OBJECTIVE: BEST-CLI, an international randomised trial, compared bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated.
METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated.
RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74).
CONCLUSIONS: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.

UNASSIGNED: Infrarenal aortic occlusion (IAO) is a life-threatening condition that often causes lower limb ischemia. Although open surgery is the current recommendation for first-line treatment, recent technological innovations have made endovascular treatment (EVT) a promising alternative. This study aims to compare the clinical outcomes of bypass surgery and EVT in the treatment of IAO.
UNASSIGNED: This study is a single-center retrospective observative study at Peking Union Medical College Hospital. Consecutive 92 patients with chronic and atherosclerotic IAO were treated with either EVT (n=40) or bypass surgery (n=52) between 2011 and 2021. The baseline clinical factors (including demographic data and comorbidities), perioperative data (including Rutherford classification changes, technical success) and complication rates were evaluated. The mid-term patency and overall survival of EVT and bypass were assessed. Follow-up was defined as the time from surgery to the last outpatient visit. Continuous variables and category variables were statistically compared, respectively. Kaplan-Meier survival analyses were conducted for vascular patency.
UNASSIGNED: The study found that the demographics and pre-operative Rutherford classification were evenly distributed between the two groups (P>0.05). As for technical success, clinical success, comorbidities, mortality, complication rate, and Rutherford classification after procedures, no significant differences were observed (P>0.05). The average post-procedure hospital stay was 5.15 days in the EVT group and was significantly shorter than that of the bypass group, which was 11.83 days (P<0.0001). As for short-term and long-term results, the 1-, 3-, and 5-year primary patency rates were 81.8%, 73.1%, and 73.1% in the EVT group and 97.8%, 80.6%, and 80.6% in the bypass group. The bypass group had significantly better primary patency (P=0.034). There was a significant difference in the secondary patency rate (Bypass 100% vs. EVT 81.6%; P=0.005). Moreover, survival rates were higher in the bypass surgery group than in the EVT group (P=0.035).
UNASSIGNED: Although EVT\'s primary patency rate was lower than that with the bypass surgery, its safety and efficacy were still comparable to anatomic bypass surgery for IAO with less severe perioperative complications and shorter hospital stay. Therefore, EVT could be a feasible option for IAO.

OBJECTIVE: To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft.
METHODS: This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy.
RESULTS: Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46-91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20-70 cm) with a median diameter of 5.0 mm (range 3-6 mm) and 4.0 mm (range 2-6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection).
CONCLUSIONS: The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD.

Diabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD).
This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial.
Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years).
In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; Pinteraction= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group.
In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828).

OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2) randomised controlled trial has shown that, for patients with chronic limb threatening ischaemia (CLTI) who require an infrapopliteal (IP) revascularisation a vein bypass (VB) first revascularisation strategy led to a 35% increased risk of major amputation or death when compared with a best endovascular treatment (BET) first revascularisation strategy. The study aims are to place the BASIL-2 trial within the context of the CLTI patient population as a whole and to investigate the generalisability of the BASIL-2 outcome data.
METHODS: This was an observational, single centre prospective cohort study. Between 24 June 2014 and 31 July 2018, the BASIL Prospective Cohort Study (PCS) was performed which used BASIL-2 trial case record forms to document the characteristics, initial and subsequent management, and outcomes of 471 consecutive CLTI patients admitted to an academic vascular centre. Ethical approval was obtained, and all patients provided fully informed written consent. Follow up data were censored on 14 December 2022.
RESULTS: Of the 238 patients who required an infrainguinal revascularisation, 75 (32%) had either IP bypass (39 patients) or IP BET (36 patients) outside BASIL-2. Seventeen patients were initially randomised to BASIL-2. A further three patients who did not have an IP revascularisation as their initial management were later randomised in BASIL-2. Therefore, 95/471 (20%) of patients had IP revascularisation (16% outside, 4% inside BASIL-2). Differences in amputation free survival, overall survival, and limb salvage between IP bypass and IP BET performed outside BASIL-2 were not subject to hypothesis testing due to the small sample size. Reasons for non-randomisation into the trial were numerous, but often due to anatomical and technical considerations.
CONCLUSIONS: CLTI patients who required an IP revascularisation procedure and were subsequently randomised into BASIL-2 accounted for a small subset of the CLTI population as a whole. For a wide range of patient, limb, anatomical and operational reasons, most patients in this cohort were deemed unsuitable for randomisation in BASIL-2. The results of BASIL-2 should be interpreted in this context.

