Wound, Ischemia, And Foot Infection 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.

A Review of WIfI Clinical Staging to Predict Outcomes in Patients With Threatened Limbs

The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification system serves to comprehensively assess the severity of disease in patients with chronic limb-threatening ischemia by identifying and grading the main factors that place the threatened limb at greatest risk: wound severity, ischemic burden, and presence of infection. Each of these three factors is graded and the limb placed into a clinical stage, with increasing stage associated with severity of limb-threat and predicted risk of major limb amputation at one-year. Globally, there is a growing body of evidence reported from multiple institutions that has assessed amputation rates and wound healing outcomes following revascularization in patients with WIfI clinical staging. Risk of major amputation at 1 year is low in clinical stage 1, moderate in stages 2 and 3, and high in stage 4. Higher clinical stages are associated with prolonged time to wound healing, while 1-year wound healing rates consistently decrease with increasing clinical stage. Additional avenues of investigation utilizing WIfI as an objective clinical staging tool have yielded new insights into which patients benefit from revascularization, complexity of care, hospital length of stay (LOS), quality of life, ethnic and socioeconomic disparities, as well as spurred interest in other modalities of assessing limb perfusion and their possible clinical utility. Ongoing study and refinement of WIfI grading and clinical staging will continue to improve its prognostic utility.

Pedal medial arterial calcification influences the outcomes of isolated infra-malleolar interventions for chronic limb-threatening ischemia

ObjectiveInframalleolar disease is present in most diabetic patients presenting with tissue loss. Inframalleolar (pedal) artery disease and pedal medial arterial calcification (pMAC) are associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). This study aimed to examine the impact of pMAC on the outcomes after isolated inframalleolar (pedal artery) interventions. MethodsA database of lower extremity endovascular intervention for patients with tissue loss between 2007 and 2022 was retrospectively queried. Patients with CLTI were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries and who had foot x-rays were identified. X-rays were assessed blindly for pMAC and scored on a scale of 0 to 5. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention to treat analysis by the patient was performed. Amputation-free survival (survival without major amputation) was evaluated. ResultsA total of 223 patients (51% female; 87% Hispanic; average age, 66 years; 323 vessels) underwent isolated infra-malleolar intervention for tissue loss. All patients had diabetes, 96% had hypertension, 79% had hyperlipidemia, and 63% had chronic renal insufficiency (55% of these were on hemodialysis). Most of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease and had various stages of pMAC: severe (score = 5) in 48%, moderate (score = 2-4) in 31%, and mild (score = 0-1) in 21% of the patients. Technical success was 94%, with a median of one vessel treated per patient. All failures were in severe pMAC. Overall, major adverse cardiovascular events was 0.9% at 90 days after the procedure. Following the intervention, most patients underwent a planned forefoot amputation (single digit, multiple digits, ray amputation, or trans-metatarsal amputation). WIfI ischemic grade was improved by 51%. Wound healing at 3 months was 69%. Those not healing underwent below-knee amputations. The overall 5-year amputation-free survival rate was 35% ± 9%. The severity of pMAC was associated with decreased AFS. ConclusionsIncreasing severity of pMAC influences the technical and long-term outcomes of infra-malleolar intervention in diabetes. Severe pMAC is associated with amputation and should be considered as a variable in the shared decision-making of diabetic patients with CLTI.

Poor short-term outcomes for prognostic high-risk patients with chronic limb-threatening ischemia undergoing endovascular therapy

