Results:

The average patient age was 34 ± 8.9 years (range 19-57 years). Tetralogy of Fallot was the pre-existing diagnosis in 60%, and prior Ross procedure in 22%. PPVI was performed to a previously placed biologic valve in 64% and to a homograft in 36%. The primary indication for intervention was stenosis of 32%, regurgitation in 28%, and mixed stenosis and regurgitation in 40%. Technical success was achieved in 24 of 25 patients (96%). A single technical failure involved placing a 26 mm Sapien valve into a stenotic 27 mm bovine bioprosthetic valve, which in retrospect had a narrower internal dimension than anticipated. Valve sizes used were 23 mm in eight, 26 mm in 16, and 29 mm in two patients (the Sapien XT valve was used in four cases). All patients underwent pre-stenting of the RVOT, using covered stents in 52%. Invasive hemodynamics documented a RV systolic pressure of 61 ± 18 mm Hg pre-procedure, which declined to 39 ± 13 mm Hg post-procedure. Pre-PPVI, the RV-to-systemic pressure ratio was 0.64, declining to 0.36. The RVOT gradient declined from 39 ± 24 to 9.9 ± 9 mm Hg post-PPVI (all p < 0.001). By echocardiography, RV systolic pressure declined from 71 ± 17 to 49 ± 11 mm Hg. No or mild pulmonary regurgitation was seen in 23% pre-procedure and moderate or severe in 77%. Post-procedure, no patient had moderate or severe pulmonic regurgitation (p < 0.001 for echo comparisons). Over a mean follow-up of 3.5 ± 2.1 years, there were no deaths and no cases of endocarditis reported. There were no instances of stent fracture. One patient required re-intervention for severe pulmonary regurgitation. At most recent follow-up, 78% of patients were New York Heart Association functional class I.