Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Krzysztof Bartus, Radoslaw Litwinowicz, Agata Bilewska, Maciej Stapor, Maciej Bochenek, Jacek Rozanski, Jerzy Sadowski, Grzegorz Filip, Mariusz Kusmierczyk, Boguslaw Kapelak, Krzysztof Bartus, Radoslaw Litwinowicz, Agata Bilewska, Maciej Stapor, Maciej Bochenek, Jacek Rozanski, Jerzy Sadowski, Grzegorz Filip, Mariusz Kusmierczyk, Boguslaw Kapelak

Abstract

Objectives: Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.

Methods: This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory.

Results: Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years.

Conclusions: The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue.

Clinical trial registration number: NCT01651052.

Keywords: Aortic valve replacement; Bioprosthesis; RESILIA.

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Figures

Figure 1:
Figure 1:
Surgical approach undertaken for the study cohort.
Figure 2:
Figure 2:
Intraoperative outcomes for the study cohort. The error bars represent ± standard deviation. AVR: aortic valve replacement.
Figure 3:
Figure 3:
Kaplan–Meier curve showing freedom from all-cause mortality and structural valve deterioration. SE: standard error; SVD: structural valve degeneration.
Figure 4:
Figure 4:
(A) Mean gradients in the patient cohort by valve size over the 5 year observational period. (B) Mean effective orifice areas in the patient cohort by valve size and over the 5 year observational period.
Figure 5:
Figure 5:
Central/transvalvular (A), paravalvular (B) and total regurgitation (C) in the study cohort over the 5 year observational study period.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/7850021/bin/ezaa311f6.jpg

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Source: PubMed

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