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Background: A subset of individuals with major depressive disorder (MDD) have a high burden of cardiovascular risk factors and cerebral small-vessel disease, implicating vascular disease in the development of depression. Cross-sectional studies demonstrate a link between endothelial dysfunction and MDD, but the prospective association between peripheral endothelial dysfunction (PED) and an incident diagnosis of MDD is unknown., Methods and Results: Patients undergoing a baseline assessment of cardiovascular risk were evaluated for PED using reactive hyperemia-peripheral arterial tonometry (≤1.8 consistent with PED). Patient medical records were reviewed to identify those who underwent a formal clinical evaluation of MDD after the index PED evaluation. The frequency of PED was compared in those with and without MDD. Logistic regression analyses were performed to assess the association between baseline PED and incident MDD. Between January 2006 and December 2020, 1614 patients underwent testing for PED. Four hundred eighty-four (30.1%) patients underwent a formal evaluation for MDD after (0-15 years) the index procedure (mean±SD age, 52.8±13.8 years; 65.2% women). Of these, 157 (32.4%) had PED and 108 (31.0%) were diagnosed with MDD. Individuals with MDD had a higher frequency of PED (40.2% versus 30.2%; P =0.034) compared with those without MDD. In multivariable analyses, PED was significantly associated with MDD (odds ratio, 2.3 [95% CI, 1.4-3.8]; P <0.001)., Conclusions: PED is significantly associated with incident MDD. Thus, PED may be a useful marker to identify individuals at increased risk of depression who may benefit from more frequent and earlier management strategies.

Background: Chronic limb-threatening ischaemia (CLTI) is an advanced and severe form of lower limb peripheral arterial disease (PAD) and can pose significant challenges in clinical management. Not all patients are able to undergo surgical intervention due to patient-related and disease-related factors., Objective: This review article aims to provide general practitioners with an overview of conservative management of patients with end-stage CLTI in the community., Discussion: The review aims to provide an overview of end-stage CLTI and approaches that are required to preserve patients' quality of life. It outlines symptom control, wound care, psychosocial support and end-of-life considerations to preserve the quality of life for patients facing this challenging condition.

Clinical Problem: More than 200 million people worldwide have peripheral artery disease (PAD). PAD affects the quality of life and is associated with significant morbidity and mortality. Standard treatment for severe cases of PAD is surgical or endovascular revascularization. However, up to 30% of patients are not candidates for open or endovascular procedures, due to high operative risk or unfavorable vascular involvement. Furthermore, revascularization procedures may be insufficient to adequately improve microvascular tissue perfusion, wound healing, or limb salvage. Accordingly, regardless of advances in treatment modalities, outcomes of patients with PAD have remained unfavorable. Therefore, new medical therapeutic approaches are much needed. Small animal models are indispensable tools for the understanding of PAD physiopathology and the development of novel medical therapies., Recommendations for Increasing Translation From Animal Models: Development of animal models that more closely mimic the pathophysiology (with occlusive atherothrombosis and chronic development of limb ischemia) can incorporate the cardiovascular risk factors associated with this disease state, and focus on more clinically relevant outcomes is critical. In practice, this means using both animals that develop atherosclerosis and methods for the application of gradual arterial occlusion to induce hind limb ischemia. Doing so will likely help identify novel targets for intervention and overcome some principal challenges confronted by previous clinical trials. While various rodent models are discussed, the optimal animal model is yet to be defined., Competing Interests: None.

Background: Despite the widespread use of drug-coated balloons (DCBs) for femoropopliteal (FP) lesions, there is still no consensus on treatment strategies for DCB restenosis. This study aimed to determine the risk factors for recurrent restenosis after repeat DCB therapy for DCB restenosis in FP lesions., Methods: This multicenter retrospective study assessed 1176 consecutive limbs in 860 patients who successfully received initial DCB therapy for FP lesions at four cardiovascular centers between May 2018 and December 2022. Among these patients, 118 consecutive limbs of 104 patients treated via repeat DCB for primary DCB restenosis were enrolled., Results: The Kaplan-Meier estimate of freedom from recurrent restenosis was 74.6% at 1 year. Cox proportional hazard multivariate analysis revealed that recurrent restenosis was independently associated with the time from initial DCB to primary restenosis (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.79-0.92; p < 0.001), history of ≥2 endovascular therapies (EVTs) (HR, 3.11; 95%CI, 1.36-7.12; p = 0.007), and PACSS grade 3 or 4 (HR, 2.76; 95%CI, 1.15-6.63; p = 0.023). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of the time from initial DCB to primary restenosis to prevent recurrent restenosis was 12.6 months, with an area under the curve of 0.841 (p < 0.001)., Conclusion: Repeat DCB therapy for DCB restenosis might be an acceptable strategy, particularly for restenosis that occurred more than 12.6 months after initial DCB, given the rate of freedom from recurrent restenosis., (© 2024 Wiley Periodicals LLC.)

We retrospectively reviewed the clinical data of 217 consecutive Chinese patients with isolated atherosclerotic popliteal artery lesions treated with atherectomy technique, DCB, and plain old balloon angioplasty from August 2017 to August 2022. There was no difference in the 48-month patency rate between the atherectomy, DCB, and POBA groups (65%, 56%, and 51%, respectively; p = 0.3), as well as in adjusted Cox regression. Similarly, no difference was observed in the 48-month clinically driven target lesion revascularization-free (CDTLR-free) rate among the groups (77%, 74%, and 65%; p = 0.34), confirmed by adjusted Cox regression. In the 48 months, a significant difference was observed in amputation-free rates between the atherectomy, DCB, and POBA groups (97%, 91%, and 83%, respectively; p < 0.05). Adjusted Cox regression indicated POBA had worse outcomes than DCB and atherectomy. In the stenosis and occlusion subgroup, the 48-month primary patency rates were 65%, 70%, and 54% (p > 0.9) and 65% versus 49% versus 49% (p = 0.3), showing no differences among the three groups. In the short lesion subgroup (<10 cm), the 48-month primary patency rates were 65%, 66%, and 61% for atherectomy, DCB, and POBA, respectively (p = 0.7). In the long lesion subgroup (≥10 cm), the 48-month patency rates were higher in the atherectomy and DCB groups compared to POBA (64%, 44%, and 34%), with no significant difference among the groups (p = 0.13). DCB and atherectomy demonstrate improved short- and mid-term clinical outcomes compared to POBA in Chinese patients with popliteal artery disease., (© 2024 The Author(s). The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)

Background: The COVID-19 pandemic has led to significant disruptions in chronic disease care and forced people to stay at home. The effects of such issues on outpatients with lower extremity peripheral artery disease (PAD) remain unknown. Patients and methods: Single-centre, retrospective-prospective study conducted in a Swiss University Hospital. Patients with PAD were included between May 1 and July 31, 2020, with a follow-up visit at 12 months. Upon both visits, the Leriche-Fontaine PAD stage was recorded, and study participants underwent ankle-brachial index (ABI) calculation to assess limb perfusion. Functional capacities were assessed through the 6-minute walking and treadmill tests. Major adverse cardiovascular (MACE) and limb events (MALE) were recorded. Data collected during the pandemic were compared with the pre-pandemic period (January 1, 2019-April 30, 2020). Results: Overall, 259 patients were included. Mean age was 69 years and male sex was prevalent (69.1%). Odds of experiencing a degradation in PAD stage were lower during the pandemic than before (odds ratio [OR]: 0.43; 95% confidence interval [CI]: 0.21-0.87; p = 0.018). No significant difference was found between periods in terms of ABI trends. Both pain-free walking time at treadmill test (p = 0.003) and maximal pain intensity at 6-minute walking test (p = 0.001) significantly improved during the pandemic. Compared with the pre-pandemic period, during the pandemic patients were hospitalized less frequently (p = 0.028) and were less likely to undergo elective limb revascularization (p<0.001). No significant difference was found between periods in terms of MALE (p = 0.311), whereas non-fatal strokes were less frequently reported during the pandemic (p = 0.043). Conclusion: In a cohort of outpatients with PAD, we found no evidence of clinical deterioration during the pandemic compared with the pre-pandemic period, though rates of adverse events were nonnegligible in both periods. In case of future pandemics, patients with PAD should be encouraged to maintain an active lifestyle while being closely monitored to avoid clinical worsening.

