Evidence map›Paper›PMID 41045241›Full record

ArticleESC heart failure2025

Percutaneous endocardial alginate-hydrogel injection in the treatment of heart failure: First-in-human study.

Bo Wang, Shuo Wang, Chao Gao, D Scott Lim, Rutao Wang, Xin Meng, Ying Liu, Cun-Jun Zhu, Yoshinobu Onuma, Yunbing Wang and 4 more

Abstract read
In one paragraph

Article in ESC heart failure, 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

14 authors.

Bo WangDepartment of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Shuo WangDigital Medical Research Center, School of Basic Medical Sciences, Fudan University, Shanghai, China.
Chao GaoDepartment of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
D Scott LimDepartment of Medicine, University of Virginia, Charlottesville, Virginia, USA.
Rutao WangDepartment of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Xin MengDepartment of Ultrasonography, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Ying LiuDepartment of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Cun-Jun ZhuDepartment of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Yoshinobu OnumaCorrib Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.
Yunbing WangNational Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China.
Patrick W J C SerruysCorrib Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.
Runlin GaoFuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Randall J LeeDepartment of Medicine, University of California-San Francisco, San Francisco, California, USA.
Ling TaoDepartment of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.

Funding

DeKe MedicalNational Key R&D Program 2022YFC2402804National Key R&D Program 2023YFC2412800National Natural Science Foundation of China 82570443
6 · The paper itself

Abstract

aimsDespite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF). METHODS AND

resultsThis first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III-IV and left ventricular ejection fraction (LVEF) ≤35%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization at 6 months, and change from baseline to 6 months post-procedure in the following parameters: LVEF as assessed by MRI; NYHA functional class; 6 min walk test distance (6MWT); the quality of life assessed by the Kansas City Cardiomyopathy Heart Failure Questionnaire (KCCQ); and serum N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level. Pre- and post-procedural biomechanical analysis was also evaluated. Ten patients successfully underwent TEAi with no SADEs at 30 days. There was one death and two HF hospitalizations at 6 months. At 6 months, LVEF improved from 17.7% ± 3.8% to 24.9% ± 11.2% (P = 0.021), end-systolic volume decreased from 297.5 ± 67.9 mL to 264.8 ± 101.4 mL (P = 0.029), and KCCQ scores increased from 49.7 ± 3.9 to 79.0 ± 8.07 (P = 0.008). No statistically significant changes were observed in end-diastolic volume, NT-proBNP and 6MWT at six months compared with the baseline. Biomechanical analysis revealed a reduction in peak left ventricular end-diastolic wall stress (6.5 ± 1.1 kPa vs. 5.9 ± 1.3 kPa, P = 0.043).

conclusionsTEAi is feasible and safe for the treatment of HFrEF, warranting further randomized, efficacy clinical trials.

Indexed as

AlginatesCardiac CatheterizationHeart FailureHydrogelsStroke VolumeVentricular Function, LeftAgedFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeAlginatesHydrogelsalginate–hydrogelheart failurepercutaneous intramyocardial injection

Identifiers

PMID41045241
PMCPMC12719817

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.