Key result
Sutureless AVR literature remains overwhelmingly observational, with RCTs comprising only ~1% of published studies.
Why the study?
Sutureless aortic valve replacement has limited global adoption and sparse randomized data, with significant geographical imbalances and unresolved clinical concerns.
Meta-Analysis (n=538)
The scientific evidence for sutureless aortic valve replacement is limited by a lack of randomized trials and significant geographical bias, highlighting the need for high-quality comparative trials.
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.
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Spadaccio et al. (2025) conducted a meta-analysis in Aortic Valve Replacement (n=538). Sutureless aortic valve replacement (SuAVR) vs. Conventional surgical aortic valve replacement (SAVR) was evaluated. A bibliographic meta-analysis of 538 studies on sutureless aortic valve replacement found the evidence base is predominantly observational, with randomized controlled trials comprising only 1.3%.
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