Clinical and Hemodynamic Outcomes Up to 7 Years After Transcatheter Pulmonary Valve Replacement in the US Melody Valve Investigational Device Exemption Trial
Background—Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good short-term outcomes, but there are no published long-term follow-up data.
Methods and Results—The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median 19 years) with right ventricular outflow tract (RVOT) conduit obstruction and/or regurgitation (PR). The 148 patients who received and were discharged with a TPV were followed annually according to a standardized protocol. During a median follow-up of 4.5 years (0.4-7 years), 32 patients underwent RVOT reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis, 1 with PR), or RV dysfunction (n=2). Eleven patients had the TPV explanted as an initial or second reintervention. Five-year freedom from reintervention and explant were 76±4% and 92±3%. A conduit pre-stent and lower discharge RVOT gradient were associated with longer freedom from reintervention. In the 113 patients who were alive and reintervention-free, the follow-up gradient (median 4.5 years after implant) was unchanged from early post-TPVR, and all but 1 had mild or less PR. Almost all patients were in NYHA class I or II. More severely impaired baseline spirometry was associated with lower likelihood of improvement in exercise function after TPVR.
Conclusions—TPVR with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implant. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was uncommon once pre-stenting became more widely adopted.
Clinical Trial Registration Information—Clinicaltrials.gov. Identifier: NCT00740870.
- Melody valve
- congenital heart disease
- pulmonary heart disease
- tetralogy of Fallot
- percutaneous pulmonary valve implantation
- Received October 2, 2014.
- Revision received March 19, 2015.
- Accepted March 23, 2015.