Key result
Mechanical pulmonary valve replacement demonstrates acceptable safety and efficacy with ~10% incidence of valvular dysfunction.
Why the study?
Major congenital heart disease guidelines lack recommendations on valve type for pulmonary valve replacement, leaving the efficacy and safety profile of mechanical pulmonary valve replacement unclear.
Does mechanical pulmonary valve replacement demonstrate acceptable efficacy and safety in patients with congenital heart diseases requiring pulmonary valve replacement?
Meta-Analysis
Does mechanical pulmonary valve replacement demonstrate acceptable efficacy and safety in patients with congenital heart diseases requiring pulmonary valve replacement?
Effect estimate: Pooled incidence proportion (95% CI 8-12)
Mechanical pulmonary valve replacement demonstrates acceptable long-term efficacy and safety with low rates of major bleeding and thromboembolic events, though high-quality prospective comparisons with bioprostheses are still needed.
Supports consideration of mechanical PVR in congenital heart disease; leaves open need for prospective comparisons with bioprostheses.
BACKGROUND: Pulmonary valve replacement (PVR) is the most common valve replacement procedure for pulmonary valve dysfunction in congenital heart diseases (CHD). Despite the long-term need for anticoagulation and potential bleeding complications in mechanical PVR (MPVR), prosthetic dysfunction and reoperation might occur less frequently. The major guidelines on the CHD management have no recommendation on the valve type for the PVR. So, we systematically reviewed the latest literature on the efficacy and safety of MPVR with different etiologies. METHODS: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The protocol was registered with PROSPERO (CRD42023425339). A systematic search was conducted in PubMed, Scopus, Web of Science, and Embase. The primary outcomes evaluated include all-cause mortality, reintervention for mechanical prostheses, valvular thrombosis, thromboembolic events, prosthetic valve dysfunction, major bleeding events, right ventricular failure, and infective endocarditis. A random-effects model was employed for the meta-analysis. The quality of the studies was assessed using the Newcastle-Ottawa Scale. RESULTS: The literature search was conducted up to June 12, 2023, and included 16 records in the qualitative synthesis, with 13 studies also included in the quantitative synthesis. Our systematic review indicates that the previously published patient-level analysis remains the most reliable evidence to date on MPVR, with 91%, 97%, and 95% 5-year freedom from valvular thrombosis, reintervention, and all-cause mortality, respectively. Our meta-analysis indicated low pooled incidence proportions of other outcomes as follows: Major bleeding (mean follow-up = 68.79 months, 16/336, 5% [95% CI 3-8]); Valvular dysfunction (mean follow-up = 68.89 months, 70/708, 10% [95% CI 8-12]); Thromboembolic events (mean follow-up = 78.28 months, 9/293, 3% [95% CI 2-6]); and Infectious endocarditis (mean follow-up = 42.03 months, 7/518, 1% [95% CI 1-3]). CONCLUSIONS: Despite showing acceptable efficacy and safety in MPVR, there is still a significant knowledge gap in choosing the most appropriate prosthetic valve in patients undergoing PVR. High-quality research is warranted to resolve the existing gap in evidence.
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Rafati et al. (2025) conducted a meta-analysis in Pulmonary valve dysfunction in congenital heart diseases. Mechanical pulmonary valve replacement vs. Bioprosthetic pulmonary valve replacement (in comparative studies) was evaluated on Valvular dysfunction (Pooled incidence proportion, 95% CI 8-12). Mechanical pulmonary valve replacement demonstrated acceptable safety and efficacy, with low pooled incidence proportions of major bleeding (5%), valvular dysfunction (10%), thromboembolic events (3%), and infectious endocarditis (1%).
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