BackgroundThe prognosis of chronic limb-threatening ischemia (CLTI) is poor, with an expected life expectancy of 2 or more years, which significantly influences treatment decisions. However, death may occur at the early stages of treatment for wound healing, and aggressive treatment may limit the quality of life of such patients. In patients with CLTI undergoing endovascular therapy (EVT), the Wound, Ischemia, and foot Infection (WIfI) clinical stage, male sex, older age, non-ambulatory status, low body mass index, and dialysis have been reported as predictors of mortality risk. However, most studies have not fully investigated the WIFI clinical stage as a prognostic predictor of CLTI. This study aimed to evaluate short-term prognosis and wound healing rates using the prognostic predictors (PPs) indicated above in risk-stratified patients with CLTI who underwent EVT.MethodsThis retrospective single-center observational study included 61 CLTI patients undergoing EVT from April 2020 to October 2022. The patients were divided into a high-risk group (PPs ≥ 4, n = 20) and low-risk group (PPs ≤ 3, n = 41) according to the number of PPs. Survival and wound healing rates within one year were compared between these two groups.ResultsThe mean age of the patients was 74.7 ± 1.6 years, and 42 (68.9%) were male. Among these patients, the high-risk group compared with the low-risk group had a significantly worse survival rate within one year (46.4% vs. 84.7%, log-rank p < 0.001). Fifteen patients died within one year. Of these, seven deaths were cardiovascular deaths and six were deaths from infectious diseases. Cox proportional hazards analysis showed that WIfI clinical stage 4 (p = 0.043, hazard ratio [HR] = 4.85) and the male sex (p = 0.037, HR = 6.34) influenced the prognosis of this population. The high-risk group tended to have a worse wound healing rate within one year than that had by the low-risk group (55.4% vs. 83.0%, log-rank p = 0.086).ConclusionsThe assessment of short-term prognosis and wound healing rates using PPs may be useful. Discussing the results of short-term clinical outcome assessments with patients should be considered when determining their individualized treatment plans.

Wound, Ischemia, Foot Infection (Wifi) Classification System And Its Predictive Ability Concerning Amputation-Free Survival, Mortality And Major Limb Amputation In A Portuguese Population: A Single Center Experience.

Commonly used chronic limb-threatening ischemia (CLTI) classifications lack granularity and detail to precisely stratify patients according to risk of limb loss, expected revascularization benefit and mortality. The aim of this study is to evaluate in a Portuguese population the prognostic value of an updated CLTI classification based on Wound, Ischemia, and foot Infection (WIfI) proposed by the Society for Vascular Surgery. Single-center retrospective evaluation of prospectively collected data of consecutive patients with CLTI submitted to lower limb revascularization from January to December of 2017. All consecutive patients with chronic peripheral artery disease with ischemic rest pain or tissue loss were included. The exclusion criteria were patients with intermittent claudication, vascular trauma, acute ischemia, non-atherosclerotic arterial disease and isolated iliac intervention. The primary end-point was major limb amputation, mortality and amputation-free survival (AFS) at 30 days, 1 year and 2 year follow-up. Secondary end-points were minor amputation, wound healing time (WHT) and rate (WHR). A total of 111 patients with CLTI were submitted to infra-inguinal revascularization: 91 endovascular and 20 open surgery. After categorizing them according to the WIfI: 20 had stage 1 (18.52%), 29 stage 2 (26.85%), 38 stage 3 (35.19%) and 21 stage 4 (19.44%). Overall mortality rate was 1.8%, 17% and 22.3% at 30 days, 1 year and 2 years follow-up. Major amputation rate was 0.9%, 2.7% and 2.7% at 30 days, 1 year and 2 years follow-up. AFS rate was 97.3%, 82.1%, and 76.8% at 30 days, 1 year, 2 years follow-up. In multi-variable analysis, higher WIfI score was the only predictive factor for mortality and AFS. WIfI 3 and 4 were also associated with increased risk of non-healing ulcer. This study proved the prognostic value of the WIfI classification in a Portuguese population by showing an association between higher scores and increased mortality, lower AFS and non-healing ulcer.

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.

Investigator attitudes on equipoise and practice patterns in the BEST-CLI trial

ObjectivesThere has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb-threatening ischemia (CLTI). We aimed to assess treatment preferences of Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) investigators prior to and following the trial. MethodsAn electronic 60-question survey was sent to 1180 BEST-CLI investigators in 2022, after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon (VS) surgical and ENDO preferences were compared with a 2010 survey administered to prospective investigators before trial funding. ResultsFor the 2022 survey, the response rate was 20.2% and was comprised of VSs (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for >20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between ENDO and OPEN procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and ENDO interventions (86%). A minority reported always or usually using the wound, ischemia, and foot infection (WIfI) criteria (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than one-half (52.9%) agreed that the statement “no bridges are burned with an ENDO-first approach” was false. Intervention choice was influenced by availability of the operating room or ENDO suite, personal schedule, and personal skill set in 30.1%, 18.0%, and 45.9% of respondents, respectively. Most respondents reported routinely using paclitaxel-coated balloons (88.1%) and stents (67.5%); however, 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing >10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing >10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI teams improved care; however, only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by VSs to the 2010 survey, there were no changes in preferred treatment based on Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification or conduit preference. In 2022, OPEN surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except a decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs 30.8%) (P < .05). ConclusionsThere is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced OPEN and ENDO techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial, there was overall similar equipoise among VSs.

