Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry.

Aortic stenosis Aortic valve replacement Real-world evidence Sutureless valves

Journal

Interdisciplinary cardiovascular and thoracic surgery
ISSN: 2753-670X
Titre abrégé: Interdiscip Cardiovasc Thorac Surg
Pays: England
ID NLM: 9918540787006676

Informations de publication

Date de publication:
01 Jun 2023
Historique:
received: 30 04 2023
revised: 17 05 2023
accepted: 11 06 2023
medline: 12 6 2023
pubmed: 12 6 2023
entrez: 12 6 2023
Statut: ppublish

Résumé

Perceval sutureless valve has been in clinical use for >15 years. The aim of this study is to report the real-word clinical and haemodynamic performance from the SURE-aortic valve replacement international prospective registry in patients who underwent aortic valve replacement with Perceval valve. From 2011 to 2021, patients from 55 institutions received a Perceval valve. Postoperative, follow-up, and echocardiographic outcomes were analysed. A total of 1652 patients were included; mean age was 75.3 ± 7.0 years (53.9% female); mean EuroSCORE II was 4.1 ± 6.3. Minimally invasive approach was performed in 45.3% of patients; concomitant procedures were done in 35.9% of cases. Within 30 days, 0.3 and 0.7% valve-related reinterventions were reported. Transient ischaemic attack, disabling and non-disabling strokes were limited (0.4%, 0.4% and 0.7%, respectively). Pacemaker implant was required in 5.7% of patients. Intra-prosthetic regurgitation ≥2 was present in 0.2% of cases, while paravalvular leak ≥2 in only 0.1%. At a maximum follow-up of 8 years, 1.9% of cardiovascular deaths and 0.8% of valve-related reintervention occurred. Among the 10 cases of structural valve deterioration (mean 5.6 ± 1.4 years after implant; range: 2.6-7.3 years), 9 were treated with a transcatheter vale-in-valve implantation and 1 with explant. Mean pressure gradient decreased from 45.8 ± 16.5 mmHg preoperatively to 13.3 ± 5.2 mmHg at discharge and remained stable during follow-up. This experience represents the largest prospective real-world cohort of patients treated with Perceval showing that Perceval is a safe and effective alternative to conventional surgical aortic valve replacement, providing favourable clinical and haemodynamic results also at mid-term follow-up.

Identifiants

pubmed: 37307090
pii: 7194138
doi: 10.1093/icvts/ivad103
pmc: PMC10281856
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : CORCYM S.r.l

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

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Auteurs

Giovanni Concistré (G)

Department of Adult Cardiac Surgery, G Pasquinucci Heart Hospital, Massa, Italy.

Max Baghai (M)

Cardiothoracic Surgery, King's College Hospital NHS Foundation Trust, London, UK.

Giuseppe Santarpino (G)

Department of Cardiac Surgery, Città di Lecce Hospital, GVM Care & Research, Lecce, Italy.

Alistair Royse (A)

Cardiothoracic Surgery, The Royal Melbourne Hospital, Parkville, VIC, Australia.

Maximilian Scherner (M)

Department of Cardiothoracic Surgery, University of Magdeburg, Magdeburg, Germany.

Giovanni Troise (G)

Department of Cardiovascular Surgery, Poliambulanza Foundation/Cardiac Surgery Unit, Brescia, Italy.

Mattia Glauber (M)

Department of Cardiac Surgery, Gruppo San Donato, Milano, Italy.

Marco Solinas (M)

Department of Adult Cardiac Surgery, G Pasquinucci Heart Hospital, Massa, Italy.

Classifications MeSH