Partial heart transplantation for pediatric heart valve dysfunction: A clinical trial protocol

Congenital heart defects are the most common type of birth defects in humans and frequently involve heart valve dysfunction. The current treatment for unrepairable heart valves involves valve replacement with an implant, Ross pulmonary autotransplantation, or conventional orthotopic heart transplant...

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Bibliographic Details
Published in:	PloS one 2023-02, Vol.18 (2), p.e0280163-e0280163
Main Authors:	Rajab, Taufiek Konrad, Ochoa, Brielle, Zilinskas, Kasparas, Kwon, Jennie, Taylor, Carolyn L, Henderson, Heather T, Savage, Andrew J, Kavarana, Minoo, Turek, Joseph W, Costello, John M
Format:	Article
Language:	eng
Subjects:	Adolescent Adult Antibiotics Aortic Valve - surgery Autopsies Biology and Life Sciences Birth defects Care and treatment Child Child, Preschool Children Clinical trials Congenital defects Congenital heart disease Consent Diseases Durability Engineering and Technology Guardians Health aspects Health risks Heart Heart diseases Heart Transplantation Heart transplants Heart valve diseases Heart Valve Prosthesis Implantation Heart valves Heart Valves - surgery Humans Hypotheses Immunosuppression Immunotherapy Infant Infant, Newborn Infants Medicine and Health Sciences Neonates Organ transplant recipients Patient outcomes Pediatrics Prospective Studies Pulmonary Valve - transplantation Risk management Study Protocol Transplantation Transplantation, Homologous Transplants Treatment Outcome Ventricle
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Summary:	Congenital heart defects are the most common type of birth defects in humans and frequently involve heart valve dysfunction. The current treatment for unrepairable heart valves involves valve replacement with an implant, Ross pulmonary autotransplantation, or conventional orthotopic heart transplantation. Although these treatments are appropriate for older children and adults, they do not result in the same efficacy and durability in infants and young children for several reasons. Heart valve implants do not grow with the. Ross pulmonary autotransplants have a high mortality rate in neonates and are not feasible if the pulmonary valve is dysfunctional or absent. Furthermore, orthotopic heart transplants invariably fail from ventricular dysfunction over time. Therefore, the treatment of irreparable heart valves in infants and young children remains an unsolved problem. The objective of this single-arm, prospective study is to offer an alternative solution based on a new type of transplant, which we call "partial heart transplantation." Partial heart transplantation differs from conventional orthotopic heart transplantation because only the part of the heart containing the heart valve is transplanted. Similar to Ross pulmonary autotransplants and conventional orthotopic heart transplants, partial heart transplants contain live cells that should allow it to grow with the recipient child. Therefore, partial heart transplants will require immunosuppression. The risks from immunosuppression can be managed, as seen in conventional orthotopic heart transplant recipients. Stopping immunosuppression will simply turn the growing partial heart transplant into a non-growing homovital homograft. Once this homograft deteriorates, it can be replaced with a durable adult-sized mechanical implant. The protocol for our single-arm trial is described. The ClinicalTrials.gov trial registration number is NCT05372757.
ISSN:	1932-6203 1932-6203