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Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.

ABSTRACT: We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3-6 months and 1 year. The primary analysis compared 'late' (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis after implantation with objective performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. We hypothesized that the upper 95% confidence bounds of the true linearized AE rates would be ??2?×?OPC; rejection of the null hypothesis would demonstrate that these rates were below acceptable rates. The analysis was required to include at least 150 patients followed to 1 year and 400 valve-years. Kaplan-Meier survival analysis was also performed.Total number of valve-years was 459.5 (n?=?686). Linearized rates were <2?×?OPC for death and valve-related thromboembolism, valve thrombosis, all and major PVL, and endocarditis, but ?2?×?OPC for all and major haemorrhage. Survival at 1 year (n?=?270) was 96.4%. Patients showed good functional recovery, and haemodynamic performance was within expected range.This analysis demonstrated a good safety profile and clinical effectiveness of the Avalus valve except for bleeding rates. The linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort.NCT02088554 (www.clinicaltrials.gov).

SUBMITTER: Klautz RJM

PROVIDER: S-EPMC5848807 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.

Klautz Robert J M RJM Kappetein A Pieter AP Lange Rüdiger R Dagenais Francois F Labrousse Louis L Bapat Vinayak V Moront Michael M Misfeld Martin M Zeng Cathy C Sabik Iii Joseph F JF

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20170901 3

<h4>Objectives</h4>We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).<h4>Methods</h4>The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3-6 months and 1 year. The primary an ...[more]

PMID: 28475690

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Project description:Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.

Project description:BACKGROUND:Transcatheter aortic valve replacement (TAVR) is a fundamentally new procedure for the treatment of native aortic regurgitation (AR). The number of cases needed to gain proficiency with the procedure is unknown. HYPOTHESIS:This study aimed to evaluate the learning curve for TAVR for native AR. METHODS:This study retrospectively reviewed a prospective database from 134 consecutive native AR patients who underwent the J-valve TAVR system, which performed by a single team interventional cardiologist. The cumulative sum (CUSUM) method was used to analyze the learning curve. Patients were divided into two groups in chronological order, defined by the surgeon's early (group 1: the first 52 cases) and skilled (group 2: the next 82 cases) experience. Demographic data, intraoperative characteristics, and short-term surgical outcomes were compared between the two groups. RESULTS:CUSUM plots revealed decreasing procedure time and fluoroscopy time after patients 52 and 43, respectively. The patient date consistently demonstrated that high-risk scores and major perioperative parameters were comparable between the two groups. The use of contrast dye (group 1, 94.22?±?30.07?mL; group 2, 70.43?±?15.02?mL, P<.05), total procedure time (group 1, 84.96?± 17.76?minutes; group 2, 59.95?±?12.83?minutes, P<.05), and fluoroscopy time (group 1, 11.52?± 3.81?minutes; group 2, 6.47?±?1.53?minutes, P<.05) were significantly reduced in group 2. The overall device success rate in group 1 was 96.2% vs 96.3% in group 2 and remained high (P = 1.0). The overall 30-day mortality was 3.8% in group 2 (group 1, 0 to group 2, 3.8%; P = .16). The complications rate, such as pulmonary hypertension, chronic kidney disease, and coronary artery disease were higher in group 2. CONCLUSIONS:For a surgeon without previous TAVR experience, 52 cases of performance is the minimal requirement to gain the proficiency of TAVR for native AR. The skilled surgeons have been observed with reduced procedural time, fluoroscopy times, radiation exposure dose, and contrast volume usage. However, the overall prognosis was not significantly different between the two groups.

Dataset Information

Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.

Publications

Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.

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