Evidence map›Paper›PMID 41107059›Full record

SynthesisOpen heart2025

Comparative outcomes of on-label and off-label transcatheter aortic valve replacement for aortic regurgitation: a systematic review and meta-analysis.

Yanren Peng, Yongqing Lin, Zizhuo Su, Shen Nie, Ruqiong Nie, Yangxin Chen

Abstract readSystematic ReviewMeta-AnalysisComparative Study
In one paragraph

Synthesis in Open heart, 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

6 authors.

Yanren PengDepartment of Cardiovascular Medicine, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China.ORCID http://orcid.org/0000-0003-2504-1637
Yongqing LinDepartment of Cardiovascular Medicine, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China.
Zizhuo SuDepartment of Cardiovascular Medicine, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China.
Shen NieDepartment of Cardiovascular Medicine, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China.
Ruqiong NieDepartment of Cardiovascular Medicine, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China chenyx39@mail.sysu.edu.cn nieruqiong@126.com.
Yangxin ChenDepartment of Cardiovascular Medicine, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China chenyx39@mail.sysu.edu.cn nieruqiong@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for aortic regurgitation (AR) in patients at high surgical risk. However, evidence comparing outcomes of different new-generation devices remains limited.

objectivesTo compare clinical outcomes of on-label, off-label self-expanding (SE) and off-label balloon-expandable (BE) TAVR devices in AR patients.

methodsA systematic review and meta-analysis were conducted, including studies reporting clinical outcomes of new-generation TAVR devices in AR. The primary outcome was 1-year all-cause mortality. Secondary outcomes included procedural success, moderate or severe AR and perioperative complications. Subgroup and meta-regression analyses assessed the impact of valve type and clinical variables.

results32 studies involving 2682 patients were included. 1-year mortality was 10.4% (95% CI: 7.2% to 14.7%) with no significant difference among valve types. Technical success was highest with on-label devices (97%), followed by off-label:BE (92%) and off-label:SE (85%) (p<0.001). Valve migration occurred in 2% of on-label, 7% of off-label:BE and 10% of off-label:SE cases (p=0.004). Moderate or severe AR was observed in 2% of on-label, 4% of off-label:BE and 8% of off-label:SE recipients (p<0.001). Meta-regression identified coronary heart disease as an independent predictor of 1 year mortality (p=0.026), while other factors showed no significant association.

conclusionsOn-label devices were associated with improved procedural outcomes, including lower rates of valve migration and residual AR, although 1-year mortality did not differ significantly between device groups. Further prospective studies with longer follow-up are needed to assess valve durability and long-term clinical outcomes. PROSPERO REGISTRATION NUMBER: CRD 42024611296.

Indexed as

Aortic ValveAortic Valve InsufficiencyHeart Valve ProsthesisOff-Label UseTranscatheter Aortic Valve ReplacementHumansProsthesis DesignRisk FactorsTreatment OutcomeAortic Valve InsufficiencyMeta-AnalysisOutcome Assessment, Health Care

Identifiers

PMID41107059
PMCPMC12542711

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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.