학술논문
Bilateral remote ischemic conditioning in children: A two-center, double-blind, randomized controlled trial in young children undergoing cardiac surgeryCentral MessagePerspective
Document Type
article
Author
Nigel E. Drury, PhD, FRCS(CTh); Carin van Doorn, MD, FRCS(CTh); Rebecca L. Woolley, MSc; Rebecca J. Amos-Hirst, MSc; Rehana Bi, BSc(Hons); Collette M. Spencer, BSc(Hons); Kevin P. Morris, MD, FRCPCH; James Montgomerie, MD, FRCA; John Stickley, BSc; Adrian Crucean, MD; Alicia Gill, MSc; Matt Hill, MSc; Ralf J.M. Weber, PhD; Lukas Najdekr, PhD; Andris Jankevics, PhD; Andrew D. Southam, PhD; Gavin R. Lloyd, PhD; Osama Jaber, MD; Imre Kassai, PhD; Giuseppe Pelella, MD; Natasha E. Khan, MD, FRCS(CTh); Phil Botha, PhD, FRCS(CTh); David J. Barron, MD, FRCS(CTh); Melanie Madhani, PhD; Warwick B. Dunn, PhD; Natalie J. Ives, MSc; Paulus Kirchhof, MD; Timothy J. Jones, MD, FRCS(CTh); Edmund D. Carver; Alistair J. Cranston; Fraser Harban; Vasco Laginha Rolo; Ritchie Marcus; Anthony Moriarty; Raju Reddy; Susanna N. Ritchie-McLean; Monica A. Stokes; Ayngara Thillaivasan; Nandlal Bhatia; Carol Bodlani; Wendy Lim; Joe Mellor; Jutta Scheffczik
Source
JTCVS Open, Vol 18, Iss , Pp 193-208 (2024)
Subject
Language
English
ISSN
2666-2736
Abstract
Objective: The study objective was to determine whether adequately delivered bilateral remote ischemic preconditioning is cardioprotective in young children undergoing surgery for 2 common congenital heart defects with or without cyanosis. Methods: We performed a prospective, double-blind, randomized controlled trial at 2 centers in the United Kingdom. Children aged 3 to 36 months undergoing tetralogy of Fallot repair or ventricular septal defect closure were randomized 1:1 to receive bilateral preconditioning or sham intervention. Participants were followed up until hospital discharge or 30 days. The primary outcome was area under the curve for high-sensitivity troponin-T in the first 24 hours after surgery, analyzed by intention-to-treat. Right atrial biopsies were obtained in selected participants. Results: Between October 2016 and December 2020, 120 eligible children were randomized to receive bilateral preconditioning (n = 60) or sham intervention (n = 60). The primary outcome, area under the curve for high-sensitivity troponin-T, was higher in the preconditioning group (mean: 70.0 ± 50.9 μg/L/h, n = 56) than in controls (mean: 55.6 ± 30.1 μg/L/h, n = 58) (mean difference, 13.2 μg/L/h; 95% CI, 0.5-25.8; P = .04). Subgroup analyses did not show a differential treatment effect by oxygen saturations (pinteraction = .25), but there was evidence of a differential effect by underlying defect (pinteraction = .04). Secondary outcomes and myocardial metabolism, quantified in atrial biopsies, were not different between randomized groups. Conclusions: Bilateral remote ischemic preconditioning does not attenuate myocardial injury in children undergoing surgical repair for congenital heart defects, and there was evidence of potential harm in unstented tetralogy of Fallot. The routine use of remote ischemic preconditioning cannot be recommended for myocardial protection during pediatric cardiac surgery.