UNASSIGNED: Percutaneous deep venous arterialization (pDVA) is a minimally invasive technique connecting the tibial arteries below the knee to the tibial venous system into plantar venous circulation to deliver oxygenated blood to otherwise nonperfused foot. This study demonstrated outcomes of pDVA with commercially available equipment and described single-center experience on pDVA for critical limb-threatening ischemia patients with small artery diseases and end-stage plantar disease (ESPD) who were deemed no-option cases.
UNASSIGNED: A single-center retrospective review was performed on patients who underwent pDVA. Primary end points were successful establishment of tibial vein flow with venous pedal loop, rate of major amputation, and major adverse events over 6 months. Secondary end points were primary and secondary patency rates, minor amputation rates, and wound healing over 6 months.
UNASSIGNED: Forty-two patients with ESPD underwent pDVA. Risk factors identified were hypertension (92.8%), hyperlipidemia (85.7%), diabetes (78.6%), tobacco abuse (42.9%), and chronic kidney disease ≥ stage 3 (42.8%). Three patients were categorized as Rutherford Class 4, 14 patients Class 5, and 25 patients (59.5%) Class 6. Of 42 procedures, 33 (78.6%) were deemed successful. Amputation-free survival at 6 months was reported in 25 patients (60.9%); 16 patients (38.1%) reported minor amputations. Wound healing rate reported at 6 months was 23.8%.
UNASSIGNED: This is one of the largest case series to date with real-world no-option patients undergoing pDVA. pDVA seems a reasonable option for limb salvage in patients with ESPD where traditional arterial revascularization is not feasible. Identifying criteria for patient selection and advanced wound care is important to ensure clinical success. Additional research is required to establish diagnostic guidelines for patients being evaluated for pDVA.

BACKGROUND: To examine the influence of liver function on patients with chronic limb-threatening ischemia (CLTI), we classified patients with CLTI after revascularization according to their modified albumin-bilirubin (ALBI) grades.
METHODS: We retrospectively analyzed single-center data of patients who underwent revascularization for CLTI between 2015 and 2020. Patients were classified with ALBI grades 1, 2a, and 2b and 3 according to the ALBI score, which was calculated, based on serum albumin and total bilirubin levels. The endpoints were the 2-year amputation-free survival (AFS) and 1-year wound healing rates.
RESULTS: We included 190 limbs in 148 patients, and 50, 54, and 86 cases were assigned as grade 1, 2a, and 2b and 3, respectively. The 2-year AFS rates for the grade 1, 2a, and 2b and 3 groups were 79 ± 6%, 66% ± 7%, and 45 ± 6%, respectively (P < 0.01). One-year cumulative wound healing rates for grade 1, 2a, and 2b and 3 groups were 68 ± 7%, 69% ± 6%, and 48% ± 5%, respectively (P = 0.01). Multivariate Cox proportional hazard analyses identified age (≥75 years), dependent ambulatory status, and modified ALBI grades 2b and 3 compared with grades 1 and 2a as significant independent predictors of AFS. The dependent ambulatory status and Wound, Ischemia, and foot Infection classification stage 4 were significant negative predictors of wound healing.
CONCLUSIONS: Many patients with CLTI had high modified ALBI grades, and impaired liver function classified as modified ALBI grade 2b and 3 is a robust negative predictor of AFS.

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2.
METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models.
RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12).
CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

UNASSIGNED: To develop a novel and accurate nomogram to predict survival without amputation in patients with acute lower limb ischemia (ALLI) during the first year following endovascular therapy.
UNASSIGNED: Patients with ALLI who underwent endovascular therapy in our department between January 2012 and September 2020 were screened and included in the research. The included patients were randomly divided into a training and validation cohorts, respectively. Univariate and multivariate analyses were used in the training cohort to identify independent risk factors for amputation-free survival (AFS). A nomogram was then developed according to the identified independent risk factors. The nomogram was then validated in the validation cohort.
UNASSIGNED: 415 Chinese patients with 417 affected limbs were included in this study. Among these patients, 311 patients were classified into the training cohort and 104 patients were assigned to the validation cohort. Most patients were men (n = 240) and the average age of patients was 71.43 (standard deviation 8.86) years old. After the univariate and multivariate analyses, advanced age (p < 0.001), history of smoking (p < 0.001), atrial fibrillation (p < 0.001), and insufficient outflow (p = 0.001) were revealed as independent risk factors for AFS during the first year. The nomogram yielded AUROC values of 0.912 (95 % confidence interval [CI]: 0.873-0.950) and 0.889 (95 % CI: 0.812-0.967) in the training and validation cohorts, respectively.
UNASSIGNED: Advanced age, history of smoking, atrial fibrillation, and insufficient outflow were independent negative predictors for AFS in ALLI patients treated by endovascular therapy. The novel nomogram offered an accurate prediction of AFS in ALLI patients.

