It Is Not Yet Time to Bury Femoropopliteal Bypass Surgery

Non peer reviewe

No Complaints on the Validity of Karbase

Non peer reviewe

Nonagenarians will be the Future Challenge for Vascular Specialists

Non peer reviewe

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain 2-Year Results From the IN.PACT Global Study

OBJECTIVES The IN. PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BACKGROUND Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. METHODS The IN. PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device-and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. RESULTS Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. CONCLUSIONS This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (c) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Peer reviewe

Analysis of the Elective Treatment Process for Critical Limb lschaemia with Tissue Loss : Diabetic Patients Require Rapid Revascularisation

Objectives: The number of elderly people is increasing; inevitably, the result will be more patients with critical limb ischaemia (CLI) in the future. Tissue loss in CLI is related to a high risk of major amputation. The aim of this study was to analyze the treatment process from referral to revascularisation, to discover possible delays and reasons behind them, and to distinguish patients benefitting the most from early revascularisation. Methods: A retrospective analysis was performed of 394 consecutive patients with a combined 447 affected limbs, referred to the outpatient clinic during 2010-2011 for tissue loss of suspected ischaemic origin. Results: For 246 limbs revascularisation was scheduled. After changes in the initial treatment strategy, endovascular treatment (ET) was performed on 221 and open surgery (OS) on 45 limbs. Notably there was crossover after ET in 17.0% of the procedures, and re-revascularisations were required in 40.1% after ET and 31.1% after OS. The median time from referral to revascularisation was 43 days (range 1-657 days) with no significant difference between ET and OS. For 29 (11.8%) patients the ischaemic limb required an emergency operation scheduled at the first visit to the outpatient clinic. For 25 (10.2%) patients the situation worsened while waiting for elective revascularisation and an emergency procedure was performed. Diabetic patients formed the majority of the study population; with 159 diabetic feet undergoing revascularisation. In multivariate analysis, diabetes was associated with poor limb salvage. When revascularisation was achieved within 2 weeks, no difference was seen in limb salvage. However, when the delay from first visit to revascularisation exceeded 2 weeks, limb salvage was significantly poorer in diabetic patients. Conclusions: Diabetic ulcers always require vascular evaluation, and when.ischaemia is suspected the diagnostics should be organised rapidly to ensure revascularisation without delay, according to this study within 2 weeks from the first evaluation. (C) 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.Peer reviewe

No Difference in Mid-term and Long-Term Mortality After Vascular Paclitaxel Exposure

Background: Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution. Methods: Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data. Results: A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the pacli-taxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mor-tality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively). Conclusions: No significant difference was seen in the overall analysis between the pacli-taxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individ-ual trials are small and should be interpreted in the context of future patient-level meta -analysis.Peer reviewe

Response to "Re. Analysis of the Elective Treatment Process for Critical Limb Ischaemia with Tissue Loss : Diabetic Patients Require Rapid Revascularisation"

Non peer reviewe

Bovine pericardial patch : A good alternative in femoral angioplasty

Objective: Bovine pericardial patch (BPP) is currently used in femoral angioplasty as an alternative for autologous vein patch (AVP), but studies comparing the results of the two methods are scarce. In this retrospective study, we aimed to discover the differences between BPP and AVP closure in long-term durability.Methods: This study consisted of all femoral endarterectomies with BPP closure performed in Helsinki University Hospital from January 1, 2014, to December 31, 2017. For comparison, the same number of consecutive patients who underwent femoral endarterectomy with AVP closure from January 1, 2014, to October 16, 2016, were reviewed. Follow-up ended December 31, 2020. The mean follow-up was 19 months (range, 0-74 months) in the BPP group and 22 months (range, 079 months) in the AVP group. The primary endpoint was primary patency. Secondary endpoints were restenosis at patch site detected by imaging or perioperatively, patch rupture, and deep surgical wound infection. Propensity score analysis was performed for adjustment of differences between the AVP and BPP groups.Results: Overall primary patency was superior in the AVP group compared with the BPP group: at 1 year, 96.5% vs 85.0% and at 5 years, 83.0% vs 72.3% (P =.04). In propensity score-matched pairs (n = 92), no difference was found between the groups in primary patency: 95.7% and 95.7% at 1 year and 92.5% and 78.6% at 5 years (P =.861) or in freedom from restenosis: 100% and 100% at 1 year and 89.1% and 84.0% at 5 years (P =.057). Deep wound infections occurred slightly more often after BPP closure (8%) than after AVP closure (4%), but the difference was not statistically significant (P =.144). There were no patch ruptures in the BPP group, but in the AVP group, there were five ruptures (3.5%) (P =.024).Conclusions: BPP is compatible to AVP in femoral endarterectomy in patency and can be regarded as the safer choice considering the risk of patch rupture.Peer reviewe

The Feasibility of Angiosome-Targeted Endovascular Treatment in Patients with Critical Limb Ischaemia and Foot Ulcer

Peer reviewe

Simulation training streamlines the real-life performance in endovascular repair of ruptured abdominal aortic aneurysms

Objective: Difficulties in distributing endovascular experience among all operating room (OR) personnel prevented full-scale use of endovascular aneurysm repair (EVAR) in emergencies. To streamline the procedure of EVAR for ruptured aneurysm (rEVAR) and to provide this method even to unstable patients, we initiated regular simulation training sessions. Methods: This is an observational study of 29 simulation sessions performed between January 2015 and December 2017. We analyzed the development of time from OR door to aortic balloon occlusion during simulations and OR door to needle times in real-life rEVARs as well as the outcome of the 185 ruptured abdominal aortic aneurysm (rAAA) patients who arrived at the university hospital between January 2013 and December 2017. A questionnaire was sent for simulation attendants before and after the simulation session. Results: In the first simulations, the door to occlusion time was 20 to 35 minutes. After adding a hemodynamic collapse to the simulation protocol, the time decreased to 10 to 13 minutes in the 10 recent simulations, including a 5-minute cardiopulmonary resuscitation (P = .01). The electronic questionnaire performed for attendees before and after the simulation session showed significant improvement in both confidence and knowledge of the OR staff regarding rEVAR procedure. In the real-life rEVARs, 75 of the 185 patients with rAAAs underwent EVAR. Among rEVAR patients, the median OR door to needle time was 65 minutes before and 16 minutes after the onset of simulations (P = .000). The overall 30-day mortality among all rAAA patients was 44.8% and 30.6% accordingly (P = .046). When patients who were turned down from the emergency surgery were excluded, the 30-day operative mortality was 39.2% and 25.1% during the periods, respectively (P = .051). The 30-day mortality was 16.2% after rEVAR and 40.6% after open surgery (P = .001). Conclusions: Simulation training for rEVAR significantly improves the treatment process in real-life patients and may enhance the outcome of rAAA patients.Peer reviewe