Percutaneous implantation of the Edwards SAPIEN(™) pulmonic valve: initial results in the first 22 patients.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) was introduced in 2000 as an interventional procedure for the treatment of right ventricular outflow tract (RVOT) dysfunction. The new Edwards SAPIEN(™) pulmonic valve has reached CE certification at the end of 2010 thus offering an attractive alternative with extended sizes (23 and 26 mm) to the conventional Melody(®) valve (sizes 18, 20 and 22 mm). PATIENTS: Over a 1-year period, PPVI using the Edwards SAPIEN(™) pulmonic valve was performed in 22 patients using a standardized procedure. Primary diagnosis was tetralogy of Fallot (n = 11), pulmonary atresia (n = 2), Truncus arteriosus (n = 3), TGA/PS-Rastelli (n = 1), Ross surgery (n = 2), double outlet right ventricle (n = 2) and absent pulmonary valve syndrome (n = 1). The character of the RVOT for PPVI was transannular patch (n = 4), bioprosthesis (n = 2), homograft (n = 5) and Contegra(®) conduit (n = 11). The leading hemodynamic problem consisted of a pulmonary stenosis (PS) (n = 2), pulmonary regurgitation (PR) (n = 11) and a combined PS/PR lesion (n = 9).
RESULTS: In 21/22 patients, PPVI was performed successfully (10 × 23 and 11 × 26 mm). There were 9 female and 13 male patients; the mean age was 21.7 years (range 6-83 years), the mean length was 162 cm (range 111-181 cm) and the weight 56.5 kg (range 20-91 kg). Invasive data showed a decrease of RV-systolic pressure from 61.2 mmHg (± 23.1) to 41.2 mmHg (± 8.6) and reduction of RV-PA gradient from 37.3 mmHg (± 23.2) to 6.9 mmHg (± 5.3). The PA-systolic pressure increased from 25.8 mmHg (± 8.6) to 33.9 mmHg (± 9.3) as did the PA diastolic pressure (from 6.0 mmHg (± 5.6) to 14.6 mmHg (± 4.3). There was a substantial reduction of pulmonary regurgitation from before (none/trivial n = 0, mild n = 2, mode rate n = 9, severe n = 11) to after PPVI (none/trivial n = 20, mild n = 1). During the short-term follow-up of 5.7 months there was no change in the immediate results.
CONCLUSION: PPVI using the Edwards SAPIEN(™) pulmonic valve can be performed safely in a wide range of patients with various diagnoses and underlying pathology of the RVOT and enables the restoration of an adult-size RVOT diameter. Although the immediate and short-term results seem promising, the long-term effects and safety have to be assessed in further clinical follow-up studies.