1-year Amputation Research Articles

Outcomes of prosthetic and biological grafts compared to arm vein grafts in patients with chronic limb-threatening ischemia

ObjectiveThe optimal conduit for infrainguinal bypass (IIB) is single-segment great saphenous vein (GSV). Unfortunately, GSV is not always available in patients with chronic limb-threatening ischemia (CLTI). Other graft choices include arm vein grafts (AVs), prosthetic grafts (PGs), or biologic grafts (BGs). Current data regarding the durability and limb salvage rates of those options is scarce; hence, we aimed to investigate the impact of alternative graft types on postoperative and long-term outcomes on IIB in patients with CLTI. MethodsThe Vascular Quality Initiative (VQI) database was queried for patients undergoing IIB from January 2003 to April 2024. Patients were stratified into three groups: AVs (cephalic, basilic), PGs (Dacron, polytetrafluoroethylene [PTFE]), and BGs (cadaveric, homograft, or xenograft). Saphenous vein grafts (greater and lesser saphenous) were excluded. Multivariate logistic regression analyzed postoperative outcomes: 30-day mortality, major adverse cardiovascular events, graft occlusion, prolonged length of stay >7 days, packed red blood cell transfusion >2 units, and infection. Cox regression was used to report 1-year outcomes: mortality, major amputation (above-ankle), and major adverse limb events (defined as major amputation, thrombectomy, or reintervention). ResultsA total of 9165 IIB procedures have been analyzed: AV, 417 (4.55%); PG, 7520 (82.05%); and BG, 1228 (13.40%). Compared with AVs, patients receiving PGs had higher odds of infection (adjusted odds ratio [aOR], 2.89; P = .045) and higher hazard of 1-year mortality (adjusted hazard ratio [aHR], 1.51; P = .035). On the other hand, patients receiving BGs had higher risk of graft occlusion (aOR, 4.55; P = .040) and infection (aOR, 2.78; P = .046), as well as higher hazard of 1-year mortality (aHR, 1.53; P = .040), amputation (aHR, 1.72; P = .019), and amputation or death (aHR, 1.52; P = .005) compared with patients receiving AVs. After stratifying by bypass configuration, patients with AVs had the highest overall survival and amputation-free survival among the three alternative conduits in below-knee popliteal and tibial bypass targets. ConclusionsIn this large multi-institutional study investigating alternative conduits to GSV, AVs are found to be the most resistant to infections and are associated with the best overall survival and limb salvage outcomes compared with PGs and BGs, particularly in below-knee distal targets. In cases where no GSV is available, AVs and PGs are acceptable alternatives with comparable 1-year amputation-free survival and major adverse limb events-free survival rates. On the other hand, BGs are associated with higher risk of graft occlusion and lower freedom from major amputation and death compared with AVs.

Atherogenic markers and 1-year amputation risk in adults with diabetic foot in a tertiary level hospital: A retrospective cohort study

AimTo determine the association between atherogenic markers, such as total cholesterol/high density lipoprotein cholesterol ratio (TC/HDL-C), triglycerides/HDL-C ratio (TG/HDL-C), and triglycerides-glucose index (TyG), and the risk of 1-year amputation in adults with diabetic foot in a tertiary level hospital. MethodsRetrospective cohort study conducted in 162 adult patients with diabetic foot. The outcome was amputation, defined as “primary amputation in patients' clinical history after their first hospitalization due to foot ulcer.”. The cutoff point was determined using Youden's J statistic. The relative risk (RR) was presented as an association measure. ResultsA TyG index of >9.4 [RR: 1.64 (1.10–2.45)] was associated with a high risk of amputation after 1-year in adults with diabetic foot. However, while a TC/HDL ratio of >4.69 [RR: 1.38 (0.94–2.03)] and a TG/HDL-C ratio > 3.57 [RR: 1.35 (0.89–2.06)] did not show associations with risk of amputation after 1-year. ConclusionsOnly a TyG index of >9.4 was associated with an increased risk of 1-year amputation in adults with diabetic foot. Future studies with larger samples and a longitudinal design may provide more robust evidence and a better understanding of clinical implications.

