Feasibility and Short-Term Outcomes of Percutaneous Transcatheter Pulmonary Valve Replacement in Small (<30 kg) Children With Dysfunctional Right Ventricular Outflow Tract Conduits

Background-In 2010, the Melody transcatheter pulmonary valve (TPV) received Food and Drug Administration approval for treatment of dysfunctional right ventricular outflow tract conduits in patients >= 30 kg. Limited data are available regarding use of this device in smaller patients. Methods and Results-We evaluated technical and short-term clinical outcomes of 25 patients <30 kg (10 patients <20 kg) who underwent TPV replacement for treatment of conduit dysfunction at 3 centers. Median age and weight were 8.0 years (3.4-14.4) and 21.4 kg (13.8-29.0). The median conduit diameter at the time of surgical implant was 17 mm (12-23). Two patients did not undergo TPV implant (risk of coronary compression in 1; inability to advance the delivery sheath beyond the common femoral vein in 1). After successful TPV implant, the peak conduit gradient fell from 29+/-16 to 9+/-6 mm Hg (P<0.001), and all but 2 patients had no/trivial regurgitation (down from moderate or severe preimplant in 20). TPV implant was via the femoral vein in 17 patients, the right internal jugular vein in 4, and the left subclavian vein in 2 patients. At a median follow-up of 16 months, 1 patient underwent conduit replacement for recurrent conduit stenosis, 2 developed stent fracture requiring a second TPV, and 2 developed bacterial endocarditis treated with antibiotics, 1 of whom then underwent conduit replacement. The average Melody valve mean Doppler gradient and conduit regurgitation were unchanged from early postimplant. Conclusions-Percutaneous TPV replacement can be performed in small children with good procedural and early hemodynamic results in the majority of patients.