Outcomes of Aortic and Mitral Valve Replacement with Dafodil™ Pericardial Bioprosthesis over 5-Years: Dafodil™-1 Trial

Hiremath Shivalingaiah Channabasavaraj^1,2,3*Anil Jain⁴Anurag Garg⁵Atul Maslekar⁶Nirmal Gupta⁷Binay krishna Sarkar⁸Seetharama Bhat⁹Manish Porwal¹⁰Zile Singh Meharwal¹¹Yugal Kishore Mishra¹²Prashant Vaijyanath¹³Vijay Grover¹⁴Shiv Kumar Choudhary¹¹Subash S. Rajput¹⁵Rajan Sethuratnam¹⁶Naman Shastri¹⁷Chandrasekar Padmanabhan¹⁸Nityanand Tukaram Thakur¹⁹Chitranjan S. J²⁰Dhaval Naik²¹Vijay Kumar Gupta²²Anand Sancheti²³

• ¹Sri Madhusudan Sai Institute of Medical Sciences and Research, Sathya Sai Grama Muddenahalli, India
• ²Director, Heart Valve Bank & Academics CTVS Senior Consultant & Chief Cardiac Surgeon Sri Madhusudan Sai Institute of Medical Sciences and Research Sri Sathya Sai Sarala Memorial Hospital, Bengaluru, India
• ³Sri Sathya Sai Institute of Higher Medical Sciences, Bangalore, Bangalore, India
• ⁴Department of Cardiovascular and Thoracic Surgery, EPIC Hospital, Ahmedabad, India
• ⁵Dr D Y Patil Medical College Hospital and Research Centre, Pune, India
• ⁶Narayana Multispeciality Hospital, Ahmedabad, Ahmedabad, India
• ⁷Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
• ⁸Nilratan Sircar Medical College, Kolkata, India
• ⁹Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, India
• ¹⁰Convenient Hospitals Limited, Indore, India
• ¹¹Fortis Escorts Heart Institute and Research Centre, New Delhi, India
• ¹²Manipal Hospital, Delhi, Delhi, India
• ¹³Kovai Medical College and Hospital, Coimbatore, India, Coimbatore, India
• ¹⁴Dr. Ram Manohar Lohia Hospital, New Delhi, New Delhi, India
• ¹⁵Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, India
• ¹⁶The Madras Medical Mission, Chennai, India
• ¹⁷Epic Hospital , Ahmedabad, Ahmedabad, India
• ¹⁸G Kuppuswamy Naidu Memorial Hospital, Coimbatore, India
• ¹⁹Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals Department of Microbiology, Pune, India
• ²⁰Sri Sathya Sai Institute of Higher Medical Sciences Whitefield, Bengaluru, India
• ²¹Care Institute of Medical Sciences (CIMS), Ahmedabad, Ahmedabad, India
• ²²Indraprastha Apollo Hospitals New Delhi, New Delhi, India
• ²³NewEra Hospital & Research Institute, Nagpur, nagpur, India

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 hemolysis, 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.