Evidence map›Paper›PMID 40923678›Full record

ArticleESC heart failure2025

First evaluation of a novel pulsatile LVAD: Feasibility and haemodynamic impact in acute heart failure.

Sara Knigge, Marcelo B Bastos, Bastian Schmack, Liam Schana, Oren Malchin, Ali S Merzah, Aron F Popov, Alexander Weymann, Arjang Ruhparwar, Felix Schumacher and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESC heart failure, 2025. 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

12 authors.

Sara KniggeDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Marcelo B BastosErasmus Medical Center, Rotterdam, The Netherlands.ORCID https://orcid.org/0000-0003-2269-8983
Bastian SchmackDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Liam SchanaErasmus Medical Center, Rotterdam, The Netherlands.
Oren MalchinPulseCath BV, Breukelen, The Netherlands.
Ali S MerzahDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Aron F PopovDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Alexander WeymannDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Arjang RuhparwarDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Felix SchumacherDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Günes DoganDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Jan D SchmittoDepartment of Cardiac-, Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Funding

PulseCath BV
6 · The paper itself

Abstract

aimsNon-pharmacological therapies for acute decompensated heart failure (HF) and cardiogenic shock have evolved considerably in recent decades. Short-term mechanical circulatory support (MCS) devices can be used as circulatory backup. While nearly all available devices use continuous flow, evidence indicates that pulsatile flow can be more effective. This study presents the first experimental use of a novel counter-pulsatile left ventricular (LV) assist device (LVAD) with a primary focus on assessing its feasibility and effectiveness.

methodsThe pulsatile ventricular assist platform (pVAP) was applied in six porcine models of acute ischaemic HF with the inlet in the left atrium and the outlet in the aorta. HF was induced through stepwise ligation of the left anterior descending artery and its diagonal branches. The pVAP functioned driven by a conventional IABP console while LV pressure-volume (PV) loops and standard haemodynamics with the device OFF and ON were recorded. Absolute values and percent variations were compared using Mann-Whitney's U test and Wilcoxon's sign-rank test.

resultsThe device's output flow is frequency dependent, with an output flow of 2.64 ± 0.22 L/min at 80 bpm. Activation reduced the EDV [132 (90-145) vs. 118 (83-130) mL, P < 0.05], EDP 9 (6-10) vs. 6 (5-9) mmHg, P < 0.001], native cardiac output [CO

conclusionsThe pVAP reduced the LV mechanical load while increasing systemic pressures and reducing pulmonary pressures. Its functionality as an LVAD is characterised by consistent and predictable performance. Further research is necessary to elucidate the physiological and clinical impact of the device in animals and, subsequently, in humans.

Indexed as

Heart-Assist DevicesHeart FailureHeart VentriclesHemodynamicsPulsatile FlowVentricular Function, LeftAcute DiseaseAnimalsDisease Models, AnimalFeasibility StudiesProsthesis DesignSwinecounter‐pulsationheart failureleft ventricular assist devicemechanical circulatory supportunloading

Identifiers

PMID40923678
PMCPMC12719851

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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.