) [3-43]–1 (17) [1-58]0 (0) [0-34]––2 (15) [3-43]4 (27) [10-52]1 (17) [1-58]–3----------------Foot infection0123012301230123Data are presented as number (%) [95% confidence interval].Color of cells denotes WIfI stage classification (estimated risk of 1-year amputation): . Amputation rates only calculated for score combinations with five or more individual patients. Open table in a new tab

Diabetes Interacts with Latinx/Hispanic Ethnicity to Increase Major Amputations After Peripheral Vascular Intervention for Chronic Limb-threatening Ischemia

Latinx/Hispanic patients treated for chronic limb-threatening ischemia (CLTI) have higher amputation rates after controlling for presenting Wound, Ischemia, and foot Infection (WIfI) status. We hypothesize that a higher incidence of diabetes mellitus (DM) in Latinx/Hispanic patients may contribute to this disparity. The Vascular Quality Initiative peripheral vascular intervention dataset (2016-2022) was queried for CLTI. Inclusion criteria were reported WIfI stage and White race or Latinx/Hispanic ethnicity. The primary endpoint was 1-year major amputation (through tibia/fibula or more proximally). A multivariate hierarchical Fine Gray analysis was performed controlling for hospital-level variation and competing risk of death. The analysis was stratified by WIfI stage, and DM was treated as an interaction term with race and ethnicity. Overall, 38,079 (45%) cases met inclusion criteria and 3247 (12%) were Latinx/Hispanic with a higher incidence of DM in Latinx/Hispanic patients (77% vs 61%; P < .01). Proportions of WIfI stages were similar between White race and Latinx/Hispanic ethnicity, respectively: stage 1 (29% vs 30%), stage 2 (38% vs 32%), stage 3 (19% vs 21%), and stage 4 (14% vs 18%). The cumulative incidence of major amputation was highest for Latinx/Hispanic patients with DM (Figure). On multivariate analysis, the 1-year subdistribution hazard ratio (SHR) for amputation was highest for Latinx/Hispanic patients with DM at 1.8 (95% confidence interval [CI], 1.3-2.4; P < .01); and 1.4; 95% CI, 0.7-2.6; P = .29) for Latinx/Hispanic without DM, and 1.4 (95% CI, 1.1-1.6; P < .01) for White race with DM compared to White race without DM. When stratified by WIfI stage, the interaction of Latinx/Hispanic ethnicity with DM conferred the greatest increase in 1-year SHR for WIfI stages 2 (SHR, 1.9; 95% CI, 1.1-3.2; P = .03) and 3 (SHR, 2.1; 95% CI, 1.2-3.7; P < .01), compared to White race without DM. Latinx/Hispanic ethnicity requiring insulin treatment for DM had the highest hazard of amputation (SHR, 2.0; 95% CI, 1.4-2.7; P < .01) (Table). The increase in major amputations for Latinx/Hispanic patients after peripheral vascular intervention for CLTI is modified by the interaction with DM with a stepwise increase for those requiring insulin treatment. This study suggests that DM prevention and treatment is a cornerstone in addressing disparities for Latinx/Hispanic patients with limb threat and reducing their amputation risk.TableSubdistribution hazard ratios (SHR) by diabetes mellitus (DM) TreatmentSHR95% CIP valueWhite racea Diet controlled0.80.5-1.2.29 Noninsulin treatment1.20.9-1.6.07 Insulin treatment1.51.2-1.8<.01Latinx/Hispanic ethnicitya No DM diagnosis1.40.8-2.6.29 Diet controlled1.50.6-3.8.26 Noninsulin treatment1.50.9-2.5.09 Insulin treatment2.01.4-2.7<.01CI, Confidence interval.Model adjusted for age, primary insurer, WIfI stage, end-stage renal disease, prior amputation, and intervention level. Boldface entries indicate statistical significance.aReference group for all: White race with no DM diagnosis. Open table in a new tab

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

ObjectiveThe 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). MethodsWe 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. ResultsWe 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). ConclusionsBypass 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.

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

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. 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. 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 < .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 < .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 < .01). The percentage of congestive heart failure (CHF) was 36.4% and 14.2% in secondary major amputation and limb salvage groups, respectively (P < .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 < .01). Limb salvage rates at 1-year were 91.0% and 68.6% in the bypass and EVT groups, respectively (P < .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 < .01) Multivariate analysis revealed that serum albumin level [Hazard ratio (HR), 0.56; 95% confidence interval (CI), 0.36-0.89; P = .01], hypertension (HR, 0.39; 95% CI, 0.21-0.75; P < .01), CHF (HR, 2.10; 95% CI, 1.09-4.05; P = .03), wound grade (HR, 1.72; 95% CI, 1.03-2.88; P = .04), IM P (HR, 2.08; 95% CI, 1.27-3.42; P < .01), and EVT (HR, 3.31; 95% CI, 1.77-6.18; P < .01) as independent risk factors for secondary major amputation being required. 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.

