Steve Bibevski1, Mark Ruzmetov2, Randall S Fortuna3, Mark W Turrentine4, John W Brown4, Richard G Ohye5. 1. Section of Pediatric and Congenital Cardiac Surgery, The Heart Institute, Joe DiMaggio Children's Hospital, Hollywood, Florida. 2. Section of Pediatric Heart Surgery, Children Hospital of Illinois, Peoria, Illinois. 3. Section of Pediatric Cardiothoracic Surgery, Banner Children's Hospital, University of Arizona College of Medicine, Phoenix, Arizona. 4. Section of Pediatric Cardiothoracic Surgery, Indiana University School of Medicine, Indianapolis, Indiana. 5. Section of Pediatric Cardiovascular Surgery, University of Michigan School of Medicine, Ann Arbor, Michigan. Electronic address: ohye@umich.edu.
Abstract
BACKGROUND: Structural deterioration of allografts over time is believed to be at least partly related to an immune response mounted against human leukocyte antigen specific to the transplanted tissue. SynerGraft (SG) processing (CryoLife, Kennesaw, GA) is a technology that decellularizes an allograft leaving only connective tissue, therefore, reducing immunogenicity and potentially increasing durability of the implant. METHODS: We performed a retrospective review of 163 SG patients and 124 standard allograft controls from 3 medical centers. Patient demographics were tabulated, and conduit stenosis and insufficiency were measured by echocardiography. RESULTS: There were 28 deaths (15 of 163 [9%] SG patients vs 13 of 124 [11%] standard patients; p = 0.72), but no deaths were attributed to structural failure of the conduit. The actuarial survival for SG vs standard cohorts was not different at 5 and 10 years. Among the 274 hospital survivors, 17% SG vs 42% standard had evidence for significant conduit dysfunction at the most recent follow-up or before conduit replacement. Freedom from conduit dysfunction was significantly worse at 10 years in the standard group (58%) than in the SG group (83%, p < 0.001). CONCLUSIONS: This study represents a multiinstitutional retrospective comparison of SG and standard cryopreserved allografts used in right ventricular outflow tract reconstruction in a broad range of patient ages. Our results demonstrate that at an intermediate-term to long-term follow-up, conduit dysfunction and pulmonary insufficiency and stenosis are higher among patients receiving standard allografts. We postulate that the improved durability of SG is related to decreased immunogenicity of the SG technology.
BACKGROUND: Structural deterioration of allografts over time is believed to be at least partly related to an immune response mounted against human leukocyte antigen specific to the transplanted tissue. SynerGraft (SG) processing (CryoLife, Kennesaw, GA) is a technology that decellularizes an allograft leaving only connective tissue, therefore, reducing immunogenicity and potentially increasing durability of the implant. METHODS: We performed a retrospective review of 163 SG patients and 124 standard allograft controls from 3 medical centers. Patient demographics were tabulated, and conduit stenosis and insufficiency were measured by echocardiography. RESULTS: There were 28 deaths (15 of 163 [9%] SG patients vs 13 of 124 [11%] standard patients; p = 0.72), but no deaths were attributed to structural failure of the conduit. The actuarial survival for SG vs standard cohorts was not different at 5 and 10 years. Among the 274 hospital survivors, 17% SG vs 42% standard had evidence for significant conduit dysfunction at the most recent follow-up or before conduit replacement. Freedom from conduit dysfunction was significantly worse at 10 years in the standard group (58%) than in the SG group (83%, p < 0.001). CONCLUSIONS: This study represents a multiinstitutional retrospective comparison of SG and standard cryopreserved allografts used in right ventricular outflow tract reconstruction in a broad range of patient ages. Our results demonstrate that at an intermediate-term to long-term follow-up, conduit dysfunction and pulmonary insufficiency and stenosis are higher among patients receiving standard allografts. We postulate that the improved durability of SG is related to decreased immunogenicity of the SG technology.
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