Abstract 11008: Stent Fracture, Valve Dysfunction, and Right Ventricular Outflow Tract Reintervention After Transcatheter Pulmonary Valve Implantation in the U.S. Melody Valve Trial
Background. Among patients (pts) undergoing transcatheter pulmonary valve (TPV) replacement with the Melody valve, stent fracture (MSF) and right ventricular outflow tract (RVOT) reintervention related to MSF are some of the most important ongoing issues.
Methods and Results. From 1/07-1/10, 150 pts were enrolled in the U.S. Melody valve IDE trial and underwent TPV implantation (median age 19 years). Overall, 25% of pts (37) had an existing conduit stent from a prior catheterization; the stent(s) were noted to be fractured in 12 of these. One or more new pre-stents were placed at the TPV implant catheterization in 51 pts (34%). During follow-up (median 30 months), MSF was diagnosed in 39 pts and type II MSF (loss of integrity) was diagnosed in 17. Freedom from MSF was 77±4% at 14 months (after the 1-year study window), 68±5% at 27 months (after the 2-year window), and 60±9% at 39 months (after the 3-year window). Freedom from type II MSF was 85±4% at 27 months and 74±11% at 39 months. Variables associated with MSF included factors indicative of more severe conduit obstruction, implant within an unprotected RVOT (no pre-stent or bioprosthetic valve), and implant in a high-risk mechanical environment. On multivariable analysis, implant within an existing stent, new pre-stent, or bioprosthetic valve (combined) was associated with longer freedom from MSF (HR 0.15 [0.07-0.32], p<0.001), while TPV compression (HR 2.7 [1.2-5.8], p=0.01) and apposition to the anterior chest wall (HR 2.2 [1.1-4.4], p=0.02) were associated with shorter freedom from MSF. Freedom from RVOT reintervention was 86±4% at 27 months. Among pts with a MSF, freedom from RVOT reintervention after the initial MSF diagnosis was 49±10% at 2 years. Factors associated with freedom from valve dysfunction and reintervention were similar to those for MSF.
Conclusions. MSF was common after TPV implant in this multicenter experience, and was more likely in pts with severely obstructed RVOT conduits, those with homograft conduits rather than bioprosthetic valves, and when the implanted TPV was directly behind the anterior chest wall and/or compressed. A protected implant site (pre-stented conduit or bioprosthetic valve) reduced the risk of MSF, as well as the risks of valve dysfunction and reintervention.
- Valvular heart disease
- Congenital heart disease
- Interventional cardiology
- Structural heart disease intervention
- © 2011 by American Heart Association, Inc.