title: Early outcomes of pulmonary valve replacement with the mitroflow bovine pericardial bioprosthesis.
abstract: BACKGROUND
  Bovine pericardial valves are often used for pulmonary valve replacement (PVR) in patients with previously repaired congenital heart disease. Attention has recently focused on the safety of the Mitroflow (Sorin Group USA, Arvada, CO) bovine pericardial valve after a national alert describing several cases of sudden valve failure in young patients. In response, we reviewed our experience using the Mitroflow bioprosthesis for PVR.
  
  
  METHODS
  Medical records were reviewed for all patients who underwent PVR using a Mitroflow valve at our center (2008-2013).
  
  
  RESULTS
  The cohort included 84 patients with a median age of 18.3 years (range, 0.8-62.1 years) and weight of 48.4 kg (range, 5.7-167.8 kg). Indications for surgical intervention included native outflow tract insufficiency (59 patients), valved conduit failure (20 patients), and isolated prosthetic valve failure (5 patients). Median length of stay was 3 days (range, 2-13 days). There were no hospital deaths. Median follow-up was 2.4 years (range, 0.2-5.6 years). Pulmonary valve insufficiency and peak gradient increased with time. At latest follow-up, freedom from insufficiency greater than or equal to a moderate degree was 83%, and freedom from a peak gradient greater than or equal to 50 mm Hg was 92%. Reintervention was required in 4 patients. One patient experienced endocarditis and underwent surgical PVR (0.6 years after initial intervention). Three patients underwent transcatheter treatment for valve stenosis including PVR (at 4.2 and 4.4 years in 2 patients) and balloon valvuloplasty (at 5.2 years in the third patient). Kaplan-Meier freedom from reintervention at 5 years was 81%.
  
  
  CONCLUSIONS
  Early outcomes using the Mitroflow bovine pericardial valve for PVR in children and adults with repaired congenital heart disease appear acceptable and similar to reported outcomes for other tissue valve options. Valve failure from premature structural deterioration was not observed.
authors.affiliation: Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia.
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Schubert
authors.affiliation: Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania; Department of Surgery, Penn State College of Medicine, Hershey, Pennsylvania.
authors.forename: John L
authors.initials: JL
authors.lastname: Myers
authors.affiliation: Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
authors.forename: Allen R
authors.initials: AR
authors.lastname: Kunselman
authors.affiliation: Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania; Department of Surgery, Penn State College of Medicine, Hershey, Pennsylvania. Electronic address: jclark7@hmc.psu.edu.
authors.forename: Joseph B
authors.initials: JB
authors.lastname: Clark
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D001705:Bioprosthesis; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D005260:Female; D006330:Heart Defects, Congenital / Q000150:complications* / Q000601:surgery; D006349:Heart Valve Diseases / Q000150:complications / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010496:Pericardium; D011474:Prosthesis Design; D011664:Pulmonary Valve; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult