Limb Salvage Rate Research Articles

Short review of diagnosis and revascularization for thromboangiitis obliterans

This short review focuses on recent diagnostic criteria and outcomes after revascularization in thromboangiitis obliterans (TAO, Buerger disease). The incidence and disease have decreased worldwide, including in Eastern Asia, except in regions where inexpensive tobacco products are widely consumed. However, the global epidemiology remains unclear due to the lack of definitive diagnostic biomarkers. Clinical diagnostic criteria are also not standardized but have been updated according to medical advances and current patient characteristics. Notably, neither of the two recently proposed criteria excludes patients with risk factors for atherosclerosis, as these conditions may coexist with TAO and are often seen in young patients. Young age at onset is no longer essential. Objective test findings are required, and typical vascular imaging findings are essential for definitive diagnosis. Suspected diagnosis is allowed for patients who have difficulty undergoing tests. Revascularization for TAO is typically directed at below-the-knee lesions, which are characterized by poor distal runoff, associated inflammation, and prone to spasm. Recently, both bypass surgery (BS) and endovascular treatment (EVT) have shown improved outcomes. Two studies on BS published after 2000 reported primary patency rates exceeding 50% at 3 years. A systematic review and meta-analysis of EVT, which mostly consisted of balloon angioplasty, revealed that multiple reinterventions were often required; however, the secondary patency and limb salvage rates at 3 years were comparable to those of BS. Short-term arterial patency, whether achieved by BS or EVT, can be sufficient for ulcer healing. Given that TAO is a highly thrombogenic condition, the administration of potent antithrombotic therapy during and after revascularization is crucial to maintain arterial patency.

Exploring the Other Side of the River: Early and Midterm Outcomes of Endovascular Pedal Arch Revascularization in Patients with Chronic Limb-Threatening Ischemia.

This study investigated the effect of patency of the pedal arch (PA) on wound healing rate and time, amputation-free survival (AFS), limb salvage, and limb-based patency (LBP) in chronic limb-threatening ischemia (CLTI) patients undergoing endovascular revascularization of infrainguinal arterial lesions. This prospective study included all CLTI patients presenting with wound, ischemia, and foot infection (WIfI) stages 2 to 4 (WIfI ischemia grades 2-3) who underwent endovascular revascularization of infrainguinal arterial disease between April 2019 and April 2021. Pedal angioplasty was attempted in all patients with significant steno-occlusive pedal artery disease. Patients were stratified according to Kawarada PA types. Successful PA revascularization (PAR) was counted when at least 1 pedal vessel is patent. Wound healing rate and time and Kaplan-Meier estimate of AFS and LBP at 2 years were evaluated and compared among the patient groups. A total of 120 patients were categorized according to PA type into type 1 (n = 34; 28.3%), type 2 (n = 64; 53.3%), and type 3 (n = 22; 18.3%). Pedal angioplasty was attempted in 97 patients and was technically successful in 75 patients (77.3%). Successful PAR (with or without pedal angioplasty) was achieved in 98 patients (81.7%). During the follow-up, successful PAR resulted in a better wound healing rate (86.7% vs 59.1%; P = 0.007), major amputation rates (5.1% vs 40.9%; P ≤ 0.001), and AFS (92.9% vs 72.7%; P = 0.018) compared with unsuccessful PAR. There were no significant differences between the 2 groups in wound healing time (3.76 ± 1.99 months vs 3.64 ± 1.94 months; P = 0.798, respectively) or LBP (80.6% vs 72.7%; P = 0.594, respectively). Global Limb Anatomic Staging System (GLASS) stage (odds ratio [OR] = 6.84; 95% CI, 1.30-36.03; P = 0.023) and unsuccessful PAR (OR = 21.64; 95% CI, 4.01-116.69; P ≤ 0.001) were independently associated with failure of wound healing, whereas site of wound lesion (OR = 5.52; 95% CI, 1.15-26.48; P = 0.033), GLASS stage (OR = 24.93; 95% CI, 2.84-218.69; P = 0.004), and unsuccessful PAR (OR = 22.44; 95% CI, 3.53-142.67; P = 0.001) were significant predictors of major amputation. Successful PAR is important for improving clinical outcomes of endovascular revascularization of CLTI patients such as wound healing, amputation-free survival, and limb salvage. Predictors of limb salvage were site of foot lesion, GLASS stage, and successful PAR, whereas GLASS stage and successful PAR were independently associated with improved wound healing. Pedal arch patency positively influences clinical outcomes in patients with chronic limb-threatening ischemia who have ischemic wounds undergoing endovascular revascularization. This study demonstrated that successful pedal arch revascularization (PAR) significantly improved wound healing, amputation-free survival, and limb salvage rates when compared to patients who did not achieve successful PAR. Additionally, the study identified the predictors of limb salvage as the site of foot lesions, GLASS staging, and successful PAR, while both GLASS staging and successful PAR were found to be independently associated with improved wound healing.