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.

Prognostic value of Wound, Ischemia and foot Infection (WIfI) score after lower extremities bypass surgery for peripheral artery disease in chronic hemodialysis patients

Abstract Background Although lower extremities bypass surgery has been commonly performed to treat peripheral artery disease (PAD) even in patients on hemodialysis (HD) as well as general population, poorer prognosis in such subjects still remains major problems compared to non-HD population. Recently, Wound, Ischemia and foot Infection (WIfI) scoring system has been developed for classification of lower extremity threatened limb to impact amputation risk. However, the utility of predictability still remain unclear in HD patients. The aim of this study is to clarify the characteristics of the WIfI score and its prognostic value after bypass surgery in such patients with PAD. Methods Pre-procedural threatened limb grade in consecutive 361 patients (224 HD patients and 137 non-HD patients) undergoing successfully bypass surgery were assessed using the WIfI scoring system. Primary outcome was amputation-free survival (AFS) defined as freedom from major amputation and/or all-cause mortality. They were followed-up for 5 years. Results Although ischemia grade ≥ 2 was comparable between HD and non-HD patients (97.8% vs. 99.2%, p=0.74), wound grade and infection grade ≥ 2 were significantly higher prevalent in HD patients than in non-HD patients (56.7% vs. 32.8%, p&amp;lt;0.0001 and 53.1% vs. 30.7%, p&amp;lt;0.0001, respectively). The AFS rate for 5-year was 72.6%, 46.5%, 44.4% and 32.7% in wound grade 0, 1, 2 and 3 [adjusted hazard ratio (aHR) 3.67, 95% confidence interval (CI) 1.67-8.31, p=0.0009 for grade 3 vs. grade 0], and was 57.0%, 57.8%, 45.7% and 19.4% in infection grade 0, 1, 2 and 3 (aHR 2.71, 95% CI 1.35-5.32, p=0.0052 for grade 3 vs. grade 0) in HD patients, respectively. However, even in subgroup without any wound, HD patients had markedly poorer AFS (vs. 100% in non-HD, p&amp;lt;0.0001) compared to non-HD patients. Also in patients without any infection, similar results were obtained (vs. 95.3% in non-HD, aHR 13.7, 95% CI 3.12-60.5, p=0.0005). HD was also consistently identified as a strong risk factor for poor AFS (aHR 2.83, 95% CI 1.67-5.09, p&amp;lt;0.0001). Conclusion Wound and foot infection grade as components of the WIfI score could stratify the risk of amputation and/or mortality after bypass surgery even in HD patients. Severity of wound or infection status was higher in HD patients compared to non-HD patients, however, high risk of poor AFS even without any wound or infection should be paid attention in this high-risk population.

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.

Internal Iliac Artery Patency as a Predictor of Above-Knee Amputation Stump Healing

PurposeThe primary aim of this study is to assess role of internal iliac patency in predicting outcome of AKA stump healing. The secondary objectives were assess accuracy of Wound, Ischemia, and foot Infection (WIfI) classification system in predicting AKA stump healing and association of delayed mortality. Materials and MethodThis is a retrospective study performed in Vascular Surgery Unit, in a tertiary hospital, on patients who underwent above-knee amputations over one year, from July 2021 until June 2022. Patient demographic data, WIfI scoring, outcome of above-knee amputations and patency of profunda femoris and internal iliac artery were collected. To minimize confounding, a single vascular surgeon performed all CT imaging reviews and arterial measurements. Approval for this study was obtained from the National Research Registry NMRR ID-23-01865-KQ4 (IIR). ResultNinety patients underwent AKA over one year, from July 2021 until June 2022. Occluded internal iliac artery in the presence of patent profunda femoris did not affect the wound healing of AKA stump. There was significant association between WIfI scoring with mortality. Patients with WIfI scoring 3 to 4 was observed to have higher mortality rate compared to patients with normal healing 47 (72.0%) vs 4 (80.0%); p= 0.021. ConclusionIn this study, the internal iliac artery patency shows no statistically significant effect on AKA stump healing; however, the small number of patients is a study drawback. This study also demonstrates that the WIfI score can be a prognostic factor for mortality in patients undergoing above-knee amputation.