Validity of the Global Vascular Guidelines in Predicting Outcomes Based on First-Time Revascularization Strategy

The Global Vascular Guidelines (GVG) recommend selecting an endovascular versus open-surgical approach to revascularization for chronic limb-threatening ischemia (CLTI), based on the Global Limb Anatomic Staging System (GLASS) and wound, ischemia, and foot infection (WIfI) classification systems. We assessed the utility of GVG-recommended strategies in predicting clinical outcomes. We conducted a single-center, retrospective review of first-time lower-extremity revascularizations within a comprehensive limb-preservation program from 2010 to 2018. Procedures were stratified by (1) treatment concordance with GVG-recommended strategy (concordant versus nonconcordant groups), (2) GLASS stages I-III, and (3) endovascular versus open strategies. The primary outcome was 5-year freedom from major adverse limb events (FF-MALE), defined as freedom from reintervention or major amputation, and secondary outcomes included 5-year overall survival, freedom from major amputation, freedom from reintervention, and immediate technical failure (ITF) during initial revascularization. Kaplan-Meier (KM) survival analysis and multivariate analysis with Cox proportional hazard models were performed on the primary and secondary outcomes. Of 281 first-time revascularizations for CLTI, 251 (89.3%) were endovascular and 186 (66.2%) were in the concordant group, with a mean clinical follow-up of 3.02±2.40years. Within the concordant group alone, 167 (89.8%) of revascularizations were endovascular. The concordant group had a higher rate of chronic kidney disease (60.8% vs. 45.3%, P=0.02), WIfI foot infection grade (0.81±1.1 vs. 0.56±0.80, P=0.03), and WIfI stage (3.1±0.79 vs. 2.8±1.2, P<0.01) compared to the non-concordant group. After both KM and multivariate analyses, there were no significant differences in 5-year FF-MALE or overall survival between concordant and non-concordant groups. There was higher freedom from major amputation in the non-concordant group on KM analysis (83.9% vs. 74.2%, P=0.025), though this difference was non-significant on multivariate analysis (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.21-1.15, P=0.10). The open group had lower MALE compared to the endovascular group (HR: 0.39, 95% CI: 0.17-0.91, P=0.029) attributed to a lower reintervention rate in the open group (HR: 0.31, 95% CI: 0.11-0.87, P=0.026). GLASS stage was not associated with significant differences in outcomes, but the severity of GLASS stage was associated with ITF (2.1% in stage 1, 6.4% in stage 2, and 11.7% in stage 3, P=0.01). In this study, CLTI treatment outcomes did not differ significantly based on whether treatment was received in concordance with GVG-recommended strategy. There was no difference in overall survival between the endovascular and open groups, though there was a higher reintervention rate in the endovascular group. The GVG guidelines are an important resource to help guide the management of CLTI patients. However, in this study, both concordance with GVG guidelines and GLASS staging were found to be indeterminate in differentiating outcomes between complex CLTI patients treated primarily with an endovascular-first approach. The revascularization approach for a CLTI patient is a nuanced decision that must take into account patient anatomy and clinical status, as well as physician skill and experience and institutional resources.

Global Limb Anatomic Staging System Inframalleolar Modifier Predicts Limb Salvage and Wound Healing in Patients with Chronic Limb Threatening Ischaemia Undergoing Endovascular Infrainguinal Revascularisation

