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Clinical Trial
. 2020 Jun 15;15(1):140.
doi: 10.1186/s13019-020-01154-7.

Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial

C S Hiremath  1 , Anil R Jain  2 , Anurag Garg  3 , Nirmal Gupta  4 , Yugal K Mishra  5 , Zile Singh Meharwal  6 , Nityanand Thakur  7 , Atul A Maslekar  8 , Naman Shastri  9
Affiliations
Clinical Trial

Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial

C S Hiremath et al. J Cardiothorac Surg. .

Abstract

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).

Keywords: Aortic valve; Bioprosthesis; Heart valve prosthesis implantation; Hemodynamic performance; Mitral valve; Quality of life.

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Conflict of interest statement

All the authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic of Dafodil™ aortic pericardial bioprosthesis
Fig. 2
Fig. 2
(a) Distribution of NYHA functional class among patients implanted with aortic bioprosthesis at pre-procedure, and post-procedure till 12-month; (b) Distribution of NYHA functional class among patients implanted with mitral bioprosthesis at pre-procedure, and post-procedure till 12-month
Fig. 3
Fig. 3
(a) Outcomes of PCS and MCS scores of SF12v1 at pre-procedure, and post-procedure till 12-month in AVR group (b) Outcomes of PCS and MCS scores of SF12v1 at pre-procedure, and post-procedure till 12-month in MVR group
Fig. 4
Fig. 4
(a) Aortic valve hemodynamic performance among patients implanted with aortic bioprosthesis at pre-procedure, and post-procedure till 12-month; (b) Mitral valve hemodynamic performance among patients implanted with mitral bioprosthesis at pre-procedure, and post-procedure till 12-month
Fig. 5
Fig. 5
(a) Aortic regurgitation among patients implanted with aortic bioprosthesis at pre-procedure, and post-procedure till 12-month; (b) Mitral regurgitation among patients implanted with mitral bioprosthesis at pre-procedure, and post-procedure till 12-month
See this image and copyright information in PMC

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