Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis
Robert A. Niebler, MD,
Muhammad Shezad,
Mohammed Absi, MD,
Othman A. Aljohani, MD,
Shahnawaz Amdani, MD,
Scott Auerbach, MD,
David W. Bearl, MD,
Katerina Boucek, MD,
Holger Buchholz, MD,
Chesney Castleberry, MD,
John Dykes, MD,
Kevin Engelhardt, MD,
Joshua Friedland-Little, MD,
Kyle Hope, MD MS,
Mehreen Iqbal, MD,
Aamir Jeewa, MD,
Anna Joong, MD,
Angela Lorts, MD,
Lindsay May, MD,
Deepa Mokshagundam, MD,
Deipanjan Nandi, MD MSc,
Matthew O'Connor,
John J. Parent, MD,
David M. Peng, MD,
Natalie Shwaish, MD,
Svetlana B. Shugh, MD,
Christina VanderPluym, MD,
Gabrielle Vaughn, MD,
Mattew Zinn, DO
Affiliations
Robert A. Niebler, MD
Department of Pediatrics, Medical College of Wisconsin and Herma Heart Institute, Children’s Wisconsin, Milwaukee, Wisconsin; Corresponding author. Robert A. Niebler, MD, 9000 W. Wisconsin Ave. Suite 647, PO Box 1997 (MS 681), Milwaukee, WI 53201.
Muhammad Shezad
The Heart Institute Cincinnati Children's Hospital Medical Center; Cincinnati, Ohio
Mohammed Absi, MD
Le Bonheur Children’s Hospital, Memphis, Tennessee
Othman A. Aljohani, MD
Department of Pediatrics, University of California San Francisco and Benioff Children’s Hospital, San Francisco, California
Shahnawaz Amdani, MD
Children’s Institute Department of Heart, Vascular and Thoracic, Cleveland Clinic Children’s, Cleveland, Ohio
Scott Auerbach, MD
Chidren’s Hospital of Colorado, Denver, Colorado
David W. Bearl, MD
Department of Pediatric Cardiology, Monroe Carrel Jr. Children’s Hospital at Vanderbilt, Nashville, Tennessee
Katerina Boucek, MD
Department of Cardiology, Ochsner Hospital for Children, New Orleans, Louisiana
Holger Buchholz, MD
Department of Cardiology, University of Alberta, Edmonton, Alberta, Canada
Chesney Castleberry, MD
Department of Pediatric Cardiology, University of Texas-Austin, Austin, Texas
John Dykes, MD
Department of Cardiology, Lucile Packard Children’s Hospital and Stanford University, Palo Alto, California
Kevin Engelhardt, MD
Department of Pediatrics, University of Arizona COM Phoenix and Phoenix Children’s Hospital, Phoenix, Arizona
Joshua Friedland-Little, MD
Department of Pediatric Cardiology, Seattle Children’s Hospital, Seattle, Washington
Kyle Hope, MD MS
Lillie Frank Abercrombie Division of Pediatric Cardiology, Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas
Mehreen Iqbal, MD
Department of Pediatric Cardiology, University of Texas-Southwestern, Dallas, Texas
Aamir Jeewa, MD
Department of Pediatric Cardiology, University of Toronto and the Hospital for Sick Children, Toronto, Ontario, Canada
Anna Joong, MD
Division of Pediatric Cardiology, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago, Illinois
Angela Lorts, MD
The Heart Institute Cincinnati Children's Hospital Medical Center; Cincinnati, Ohio
Lindsay May, MD
University or Utah and Primary Children’s Hospital, Salt Lake City, Utah
Deepa Mokshagundam, MD
Division of Pediatric Cardiology, Washington University and St. Louis Children’s Hospital, St. Louis, Missouri
Deipanjan Nandi, MD MSc
Department of Cardiology, Nationwide Children’s Hospital, Columbus, Ohio
Matthew O'Connor
Children's Hospital of Philadelphia, Wynnewood, Pennsylvania
John J. Parent, MD
Department of Pediatrics, Indiana University School of Medicine and Riley Children’s Hospital, Indianapolis, Indiana
David M. Peng, MD
Congenital Heart Center at Mott Children’s Hospital, University of Michigan, Ann Arbor, Michigan
Natalie Shwaish, MD
Department of Pediatrics, Loma Linda University, Loma Linda, California
Svetlana B. Shugh, MD
Heart Institute, Joe DeMaggio Children’s Hospital, Hollywood, Florida
Christina VanderPluym, MD
Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts
Gabrielle Vaughn, MD
Department of Pediatrics, University of California San Diego and Rady Children’s Hospital, San Diego, California
Mattew Zinn, DO
University of Pittsburgh School of Medicine; Pittsburgh, Pennsylvania
Background: The HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The study aims to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device (VAD) utilization and outcomes. Methods: The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry was queried for type of VAD utilization and outcomes/adverse event rates in patients with a body surface area of 0.7 to 1.4 m2. Results were compared from before and after July 2021. All patients in the registry implanted with an HVAD were reported to determine overall outcomes of these patients and define who remains on the device. Results: The HeartMate 3 (HM3) primarily replaced the HVAD in pediatric patients increasing from 29 of 258 (11%) of implants before July 2021 to 31 of 109 (29%) of implants after. A small increase in the use of the Berlin Heart EXCOR (40 of 258, 16% before to 20 of 109, 18% after) and paracorporeal continuous flow devices (116 of 258, 45% before to 58 of 109, 53% after) was also observed. The rate of ischemic stroke increased in the overall population and a decrease in bleeding complications in the EXCOR group was observed. Of the 187 pediatric patients implanted with an HVAD in the registry, 7 patients remain supported, 1 patient transitioned from the HVAD to an HM3, and 6 patients were lost to follow-up. Conclusions: The HM3 has been the primary replacement for the HVAD in the medium-sized pediatric population. The rate of ischemic stroke was higher after July 2021.