This study aimed to analyse the influence of the Global Anatomic Staging System (GLASS) and inframalleolar (IM) disease on the treatment outcomes of patients with chronic limb threatening ischaemia (CLTI) who undergo endovascular treatment (EVT) METHODS: Data of patients who underwent infrainguinal endovascular therapy (EVT) for CLTI between 2015 and 2019 at two centres were analysed retrospectively. The endpoints were major amputation, major adverse limb events (MALE), and wound healing. Overall, 276 patients and 340 limbs were analysed. The number of revascularisations for an infrapopliteal lesion was 48 (70.6%), 63 (63.0%), and 142 (82.6%) in the GLASS I, GLASS II, and GLASS III stages, respectively (p < .001). There was no statistically significant difference in limb salvage among the GLASS stages (p= .78). The limb salvage rates at one year were 94.6%, 88.0%, and 70.0% in the IM P0 P1, and P2 groups, respectively (p < .001). Multivariable analysis showed that Wound, Ischemia, and foot Infection (WIfI) stage, and IM grade were risk factors for major amputation. The freedom from MALE rates at two years were 60.5%, 45.3%, and 41.1% in the GLASS I, II, and III stages, respectively (p= .003) and 64.1%, 43.5%, and 18.4% in the IM P0, P1, and P2 groups, respectively (p < .001). Multivariable analysis demonstrated that WIfI stage, GLASS stage, IM grade, and infrapopliteal revascularisation were risk factors for MALE. There was no significant difference in wound healing among GLASS I - III (p= .75). The wound healing rates at 365 days were 78.6%, 68.6%, and 42.0% in the IM P0, P1, and P2 groups, respectively (p= .065). Multivariable analysis showed that WIfI stage and IM P2 were risk factors for incomplete wound healing. GLASS IM was associated with major amputation, MALE, and wound healing, while GLASS stage was associated with only MALE.

Association of cardiac prognosis in chronic limb-threatening ischemia patients after endovascular intervention and wound, ischemia, and foot infection clinical stage

Abstract Background Chronic limb-threatening ischemia (CLTI) represents the end-stage manifestation of peripheral artery disease. Recently, the Society for Vascular Surgery established the Wound, Ischemia, and foot Infection (WIfI) classification system, focusing on disease severity rather than arterial lesion characteristics. While the WIfI clinical stage has been thought to have a prognostic value in CLTI patients, the hemodialysis and left ventricular ejection fraction (LVEF) also appear to represent pivotal factor affecting prognosis among CLTI patients. However, few reports have addressed associations between WIfI clinical stage and cardiac death. Purpose The purpose of this study was to investigate the patient's clinical factors including WIfI clinical stage and mortality of CLTI patients undergoing endovascular intervention based on WIfI clinical stage. Methods This retrospective study investigated 200 consecutive CLTI patients and we individually assessed WIfI clinical stage. We then compared mortality after endovascular intervention between a WIfI stage 1, 2 group and a stage 3, 4 group, and investigated associations between baseline characteristics and WIfI clinical stage 1, 2 group and a stage 3, 4 group. Results Among 200 patients, 123 patients (62%) showed WIfI stage 1 or 2, and the remaining 77 patients (38%) had WIfI stage 3 or 4. Age was significantly higher in the WIfI stage 3, 4 group [median 75, interquartile range (IQR) 68–82] compared with the WIfI stage 1, 2 group (median 70, IQR 63–79, p=0.004). The rate of diabetes mellitus patients was significantly higher in the WIfI stage 3, 4 group (62% vs. 82%, p=0.003), but no differences in the rate of hemodialysis between WIfI stage 3, 4 group and WIfI stage 1, 2 group (53% vs. 37%, p=0.056). Median duration of follow-up was 966 days (IQR, 540–1268 days). Forty patients (20%) died after endovascular intervention. Incidences of all-cause and cardiac deaths were higher in the WIfI stage 3, 4 group than in theWIfI stage 1, 2 group (27% vs. 15%, p=0.047 and 12% vs. 3%, p=0.040, respectively). Kaplan–Meier analysis showed a significantly lower survival rate in the WIfI stage 3, 4 group than in theWIfI stage 1, 2 group (p=0.002 by log-rank test). Cox proportional hazard univariate analysis revealed that WIfI stage 3 or 4 [odds ratio (OR) 4.22, 95% confidence interval (CI) 1.29–13.72, p=0.012), hemodialysis (OR 4.67, 95% CI 1.28–16.96, p=0.010), LVEF (OR 0.96, 95% CI 0.92–0.99, p=0.045) were correlated to cardiac death. Multivariate analysis models using relevant factors from univariate analysis showed only WIfI stage 3 or 4 [odds ratio (OR) 3.74, 95% confidence interval (CI) 1.08–12.87, p=0.028) was significantly associated with cardiac death. Conclusion These results indicate that CLTI patients with high WIfI clinical stage may be associated with poor cardiac prognosis after endovascular intervention. Funding Acknowledgement Type of funding sources: None.

