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Safety of direct oral anticoagulants in surgical bioprosthetic heart valves: a paediatric institution’s experience

Published online by Cambridge University Press:  11 August 2025

Daniela Barisano ,
Gwen Nance ,
Michelle Gleason ,
Paul Chai ,
Michael P. Fundora ,
Gary Woods ,
Joshua M. Rosenblum  and
Joshua W. Branstetter Open the ORCID record for Joshua W. Branstetter [Opens in a new window]
Daniela Barisano
Affiliation:
Department of Pharmacy, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Gwen Nance
Affiliation:
Department of Pharmacy, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Michelle Gleason
Affiliation:
Information Services and Technology, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Paul Chai
Affiliation:
Division of Cardiothoracic Surgery, Children’s Healthcare of Atlanta and Emory University School of Medicine, Atlanta, GA, USA
Michael P. Fundora
Affiliation:
Department of Pediatric Cardiology, Children’s Healthcare of Atlanta and Emory University, Atlanta, GA, USA
Gary Woods
Affiliation:
Division of Pediatrics, Aflac Cancer and Blood Disorders Center and Emory University School of Medicine, Atlanta, GA, USA
Joshua M. Rosenblum
Affiliation:
Division of Cardiothoracic Surgery, Children’s Healthcare of Atlanta and Emory University School of Medicine, Atlanta, GA, USA
Joshua W. Branstetter*
Affiliation:
Department of Pharmacy, Children’s Healthcare of Atlanta, Atlanta, GA, USA
*
Corresponding author: Joshua Branstetter; Email: joshbranstetter09@gmail.com
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Abstract

Introduction:

Surgical pulmonary valve replacement is commonly required to palliate patients with CHD affecting the right ventricular outflow tract; however, concerns remain about mid- and long-term durability. Post-operative short-term anticoagulation has been hypothesised to improve valve durability.

Methods:

This is a single-centre, retrospective study of paediatric patients who underwent surgical pulmonary valve replacement and received a direct oral anticoagulant in addition to aspirin post heart valve insertion. The primary objective was a composite safety score consisting of clinically relevant non-major bleeding, major bleeding, bleeding-related readmission, and medication discontinuation.

Results:

The study analysed 34 patients with a median age 14 years (Interquartile range (IQR): 11, 15) and weight 45 kg (IQR: 35, 55). Ten patients met the composite endpoint (10/34, 29%), with 4 patients experiencing major bleeding (4/34, 12%), 6 experiencing clinically relevant non-major bleeding (6/34, 18%), and 3 patients being readmitted within 90 days of surgical pulmonary valve replacement for bleeding (3/29, 8.8%) resulting in 10 patients discontinuing medication early (10/34, 29%). Lower weight was identified as a significant risk factor for adverse event development (p = 0.04).

Conclusion:

We observed a higher overall bleeding rate, driven predominately by clinically relevant non-major bleeding events, than other studies using short-term anticoagulation after surgical pulmonary valve replacement. Additional studies should be aimed at evaluating the dosing and safety of direct oral anticoagulants in children in the post-operative period.

Keywords

direct oral anticoagulantsbioprosthetic valvechildrenpaediatricscardiothoracic surgery

Information

Type
Original Article
Information
Cardiology in the Young , Volume 35 , Issue 8 , August 2025 , pp. 1631 - 1636
Copyright
© The Author(s), 2025. Published by Cambridge University Press

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