Objective: To investigate the role of the Omniflow II prosthesis in the prevention of vascular graft infection (VGI) in patients with peripheral arterial disease and to report on short-and mid-term graft-related morbidity., Material and Methods: Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection-related problems, operation-related wound problems, and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates., Results: A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft, and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal or femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. The mean follow-up time was 352 days (range 0-1108 days). 3.4% of the patients suffered a wound infection limited to the dermis, and in 8.2%, the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above-the-knee bypass was significantly better compared to the bypass below the knee (74.5% ± 0.131 versus 54% ± 0.126 (P = 0.049)). This difference was not significantly different when below-the-knee bypass surgery was compared with crural bypass surgery (54% ± 0.126 versus 23.8% ± 0.080 (P = 0.098))., Conclusions: The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high-risk population is similar to reported outcomes in other prosthetic grafts., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: To validate the correlation between the Global Limb Anatomic Staging System (GLASS) and primary limb-based patency (LBP) and to identify the risk factors associated with LBP loss., Materials and Methods: A single-center retrospective analysis was performed on patients with chronic limb-threatening ischemia (CLTI) who underwent endovascular therapy (EVT) between January 2018 and May 2022. All lesions were categorized into 3 groups (GLASS Stages I, II, and III). The primary LBP rates were analyzed and compared across the GLASS stages. The risk factors for the loss of primary LBP were identified using Cox regression analysis., Results: In total, 236 limbs from 231 patients were included, with 52 (22%) limbs stratified as GLASS Stage I, 59 (25%) limbs as GLASS Stage II, and 125 (53%) limbs as GLASS Stage III. The 1-year LBP rates for limbs classified as GLASS Stages I, II, and III were 78.8%, 69.5%, and 41.6%, respectively (P < .001). The long-term LBP rate was 54.2% in GLASS Stage I, 38.6% in GLASS Stage II, and 10.5% in GLASS Stage III (P < .001). Multivariate analysis revealed that GLASS stages (GLASS Stage Ⅰ vs Ⅲ, hazard ratio [HR], 0.36; 95% CI, 0.18-0.72; P = .004; GLASS Stage Ⅱ vs Ⅲ, HR, 0.47; 95% CI, 0.25-0.86; P = .02), diabetes, smoking, and sex were independently associated with LBP., Conclusions: GLASS Stage III was associated with lower LBP rates in patients with CLTI who underwent EVT. The GLASS stages may serve as prognostic indicators for patients with CLTI after intervention., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: Residual dissection is a concern in endovascular treatment with a DCB, and there is limited knowledge of hemodynamics at a dissection lesion. Therefore, the objective of this study is to evaluate the mean pressure gradient (MPG) and fractional flow reserve (FFR) at a residual dissection after DCB angioplasty for the superficial femoral artery (SFA)., Methods: A total of 59 cases with residual SFA dissection treated with DCB angioplasty at a single center were analyzed retrospectively. The dissection was classified into 6 types (A-F). The primary endpoints were MPG and FFR at a residual dissection lesion after DCB angioplasty, using evaluation with a pressure wire., Results: The median lesion length was 70 (40-130) mm with 24% popliteal involvement, and 11 cases (18%) had chronic total occlusion. A completion angiogram revealed dissection of types A (n = 33, 56%), B (n = 18, 31%), C (n = 7, 12%), and D (n = 1, 2%). The median MPGs in type A, B, and C cases were 0 (0-2), 0 (0-4), and 3 (0-6) mmHg, with a significant lower in type C cases than in type A cases (A vs C, P = .021). The median FFRs in type A, B, and C cases of 1.0 (.98-1.00), 1.0 (.96-1.00), and .98 (.95-1.00) did not differ significantly among dissection types (A vs B, P = .86; A vs C, P = .055; B vs C, P = .15)., Conclusions: This is the first report of hemodynamics at a SFA dissection. The results suggest that low-grade dissection (types A or B) does not affect MPG and FFR at a SFA lesion. This indicates that a bailout stent may be unnecessary for patients with dissection of types A or B. A further investigation is needed to determine whether a scaffold is required for a SFA lesion with type C dissection., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: This study aimed to determine the impact of infrapopliteal (IP) revascularisation establishing in line flow to the wound (IFW) on wound healing in chronic limb threatening ischaemia (CLTI), using a core laboratory assessment for wounds and in line flow., Methods: The Wound directed Angiosome RevasculaRIsation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation. IP revascularisation establishing IFW was defined as revascularisation after which a tibiopedal artery that actually fed an injured pedal unit was patent. The incidence of wound healing was compared between the IFW and non-IFW groups using inverse probability of treatment weighting based on the propensity score., Results: A total of 440 patients with CLTI (median age, 75 years; male, 64.1%; diabetes mellitus, 72.0%; dialysis, 57.7%) with tissue loss (Wound, Ischaemia, and foot Infection stage 4, 66.4%) who underwent IP revascularisation (endovascular procedure, n = 304; bypass grafting, n = 136) between October 2017 and June 2020 were registered. During a median follow up of 23.6 months, 51.1% achieved wound healing. Successful IP revascularisation with IFW was achieved in 68.2%. After analysis, the IFW group had a higher rate of wound healing than the non-IFW group (34.5 vs. 16.1 per 100 person years; p = .030). The association between IFW and wound healing was not statistically different between patients undergoing bypass grafting and those undergoing an endovascular procedure (p for interaction = .38). There was no statistically significant interaction effect between IFW and direct revascularisation for wound healing (p for interaction = .51)., Conclusion: IP revascularisation establishing IFW was statistically significantly associated with a higher wound healing rate in patients with CLTI., (Copyright © 2024 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

The aim of this study was to identify anatomical and clinical factors associated with limb-based patency (LBP) loss, major adverse limb events (MALEs), and poor amputation-free survival (AFS) after an infrapopliteal arterial bypass (IAB) surgery according to the Global Limb Anatomic Staging System. A retrospective analysis of patients undergoing IAB surgery between January 2010 and December 2021 at a single institution was performed. Two-year AFS, freedom from LBP loss, and freedom from MALEs were assessed using the Kaplan-Meier method. Anatomical and clinical predictors were assessed using multivariate analysis. The total number of risk factors was used to calculate risk scores for subsequent categorization into low-, moderate-, and high-risk groups. IABs were performed on 103 patients. The rates of two-year freedom from LBP loss, freedom from MALEs, and AFS were 71.3%, 76.1%, and 77.0%, respectively. The multivariate analysis showed that poor run-off beyond the ankle and a bypass vein caliber of < 3 mm were significantly associated with LBP loss and MALEs. Moreover, end-stage renal disease, non-ambulatory status, and a body mass index of < 18.5 were significantly associated with poor AFS. The rates of freedom from LBP loss and MALEs and the AFS rate were significantly lower in the high-risk group than in the other two groups (12-month low-risk rates: 92.2%, 94.8%, and 94.4%, respectively; 12-month moderate-risk rates: 58.6%, 84.6%, and 78.3%, respectively; 12-month high-risk rates: 11.1%, 17.6%, and 56.2%, respectively; p < 0.001, p < 0.001, and p < 0.001, respectively). IAB is associated with poor clinical outcomes in terms of LBP, MALEs, and AFS in high-risk patients. Risk stratification based on these predictors is useful for long-term prognosis., (© 2024. The Author(s).)

This brief report reviews the clinical, procedural, and imaging data of 7 patients with p.Arg4810Lys variant of the ring finger protein 213 (RNF213) gene-related peripheral pulmonary arterial stenosis who underwent percutaneous transluminal pulmonary angioplasties (PTPAs) for demographics, clinical presentation, indications for angioplasty, and procedural and clinical outcomes. During median follow-up of 64.4 months since the first confirmed diagnosis, PTPA was performed for 62 segmental pulmonary arteries with 38 sessions of the procedure in 7 patients. Vascular stent placement because of resistance to balloon dilation and immediate elastic recoil was performed in 48 of 62 procedures (77%). Except for 1 death, 6 patients showed an improvement in dyspnea and 5 patients showed a decrease in mean pulmonary arterial pressure (mean, 55.5-42.7 mm Hg) and increase in 6-minute walk distance (mean, 415.5-484.3 m). Reperfusion edema occurred in 4 of 7 patients (57%), which was 6 of 38 sessions (16%)., (Copyright © 2024. Published by Elsevier Inc.)