Predictors of Amputation-free Survival after Endovascular Intervention for Chronic Limb-Threatening Ischemia in the Modern era

Chronic limb-threatening (CLTI) is associated with 25% limb loss and 25% mortality at 1-year. Its lethality increases to 45% in patients subjected to a major amputation. Percutaneous peripheral intervention (PPI) constitutes an attractive and less morbid treatment option for patients with CLTI. The purpose of this study was to assess amputation-free survival (AFS) in a contemporary cohort treated with endovascular recanalization and assess its predictors. Patients with CLTI undergoing endovascular revascularization at a single regional hospital between 2015-2019 were reviewed. Baseline demographic characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, technical details, and clinical outcomes were tabulated. The primary endpoint was AFS; a P-value < 0.05 was used for univariate screening and inclusion in a multivariable model. A total of 137 limbs in 111 patients were studied. Comorbidities were prevalent and included diabetes (65%), congestive heart failure (21%), and dialysis dependence (18%). The majority of revascularized limbs presented with advanced wounds (66% WIfI stages 3-4; 47% Rutherford category 6). Presenting WIfI stages were similar across races (P=0.26). Peripheral interventions most commonly targeted femoropopliteal disease (69%), although 26% were multilevel. Percutaneous atherectomy, stenting, and paclitaxel-coated or eluting devices were utilized in 68%, 28%, and 15% of cases, respectively. After a median follow-up of 16months (interquartile range IQR=4-29months), significant independent predictors of reduced AFS included nonWhite race (HR=2.96 [1.42-6.17]; P=0.004) and WIfI stage 4 wounds (HR=2.23 [1.10-4.52]; P=0.026). At one year following successful revascularization, only 59%±1% of patients were alive with their limb intact. Despite considerable and consistent advances in urban health care delivery and the techniques of PPI, CLTI remains a morbid and deadly disease. Even in the endovascular era, nearly half of all patients presenting with CLTI will lose their limb and/or life within the first year. Unfortunately, late-stage presentation continues to be commonplace. Although endovascular intervention can reliably restore patency to affected arteries, this appears insufficient to restore most patients to health.

The Impact of Chronic Limb-Threatening Ischemia on Cardiac Surgery.

PurposeThe effect of chronic limb threatening ischemia (CLTI) on advanced cardiac disease, which requires surgical treatment, has rarely been reported. The purpose of this study was to review the outcomes of cardiac surgery in patients with CLTI and determine the risk factors, with a particular focus on the severity of CLTI.PatientsThe baseline characteristics and outcomes of 33 patients who were treated for CLTI and underwent cardiac surgery were retrospectively analyzed. The states of CLTI were evaluated based on the Wound, Ischemia, and foot Infection (WIfI) classification system, and 33 patients were divided into the low-WIfI group (stages 1–2, n = 13) and high-WIfI group (stages 3–4, n = 20).ResultsThe in-hospital mortality rate was 0% in low-WIfI group and 35% in high-WIfI group (p = 0.027). Postoperative complications, particularly severe infections, occurred more frequently among high-WIfI group than low-WIfI group (70.0% vs. 23.1%, p < 0.01). Multivariable analysis identified foot infection grade as a WIfI classification factor and lower albumin levels as factors significantly associated with postoperative complications. The 1-year and 2-year survival rates were 84.6% and 67.7% in low-WIfI group and 45% and 28.1% in high-WIfI group, respectively (p = 0.011).ConclusionsCardiac surgery in patients with high WIfI stage was an extremely high-risk procedure. In such patients, lowering the WIfI stage by lower extremity revascularization and/or debridement of diseased parts prior to cardiac surgery can be considered.

Association of wound, ischemia, and foot infection clinical stage with frailty and malnutrition in chronic limb-threatening ischemia patients undergoing endovascular intervention.

