Trial reportEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2017
Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.
Trial report in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02088554 (Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease), which is not on this map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
Who cites it
19 citing papers in PubMed, 44 citations in OpenAlex.
- Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicentre analysis.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024Trial
- Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial.Journal of cardiothoracic surgery · 2020Trial
- Left Ventricular Outflow Tract Diameter Variability and Prosthesis-Patient Mismatch: A Simulation Study.Interdisciplinary cardiovascular and thoracic surgery · 2026Article
- Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve.Echocardiography (Mount Kisco, N.Y.) · 2024Article
- Successful Redo Surgical Replacement of a Flail Bioprosthetic Aortic Valve: A Case Report.The American journal of case reports · 2024Article
- Current definitions of hemodynamic structural valve deterioration after bioprosthetic aortic valve replacement lack consistency.JTCVS open · 2024Article
- Do postoperative hemodynamic parameters add prognostic value for mortality after surgical aortic valve replacement?JTCVS open · 2024Article
- Article
- Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis.Brazilian journal of cardiovascular surgery · 2023Observational
- Minimally Invasive Aortic Valve Replacement in Contemporary Practice: Clinical and Hemodynamic Performance from a Prospective Multicenter Trial.The Thoracic and cardiovascular surgeon · 2023Article
- Article
- Pledgeted versus nonpledgeted sutures in aortic valve replacement: Insights from a prospective multicenter trial.JTCVS techniques · 2023Article
- Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2022Article
- Biological Surgical Options in Young Patients for the Treatment of Severe Aortic Stenosis: Is the Jury Still Out? A Review.Reviews in cardiovascular medicine · 2022Review
- Aortic valve replacement in a patient with self-reported systemic multiple metal allergy.General thoracic and cardiovascular surgery · 2022Article
- Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients.General thoracic and cardiovascular surgery · 2021Article
- Open heart mitral valve replacement using the Edwards-Sapien 3 for severe mitral annular calcification prevents left ventricular outflow tract obstruction.Clinical case reports · 2021Article
- The fallacy of indexed effective orifice area charts to predict prosthesis-patient mismatch after prosthesis implantation.European heart journal. Cardiovascular Imaging · 2020Article
- Bioprosthetic or mechanical heart valves: prosthesis choice for borderline patients?-Results from 9,616 cases recorded in Polish national cardiac surgery registry.Journal of thoracic disease · 2020Article
Corrections and comments
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Authors and funding
11 authors at 10 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).
methodsThe 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.
resultsTotal 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.
conclusionsThis 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.
trial registrationNCT02088554 (www.clinicaltrials.gov).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.