Evidence map›Paper›PMID 38396197›Full record

ArticleJournal of artificial organs : the official journal of the Japanese Society for Artificial Organs2024

Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device.

Takashi Nishimura, Koichi Toda, Junya Ako, Atsushi Hirayama, Koichiro Kinugawa, Yoshio Kobayashi, Minoru Ono, Naoki Sato, Takahiro Shindo, Akira Shiose and 4 more

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Article in Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs, 2024. 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.

Takashi NishimuraDepartment of Cardiovascular and Thoracic Surgery, Graduate School of Medicine, Ehime University, Ehime, Japan. nishimura.takashi.rb@ehime-u.ac.jp.ORCID http://orcid.org/0000-0003-2694-3413
Koichi TodaDepartment of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Junya AkoDepartment of Cardiovascular Medicine, School of Medicine, Kitasato University, Kanagawa, Japan.
Atsushi HirayamaDepartment of Cardiology, Osaka Police Hospital, Osaka, Japan.
Koichiro KinugawaThe Second Department of Internal Medicine, University of Toyama, Toyama, Japan.
Yoshio KobayashiDepartment of Cardiovascular Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.
Minoru OnoDepartment of Cardiac Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Naoki SatoDepartment of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, Saitama, Japan.
Takahiro ShindoDivision of Cardiology, National Center for Child Health and Development, Tokyo, Japan.
Akira ShioseDepartment of Cardiovascular Surgery, Kyushu University Graduate School of Medicine, Fukuoka, Japan.
Morimasa TakayamaDepartment of Cardiovascular Internal Medicine, Sakakibara Heart Institute, Tokyo, Japan.
Satoshi YasukochiDepartment of Pediatric Cardiology, Nagano Children's Hospital, Nagano, Japan.
Yoshiki SawaDepartment of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
J.-PVAD investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeBleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella.

methodsAll consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed.

resultsA total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events.

conclusionThis study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.

Indexed as

Heart-Assist DevicesHeart FailureHemorrhageRegistriesAdultAgedEast Asian PeopleExtracorporeal Membrane OxygenationFemaleHumansJapanMaleMiddle AgedPrevalenceRisk FactorsBleedingCardiogenic shockImpellaMechanical circulatory supportVeno-arterial extracorporeal membrane oxygenation

Identifiers

PMID38396197

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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.