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Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes.

Authors
  • Bartuś, Krzysztof
  • Litwinowicz, Radosław1
  • Kuśmierczyk, Mariusz
  • Bilewska, Agata
  • Bochenek, Maciej
  • Stąpór, Maciej
  • Woźniak, Sebastian
  • Różański, Jacek
  • Sadowski, Jerzy
  • Kapelak, Bogusław
  • 1 Klinika Chirurgii Serca, Naczyń i Transplantologii, Instytut Kardiologii, Collegium Medicum Uniwersytetu Jagiellońskiego, Krakowski Szpital Specjalistyczny im. Jana Pawła II ul. Prądnicka 80, 30-001 Kraków. [email protected]
Type
Published Article
Journal
Kardiologia Polska
Publisher
VM Media Sp zo.o. - VMGroup SK
Publication Date
Jan 01, 2018
Volume
76
Issue
3
Pages
618–624
Identifiers
DOI: 10.5603/KP.a2017.0262
PMID: 29297188
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Structural valve deterioration (SVD) is a major obstacle to lifetime durability for bioprosthetic heart valves. A bio-prosthetic valve created with RESILIA™ tissue was designed to produce long-term resistance to SVD. The objective of this study was to evaluate the safety and performance of this new class of RESILIA™ tissue aortic bio-prosthesis. A nonrandomised, prospective, multi-centre, single-arm, observational study was performed in 133 patients who underwent surgical aortic valve replacement between July 2011 and February 2013. Patients were assessed at 3-6 months and one year for haemodynamic performance, clinical outcomes, and functional improvement. The mean age was 65.3 ± 13.5 years, with 34 (25.6%) of patients < 60 years of age. Early (≤ 30 day) and late (> 30 day) all-cause mortality rates were 2.3% (n = 3) and 4.5% (n = 6), respectively. Early events included thromboembolism in three (2.3%) patients and major bleeding events requiring transfusion in six (4.5%) patients. Late events included one endocarditis leading to explant. Mean gradients were reduced across all valve sizes and were maintained at one year of follow-up. The mean effective orifice area and effective orifice area index increased across all valve sizes postoperatively and were maintained at one year. The rates of paravalvular leak (> 2+) at 3-6 months and one-year follow-up were 0.7% and 0.7%, respectively. The new generation RESILIA™ tissue aortic valve bioprosthesis demonstrated excellent haemodynamic per-formance and safety outcomes at one year of follow-up. Longer follow-up of these patients will provide further insight on long-term durability.

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