Outcomes of aortic and mitral valve replacement with Dafodil™ pericardial bioprosthesis over 5-years: Dafodil™-1 trial
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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 cm 2 to 1.72 ± 0.52 cm 2 ( p < 0.001). In the MVR group, the indexed EOA improved from 0.68 ± 0.4 cm 2 /m 2 to 1.28 ± 0.39 cm 2 /m 2 ( 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.
Authors: Channabasavaraj Shivalingaiah Hiremath, Anil Jain, Anurag Garg, Atul Maslekar, Nirmal Gupta, Binay Krishna Sarkar, Seetharama Bhat, Manish Porwal, Zile Singh Meharwal, Yugal Kishore Mishra, Prashant Vaijyanath, Vijay Grover, Shiv Kumar Chaudhary, Subash. S. Rajput, Rajan Sethuratnam, Naman Shastri, Chandrasekar Padmanabhan, Nityanand Tukaram Thakur, Chittaranjan S. J., Dhaval Naik, Vijay Kumar Gupta, Anand Sancheti
Institutions: Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Nil Ratan Sircar Medical College and Hospital, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Fortis Escorts Heart Institute, Kovai Medical Center and Hospital, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, Dr. Ram Manohar Lohia Institute of Medical Sciences, Madras Medical Mission, G. Kuppuswamy Naidu Memorial Hospital, B. J. Medical College & Sassoon Hospital, Care Institute of Medical Sciences
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
Funder: Meril Life Sciences
OpenAlex ID: W7119539144