Real-world application of Wound, Ischemia, and foot Infection scores in peripheral arterial disease patients

ObjectiveThe Society for Vascular Surgery (SVS) 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 use of the system and whether it predicts outcomes accurately after 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. MethodsUsing data from a large statewide collaborative, we identified patients with CLTI undergoing open surgical revascularization or peripheral vascular intervention (PVI) between 2016 and 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 stages 1, 2, 3, or 4. The primary outcomes were 30-day and 1-year amputation and mortality rates. Multivariable logistic regression was performed to estimate the association of WIfI stage on postrevascularization outcomes. ResultsIn the cohort of 17,417 patients, 83.4% (n = 14,529) had WIfI stage documented. PVIs were performed on 57.6% of patients, and 42.4% underwent an open surgical revascularization. Of the patients, 49.5% 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 open surgical revascularization, whereas 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 < .001), 30-day amputation rates increased from 5% to 38% (P < .001), and 1-year amputation rates increased from 15% to 55% (P < .001). Finally, patients who did not have WIfI scores classified had significantly higher 30-day and 1-year mortality rates, as well as higher 30-day and 1-year amputation rates. ConclusionsThe SVS WIfI clinical stage is significantly associated with 1-year amputation rates in patients with CLTI after lower extremity revascularization. Because nearly 55% of stage 4 patients require a major amputation within 1 year of intervention, this finding study supports use of the WIfI classification system in clinical decision-making for patients with CLTI.

Intravascular Ultrasound Use is Associated with Improved Patency in Lower Extremity Peripheral Arterial Interventions

ObjectivesIntravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear if IVUS use improves clinical outcomes of peripheral vascular interventions (PVI) for peripheral arterial disease (PAD). This study aimed to evaluate the impact of IVUS on 1-year outcomes of PVI in the vascular quality initiative (VQI). MethodsThe VQI-PVI modules were reviewed (2016-2020). All patients with available one-year follow up after lower extremity PVI were included and grouped as IVUS-PVI or non-IVUS PVI based on use of IVUS. Propensity matching (1:1) was performed using demographics and comorbidities. One-year major amputation and patency rates were compared. A generalized estimating equation (GEE) model was used to identify predictors of 1-year outcomes. Subgroup analysis based on Trans-Atlantic Inter-Society Consensus (TASC) classification, treatment length and treatment modalities were performed using same modeling approaches. ResultsThere were 56,633 procedures (non-IVUS PVI=55,302 vs IVUS-PVI=1,331) in 44,042 patients. Propensity matching yielded a total cohort of 1,854 patients matched (1:1), with no baseline differences. LER for claudication was performed in 60.4%, while one-third (33.9%) had chronic limb threatening ischemia (CLTI). IVUS was more commonly used for lesions >15cm in length (46.6% vs 43.3%) and for aortoiliac disease (31.8% vs 27.2%). Rates of atherectomy and stenting were significantly higher with IVUS-PVI (21.1% vs 16.8%), while balloon angioplasty was less common (13.5% vs 24.4%). One-year patency was better with IVUS-PVI (97.7% vs 95.2%, p=0.004). On subgroup analysis, IVUS (OR 2.20, 95% CI 1.29- 3.75) was associated with improved patency in CLTI patients, TASC C or D lesions, and treatment length >15cm. Adjunctive IVUS use during PVI did not significantly impact 1-year amputation (OR 1.7, 95%CI 0.78-3.91). On multivariable regression, adjunctive use of IVUS (OR 2.46 95%CI 1.43-4.25) and aortoiliac interventions (OR 2.91, 95%CI 1.09-7.75) were independent predictors of patency. Treatment modalities such as atherectomy, stenting or balloon angioplasty did not significantly impact patency at 1-year. ConclusionIVUS during lower extremity PVI is associated with improved 1-year patency, when compared to angiography alone. Certain subgroups, such as CLTI patients, lesions>15cm, and TASC C or D lesions might benefit from adjunctive use of IVUS.

The impact of the Affordable Care Act Medicaid Expansion in Medicare beneficiaries with peripheral artery disease.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME (n = 25) versus those who were in states that did not (n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality (p = 0.15) or amputation (p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

The relationship between hyperpolypharmacy and one-year outcomes in patients with critical limb ischemia undergoing below-knee endovascular therapy.

