Performance of the CryoValve∗ SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years

Brown, John W.; Elkins, Ronald C.; Clarke, David R.; Tweddell, James S.; Huddleston, Charles B.; Doty, John R.; Fehrenbacher, John W.; Takkenberg, Johanna J.M.

doi:10.1016/j.jtcvs.2009.04.065

Cited by 61 publications

(44 citation statements)

References 22 publications

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“…Clinical reports have demonstrated a significant reduction in the immunologic response in recipients of SynerGrafts as measured by panel-reactive antibody levels compared to recipients of standard cryopreserved allografts (1,2). Furthermore, previous data comparing standard allograft to SynerGraft has demonstrated an improved profile in terms of conduit failure; however these have been from single institutions and included limited numbers of patients (1,(3)(4)(5). In addition, data from single institutions can be influenced by particular techniques in use, as well as different eras within institutions encompassing changing surgeons and other practices.…”

Section: Introductionmentioning

confidence: 99%

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Performance of SynerGraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results From Multiinstitutional Data

Bibevski

Ruzmetov

Fortuna

et al. 2017

The Annals of Thoracic Surgery

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Background. Structural deterioration of allografts over time is believed to be related at least in part, to an immune response mounted against human leukocyte antigen specific to the transplanted tissue. SynerGraft processing 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 one hundred sixty-three SynerGraft patients and one hundred twenty four standard allograft controls from three medical centers. Patient demographics were tabulated and conduit stenosis and insufficiency were measured by echocardiography.Results. There were twenty-eight deaths (SG, 15/163 9% vs standard, 13/124 11%; P= 0.72) but no death was attributed to structural failure of the conduit. The actuarial survival for Synergraft versus standard cohorts was not different at 5 and 10 yrs. Among the 274 hospital survivors, 17% SG versus 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%) as compared with SG (83%, P<001).Conclusions. This study represents a multi-institutional retrospective comparison of Synergraft and standard cryopreserved allografts used in RVOT reconstruction in a broad range of patient ages. Our results demonstrate that at an intermediate 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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Section: Introductionmentioning

confidence: 99%

“…The purpose of this project was therefore to assess the durability of the SynerGraft-processed allografts compared with standard cryopreserved allografts using data from multiple institutions. 4 …”

Section: Introductionmentioning

confidence: 99%

Performance of SynerGraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results From Multiinstitutional Data

Bibevski

Ruzmetov

Fortuna

et al. 2017

The Annals of Thoracic Surgery

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“…Right ventricular outflow tract reconstruction (pulmonary valve replacement) is accomplished with a variety of bioprosthetic valves and valved conduits, including allografts and both porcine and bovine xenografts. [318][319][320][321][322][323][324] The risk of systemic embolization is essentially nonexistent. Some authors have reported using aspirin after implantation of bioprosthetic valves in the pulmonary position, but this practice is uncommon.…”

Section: Recommendations For Long-term Prevention Ofmentioning

confidence: 99%

“…318,320 The risk of thromboembolic complications after bioprosthetic replacement of the pulmonary valve appears to be very low, and for the patient without additional risk factors, there is no indication for anticoagulation. [318][319][320][321]323,324 The use of mechanical valves for pulmonary valve replacement has been reported. In 2 series totaling 13 patients in whom aspirin and/or dipyramidole were used without VKAs, early valve failure was common, occurring in 7 of 13 patients within 1 year of valve implantation.…”

Section: Recommendations For Long-term Prevention Ofmentioning

confidence: 99%

Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease

Giglia¹,

Massicotte²,

Tweddell³

et al. 2013

Circulation

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“…Near complete removal of cells and cellular components was demonstrated through histological and immunocytochemical analysis with no corresponding change in the in vitro biomechanics (Elkins et al ., 2001b). The CryoValve SG™ pulmonary valve has subsequently been reported to perform well clinically in the short to mid‐term and outcomes in adults and children with a mean follow‐up of 4 years have been comparable to (Bechtel et al ., 2005, 2008; Brown et al ., 2010; Burch et al ., 2010; Hawkins et al ., 2003) or better than (Konuma et al ., 2009; Ruzmetov et al ., 2012; Tavakkol et al ., 2005) conventional cryopreserved human pulmonary allografts. The SynerGraft process has also been applied to thicker human aortic valve conduits.…”

Section: Introductionmentioning

confidence: 99%

Decellularization of human donor aortic and pulmonary valved conduits using low concentration sodium dodecyl sulfate

Vafaee

Thomas

Desai

et al. 2017

J Tissue Eng Regen Med

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The clinical use of decellularized cardiac valve allografts is increasing. Long‐term data will be required to determine whether they outperform conventional cryopreserved allografts. Valves decellularized using different processes may show varied long‐term outcomes. It is therefore important to understand the effects of specific decellularization technologies on the characteristics of donor heart valves. Human cryopreserved aortic and pulmonary valved conduits were decellularized using hypotonic buffer, 0.1% (w/v) sodium dodecyl sulfate and nuclease digestion. The decellularized tissues were compared to cellular cryopreserved valve tissues using histology, immunohistochemistry, quantitation of total deoxyribose nucleic acid, collagen and glycosaminoglycan content, in vitro cytotoxicity assays, uniaxial tensile testing and subcutaneous implantation in mice. The decellularized tissues showed no histological evidence of cells or cell remnants and >97% deoxyribose nucleic acid removal in all regions (arterial wall, muscle, leaflet and junction). The decellularized tissues retained collagen IV and von Willebrand factor staining with some loss of fibronectin, laminin and chondroitin sulfate staining. There was an absence of major histocompatibility complex Class I staining in decellularized pulmonary valve tissues, with only residual staining in isolated areas of decellularized aortic valve tissues. The collagen content of the tissues was not decreased following decellularization however the glycosaminoglycan content was reduced. Only moderate changes in the maximum load to failure of the tissues were recorded postdecellularization. The decellularized tissues were noncytotoxic in vitro, and were biocompatible in vivo in a mouse subcutaneous implant model. The decellularization process will now be translated into a good manufacturing practices‐compatible process for donor cryopreserved valves with a view to future clinical use. Copyright © 2016 The Authors Tissue Engineering and Regenerative Medicine published by John Wiley & Sons, Ltd.

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Performance of the CryoValve∗ SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years

Cited by 61 publications

References 22 publications

Performance of SynerGraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results From Multiinstitutional Data

Performance of SynerGraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results From Multiinstitutional Data

Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease

Decellularization of human donor aortic and pulmonary valved conduits using low concentration sodium dodecyl sulfate

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