UNASSIGNED: Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown.
UNASSIGNED: We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms.
UNASSIGNED: Among patients with new-onset or recent exacerbation of PAD in the 10-center Patient-centered Outcomes Related to TReatment practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) study enrolled between June 2011 and September 2015, we classified early revascularization (endovascular or surgical) as procedures being performed within 3 months of presentation. Hierarchical logistic regression was used to identify patient characteristics associated with early revascularization. Variability across sites was estimated using the median odds ratio (OR).
UNASSIGNED: Among 797 participants, early revascularization procedures were performed in 224 (28.1%). Rutherford class 3 (vs Rutherford class 1; OR=1.86, 95% confidence interval [CI] 1.04-3.33) and having lesions in both iliofemoral and below-the-knee arterial segments (vs below the knee only; OR=1.75, 95% CI: 1.15-2.67) were associated with a higher odds of revascularization. Longer PAD duration >12 months (vs 1-6 months; OR=0.50, 95% CI: 0.32-0.77), higher ankle-brachial index scores (per 0.1 unit increase; OR=0.86, 95% CI: 0.78-0.96), and higher Peripheral Artery Questionnaire Summary scores (per 10 unit increase; OR=0.89, 95% CI: 0.80-0.99) were associated with a lower odds of revascularization. The raw rates for revascularization in different sites ranged from 6.25% to 66.28%, and the median OR was 1.88, 95% CI: 1.38-3.57.
UNASSIGNED: About 1 in 3 patients with symptomatic PAD received early revascularization. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD. There was significant site variability in revascularization patterns, and further studies will better understand the source of this variability and optimal selection criteria for early revascularization.
CONCLUSIONS: Real world patterns and predictors of early revascularization in peripheral artery disease are not well understood. In this retrospective analysis of the POTRAIT study, about 1 out of 3 patients with PAD symptoms received early revascularization, with significant site variability. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD.

(1) Background: High-level evidence on antithrombotic therapy after infrainguinal arterial bypass surgery in specific clinical scenarios is lacking. (2) Methods: A modified Delphi procedure was used to develop consensus statements. Experts voted on antithrombotic treatment regimens for three types of infrainguinal arterial bypass procedures: above-the-knee popliteal artery; below-the-knee popliteal artery; and distal, using vein, prosthetic, or biological grafts. The treatment regimens for these nine procedures were then voted on in three clinical scenarios: isolated PAOD, atrial fibrillation, and recent coronary intervention. (3) Results: The survey was conducted with 28 experts from 15 European countries, resulting in consensus statements on 25/27 scenarios. Experts recommended single antiplatelet therapy after above-the-knee popliteal artery bypasses regardless of the graft material used. For below-the-knee popliteal artery bypasses, experts suggested combining single antiplatelet therapy with low-dose rivaroxaban if the graft material used was autologous or biological. They did not recommend switching to triple therapy for patients on oral anticoagulants for atrial fibrillation or dual antiplatelet therapy in any scenario. (4) Conclusions: Great inconsistency in the antithrombotic therapy administered was found in this study. This consensus offers guidance for scenarios that are not covered in the current ESVS guidelines but must be interpreted within its limitations.

OBJECTIVE: The study aimed to determine the frequency of successful limb salvage in patients presenting with critical limb ischemia utilizing the available revascularization modalities. This descriptive cross-sectional study was conducted in the Department of General Surgery, Shifa International Hospital, Islamabad, from April 2017 to August 2017.
METHODS: A total of 96 patients with critical limb ischemia requiring urgent surgery for limb salvage were included in our study. Patients who had undergone previous surgeries for limb ischemia involving the same limb, had concurrent venous disease, or suffered from acute limb ischemia were excluded. All patients underwent either endoscopic angioplasty or bypass surgery. All patients were followed up for six months for the success of limb salvage and the requirement for amputation. Data were analyzed by SPSS version 26.0 (Armonk, NY: IBM Corp.).
RESULTS: Our patients had a mean age of 62.03±8.46 years, of whom 63 (65.6%) were men. A total of 47 (49.0%) patients required surgery for a non-healing ulcer, while 49 (51.0%) had resting leg pain. In 55 (57.3%) patients, bypass surgery was performed, while 35 (36.5%) underwent endoscopic angioplasty. The remaining six (6.2%) patients received a combination of both procedures. Limb salvage was successful in 78 (81.3%) patients. There was no difference between outcomes across gender (p=0.122), nor was there any difference in outcome between bypass surgery and endoscopic angioplasty (p=0.665).
CONCLUSIONS: Encouraging results can be obtained in treatment of critical limb ischemia if revascularization techniques are utilized prudently in a time-effective manner and individualized to each patient\'s requirements.

