title: Percutaneous implantation of the Edwards SAPIEN(™) pulmonic valve: initial results in the first 22 patients.
abstract: 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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Congenital Heart Defects, Heart and Diabetes Centre NRW, Georgstrasse 11, 32545, Bad Oeynhausen, Germany. nhaas@hdz-nrw.de
authors.forename: Nikolaus A
authors.initials: NA
authors.lastname: Haas
authors.forename: Axel
authors.initials: A
authors.lastname: Moysich
authors.forename: Ulrich
authors.initials: U
authors.lastname: Neudorf
authors.forename: Hojjat
authors.initials: H
authors.lastname: Mortezaeian
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.forename: Heike
authors.initials: H
authors.lastname: Schneider
authors.forename: Daniel
authors.initials: D
authors.lastname: De Wolf
authors.forename: Jerome
authors.initials: J
authors.lastname: Petit
authors.forename: Sreeram
authors.initials: S
authors.lastname: Narayanswami
authors.forename: Kai Thorsten
authors.initials: KT
authors.lastname: Laser
authors.forename: Eugen
authors.initials: E
authors.lastname: Sandica
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D017023:Coronary Angiography; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000503:physiopathology*; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011666:Pulmonary Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D016278:Ventricular Function, Right; D055815:Young Adult