Critical limb ischemia (CLI) patients take too many medications because they are elderly and frail patients with multiple comorbidities. Polypharmacy is associated with frailty, although its prognostic significance in CLI patients is unknown. In this study, we aimed to determine the prevalence of hyperpolypharmacy among adults with CLI and its effect on 1-year amputation and mortality. A total of 200 patients with CLI who underwent endovascular therapy (EVT) for below-knee (CTC) lesions were included in this study. Hyperpolypharmacy was defined as using ≥10 drugs. Patients were divided into two groups according to the presence of hyperpolypharmacy. We detected hyperpolypharmacy in 66 patients. The incidence of 1-year amputation [24 (36.4) versus 12 (9), p<.001] and mortality [28 (42.4) versus 12 (9), p<.001] were higher in patients with hyperpolypharmacy. Univariate and multivariate cox regression analyses were used to determine the independent predictors of amputation and mortality. In the receiver operating characteristic curve analysis, the cut-off value was defined as 10 or more drug use was able to detect the presence of 1-year mortality with 67.5% sensitivity and 79.4% specificity. The Kaplan-Meier method showed a significant difference (rank p <.001 between log groups), and hyperpolypharmacy was associated with 1-year amputation and mortality. Hyperpolypharmacy was significantly associated with 1-year mortality and major amputation in CLI patients. Hyperpolypharmacy can be a valuable aid in patient risk assessment in the CLI.

Skeletal muscle regeneration failure in ischemic-damaged limbs is associated with pro-inflammatory macrophages and premature differentiation of satellite cells

BackgroundChronic limb-threatening ischemia (CLTI), a severe manifestation of peripheral arterial disease (PAD), is associated with a 1-year limb amputation rate of approximately 15–20% and substantial mortality. A key feature of CLTI is the compromised regenerative ability of skeletal muscle; however, the mechanisms responsible for this impairment are not yet fully understood. In this study, we aim to delineate pathological changes at both the cellular and transcriptomic levels, as well as in cell–cell signaling pathways, associated with compromised muscle regeneration in limb ischemia in both human tissue samples and murine models of CLTI.MethodsWe performed single-cell transcriptome analysis of ischemic and non-ischemic muscle from the same CLTI patients and from a murine model of CLTI. In both datasets, we analyzed gene expression changes in macrophage and muscle satellite cell (MuSC) populations as well as differential cell–cell signaling interactions and differentiation trajectories.ResultsSingle-cell transcriptomic profiling and immunofluorescence analysis of CLTI patient skeletal muscle demonstrated that ischemic-damaged tissue displays a pro-inflammatory macrophage signature. Comparable results were observed in a murine CLTI model. Moreover, integrated analyses of both human and murine datasets revealed premature differentiation of MuSCs to be a key feature of failed muscle regeneration in the ischemic limb. Furthermore, in silico inferences of intercellular communication and in vitro assays highlight the importance of macrophage-MuSC signaling in ischemia induced muscle injuries.ConclusionsCollectively, our research provides the first single-cell transcriptome atlases of skeletal muscle from CLTI patients and a murine CLTI model, emphasizing the crucial role of macrophages and inflammation in regulating muscle regeneration in CLTI through interactions with MuSCs.

Abstract 16165: Implicit Bias and Unintentional Harm in Vascular Care: The Case for Intervention

Introduction. Unconscious, or implicit, bias may influence physician treatment decisions and contribute to healthcare disparities. Research Questions. Is implicit bias associated with inappropriate care for claudication and 1-year major amputation? Methods: All vascular interventionists of the Society for Vascular Surgery Vascular Quality Initiative (VQI) were invited to take the race Implicit Association Test (IAT). The IAT asks participants to classify sequential images of African American (Black) and European American (White) faces to positive and negative attributes and groups them by racial preference based on reaction time. IAT results were weighted and linked to VQI peripheral revascularization data to test the association between implicit bias with patient race and performance of below-knee procedures for claudication, a measure of inappropriate care. We assessed the association of below-knee procedures and patient race with odds of 1-yr amputation, using physician implicit bias as a moderator. Results: Among the 218 physicians that completed the IAT, physicians with White preference (70%) were more likely to perform a below-knee procedure on Black patients ( Fig A ) and their Black patients had increased odds of 1-yr amputation compared to White patients (OR: 3.0, 95%CI: 1.7-5.4). Physicians with no preference (20%) had no variability in below-knee procedures by patient race and fewer 1-yr amputations. A below knee procedure for claudication (ref: above-knee) was associated with increased odds of 1-year amputation, but the effect was greater among physicians with White bias (OR: 8.2;4.7-14.5) compared to no bias (OR: 3.6;1.4-9.7) ( Fig B ). Conclusions: Implicit bias is associated with inappropriate treatment selection, especially for Black patients. These results suggest the need for system level interventions that transparently identify procedures that are not aligned with best practices to reduce the negative effect of implicit bias.

