Transcatheter Pulmonary Valve Replacement With the Edwards Sapien System
What are the outcomes for use of the Sapien and Sapien XT valves for percutaneous implantation into the pulmonary valve position (PPVI)?
This was a review of 25 patients who underwent PPVI at a single center between October 2007 and October 2014 using the Edwards LifeSciences Sapien and Sapien XT valves. Patients underwent pre- and post-procedure hemodynamic and echocardiographic studies and were followed for 3.5 ± 2.1 years (range 0.3-7.2 years). Success was defined as deployment of the valve to the target area without significant residual right ventricular outflow tract (RVOT) dysfunction and pulmonary regurgitation severity of mild or less.
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.
The authors concluded that the Edwards Sapien percutaneous valve implantation system is a viable option for PPVI.
Surgical reconstruction of the RVOT is commonly performed in patients with congenital heart disease and is nearly universal in patients undergoing repair of tetralogy of Fallot. Deterioration of bioprosthesis or homograph valves in the pulmonary position is nearly inevitable in view of the young age in which these procedures are performed. Previously, correction of recurrent pulmonic insufficiency or pulmonary valve stenosis required an open procedure for valve replacement. More recently, a percutaneous approach, initially using the melody transcatheter pulmonary valve (Medtronic, Minneapolis, MN), has shown significant success. More recently, small series have utilized the Edwards-Sapien transcatheter valve system, initially developed for placement into the aortic position for pulmonary valve replacement. This study nicely demonstrates the high procedural success rate with this valve in this position with excellent clinical outcomes. Of note, when used in this position, all patients require pre-stenting of the RVOT to ensure a secure landing zone. This is a single-center experience of a relatively small number of patients, but suggests the high degree of success with the procedure, which presumably might become more commonly employed for the RVOT.
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