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

Abstract

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). 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). 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. 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.