Valvular & structural heart diseaseCohort study
Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Implant in Patients Weighing ≤30 kg
- Retrospective multicentre registry cohort study
- 10 centres
Authors' conclusion
In this large multicenter study, longer term survival and freedom from reintervention or explantation after TPVR were similar to previously reported data for small patients with a surgical pulmonary conduit or bioprosthetic valve.
Study context
- Population
- Patients weighing ≤30 kg with successful Melody valve placement, April 2009–April 2019
- Participants
- 199 patients · 10 centres
- Outcome
- Long-term outcomes after Melody valve placement:
- Reintervention
- Explantation
- Endocarditis
Main finding
As reported in the abstract
Estimated freedom from pulmonary valve reintervention at 10 years
46% (95% CI: 36%-55%)
Initial reintervention during median follow-up of nearly 8 years (balloon dilation n = 20, valve-in-valve n = 30, explantation n = 28)
78
RV systolic pressure immediately after implantation associated with freedom from reintervention (age- and weight-adjusted multivariable Cox regression)
HR: 1.03; 95% CI: 1.00-1.05; P = 0.026
Observational data: associations, not effects.
Further findings
Freedom from Melody valve explantation · 10 years
- Freedom from Melody valve explantation at 10 years
- 78% (95% CI: 69%-85%)
Valve function (patients without reintervention, with available echocardiograms)
- Good valve function
- 81%
Outcomes by weight, delivery system or era of implantation
- Did not vary significantly according to weight, delivery system, or era of implantation
Safety
Endocarditis
- Patients who developed endocarditis
- 32
- With predisposing factors
- 20
- Managed medically
- 9
- Freedom from endocarditis at 10 years
- 79% (95% CI: 71%-86%)
Original publication
Summarised from the published abstract; every number is checked against it