Evidence map›Paper›PMID 38110762›Full record

ArticleCardiovascular engineering and technology2024

Preclinical Proof-of-Concept of a Minimally Invasive Direct Cardiac Compression Device for Pediatric Heart Support.

Erica C Hord, Melanie P Hager, Christina M Bolch, Katherine Bonugli, Lee-Jae Guo, Egemen Tuzun, John C Criscione

Abstract read
In one paragraph

Article in Cardiovascular engineering and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Direct Cardiac Compression Device for Short-Term Mechanical Circulatory Support.ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2026
    Article
  2. Article
  3. Review
  4. 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

7 authors.

Erica C HordCorInnova, Inc. JLABS @ TMC, 2450 Holcombe Blvd Suite J, Houston, TX, 77021, USA.ORCID 0000-0003-4479-2778
Melanie P HagerDepartment of Biomedical Engineering, Texas A&M University, 5045 Emerging Technologies Building 3120 TAMU, College Station, TX, 77843-3120, USA.ORCID 0000-0003-4954-532X
Christina M BolchCorInnova, Inc. JLABS @ TMC, 2450 Holcombe Blvd Suite J, Houston, TX, 77021, USA.ORCID 0000-0003-4166-0825
Katherine BonugliTexas A&M University Institute for Preclinical Studies, 4478 TAMU, College Station, TX, 77843-4478, USA.
Lee-Jae GuoTexas A&M University Institute for Preclinical Studies, 4478 TAMU, College Station, TX, 77843-4478, USA.ORCID 0000-0002-9633-1167
Egemen TuzunTexas A&M University Institute for Preclinical Studies, 4478 TAMU, College Station, TX, 77843-4478, USA.
John C CriscioneCorInnova, Inc. JLABS @ TMC, 2450 Holcombe Blvd Suite J, Houston, TX, 77021, USA. jccriscione@tamu.edu.ORCID 0000-0002-5988-773X

Funding

National Capital Consortium for Pediatric Device Innovation National Capital Consortium for Pediatric Device Innovation
6 · The paper itself

Abstract

purposeFor pediatric patients, extracorporeal membrane oxygenation (ECMO) remains the predominant mechanical circulatory support (MCS) modality for heart failure (HF) although survival to discharge rates remain between 50 and 60% for these patients. The device-blood interface and disruption of physiologic hemodynamics are significant contributors to poor outcomes.

methodsIn this study, we evaluate the preclinical feasibility of a minimally invasive, non-blood-contacting pediatric DCC prototype for temporary MCS. Proof-of-concept is demonstrated in vivo in an animal model of HF. Hemodynamic pressures and flows were examined.

resultsMinimally invasive deployment on the beating heart was successful without cardiopulmonary bypass or anticoagulation. During HF, device operation resulted in an immediate 43% increase in cardiac output while maintaining pulsatile hemodynamics. Compared to the pre-HF baseline, the device recovered up to 95% of ventricular stroke volume. At the conclusion of the study, the device was easily removed from the beating heart.

conclusionsThis preclinical proof-of-concept study demonstrated the feasibility of a DCC device on a pediatric scale that is minimally invasive and non-blood contacting, with promising hemodynamic support and durability for the initial intended duration of use. The ability of DCC to maintain pulsatile MCS without blood contact represents an opportunity to mitigate the mortality and morbidity observed in non-pulsatile, blood-contacting MCS.

Indexed as

Disease Models, AnimalFeasibility StudiesHeart-Assist DevicesHeart FailureProof of Concept StudyAnimalsEquipment DesignHemodynamicsRecovery of FunctionTime FactorsVentricular Function, LeftDCCMCSMechanical circulatory supportMedical DevicePediatric Heart Failure

Identifiers

PMID38110762
PMCPMC11116177

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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.