Evidence map›Paper›PMID 41584284›Full record

ArticleFrontiers in cardiovascular medicine2025

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

Channabasavaraj Shivalingaiah Hiremath, Anil Jain, Anurag Garg, Atul Maslekar, Nirmal Gupta, Binay Krishna Sarkar, Seetharama Bhat, Manish Porwal, Zile Singh Meharwal, Yugal Kishore Mishra and 12 more

Abstract read
In one paragraph

Article in Frontiers in cardiovascular medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

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4 · The record

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5 · Who and what money

Authors and funding

22 authors.

Channabasavaraj Shivalingaiah HiremathSri Madhusudan Sai Institute of Medical Sciences and Research, Sri Sathya Sai Sarala Memorial Hospital, Sathya Sai Grama, Muddenahalli, Chikkaballapur, India.
Anil JainDepartment of Cardiovascular and Thoracic Surgery, EPIC Hospital, Ahmedabad, India.
Anurag GargDepartment of Cardiothoracic Surgery, Dr. D.Y. Patil Medical College & Hospital & Research Centre, Pune, India.
Atul MaslekarDepartment of Cardiothoracic and Vascular Surgery, Narayana Multispeciality Hospital, Ahmedabad, India.
Nirmal GuptaDepartment of Cardiovascular and Thoracic Surgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Binay Krishna SarkarDepartment of Cardiothoracic and Vascular Surgery, Nil Ratan Sircar Medical College & Hospital, Kolkata, India.
Seetharama BhatDepartment of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bangalore, India.
Manish PorwalDepartment of Cardiothoracic Surgery, Convenient Hospitals Limited (CHL), Indore, India.
Zile Singh MeharwalDepartment of Cardiothoracic and Vascular Surgery, Fortis Escorts Heart Institute, New Delhi, India.
Yugal Kishore MishraDepartment of Cardiothoracic and Vascular Surgery, Manipal Hospital, Delhi, India.
Prashant VaijyanathDepartment of Cardiothoracic Surgery, Kovai Medical College and Hospital, Coimbatore, India.
Vijay GroverDepartment of Cardiothoracic and Vascular Surgery, Dr. Ram Manohar Lohia Hospital, New Delhi, India.
Shiv Kumar ChaudharyDepartment of Cardiothoracic and Vascular Surgery, Fortis Escorts Heart Institute, New Delhi, India.
Subash S RajputDepartment of Cardiothoracic and Vascular Surgery, Ram Manohar Lohia Institute of Medical Sciences, Lucknow, India.
Rajan SethuratnamDepartment of Cardiac Surgery, The Madras Medical Mission Hospital, Chennai, India.
Naman ShastriDepartment of Cardiovascular and Thoracic Surgery, EPIC Hospital, Ahmedabad, India.
Chandrasekar PadmanabhanDivision of Cardiothoracic Surgery, G Kuppuswamy Naidu Memorial Hospital, Coimbatore, India.
Nityanand Tukaram ThakurDepartment of Cardiothoracic Surgery, B.J.Govt. Medical College & Sassoon General Hospitals, Pune, India.
Chittaranjan S JSri Madhusudan Sai Institute of Medical Sciences and Research, Sri Sathya Sai Sarala Memorial Hospital, Sathya Sai Grama, Muddenahalli, Chikkaballapur, India.
Dhaval NaikCardiac & Heart Transplant Surgery, Care Institute of Medical Sciences (CIMS), Ahmedabad, India.
Vijay Kumar GuptaDepartment of Cardiothoracic & Vascular Surgery, Apollo, Delhi, India.
Anand SanchetiCardiothoracic and Vascular Surgery, New Era Hospital & Research Institute, Nagpur, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 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.

Indexed as

aortic valveheart valve prosthesis implantationmitral valvepericardial bioprosthesisquality of lifevalvular heart disease

Identifiers

PMID41584284
PMCPMC12828671

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