Key result
Dafodil pericardial bioprosthesis shows ~93% 1-year survival alongside hemodynamic and functional improvements.
Why the study?
The clinical safety and hemodynamic performance of the Dafodil pericardial bioprosthesis in aortic or mitral valve replacement patients had not been evaluated in a first-in-human trial.
The Dafodil pericardial bioprosthesis demonstrated favorable safety, hemodynamic performance, and quality of life improvements at 1 year in a first-in-human trial for aortic and mitral valve replacement.
Favorable 1-year safety and hemodynamics in this first-in-human cohort support initial evaluation; leaves open durability and comparative efficacy pending larger randomized trials.
Background Bioprosthesis has been increasingly implanted for the treatment of transvalvular disease across the world. A new Dafodil™ pericardial bioprosthesis (Meril Life Sciences Pvt. Ltd., India) recently approved by Conformité Européenne (CE) is a tri-leaflet, stented, bovine valve. The purpose of Dafodil-1 first-in-human trial was to evaluate clinical safety and performance (including hemodynamic parameters) of the Dafodil pericardial bioprosthesis in patients who underwent aortic or mitral valve replacement. Methods This prospective, multicenter clinical trial enrolled 60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India. Safety endpoints were early (≤30 days) and late (> 30 days) mortality and valve-related morbidity. The performance endpoints were hemodynamic performance, improvement in NYHA functional class, and change in the quality of life using SF-12v1 health survey. Results From July 2017 to July 2018, 60 patients underwent implantation of the Dafodil pericardial bioprosthesis. Post-operatively, NYHA functional class significantly improved in all the patients (Aortic: 90% NYHA class-I and 10% NYHA class-II; Mitral: 96.55% NYHA class-I and 3.45% NYHA class-II; P < 0.001). There was no death in aortic valve replacement patients till 12-month. In mitral valve replacement patients, early mortalities occurred in three patients, and late mortality occurred in one patient; none of these were valve-related. Freedom from all-cause mortality reported was 93.33% at 12-month. Mean aortic pressure gradient decreased from 52.71 ± 24.47 mmHg [with 0.89 ± 0.70 cm2 effective orifice area (EOA)] pre-operatively to 14.49 ± 6.58 mmHg (EOA: 1.85 ± 0.27 cm2) at 12-month. Overall, the mitral mean pressure gradient and EOA were 4.41 ± 1.69 mmHg and 2.67 ± 0.48 cm2, respectively, at 12-month. Significant improvement (P < 0.05) in the patients’ quality of life was reported at all follow-ups. Conclusions The clinical safety and performance of the Dafodil pericardial bioprosthesis were favourable at 12-month. Moreover, a study with a larger patient population and longer follow-up is warranted to further assess the device. Trial registration Dafodil-1 trial has been prospectively registered on 10/07/2017 under Clinical Trial Registry-India ( http://www.ctri.nic.in ). (Registration number: CTRI/2017/07/009008 ).
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Hiremath et al. (2020) studied Aortic or mitral valvular disease requiring replacement (n=60). Dafodil pericardial bioprosthesis was evaluated on All-cause mortality free survival at 12 months (95% CI 90.0-98.3). The Dafodil pericardial bioprosthesis demonstrated favorable safety and performance at 12 months, with a 93.33% freedom from all-cause mortality and significant improvements in hemodynamics and NYHA functional class.
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