Association Between the Society for Vascular Surgery (SVS)-WIfI (Wound, Ischemia, Foot Infection) Classification, Wagner-Meggitt Classification, and Amputation Rate in Patients With Diabetic Foot Infection.

Diabetic foot infection (DFI) is a common problem in patients with diabetic foot disease. Amputations and other complications of DFI lead to significant morbidity and mortality. The Society for Vascular Surgery (SVS)-WIfI (wound, ischemia, and foot infection) classification system can evaluate the benefit from revascularization and the risk of amputation in 1 and 3 years. We aimed to evaluate SVS-WIfI and Wagner-Meggitt (WM) prediction of DFI outcome, and to determine factors associated with major amputation and mortality rate. The patients with diabetes who presented between June 2018 and May 2020 with characteristics suggesting a more serious DFI or potential indications for hospitalization were reviewed in this cohort study. Demographic data, clinical characteristics, and type of revascularization were evaluated. One-year and 3-year amputation and mortality rates were the main outcomes. The grading of WM classification and the SVS-WIfI score were compared between amputation and nonamputation groups. Association between mortality and comorbidity were analyzed. One hundred and thirty-one patients admitted with DFI were included in study. And 73.28% had peripheral arterial disease (PAD). The 1-year and 3-year major amputation rates were 16.03% and 26.23%, respectively. Seventy-eight (59.54%) patients required minor amputation to control infection before revascularization. PAD (risk ratio [RR] 1.47: 95% confidence interval [CI] 1.29-1.67, P = .032), benefit from revascularization clinical stage 3 on SVS-WIfI score (RR 4.56: 95%CI 1.21-17.21, P = 0.007), and high WM classification score (RR 9.46: 95% CI 5.65-15.82, P < 0.001) were associated by multivariate analysis with high amputation rates. 1-year & 3-year amputation risk on SVS-WIfI score were not associated with amputation rates in DFI (P = .263 and .496). Only 9 (6.8%) patients were lost to follow up during the 3-year period. WM classification score, SVS-WIfI score on benefit from revascularization, and PAD were strongly associated with major amputation rates in patients with DFI.

Investigating the impact of suboptimal prescription of preoperative antiplatelets and statins on race and ethnicity-related disparities in major limb amputation.

Non-Hispanic Black and Hispanic patients with symptomatic PAD may receive different treatments than White patients with symptomatic PAD. The delivery of guideline-directed medical treatment may be a modifiable upstream driver of race and ethnicity-related disparities in outcomes such as limb amputation. The purpose of our study was to investigate the prescription of preoperative antiplatelets and statins in producing disparities in the risk of amputation following revascularization for symptomatic peripheral artery disease (PAD). We used data from the Vascular Quality Initiative, a vascular procedure-based registry in the United States (2011-2018). We estimated the probability of preoperative antiplatelet and statin prescriptions and 1-year incidence of amputation. We then estimated the amputation risk difference between race/ethnicity groups that could be eliminated under a hypothetical intervention. Across 100,579 revascularizations, the 1-year amputation risk was 2.5% (2.4%, 2.6%) in White patients, 5.3% (4.9%, 5.6%) in Black patients, and 5.3% (4.7%, 5.9%) in Hispanic patients. Black (57.5%) and Hispanic patients (58.7%) were only slightly less likely than White patients (60.9%) to receive antiplatelet and statin therapy. However, the effect of antiplatelets and statins was greater in Black and Hispanic patients such that, had all patients received these medications, the estimated risk difference comparing Black to White patients would have reduced by 8.9% (-2.9%, 21.9%) and the risk difference comparing Hispanic to White patients would have been reduced by 17.6% (-0.7%, 38.6%). Even though guideline-directed care appeared evenly distributed by race/ethnicity, increasing access to such care may decrease health care disparities in major limb amputation.