Mid-Term Results of Popliteal-Pedal Inframalleolar Vein Bypasses in Chronic Limb-Threatening Ischemia Patients After Previous Failed Tibial Endovascular Recanalization

Inframalleolar bypass still preserves its role in the modern endovascular era. Aim of this study was to evaluate the mid-term outcomes of "short" inframalleolar vein bypasses in patients with chronic limb-threatening ischemia (CLTI) after previous failed tibial endovascular recanalization. Between January 2015 and December 2021 107 CLTI patients in 3 Italian Departments of Vascular Surgery underwent "short" inframalleolar vein bypass after failed tibial endovascular recanalization. Early (30-day) and 3-year outcomes were evaluated in terms of survival, primary patency, primary assisted patency, secondary patency, and amputation-free survival. Univariate analysis of the perioperative factors affecting outcomes were performed by means of log-rank test. Associations of procedure variables were sought based on a multivariate Cox regression analysis. Distal anastomosis (inframalleolar) was mostly performed on dorsal pedis (64, 59.8%). At 30 days bypass occlusion was recorded in 5 cases (4.6%). Mean follow-up period was 20.5 ± 17.9 months. Estimated 3-year overall survival was 66.7%. Three-year estimates of primary patency, primary assisted patency, secondary patency, and amputation-free survival were 68.5%, 70.1%, 70.2%, and 76.7%, respectively. Multivariate analysis showed a negative association of insulin treatment with primary patency (HR 4.3, p = .04), primary assisted patency (HR 5.1, p = .02), and secondary patency (HR 5.1, p = .02). Negative association of long-term corticosteroid use was also found with primary patency (HR 7.8, p = .005), primary assisted patency (HR 8.7, p = .003), secondary patency (HR 8.7, p = .003), and amputation-free survival (HR 3.9, p = .05). "Short" vein bypasses to the foot arteries in CLTI patients yielded good mid-term overall patency, and limb salvage rates after a failed tibial endovascular recanalization. Insulin dependent diabetes mellitus, and long-term corticosteroid use seemed to affect the outcomes.

The Comorbidity-Polypharmacy Score as a Predictive Tool of Survival and Limb Salvage in Patients Undergoing Lower Limb Revascularization Procedures for Chronic Limb-Threatening Ischemia

ObjectiveThe comorbidity-polypharmacy score (CPPS) was created to evaluate the clinical burden of comorbidities in geriatric patients. It represents an objective tool to stratify patients’ risk in different settings. The study aimed to evaluate CPPS in predicting mortality and amputation in patients undergoing elective revascularization procedures in CLTI patients. MethodsThis is 2 years retrospective single-centre study. We included all patients undergoing elective lower-limb revascularization procedures admitted with CLTI diagnosis. Four CPPS groups were defined: mild, moderate, severe and morbid. The primary early and long-term outcomes were 30-day overall mortality, 30-day amputation rate and overall survival and limb salvage respectively. ResultsA total of 442 patients were enrolled in the study. Mean age was 76.5±9.9 years and 61.5% (272/442) were male. CPPS was calculated: 22.6% (100/442) have mild CPPS, 54.3% (240/442) moderate, 21.9% (97/442) severe and 1.2% (5/442) morbid.Kaplan-Meier curves for overall survival stratified for CPPS grade highlighted a strong statistically significant difference (p<0.0001) among the four CPPS classes.Mild CPPS has significantly higher limb salvage rate among moderate, severe and morbid CPPS groups (p<0.0001). Limb salvage for mild and severe CPPS, at 36 months was 95% vs. 85.1% respectively.Stepwise multivariable Cox-analysis revealed that mortality was independently associated with dialysis, Rutherford Classification V, age and CPPS. Male sex, multilevel arterial disease, and hybrid surgical repair were independently associated with amputations. ConclusionCPPS is a straightforward tool to evaluate the patient’s complexity and could be used as an adjuvant tool to stratify early- and long-term outcomes in CLTI patients undergoing elective revascularization procedures.

Great Saphenous Vein Arterialization in Patients with Severe Chronic Limb Threatening Ischemia: A Last Resort for Limb Salvage

ObjectiveIn one-fifth of patients with chronic limb-threatening ischemia there are no revascularisation options. In those cases, venous arterialisation could be a last resort for limb salvage. This study examines the clinical outcome of 17 patients, with non-healing wounds (Fontaine 4), who underwent Great Saphenous Vein (GSV) arterialisation leaving the distal saphenous side branches open and avoiding incisions in the lower leg and foot. MethodsIn this retrospective study all the patients who underwent GSV arterialisation between 1 January 2020 and 1 October 2023 were included. During the procedure, a small incision was made in the groin to identify the GSV and SFA. The GSV was detached from the deep venous system, the upper leg side branches were ligated, and the side branches distal to the knee joint were left open to create a pressure drop. Valvulotomy of the GSV down to the foot was performed in all patients. This approach does not necessitate the use of grafts or stents so that a serious infected foot can also be treated. For this study we have analysed the Limb salvage, wound healing, and mobility after treatment and observed pre and postoperative skin oxygenation over a one-year period. ResultsThis intervention resulted in a limb salvage rate of 46% and a secondary patency of 88% after one year in cases where amputation would have otherwise been necessary. Pre- and postoperative TcPO2 measurements indicated a gradual but consistent increase in skin oxygenation in 71% of the patients with a GSV larger than 3mm, underscoring the importance of future patient selection. All patients who successfully received arterialisation showed complete wound healing and improved mobility. ConclusionThis study introduced a promising approach to venous arterialisation in patients with severe CLTI who have no other treatment options, potentially impacting disease burden and quality of life significantly.

Clinical Outcomes After Distal Bypass in Patients With Chronic Limb-Threatening Ischemia due to Connective Tissue Disease.

Chronic limb-threatening ischemia (CLTI) is mostly caused by arteriosclerosis, but is sometimes due to connective tissue disease. However, there is a limited knowledge of clinical outcomes of patients with CLTI with connective tissue disease. The objective of the study was to assess outcomes after distal bypass in these patients using global vascular guidelines. Data from distal bypasses performed for CLTI at a single center from 2014 to 2023 were evaluated retrospectively. Clinical outcomes after distal bypass were compared for patients with CLTI with arteriosclerosis (AS group) and those with connective tissue disease (CD group). The primary endpoints were limb salvage and wound healing. Of the 282 distal bypasses performed for 222 patients with CLTI, 22 were conducted for 21 patients with connective tissue disease (CD group). The connective tissue disease was progressive systemic scleroderma (n = 11 patients), pemphigoid diseases (n = 2), polyarteritis nodosa (n = 2), rheumatoid arthritis (n = 2), and others (n = 4). Compared with the AS group, the CD group included more females (P = .007) and had greater oral steroid use (P < .001) and a higher Global Limb Anatomical Staging System (GLASS) inframalleolar (IM) modifier P2 (P < .001). The mean follow-up period of the whole cohort was 27 ± 22 months with no significant difference between the groups (P = .25), and 22 limbs required major amputation during this period. The 2-year limb salvage rate was significantly lower in the CD group compared to the AS group (75% vs 94%, P = .020). Wound healing was achieved in 220 (78%) limbs, and the 12-month wound healing rate was significantly lower in the CD group (52% vs 86%, P = .006). The low 2-year limb salvage and 12-month wound healing rates in patients with CLTI with connective tissue disease indicate that distal bypass may be challenging in these patients.

National Trends and Outcomes of Pedal Bypass Surgery

ObjectiveThe technical demands associated with pedal bypass (PB) surgery place it at risk of underutilization and may be limiting its widespread adoption as a valuable revascularization modality. This study aims to evaluate trends in PB performance, assess its outcomes, and compare its results between high- and low-volume centers. MethodsAll patients receiving a PB between 2003 and 2023 were identified in the Vascular Quality Initiative (VQI) infrainguinal bypass (IIB) module. The ratio of PB to total IIB performed was calculated for each year and trended over the study period. Centers performing PB were categorized according to their annual PB volume into tertiles of low-volume centers (LVC, <2 PB/year), medium-volume centers (MVC, 2-4 PB/year), and high-volume centers (HVC, >4 PB/year) for comparison. Patient characteristics and outcomes were compared using the χ2 or Fisher exact test as appropriate for categorical variables and the analysis of variance test or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between center volume and the primary outcomes of primary patency, primary-assisted patency, secondary patency, reintervention, amputation, and major adverse limb events (MALE), defined as the composite outcome of amputation and/or reintervention. ResultsA total of 3466 patients received a PB during the study period. The ratio of PB to IIB dropped from 14% to 4% between 2003 and 2023. Primary, primary-assisted, and secondary patency rates were 65%, 76%, and 80%, respectively, and limb salvage rate was 83% at 1 year. Nineteen percent of centers performing IIBs in the VQI did not perform any PBs during the study period. Of the 246 centers performing PBs, 78% were LVC, 15% were MVC, and only 7% were HVC. On Cox regression analysis, HVCs were associated with a lower risk of primary patency loss (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.95; P = .010), reintervention (HR, 0.75; 95% CI, 0.60-0.95; P = .016), amputation (HR, 0.77; 95% CI, 0.61-0.98; P = .034), and MALE (HR, 0.78; 95% CI, 0.66-0.93; P = .005) compared with LVCs. No difference in secondary patency between high- and low-volume centers was observed (P = .680). ConclusionsThe utilization of PB operations experienced a four-fold decrease over the past 20 years, despite favorable patency and limb salvage outcomes. Centers with a higher operative volume in PB achieve better outcomes than LVCs, and accordingly, patients with extensive tibioperoneal disease may benefit from evaluation at centers with documented expertise in PB before resorting to an alternative revascularization modality or a major limb amputation.

Optimizing Lower Extremity Local Flap Reconstruction in Peripheral Vascular Disease.

Local flaps remain a valuable reconstructive tool as a means for limb salvage for patients with advanced arterial disease. Our single-center, retrospective cohort study aims to compare the outcomes of different patterns of blood flow affected by vascular disease to pedicles in local flap reconstruction of the foot and ankle. A retrospective review of 92 patients and 103 flaps was performed. On angiograms, pattern of blood flow to the flap pedicle was determined to be direct inline flow (DF) or indirect flow (IF). Patterns of IF were either by arterial-arterial connections (AC) or unnamed randomized collaterals (RC). Primary outcomes were immediate flap success and limb salvage. Comparative analyses were performed using the χ2 and Fisher tests for categorical variables. Among all flaps, 73.8% (n = 76/103) had DF and 26.2% (n = 27/103) had IF. Both groups experienced similar rates of immediate flap success (DF = 97.3% vs IF = 92.6%, P = 0.281) and limb salvage (DF = 75.% vs IF = 66.7%, P = 0.403). However, the rate of contralateral amputation was significantly higher in the IF group (26.9% vs 5.3%, P = 0.006). When comparing the 3 distinct patterns of blood flow (DF vs AC vs RC), pedicled flaps were more commonly supplied by DF and AC, while random pattern flaps were more commonly supplied by RC (P = 0.042). Alternative routes of revascularization can maintain local flap viability and achieve similar rates of limb salvage but risks contralateral amputation. We found that pedicled and local muscle flaps require inline blood flow or blood supply by ACs. Meanwhile, random pattern flap can be supported by random collaterals.

The impact of alternative autologous venous material on limb salvage rates in patients with chronic limb-threatening ischemia

The impact of alternative autologous venous material on limb salvage rates in patients with chronic limb-threatening ischemia

Outcomes of Prosthetic and Biological Grafts Compared to Arm Vein Grafts in Patients with Chronic Limb Threatening Ischemia

ObjectivesThe 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 (AV), prosthetic grafts (PG) or biologic grafts (BG). 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 post-operative 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: arm vein (cephalic, basilic), prosthetic grafts [Dacron, polytetrafluoroethylene (PTFE)], and biologic grafts (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 (MACE), graft occlusion, prolonged length of stay >7days (PLOS), packed red blood cell (pRBC) transfusion >2 units, and infection. Cox Regression was used to report one-year outcomes: mortality, major amputation (above-ankle), and major adverse limb events (MALE defined as major amputation, thrombectomy or reintervention). ResultsA total of 9165 IIB procedures have been analyzed: AV 417 (4.55%); PG 7520 (82.05%); BG 1228 (13.40%). Compared to AV, patients receiving PG had higher odds of infection (aOR 2.89, p=0.045) and higher hazard of one-year mortality (aHR 1.51, p=0.035). On the other hand, patients receiving BG had higher risk of graft occlusion (aOR 4.55, p=0.040) and infection (aOR 2.78, p=0.046) as well higher hazard of one-year mortality (aHR 1.53, p=0.040), amputation (aHR 1.72, p=0.019) and amputation or death (aHR 1.52, p=0.005) compared to AV. After stratifying by bypass configuration, AV 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, AV are found to be the most resistant to infections and are associated with the best overall survival and limb salvage outcomes compared to PG and BG particularly in below-knee distal targets. In cases where no GSV is available, AV and PG are acceptable alternatives with comparable one-year amputation-free survival and MALE-free survival rates. On the other hand, BG are associated with higher risk of graft occlusion and lower freedom from major amputation and death compared to AV.

Catheter-Directed Thrombolysis in the Management of Thrombotic Peripheral Artery Occlusions-Acute and Mid-Term Clinical Outcomes.

Objectives: To evaluate the safety and efficacy of catheter-directed thrombolysis (CDT) with the recombinant tissue plasminogen activator (rt-PA) in all patients with symptomatic peripheral artery disease in real world practice. Methods: Consecutive patients treated with CDT between January 2013 and December 2020 were included in this retrospective analysis. The primary endpoint was the rate of serious adverse events (SAEs) until discharge. Secondary endpoints included interventional success, predictors for SAEs, bleeding and reperfusion edema/compartment syndrome, limb salvage, and clinical outcomes including target lesion revascularization rate (TLR). Results: Overall, 1238 patients were treated with CDT. SAEs occurred in 511 (41.3%) of the patients, 314 (25.4%) being bleeding complications. There were 95 cases of reperfusion edema/compartment syndrome. Forty-two patients underwent amputation and 33 patients (2.7%) died. CDT was successful in 1177 cases (95.1%). Multivariate logistic regression analysis identified age, abciximab and alprostadil usage, and lysis duration as predictors for SAEs and the use of abciximab as a predictor of reperfusion edema/compartment syndrome. Predictors for bleeding were age, alprostadil usage, and lysis duration. At 12 and 24 months, the limb salvage rate was 91.6% and 88.8%, and TLR rate was 46% and 57.2%, respectively. Conclusions: CDT is an effective endovascular method for the treatment of thrombotic peripheral artery occlusions but is associated with a high complication rate. For SAEs in general and bleeding specifically, increasing age, alprostadil use, and lysis duration were independent risk factors.

Short Term Outcomes of a Prospective Registry in Popliteal and Infrapopliteal Endovascular Interventions for Chronic Limb Threatening Ischaemia

The prevalence of chronic limb threatening ischaemia (CLTI) is increasing worldwide, resulting in the need for more patients undergoing revascularisation, especially for below the knee pathology. Nevertheless, prospective data on below the knee endovascular interventions are lacking. The aim of the study was to provide large scale, real world data on procedural and short term outcomes of popliteal and infrapopliteal endovascular interventions in patients with CLTI. This study is an analysis of the first 1 000 interventions of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER). It includes all patients with CLTI undergoing popliteal or infrapopliteal endovascular revascularisation in seven hospitals in the Netherlands. The primary outcomes were limb salvage and amputation free survival (AFS) at three months estimated with the Kaplan-Meier method. Secondary outcomes were procedural complications and primary patency. Between February 2021 and July 2023, 1 000 endovascular procedures were performed in 840 patients (947 limbs), treating 486 popliteal and 1 209 tibial lesions. Wound, Ischemia, and foot Infection (WIfI) stages 1 - 4 were present in 16.8%, 17.2%, 25.4%, and 40.6% of the limbs, respectively. Technical success was hampered by arterial perforation, acute thrombosis, and distal embolisation in 8.7%, 1.0%, and 2.3% of the interventions, respectively. Limb salvage was 100.0%, 96.9%, 94.9%, and 86.1% (p < .001), whereas AFS was 96.9%, 93.2%, 86.6%, and 76.4% for WIfI stages 1 - 4 at three months (p < .001), respectively. Primary patency at the 6 - 8 week visit was 86.4% for popliteal and 74.3% for tibial lesions, respectively. THRILLER presents a large prospective database on outcomes of CLTI endovascular interventions. Popliteal and infrapopliteal endovascular revascularisation for CLTI is safe. Interventions with initial technical success have high rates of limb salvage and survival at three months. The WIfI classification provides a reliable instrument to predict limb salvage and AFS independently at three months.

Role of Multistate Models to Predict Patency, Limb Salvage, and Survival: New Concepts to Analyse Data in Peripheral Arterial Disease

In peripheral arterial disease, patency, limb salvage, and survival rates are mostly reported using Kaplan-Meier analyses. When comparing different revascularisation techniques, these methods have limitations in analysing complex patient flows over time. This study aimed to present, illustrate, and discuss new concepts based on multistate models of analysing outcome parameters in peripheral arterial disease. Previously published data from a single centre, randomised controlled trial (RCT) with 218 cases that underwent either vein bypass surgery (bypass group, n = 109) or nitinol stent angioplasty (stent group, n = 109) of long femoropopliteal lesions were re-analysed using non-homogeneous Markov models. A step by step description of the concepts of states, state space, definitions, and illustration of transition probability curves as well as the benefits of multistate models is given. The RCT was registered at ISRCTN.com (ISRCTN18315574). Transition probability curves over time showed similar patterns in the bypass and stent groups. Significant differences in the transition probabilities were found for transitions from primary patency as well as secondary patency to end of patency. The transition probability for patients with preserved primary patency at 24 months who moved to end of patency at 48 months was 19.9% in the stent group vs. 6.4% in the bypass group (p < .001). The proposed method can answer important questions, such as: Did patients after femoropopliteal stenting with preserved primary patency at two years lose their patency more quickly within the following years compared with bypass surgery? and Did stent patients after a re-intervention to maintain patency at one year lose their patency more quickly compared with bypass surgery within the following years? Completely new research questions can now be raised and answered to optimise treatment and follow up strategies; this might lead to better identification of subgroups at higher risk of clinical deterioration following revascularisation procedures.

