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J Thorac Cardiovasc Surg 2009;137:907-913
© 2009 The American Association for Thoracic Surgery

Congenital Heart Disease

Decellularization reduces calcification while improving both durability and 1-year functional results of pulmonary homograft valves in juvenile sheep

^a Cardiac Surgery Research Laboratories, The Children's Mercy Hospitals and Clinics, Kansas City, Mo
^b LifeNet Health, Virginia Beach, Va
^c Brown University Medical School, Providence, RI

Received for publication June 19, 2008; revisions received November 7, 2008; accepted for publication December 19, 2008.

^_* Address for reprints: Richard A. Hopkins, MD, Children's Mercy Hospitals and Clinics, 2401 Gillham Rd, Kansas City, MO 64108. (Email: rahopkins{at}cmh.edu).

Objective: The juvenile sheep functional valve chronic implant calcification model was used to compare long-term calcification rates, functional performance, and durability for 3 types of right ventricular outflow tract implants: classically cryopreserved homografts and 2 decellularized pulmonary valved conduits.

Methods: Fifteen juvenile sheep were randomly assigned to one of 3 study arms and underwent pulmonary valve replacement. The arms included the following: (1) cryopreserved ovine pulmonary valves; (2) cryopreserved, decellularized, saline (1°C–10°C)–stored ovine pulmonary valves; and (3) cryopreserved, decellularized, glycerolized (–80°C) stored ovine pulmonary valves. Animal growth, serial echocardiographic results (with valve performance assessment), dimensions, and tissue-specific calcification measurements were compared with pre-explant angiographic analysis and right ventricular outflow tract pressure measurements, cardiac magnetic resonance imaging, specimen radiographic analysis, gross explant pathology, and histopathology. Parametric and nonparametric statistical analysis were performed.

Results: All but 2 study animals receiving implants thrived postoperatively, with similar growth rates, explant valve dimensions, ventricular functions, cardiac output, and indices during the study. As determined by means of echocardiographic analysis, 3 animals in arm 1 (and one in arm 2) had leaflet dysfunction. Valve regurgitation was recognized in 1 survivor each from both arms 1 and 2. Although 1 arm 1 animal died with calcified subacute bacterial endocarditis, and the other 4 had leaflet and conduit wall calcification by the time of death, no arm 2 or arm 3 animals demonstrated leaflet calcium, and no arm 3 and only 1 arm 2 animals had calcium in the conduit wall over the entire year, as determined with any measurement method. All cryopreserved conduit walls had calcium by 20 weeks, whereas only 1 of 10 decellularized conduits (arms 2 plus 3) had wall calcium.

Conclusion: Cryopreserved–decellularized–glycerolized valves retained normal valve function, with absent leaflet and minimal wall calcifications 1 year postoperatively, as opposed to classically cryopreserved allografts. These results might be predictive of the prolonged durability and functionality of a cryopreserved–decellularized–glycerolized allograft valve.