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CC BY-NC-ND 4.0 · Thorac Cardiovasc Surg 2023; 71(05): 387-397
DOI: 10.1055/s-0042-1743593
Original Cardiovascular

Minimally Invasive Aortic Valve Replacement in Contemporary Practice: Clinical and Hemodynamic Performance from a Prospective Multicenter Trial

Authors

  • Bart J.J. Velders 

    1   Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands

  • Michiel D. Vriesendorp

    1   Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands

  • Michael J. Reardon

    2   Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, United States

  • Vivek Rao

    3   Department of Cardiovascular Surgery, Toronto General Hospital, Toronto, Canada

  • Rüdiger Lange

    4   Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany

  • Himanshu J. Patel

    5   Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, United States

  • Elizabeth Gearhart

    6   Department of Biostatistics, Medtronic, Mounds View, Minnesota, United States

  • Joseph F. Sabik III

    7   Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States

  • Robert J.M. Klautz

    1   Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands

Funding The PERIGON Pivotal trial was sponsored by Medtronic.
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Abstract

Background The advent of transcatheter aortic valve replacement (AVR) has led to an increased emphasis on reducing the invasiveness of surgical procedures. The aim of this study was to evaluate clinical outcomes and hemodynamic performance achieved with minimally invasive aortic valve replacement (MI-AVR) as compared with conventional AVR.

Methods Patients who underwent surgical AVR with the Avalus bioprosthesis, as part of a prospective multicenter non-randomized trial, were included in this analysis. Surgical approach was left to the discretion of the surgeons. Patient characteristics and clinical outcomes were compared between MI-AVR and conventional AVR groups in the entire cohort (n = 1077) and in an isolated AVR subcohort (n = 528). Propensity score adjustment was performed to estimate the effect of MI-AVR on adverse events.

Results Patients treated with MI-AVR were younger, had lower STS scores, and underwent concomitant procedures less often. Valve size implanted was comparable between the groups. MI-AVR was associated with longer procedural times in the isolated AVR subcohort. Postprocedural hemodynamic performance was comparable. There were no significant differences between MI-AVR and conventional AVR in early and 3-year all-cause mortality, thromboembolism, reintervention, or a composite of those endpoints within either the entire cohort or the isolated AVR subcohort. After propensity score adjustment, there remained no association between MI-AVR and the composite endpoint (hazard ratio: 0.86, 95% confidence interval: 0.47–1.55, p = 0.61).

Conclusion Three-year outcomes after MI-AVR with the Avalus bioprosthetic valve were comparable to conventional AVR. These results provide important insights into the overall ability to reduce the invasiveness of AVR without compromising outcomes.

Keywords

aortic valve replacement - minimally invasive - surgical techniques

Note

Presented at the 34th Annual Meeting of the European Association for Cardio-Thoracic Surgery, Barcelona, Spain, October 8–10, 2020.


Authors' Contribution

B.J.J.V. and M.D.V. were involved in writing of the original draft, methodology, and visualization. M.J.R., V.R., R.L., and H.J.P. helped in providing resources, and were involved in writing and review and editing of the manuscript. E.G. was involved in software, validation, formal analysis, data curation, visualization, and in writing, review and editing of the manuscript. J.F.S. III and R.J.M.K. were involved in supervision, conceptualization, resources, writing and review and editing of the manuscript.


ClinicalTrials.gov Identifier

NCT02088554


Supplementary Material



Publication History

Received: 17 September 2021

Accepted: 04 January 2022

Article published online:
29 May 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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