Objective: Occlusive disease of the common femoral artery can generate profound lower extremity ischemia as the normal collateral pathways from the profunda to the superficial femoral artery cannot adequately develop. In patients with lifestyle-limiting claudication, isolated common femoral endarterectomy (CFE) is highly effective. Because CFE does not provide direct, in-line flow to the plantar arch, it has been felt to provide inadequate revascularization to patients with chronic limb-threatening ischemia (CLTI). The purpose of this retrospective clinical study was to report and assess the natural history of selected patients with CLTI treated with isolated CFE (without concomitant infrainguinal revascularization)., Methods: Consecutive CFEs performed in a large, urban hospital for CLTI between 2014 and 2021 were reviewed. Patient characteristics, limb, and anatomical stages using the Wound, Ischemia, foot Infection (WIfI) and Global Limb Anatomic Staging System were tabulated. Limb-specific and survival-related end points were analyzed., Results: Fifty-eight patients presenting with CLTI underwent isolated CFE (mean age, 74 ± 10 years; 62% male, 90% current or prior smoker). Comorbidities included diabetes (52%), coronary artery disease (55%), congestive heart failure (22%), and end-stage renal failure on hemodialysis (5%). Patients presented with either rest pain (36%) or tissue loss (64%); the latter group exhibited advanced limb threat (68% in WIfI stage 3 or 4). The majority of patients had associated severe infrainguinal disease (50% Global Limb Anatomic Staging Systems 3). After a median follow-up of 17 months (range, 10-29 months), vascular reintervention was required in 7 patients (12%). One patient (2%) required major limb amputation after presentation in WIfI stage 4 (W3I3fI0). Indeed, WIfI stage 4 was a significant univariate predictor of the need for subsequent infrainguinal bypass (P = .034)., Conclusions: Isolated CFE as primary therapy in highly selected patients with CLTI was safe and effective. Index limb stage is predictive of the need for associated infrainguinal revascularization in this complex population., Competing Interests: Disclosures L.S. is a founding member of EFemoral. All other authors have no competing interests., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We compared the efficacy of percutaneous deep venous arterialization (pDVA) in patients with no-option chronic limb-threatening ischemia in the hospital vs in office-based laboratory (OBL) settings., Methods: A retrospective chart review was performed of all patients who underwent pDVA using off-the-shelf devices from January 2018 to March 2023 in a hospital and an OBL. We identified 73 eligible patients, 41 from a hospital setting (59% male; median age, 72 years; interquartile range, 18 years) and 32 from an OBL setting (59% males; 67 years; interquartile range, 16 years). All eligible patients were deemed to have no-option critical limb ischemia, had at least one patent proximal tibial artery available for the creation of an arteriovenous anastomosis, and were classified as having Rutherford classification IV or higher peripheral arterial disease. Patients were ineligible if classified as Rutherford classification III or lower, had active infection, did not have at least one appropriate venous target, and/or had rapidly progressing wounds requiring immediate major amputation. The primary outcome was major amputation-free survival (AFS). Secondary outcomes included technical success, limb salvage, survival, primary patency, reintervention rate, adverse events, and partial and complete wound healing. Outcomes were evaluated using Kaplan-Meier method, log-rank, and two-stage procedure tests., Results: Technical success was achieved in 70 patients (96%) with 1 hospital (2.4%) and 2 OBL (6.3%) patients lost to follow-up. Major AFS estimates at 6 months, 1 year, and 2 years were 51.4%, 40.4%, and 30.2% in the hospital group and 69.4%, 54.0%, and 49.5% in the OBL group, respectively. Partial wound healing estimates at 6 months, 1 year, and 2 years were 27.5%, 71.7%, and 81.2% in the hospital group and 62.7% at all time points in the OBL group. Complete wound healing estimates at 6 months, 1 year, and 2 years were 6.7%, 33.3%, and 33.3% in the hospital group and 5.3%, 37.7%, and 41.6% in the OBL group, respectively. There was no significant difference in major AFS (P = .13), limb salvage (P = .07), survival (P = .69), primary patency (P = .53), partial (P = .08), or complete wound healing (P = .79) between groups. Reintervention was performed in 8 hospital (20.5%) and 14 OBL (45.2%) patients., Conclusions: pDVA is a feasible and safe procedure for no-option critical limb ischemia in the hospital and OBL setting without significant differences in outcomes at ≤2 years., Competing Interests: Disclosures J.R. is a consultant for Abbott, Angiodynamics, BD Bard, Boston Scientific, Cordis, Inari Medical, Medtronic, and Philips; a board member of the CLI Global Society; honoraria from Abbott, Angiodynamics, BD Bard, Boston Scientific, Medtronic, and Philips; and owns stocks/options in Aveera, Protexa, Summa, Evident, and Inquis. K.H. is a consultant for Abbott, Cordis, and Reflow Medical and owns stocks/options Protexa, Summa, and Vasorum., (Published by Elsevier Inc.)

Background: After drug-coated balloon (DCB) treatment of the femoropopliteal artery in-stent restenosis (ISR), a certain proportion of patients also experience target lesion restenosis. The purpose of this study was to explore the efficacy and safety of rivaroxaban combined with aspirin in the treatment of ISR after DCB intervention., Methods: Patients who underwent DCB treatment for ISR after femoropopliteal artery intervention at our center from March 2017 to February 2022 were included consecutively. According to the drug treatment after DCB intervention of ISR, the patients were divided into rivaroxaban and aspirin group (RA Group) and dual antiplatelet therapy (DAPT) group. The outcomes of 2 groups during the 12-month follow-up after DCB intervention were compared., Results: A total of 92 patients were included in final analysis, with 43 in RA group and 49 in DAPT group. During 12-month follow-up, a total of 15 cases of recurrent ISR were detected, and the recurrence rate of ISR and clinically driven target lesion revascularization in the RA group were lower than those in the DAPT group (P < 0.05). The vascular patency rate in the RA group was higher than that in the DAPT group at 6 and 12 months of follow-up (P < 0.05). During the follow-up, there were no adverse events such as death, myocardial infarction, stroke, amputation, or major bleeding, and only a total of 5 cases of minor bleeding occurred., Conclusions: Compared with the standard DAPT regimen, rivaroxaban combined with aspirin can safely improve the follow-up outcome after DCB for femoropopliteal ISR., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: To assess the safety and efficacy of ultrasound-assisted sagittal view for retrograde puncture of the P2 segment of popliteal artery (PA) for treating femoropopliteal lesions., Methods: A retrospective study was conducted on consecutive patients who underwent retrograde puncture of the PA for the recanalization of femoropopliteal lesions. A retrograde access was made to either the P2 or P3 segment of the PA in 23 cases. In 10 cases (8 men; mean age 68 ± 9 years), ultrasound-guided retrograde PA (P2 segment) puncture using the long-axis in-the-plane approach was performed, and in 13 cases (11 men; mean age 69 ± 5 years), angiography-guided retrograde PA (P3 segment) puncture was performed. Clinical data was compared preintraoperatively and postoperatively in the 2 groups., Results: All occluded lesions were successfully recanalized via dual channel intervention. Puncture success were 100% (10/10) in the P2 group compared with 92.3% (12/13) in the P3 group (P > 0.05). The mean puncture time in the P2 group was significantly shorter when compared to the P3 group (4.70 ± 0.95 mins vs 11.33 ± 6.37 mins; P < 0.05). There was no difference in mean hemostasis time between the 2 groups (6.11 ± 2.20 mins vs 8.46 ± 3.76 mins; P > 0.05). There were no in-hospital deaths in all patients. The occurrence of puncture-related complications in the P2 group was 10% compared with 15% in the P3 group (P > 0.05). A low-flow arteriovenous fistula was observed in one case in the P3 group. None of the patients reported any access-related complication at a mean follow-up of 11.3 ± 5.5 months., Conclusions: Ultrasound-assisted sagittal view for retrograde puncture of the P2 segment of PA is at least as safe as angiography-guided retrograde puncture of the P3 segment for femoropopliteal lesions. Furthermore, this technique appears to be more suitable for patients with tandem iliofemoral artery occlusion, as it allows for the creation of a retrograde access., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Acute limb ischemia (ALI) remains a vascular emergency with high morbidity and mortality. While the JETi Hydrodynamic Thrombectomy System (Abbott) offers a percutaneous approach to fragment and aspirate the thrombus in patients with arterial occlusions, data on its efficacy and safety are limited. This study reports our early experience using the JETi device to treat ALI at our institution., Methods: This is a single-center, retrospective review of patients with ALI treated with the JETi device between September 2020 and December 2022. Patients were included if the JETi device was used either as a primary intervention or as an adjunct procedure. The primary endpoint was technical success defined as <50% residual thrombus after intervention. Secondary endpoints included achieving complete resolution of the thrombus on angiogram, acute kidney injury (AKI), major bleeding, 30-day major amputation, and 30-day mortality., Results: A total of 59 JETi procedures for ALI (median age 62 years [interquartile range: 56-71 years]) were performed on 39 male and 20 female patients. The median time from onset of symptoms to hospitalization was 24 hours (interquartile range: 4-168 hours). Rutherford classifications were I (10), IIa (27), IIb (14), and undocumented (8). Etiology of ALI was native vessel thrombosis (27), embolism (16), graft/stent thrombosis (14), and iatrogenic (2). A total of 124 vessels were treated, with an average of 2.1 vessels per procedure. The primary outcome was achieved in 86% (107/124) of the arteries, with 82% (102/124) successfully opened using the JETi device alone without the need for any adjunctive therapy. Complete resolution of the thrombus using JETi was achieved in 81% (101/124) arteries, with or without the use of adjunctive therapy. A total of 6.7% (4/59) patients required a major limb amputation within 30 days despite successful recanalization, and one 30-day mortality was recorded. Complications included distal embolization (5), access site hematoma (2), and AKI (4). No major bleeding, hemolysis-induced AKI, or vessel dissection or perforation was observed., Conclusions: The JETi device appears to be a safe and effective percutaneous treatment option in the management of ALI. It provides definitive treatment with a high technical success rate of 86% and a good safety profile., Competing Interests: Disclosures L.K. and K.O. report a speaker/consultant disclosure with Abbott. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: There is a paucity of data evaluating outcomes of lower extremity bypass (LEB) using supra-inguinal inflow for revascularization of infra-inguinal vessels. The purpose of this study is to report outcomes after LEB originating from aortoiliac arteries to infra-femoral targets., Methods: The Vascular Quality Initiative database (2003-2020) was queried for patients undergoing LEB from the aortoiliac arteries to the popliteal and tibial arteries. Patients were stratified into 3 cohorts based on outflow targets (above-knee [AK] popliteal, below-knee [BK] popliteal, and tibial arteries). Perioperative and 1-year outcomes including primary patency, amputation-free survival (AFS), and major adverse limb events (MALEs) were compared. A Cox proportional hazards model was used to estimate the independent prognostic factors of outcomes., Results: Of 403 LEBs, 389 (96.5%) originated from the external iliac artery, while the remaining used the aorta or common iliac artery as inflow. In terms of the distal target, the AK popliteal was used in 116 (28.8%), the BK popliteal in 151 (27.5%), and tibial vessels in 136 (43.7%) cases. BK popliteal and tibial bypasses, compared to AK popliteal bypasses, were more commonly performed in patients with chronic limb-threatening ischemia (69.5% and 69.9% vs. 48.3%; P < 0.001). Vein conduit was more often used for tibial bypass than for AK and BK popliteal bypasses (46.3% vs. 21.9% and 16.3%; P < 0.001). In the perioperative period, BK popliteal and tibial bypass patients had higher reoperation rates (16.9% and 13.2% vs. 5.2%; P = 0.02) and lower primary patency (89.4% and 89% vs. 95.7%; P = 0.04) than AK bypass patients. At 1 year, compared with AK popliteal bypasses, BK and tibial bypasses demonstrated lower primary patency (81.9% vs. 56.7% vs. 52.4%, P < 0.001) and freedom from MALE (77.6% vs. 70.2% vs. 63.1%, P = 0.04), although AFS was not significantly different (89.7% vs. 90.6% vs. 83.8%, P = 0.19).On multivariable analysis, compared with AK popliteal bypasses, tibial bypasses were independently associated with increased loss of primary patency (hazard ratio 1.9, 95% confidence interval, 1.03-3.51, P = 0.04). Subanalysis of patients with chronic limb-threatening ischemia demonstrated significantly higher primary patency in the AK popliteal cohort at discharge and 1 year, but no difference in AFS or freedom from MALE between the cohorts at follow-up., Conclusions: LEB with supra-inguinal inflow appear to have acceptable rates of 1-year patency and limb salvage in patients at high risk of bypass failure. Tibial outflow target was independently associated with worse primary patency but not with MALE or AFS., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Peripheral arterial disease (PAD) of the lower limbs is caused by atherosclerotic occlusive disease in which narrowing of arteries reduces blood flow to the lower limbs. PAD is common; it is estimated to affect 236 million individuals worldwide. Advanced age, smoking, hypertension, diabetes and concomitant cardiovascular disease are common factors associated with increased risk of PAD. Complications of PAD can include claudication pain, rest pain, wounds, gangrene, amputation and increased cardiovascular morbidity and mortality. It is therefore clinically important to use diagnostic tests that accurately identify PAD. Accurate and timely detection of PAD allows clinicians to implement appropriate risk management strategies to prevent complications, slow progression or intervene when indicated. Toe-brachial index (TBI) and toe systolic blood pressure (TSBP) are amongst a suite of non-invasive bedside tests used to detect PAD. Both TBI and TSBP are commonly utilised by a variety of clinicians in different settings, therefore a systematic review and meta-analysis of their diagnostic accuracy is warranted and highly relevant to inform clinical practice., Objectives: To (1) estimate the accuracy of TSBP and TBI for the diagnosis of PAD in the lower extremities at different cut-off values for test positivity in populations at risk of PAD, and (2) compare the accuracy of TBI and TSBP for the diagnosis of PAD in the lower extremities. Secondary objectives were to investigate several possible sources of heterogeneity in test accuracy, including the following: patient group tested (people with type 1 or type 2 diabetes, people with renal disease and general population), type of equipment used, positivity threshold and type of reference standard., Search Methods: The Cochrane Vascular Information Specialist searched the MEDLINE, Embase, CINAHL, Web of Science, LILACS, Zetoc and DARE databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 27 February 2024., Selection Criteria: We included diagnostic case-control, cross-sectional, prospective and retrospective studies in which all participants had either a TSBP or TBI measurement plus a validated method of vascular diagnostic imaging for PAD. We needed to be able to cross-tabulate (2 x 2 table) results of the index test and the reference standard to include a study. To be included, study populations had to be adults aged 18 years and over. We included studies of symptomatic and asymptomatic participants. Studies had to use TSBP and TBI (also called toe-brachial pressure index (TBPI)), either individually, or in addition to other non-invasive tests as index tests to diagnose PAD in individuals with suspected disease. We included data collected by photoplethysmography, laser Doppler, continuous wave Doppler, sphygmomanometers (both manual and aneroid) and manual or automated digital equipment., Data Collection and Analysis: Two review authors independently completed data extraction using a standardised form. We extracted data to populate 2 x 2 contingency tables when available (true positives, true negatives, false positives, false negatives). Where data were not available to enable statistical analysis, we contacted study authors directly. Two review authors working independently undertook quality assessment using QUADAS-2, with disagreements resolved by a third review author. We incorporated two additional questions into the quality appraisal to aid our understanding of the conduct of studies and make appropriate judgements about risk of bias and applicability., Main Results: Eighteen studies met the inclusion criteria; 13 evaluated TBI only, one evaluated TSBP only and four evaluated both TBI and TSBP. Thirteen of the studies used colour duplex ultrasound (CDU) as a reference standard, two used computed tomography angiography (CTA), one used multi-detector row tomography (MDCT), one used angiography and one used a combination of CDU, CTA and angiography. TBI was investigated in 1927 participants and 2550 limbs. TSBP was investigated in 701 participants, of which 701 limbs had TSBP measured. Studies were generally of low methodological quality, with poor reporting of participant recruitment in regard to consecutive or random sampling, and poor reporting of blinding between index test and reference standard, as well as timing between index test and reference standard. The certainty of evidence according to GRADE for most studies was very low., Authors' Conclusions: Whilst a small number of diagnostic test accuracy studies have been completed for TBI and TSBP to identify PAD, the overall methodological quality was low, with most studies providing a very low certainty of evidence. The evidence base to support the use of TBI and TSBP to identify PAD is therefore limited. Whilst both TBI and TSBP are used extensively clinically, the overall diagnostic performance of these tests remains uncertain. Future research using robust methods and clear reporting is warranted to comprehensively determine the diagnostic test accuracy of the TBI and TSBP for identification of PAD with greater certainty. However, conducting such research where some of the reference tests are invasive and only clinically indicated in populations with known PAD is challenging., (Copyright © 2024 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.)

