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

**Authors:** Cristiano Spadaccio, Arnaldo Dimagli, Clayton J. Agler, Dane C. Paneitz, Stanley B. Wolfe, Antonio Nenna, Asishana A. Osho, David Rose

PMC · DOI: 10.3390/jcm14124049 · 2025-06-07

## 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.

## Key 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.

## Full-text entities

- **Diseases:** injury to (MESH:D014947), ischemic (MESH:D002545), stenosis (MESH:D003251), morbid obesity (MESH:D009767), renal or respiratory failure (MESH:D012131), obese (MESH:D009765), leak (MESH:D019559), low-output syndrome (MESH:D002303), SuAVR (MESH:D001024), stroke (MESH:D020521), valve degeneration (MESH:D006349), atrial fibrillation (MESH:D001281), aortic valve disease (MESH:D000082862)
- **Chemicals:** SuAVR (-), glutaraldehyde (MESH:D005976)
- **Species:** Homo sapiens (human, species) [taxon 9606], Meleagris gallopavo (common turkey, species) [taxon 9103]

## Figures

1 figure with captions in the complete paper: https://tomesphere.com/paper/PMC12194476/full.md

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Source: https://tomesphere.com/paper/PMC12194476