title: Randomized trial of pulmonary valve replacement with and without right ventricular remodeling surgery.
abstract: BACKGROUND
  Although pulmonary valve replacement (PVR) is effective in reducing right ventricular (RV) volume overload in patients with chronic pulmonary regurgitation, persistent RV dysfunction and subsequent adverse clinical outcomes have been reported. This trial was conducted to investigate whether the addition of surgical RV remodeling with exclusion of scar tissue to PVR would result in improved RV function and laboratory and clinical parameters, as compared with PVR alone.
  
  
  RESULTS
  Between February 2004 and October 2008, 64 patients who underwent RV outflow tract procedures in early childhood had more than or equal to moderate pulmonary regurgitation, and fulfilled defined criteria for PVR were randomly assigned to undergo either PVR alone (n=34) or PVR with surgical RV remodeling (n=30). No significant difference was observed in the primary outcome (change in RV ejection fraction, -2±7% in the PVR alone group and -1±7% in the PVR with RV remodeling group; P=0.38) or in any of the secondary outcomes at 6-month postoperative follow-up. Multivariable analysis of the entire cohort identified preoperative RV end-systolic volume index <90 mL/m(2) and QRS duration <140 ms to be associated with optimal postoperative outcome (normal RV size and function), and RV ejection fraction <45% and QRS duration ≥160 ms to be associated with suboptimal postoperative outcome (RV dilatation and dysfunction).
  
  
  CONCLUSIONS
  The addition of surgical remodeling of the RV to PVR in patients with chronic pulmonary regurgitation did not result in a measurable early benefit. Referral to PVR based on QRS duration, RV end-systolic volume, or RV ejection fraction may be beneficial. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00112320.
authors.affiliation: Department of Cardiology, Children's Hospital Boston, Department of Pediatrics, Harvard Medical School, Boston, MA 02115, USA. tal.geva@cardio.chboston.org
authors.forename: Tal
authors.initials: T
authors.lastname: Geva
authors.forename: Kimberlee
authors.initials: K
authors.lastname: Gauvreau
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Powell
authors.forename: Frank
authors.initials: F
authors.lastname: Cecchin
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rhodes
authors.forename: Judith
authors.initials: J
authors.lastname: Geva
authors.forename: Pedro
authors.initials: P
authors.lastname: del Nido
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011664:Pulmonary Valve / Q000503:physiopathology / Q000601:surgery*; D011665:Pulmonary Valve Insufficiency / Q000503:physiopathology / Q000601:surgery*; D012189:Retrospective Studies; D016278:Ventricular Function, Right; D020257:Ventricular Remodeling