BACKGROUND: Occlusion after infra-inguinal bypass surgery for peripheral artery disease is a major complication with potentially devastating consequences. In this descriptive analysis, we sought to describe the natural history and explore factors associated with long-term major amputation-free survival following occlusion of a first-time infra-inguinal bypass.
METHODS: Using a prospective database from a tertiary care vascular center, we conducted a retrospective cohort study of all patients with peripheral artery disease who underwent a first-time infra-inguinal bypass and subsequently suffered a graft occlusion (1997-2021). The primary outcome was longitudinal rate of major amputation-free survival after bypass occlusion. Cox proportional hazard models were used to generate hazard ratios (HRs) and 95% confidence intervals (CIs) to explore predictors of outcomes.
RESULTS: Of the 1318 first-time infra-inguinal bypass surgeries performed over the study period, 255 bypasses occluded and were included in our analysis. Mean age was 66.7 (12.6) years, 40.4% were female, and indication for index bypass was chronic limb threatening ischemia (CLTI) in 89.8% (n = 229). 48.2% (n = 123) of index bypass conduits used great saphenous vein, 29.0% (n = 74) prosthetic graft, and 22.8% (n = 58) an alternative conduit. Median (interquartile range) time to bypass occlusion was 6.8 (2.3-19.0) months, and patients were followed for median of 4.3 (1.7-8.1) years after bypass occlusion. Following occlusion, 38.04% underwent no revascularization, 32.94% graft salvage procedure, 25.1% new bypass, and 3.92% native artery recanalization. Major amputation-free survival following occlusion was 56.9% (50.6%-62.8%) at 1 y, 37.1% (31%-43.3%) at 5 y, and 17.2% (11.9%-23.2%) at 10 y. In multivariable analysis, factors associated with lower amputation-free survival were older age, female sex, advanced cardiorenal comorbidities, CLTI at index procedure, CLTI at time of occlusion, and distal index bypass outflow. Initial treatment after occlusion with both a new surgical bypass (HR 0.44, CI: 0.29-0.67) or a graft salvage procedure (HR 0.56, CI: 0.38-0.82) showed improved amputation-free survival. One-year rate of major amputation or death were 59.8% (50.0%-69.6%) for those who underwent no revascularization, 37.9% (28.7%-49.0%) for graft salvage, and 26.7% (17.6%-39.5%) for new bypass.
CONCLUSIONS: Long-term major amputation-free survival is low after occlusion of a first-time infra-inguinal bypass. While several nonmodifiable risk factors were associated with lower amputation-free survival, treatment after graft occlusion with either a new bypass or a graft salvage procedure may improve longitudinal outcomes.

OBJECTIVE: This study aimed to evaluate treatment outcomes after bypass surgery or endovascular therapy (EVT) in average- and high-risk patients with chronic limb-threatening ischemia (CLTI).
METHODS: We retrospectively analyzed multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. A high-risk patient was defined as one with estimated 30-day mortality rate ≥5% or 2-year survival rate ≤50%, as determined by the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) calculator. The amputation-free survival (AFS), limb salvage (LS), wound healing, and 30-day mortality were compared separately for the average- and high-risk patients between the bypass and EVT with propensity score matching.
RESULTS: We analyzed 239 and 31 propensity score-matched pairs in the average- and high-risk patients with CLTI. In the average-risk patients, the 2-year AFS and LS rates were 78.1% and 94.4% in the bypass group and 63.0% and 87.7% in the EVT group (P < .001 and P = .007), respectively. The 1-year wound healing rates were 88.6% in the bypass group and 76.8% in the EVT group, respectively (P < .001). The 30-day mortality was 0.8% in the bypass surgery and 0.8% in the EVT group (P = .996). In the high-risk patients, there was no differences in the AFS, LS, and wound healing between the groups (P = .591, P = .148, and P = .074). The 30-day mortality was 3.2% in the bypass group and 3.2% in the EVT group (P = .991).
CONCLUSIONS: Bypass surgery is superior to EVT with respect to the AFS, LS, and wound healing in the average-risk patients. EVT is a feasible first-line treatment strategy for high-risk patients with CLTI undergoing revascularization, based on the lack of significant differences in the 2-year AFS rate, between the bypass surgery and EVT cohorts.

