Abstract
BackgroundValve 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.MethodsSystematic 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.ResultsSeventeen 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).ConclusionsDecellularized 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.
Highlights
Valve replacement surgery is the definitive management strategy for patients with advanced valvular disease [1– 3]
Lower postoperative mortality rates were observed in patients with decellularized heart valves, when compared to patients with standard tissue conduits, these findings were not statistically significant (4.7% vs. 6.1%; pooled relative risks (RR) 0.94, 95% confidence intervals (CI): 0.60 to 1.47; P = 0.77; Fig. 2)
We found that patients with decellularized heart valves implanted within the right ventricular outflow tract had significantly lower reoperation rates and transvalvular gradients, when compared to patients with standard tissue conduits
Summary
Valve replacement surgery is the definitive management strategy for patients with advanced valvular disease [1– 3]. For women of child-bearing age or the elderly, a bioprosthetic valve might be selected instead, thereby obviating the need for anticoagulants [9]. Despite this advantage, bioprosthetic valves elicit an inflammatory response that leads to progressive calcification, graft failure, and earlier reintervention [8, 10]. Bioprosthetic valves elicit an inflammatory response that leads to progressive calcification, graft failure, and earlier reintervention [8, 10] This inflammatory reaction is especially profound in children, which is why homografts are often selected as the conduits of choice for pediatric patients [11]. Valve replacement surgery is the definitive management strategy for patients with severe valvular disease. 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
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