title: Single-center comparative outcomes of the Edwards SAPIEN and Medtronic Melody transcatheter heart valves in the pulmonary position.
abstract: BACKGROUND
  Two transcatheter pulmonary valve replacement (tPVR) systems (Edwards SAPIEN and Medtronic Melody) are available; however, comparative studies evaluating outcome data are lacking. The aim of this study was to compare short- with medium-term outcome data of these valves in the pulmonary position from a single institution.
  
  
  METHODS
  Retrospective data analysis of all patients undergoing tPVR from April 2008 until April 2012. Pre-procedural investigations, patient demographics, procedural hemodynamics, and clinical and echocardiographic follow-up data were included. Data are presented as mean ± standard deviation.
  
  
  RESULTS
  Thirty-three patients underwent successful tPVR (SAPIEN (S) n = 20, Melody (M) n = 13). Patient age and weight were similar between the two groups. Primary indication included regurgitation (S (n = 2), M (n = 3)), stenosis (S (n = 13), M (n = 7)), or mixed (S (n = 5), M (n = 3)). There was no difference in pre-procedural peak Doppler gradients across the pulmonary outflow (S = 47.73 ± 21.14 mm Hg, M = 42.62 ± 15.59 mm Hg, P = 0.46). All but one patient underwent pre-stenting prior to valve implantation. Immediately following valve deployment, the transvalvar gradient was not statistically different between the two groups (S = 11.5 ± 8.07 mm Hg, M = 8.15 ± 4.56 mm Hg, P = 0.18). There were no procedural deaths. Follow-up mean pulmonary Doppler gradients were higher with the SAPIEN cohort (18.43 ± 9.06 mm Hg (S) and 11.17 ± 5.24 mm Hg (M), P = 0.016); however, no differences were seen when similar procedural epochs were assessed. All but one patient remained with PR grade = 2.
  
  
  CONCLUSIONS
  In a single-center series, the SAPIEN and Melody valves demonstrated comparable medium-term valve function. Greater residual gradients with the SAPIEN valve may represent a more conservative early pre-stenting approach with this valve.
authors.affiliation: Rush Center for Congenital and Structural Heart Disease, Rush University Medical Center, Chicago, IL.
authors.forename: Nadeen
authors.initials: N
authors.lastname: Faza
authors.forename: Damien
authors.initials: D
authors.lastname: Kenny
authors.forename: Clifford
authors.initials: C
authors.lastname: Kavinsky
authors.forename: Zahid
authors.initials: Z
authors.lastname: Amin
authors.forename: Mary
authors.initials: M
authors.lastname: Heitschmidt
authors.forename: Ziyad M
authors.initials: ZM
authors.lastname: Hijazi
mesh_terms: D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000295:instrumentation*; D002641:Chicago; D002648:Child; D015150:Echocardiography, Doppler; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011666:Pulmonary Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult