Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials

Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.

Abstract

Objectives: To investigate whether age and valve size at implant contribute to outcomes after Melody transcatheter pulmonary valve replacement (TPVR).

Background: Patient age and valve size at implant contribute to longevity of surgical pulmonary valves.

Methods: All patients discharged with a Melody valve in the pulmonary position, as part of three prospective Melody valve multicenter studies, comprised the study cohort. Acute and time-related outcomes were analyzed according to age: children (≤12 years), adolescents (13-18 years), young adults (19-29 years), and older adults (≥30 years).

Results: Successful Melody valve implantation occurred in 49 children, 107 adolescents, 96 young adults, and 57 older adults. Pediatric patients (≤18 years) were more likely to have TPVR for conduit stenosis than adults (62% vs. 44%); children had the smallest conduits. After TPVR, pediatric and adult patients had similar decreases in right ventricular (RV) size by MRI, but adults had improved percentage predicted peak VO2 (58% preimplant to 64% postimplant, p = .02) and FEV1 (69% pre to 71% post, p = .005). Younger age was associated with shorter freedom from RVOT dysfunction, reintervention, and explant. Children had the shortest freedom from endocarditis (p = .041), but all other groups had 5-year freedom from endocarditis of ≥90%.

Conclusions: Younger age was associated with shorter time to RVOT dysfunction, reintervention, and explant after Melody TPVR. Patients ≥13 years of age were at low risk for endocarditis and explant to 5 years. A better understanding of time-related outcomes by age will aid in the comparison of therapeutic options for TPVR candidates.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT00740870 (NCT00740870), https://clinicaltrials.gov/ct2/show/NCT01186692 (NCT01186692), and https://clinicaltrials.gov/ct2/show/NCT00688571 (NCT00688571).

Keywords: TPVR; tetralogy of Fallot.

MeSH terms

  • Adolescent
  • Age Factors
  • Canada
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Child
  • Clinical Trials as Topic
  • Databases, Factual
  • Device Removal
  • Endocarditis / etiology
  • Endocarditis / physiopathology
  • Endocarditis / surgery
  • Europe
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Humans
  • Male
  • Progression-Free Survival
  • Prosthesis Design
  • Prosthesis Failure
  • Pulmonary Valve / diagnostic imaging
  • Pulmonary Valve / physiopathology
  • Pulmonary Valve / surgery*
  • Reoperation
  • Risk Factors
  • Time Factors
  • United States
  • Ventricular Outflow Obstruction / etiology
  • Ventricular Outflow Obstruction / physiopathology
  • Ventricular Outflow Obstruction / surgery
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT00740870
  • ClinicalTrials.gov/NCT01186692
  • ClinicalTrials.gov/NCT00688571

Grants and funding