Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial

Abstract Objectives Our aim was to assess midterm safety and clinical outcomes of intracoronary infusion of cardiosphere-derived cells (CDCs) after staged palliation in patients with hypoplastic left heart syndrome (HLHS). Methods In this prospective, controlled study, 14 consecutive patients with H...

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Published in:The Journal of thoracic and cardiovascular surgery 2015-11, Vol.150 (5), p.1198-1208.e2
Main Authors: Tarui, Suguru, MD, Ishigami, Shuta, MD, Ousaka, Daiki, RDCS, Kasahara, Shingo, MD, PhD, Ohtsuki, Shinichi, MD, PhD, Sano, Shunji, MD, PhD, Oh, Hidemasa, MD, PhD
Format: Article
Language:English
Subjects:
Age Factors
Cardiac Catheterization
cardiosphere
Cardiothoracic Surgery
Cells, Cultured
Child Development
Child, Preschool
congenital heart disease
Feasibility Studies
Female
Fontan Procedure
heart failure
Heart Failure - etiology
Heart Failure - physiopathology
Heart Failure - prevention & control
Humans
hypoplastic left heart syndrome
Hypoplastic Left Heart Syndrome - complications
Hypoplastic Left Heart Syndrome - diagnosis
Hypoplastic Left Heart Syndrome - physiopathology
Hypoplastic Left Heart Syndrome - surgery
Infant
Infant, Newborn
Japan
Male
Palliative Care
Prospective Studies
Recovery of Function
Risk Factors
stem cell therapy
Stem Cell Transplantation - adverse effects
Stem Cell Transplantation - methods
Stroke Volume
Time Factors
Treatment Outcome
Ventricular Function, Right
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Summary:Abstract Objectives Our aim was to assess midterm safety and clinical outcomes of intracoronary infusion of cardiosphere-derived cells (CDCs) after staged palliation in patients with hypoplastic left heart syndrome (HLHS). Methods In this prospective, controlled study, 14 consecutive patients with HLHS who were undergoing 2- or 3-stage surgical palliations were assigned to receive intracoronary CDC infusion 1 month after cardiac surgery (n = 7), followed by 7 patients allocated to a control group with standard care alone. The primary end point was to assess procedural feasibility and safety; the secondary end point was to evaluate cardiac function and heart failure status through 36-month follow-up. Results No complications, including tumor formation, were reported within 36 months after CDC infusion. Echocardiography showed significantly greater improvement in right ventricular ejection fraction (RVEF) in infants receiving CDCs than in controls at 36 months (+8.0% ± 4.7% vs +2.2% ± 4.3%; P  = .03). These cardiac function improvements resulted in reduced brain natriuretic peptide levels ( P  = .04), lower incidence of unplanned catheter interventions ( P  = .04), and higher weight-for-age z score ( P  = .02) at 36 months relative to controls. As independent predictors of treatment responsiveness, absolute changes in RVEF at 36 months were negatively correlated with age, weight-for-age z score, and RVEF at CDC infusion. Conclusions Intracoronary CDC infusion after staged procedure in patients with HLHS is safe and improves RVEF, which persists during 36-month follow-up. This therapeutic strategy may enhance somatic growth and reduce incidence of heart failure.
ISSN:0022-5223
1097-685X
DOI:10.1016/j.jtcvs.2015.06.076