Outcomes of Sutureless/Rapid Deployment Valves Compared to Traditional Bioprosthetic Aortic Valves.

ABSTRACT

BACKGROUND: Sutureless/rapid-deployment (SRD) valves for aortic valve replacement (AVR) are new surgical bioprosthetic valves that allow for expedited implantation and facilitate minimally invasive approaches. Although clinical trial data are available for SRDs in the United States, how their clinical outcomes compare with traditional stented bioprosthetic (SBP) valves is unknown in a post-approval, commercial setting. METHODS: The Society of Thoracic Surgery Adult Cardiac Surgery Database was queried for patients who underwent an AVR. Transcatheter AVR cases were excluded. Thirty-day outcomes were compared between SRD valves (Perceval S [LivaNova, Houston, TX] and Intuity Elite [Edwards Lifesciences, Irvine CA]) and SBP valve patients. The SRD and SBP patients were propensity score-matched in a 1(up to) 3 ratio. Primary outcome was 30-day mortality and secondary outcomes were major comorbidities, paravalvular regurgitation, and predischarge pacemaker implant. RESULTS: Propensity score matching resulted in 4486 SRD patients and 13,215 SBP patients. The SRD recipients had more permanent pacemakers (11.4% vs 4.9%, P < .001) shorter cross-clamp times (median 68 vs 86 minutes, P < .001), and fewer full sternotomies (75% vs 77% , P < .024) than SBP but similar 30-day mortality (3.1% vs 3.1%, P = .98) and moderate or greater paravalvular regurgitation (0.2% vs 0.1%, P = .21). CONCLUSIONS: SRD implantation was associated with reduced operative times and smaller incisions. Rates of 30-day mortality, major comorbidities, and perivalvular regurgitation were similar between SRD and SBP patients. Longer follow-up is needed to determine the implications of increased permanent pacemaker implantation rates in SRD patients.