BACKGROUND: Iloprost has been proposed as an alternative to amputation in Critical Limb Ischemia (CLI) patients when revascularization was unsuccessful or not possible. Nonetheless, there is limited evidence of its benefit. The main objective was to evaluate the effectiveness of iloprost and the secondary objective was to evaluate its safety.
METHODS: In this cohort study including CLI patients from the COPART registry from 2006/10 to 2021/01, patients exposed to iloprost were matched with up to three unexposed patients according to age, sex, and Propensity Score (PS) for exposure to iloprost. The main outcome combined the occurrence of all-cause death and major amputations; survival was assessed over one-year using Kaplan-Meier estimates and Cox model analyses. Major Adverse Cardiovascular Events (MACE) were chosen as the safety outcome; the association with iloprost was estimated using a logistic regression model.
RESULTS: Among 1850 CLI patients, 201 were exposed to iloprost (71.6% men; median age: 72 years vs. 72.1%; 75 years for unexposed). In 134 exposed patients matched to 375 unexposed patients, 14 major amputations and 24 deaths occurred in exposed patients (28.4%) vs. 33 and 46 respectively in the unexposed patients (20.9%). The hazard ratio (HR) was of 1.49 (95% Confidence Interval: 1.01-2.20). The association remained in the subgroup of \"no option\" patients (HR: 1.74; [1.01-2.20]). Regarding safety, 21/201 (10.7%) exposed patients experienced MACE vs. 146/1649 (9.41%) unexposed patients (unadjusted Odds Ratio [OR]: 1.17 [0.72-1.90]; adjusted OR: 1.23 [0.72-2.11]).
CONCLUSIONS: The study did not find any benefit of iloprost in CLI patients and even suggested a deleterious effect.

BACKGROUND: Critical limb threatening ischemia (CLTI), particularly in patients with ischemic ulceration has been associated with significant morbidity and mortality. Typically, endovascular therapy has been first-line therapy for our patients, but this strategy has come into question based upon the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Threatening Ischemia (BEST-CLI) trial data.
RESULTS: For comparative purposes, we evaluated outcomes from 150 CLTI patients with ischemic ulceration treated with endovascular-first therapy. The mean age was 72 years in this predominate male, Caucasian, ambulatory group. The major co-morbidities were smoking history in 49% and diabetes mellitus in 67%.` Anatomic scoring, using Society for Vascular Surgery criteria, revealed only 35.6% had favorable anatomy (Global Limb Anatomical Staging System stage of 0,1) for long-term patency compared to 64.4% of limbs with unfavorable anatomy for long-term patency (Global Limb Anatomical Staging System stage 2,3). Stents were used in 47% of cases. Reintervention occurred in 36% over 24 months follow-up. At 12 and 24 months, the Kaplan-Meier projections for survival was 0.80 (0.73, 0.87) and 0.69 (0.59, 0.79); amputation was 0.69 (0.61, 0.77) and 0.59 (0.46, 0.71); amputation-free survival (AFS) was 0.56 (0.48, 0.65) and 0.38 (0.27, 0.50), respectively. Amputation was more common in those with reinterventions (P = 0.033). Mortality was predicted with ankle brachial index ≤0.40 or ≥1.30 (P = 0.0019) and the presence of infection (P = 0.0047). AFS was predicted by the presence of any infection (P = 0.0001).
CONCLUSIONS: Despite technically successful endovascular treatment, patients who present with CLTI maintain a high-risk for limb loss and mortality. Amputation prevention must vigilantly address infection risk. These data correlate with outcomes from BEST-CLI trial enhancing applicability to patient-centered care.

