The Ozaki Procedure With CardioCel Patch for Children and Young Adults With Aortic Valve Disease: Preliminary Experience – a Word of Caution

Abstract

Background: The Ozaki procedure is a surgical technique for patients with significant aortic stenosis or regurgitation or both where valve repair cannot be performed. Individual cusps are cut from glutaraldehyde-treated autologous pericardium or bovine pericardium and implanted into the aortic valve position. Encouraging results have been reported within the adult population. There are limited published data on success of this procedure in younger patients. Methods: We present a series of five children and young adults who underwent the Ozaki procedure with neoaortic valve cusps made from CardioCel, a decellularized bovine pericardial patch treated with a monomeric glutaraldehyde. Results: There were no complications in the initial postoperative period and short inpatient stay. At a mean follow-up of 29.6 months (range: 22-36 months), 4 patients had no evidence of stenosis and 3 patients had trivial or no regurgitation from the neoaortic valve. Overall, two patients had complications related to the valve and underwent reintervention during the follow-up period with a Ross procedure. One of these patients who was not taking long-term anticoagulation experienced a transient ischemic attack. Conclusions: Our experience demonstrates that the Ozaki procedure with CardioCel in pediatric and young adult patients should be approached with caution. Further research with larger groups of pediatric patients, comparison of different graft materials, and longer follow-up is required to ascertain long-term success in children.

Aortosubpulmonary Fistula after Konno-Rastan Aortoventriculoplasty

“…However, inflammation, fibrosis, and calcification persist, causing concern with its use, as documented in various reports. [9][10][11] Dacron, bovine pericardium, and polyfluoroethylene are alternative patch materials used to reconstruct the surgical defects of the Konno-Rastan procedure. Synthetic patch materials are advantageous as they are resistant to degeneration, aneurysm formation, and rupture, but they are associated with more bleeding.…”

“…However, inflammation, fibrosis, and calcification persist, causing concern with its use, as documented in various reports. 9 , 10 , 11 …”

Commentary: Aortic valve reconstruction with neocuspidization—A word of caution?

“…There are otherwise only 2 other published series or anecdotal experiences. 2,4 Overall, the short-term results have been good. This also mirrors my own group's experience with a smaller group of patients.…”

“…Emile Bacha, MD, FACS The history of cardiac surgery is riddled with examples of failed operations and failed patches, prostheses, and implants. 1,2 They typically start on a wave of enthusiasm, sometimes (for pediatric cardiac surgery) as an offshoot of a strong adult experience, such as what we are witnessing here with the aortic valve reconstruction (AVRec) neocuspidization (Ozaki) procedure. This is not necessarily bad, as long as patients do not get hurt, and it sometimes even leads to progress.…”

Aortic Valve Neo-Cuspidization in Children – Ready for Prime Time Yet?

“…There is insufficient evidence to directly compare these different patches. In this issue of World Journal for Pediatric and Congenital Heart Surgery , Chivers et al 6 report their experience with use of CardioCel for Ozaki procedure in five children and young adults. Although initial results were excellent, two repairs failed within two years, and in both cases, accelerated degeneration of the neo-cusps was demonstrated.…”