Key result
Decellularized heart valves implanted within the right ventricular outflow tract significantly reduced reoperation rates compared to standard tissue conduits (4.8% vs. 7.4%; RR 0.55).
Why the study?
Current valvular conduits have significant limitations, prompting evaluation of the clinical performance of alternative decellularized heart valves compared with standard tissue conduits in outflow tract positions.
Do decellularized heart valves reduce postoperative mortality and reoperation rates compared to standard tissue conduits in patients undergoing right ventricular outflow tract reconstruction?
Meta-Analysis (n=4,143)
Do decellularized heart valves reduce postoperative mortality and reoperation rates compared to standard tissue conduits in patients undergoing right ventricular outflow tract reconstruction?
Relative Risk: 0.55 (95% CI 0.36–0.84)
Absolute Event Rate: 4.8% vs 7.4%
p-value: p=0.0057
Decellularized heart valves for right ventricular outflow tract reconstruction significantly reduce reoperation rates compared to standard tissue conduits.
Decellularized valves link to fewer reoperations in RVOT reconstructions; extends meta-analytic support for their preferential use.
Background Valve replacement surgery is the definitive management strategy for patients with severe valvular disease. However, valvular conduits currently in clinical use are associated with significant limitations. Tissue-engineered (decellularized) heart valves are alternative prostheses that have demonstrated promising early results. The purpose of this systematic review and meta-analysis is to perform robust evaluation of the clinical performance of decellularized heart valves implanted in either outflow tract position, in comparison with standard tissue conduits. Methods Systematic searches were conducted in the PubMed, Scopus, and Web of Science databases for articles in which outcomes between decellularized heart valves surgically implanted within either outflow tract position of human subjects and standard tissue conduits were compared. Primary endpoints included postoperative mortality and reoperation rates. Meta-analysis was performed using a random-effects model via the Mantel-Haenszel method. Results Seventeen articles were identified, of which 16 were included in the meta-analysis. In total, 1418 patients underwent outflow tract reconstructions with decellularized heart valves and 2725 patients received standard tissue conduits. Decellularized heart valves were produced from human pulmonary valves and implanted within the right ventricular outflow tract in all cases. Lower postoperative mortality (4.7% vs. 6.1%; RR 0.94, 95% CI: 0.60–1.47; P = 0.77) and reoperation rates (4.8% vs. 7.4%; RR 0.55, 95% CI: 0.36–0.84; P = 0.0057) were observed in patients with decellularized heart valves, although only reoperation rates were statistically significant. There was no statistically significant heterogeneity between the analyzed articles (I2 = 31%, P = 0.13 and I2 = 33%, P = 0.10 respectively). Conclusions Decellularized heart valves implanted within the right ventricular outflow tract have demonstrated significantly lower reoperation rates when compared to standard tissue conduits. However, in order to allow for more accurate conclusions about the clinical performance of decellularized heart valves to be made, there need to be more high-quality studies with greater consistency in the reporting of clinical outcomes.
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Waqanivavalagi et al. (2020) conducted a meta-analysis in Severe valvular disease requiring outflow tract reconstruction (n=4,143). Decellularized heart valves vs. Standard tissue conduits was evaluated on Reoperation rates (RR 0.55, 95% CI 0.36-0.84, p=0.0057). Decellularized heart valves implanted within the right ventricular outflow tract significantly reduced reoperation rates compared to standard tissue conduits (4.8% vs. 7.4%; RR 0.55).
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