Does valve size impact hemodynamic, left ventricular mass regression, and prosthetic valve deterioration with a sutureless aortic valve?

Objective: To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes. Methods: Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 de fi nition for bioprosthetic valve failure was applied. Results: A Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2 % were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3 % (range, 2.1 %-6.2 % ), and 33.4 % had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9 % vs 1.9 % for small and 55.1 % vs 19.5 % for medium; P < .001). The mean aortic valve gradients decreased signi fi cantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient - prosthesis mismatch (with an effective ori fi ce area/m(2) of > 0.8). Signi fi cant LV mass regression was documented regardless valve sizes, plateaued at-9.1 % at 5 years. Freedom from SVD and reintervention were 95.2 % and 96.3 % , respectively, at 5 years and were independent of implanted valve size ( P = .22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8 % at 5 years. Conclusions: The Perceval valve demonstrated low and stable mean gradients, signi fi cant LV mass regression, and low SVD and reintervention rates across all valve sizes.