Background: Alternative splicing in the eighth exon C-terminus of VEGF-A (vascular endothelial growth factor-A) results in the formation of proangiogenic VEGF 165 a and antiangiogenic VEGF 165 b isoforms. The only known difference between these 2 isoform families is a 6-amino acid switch from CDKPRR (in VEGF 165 a) to SLTRKD (in VEGF 165 b). We have recently shown that VEGF 165 b can induce VEGFR2-activation but fails to induce VEGFR1 (VEGF receptor 1)-activation. The molecular mechanisms that regulate VEGF 165 b's ability toward differential VEGFR2 versus VEGFR1 activation/inhibition are not yet clear., Methods and Results: Hypoxia serum starvation was used as an in vitro peripheral artery disease model. Unilateral single ligation of the femoral artery was used as a preclinical peripheral artery disease model. VEGFR1 activating ligands have 2 arginine (RR) residues in their eighth exon C-terminus, that were replaced by lysine-aspartic acid (KD) in VEGF 165 b. A synthetic anti-angiogenic VEGF 165 b splice variant in which the KD residues were switched to RR (VEGF 165 b KD→RR ) activated both VEGFR1- and VEGFR2-signaling pathways to induce ischemic-endothelial cell angiogenic capacity in vitro and enhance perfusion recovery in a severe experimental-peripheral artery disease model significantly higher than VEGF 165 a. Phosphoproteome arrays showed that the therapeutic efficacy of VEGF 165 b KD→RR over VEGF 165 a is due to its ability to induce P38-activation in ischemic endothelial cells., Conclusions: Our data shows that the KD residues regulate VEGF 165 b's VEGFR1 inhibitory property but not VEGFR2. Switching these KD residues to RR resulted in the formation of a synthetic/recombinant VEGF 165 b KD→RR isoform that has the ability to activate both VEGFR1- and VEGFR2-signaling and induce ischemic-endothelial cell angiogenic and proliferative capacity that matched the angiogenic requirement necessary to achieve perfusion recovery in a severe experimental-peripheral artery disease model.

The estimation of vessels' centerlines is a critical step in assessing the geometry of the vessel, the topological representation of the vessel tree, and vascular network visualization. In this research, we present a novel method for obtaining geometric parameters from peripheral arteries in 3D medical binary volumes. Our approach focuses on centerline extraction, which yields smooth and robust results. The procedure starts with a segmented 3D binary volume, from which a distance map is generated using the Euclidean distance transform. Subsequently, a skeleton is extracted, and seed points and endpoints are identified. A search methodology is used to derive the best path on the skeletonized 3D binary array while tracking from the goal points to the seed point. We use the distance transform to calculate the distance between voxels and the nearest vessel surface, while also addressing bifurcations when vessels divide into multiple branches. The proposed method was evaluated on 22 real cases and 10 synthetically generated vessels. We compared our method to different state-of-the-art approaches and demonstrated its better performance. The proposed method achieved an average error of 1.382 mm with real patient data and 0.571 mm with synthetic data, both of which are lower than the errors obtained by other state-of-the-art methodologies. This extraction of the centerline facilitates the estimation of multiple geometric parameters of vessels, including radius, curvature, and length.