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.

Clinical characteristics of patients with diabetic foot using WIfI classification—A pilot study in Vietnam

BackgroundDue to its effect on patient health and healthcare resources, the study of diabetic foot is essential. Despite the existence of classification and grading systems, further evidence is required. Current systems are prone to a lack of validation in specific populations, inadequate consideration of regional variations, and an incomplete evaluation of risk factors and outcomes. The prevalence and complications of diabetes, such as diabetic foot, are on the rise worldwide, necessitating regionally specific research. To fill these gaps, this study focuses on a Southeast Asian subpopulation. ObjectiveThe study aims to evaluate the clinical characteristics of diabetic foot patients using the WIfI classification system, and to develop a risk calculator for patients to predict and evaluate potential outcomes. MethodsA retrospective analysis was conducted on the medical records of patients with diabetic foot who visited a tertiary hospital in Vietnam between December 2021 and July 2022. Demographic data, clinical characteristics, and outcomes were collected and classified according to the WIfI (Wound, Ischemia, and foot Infection) classification system. Descriptive statistics were used to analyze the data, and a multivariable logistic regression model was employed to develop a risk calculator. ResultsThe study included 60 patients with diabetic foot. Gender distribution was similar (56.7% male), with a mean age of 44 years. Most patients had ulcers of varying degrees, while ischemia contributed to higher grades, placing 43.3% at moderate-to-high risk of amputation (stages 3 and 4). HbA1c positively correlated with amputation risk (p<0.05), while ABI, TBI, and TP showed inverse correlations (p<0.001). The amputation risk equation based on the WIfI scale was: risk=3.701−0.788ABI−1.260TP. A risk calculator was developed using these predictors to estimate adverse outcomes. ConclusionIn diabetic foot patients, early identification and management of risk factors are crucial. The findings of this study highlight the importance of ischemia and its association with amputation risk. Incorporating HbA1c, ABI, and TP, the risk calculator enables personalized assessments of amputation risk, thereby assisting healthcare professionals in treatment planning. Further validation and refinement of the risk calculator is required for broader clinical application.

Clinical characteristics of patients with diabetic foot using WIfI classification—A pilot study in Vietnam

BackgroundDue to its effect on patient health and healthcare resources, the study of diabetic foot is essential. Despite the existence of classification and grading systems, further evidence is required. Current systems are prone to a lack of validation in specific populations, inadequate consideration of regional variations, and an incomplete evaluation of risk factors and outcomes. The prevalence and complications of diabetes, such as diabetic foot, are on the rise worldwide, necessitating regionally specific research. To fill these gaps, this study focuses on a Southeast Asian subpopulation. ObjectiveThe study aims to evaluate the clinical characteristics of diabetic foot patients using the WIfI classification system, and to develop a risk calculator for patients to predict and evaluate potential outcomes. MethodsA retrospective analysis was conducted on the medical records of patients with diabetic foot who visited a tertiary hospital in Vietnam between December 2021 and July 2022. Demographic data, clinical characteristics, and outcomes were collected and classified according to the WIfI (Wound, Ischemia, and foot Infection) classification system. Descriptive statistics were used to analyze the data, and a multivariable logistic regression model was employed to develop a risk calculator. ResultsThe study included 60 patients with diabetic foot. Gender distribution was similar (56.7% male), with a mean age of 44 years. Most patients had ulcers of varying degrees, while ischemia contributed to higher grades, placing 43.3% at moderate-to-high risk of amputation (stages 3 and 4). HbA1c positively correlated with amputation risk (p<0.05), while ABI, TBI, and TP showed inverse correlations (p<0.001). The amputation risk equation based on the WIfI scale was: risk=3.701−0.788ABI−1.260TP. A risk calculator was developed using these predictors to estimate adverse outcomes. ConclusionIn diabetic foot patients, early identification and management of risk factors are crucial. The findings of this study highlight the importance of ischemia and its association with amputation risk. Incorporating HbA1c, ABI, and TP, the risk calculator enables personalized assessments of amputation risk, thereby assisting healthcare professionals in treatment planning. Further validation and refinement of the risk calculator is required for broader clinical application.

