Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial. (Record no. 668)

MARC details
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fixed length control field 04289nam a22003497a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 220511s20222022 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 2297-055X
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.3389/fcvm.2022.844876 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code PMC8894864 [pmc]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 35252408
245 ## - TITLE STATEMENT
Title Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.
251 ## - Source
Source Frontiers in Cardiovascular Medicine. 9:844876, 2022.
252 ## - Abbreviated Source
Abbreviated source Front. cardiovasc. med.. 9:844876, 2022.
253 ## - Journal Name
Journal name Frontiers in cardiovascular medicine
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status epublish
266 ## - Date added to catalog
Date added to catalog 2022-05-11
520 ## - SUMMARY, ETC.
Abstract Conclusion: 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. Copyright © 2022 Fischlein, Caporali, Asch, Vogt, Pollari, Folliguet, Kappert, Meuris, Shrestha, Roselli, Bonaros, Fabre, Corbi, Troise, Andreas, Pinaud, Pfeiffer, Kueri, Tan, Voisine, Girdauskas, Rega, Garcia-Puente, De Kerchove, Lorusso and on behalf of the PERSIST-AVR Investigators.
520 ## - SUMMARY, ETC.
Abstract Methods: 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)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance.
520 ## - SUMMARY, ETC.
Abstract Objective: 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.
520 ## - SUMMARY, ETC.
Abstract Results: 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 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element IN PROCESS -- NOT YET INDEXED
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Asch, Federico M
790 ## - Authors
All authors Andreas M, Asch FM, Bonaros N, Caporali E, Corbi P, De Kerchove L, Fabre O, Fischlein T, Folliguet T, Garcia-Puente J, Girdauskas E, Kappert U, Kueri S, Lorusso R, Meuris B, Pfeiffer S, Pinaud F, Pollari F, Rega F, Roselli EE, Shrestha ML, Tan E, Troise G, Vogt F, Voisine P
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.3389/fcvm.2022.844876">https://dx.doi.org/10.3389/fcvm.2022.844876</a>
Public note https://dx.doi.org/10.3389/fcvm.2022.844876
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
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          MedStar Authors Catalog MedStar Authors Catalog 05/11/2022   35252408 35252408 05/11/2022 05/11/2022 Journal Article

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