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

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

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

Age is Associated With Increased Mortality but Not Other Complications in Patients Undergoing Catheter-directed Arterial Thrombolysis for Acute Lower Extremity Ischemia

Catheter-directed arterial thrombolysis (CDAT) has become a mainstay for the treatment of acute lower extremity ischemia (ALI). Although CDAT can be effective therapy, its use in older patients (>80 years) is considered a relative contraindication due to concern for complications. We evaluated short-term clinical outcomes of patients undergoing CDAT for ALI stratified by age. Patients with ALI undergoing CDAT between 2011 and 2021 were identified using the TriNetX Analytics Network, a federated network of nationwide health care organizations that provides de-identified patient data. The cohort was stratified by age (40-59, 60-79, and 80+ years) and analyzed by those receiving post-procedural tPA infusion and those not (itPA+ or itPA−). Outcomes included mortality, myocardial infarction (MI), amputation, acute blood loss, and reintervention. One-year outcomes were analyzed after propensity matching for demographics, comorbidities, and medications. After 1:1 propensity matching, there were significantly higher rates of mortality in the 60 to 79/itPA− group compared with the 40 to 59/itPA− group (8.7% vs 4.5%; P = .0020) and significantly higher rates of amputation in the 40 to 59/itPA− group compared with the 60 to 79/itPA− group (27.5% vs 22.6%; P = .0425). There were significantly higher rates of mortality in the 80+ group compared with the 40 to 59 group when stratifying in both itPA− (17.3% vs 4.1%; P < .0001) and itPA+ patients (18.0% vs 7.8%; P = .0153). There were also significantly higher rates of mortality in the 80+ group compared with the 60 to 79 group when stratifying in both itPA− (19.5% vs 9.0%; P < .0001) and itPA+ patients (16.7% vs 8.0%; P = .0043). Amputation rates in the 80+/itPA+ group were significantly higher compared with the 60 to 79/itPA+ group (28.1% vs 20.2%; P = .0488); there were similar rates of amputation in the 60 to 79/itPA− and 80+/itPA− groups. In patients undergoing CDAT for ALI there were higher rates of 1-year mortality in the 80+ patient group regardless of itPA status. Although there were significantly higher rates of 1-year mortality in 60 to 79/itPA− patients compared with 40 to 59/itPA− patients, mortality rates were similar in itPA+ patients. Complication rates were similar across all groups regardless of itPA status, apart from significantly higher 1-year amputation rates in 80+/itPA+ patients compared with 60 to 79/itPA+ patients. Older age is associated with increased mortality rates in patients undergoing CDAT for ALI. We found no association between increasing age and other postoperative complications.

Necessity, Role, and Outcomes of Fasciotomy in Patients with Acute Limb Ischemia

The incidence of compartment syndrome in patients with acute lower limb ischemia (ALLI) and the effects of fasciotomy on outcomes are largely undefined. This study aimed to define the incidence of compartment syndrome in patients with ALLI and to examine whether different fasciotomy strategies are associated with specific patient outcomes. A single-center retrospective study of patients who had ALLI between April 2016 and October 2020 at a tertiary care center. Patients were categorized into groups as having received early and late therapeutic fasciotomy (TF), early prophylactic fasciotomy (PF), early exploratory fasciotomy, and no fasciotomy. Primary outcome was 30-day amputation rate. Secondary outcomes were 30-day and 1-year mortality, 1-year amputation rate, and length of stay. Groups were compared using descriptive statistics to assess the association of fasciotomy approach with outcomes. During the study period, 266 patients were treated for ALLI, and 62 patients (23%) underwent 66 fasciotomies. A total of 41TF, 23 PF, and 2 exploratory fasciotomies were done. There were 58 early fasciotomies performed (88% of 66 limbs): 33 (57%) early TF, 23 (40%) PF, and 2 (3%) exploratory. There were 8 patients who developed compartment syndrome after their revascularization operation and received delayed TF (12% of 66 limbs). The total number of TF was 41, which was 15% of all ALLI patients. The mean±SD time to fasciotomy closure was 6.7±5.7days, which did not differ between PF and TF groups. Significantly more patients in the TF group had an amputation at 30days (11 [29%] vs. 1 [5%]; P=0.03) and at 1year (6 [18%] vs. 2 [9%]; P=0.02) than those in the PF group. Length of stay was increased in both TF (16days) and PF (19days) patients compared to nonfasciotomy patients (10days; P<0.01) but did not differ between the 2 fasciotomy groups (P=0.4). Thirty-day limb loss was highest in patients who underwent early TF (10/33, 33%), intermediate in those with delayed TF (1/8, 13%), and lowest in PF (1/23, 5%; P=0.03). Approximately 15% of patients with ALLI in our cohort required a TF for compartment syndrome. Close postoperative monitoring of ALLI patients who did not undergo early fasciotomy did detect delayed compartment syndrome; however, this approach did not prevent limb loss. To optimize limb salvage, physicians treating patients with ALLI should be experienced in how to recognize and treat compartment syndrome.