The Wound, Ischemia, and foot Infection (WIfI) clinical stage has been thought to have a prognostic value in Chronic limb-threatening ischemia (CLTI) patients, and frailty and nutritional status appear to represent pivotal factor affecting prognosis among CLTI patients. The purpose of this study was to examine clinical factors (including frailty and nutritional status) relevant to WIfI clinical stage. This retrospective study investigated 200 consecutive CLTI patients. We individually assessed WIfI clinical stage, frailty according to the Clinical Frailty Scale (CFS) score, and malnutrition according to Geriatric Nutritional Risk Index (GNRI). We then compared mortality after endovascular intervention between a WIfI stage 1, 2 group and a stage 3, 4 group, and investigated associations between baseline characteristics (including CFS and GNRI) and WIfI clinical stage. Among 200 patients, 123 patients (62%) showed WIfI stage 1 or 2, and the remaining 77 patients (38%) had WIfI stage 3 or 4. CFS score was significantly higher in the WIfI stage 3, 4 group [median 6.0, interquartile range (IQR) 5.5-7.0] compared with the WIfI stage 1, 2 group (median 5.0, IQR 4.0-6.0, p < 0.001), and GNRI was significantly lower in the WIfI stage 3, 4 group (median 88, IQR 80-97) than in the WIfI stage 1, 2 (median 103, IQR 94-111, p < 0.001). Forty patients (20%) died after endovascular intervention. Incidences of all-cause and cardiac deaths were higher in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (27% vs. 15%, p = 0.047 and 12% vs. 3%, p = 0.040, respectively). Kaplan-Meier analysis showed a significantly lower survival rate in the WIfI stage 3, 4 group than in the WIfI stage 1, 2 group (p = 0.002 by log-rank test). Multivariate logistic regression analysis using relevant factors from univariate analysis showed CFS score [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.41-3.13, p < 0.001), diabetes mellitus (OR 3.17, 95%CI 1.17-8.61, p = 0.023) and GNRI (OR 0.93, 95%CI 0.89-0.97, p = 0.002) significantly associated with WIfI stage 3 or 4. In addition, multivariate ordinal logistic regression analysis for WIfI clinical stage showed CFS score (OR 1.43, 95%CI 1.09-1.89, p = 0.011), diabetes mellitus (OR 1.77, 95%CI 1.26-2.54, p < 0.001), and high-sensitivity C-reactive protein (OR 1.14, 95%CI 1.02-1.28, p = 0.041) were positively associated with WIfI clinical stage, and GNRI correlated negatively with WIfI clinical stage (OR 0.95, 95%CI 0.91-0.97, p < 0.001). These results indicate that CLTI patients with high WIfI clinical stage may be more frail and malnourished, and be associated with poor prognosis after endovascular intervention.

Multidisciplinary Telehealth-Focused Approach to Chronic Limb-Threatening Ischemia Prevents Increased Amputation Rates During COVID-19 Pandemic

Introduction and ObjectiveDuring the Coronavirus Disease 2019 (COVID-19) pandemic, global reports have surfaced describing patient- and system-level delays in care secondary to scarcity of resources, fear of exposure, and even reassignment of providers, with subsequent adverse outcomes for patients. After early reports suggested increased major amputation rates among patients with chronic limb-threatening ischemia (CLTI), our healthcare system employed a multidisciplinary strategy to monitor these patients closely. The objective of our study was to evaluate primary amputation rates and disease severity among Veterans who presented with CLTI during the COVID-19 pandemic.MethodsA retrospective cohort study of all patients treated at our Veterans Affairs Medical Center (VAMC) for CLTI was performed. Veterans with CLTI (Rutherford Classification 4-6) who underwent lower extremity revascularization (LER) within the first 7 months of the pandemic (COVID cohort) were compared to those who underwent LER within the same 7-month period one year prior to the pandemic (pre-COVID cohort). Exclusion criteria included acute limb ischemia presentation and LER within 3 months prior to the study period. During the COVID study period, a multidisciplinary team of vascular surgeons, podiatrists, advanced practice providers, and trainees screened all upcoming Veteran appointments for peripheral artery disease or leg wounds. Those with known or suggested CLTI were scheduled for either telehealth or telephone encounters based on access to compatible devices.Table 1Table 1. Comparison of patients undergoing lower extremity revascularization (LER) for chronic limb threatening ischemia (CLTI) before versus during the COVID-19 pandemic.Table 1Image, table 1ResultsThe pre-COVID and COVID cohorts consisted of 32 and 35 patients, respectively. Both displayed similar demographics (Table 1Table 1Comparison of patients undergoing lower extremity revascularization (LER) for chronic limb threatening ischemia (CLTI) before versus during the COVID-19 pandemic.Table 1Image, table 1). Nearly 80% of all patients presented with Rutherford 5-6 disease. WIfI (Wound, Ischemia, and Foot Infection) stage did not significantly differ between the two cohorts. Primary major amputation rate was 15.7% in the pre-COVID cohort compared to 14.3% in the COVID cohort (p=0.980). Based on WIfI score, primary amputation was driven by ischemia (versus infection) in both the pre-COVID and COVID cohorts. During the first 7 months of the pandemic, vascular surgery alone increased monthly telehealth encounters nearly 14-fold, with overall improvement in the number of successful multidisciplinary telehealth visits as the pandemic persisted (Figure 1).Figure 1Progression of successful telehealth visits during the first seven months of the COVID-19 pandemic, by month.Figure 1ConclusionsOur institution did not experience increased amputation rates or advanced disease presentation for patients with CLTI during the COVID-19 pandemic. This may be due to the coordinated approach that has capitalized on continued collaboration between vascular surgery and podiatric surgery, as well as the rapid roll-out of a robust tele-wound program to surveil high-risk Veterans. Further investigation is necessary to determine how telehealth can be leveraged to improve limb outcomes.

