SUTURELESS VALVE IMPLANTATION VIA MINIMALLY INVASIVE APPROACH: RESULTS FROM THE INTERNATIONAL PROSPECTIVE MANTRA STUDY

U. Kappert1, HG. Je2, S. Shehada3, M. Torella4, M. Solinas5, B. Meuris6, M. Rinaldi7, JW. Choi8, F. Pollari9, KY. Lam10, C. Baeza11, V. Argano12, T. Bové 13, G.Troise14, M. Baghai15, E. Parrino16, D. Pacini17, H. Gutermann18, GS. Aldea19, S. Micovic20

1 Herzzentrum Dresden GmbH Universitätsklinik , Dresden, Germany; 2 Pusan National University Yangsan Hospital, Yangsan, South Korea; 3 Universitätsklinikum Essen, Essen Germany; 4 University of Campania “L. Vanvitelli” - Monaldi Hospital, Napoli, Italy; 5 Ospedale del Cuore di Massa, Massa Italy; 6 UZ Leuven, Leuven, Belgium; 7 A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette, Torino, Italy; 8 Seoul National University Hospital. Seoul, South Korea; 9 Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany; 10 Catharina Ziekenhuis, Eindhoven, The Netherlands; 11 University Hospitals Cleveland Medical Center, USA; 12 Policlinico Paolo Giaccone, Palermo, Italy; 13UZ Gent, Gent, Belgium; 14 Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy; 15 King’s College Hospital, London, UK, 16 Ochsner Clinic Foundation, New Orleans, USA; 17 Policlinico S.Orsola-Malpighi, Bologna, Italy; 18 Ziekenhuis Oost Limburg, Genk, Belgium; 19 University of Washington, Seattle, WA, USA; 20 Dedinje Cardiovascular Institute, Belgrade Serbia.

OBJECTIVE

To report the early real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing isolated minimally invasive aortic valve replacement (MI-AVR) with the Perceval Plus sutureless bioprosthesis.

METHODS

MANTRA is an ongoing “umbrella” prospective, multi-center, international post-market study designed to collect real-life safety and performance data on Corcym devices (Corcym S.r.l., Saluggia, Italy).

Clinical and echocardiographic outcomes collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L questionnaires collected preoperatively and at the 30-day visit.

PATIENTS

141 patients underwent isolated MI-AVR in 19 International institutions with implant of the Perceval Plus valve. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing.

 

CONCLUSIONS

In this prospective multicenter study, MI-AVR with the Perceval Plus sutureless valve confirmed to be safe, reproducible and effective, providing excellent clinical recovery at the 30-day follow-up, pacemaker implant rate aligned with standard AVR, with moderate-to-large improvements of Quality of Life and a good early hemodynamic performance.