Evidence map›Paper›PMID 29703578›Full record

ArticleThe Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation2018

Early in vivo experience with the pediatric continuous-flow total artificial heart.

Jamshid H Karimov, David J Horvath, Nicole Byram, Gengo Sunagawa, Barry D Kuban, Shengqiang Gao, Raymond Dessoffy, Kiyotaka Fukamachi

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% of its field
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 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  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

8 authors at 1 institution in 1 country.

Jamshid H KarimovDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
David J HorvathR1 Engineering LLC, Euclid, Ohio, USA.
Nicole ByramDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Gengo SunagawaDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Barry D KubanMedical Device Solutions, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Shengqiang GaoMedical Device Solutions, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Raymond DessoffyDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Kiyotaka FukamachiDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address: fukamak@ccf.org.
Cleveland Clinic Lerner College of Medicine · US

Funding

Pediatric Implantable Artificial LungR01HD015434 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HIRSCHL, RONALD BRUCE · 1985 to 2021
$10.8M
NICHD NIH HHS R01 HD015434
6 · The paper itself

Abstract

backgroundHeart transplantation in infants and children is an accepted therapy for end-stage heart failure, but donor organ availability is low and always uncertain. Mechanical circulatory support is another standard option, but there is a lack of intracorporeal devices due to size and functional range. The purpose of this study was to evaluate the in vivo performance of our initial prototype of a pediatric continuous-flow total artificial heart (P-CFTAH), comprising a dual pump with one motor and one rotating assembly, supported by a hydrodynamic bearing.

methodsIn acute studies, the P-CFTAH was implanted in 4 lambs (average weight: 28.7 ± 2.3 kg) via a median sternotomy under cardiopulmonary bypass. Pulmonary and systemic pump performance parameters were recorded.

resultsThe experiments showed good anatomical fit and easy implantation, with an average aortic cross-clamp time of 98 ± 18 minutes. Baseline hemodynamics were stable in all 4 animals (pump speed: 3.4 ± 0.2 krpm; pump flow: 2.1 ± 0.9 liters/min; power: 3.0 ± 0.8 W; arterial pressure: 68 ± 10 mm Hg; left and right atrial pressures: 6 ± 1 mm Hg, for both). Any differences between left and right atrial pressures were maintained within the intended limit of ±5 mm Hg over a wide range of ratios of systemic-to-pulmonary vascular resistance (0.7 to 12), with and without pump-speed modulation. Pump-speed modulation was successfully performed to create arterial pulsation.

conclusionThis initial P-CFTAH prototype met the proposed requirements for self-regulation, performance, and pulse modulation.

Indexed as

Heart, ArtificialProsthesis DesignAnimalsChildHeart FailureHemodynamicsHumansInfantSheepblood pumpschildheart-assist devicesheart failureinfantmechanical circulatory supporttransition to adult care

Identifiers

PMID29703578
PMCPMC6647019
OpenAlexW2794925139

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.