Background: Although ankle-brachial index (ABI) and photoplethysmography (PPG) have also shown adequate sensitivity in detecting peripheral arterial disease, their diagnostic performance is less reliable in asymptomatic cases or those with high atherosclerotic cardiovascular risks., Methods and Results: We evaluated 130 participants using ABI, PPG, and duplex ultrasonography, diagnosing 65 with peripheral arterial disease. From the PPG, we derived 2 parameters: PPG amplitude ratio of the lower-to-upper extremities (PPG ratio ) and the PPG amplitude of the lower extremity (PPG amp ). Sensitivity, specificity, accuracy, and the area under receiver operating characteristic (ROC) curve were calculated for PPG parameters and ABI, and their combination of both methods. Univariate and multivariate logistic regression assessed the prognostic potential of these parameters. ROC analysis revealed optimal cutoff values in diagnosing peripheral arterial disease were 0.417 for PPG ratio and "58" for PPG amp . Both PPG ratio and PPG amp demonstrated significantly higher sensitivities, 78.4% and 75.7%, respectively, compared with 55.9% for ABI <0.9 ( P <0.05). The areas under the ROC curves of combination models, including model 1 (ABI <0.9 and PPG ratio ), model 2 (ABI <0.9 and PPG amp ), and model 3 (ABI <0.9, PPG ratio , and PPG amp ), exhibited improved performance with areas under the ROC curves of 0.922, 0.922, and 0.931 (all P <0.01) compared with ABI alone (area under the ROC curve, 0.822). Additionally, the PPG parameters, both alone and combined with ABI, were associated with major adverse cardiac events and all-cause mortality after adjusting for other relevant factors., Conclusions: On the basis of duplex ultrasonography, combining ABI and PPG markedly improves peripheral arterial disease diagnosis in high-risk individuals compared with either method alone and provides crucial insights into major adverse cardiac events and all-cause mortality risks.

Competing Interests: Disclosures None.

Background and Aims: The potential impact of peripheral artery disease (PAD) on kidney outcomes is not well understood. The aim of this study was to explore the association between PAD and end-stage kidney disease (ESKD) and chronic kidney disease (CKD)., Methods: Among 14,051 participants (mean age 54 [SD 6 years]) from the Atherosclerosis Risk in Communities study, we categorized PAD status as symptomatic PAD (intermittent claudication or leg revascularization), asymptomatic PAD (ankle-brachial index [ABI] ≤0.90 without clinical history of symptoms), and ABI 0.91-1.00, 1.01-1.10, 1.11-1.20 (reference), 1.21-1.30, and >1.30. We evaluated their associations with two kidney outcomes: ESKD (the need of renal replacement therapy or death due to kidney disease) and CKD (ESKD cases or an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m 2 with a ≥25 % decline from the baseline) using multivariable Cox proportional hazards models., Results: Over ∼30 years of follow-up, there were 598 cases of incident ESKD and 4686 cases of incident CKD. After adjusting for potential confounders, both symptomatic PAD and asymptomatic PAD conferred a significantly elevated risk of ESKD (hazard ratio 2.28 [95 % confidence interval 1.23-4.22] and 1.75 [1.19-2.57], respectively). Corresponding estimates for CKD were 1.54 (1.14-2.09) and 1.63 (1.38-1.93). Borderline low ABI 0.91-1.00 also showed elevated risk of adverse kidney outcomes after adjustment for demographic variables. Largely consistent results were observed across demographic and clinical subgroups., Conclusions: Symptomatic PAD and asymptomatic PAD were independently associated with an elevated risk of ESKD and CKD. These results highlight the importance of monitoring kidney function in persons with PAD, even when symptoms are absent., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: K.M. reports personal fees from Fukuda Denshi and Kowa Company, Ltd. Outside of the submitted work. The other authors do not have relevant conflicts of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objective: Most individuals with lower extremity peripheral artery disease (PAD) experience symptoms other than claudication and live with undiagnosed PAD yet no tools exist to detect atypical PAD symptoms. The purpose of this study was to identify discriminating PAD symptom descriptors from a community-based sample of patients with no current diagnosis of PAD., Methods: Symptoms descriptors were obtained in a sample of 22 participants with persistent lower extremity symptoms pre/post exercise. An ankle brachial index with exercise was used to classify participants as "PAD" or "No PAD.", Results: Thirteen (59%) participants had a positive ankle brachial index (<0.9, ≥20% drop postexercise, or 30 mmHg drop postexercise). Symptoms do not disappear while walking, trouble keeping up with friends/family, positive response to pain or discomfort while sitting, and pain outside of the calves and thighs were associated with a positive ankle brachial index., Conclusion: Atypical symptoms were common among study participants. Symptoms while sitting and symptoms outside of the calf and thigh were negatively associated with a positive ankle brachial index. More precise descriptions of symptom characteristics are needed to improve PAD symptom recognition., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Deep venous arterialization (DVA) is a final option for limb salvage in patients with end stage arterial anatomy. We report a 66-year-old dialysis dependent male with forefoot gangrene, Rutherford class 6 chronic limb ischemia, who required a redo endovascular DVA. On initial presentation an angiogram was demonstrated a desert foot with absent tibial runoff to his bilateral lower extremities. After discussion, patient elected to trial DVA in hope of avoiding a major amputation. A hybrid DVA was performed using a Pioneer Plus and .018″ Viabahn stents from the peroneal artery into the peroneal venous system; following this, the peroneal vein was anastomosed to the lesser saphenous vein via an open posterior approach at the ankle. 3 months later, a second DVA was performed by exposing the above knee popliteal artery and vein and creating an end-to-side anastomosis. Of note, the great saphenous vein was less than 2 mm in diameter and no arm vein was available due to history of prior fistulas in bilateral arms. Via the popliteal vein, the posterior tibial vein was selected and additional .018″ Viabahn stents were deployed from the malleolus to the P2 segment of the popliteal vein. Three months after the second hybrid DVA, the patient's forefoot had healed after split thickness skin grafting. Continued patency is noted of the re-do hybrid DVA with minimal calf edema. Newer creative strategies are required for "No Option Chronic Limb Ischemia" which is becoming more relevant in diabetic and dialysis dependent patients. This case illustrates the potential to convert a deep venous arterialization to a superficial venous arterialization for improved venous outflow and wound healing., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: The utility and benefit of intravascular ultrasound (IVUS) has been well established in coronary interventions, however widespread adoption for peripheral interventions has lagged. The objectives of this review article were to discuss the technical components of IVUS, describe key learning pearls for IVUS utilization, and review the literature describing the clinical outcomes of endovascular peripheral arterial interventions using IVUS., Methods: A scoping review of the current literature utilizing Pubmed. Terms used to search the literature included "intravascular ultrasound (IVUS)" in conjunction with "peripheral arterial disease (PAD)," "endovascular interventions," "chronic limb threatening ischemia," "balloon angioplasty" "stenting," "percutaneous coronary intervention," and "outcomes." All types of articles were reviewed including review articles, retrospective reviews, meta-analyses, and prospective observational and randomized studies., Results: Published literature regarding IVUS use in peripheral arterial interventions is heterogeneous and limited to mainly retrospective studies, registry analyses and metanalyses. Outcomes are generally favorable with the adjunct of IVUS compared to traditional angiography-driven peripheral interventions. The addition of IVUS improves stent expansion, stent patency, and reduces reintervention rates, particularly in infrainguinal arterial lesions. Long-term costs may also be lower with IVUS-guided procedures., Conclusions: Expert consensus largely supports the implementation of IVUS in endovascular interventions for peripheral arterial disease. However, more robust high-quality data evaluating the efficacy, durability, and cost of IVUS in peripheral arterial disease are still needed., (Copyright © 2024. Published by Elsevier Inc.)

Background: Endovascular therapy (EVT) is often performed for diffuse femoropopliteal lesions. This study investigated 3-year patency and clinical outcomes in patients with EVT-treated femoropopliteal lesions >25 cm., Methods: This retrospective multicenter registry analyzed patients who presented with lower extremity artery disease having femoropopliteal lesions >25 cm who underwent EVT between 2017 and 2021. The primary outcome was restenosis 3 years after EVT., Results: Overall, 504 patients with 614 lesions undergoing EVT for diffuse femoropopliteal lesions were enrolled. The prevalence of restenosis was 184.3 per 1000 lesion-years. Kaplan-Meier estimate of freedom from restenosis was 58.6% at 3 years. In the multivariate Poisson regression model, female sex (adjusted incidence risk ratio: 1.54; p = 0.003), cilostazol use (0.44; p < 0.001), revascularization history (1.87; p = 0.001), P3 involvement (2.09; p < 0.001), and reference vessel diameter <5 mm (1.88; p < 0.001) were associated independently with restenosis risk. The accumulation of these factors was associated with a lower rate of freedom from restenosis; the Kaplan-Meier estimates of the rates were 49.3% and 22.4% in the subgroups with two and more risk factors, respectively, while they were 81.1% in patients without any risk factors and 70.3% in those with one risk factor., Conclusions: Female sex, nonuse of cilostazol, revascularization history, P3 involvement, and small vessels were associated with high restenosis risk after EVT for diffuse femoropopliteal lesions. Although patients with multiple risk factors have a low patency rate, EVT offers an acceptable patency rate for those with fewer risk factors., (© 2024 Wiley Periodicals LLC.)

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Peripheral artery disease is a major atherosclerotic disease that is associated with poor outcomes such as limb loss, cardiovascular morbidity, and death. Artificial intelligence (AI) has seen increasing integration in medicine, and its various applications can optimize the care of peripheral artery disease (PAD) patients in diagnosis, predicting patient outcomes, and imaging interpretation. In this review, we introduce various AI applications such as natural language processing, supervised machine learning, and deep learning, and we analyze the current literature in which these algorithms have been applied to PAD., (Published by Elsevier Inc.)

