Outcomes of aortic and mitral valve replacement with Dafodil™ pericardial bioprosthesis over 5-years: Dafodil™-1 trial.

Objectives: The durability and performance of bioprosthetic valves are pivotal in managing valvular heart disease (VHD). This 5-year follow-up study evaluated the long-term clinical safety, haemodynamic performance, and quality-of-life (QoL) outcomes of the Dafodil™ pericardial bioprosthesis in patients undergoing aortic or mitral valve replacement (AVR/MVR). Methods: In this prospective, multicenter, first-in-human trial conducted across 19 Indian centers, 136 patients with advanced VHD (67 AVR, 69 MVR) were enrolled. Key endpoints were evaluated over 5 years. Results: The mean age of the patients in the AVR and MVR cohorts was 60.2 ± 8.3 years and 49.7 ± 14.4 years, respectively. A total of 124 patients (61 AVR, 63 MVR) completed the 5-year follow-up. In the AVR cohort, mean pressure gradients decreased from 51.2 ± 24.1 mmHg at baseline to 11.3 ± 5.3 mmHg at five years, while effective orifice area (EOA) increased from 0.88 ± 0.56 cm2 to 1.72 ± 0.52 cm2 (p < 0.001). In the MVR group, the indexed EOA improved from 0.68 ± 0.4 cm2/m2 to 1.28 ± 0.39 cm2/m2 (p < 0.001). Both cohorts exhibited significant improvements in New York Heart Association (NYHA) class and SF-12 QoL scores. There were no cases of haemolysis, structural valve deterioration (SVD), or myocardial infarction. At five years, the incidence of all cause of mortality was 9.8% in the AVR group and 22.2% in the MVR group. The major adverse cardiac event-free survival rates were 88.0% (AVR) and 76.7% (MVR). Conclusions: Over five years, the bioprosthesis demonstrated sustained haemodynamic performance, clinical safety, and QoL. The absence of SVD and low rates of adverse events encourage its use in young patients requiring surgical valve replacement. Furthermore, a long-term follow-up is warranted to evaluate its durability.