Infrapopliteal 3-Vessel Occlusive Disease Is the Only Predictor of Wound Recurrence After Complete Wound Healing via Endovascular Therapy in Patients With Chronic Limb-threatening Ischemia.

To determine the predictors of wound recurrence after complete wound healing in patients with chronic limb-threatening ischemia (CLTI) who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions with consideration of IP arterial anatomic severity, including classification by the Global Limb Anatomic Staging System (GLASS). This retrospective single-center study assessed patients with de novo CLTI limbs with tissue loss treated via EVT for IP lesions from September 2016 to May 2021. Among these patients, 149 consecutive limbs from 133 patients who achieved complete wound healing were enrolled. The Kaplan-Meier method was used to estimate the wound recurrence rate after complete wound healing. The Cox proportional hazard model was used to assess the association between baseline characteristics and wound recurrence. The cumulative wound recurrence rate 1 year after complete wound healing was 30%. The mean time for wound recurrence was 7±5 months. Only IP arterial anatomic characteristics remained as a predictor of wound recurrence, whereas wound status and management, including the Wound, Ischemia, and foot Infection (WIfI) clinical stage and minor amputation, were not associated with wound recurrence. Multivariate analysis revealed independent associations between wound recurrence and IP 3-vessel occlusive disease (hazard ratio, 2.97; 95% confidence interval, 1.39-6.35), but not poor below-the-ankle runoff, IP Peripheral Arterial Calcium Scoring System (PACSS) grade, and the GLASS IP grade. The only independent predictor of wound recurrence after complete wound healing via EVT in patients with CLTI was IP 3-vessel occlusive disease. In patients with chronic limb-threatening ischemia (CLTI), wound recurrence after complete wound healing remains a challenge, and studies focused exclusively on wound recurrence are still limited. The present study aimed to determine the risk factors for wound recurrence after complete wound healing in patients with CLTI who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions, with consideration of IP arterial anatomic severity for the first time. The results showed that IP 3-vessel occlusive disease was the only predictor of wound recurrence, whereas wound status/management and other arterial anatomic characteristics including WIfI clinical stages and GLASS grades were not predictors.

Assessing the Utility of Toe Arm Index and Toe Pressure in Predicting Wound Healing in Patients Undergoing Vascular Intervention

Objective measures of perfusion such as an ankle-brachial index (ABI) and toe pressure remain important in prognosticating wound healing. However, the use of ABI is limited in patients with incompressible vessels and toe pressure may not be comparable across patients. While a toe arm index (TAI) may be of value in this setting, its role as clinical indicator of perfusion for healing in patients with lower-extremity wounds has not been well established. A retrospective review was performed of all vascular patients with lower-extremity wounds that underwent peripheral vascular intervention between 2014-2019. Data regarding patient demographics, comorbidities, TAI, ABI, toe pressures, and the wound, ischemia, and foot infection (WIfI) score were collected. Associations between patient variables and wound healing at various time points were evaluated. A total of 173 patients (67.7±10.9years; 71.1% male) were identified with lower-extremity wounds. Most patients underwent endovascular intervention (77.5%). Patients were followed for a median of 416 (IQR 129-900) days. Mean postoperative TAI was 0.35±0.19 and mean WIfI score was 2.60±1.17. Nine percent (15) of patients healed within 1month, 44.8% (69) healed within 6months, and 65.5% (97) healed within 1year of revascularization without need for major amputation. Those that healed within 1year without any major amputation did not differ from those that did not heal based on age, gender, race, comorbidities, periprocedural medications, or procedures performed. However, patients that healed without major amputation had a higher postoperative TAI (0.38 vs. 0.30, P=0.02), higher toe pressure (53 vs. 40mm Hg, P=0.004), and lower WIfI score (2.26 vs. 3.12, P<0.001). Patients that healed with 1year without requiring any amputation had similar associations with postoperative TAI, toe pressure, and WIfI. Additionally, they were more likely to be White (P=0.019) and have an open surgical procedure (P<0.001) and less likely to have chronic kidney disease (P=0.001) or diabetes (P=0.008). A Youden index was calculated and identified a TAI value of 0.30 that optimized sensitivity and specificity for wound healing. The area under the curve for TAI as a predictor of wound healing was 0.62. Higher postoperative TAI is associated with higher odds of wound healing without need for major amputation. Toe arm index is therefore a useful tool to identify patients with adequate arterial perfusion to heal lower-extremity wounds. However, the area under the curve is poor for TAI when used as a sole predictor of wound healing potential suggesting that TAI should be one of multiple factors to considered when prognosticating wound healing potential.