Objective: Long-term outcomes for harvesting techniques for great saphenous vein (GSV) and its impact on the outcomes of infrainguinal arterial bypass remains largely unknown. Endoscopic GSV harvesting (EVH) has emerged as a less invasive alternative to conventional open techniques. Using the Vascular Quality initiative Vascular Implant Surveillance & Interventional Outcomes Network (VQI-VISION) database, we compared the long-term outcomes of infrainguinal arterial bypass using open and endoscopic GSV harvest techniques., Methods: Patients who underwent infrainguinal GSV bypass between 2010 and 2019 were identified in the VQI-VISION Medicare linked database. Long-term outcomes of major/minor amputations, and reinterventions up to 5 years of follow-up were compared between continuous incisions, skip incision, and EVH, with continuous incisions being the reference group. Secondary outcomes included 30- and 90-day readmission, in addition to surgical site infections and patency rates at 6 months to 2 years postoperatively. Survival analysis using Kaplan-Meier curves and Cox regression hazard models were utilized to compare outcomes between groups. To adjust for multiple comparisons between the study groups, a P value of 2.5% was considered significant., Results: Among the 8915 patients included in the study, continuous and skip vein harvest techniques were used in 44.4% and 43.4% of cases each, whereas 12.3% underwent EVH. The utilization of EVH remained relatively stable at around 12% throughout the study period. Compared with GSV harvest using continuous incisions, EVH was associated with higher rates of reintervention at 1 year (46.5% vs 41.3%; adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 1.06-1.41; P = .01]. However, no significant difference was observed between EVH and continuous incisions, and between skip and continuous incisions in terms of long-term reintervention or major and minor amputations on adjusted analysis. Compared with continuous incision vein harvest, both EVH and skip incisions were associated with lower surgical site infection rates within the first 6 months post-bypass (aHR, 0.53; 95% CI, 0.35-0.82 and aHR, 0.68; 95% CI, 0.53-0.87, respectively). Loss of primary, primary-assisted, and secondary patency was higher after EVH compared with continuous incision vein harvest. Among surgeons performing EVH, comparable long-term outcomes were observed regardless of low (<4 cases/year), medium (4-7 cases/year), or high procedural volumes (>7 cases/year)., Conclusions: Despite higher 1-year reintervention rates, EVH for infrainguinal arterial bypass is not associated with a significant difference in long-term reintervention or amputation rates compared with other harvesting techniques. These outcomes are not influenced by procedural volumes for EVH technique., Competing Interests: Disclosures H.A. is a 2022-2024 trainee in the Society for Vascular Surgery Patient Safety Organization Quality Fellowship in Training (FIT) program. J.M. effort is supported by NHLBI career development award K01HL159315., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Retrograde tibio-pedal access represents a feasible method for endovascular revascularization when antegrade methods fail. The article offers an extensive review of retrograde tibio-pedal access, emphasizing the technique and documented outcomes., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The treatment of peripheral arterial disease (PAD) has undergone many advancements and management continues to evolve. These changes include techniques, adjunctive therapies, medical management, and site of service. However, despite these advances, there still continues to be much debate about the best treatment. This Annals of Vascular Surgery special issue on PAD seeks to highlight current available evidence and expert views on treatment of PAD., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: To provide an updated systematic review and meta-analysis of safety and effectiveness outcomes with paclitaxel-containing devices., Materials and Methods: A systematic review and meta-analysis of randomized controlled trials (RCTs) investigating paclitaxel-containing balloons or stents in the treatment of femoropopliteal disease was performed. Pooled risk ratio (RR) was calculated using the inverse-variance, random-effects model in the assessment of primary patency, all-cause mortality, target limb major amputation, target lesion revascularization (TLR), and thrombosis., Results: In total, 19 RCTs were included comprising 4,284 participants. All-cause mortality rates did not differ significantly between the 2 arms at 12 months (RR, 1.06; 95% confidence interval [CI], 0.66-1.72; P = .80), 24 months (RR, 0.92; 95% CI, 0.56-1.50; P = .73), 36 months (RR, 1.21; 95% CI, 0.65-2.25; P = .55), or 48-60 months (RR, 0.95; 95% CI, 0.66-1.39; P = .81) after intervention. Primary patency was significantly higher at 12 months in the paclitaxel-containing arm: 80.92% (1,438/1,777) versus 57.48% (607/1,056) in the control arm (RR, 1.44; 95% CI, 1.30-1.59; P < .00001)., Conclusions: The present study demonstrates no statistically significant difference in all-cause mortality, target limb major amputation, or thrombosis with paclitaxel drug-eluting therapy to the femoropopliteal region. Additionally, improved and durable patency rates with a statistically significantly lower risk of clinically driven TLR with paclitaxel drug-eluting therapy have been demonstrated., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the safety and effectiveness of using carbon dioxide (CO 2 ) contrast in both supra- and infra-genicular endovascular interventions in patients with renal impairment., Material and Methods: This is a multicentric prospective observational study conducted over a period of 3 years from 2017 to 2020; the study included 114 patients presented with chronic threatening limb ischemia (CTLI) and renal impairment (lowest serum creatinine levels ≥1.3 mg/dL) for whom endovascular procedures were done using CO 2 as a contrast medium. Endovascular angiography was guided by CO 2 either exclusively (zero contrast) or with the aid of small amount of supplementary iodinated contrast media (ICM) injections. The qualitative assessment of the angiographic images in both supra- and infra-genicular fields were reported and scaled., Results: The qualitative diagnostic images were excellent in 86.5% in the supra-genicular and 66.5% in infra-genicular images. There were no significant changes in mean serum creatinine levels from baseline to first and fifth days post procedural (mean 1.8 mg/dL vs mean 1.9 mg/dL and mean 1.7 mg/dL)., Conclusion: CO 2 is a non-nephrotoxic alternative to traditional ICM that could be safely used and well tolerated during endovascular interventions for peripheral arterial disease in patients with renal impairment. Primary safety and efficacy endpoints were achieved in 100% of cases. The use of automated injector system provides adequate delivery, optimizes the dose, and avoids air contamination. For infra-genicular segment opacification, we recommend super-selective injections and some changes in angiographic techniques from contrast preparation to image post-processing., Clinical Impact: Co 2 is a non-nephrotoxic alternative to traditional ICM that could be safely used and well tolerated during peripheral endovascular interventions in patients with renal impairment. The use of automated injector system would provide adequate delivery, optimizes the dose and avoids air contamination. For infra-genicular segment opacification, its recommended to use selective injection as close to the target artery as possible and some changes in angiographic techniques from contrast preparation to image post-processing., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Best Endovascular Versus Best Surgical Therapy in Patients With Chronic Limb-Threatening Ischemia trial was a landmark trial which provides high-quality data for the decision-making regarding the treatment of chronic-limb threatening ischemia. Overall, the trial suggests that in patients with adequate greater saphenous vein conduit, bypass surgery should be offered as a first line treatment given superior outcomes. In this article, we outline the common critiques of the trial, followed by responses to provide a deeper understanding of the strengths and limitations of this important trial., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: This is a narrative review that aims to highlight key advancements that led to the current state of lower extremity bypass surgery. It focuses on key contributors during the last century who have driven the standardization of surgical treatment of peripheral arterial occlusive disease., Methods: A narrative review was conducted utilizing available resources in the scientific and historical literature to track landmark achievements in the development of modern lower extremity bypass surgery for occlusive disease, focusing primarily on the last century of advancement., Results: Several critical conceptual, technological, and technical landmarks were identified as critical components of modern lower extremity bypass surgery. This includes fundamental developments in the techniques of vascular anastomosis led by Carrel and others, a developing understanding of vascular occlusive disease as a localized and segmental process with broad implementation of the techniques of arteriography, and the development of safe thromboendarterectomy aided by the development and utilization of heparin for anticoagulation. These factors led to the first femoral-to-popliteal artery bypass by Jean Kunlin in 1948. From here, advances in vascular prosthetic material pioneered by Voorhees and others, alternative vascular conduits, increasing acceptance of tibial revascularization, and dispelling the myth of diabetic "small vessel" disease broadened revascularization options for patients with complex patterns of occlusive disease and those who have limited conduit availability., Conclusions: Modern lower extremity bypass surgery for occlusive disease arose steadily over a course of a century, driven by complex problem-solving in the pathophysiological understanding of atherosclerosis, technical developments in vascular anastomosis and arteriography, and evolution of conduit materials and pharmacologic therapy. Future advancements in bypass surgery are targeted at solving the complex problems of anastomotic intimal hyperplasia, expanding technology for alternative vascular conduits, ongoing optimization of risk factors, and scrutinizing of outcomes to make patient-centered, evidence-based decisions regarding revascularization strategy., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Lower extremity arterial disease (LEAD) and increased aortic stiffness are associated with higher mortality in patients with chronic coronary syndrome, while their prognostic significance after an acute coronary syndrome (ACS) is less known., Methods: We analyzed prevalence, clinical phenotypes and association of LEAD - assessed by the ankle-brachial index (ABI) - and increased aortic stiffness - assessed by the aortic pulse wave velocity (PWV) - with all-cause mortality and major adverse cardiovascular events (MACE) in patients admitted with an ACS., Results: Among 270 patients admitted for ACS (mean age 67 years, 80% males), 41 (15%) had an ABI ≤0.9, with 14 of them (34%) presenting with intermittent claudication (symptomatic LEAD). Patients with symptomatic LEAD, compared with those with asymptomatic LEAD or without LEAD, had higher prevalence of cardiovascular risk factors, lower estimated glomerular filtration rate and higher high-sensitivity C-reactive protein. Patients with LEAD, either symptomatic or asymptomatic, more frequently presented with non-ST-elevation myocardial infarction and more frequently had multivessel coronary artery disease. Both symptomatic and asymptomatic LEAD were significantly associated with all-cause mortality after adjustment for confounders, including multivessel disease or carotid artery disease (hazard ratio 4.03, 95% confidence interval 1.61-10.08, P  < 0.01), whereas PWV was not associated with the outcome in the univariable model. LEAD and PWV were not associated with a higher risk of MACE (myocardial infarction or unstable angina, stroke, or transient ischemic attack)., Conclusions: LEAD, either clinical or subclinical, but not increased aortic stiffness, is an independent predictor of all-cause mortality in patients admitted for ACS., (Copyright © 2024 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Objective: The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass., Methods: Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency's Expanded Access Program., Results: Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P = .059), coronary artery disease (71% vs 43%; P = .007), and prior coronary artery bypass grafting (38% vs 14%; P = .003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P = .018) and with previous index leg revascularizations (97% vs 53%; P < .001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P = .693) and Global Anatomic Staging System stage III (91% vs 96%; P = .346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P < .001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P < .001). At a median of 12 months, major amputation-free survival (73% vs 81%; P = .55) and overall survival (84% vs 88%; P = .20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P = .044), primary-assisted patency (45% vs 72%; P = .002), and secondary patency (64% vs 72%; P = .003) compared with group 2., Conclusions: Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months., Competing Interests: Disclosures Humacyte Inc provides funding to Mayo Clinic to support the performance of this IND study. T.E.R. serves in a clinical advisory role for Humacyte, Inc., with funds paid to Mayo Clinic., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Peripheral arterial disease (PAD) can reduce wound healing rates by ≤30%. Current literature suggests wound outcomes are improved when management is driven by vascular providers. However, whether this benefit is derived solely from early vascular provider involvement remains unclear., Methods: A retrospective analysis was performed of 80 limbs with chronic wounds and underlying PAD seen at our institution's wound center between July 2022 and July 2023. Arterial disease was defined by the following criteria: (1) prior PAD diagnosis, (2) ankle-brachial-index of <0.9 or toe pressure of <70 mm Hg, or (3) absent peripheral pulses. Patients were divided into early (<6 week) vascular provider exposure (EVE; n = 45) or late/no vascular exposure (LNVE; n = 35). Providers included vascular surgeons and affiliated advanced practitioners. The primary outcome studied was overall time to wound healing. Statistical analysis included χ 2 tests, t test, Pearson correlation, Kaplan-Meier analysis, and Cox regression modeling (variables included in a multivariate model if univariate effect on healing was associated at P < .1)., Results: Baseline demographic profiles were similar between groups with exception of lower baseline albumin (P = .037), more heart failure (P = .013), and more prior peripheral endovascular interventions (P = .013) in the EVE group. Although the initial wound locations and sizes were similar, EVE wounds had significantly higher WIfI wound scores (1.9 ± 0.1 vs 1.6 ± 0.1; P = .039). Although more LNVE patients developed radiographic osteomyelitis (31.8% vs 55.6%; P = .033), fewer underwent operative debridement or amputation (100% vs 63.2%; P = .008). On univariate analysis, healing time tended to be shorter in EVE, but not significantly (P = .089). When controlled for comorbidities, however, healing rates were nearly two-fold higher in EVE (hazard ratio, 2.42; 95% confidence interval, 1.21-4.84). LNVE wounds also took significantly longer to reach checkpoints including time to >75% granulation (P = .05), 15% weekly size decrease (P = .044), and epithelialization (P = .026). LNVE patients required more wound center visits (P = .024) and procedures (P = .005) with a longer time to intervention (P = .041). All EVE patients obtained ankle-brachial indices, with 90.9% of them available at their first wound care visit (P < .001). Although a slightly greater proportion of patients underwent a major amputation in EVE (15.6% vs 11.4%; P = .595), this difference did not attain significance; additionally, 100% of EVE patients had documented discussion of nonsalvageable limbs before amputation., Conclusions: Early exposure to vascular practitioners improves wound healing time, timeliness to intervention, and wound center and hospital resource use in patients with PAD. Further investigation into benefits of vascular involvement within community wound center models could significantly improve awareness and accessibility of arterial wound care in smaller/remote communities., Competing Interests: Disclosures None., (Published by Elsevier Inc.)

