title: Performance of CryoValve SG decellularized pulmonary allografts compared with standard cryopreserved allografts.
abstract: BACKGROUND
  There is no ideal option for pulmonary valve replacement in children. Cryopreserved pulmonary allografts frequently demonstrate early valve regurgitation and may elicit an immune response. To improve these shortcomings, the SynerGraft process (CryoLife, Kennesaw, GA) decellularizes an allograft, leaving only connective tissue, which then becomes repopulated with host cells. A previous study at our institution demonstrated superior short-term durability of the SynerGraft-processed CryoValve SG compared with standard allografts. Longer-term impact of the technology remains unknown.
  
  
  METHODS
  A single institution review was performed of all CryoValve SGs implanted between 2001 and 2004. Forty-one CryoValve SG patients and 41 age and diagnosis-matched standard allograft controls were evaluated. Demographics, survival, reintervention, and echocardiographic findings were analyzed.
  
  
  RESULTS
  There were no significant differences between groups in demographics, valve diameter, orthotopic-heterotopic allograft position, or follow-up. For the entire cohort, there was no difference in early or late insufficiency or stenosis at a mean follow-up of 46 +/- 14 months. However, freedom from moderate to severe insufficiency (>3+) was significantly better for CryoValve SG patients (p = 0.05). In addition, for patients greater than 2 years of age, CryoValve SGs were significantly less regurgitant (p = 0.045) and stenotic (p = 0.041). Long-term survival was identical at 85% (35 of 41).
  
  
  CONCLUSIONS
  When compared with standard allografts, CryoValve SGs demonstrate superior freedom from significant insufficiency at intermediate follow-up. In older children, CryoValve SGs display less insufficiency and stenosis. For infants, patient age, valve diameter, previous conduit, and rapid somatic growth would likely be the predominant factors leading to allograft failure.
authors.affiliation: Division of Pediatric Cardiovascular Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Konuma
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Devaney
authors.forename: Edward L
authors.initials: EL
authors.lastname: Bove
authors.forename: Sarah
authors.initials: S
authors.lastname: Gelehrter
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Hirsch
authors.forename: Zarry
authors.initials: Z
authors.lastname: Tavakkol
authors.forename: Richard G
authors.initials: RG
authors.lastname: Ohye
mesh_terms: D000293:Adolescent; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery; D001705:Bioprosthesis; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D015925:Cryopreservation; D004452:Echocardiography; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D008297:Male; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000209:etiology* / Q000601:surgery; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000637:transplantation*; D012086:Reoperation / Q000706:statistics & numerical data; D012189:Retrospective Studies; D018608:Ultrasonography, Doppler; D014694:Ventricular Outflow Obstruction / Q000000981:diagnostic imaging / Q000601:surgery*