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Mitral Valve Replacement in Infants and Children: Five-Year Outcomes of the HALO Clinical Trial

Fawwaz R Shaw1, Brian Kogon2, Jonathan Chen3

  • 1Department of Cardiothoracic Surgery, Children's Healthcare of Atlanta/Emory University, Atlanta, Georgia.

The Annals of Thoracic Surgery
|May 16, 2024
PubMed

Insights

Mitral valve replacement in infants using the 15-mm St Jude mechanical valve showed acceptable hemodynamics but carried significant risks. Avoid low-molecular-weight heparin for anticoagulation in pediatric patients, as valve replacement is often necessary.

Area of Science:

  • Cardiology
  • Pediatric Cardiac Surgery
  • Biomedical Engineering

Background:

  • Mitral valve disease in children often necessitates surgical intervention.
  • While repair is preferred, mitral valve replacement (MVR) is sometimes required for pediatric patients.
  • This study evaluates the 15-mm St Jude mechanical mitral valve in a pediatric population.

Purpose of the Study:

  • To assess the safety and efficacy of the 15-mm St Jude mechanical mitral valve in pediatric patients undergoing MVR.
  • To report outcomes including mortality, complications, and reinterventions in this cohort.
  • To provide insights into anticoagulation strategies for pediatric MVR patients.

Main Methods:

  • A multi-institutional Investigational Device Exemption trial.
  • 23 children (mean age 7.8 months) received the 15-mm St Jude mechanical mitral valve.
  • 100% complete follow-up was achieved for all patients.

Main Results:

  • The 15-mm St Jude mechanical mitral valve demonstrated satisfactory hemodynamics in small children.
  • The 1- and 5-year freedom from death or valve explantation was 71.0%.
  • Complications included 6 deaths (all within 12 months, none valve-related), 4 pacemaker insertions, 3 thromboses requiring explantation, and 5 bleeding events.

Conclusions:

  • The 15-mm St Jude mechanical mitral valve offers satisfactory hemodynamics for pediatric MVR.
  • Mortality and complication rates in this high-risk pediatric group are significant.
  • Low-molecular-weight heparin should be avoided as primary anticoagulation; eventual valve replacement is likely.
Abstract

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