Exploring Use-Rates of and Scientific Evidence on Sutureless Devices in Aortic Valve Replacement: A Bibliographic Meta-Analysis and Clinical Considerations

TL;DR

This paper reviews global research and adoption of sutureless aortic valve replacement, finding limited randomized trials and regional disparities in use.

Contribution

A bibliographic meta-analysis of 538 studies reveals geographic and methodological gaps in sutureless aortic valve replacement research.

Findings

80% of SuAVR research comes from Europe, with North America contributing less than 10%.

Only 1.3% of studies are randomized controlled trials, highlighting a lack of high-quality evidence.

SuAVR adoption is influenced by reimbursement policies and regulatory approvals, but concerns about cost and durability remain.

Abstract

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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