OBJECTIVE: Patients with Critical Limb Ischemia (CLI) present a high risk of cardiovascular events and death. Revascularization is the cornerstone of therapy to relieve ischemic pain and prevent limb loss. Literature data suggest that women tend to present with worse outcomes after revascularization. The aim of the present study is to determine amputation-free survival in a long-term follow-up in women and men following endovascular revascularization procedure for CLI.
METHODS: From November 2013 to December 2020, 357 consecutive patients were retrospectively included. Clinical and biological parameters were recorded at baseline before endovascular revascularization. During follow-up until February 2023, overall survival and amputation-free survival (freedom from major amputation) were analysed using the Kaplan-Meier method. Univariate and multivariate analyses were performed to study the parameters associated with amputation-free survival. A P<0.05 was considered as statistically significant.
RESULTS: A total of 357 consecutive patients were included, 189 men and 168 women with CLI, with a mean age of 78.6±12 years. Treated hypertension (79%), diabetes mellitus (48%), coronary artery disease (39%) and protein malnutrition (61%) were the most prevalent comorbidities. Women were older than men with a mean age of 82.4±11.4 years (versus 75.4±11 years in men) and presented more frequently with protein malnutrition (70% of women). Prevalence of diabetes, tobacco use and history of coronary heart disease were significantly higher in men. During the 10-year follow-up period, 241 patients had died (68%) and 38 (11%) underwent major amputation, of whom 22 patients were still alive on February 2023. Median survival was 35.5 months [IQR: 29.5; 43] in the overall population, 38.5 [32; 50.4] months in women and 33.5 months [24.7; 43.5] in men. No gender-related differences were noted according to peri-procedural complications, survival probability and amputation-free survival. In multivariate analysis for amputation-free survival, age, previous coronary heart disease, C-reactive protein level, left ventricular ejection fraction (LVEF)<60% and albumin level<35g/L were correlated with poor outcome. In particular, protein malnutrition, as a treatable risk factor, appears significantly correlated with poor outcome in both men and women (HR=2.50 [1.16;5.38], P=0.0196 in men; HR=1.77 [1.00;3.13], P=0.049 in women).
CONCLUSIONS: The present results highlight that mortality in patients after endovascular revascularization remains high with a mortality rate of 28% at 1 year, 40% at 2 years and 51% at 3 years. Women represented a distinct population, almost 10-year older than their male counterparts, with more prevalent protein malnutrition. However, no gender-related difference was noted according to amputation-free survival on the long-term follow-up. Associated risk factors are mainly age, a history of coronary heart disease, pre-procedural inflammatory syndrome and protein malnutrition. Correction of malnutrition could have the potential to improve functional and general long-term prognosis in patients with CLI together with optimal medical and interventional management.

The use of basilic vein in iliofemoral revascularizations was previously described in the literature as an autologous option for the treatment of vascular prosthesis infection and as a primary conduit in patients at high risk of infectious surgical complications. However, the publications available include several different indications and are limited to case reports. Therefore, the aim of this study was to evaluate the outcomes of the use of arm veins as a safe and effective autologous alternative for iliofemoral reconstruction in patients with chronic limb-threatening ischemia (CLTI) and at high risk of prosthesis infection.
We performed a multicenter, retrospective cohort study with 53 consecutive iliofemoral bypasses using arm veins as an alternative conduit. The procedures were performed between November 2013 and November 2021, exclusively for patients with CLTI classified as TASC aortoiliac C or D with increased risk of postoperative surgical infection. Demographic, clinical variables, and outcomes were collected from a prospective database. Main endpoints were amputation-free survival (AFS) and major adverse cardiovascular events. Secondary endpoints included primary and secondary patencies and overall survival. Cox regression analysis was used to identify the predictors of AFS. Postoperative surgical complications and 30-day mortality were also assessed.
The mean age was 64.2 ± 8.4 years, with a predominance of male gender. The median follow-up period was 615 days. All patients had CLTI, with a predominance of tissue loss (n = 51; 96.2%) and a median ankle-brachial index of 0.28. The basilic vein was utilized in most procedures (69.8%). Thirty-day major adverse cardiovascular events occurred in five cases (9.4%), and the 30-day mortality rate was 3.8%. The AFS, primary patency, secondary patency, and overall survival in 720 days were 71%, 72%, 89%, and 75%, respectively. Cox regression analysis revealed no association between the variables analyzed for AFS. There was no graft late infection nor pseudoaneurysmal degeneration.
Iliofemoral bypass using arm veins as an autologous conduit proved to be an effective and safe procedure with low incidence of postoperative cardiovascular complications and high rates of AFS in patients with CLTI. Also, this suggests that arm veins can be an interesting and suitable autologous alternative conduit for iliofemoral reconstructions, especially in cases in which a prosthesis should be avoided or when it is not available.