Postoperative complications of surgical revascularization in moyamoya disease (MMD) are difficult to predict because of poor knowledge of the underlying pathophysiological process. Since the aim of surgery is to improve brain dynamics by increasing regional blood flow, we hypothesize that postoperative complications are closely related to aberrant electrophysiological changes. Thus, we evaluated the clinical significance of intraoperative electrocorticography (iECoG) in bypass surgery for adult MMD.
Ninety-one adult patients operated on by the same neurosurgeon in our institute were involved (26 in the iECoG group, 65 in the traditional group). Two 1 × 6 subdural electrode grids were placed parallel to the middle frontal gyrus and superior temporal gyrus to record ECoG data continuously during the procedure in the iECoG group. Selected from several M4 candidate arteries, the recipient artery was determined to be closer to the cortex with lower power spectral density (PSD) in the beta band. The PSD parameter we used was the (delta+theta)/(alpha+beta) (DTAB) ratio (DTABR). Next, the pre- and post-bypass PSD values were evaluated, and correlations between post-/pre-bypass PSD parameter ratios and neurological/neuropsychological performance (in terms of changes in National Institutes of Health Stroke Scale [NIHSS] and Mini-Mental State Examination [MMSE] scores) were analyzed.
Postoperative complications (transient neurological events) in the iECoG group were significantly lower than those in the traditional group (p = 0.046). In the iECoG group, the post-/pre-bypass DTABR ratio in the bypass area was significantly correlated with postoperative NIHSS (p = 0.002, r2 = 0.338) and MMSE changes (p = 0.007, r2 = 0.266). In the nonbypass area, neither postoperative NIHSS nor MMSE changes showed a significant correlation with the post-/pre-bypass DTABR ratio (p > 0.05). Additionally, patients with postoperative complications exhibited significantly higher DTABR (1.67 ± 0.33 vs. 0.95 ± 0.08, p = 0.003) and PSD of the theta band (1.54 ± 0.21 vs. 1.13 ± 0.08, p = 0.036).
This study is the first to explain and guide surgical revascularization from the perspective of electrophysiology. Intraoperative ECoG is not only sensitive in reflecting and predicting postoperative neurological and cognitive performance but also usable as a reference for recipient artery selection.

Background: Previous observational studies reported a wide variation and possible room for improvement in the treatment of patients suffering from symptomatic peripheral artery disease (PAD). Yet, systematic assessment of everyday clinical practice is lacking. A General Data Protection Regulation (GDPR) compliant registry was developed and used to collect comprehensive data on clinical treatment and outcomes regarding PAD in Germany. Here, we report baseline characteristics of patients prospectively enrolled until the end of 2020. Methods: The GermanVasc registry study is a prospective longitudinal multicentre cohort study. Between 1st May 2018 and 31st December 2020, invasive endovascular, open-surgical, and hybrid revascularisations of patients suffering from chronic symptomatic PAD were prospectively included after explicit informed consent (NCT03098290). For ensuring high quality of the data, we performed comprehensive risk-based and random-sample external and internal validation. Results: In total, 5608 patients from 31 study centres were included (34% females, median 69 years). On-site monitoring visits were performed at least once in all centres. The proportion of chronic limb-threatening ischaemia was 30% and 13% were emergent admissions. 55% exhibited a previous revascularisation. Endovascular techniques made 69% among all documented invasive procedures (n=6449). Thirty-five percent were classified as patients with severe systemic disease, and 3% exhibited a constant threat to life according to the American Society of Anaesthesiologists classification. The risk profile comprised of 75% former or current smokers, 36% diabetes mellitus, and in 30% a current ischemic heart disease was present. At discharge, 93% of the patients received antiplatelets and 77% received statins. Conclusions: The GermanVasc registry study provides insights into real-world practice of treatment and outcomes of 5,608 patients with symptomatic PAD in Germany. The cohort covers a broader range of disease severity and types of interventions than usually found in trials. In future studies, comparative outcomes will be analysed in more detail.