High- Versus Low-Dose Paclitaxel-Coated Balloons for Femoropopliteal Disease: A systematic review and meta-analysis.

To evaluate the comparative effectiveness of high- and low doses of paclitaxel in endovascular revascularization procedures for patients with femoropopliteal disease. The databases (Embase, PubMed, Scopus, and Web of Science) were searched for studies that had compared outcomes of high-dose and low-dose paclitaxel-coated balloons (PCBs) in the treatment of patients with femoropopliteal disease. Randomized controlled trials and nonrandomized comparative studies (eg, cohort studies and case-control studies) were eligible for inclusion. The primary outcomes of interest were patency rates, risk of restenosis, and clinically-driven target lesion revascularization (CD-TLR). Pooled effect sizes were reported as relative risk (RR) with 95% confidence intervals (CI). The analysis included 7 studies. High-dose PCB use was associated with higher patency (RR, 1.10; 95% CI, 1.00-1.21), reduced risk of restenosis (RR, 0.60; 95% CI, 0.46-0.79), and reduced need for CT-TLR (RR, 0.57; 95% CI, 0.41-0.79) compared to low-dose PCB. Rates of limb salvage (RR, 1.01; 95% CI, 0.99-1.04), freedom from major adverse limb events (RR, 1.39; 95% CI, 0.79-2.42), and overall survival (RR, 1.02; 95% CI, 0.99-1.05) were comparable in the 2 groups. There was no evidence of publication bias. High-dose PCB correlates with superior outcomes in patients with femoropopliteal disease, particularly in terms of better vascular patency, reduced restenosis risk, and lower need for target lesion revascularization, compared to low-dose PCB.

Isolated Limb Infusion for Limb-Threatening Sarcomas.

Isolated limb infusion (ILI) treats unresectable extremity malignancies with high-dose regional chemotherapy limited to the limb. This study assessed long-term outcomes after ILI for limb-threatening sarcomas. A retrospective review analyzed patients with an extremity sarcoma who underwent ILI with melphalan and dactinomycin from 2008 to 2023 at a single institution. The study identified 61 patients (52.5% female; median age, 73 years; range, 20-94 years). Of these patients, 68.9% had lower-extremity disease. The median follow-up period was 6.9 years. The overall response rate was 48.3% (complete response [CR], 21.7%; partial response [PR], 26.7%), and the disease control rate (DCR: CR+PR+stable disease [SD]) was 65%. The median progression-free survival (PFS) for the patients with CR/PR/SD/progressive disease (PD) was respectively 16.8/9.6/4.8/2.4 months (P<0.0001). The responders (CR+PR) had significantly longer PFS than the non-responders (SD+PD) (hazard ratio [HR], 6.3; 95% confidence interval [CI], 3.1-12.9; P<0.001). The median in-field PFS times for CR/PR/SD/PD were respectively 16.8/12/4.8/2.4 months (P<0.001). The responders had a significantly longer risk of in-field PFS than the non-responders (HR, 5.9; 95% CI 2.9-12.0; P<0.001). The median distant relapse PFS for CR/PR/SD/PD was not reached (NR)/NR/44.4/40.8 months (P=0.02). The responders had a significantly longer distant relapse PFS than the non-responders (HR, 2.7; range, 1.1-6.8; P=0.04). The median overall survival (OS) was 8.6 years for the responders and 4.1 years for the non-responders (P=0.02). The disease-specific survival (DSS) rates were 87% at 1 year, 71% at 3 years, and 64% at 5 years. The median DSS was not reached for the responders and was 4.1 years for the non-responders (P=0.003). The limb salvage rates at 6 months were 85% at 1 year, 80% at 3 years, and 70% at 5 years. The patients with PD had a higher risk of requiring amputation than the patients with CR+PR+SD (HR, 3.0; 95% CI 1.0-8.7; P=0.04). The 5-year limb salvage rates after ILI are notably high, reaching 70%. After ILI, the responders had significantly better in-field and distant relapse PFS, OS, and DSS.

