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Decellularized Cryopreserved Allografts as Off-the-Shelf Allogeneic Alternative for Heart Valve Replacement: In Vitro Assessment Before Clinical Translation

Decellularized Cryopreserved Allografts as Off-the-Shelf Allogeneic Alternative for Heart Valve Replacement: In Vitro Assessment Before Clinical Translation

Laura Iop, Adolfo Paolin, Paola Aguiari, Diletta Trojan, Elisa Cogliati, Gino Gerosa 09 March 2017

J. of Cardiovasc. Trans. Res. (2017) 10:93–103

DOI 10.1007/s12265-017-9738-0

Cryopreserved allogeneic conduits are the elective biocompatible choice among currently available substitutes for surgical replacement in end-stage valvulopathy. However, degeneration occurs in 15 years in adults or faster in children, due to recipient's immunological reactions to donor's antigens. Here, human aortic valves were decellularized by TRICOL, based on Triton X-100 and sodium cholate, and submitted to standard cryopreservation (TRICOL-human aortic valves (hAVs)). Tissue samples were analyzed to study the effects of the combined procedure on original valve architecture and donor's cell removal. Residual amounts of nucleic acids, pathological microorganisms, and detergents were also investigated. TRICOL-hAVs proved to be efficaciously decellularized with removal of donor's cell components and preservation of valve scaffolding. Trivial traces of detergents, no cytotoxicity, and abrogated bioburden were documented. TRICOL-hAVs may represent off-the-shelf alternatives for both aortic and pulmonary valve replacements in pediatric and grown-up with congenital heart disease patients.

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Determination of residual dimethylsulfoxide in cryopreserved cardiovascular allografts

Determination of residual dimethylsulfoxide in cryopreserved cardiovascular allografts

R. Di´az Rodri´guez . B. Van Hoeck . S. De Gelas . F. Blancke . R. Ngakam . K. Bogaerts . R. Jashari 05 January 2017

Cell Tissue Bank (2017) 18:263–270 DOI 10.1007/s10561-016-9607-0

Abstract Dimethylsulfoxide (DMSO) is a solvent which protects the structure of allografts during the cryopreservation and thawing process. However, several toxic effects of DMSO in patients after transplantation of cryopreserved allografts have been described. The aim of this study is to determine the residual DMSO in the cardiovascular allografts after thawing and preparation of cryopreserved allografts for clinical application following guidelines of the European Pharmacopoeia for DMSO detection. Four types of EHB allografts (aortic valve-AV, pulmonary valvePV, descending thoracic aorta-DA, and femoral artery-FA) are cryopreserved using as cryoprotecting solution a 10% of DMSO in medium 199. Sampling is carried out after thawing, after DMSO dilution and after delay of 30 min from final dilution (estimated delay until allograft implantation). After progressive thawing in sterile water bath at 37–42 C (duration of about 20 min), DMSO dilution is carried out by adding consecutively 33, 66 and 200 mL of saline. Finally, tissues are transferred into 200 mL of a new physiologic solution. Allograft samples are analysed for determination of the residual DSMO concentration using a validated Gas Chromatography analysis. Femoral arteries showed the most important DMSO reduction after the estimated delay: 92.97% of decrease in the cryoprotectant final amount while a final reduction of 72.30, 72.04 and 76.29% in DMSO content for AV, PV and DA, was found, respectively. The residual DMSO in the allografts at the moment of implantation represents a final dose of 1.95, 1.06, 1.74 and 0.26 mg kg-1 in AV, PV, DA and FA, respectively, for men, and 2.43, 1.33, 2.17 and 0.33 mg kg-1 for same tissues for women (average weight of 75 kg in men, and 60 kg in women). These results are seriously below the maximum recommended dose of 1 g DMSO kg-1 (Regan et al. in Transfusion 50:2670–2675, 2010) of weight of the patient guaranteeing the safety and quality of allografts.

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Outcome after aortic valve replacement in children: A systematic review and meta-analysis.

Outcome after aortic valve replacement in children: A systematic review and meta-analysis.

Etnel JR, Elmont LC, Ertekin E, Mokhles MM, Heuvelman HJ, Roos-Hesselink JW, de Jong PL, Helbing WA, Bogers AJ, Takkenberg JJ4 28 September 2015

 

2016 Jan;151(1):143-52.e1-3. doi: 10.1016/j.jtcvs.2015.09.083. Epub 2015 Sep 28.

OBJECTIVE:

Despite an increasing interest in pediatric aortic valve repair, aortic valve replacement in children may be unavoidable. The evidence on outcome after pediatric aortic valve replacement is limited and usually reported in small case series. This systematic review and meta-analysis aims to provide an overview of reported outcome of pediatric patients after aortic valve replacement.
METHODS:

A systematic literature search for publications reporting outcome after pediatric aortic valve replacement published between January 1990 and May 2015 was conducted. Studies written in English with a study size of more than 30 patients were included.

RESULTS:

Thirty-four publications reporting on 42 cohorts were included in this review: 26 concerning the Ross procedure (n = 2409), 13 concerning mechanical prosthesis aortic valve replacement (n = 696), and 3 concerning homograft aortic valve replacement (n = 224). There were no studies on bioprostheses that met our inclusion criteria. The pooled mean patient age was 9.4 years, 12.8 years, and 8.9 years for Ross, mechanical prosthesis, and homograft recipients, respectively. Pooled mean follow-up was 6.6 years. The Ross procedure was associated with lower early (4.20%; 95% confidence interval [CI], 3.37-5.22 vs 7.34%; 95% CI, 5.21-10.34 vs 12.82%; 95% CI, 8.91-18.46) and late mortality (0.64%/y; 95% CI, 0.49-0.84 vs 1.23%/y; 95% CI, 0.85-1.79 vs 1.59%/y; 95% CI, 1.03-2.46) compared with mechanical prosthesis aortic valve replacement and homograft aortic valve replacement, respectively. No significantly different aortic valve reoperation rates were observed between the Ross procedure and mechanical prosthesis aortic valve replacement (1.60%/y; 95% CI, 1.27-2.02 vs 1.07%/y; 95% CI, 0.68-1.68, respectively), whereas homograft aortic valve replacement was associated with significantly higher aortic valve reoperation rates (5.44%/y; 95% CI, 4.24-6.98). The Ross procedure-associated right ventricular outflow tract reoperation rate was 1.91% per year (95% CI, 1.50-2.44).

CONCLUSIONS:

This systematic review illustrates that all currently available aortic valve substitutes are associated with suboptimal results in children, reflecting the urgent need for reliable and durable repair techniques and innovative replacement solutions for this challenging group of patients.

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Ten-year experience with cryopreserved aortic allografts in the surgical treatment of aortic valve pathologies.

Ten-year experience with cryopreserved aortic allografts in the surgical treatment of aortic valve pathologies.

Rocco F, Ius P, Mirone S, Paolin A, Gatto C, Bredariol S, Tamari W, Valfré C. 05 July 2004

Italian heart journal (2004)
The aim of this study was to evaluate the performance of cryopreserved aortic allografts (CAA) in the treatment of adult aortic valve pathologies. From our experience we conclude that CAA are good substitutes for aortic valve replacement and even in desperate situations exhibit an acceptable long-term performance.

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