Evidence map›Paper›PMID 40145033›Full record

ArticleJHLT open2024

Quality of life in pediatric patients on a paracorporeal ventricular assist device with a novel mobile driving system.

Oliver Miera, Eugen Sandica, Nikolaus A Haas, Martin Schweiger, Brigitte Stiller, Rainer Kozlik-Feldmann, Maria-Helena Perez, Ina Michel-Behnke, Katharina R L Schmitt, Stephan Schubert and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in JHLT open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04634708 (The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support), which is not on this 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.

NCT04634708 completednot on this map

The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support

TypeobservationalSponsorBerlin Heart GmbHRan2020 to 2022Enrolled24ConditionsHeart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart DiseasesArmsNo intervention
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

11 authors.

Oliver MieraDepartment of Congenital Heart Disease - Pediatric Cardiology, Deutsches Herzzentrum der Charité, Berlin, Germany.
Eugen SandicaDepartment of Pediatric Heart Surgery and Surgery for Congenital Heart Defects, Heart, and Diabetes Center NRW, Bad Oeynhausen, Germany.
Nikolaus A HaasDepartment of Pediatric Cardiology and Pediatric Intensive Care, Ludwig Maximilian University of Munich, Munich, Germany.
Martin SchweigerDepartment of Congenital Cardiovascular Surgery, Pediatric Heart Center, University Children's Hospital Zurich, Switzerland.
Brigitte StillerDepartment of Congenital Heart Defects and Pediatric Cardiology, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
Rainer Kozlik-FeldmannClinic for Children's Heart Medicine and Adults with Congenital Heart Disease, University Heart & Vascular Center, Hamburg, Germany.
Maria-Helena PerezWomen-Mother-Child Department, University Hospital of Lausanne, Lausanne, Switzerland.
Ina Michel-BehnkeDepartment of Pediatric Cardiology, Medical University of Vienna, Wien, Austria.
Katharina R L SchmittDepartment of Congenital Heart Disease - Pediatric Cardiology, Deutsches Herzzentrum der Charité, Berlin, Germany.
Stephan SchubertDepartment of Pediatric Cardiology and Congenital Heart Defects, Heart, and Diabetes Center NRW, Bad Oeynhausen, Germany.
Daniel ZimpferDepartment of Heart Surgery, Medical University of Vienna, Wien, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: EXCOR ventricular assist device (VAD) is the gold standard circulatory support for children with end-stage heart failure. Until recently, the only available driving unit was the stationary Ikus. This study (NCT04634708) investigates the impact of the novel mobile EXCOR Active driving unit on patients' mobility and the quality of life (QoL) of their families. Methods: Children on EXCOR VAD support with the Ikus who were mobilizable outside the hospital room were eligible for the prospective study. Patients remained on Ikus for 7 days, then switched to Excor Active, and were observed for another 45 days. The end-points were the rates of clinically relevant device exchanges (i.e., exchanges that could raise safety concerns for the patient) and successful patient outcomes, respectively. QoL of patients' families was recorded through 2 validated questionnaires: the Pediatric Quality of Life Inventory Family Impact Module and Depression, Anxiety and Stress Scale 21. Patients' mobility and activity levels were monitored through diary entries. Results: A total of 24 patients were enrolled of which 23 patients completed the study. No clinically relevant device exchanges occurred and there was a successful outcome in 22/23 (95.7%) patients. Changing from the Ikus to the EXCOR Active improved QoL as seen in family impact total score (from 53.8 ± 19.8-66.5 ± 20.8, Conclusions: The EXCOR Active driving unit is safe and performs equivalent to Ikus. This study indicates considerable improvement in patients' mobility. In addition, data suggest that families' QoL is positively affected by means of the novel driving unit.

Indexed as

driving unitmobilitypediatricquality of lifeventricular assist device

Identifiers

PMID40145033
PMCPMC11935330

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Registered trials

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.