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Clinical Trial
. 2024 Dec 26;67(1):ezae414.
doi: 10.1093/ejcts/ezae414.

Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicentre analysis

Joseph F Sabik 3rd  1 , Vivek Rao  2 , Francois Dagenais  3 , Michael G Moront  4 , Michael J Reardon  5 , Himanshu J Patel  6 , Jae K Oh  7 , Shinichi Fukuhara  6 , Louis Labrousse  8 , Ralf Günzinger  9 , Kamran Baig  10 , Saki Ito  7 , Tianhua Wu  11 , Robert J M Klautz  12 ; PERIGON Investigators
Collaborators, Affiliations
Clinical Trial

Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicentre analysis

Joseph F Sabik 3rd et al. Eur J Cardiothorac Surg. .

Abstract

Objectives: Safety, efficacy and durability are important considerations when selecting a bioprosthesis for aortic valve replacement (AVR). This study assessed 7-year clinical outcomes and haemodynamic performance of the Avalus bioprosthesis.

Methods: Patients indicated for surgical AVR were enrolled in this prospective, nonrandomized trial, conducted across 39 sites globally. The primary end-point of this analysis was freedom from surgical explant or percutaneous valve-in-valve reintervention due to structural valve deterioration (SVD) at 7 years of follow-up, determined using Kaplan-Meier (KM) analysis. We also evaluated a composite end-point of SVD and/or severe haemodynamic dysfunction requiring reintervention. Survival, valve-related safety events and haemodynamic performance were assessed. Deaths and safety events were adjudicated by an independent clinical events committee.

Results: A total of 1132 patients underwent surgical AVR. Mean age was 70 years; 854 patients (75%) were men. The mean STS risk of mortality was 2.0 ± 1.4%, and 659 patients (58%) had a New York Heart Association classification of I/II. One or more concomitant procedures were performed in 577 patients (51%). At 7 years, the Kaplan-Meier rate of freedom from SVD/severe haemodynamic dysfunction requiring reintervention was 1.2% (0.5-2.5%) with no cases adjudicated as SVD. The survival rate was 82.6% (79.5-85.0%). The KM event rate was 5.7% (4.3-7.7%) for reintervention, 6.3% (4.9-8.3%) for endocarditis and 0.4% (0.1-1.1%) for valve thrombosis. Mean aortic gradient, dimensionless velocity index and effective orifice area were 13.8 ± 5.9 mmHg, 0.42 ± 0.09 and 1.99 ± 0.53 cm2, respectively.

Conclusions: This analysis demonstrated excellent durability of the Avalus valve with good clinical outcomes and stable haemodynamic performance through 7 years of follow-up.

Keywords: Durability; Hemodynamic performance; Surgical aortic valve replacement.

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Figures

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Graphical abstract
Figure 1:
Figure 1:
Survival (KM event rates of freedom from all-cause, cardiac and valve-related mortality) through 7 years of follow-up. KM: Kaplan–Meier.
Figure 2:
Figure 2:
KM rate of reintervention (surgical or percutaneous) stratified by cause through 7 years of follow-up. KM: Kaplan–Meier.
See this image and copyright information in PMC

Comment in

References

    1. US Food and Drug Administration. Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration—Letter to Health Care Providers. Silver Spring, MD, 2023. https://www.fda.gov/medical-devices/letters-health-care-providers/abbott... (16 July 2024, date last accessed).
    1. David TE, Feindel CM, Bos J, Ivanov J, Armstrong S.. Aortic valve replacement with Toronto SPV bioprosthesis: optimal patient survival but suboptimal valve durability. J Thorac Cardiovasc Surg 2008;135:19–24. - PubMed
    1. Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V et al; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg 2017;52:425–31. - PMC - PubMed
    1. Sabik JF, Rao V, Lange R, Kappetein AP, Dagenais F, Labrousse L et al; PERIGON Investigators. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg 2018;156:1368–77.e5. - PubMed
    1. Klautz RJM, Dagenais F, Reardon MJ, Lange R, Moront MG, Labrousse L et al Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg 2022;62:ezac374. - PMC - PubMed

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