Contemporary quality control methods are often insufficient in predicting clinical outcomes after revascularization in lower extremity arterial disease (LEAD) patients. This study evaluates the potential of near-infrared fluorescence imaging with indocyanine green to predict the clinical outcome following revascularization. Near-infrared fluorescence imaging was performed before and within 5 days following the revascularization procedure. Clinical improvement was defined as substantial improvement of pain free walking distance, reduction of rest- and/or nocturnal pain, or tendency toward wound healing. Time-intensity curves and 8 perfusion parameters were extracted from the dorsum of the treated foot. The quantified postinterventional perfusion improvement was compared within the clinical outcome groups. Successful near-infrared fluorescence imaging was performed in 72 patients (76 limbs, 52.6% claudication, 47.4% chronic limb-threatening ischemia) including 40 endovascular- and 36 surgical/hybrid revascularizations. Clinical improvement was observed in 61 patients. All perfusion parameters showed a significant postinterventional difference in the clinical improvement group ( P -values <.001), while no significant differences were seen in the group without clinical improvement ( P -values .168-.929). Four parameters demonstrated significant differences in percentage improvement comparing the outcome groups ( P -values within .002-.006). Near-infrared fluorescence imaging has promising additional value besides clinical parameters for predicting the clinical outcome of revascularized LEAD patients., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Advanced endovascular techniques are increasingly being utilized to treat patients with peripheral arterial disease and chronic limb-threatening ischemia to improve lower extremity arterial perfusion. In diabetic patients, pedal arch patency has been associated with improved wound healing, limb salvage, and overall survival. Pedal-plantar loop revascularization is a technique that can restore arterial inflow between the dorsal and plantar arteries of the foot. This article will describe the inframallelolar arterial anatomy and focus on imaging, percutaneous endovascular techniques, and clinical study outcomes of pedal artery interventions., (Published by Elsevier Inc.)