Direct and Indirect Effects of Race and Socioeconomic Deprivation on Outcomes After Lower Extremity Bypass.

To evaluate the potential pathway, through which race and socioeconomic status, as measured by the social deprivation index (SDI), affect outcomes after lower extremity bypass chronic limb-threatening ischemia (CLTI), a marker for delayed presentation. Racial and socioeconomic disparities persist in outcomes after lower extremity bypass; however, limited studies have evaluated the role of disease severity as a mediator to potentially explain these outcomes using clinical registry data. We captured patients who underwent lower extremity bypass using a statewide quality registry from 2015 to 2021. We used mediation analysis to assess the direct effects of race and high values of SDI (fifth quintile) on our outcome measures: 30-day major adverse cardiac event defined by new myocardial infarction, transient ischemic attack/stroke, or death, and 30-day and 1-year surgical site infection (SSI), amputation and bypass graft occlusion. A total of 7077 patients underwent a lower extremity bypass procedure. Black patients had a higher prevalence of CLTI (80.63% vs 66.37%, P < 0.001). In mediation analysis, there were significant indirect effects where Black patients were more likely to present with CLTI, and thus had increased odds of 30-day amputation [odds ratio (OR): 1.11, 95% CI: 1.068-1.153], 1-year amputation (OR: 1.083, 95% CI: 1.045-1.123) and SSI (OR: 1.052, 95% CI: 1.016-1.089). There were significant indirect effects where patients in the fifth quintile for SDI were more likely to present with CLTI and thus had increased odds of 30-day amputation (OR: 1.065, 95% CI: 1.034-1.098) and SSI (OR: 1.026, 95% CI: 1.006-1.046), and 1-year amputation (OR: 1.068, 95% CI: 1.036-1.101) and SSI (OR: 1.026, 95% CI: 1.006-1.046). Black patients and socioeconomically disadvantaged patients tended to present with a more advanced disease, CLTI, which in mediation analysis was associated with increased odds of amputation and other complications after lower extremity bypass compared with White patients and those that were not socioeconomically disadvantaged.

Outcomes following ipsilateral great saphenous vein bypass for lower extremity arterial injuries

ObjectiveUse of autologous great saphenous vein (GSV) grafts for repair of extremity arterial injuries is well established. Contralateral great saphenous vein (cGSV) is traditionally used in the setting of lower extremity vascular injury given the risk of occult ipsilateral superficial and deep venous injury. We evaluated outcomes of ipsilateral GSV (iGSV) bypass in patients with lower extremity vascular trauma. MethodsPatient records at an ACS verified Level I urban trauma center between 2001 and 2019 were retrospectively reviewed. Patients who sustained lower extremity arterial injuries managed with autologous GSV bypass were included. Propensity-matched analysis compared the iGSV and cGSV groups. Primary graft patency was assessed via Kaplan-Meier analysis at 1-year and 3-years following the index operation. ResultsA total of 76 patients underwent autologous GSV bypass for lower extremity vascular injuries. 61 cases (80%) were secondary to penetrating trauma, and 15 patients (20%) underwent repair with iGSV bypass. Arteries injured in the iGSV group included popliteal (33.3%), common femoral (6.7%), superficial femoral (33.3%), and tibial (26.7%), while those in the cGSV group included common femoral (3.3%), superficial femoral (54.1%), and popliteal (42.6%). Reasons for using iGSV included trauma to the contralateral leg (26.7%), relative accessibility (33.3%), and other/unknown (40%). On unadjusted analysis, iGSV patients had a higher rate of 1-year amputation than cGSV patients (20% vs. 4.9%), but this was not statistically significant (P = 0.09). Propensity matched analysis also found no significant difference in 1-year major amputation (8.3% vs. 4.8%, P = 0.99). Regarding ambulatory status, iGSV patients had similar rates of independent ambulation (33.3% vs. 38.1%), need for assistive devices (58.3% vs. 57.1%), and use of a wheelchair (8.3% vs. 4.8%) compared cGSV patients at subsequent follow-up (P = 0.90). Kaplan-Meier analysis of bypass grafts revealed comparable primary patency rates for iGSV versus cGSV bypasses at 1-year (84% vs. 91%) and 3-years post-intervention (83% vs. 90%, P = 0.364). ConclusionIpsilateral GSV may be used as a durable conduit for bypass in cases of lower extremity arterial trauma where use of contralateral GSV is not feasible, with comparable long-term primary graft patency rates and ambulatory status.

