Evidence map›Paper›PMID 40420269›Full record

SynthesisJournal of cardiothoracic surgery2025

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

Ali Rafati, Sina Rashedi, Yeganeh Pasebani, Milad Vahedinejad, Hamed Ghoshouni, Yaser Toloueitabar, Mostafa Mousavizadeh, Sedigheh Saedi, Amirhosein Jalali, Zahra Khajali and 6 more

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Journal of cardiothoracic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Ali Rafati *Vascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Sina Rashedi *Vascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Yeganeh PasebaniVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Milad VahedinejadVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Hamed GhoshouniVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Yaser ToloueitabarCongenital Heart Disease Research Center, Rajaie Cardiovascular Institute, Tehran, Iran.
Mostafa MousavizadehHeart valve Diseases Research Center, Rajaie Cardiovascular Institute, Tehran, Iran.
Sedigheh SaediCongenital Heart Disease Research Center, Rajaie Cardiovascular Institute, Tehran, Iran.
Amirhosein JalaliVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Zahra KhajaliCongenital Heart Disease Research Center, Rajaie Cardiovascular Institute, Tehran, Iran.
Hassan TatariVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Fahimeh FarrokhzadehVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Hooman BakhshandehVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Maziar Gholampour DehakiCongenital Heart Disease Research Center, Rajaie Cardiovascular Institute, Tehran, Iran.
Behshid GhadrdoostVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran.
Parham SadeghipourVascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Institute, Vali-Asr Ave, Tehran, 1995614331, Iran. psadeghipour@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulmonary 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.

methodsThis 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.

resultsThe 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]).

conclusionsDespite 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.

Indexed as

Heart Valve ProsthesisHeart Valve Prosthesis ImplantationPulmonary ValveHumansPostoperative ComplicationsTreatment OutcomeCongenital heart defectHeart valve prosthesisHeart valve prosthesis implantationPulmonary valveReoperation

Identifiers

PMID40420269
PMCPMC12105212

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.