Peripheral artery disease (PAD), a highly prevalent global disease, associates with significant morbidity and mortality in affected patients. Despite progress in endovascular and open revascularization techniques for advanced PAD, these interventions grapple with elevated rates of arterial restenosis and vein graft failure attributed to intimal hyperplasia (IH). Novel multiomics technologies, coupled with sophisticated analyses tools recently powered by advances in artificial intelligence, have enabled the study of atherosclerosis and IH with unprecedented single-cell and spatial precision. Numerous studies have pinpointed gene hubs regulating pivotal atherogenic and atheroprotective signaling pathways as potential therapeutic candidates. Leveraging advancements in viral and nonviral gene therapy (GT) platforms, gene editing technologies, and cutting-edge biomaterial reservoirs for delivery uniquely positions us to develop safe, efficient, and targeted GTs for PAD-related diseases. Gene therapies appear particularly fitting for ex vivo genetic engineering of IH-resistant vein grafts. This manuscript highlights currently available state-of-the-art multiomics approaches, explores promising GT-based candidates, and details GT delivery modalities employed by our laboratory and others to thwart mid-term vein graft failure caused by IH, as well as other PAD-related conditions. The potential clinical translation of these targeted GTs holds the promise to revolutionize PAD treatment, thereby enhancing patients' quality of life and life expectancy., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: The recent Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) study showed that bypass was superior to endovascular therapy (ET) in patients with chronic limb-threatening ischemia (CLTI) deemed suitable for either approach who had an available single-segment great saphenous vein (GSV). However, the superiority of bypass among those lacking GSV was not established. We aimed to examine comparative treatment outcomes from a real-world CLTI population using the Vascular Quality Initiative-Medicare-linked database., Methods: We queried the Vascular Quality Initiative-Medicare-linked database for patients with CLTI who underwent first-time lower extremity revascularization (2010-2019). We performed two one-to-one propensity score matchings (PSMs): ET vs bypass with GSV (BWGSV) and ET vs bypass with a prosthetic graft (BWPG). The primary outcome was amputation-free survival. Secondary outcomes were freedom from amputation and overall survival (OS)., Results: Three cohorts were queried: BWGSV (N = 5279, 14.7%), BWPG (N = 2778, 7.7%), and ET (N = 27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4705 pairs of ET vs BWGSV and 2583 pairs of ET vs BWPG. In the matched cohorts of ET vs BWGSV, ET was associated with greater hazards of death (hazard ratio [HR] = 1.34, 95% confidence interval [CI], 1.25-1.43; P < .001), amputation (HR = 1.30, 95% CI, 1.17-1.44; P < .001), and amputation/death (HR = 1.32, 95% CI, 1.24-1.40; P < .001) up to 4 years. In the matched cohorts of ET vs BWPG, ET was associated with greater hazards of death up to 2 years (HR = 1.11, 95% CI, 1.00-1.22; P = .042) but not amputation or amputation/death., Conclusions: In this real-world multi-institutional Medicare-linked PSM analysis, we found that BWGSV is superior to ET in terms of OS, freedom from amputation, and amputation-free survival up to 4 years. Moreover, BWPG was superior to ET in terms of OS up to 2 years. Our study confirms the superiority of BWGSV to ET as observed in the BEST-CLI trial., Competing Interests: Disclosures A.F. is a consultant for Sanifit, LeMaitre, BiogenCell, and DilaysisX. M.T.M. is a member of the advisory board for Janssen, Inc. M.S.C. is a member of the Data and Safety Monitoring Board for Abbott Vascular and is a consultant for Medistim and BioGenCell. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Catheter-directed thrombolysis is one of the main treatments for acute limb ischaemia. Urokinase is still a widely used thrombolytic drug in some regions. However, there needs to be a clear consensus on the protocol of continuous catheter-directed thrombolysis using urokinase for acute lower limb ischaemia., Methods: A single-centre protocol of continuous catheter-directed thrombolysis with low-dose urokinase (20,000 IU/hour) lasting 48-72 h for acute lower limb ischaemia was proposed based on our previous experiences. A retrospective study from June 2016 to December 2020 was conducted to evaluate the efficacy and safety of this protocol. The target lesion revascularisation, amputation and death were also monitored during follow-up. The Kaplan-Meier estimator was used for the subgroup analysis, and univariate and multivariate Cox regression analysis was applied to identify risk factors for reinterventions and death., Results: 90 lower limbs were involved, including 51 Rutherford Grade I, 35 Grade IIa and four Grade IIb. During a 60.8-h thrombolysis, 86 cases (95.5%) were considered effective according to the angiogram. No major bleeding complication occurred during thrombolysis, and one amputation occurred after. Freedom from target lesion revascularisation, amputation and death were 75.6%, 94.4% and 91.1% during a mean 27.5-month follow-up, respectively. According to the Kaplan-Meier estimator, aortoiliac lesions had lower reintervention rates than femoropopliteal lesions (Log-rank p = 0.010), and cases without narrowing atheromatous plaque had a lower reintervention rate (Log-rank p = 0.049). Age was an independent risk factor for death ( p = 0.038, hazard ratio 1.076, 95% confidence interval 1.004-1.153)., Conclusions: The single-centre protocol of catheter-directed thrombolysis we proposed for acute lower limb ischaemia was effective and safe. Strict blood pressure control during catheter-directed thrombolysis ensured safety. Aortoiliac lesions and cases without narrowing atheromatous plaque had lower reintervention rates during follow-up., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported., Materials and Methods: This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group., Results: The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference ( P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference ( P = .090). No baseline characteristics had any significant interaction effect (all P > .05)., Conclusions: The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Kenji Suzuki had a payment for lectures from Boston Scientific Japan, Japan GORE, Kaneka, Cook Medical, Cordis, and Bayer. Mitsuyoshi Takahara had a payment for lectures from Japan GORE, Boston Scientific Japan, and TERUMO. Kazuki Tobita had a payment for lectures from Medtronic, TERUMO, BD, and Kaneka, and had a consulting fees from Japan GORE. Naoki Hayakawa had a payment for lectures from Boston Scientific Japan, TERUMO, Kaneka, Medtronic, and Medicos Hirata. Yo Iwata had a payment for lectures from Boston Scientific Japan, Cook, and Philips Japan. Tatsuya Nakama had a payment for lectures from Boston Scientific Japan, Medtronic, Cook, TERUMO, Abbott Vascular, and Becton Dickinson and Company, had a consulting fee from Boston Scientific Japan, Medtronic, Cook, Century Medical, Cordis, OrbusNeichi, and Becton Dickinson and Company, had a payment for expert testimony from NIPRO, Kaneka, and Asahi Intecc.

Background: To establish the feasibility and safety of multimodal prehabilitation (MP), and to obtain pilot data on the change in quality of life, functional walking capacity, and the need for surgery for a full-scale trial., Methods: Pilot randomized controlled trial that included patients older than 50 years old suffering from moderate to severe intermittent claudication and who were candidates for endovascular revascularization (ER). Participants were excluded if they presented with ischemic rest pain, gangrene or ulceration of the index leg, significant lesions in the iliac vessels, planned surgical bypass, comorbidities in which exercise was contraindicated or if they were unable to speak English or French. Participants were randomized in a 1:1 ratio to 12 weeks of MP or institutional standard of care (unsupervised walking advice). MP consisted of i)1 weekly supervised exercise session; ii) home-based exercise prescription; iii) nutritional counseling and supplementation; iv) smoking cessation therapy; and v) psychosocial support. Feasibility and safety were measured with recruitment and retention rates, as well as the occurrence of any adverse events. In addition, barriers to attend supervised sessions and compliance to each component were assessed. Change in functional walking capacity, health-related quality of life, and the rates of patients deciding not to undergo ER were collected and analyzed throughout the follow-up period of 12 months., Results: Of the 37 patients referred for eligibility, 27 (73%) accepted to participate in the trial and were randomized. Of the 27 patients included, 24 completed the 12-week program. Adherence to each prehabilitation component was 83% interquartile range [72,93] for supervised exercise, 90% [83,96] for home-based exercise and 69% [45,93] for nutritional sessions. Fifty percent of patients were referred for and underwent psychosocial intervention and 40% of the active smokers enrolled in the smoking cessation program. No adverse events were observed during the program. The 2 main barriers for not fully adhering to the intervention were excessive pain while performing the exercises and the difficulty to keep up with the prescribed exercises. A statistically significant mean change (standard deviation (SD)) was seen in the MP group versus standard of care for functional capacity, mean (SD) 6 Min Walk Test 60 (74) vs. -11 (40) meters P < 0.05, and quality of life mean (SD) VascuQol 1.15 (0.54) vs. -0.3 (1.09) points P < 0.05. There was no statistically significant difference between groups in the rates of patients deciding to undergo ER during the 1-year follow-up period., Conclusions: The results of this pilot trial demonstrate that MP is safe and feasible. A 12-week MP program seems to improve quality of life and functional walking capacity to a greater extent than unsupervised walking advice. There is a need for a large-scale trial to investigate the effectiveness of MP at improving quality of life and assessing its impact on the rates of patients deciding not to undergo or delay ER. The long-term functional and quality of life outcomes of the patients deciding to undergo ER after prehabilitation also need to be assessed., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Mixed Arterial and Venous Leg Ulcers (MAVLU) are challenging. Clinical evidence specific to MAVLU management is scarce. We evaluated our recent experience with MAVLU patients and reviewed current data regarding MAVLU epidemiology, aetiology, diagnostic assessment and management options., Methods: A prospective leg ulcer database was retrospectively interrogated to determine the prevalence and clinical outcome of MAVLU over 2-year period (2021-2022). The literature was reviewed to determine if optimal treatment strategies., Results: 307 patients attended the ulcer clinic over a 2-year period. Most were venous leg ulcers (71%), 24% were arterial and 5% were MAVLU. The highest healing rate was in MAVLU (93%), followed by (74%) and (41%), in arterial and venous leg ulcer groups, respectively., Conclusion: Evidence-based guidelines for MAVLU remain lacking. Well-developed randomised controlled trials are warranted to guide current clinical practice., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: To evaluate the safety and efficacy of Innospring ® stent, a novel self-expanding interwoven nitinol stent, in treating femoropopliteal atherosclerotic lesions., Methods: A prospective, single-center, single-arm, first-in-human study enrolled 15 patients (mean age 73.1 years; 13 men) to evaluate the safety and efficacy of the Innospring ® stent monitored by core laboratories. The inclusion criteria were claudication or ischemic rest pain, de novo lesions or nonstented restenosis, >70% stenosis, lesion length <20 cm, and a reference vessel diameter of 4-7 mm. The primary safety endpoint was 30-day major adverse events. The primary efficacy end point was stent patency at 12 months. Follow-up evaluations were conducted at 30 days, 6 months, and 12 months., Results: The lesion length was 6.1 ± 3.5 mm. Fourteen (93.3%) patients had lesions of the superficial femoral artery and 3 (20.0%) patients had lesions of the popliteal artery. Nine (60.0%) patients had moderate-to-severe calcified lesion. Technical and procedural success was 100%. No patients experienced major adverse events in the first 30 days. The Rutherford category showed significant and sustained improvement at 6 and 12 months. The 12-month follow-up radiographs obtained in 13 patients confirmed the absence of stent fractures in 100% of examinations. The cumulative primary stent patency rate at 6 and 12 months were 93.3% and 84.6%, respectively., Conclusion: Stenting of the superficial femoral and popliteal arteries using the Innospring ® stent is safe and effective. This competing interwoven nitinol stent may provide superior stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress., Clinical Impact: Endovascular recanalization is a widely accepted and recommended treatment for symptomatic peripheral artery diseases. The Innospring® stent is a novel self-expanding interwoven stent containing eight nitinol wires with additional radial force, fracture-resistance, and visibility under fluoroscopy. This first-in-human study using the Innospring® stent in patients with femoropopliteal occlusive disease reported that stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide an impressive stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.