Single-Center Experience of Treating Chronic Limb-Threatening Ischemia of Lower Limbs Combined with Diabetes

To summarize our hospital's single-center experience of and reflections on the treatment of chronic limb-threatening ischemia (CLTI) of lower limbs combined with diabetes in the past 5 years. We retrospectively analyzed cases of lower limb CLTI combined with diabetes diagnosed at our hospital from March 2017 to June 2021. The baseline data, surgical information, and follow-up results of the patients were collected. The primary outcome indicator was the patency rate of lower limb target artery within 1 year post-op, and the secondary indicators were the reoperation rate within 1 year post-op and the amputation rate within 1 year post-op. A total of 89 patients with lower limb CLTI combined with diabetes were included in the study. A total of 85 patients underwent percutaneous transluminal angioplasty and the operation of 7 patients ended in failure, with the operation success rate reaching 91.76% (78/85). Three patients underwent femoral popliteal artery bypass grafting with artificial blood vessels and one patient underwent iliac femoral artery bypass grafting with artificial blood vessels, with the success rate of the operations reachign 100% (4/4). Among 78 patients who successfully underwent percutaneous transluminal angioplasty, the median follow-up time was 33 months (13, 64). Two patients died within one year after operation, with the post-op one-year survival rate being 97.44% (76/78). The post-op 1-year reoperation rate was 19.23% (15/78), the 1-year target vascular patency rate (deaths not included) was 85.53% (65/76), and the 1-year amputation rate was 3.85% (3/78). Among the patients who underwent bypass surgery, the follow-up period was 13-48 months. No thrombosis in or re-occlusion of the artificial blood vessels were observed during the follow-up period, and the artificial blood vessels remained unoccluded. Transluminal angioplasty has a relatively ideal rate of postoperative vascular patency. In addition, it is a minimally invasive procedure involving low perioperative risks and is performed under local anesthesia. Therefore, it can be used as the preferred treatment for patients with CLTI. On the other hand, bypass surgery has good long-term patency rate, but it involves higher perioperative risks and the procedure is more invasive. Therefore, bypass surgery can be used as an alternative when transluminal angioplasty ends in failure.

The relationship between sarcopenia and one-year mortality in patients with critical limb ischemia undergoing endovascular therapy below the knee.

Critical limb ischemia (CLI) is a progressive form of peripheral artery disease (PAD). Patients with CLI have poor long-term prognosis. The aim of this study was to investigate the value of sarcopenia in terms of 1-year mortality in patients with below-the-knee lesions who underwent endovascular treatment for CLI. A total of 190 patients with critical limb ischemia who underwent endovascular treatment (EVT) for below-the-knee (BTK) lesions were enrolled in this study. Sarcopenia was defined using the psoas muscle index (PMI). PMI was obtained by calculating the average psoas muscle area (APMA) of the left and right psoas muscles at the third lumbar vertebra level and dividing by the square of the height (cm2/m2). The primary endpoint of the study was 1-year mortality and the secondary endpoint was 1-year amputation. Patients were divided into 2 groups according to presence of sarcopenia. We detected sarcopenia in 64 patients. The mean age, height, and EF were higher in sarcopenia group. The psoas muscle area, weight, psoas muscle index, body-mass index, albumin level, and GFR were lower in sarcopenia group. The incidence of amputation (11.9% vs 29.7%, p = 0.003) and mortality (15.1% vs 35.9%, p = 0.001) were higher in patients with sarcopenia. Univariate and multivariate logistic regression analyses were used to determine the independent predictors of amputation and mortality. The survival curve for 1-year using the sarcopenia was analyzed using the Kaplan-Meier method, and statistical analysis was performed with the log-rank test. The presence of sarcopenia, glomerular filtration rate level, and low ejection fraction were found to be independent predictors of mortality. Sarcopenia was associated with 1-year mortality in patients with CLI undergoing EVT for BTK lesions. Also, patients with sacropenia had higher 1-year amputation rates. Sarcopenia may be a simple method to help patient selection, assessment, and intervention strategy for EVT and may improve patient outcomes.