Validation of the correlation between angiosome-based target arterial path, mid-term limb-based patency, and the global limb anatomical staging system

This study aimed to validate the correlation between the Global Limb Anatomical Staging System (GLASS) and limb-based patency (LBP) and angiosome-based target arterial path (TAP) and to detect the predictors of LBP loss. After the publication of the Global Vascular Guidelines in 2019, the evaluation of GLASS and identification of TAP have been recommended. However, there are few reports regarding GLASS. Eighty-three patients with chronic limb-threatening ischemia (CLTI) and tissue loss from 2016 to 2020 were evaluated. The correlation between GLASS and LBP and successful revascularization of angiosome-based TAP was analyzed. We also investigated the predictors of LBP loss. The number of patients in each GLASS stage was as follows: GLASS I, 6 patients; GLASS II, 15 patients; GLASS III, 62 patients. At 6months, the Kaplan-Meier estimate of LBP was 66.7% in GLASS I, 41.6% in GLASS II, and 16.4% in GLASS III, respectively (p = 0.034). The rate of successful revascularization of angiosome-based TAP was 100% in GLASS I, 86.7% in GLASS II, and 46.8% in GLASS III, respectively (p = 0.002). Multivariate analysis showed that the Wound, Ischemia, and foot Infection (WIfI) stage [hazard ratio (HR) 1.58; 95% confidence interval (CI) 1.07-2.33; p = 0.021] and GLASS infrapopliteal (IP) grade (HR 1.96; 95% CI 1.31-2.95; p = 0.001) were the independent predictors of LBP loss. The GLASS stage was significantly correlated with successful revascularization of angiosome-based TAP and mid-term LBP. The WIfI stage and GLASS IP grade were the independent predictors of loss of LBP.

Early evaluation of the infrainguinal revascularization strategy selection tool of the Global Vascular Guidelines for chronic limb-threatening ischemia patients

ObjectiveThe Global Vascular Guidelines (GVG) propose a novel Global Anatomic Staging System (GLASS) with the Wound, Ischemia, and foot Infection (WIfI) classification system as a clinical decision-making tool for interventions in chronic limb-threatening ischemia (CLTI). We assessed the validity of clinical staging and the relationship between the treatments recommended by the GVG and the outcomes of the actual procedures. MethodsThis retrospective, single-center, observational study included 117 patients with CLTI undergoing infrainguinal revascularization in our hospital between 2015 and 2019. Of those patients, 55 underwent open bypass (OB) and 62 underwent endovascular revascularization (EVR). Femoropopliteal, infrapopliteal, and inframalleolar GLASS grades were assigned based on angiographic images. These grades were combined to determine the revascularization strategy recommended by the GVG: “endovascular,” “indeterminate,” and “open bypass.” The indeterminate category includes three subcategories: GLASS stage III, WIfI stage 2; GLASS stage II, WIfI stage 3; and GLASS stage II, WIfI stage 4. For the purposes of this study, we labeled these subcategories A, B, and C, respectively. The primary outcome was the correlation between the revascularization strategies recommended by the GVG and the actual procedures performed. The relationships between the actual procedures and overall survival, limb salvage, and patency were also examined. ResultsThe femoropopliteal and infrapopliteal GLASS grades were higher in the OB group. EVR was performed more often for GLASS stages I and II and was more often classified as indeterminate B and C, whereas OB was performed more often in GLASS stage III and was more often classified as indeterminate A. There were no statistically significant differences in the inframalleolar/pedal disease descriptor or in the 30-day postoperative complication rates between the two groups. In higher GLASS stages, the technical success rate of EVR was lower, and lesion complexity was more severe. Patients for whom the recommended strategy according to the GVG would have been OB but who underwent EVR were associated with low limb salvage and patency rates. ConclusionsThe GVG provide good guidance for the selection of the revascularization strategy. When the GVG indicate OB, it should be the treatment of choice, rather than EVR, for patients who are fit to undergo the procedure.