Surgical atrioventricular valve replacement with melody valve in infants and children

A multicenter study

Francesca R. Pluchinotta, Breanna L. Piekarski, Valentina Milani, Oliver Kretschmar, Phillip T. Burch, Lale Hakami, David B. Meyer, Frederic Jacques, Olivier Ghez, Matteo Trezzi, Adriano Carotti, Shakeel A. Qureshi, Ina Michel-Behnke, James M Hammel, Paul Chai, David McMullan, Bret Mettler, Queralt Ferrer, Mario Carminati, Sitaram M. Emani

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Article numbere007145
JournalCirculation: Cardiovascular Interventions
Volume11
Issue number11
DOIs
StatePublished - Jan 1 2018

Fingerprint

Surgical Instruments
Multicenter Studies
Prostheses and Implants
Catheters
Pediatrics
Equipment Design
Ventricular Outflow Obstruction
Jugular Veins
Heart Transplantation
North America
Reoperation
Catheterization
Cohort Studies
Retrospective Studies
Transplantation
Clinical Trials
Transplants

Keywords

  • Bioprosthetic valve
  • Heart valve prosthesis implantation
  • Mitral valve
  • Pediatrics
  • Tricuspid valve

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Pluchinotta, F. R., Piekarski, B. L., Milani, V., Kretschmar, O., Burch, P. T., Hakami, L., ... Emani, S. M. (2018). Surgical atrioventricular valve replacement with melody valve in infants and children: A multicenter study. Circulation: Cardiovascular Interventions, 11(11), [e007145]. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007145

Surgical atrioventricular valve replacement with melody valve in infants and children : A multicenter study. / Pluchinotta, Francesca R.; Piekarski, Breanna L.; Milani, Valentina; Kretschmar, Oliver; Burch, Phillip T.; Hakami, Lale; Meyer, David B.; Jacques, Frederic; Ghez, Olivier; Trezzi, Matteo; Carotti, Adriano; Qureshi, Shakeel A.; Michel-Behnke, Ina; Hammel, James M; Chai, Paul; McMullan, David; Mettler, Bret; Ferrer, Queralt; Carminati, Mario; Emani, Sitaram M.

In: Circulation: Cardiovascular Interventions, Vol. 11, No. 11, e007145, 01.01.2018.

Research output: Contribution to journalArticle

Pluchinotta, FR, Piekarski, BL, Milani, V, Kretschmar, O, Burch, PT, Hakami, L, Meyer, DB, Jacques, F, Ghez, O, Trezzi, M, Carotti, A, Qureshi, SA, Michel-Behnke, I, Hammel, JM, Chai, P, McMullan, D, Mettler, B, Ferrer, Q, Carminati, M & Emani, SM 2018, 'Surgical atrioventricular valve replacement with melody valve in infants and children: A multicenter study', Circulation: Cardiovascular Interventions, vol. 11, no. 11, e007145. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007145
Pluchinotta, Francesca R. ; Piekarski, Breanna L. ; Milani, Valentina ; Kretschmar, Oliver ; Burch, Phillip T. ; Hakami, Lale ; Meyer, David B. ; Jacques, Frederic ; Ghez, Olivier ; Trezzi, Matteo ; Carotti, Adriano ; Qureshi, Shakeel A. ; Michel-Behnke, Ina ; Hammel, James M ; Chai, Paul ; McMullan, David ; Mettler, Bret ; Ferrer, Queralt ; Carminati, Mario ; Emani, Sitaram M. / Surgical atrioventricular valve replacement with melody valve in infants and children : A multicenter study. In: Circulation: Cardiovascular Interventions. 2018 ; Vol. 11, No. 11.
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abstract = "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.",
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T1 - Surgical atrioventricular valve replacement with melody valve in infants and children

T2 - A multicenter study

AU - Pluchinotta, Francesca R.

AU - Piekarski, Breanna L.

AU - Milani, Valentina

AU - Kretschmar, Oliver

AU - Burch, Phillip T.

AU - Hakami, Lale

AU - Meyer, David B.

AU - Jacques, Frederic

AU - Ghez, Olivier

AU - Trezzi, Matteo

AU - Carotti, Adriano

AU - Qureshi, Shakeel A.

AU - Michel-Behnke, Ina

AU - Hammel, James M

AU - Chai, Paul

AU - McMullan, David

AU - Mettler, Bret

AU - Ferrer, Queralt

AU - Carminati, Mario

AU - Emani, Sitaram M.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Bioprosthetic valve

KW - Heart valve prosthesis implantation

KW - Mitral valve

KW - Pediatrics

KW - Tricuspid valve

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