Benefits of Aerosolized, Point-of-care, Autologous Skin Cell Suspension (ASCS) for the Closure of Full-thickness Wounds From Thermal and Nonthermal Causes: Learning Curves From the First 50 Consecutive Cases at an Urban, Level 1 Trauma Center.

To determine the utility of Autologous Skin Cell Suspension (ASCS) in closing full-thickness (FT) defects from injury and infection. Although ASCS has documented success in closing partial-thickness burns, far less is known about the efficacy of ASCS in FT defects. Fifty consecutive patients with FT defects (burn 17, necrotizing infection 13, crush 7, degloving 5, and other 8) underwent closure with the bilayer technique of 3:1 widely meshed, thin, split-thickness skin graft and 80:1 expanded ASCS. End points were limb salvage rate, donor site reduction, operative and hospital throughput, incidence of complications, and re-epithelialization by 4, 8, and 12 weeks. Definitive wound closure was achieved in 76%, 94%, and 98% of patients, at 4, 8, and 12 weeks, respectively. Limb salvage occurred in 42/43 patients (10 upper and 33 lower extremities). The mean area grafted was 435cm 2 ; donor site size was 212cm 2 , representing a potential reduction of 50%. The mean surgical time was 71 minutes; the total operating room time was 124 minutes. The mean length of stay was 26.4 days; the time from grafting to discharge was 11.2 days. Four out of 50 patients (8%) required 6 reoperations for bleeding (1), breakdown (4), and amputation (1). Four out of 50 patients (8%) developed hypertrophic scarring, which responded to silicone sheeting (2) and laser resurfacing (2). The mean follow-up was 92.7 days. When used for the closure of FT wounds, point-of-care ASCS is effective and safe. Benefits include rapid re-epithelialization, high rate of limb salvage, reduction of donor site size and morbidity, and low incidence of hypertrophic scarring.

Hemoglobin A1c levels are related to patency and adverse limb events in diabetics after revascularization

ObjectivePoor glycemic control in the perioperative period has been reported to be associated with early and late major adverse limb events (MALEs). However, these studies were mostly from large databases or lacked long-term outcomes. We examined the long-term effects of high hemoglobin A1c (HbA1c) level on patency, MALE, limb salvage (LS) and survival after lower extremity revascularization procedures in patients with diabetes. MethodsPatients with diabetes who underwent revascularization for Rutherford class 3 to 6 ischemia between May 2002 and December 2018 were identified. Patients with an HbA1c of ≤7% were compared with those with an HbA1c of >7% for patency, MALE, survival, LS, and amputation-free survival. ResultsOf 706 patients, 699 had HbA1c data (775 limbs), with 311 (357 limbs) in the HbA1c ≤7% and 388 (418 limbs) in the HbA1c >7% groups. Patients with an HbA1c of >7% were younger (69.9 ± 10.2 years vs 71.7 ± 9.5 years; P = .011), had higher lipid levels, insulin use (70% vs 49%; P < .01), American Society of Anesthesiologists classification of 4, and had a lower prevalence of chronic kidney disease (32% v s41%; P = .023). Patients with an HbA1c of >7% were more likely to present with chronic limb-threatening ischemia (CLTI) (79% vs 72%; P = .019) and undergo infrapopliteal interventions (49% vs 42%; P = .005), with no difference in anatomical complexity (TransAtlantic Inter Society Consensus class C/D, 75% vs 77%; P = .72) or type of revascularization (24% vs 18% open, 66% vs 70% endovascular, 10% vs 12% hybrid; P = .236). Patency and freedom from MALE were significantly lower in patients with an HbA1c of >7% for infrainguinal revascularizations, whereas amputation-free survival and overall survival were similar. In patients with chronic limb-threatening ischemia, LS rates at 5 years were significantly lower in patients undergoing open revascularization (HbA1c > 7%: 64% ± 6% vs HbA1c < 7%:86% ± 5%; P = .020), whereas it was similar after endovascular interventions (HbA1c > 7%:79% ± 4% vs HbA1c < 7%:77% ± 3%; P = .631). Seventy patients with an HbA1c of >7% lost limbs vs 38 patients with an HbA1c of ≤7% (P = .007). In multivariate analysis, HbA1c was associated significantly with primary patency. HbA1c, insulin use, level of intervention, and angiotensin-converting enzyme inhibitor use were associated with MALE. ConclusionsA perioperative HbA1c of >7% is associated with poorer patency rates and increased MALE, especially at the infrainguinal level revascularization in patients with diabetes, with no significant impact on survival. LS is impacted after open, but not after endovascular revascularization.

Long-term clinical efficacy of drug-coated balloon angioplasty for TASCII C/D femoropopliteal lesions in older patients with chronic limb-threatening ischemia: A retrospective study.