Outcomes of axillofemoral bypass for intermittent claudication

ObjectiveAlthough endovascular therapy is often the first-line option for medically refractory intermittent claudication (IC) caused by aortofemoral disease, suprainguinal bypass is often performed. Although this will often be aortofemoral bypass (AoFB), axillofemoral bypass (AxFB) is still sometimes performed despite limited data evaluating its utility in the management of IC. Our goal was to assess the safety and durability of AxFB performed for IC. MethodsThe Vascular Quality Initiative (2009-2019) was queried for suprainguinal bypass performed for IC. Univariable and multivariable analyses were used to compare the perioperative and 1-year outcomes between AxFB and a comparison cohort of AoFB. ResultsWe identified 3261 suprainguinal bypasses performed for IC: 436 AxFBs and 2825 AoFBs. The mean age was 61.4 ± 9.1 years, 58.8% of the patients were men, and 59.7% currently smoked. Patients undergoing AxFB, compared with AoFB, were more often older, male, never smokers and ambulated with assistance (P < .001 for all). They had more often had hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, and end-stage renal disease and had more often undergone previous outflow peripheral endovascular interventions and previous inflow or outflow bypass. The AxFBs, compared with the AoFBs, were more often unifemoral (P < .05). Patients who had undergone AxFB, compared with AoFB, had had a shorter postoperative length of stay (median, 4 vs 6 days) and fewer perioperative pulmonary (3% vs 7.9%) and renal (5.5% vs 9.9%) complications but had required more perioperative ipsilateral major amputations (0.9% vs 0.04%; P < .05 for all). No significant differences were found in the incidence of perioperative myocardial infarction (2.8% vs 2.7%), stroke (0.7% vs 1.1%), or death (1.8% vs 1.7%). At 1 year, the Kaplan-Meier analysis demonstrated that the AxFB cohort, compared with the AoFB cohort, had had higher rates of death (7.3% vs 3.6%; P = .002), graft occlusion or death (14.3% vs 7.2%; P = .001), ipsilateral major amputation or death (12.5% vs 5.6%; P < .001), and reintervention, amputation, or death (19% vs 8.6%; P < .001). On multivariable analysis, AxFB was independently associated with an increased risk of 1-year reintervention, amputation, or death (hazard ratio, 1.6; 95% confidence interval, 1.03-2.4; P = .04). ConclusionsThe results from the present retrospective analysis suggest that long-term complications were more frequent in patients who had undergone AxFB compared with AoFB, although patients treated with AxFB had had a greater risk with more comorbidities. Because AxFB was associated with significant perioperative morbidity, mortality, and long-term complications, serious consideration should be given before its use to treat IC.

Percutaneous Deep Vein Arterialization for a Chronic Limb-Threatening Ischemia Patient in Taiwan.

Patients with a severe peripheral arterial occlusive disease, defined as chronic limb-threatening ischemia (CLTI),1 with an increase of 1-year mortality and amputation rates.2 Deep venous arterialization (DVA) creates a shunting blood flow from the artery to the deep vein. The DVA provides an alternative treatment for CLTI, and the safety and successful revascularization by percutaneous DVA (pDVA) was reported in Europe.3 There was also a successful pilot study in Singapore for pDVA by using the LimFlow device.4 Here, we report a case in Taiwan with CLTI, which failed in the prior endovascular procedure. We used total pDVA to create an arterial-venous bypass for ischemic limb salvage and with a perfect long-term outcome without using LimFlow device.