Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study

• Published in: Journal of cardiothoracic surgery 2024-06, Vol.19 (1), p.340-10, Article 340
• Main Authors: Micovic, Slobodan, Nobre, Angelo, Choi, Jae Woong, Solinas, Marco, Shehada, Sharaf-Eldin, Torella, Michele, Baeza, Cristian, Parrino, Eugene, Pollari, Francesco, Troise, Giovanni, Kappert, Utz, Mellert, Friedrich, Je, Hyung Gon, Argano, Vincenzo, Lam, Ka Yan, Rinaldi, Mauro, Gutermann, Herbert, Meuris, Bart
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aorta; Aortic valve; Aortic Valve - surgery; Aortic valve replacement; Aortic Valve Stenosis - surgery; Catheters; Disease; Female; Heart; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - methods; Heart valves; Hemodynamics; Hemodynamics - physiology; Humans; Male; Middle Aged; Mineralization; Mortality; Ostomy; Patients; Perceval plus; Prospective Studies; Prostheses; Prosthesis Design; Quality of Life; Questionnaires; Real-life data; Recovery (Medical); Surgeons; Surgery; Sutureless Surgical Procedures - methods; Sutureless valve; Treatment Outcome
• ISSN: 1749-8090; 1749-8090
• DOI: 10.1186/s13019-024-02861-1

The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve. MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p