Efficacy and safety of mechanical pulmonary valve replacement: a comprehensive systematic review and meta-analysis
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.036 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.019 | 0.037 |
| Bibliometrics | 0.007 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".