Efficacy and safety of mechanical pulmonary valve replacement: a comprehensive systematic review and meta-analysis.

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.