TY - JOUR
T1 - Pulmonary valve tissue engineering strategies in large animal models
AU - Uiterwijk, M.
AU - van der Valk, D. C.
AU - van Vliet, R.
AU - de Brouwer, I. J.
AU - Hooijmans, C. R.
AU - Kluin, J.
N1 - Publisher Copyright: © 2021 Uiterwijk et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2021/10/1
Y1 - 2021/10/1
N2 - In the last 25 years, numerous tissue engineered heart valve (TEHV) strategies have been studied in large animal models. To evaluate, qualify and summarize all available publications, we conducted a systematic review and meta-analysis. We identified 80 reports that studied TEHVs of synthetic or natural scaffolds in pulmonary position (n = 693 animals). We identified substantial heterogeneity in study designs, methods and outcomes. Most importantly, the quality assessment showed poor reporting in randomization and blinding strategies. Meta-analysis showed no differences in mortality and rate of valve regurgitation between different scaffolds or strategies. However, it revealed a higher transvalvular pressure gradient in synthetic scaffolds (11.6 mmHg; 95% CI, [7.31–15.89]) compared to natural scaffolds (4,67 mmHg; 95% CI, [3,94–5.39]; p = 0.003). These results should be interpreted with caution due to lack of a standardized control group, substantial study heterogeneity, and relatively low number of comparable studies in subgroup analyses. Based on this review, the most adequate scaffold model is still undefined. This review endorses that, to move the TEHV field forward and enable reliable comparisons, it is essential to define standardized methods and ways of reporting. This would greatly enhance the value of individual large animal studies.
AB - In the last 25 years, numerous tissue engineered heart valve (TEHV) strategies have been studied in large animal models. To evaluate, qualify and summarize all available publications, we conducted a systematic review and meta-analysis. We identified 80 reports that studied TEHVs of synthetic or natural scaffolds in pulmonary position (n = 693 animals). We identified substantial heterogeneity in study designs, methods and outcomes. Most importantly, the quality assessment showed poor reporting in randomization and blinding strategies. Meta-analysis showed no differences in mortality and rate of valve regurgitation between different scaffolds or strategies. However, it revealed a higher transvalvular pressure gradient in synthetic scaffolds (11.6 mmHg; 95% CI, [7.31–15.89]) compared to natural scaffolds (4,67 mmHg; 95% CI, [3,94–5.39]; p = 0.003). These results should be interpreted with caution due to lack of a standardized control group, substantial study heterogeneity, and relatively low number of comparable studies in subgroup analyses. Based on this review, the most adequate scaffold model is still undefined. This review endorses that, to move the TEHV field forward and enable reliable comparisons, it is essential to define standardized methods and ways of reporting. This would greatly enhance the value of individual large animal studies.
UR - http://www.scopus.com/inward/record.url?scp=85116586228&partnerID=8YFLogxK
U2 - https://doi.org/10.1371/journal.pone.0258046
DO - https://doi.org/10.1371/journal.pone.0258046
M3 - Article
C2 - 34610023
SN - 1932-6203
VL - 16
JO - PLOS ONE
JF - PLOS ONE
IS - 10 October
M1 - e0258046
ER -