Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.

Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab. Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] ( The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

Informations de copyright

Copyright © 2022 Fischlein, Caporali, Asch, Vogt, Pollari, Folliguet, Kappert, Meuris, Shrestha, Roselli, Bonaros, Fabre, Corbi, Troise, Andreas, Pinaud, Pfeiffer, Kueri, Tan, Voisine, Girdauskas, Rega, García-Puente, De Kerchove, Lorusso and on behalf of the PERSIST-AVR Investigators.

Déclaration de conflit d'intérêts

UK was employed by Herzzentrum Dresden GmbH Universitätsklinik. This study received funding from Corcym S.r.l. The funder had the following involvement with the study: all trial-related activities and participated in site selection, data monitoring, trial management, and statistical analysis. TFi: consultant CORCYM and BioStable. TFo: consultant CORCYM (Steering Committee). BM and MS: consultant CORCYM Steering Committee and Proctor. ER: consultant CORCYM (Steering Committee and Proctor), speaker for Abbott, consultant, speaker and investigator for Edwards and Medtronic. NB: educational grants: Edwards Lifesciences and CORCYM, Speaker Honoraria: Edwards Lifesciences, CORCYM and Medtronic. OF, GT, SP, SK, JG-P: consultant CORCYM (Proctor). MA: consultant Abbott and Edwards (Proctor), advisor Medtronic. FR: consultant CORCYM and AtriCure (Proctor), Research Support Recipient Medtronic. RL: Consultant Medtronic, LivaNova, CORCYM and Getinge (honoraria paid to the Maastricht University) and Member of the Medical Advisory Board for Eurosets (honoraria paid to the Maastricht University). FA has no personal conflict of interest but directs an academic Core laboratory carrying institutional contracts (MedStar Health) for his work with Corcym/Livanova, Edwards, Medtronic, Boston Scientific, Abbott, Foldax, Biotronik. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.