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

Suguru Tarui, Shuta Ishigami, Daiki Ousaka, Shingo Kasahara, Shin-ichi Ohtsuki, Shunji Sano, Hidemasa Oh

Research output: Contribution to journalArticle

50 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1198-1207
Number of pages10
JournalJournal of Thoracic and Cardiovascular Surgery
Volume150
Issue number5
DOIs
Publication statusPublished - Nov 1 2015

Fingerprint

Hypoplastic Left Heart Syndrome
Stem Cells
Stroke Volume
Heart Failure
Safety
Weights and Measures
Brain Natriuretic Peptide
Incidence
Thoracic Surgery
Echocardiography
Catheters
Prospective Studies
Control Groups
Therapeutics
Growth
Neoplasms

Keywords

  • cardiosphere
  • congenital heart disease
  • heart failure
  • hypoplastic left heart syndrome
  • stem cell therapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

@article{15ffdc3bf48d46e38c0fef3378c14bfa,
title = "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 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.",
keywords = "cardiosphere, congenital heart disease, heart failure, hypoplastic left heart syndrome, stem cell therapy",
author = "Suguru Tarui and Shuta Ishigami and Daiki Ousaka and Shingo Kasahara and Shin-ichi Ohtsuki and Shunji Sano and Hidemasa Oh",
year = "2015",
month = "11",
day = "1",
doi = "10.1016/j.jtcvs.2015.06.076",
language = "English",
volume = "150",
pages = "1198--1207",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome

T2 - Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients with Single-Ventricle Physiology (TICAP) trial

AU - Tarui, Suguru

AU - Ishigami, Shuta

AU - Ousaka, Daiki

AU - Kasahara, Shingo

AU - Ohtsuki, Shin-ichi

AU - Sano, Shunji

AU - Oh, Hidemasa

PY - 2015/11/1

Y1 - 2015/11/1

N2 - 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.

AB - 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.

KW - cardiosphere

KW - congenital heart disease

KW - heart failure

KW - hypoplastic left heart syndrome

KW - stem cell therapy

UR - http://www.scopus.com/inward/record.url?scp=84948714563&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84948714563&partnerID=8YFLogxK

U2 - 10.1016/j.jtcvs.2015.06.076

DO - 10.1016/j.jtcvs.2015.06.076

M3 - Article

C2 - 26232942

AN - SCOPUS:84948714563

VL - 150

SP - 1198

EP - 1207

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 5

ER -