Evidence map›Paper›PMID 40525402›Full record

ArticleArtificial organs2025

Physiological Control of Realheart Total Artificial Heart.

Emanuele Perra, Daniel Jonasson, Shaikh Faisal Zaman, Nils Brynedal Ignell, Michael Broomé, Thomas Finocchiaro, Ina Laura Perkins, Seraina Anne Dual

Abstract read
In one paragraph

Article in Artificial organs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Technological evolution ofFrontiers in physiology · 2025
    Review
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.

Emanuele PerraIntelligent Heart Technology Lab, Department of Biomedical Engineering and Health Systems, KTH Royal Institute of Technology, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-7432-2139
Daniel JonassonScandinavian Real Heart AB, Västerås, Sweden.
Shaikh Faisal ZamanScandinavian Real Heart AB, Västerås, Sweden.ORCID https://orcid.org/0000-0002-3144-3176
Nils Brynedal IgnellScandinavian Real Heart AB, Västerås, Sweden.ORCID https://orcid.org/0000-0002-4618-4752
Michael BrooméAnesthesia and Intensive Care, Department of Physiology and Pharmacology, Karolinska Institute, Stockholm, Sweden.
Thomas FinocchiaroScandinavian Real Heart AB, Västerås, Sweden.ORCID https://orcid.org/0000-0002-2722-0260
Ina Laura PerkinsScandinavian Real Heart AB, Västerås, Sweden.
Seraina Anne DualIntelligent Heart Technology Lab, Department of Biomedical Engineering and Health Systems, KTH Royal Institute of Technology, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-6867-8270

Funding

Digital FuturesThe work was carried out within the strategic innovation programme 'Smarter Electronics Systems', a joint initiative by Vinnova, Formas and the Swedish Energy Agency (Energimyndigheten)VINNOVA 2022-00849VINNOVA 2024-00592
6 · The paper itself

Abstract

backgroundHeart failure (HF) affects approximately 64 million patients worldwide, where the heart's impaired ability to pump blood leads to reduced quality of life and a high 5-year mortality rate. Total artificial hearts (TAHs) offer a promising solution, but to ensure a good quality of life and prolong life expectancy for end-stage HF patients, TAHs must adapt to the body's varying metabolic demands.

methodsThis study evaluates the physiological control performance of the Realheart TAH using a hybrid mock circulation loop that simulates dynamic physiological states, such as sleep, rest, and exercise. The Realheart TAH features a preload-based control mechanism that adjusts heart rate (HR) and stroke volume (SV) in response to changes in atrial pressure, closely mimicking the native heart's ability to meet varying blood flow demands. The controller's adaptability and robustness were further tested under different levels of pulmonary vascular resistance (PVR), simulating conditions that challenge flow balance.

resultsThe results demonstrate that the Realheart TAH maintains flow balance between the right and left ventricles and stabilizes atrial pressures across all tested conditions. During simulated exercise, the controller increased cardiac output (CO) by up to 2.1 times from rest while maintaining stable atrial pressures, compared to a maximum increase of 1.2 times without the controller. During sleep, CO decreased by 25%, whereas a decrease of only 5% was observed without the controller. Under increased PVR, the controller adjusted SV and HR to preserve consistent CO and prevent blood volume build-up in the atria, which could otherwise lead to dangerously high atrial pressures.

conclusionThe physiological control system demonstrated its ability to adapt to rapid transitions between physiological states, although occasional undershoots in pressure were observed during transitions from exercise to rest conditions. This study highlights the Realheart TAH's ability to autonomously adjust to varying physiological conditions and patient needs, showing promise for treating patients with advanced HF. Future work will focus on optimizing the control system to further enhance the device's responsiveness and stability during rapid physiological transitions.

Indexed as

Heart, ArtificialHeart FailureCardiac OutputExerciseHeart RateHemodynamicsHumansModels, CardiovascularStroke VolumeVascular Resistancecardiovascular system modelinghybrid mock loopphysiological controlpulmonary hypertensiontotal artificial heart

Identifiers

PMID40525402
PMCPMC12625488

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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.