Exploring Use-Rates of and Scientific Evidence on Sutureless Devices in Aortic Valve Replacement: A Bibliographic Meta-Analysis and Clinical Considerations
Sutureless aortic valve replacement (SuAVR) has emerged as a potential alternative to conventional surgical aortic valve replacement (SAVR), particularly in minimally invasive settings. However, its global adoption remains limited, with a notable concentration of use and scientific production in select European countries. This bibliographic meta-analysis systematically reviewed 538 studies to assess the evidence landscape surrounding SuAVR, highlighting a predominance of observational data, sparse randomized controlled trials (1.3%), and significant geographical imbalances in research output. Europe accounted for 80% of publications, while North America contributed less than 10%. Key structural factors-including reimbursement policies, earlier regulatory approvals, and population characteristics-appear to influence SuAVR adoption. Despite procedural advantages such as reduced cross-clamp times, concerns over cost, pacemaker implantation rates, and uncertain long-term durability persist. Importantly, SuAVR may offer its greatest clinical value by facilitating minimally invasive surgery, a niche still underutilized worldwide. The limited randomized data and industrial focus on transcatheter approaches have further hindered widespread acceptance. Our findings underscore the need for high-quality comparative trials and standardized guidelines to define the role of SuAVR in modern valve therapy.
Authors
- Arnaldo Dimagli (ORCID: https://orcid.org/0000-0003-0055-8656)
- Antonio Nenna (ORCID: https://orcid.org/0000-0002-4069-6781)
- Dane C. Paneitz (ORCID: https://orcid.org/0000-0002-5760-699X)
- Cristiano Spadaccio (ORCID: https://orcid.org/0000-0002-1672-7576)
- Stanley B. Wolfe (ORCID: https://orcid.org/0000-0002-0600-8180)
- David Rose
- Asishana A. Osho (ORCID: https://orcid.org/0000-0002-1140-097X)
- Clayton J. Agler (ORCID: https://orcid.org/0009-0007-4526-4770)
Institutions
- West Virginia University (US)
- Harvard University (US)
- Johns Hopkins University (US)
- University of Liverpool (GB)
- Johns Hopkins Medicine (US)
- Blackpool Victoria Hospital (GB)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
- Ospedale Maggiore (IT)
- Massachusetts General Hospital (US)
- Sabin Vaccine Institute (US)
- Columbia University (US)
- University of Cincinnati Medical Center (US)
Publication Details
- Journal
- Journal of Clinical Medicine
- Published
- 2025-06-07
- DOI
- https://doi.org/10.3390/jcm14124049
- Primary Topic
- Cardiac Valve Diseases and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00