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Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.

Authors :
Beaver, Thomas
Bavaria, Joseph E.
Griffith, Bartley
Svensson, Lars G.
Pibarot, Philippe
Borger, Michael A.
Sharaf, Omar M.
Heimansohn, David A.
Thourani, Vinod H.
Blackstone, Eugene H.
Puskas, John D.
Source :
Journal of Thoracic & Cardiovascular Surgery; Sep2024, Vol. 168 Issue 3, p781-791, 11p
Publication Year :
2024

Abstract

As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm<superscript>2</superscript> (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed. We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses. [Display omitted] [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00225223
Volume :
168
Issue :
3
Database :
Supplemental Index
Journal :
Journal of Thoracic & Cardiovascular Surgery
Publication Type :
Academic Journal
Accession number :
179599489
Full Text :
https://doi.org/10.1016/j.jtcvs.2023.09.047