Long-Term Outcomes and Complications of Pulmonary Valve Replacement: A Meta-Analysis of Mechanical Versus Biological Prostheses.

Abstract

This meta-analysis exclusively examines pulmonary valve replacement (PVR) outcomes in congenital heart disease (CHD) patients. CHD affects nearly 1% of live births globally, with a significant subset eventually requiring PVR due to valve dysfunction following primary repair procedures. Choosing between mechanical and biological valves is challenging, as both have significant limitations, including thrombosis, bleeding, degradation, and the need for reoperations. This study systematically evaluates the long-term outcomes and complications of PVR options to provide evidence-based guidance. Its goal is to optimize care and improve outcomes for pediatric CHD patients. This systematic review and meta-analysis followed PRISMA guidelines to compare outcomes and complications of mechanical versus biological PVR in congenital heart disease patients. A comprehensive search was conducted in PubMed, World of Science, and Scopus, screening studies based on defined inclusion and exclusion criteria. Data extraction and analysis were performed independently by two reviewers, with pooled prevalence rates calculated using a random-effects model. Ethical approval was not required as only published data were analyzed. This meta-analysis included 158 studies with a marked imbalance between valve types: 145 biological PVR studies (20,499 patients) versus only 13 mechanical PVR studies (1060 patients) from 7178 screened articles. This 19:1 patient ratio reflects the clinical rarity of mechanical PVR in CHD patients. For biological PVR, valve dysfunction rates increased over time: 4% at 1 year, 8% at 2-3 years, 12% at 4-6 years, 31% at 7-10 years, and 27% at 15-20 years. Reintervention rates also rose: 3% at 1 year, 7% at 2-3 years, 12% at 4-6 years, 29% at 7-10 years, and 43% at 15-20 years. Redo-PVR rates followed a similar trend: 2% at 1 year, 4% at 2-3 years, 8% at 4-6 years, 22% at 7-10 years, and 26% at 15-20 years. Mortality rates remained stable: 4% at 1-3 years, 6% at 4-6 years, and 6% at 15-20 years. Complications included arrhythmias (5%), infective endocarditis (3%), and overall complications (11%). For mechanical PVR, valve dysfunction was 4%, reoperation 6%, and redo-PVR 5%. Thrombosis occurred in 9%, bleeding in 4%, and mortality was 1%. Mechanical valves showed lower reintervention rates but higher thrombosis risks compared to biological valves. PVR shows low long-term mortality and complication rates for both mechanical and biological valves, though mechanical valves reduce redo-PVR but increase thrombosis and bleeding risks. The limited mechanical PVR data necessitates cautious interpretation due to small sample sizes and potential selection bias. Future research should explore outcomes across diverse patients, CHD types, and implantation methods.