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Surgical Atrioventricular Valve Replacement With Melody Valve in Infants and Children.

  • Pluchinotta FR Department of Pediatric Cardiology and Adult Congenital Heart Disease, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milan, Italy (F.R.P., M.C.).
  • Piekarski BL Department of Cardiac Surgery, Boston Children's Hospital, MA (B.L.P.).
  • Milani V Department of Cardiology and Cardiac Surgery, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milan, Italy (V.M., S.M.E.).
  • Kretschmar O Department of Pediatric Cardiology, University Children's Hospital Zurich, Switzerland (O.K.).
  • Burch PT Department of Cardiothoracic Surgery, Cook Children's Medical Center, Fort Worth, TX (P.T.B.).
  • Hakami L Department of Heart Surgery, Medical Center of the University of Munich, Germany (L.H.).
  • Meyer DB Division of Cardiothoracic Surgery, Cohen Children's Medical Center, New Hyde Park, NY (D.B.M.).
  • Jacques F Department of Cardiology and Cardiac Surgery, Centre mère-enfant Soleil, CHU de Québec, Service of Cardiac Surgery, Canada (F.J.).
  • Ghez O Department of Cardiac Surgery, Royal Brompton Hospital, London, England (O.G.).
  • Trezzi M Department of Pediatric Cardiac Surgery, Bambino Gesù Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy (M.T., A.C.).
  • Carotti A Department of Pediatric Cardiac Surgery, Bambino Gesù Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy (M.T., A.C.).
  • Qureshi SA Department of Cardiology and Cardiac Surgery, Evelina London Children's Hospital, England (S.A.Q.).
  • Michel-Behnke I Division of Pediatric Cardiology, Pediatric Heart Center Vienna, University Clinic for Pediatrics and Adolescent Medicine, Medical University of Vienna, Austria (I.M.-B.).
  • Hammel JM Department of Cardiothoracic Surgery, Children's Hospital and Medical Center, Omaha, NE (J.M.H.).
  • Chai P Department of Cardiac Surgery, New York-Presbyterian Morgan Stanley Children's Hospital (P.C.).
  • McMullan D Department of Cardiac Surgery, Seattle Children's Hospital, WA (D.M.).
  • Mettler B Division of Pediatric Cardiac Surgery, Vanderbilt University Medical Center, Nashville, TN (B.M.).
  • Ferrer Q Department of Pediatric Cardiology and Pediatric Cardiac Surgery, University Hospital Vall d'Hebron, Barcelona, Spain (Q.F.).
  • Carminati M Department of Pediatric Cardiology and Adult Congenital Heart Disease, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milan, Italy (F.R.P., M.C.).
  • Emani SM Department of Cardiology and Cardiac Surgery, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milan, Italy (V.M., S.M.E.).
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  • 2018-12-21
Published in:
  • Circulation. Cardiovascular interventions. - 2018
bioprosthetic valve
heart valve prosthesis implantation
mitral valve
pediatrics
tricuspid valve
Adolescent
Age Factors
Bioprosthesis
Child
Child, Preschool
Echocardiography, Doppler, Color
Europe
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Hemodynamics
Humans
Infant
Infant, Newborn
Male
Mitral Valve
Mitral Valve Prolapse
Mitral Valve Stenosis
North America
Postoperative Complications
Prosthesis Design
Recovery of Function
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
English Background Pediatric patients with atrioventricular valve disease have limited options for prosthetic valve replacement in sizes <15 mm. Based on successful experience with the stented bovine jugular vein graft (Melody valve) in the right ventricular outflow tract, the prosthesis has been modified for surgical valve replacement in pediatric patients with atrioventricular dysfunction with the intention of subsequent valve expansion in the catheterization laboratory as the child grows. Methods and Results A multicenter, retrospective cohort study was performed among patients who underwent atrioventricular valve replacement with Melody valve at 17 participating sites from North America and Europe, including 68 patients with either mitral (n=59) or tricuspid (n=9) replacement at a median age of 8 months (range, 3 days to 13 years). The median size at implantation was 14 mm (range, 9-24 mm). Immediately postoperatively, the valve was competent with low gradients in all patients. Fifteen patients died; 3 patients underwent transplantation. Nineteen patients required reoperation for adverse outcomes, including valve explantation (n=16), left ventricular outflow tract obstruction (n=1), permanent pacemaker implantation (n=1), and paravalvular leak repair (n=1). Twenty-five patients underwent 41 episodes of catheter-based balloon expansion, exhibiting a significant decrease in median gradient ( P<0.001) with no significant increase in grade of regurgitation. Twelve months after implantation, cumulative incidence analysis indicated that 55% of the patients would be expected to be free from death, heart transplantation, structural valve deterioration, or valve replacement. Conclusions The Melody valve is a feasible option for surgical atrioventricular valve replacement in patients with hypoplastic annuli. The prosthesis shows acceptable short-term function and is amenable to catheter-based enlargement as the child grows. However, patients remain at risk for mortality and structural valve deterioration, despite adequate early valvular function. Device design and implantation techniques must be refined to reduce complications and extend durability. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02505074.
Language
  • English
Open access status
green
Identifiers
Persistent URL
https://sonar.ch/global/documents/48037
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