Abstract 12255: Up to Seven-Year Outcomes After Transcatheter Pulmonary Valve Replacement in the Prospective Multicenter US Melody Valve Investigational Device Exemption Trial
Introduction: Transcatheter pulmonary valve replacement (TPVR) with the Melody valve was introduced in the US in 2007 through the Investigational Device Exemption (IDE) trial. Although earlier European and IDE reports showed good short-term outcomes, there are no published long-term follow-up (FU) data. The studies with the longest FU reported outcomes a median of ~2.5 yrs post-TPVR.
Methods and Results: The IDE trial enrolled 171 pts with postoperative right ventricular outflow tract (RVOT) conduit dysfunction from Jan 2007 to Jan 2010; the 148 pts (median age 19 yrs) who received a TPV and were discharged with the valve in place comprise the cohort for this study. During a median FU of 4.5 yrs (max 7 yrs), 4 pts died: 1 after endocarditis and RVOT reintervention, 3 unrelated to the TPV. A total of 32 pts underwent RVOT reintervention: initially TPV dilation in 7, redo TPVR in 18, and TPV explant in 7. Of 25 pts who underwent catheter-based reintervention, 8 had another intervention (transcatheter-4 or explant-4) a median of 1.5 yrs later. Reinterventions were for RVOT obstruction in 28 pts (with stent fracture in 25), endocarditis in 2 (1 with stenosis, 1 with regurgitation [PR]), and RV dysfunction in 2. In the 113 pts who were alive and reintervention-free (median FU 4.5 yrs), the most recent gradient was unchanged from early post-TPVR (17±7 vs 16±8mmHg, p=0.7), and all but 1 had mild or less PR (most trivial/none). Stent fractures were diagnosed in 50 pts, half of whom were reintervention-free and had good TPV function a median of 2 yrs later. At 5 yrs, freedom from RVOT reintervention and explant were 76±4% and 91±3%, respectively. A homograft conduit, no conduit pre-stent, discharge mean RVOT gradient >25mmHg, and pre-implant ≥moderate TR were associated with shorter freedom from reintervention on multivariable Cox regression. Almost all pts were in NYHA class I or II at FU.
Conclusions: TPVR with the Melody valve provided good hemodynamic and clinical outcomes 4-7 yrs after implant. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was less common once pre-stenting became more widely adopted. Based on these findings, TPVR appears to be a good option for at least mid-term palliation of RVOT conduit dysfunction.
- Pulmonary valve
- Congenital heart disease
- Adult congenital heart disease
- Tetralogy of Fallot
- Pediatric cardiology
Author Disclosures: J.P. Cheatham: Consultant/Advisory Board; Modest; Consultant, Proctor, and P.I. for Medtronic and NuMED. J.A. Vincent: Consultant/Advisory Board; Modest; Proctor for Medtronic. E.M. Zahn: Consultant/Advisory Board; Modest; Paid consultant/proctor for Medtronic. L. Bergersen: Consultant/Advisory Board; Modest; Consultant, 480 Biomedical, Inc. D.P. Berman: None. J.E. Lock: None. W.E. Hellenbrand: Consultant/Advisory Board; Modest; Consultant/Proctor to Medtronic. T.K. Jones: Research Grant; Modest; Medtronic. Consultant/Advisory Board; Modest; Consultant/Proctor for Medtronic. D.B. McElhinney: Consultant/Advisory Board; Modest; Consultant/Proctor to Medtronic.
- © 2014 by American Heart Association, Inc.