This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII C = 67, 54.9%; TASCII D = 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (P < .001) and ankle-brachial index measurements (P < .001). Complex target lesions (P = .017) and 1 stenosis-free outflow vessel (P = .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (P = .044), diabetes (P = .007), and 1 stenosis-free outflow vessel (P = .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.

Percutaneous Deep Venous Arterialization Using an IVUS-Guided Technique in no-Option Patients with Chronic Limb-Threatening Ischemia: 24-Month Results.

In some patients, revascularization is not possible or is not effective. For these, percutaneous deep vein arterialization (p-DVA) could be considered an alternative treatment. The aim of this study is to evaluate the long-term results of an intravascular ultrasound (IVUS)-guided technique that has only one percutaneous access. This is a prospective monocentric study on 18 no-option CLTI limbs treated with an IVUS-guided p-DVA. The primary outcome measures are: the freedom from major adverse events (MAEs) and survival at 30 days; limb salvage and amputation free survival (AFS) at 30 days, 6 months, 12months and 24 months. The secondary outcome measures are: procedural success, survival, patency and wound healing. We treated 14 patients with no-option CLTI, carrying out 18 p-DVA. Median age was 74,4years (60-87). All these patients had a previous failed angioplasty of the tibial and foot arteries. Procedural success rate, defined as the establishment of arterial flow into the venous system of the foot, was 100%. No deaths and MAEs recorded at 30 days. Survival was 100%, 83.4% and 77.8%; limb salvage was 88.9%, 77.8% and 77.8%; AFS was 88.9%, 61.1% and 55.6% at 6, 12 and 24 months. Complete wound healing was 18.7% at 6 months, 80.0% at 12 months and 100% at 24 months. Based on these results, the IVUS-guided p-DVA seems to be safe and effective for no-option CLTI patients, with no mortality related to the intervention, an acceptable limb salvage rate and amputation free survival.

Outcomes of Noncompliant Balloons in the Treatment of Lower Extremity Chronic Limb Threatening Ischemia: A Prospective Study.

This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI). This is a prospective single-center cohort study performed at a local tertiary hospital in Singapore. Consecutive patients who underwent lower limb angioplasty for CLTI using a noncompliant balloon catheter were enrolled if they were aged 40 years and above, presented with CLTI Rutherford grade 4 to 6, and had TASC C or D lesions in the lower limb vessels that were at least 100mm in length. Patient demographics, Rutherford grading, lesion characteristics, complications, and follow-up data were collected and analyzed. The primary outcomes were 30-day freedom from major adverse events, amputation-free survival (AFS) at 12 months, and freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes included clinical success and target lesion primary patency (TLPP) at 12 months. Amputation-free survival, freedom from cdTLR, and TLPP were calculated by Kaplan-Meier analysis. From May 2020 to December 2021, 50 patients (50 limbs) were enrolled. 43 (86%) patients had diabetes mellitus, while 12 patients (24%) had end-stage renal failure. 85 lesions were treated, including 59 (69.4%) below-the-knee (BTK) lesions. All the lesions were TASC C (n=45, 52.9%) or TASC D (n=40, 47.1%) lesions. Mean lesion length was 231.4±116.2mm. Technical success rate was 96.5%. No patients were lost to follow-up. Median follow-up duration was 282 days (IQR: 31-390 days). One patient died on day 26 due to an acute myocardial infarction. Two patients had groin hematomas postprocedure, both of which were treated conservatively. AFS, freedom from cdTLR, and TLPP at 12 months postprocedure was 70.0% (95% confidence interval [CI]: 58.4%-83.9%), 90.1% (95% CI: 83.4%-97.4%), and 61.1% (95% CI: 50.7%-73.6%), respectively. Early results have shown that the use of a high-pressure, noncompliant balloon is effective in lower limb angioplasty for CLTI in a highly challenging group of patients with a high prevalence of long BTK disease. Good vessel patency and limb salvage rates can be achieved, with a low complication rate. We await more long-term outcomes on vessel patency. There are many devices in the market for use in lower limb angioplasty. However, many of them come with an increased financial cost, procedural time and procedural difficulty. We report our prospective results with the exclusive use of a high pressure, non-compliant balloon, in a challening group of patients with a high prevalence of diabetes and end stage renal failure, achieving amputation free surival at 6 and 12 months post-procedure of 84.0% and 70.0% respectively. The use of non-compliant balloon is technically easy and does not add additional steps compared to a standard POBA procedure, thus limiting costs. We believe this article can be a push factor for clinicians to consider the use of these high pressure, non-compliant balloons in their patient care.