Clinical Outcomes of Patients With Cholesterol Crystal Embolism Accompanied by Lower Extremity Wound.

Cholesterol crystal embolism (CCE) accompanied by a lower extremity wound is occasionally difficult to differentiate from chronic limb-threatening ischemia (CLTI) and treat. The present multi-center retrospective observational study investigated the clinical characteristics and prognosis of CCE with lower extremity wounds. Consecutive patients (n = 58) clinically diagnosed as CCE with lower extremity wounds between April 2010 and December 2019 were studied. CCE was diagnosed using histological findings, foot condition, renal impairment, and eosinophilia. The primary outcome was 1-year wound healing rate. Patients with CCE were compared with 1309 patients diagnosed with CLTI with tissue loss during the same study period. The CCE group had a significantly more severe Wound, Ischemia, and foot Infection (WIfI) classification compared with the CLTI group. After Kaplan-Meier analysis, the CCE group had a similar 1-year wound healing (55.1 vs 58.3%, P = .096) as the CLTI group. In multivariate stratified Cox regression analysis by WIfI stages, CCE was significantly associated with poor wound healing compared with CLTI [hazard ratio .36 (95% confidence interval .21-.62)]. In conclusion, among the similar WIfI clinical stages, wound healing was significantly worse in the CCE group than in the CLTI group.

Topicality of the fundamental and determining importance of chronic critical ischemia of the extremities and its restorative treatment using crural/pedal bypasses in Germany and in Saxony-Anhalt

Currently, there is an increase in severe stages of peripheral arterial occlusive disease (PAOD) with critical ischemia. This seems to correspond to the general demographic change as well as aconsequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic of the last 3years. The now established and accepted interventional/endovascular approach for severe lower leg PAOD in experienced hands is still considered the first-line treatment but from the authors' perspective crural/pedal venous bypass is experiencing arenaissance. Compact narrative review of the current state of crural/pedal bypass surgery in Germany and Saxony-Anhalt (SA) combined with selective references from the current scientific medical literature and own clinical experiences. The current statistics of case-related diagnosis-related groups (DRG) data show that, especially with the occurrence of the corona pandemic, adecrease in inpatient case numbers of patients with PAOD stage IIB can be observed nationwide and also in SA. The severe PAOD stages have remained approximately the same in case numbers but increased in SA. The risk stratification based on the wound, ischemia and foot infection (WIFI) classification offers the possibility to be able to make statements about the risk of amputation, benefits and type of revascularization measures. The length of the occlusion, occlusion site of the affected vessels and degree of calcification are taken into account in the global limb anatomic staging system (GLASS) to assess the prognosis. The evaluation of the case-based hospital statistics from 2015 to 2020 showed aconstant use of femorocrural/femoropedal bypass surgery in Germany as well as aslight increase in reconstruction using femorocrural bypasses in SA, which seems to correlate with the tendency for an increase in the number of cases of severe PAOD. Parameter-based objectification of the severity of critical limb ischemia should be included in the indications for placement of a crural/pedal bypass. The WIFI classification and GLASS are suitable for this purpose as arelative prognosis of success is also possible. The treatment of critical limb ischemia by crural/pedal bypass surgery continues to find aconstant application in Germany and SA.