Evidence map›Paper›PMID 40352318›Full record

ArticleHealth science reports2025

Clinical and Preclinical Evidence on a Novel Percutaneous Pulsatile Ventricular Assist Device (PulseCath): Protocol for a Scoping Review.

Viviana Teresa Agosta, Alice Bottussi, Jacopo D'Andria Ursoleo, Letizia Perinati, Fabrizio Monaco

Abstract read
In one paragraph

Article in Health science reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Viviana Teresa AgostaDepartment of Anesthesia and Intensive Care IRCCS San Raffaele Scientific Institute Milan Italy.
Alice BottussiDepartment of Anesthesia and Intensive Care IRCCS San Raffaele Scientific Institute Milan Italy.
Jacopo D'Andria UrsoleoDepartment of Anesthesia and Intensive Care IRCCS San Raffaele Scientific Institute Milan Italy.ORCID https://orcid.org/0000-0002-6313-9160
Letizia PerinatiDepartment of Anesthesia and Intensive Care IRCCS San Raffaele Scientific Institute Milan Italy.
Fabrizio MonacoDepartment of Anesthesia and Intensive Care IRCCS San Raffaele Scientific Institute Milan Italy.ORCID 0000-0001-5186-1976

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Aims: Temporary mechanical circulatory support (tMCS) devices play a crucial role in improving survival for patients with hemodynamic instability by providing cardiac assistance, and may serve as either a bridge to recovery or destination therapy. Recently, the PulseCath (iVAC2L and iVAC3L) has been introduced into the broader tMCS landscape. Due to its ease of implantation and low cost, it appears to enhance and complement the spectrum of tMCS devices. This planned scoping review aims to summarize the potential applications and reported side effects of PulseCath, while elucidating its underlying pathophysiological principles and hemodynamic effects, incorporating both preclinical in vivo and clinical published data. Methods: We will perform a scoping review in accordance to the JBI methodology and the extension for Scoping Reviews of the PRISMA checklist. We will conduct a comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, and Google Scholar (from their inception until February 28, 2025) to identify and retrieve preclinical in vivo and clinical investigations on the implantation of the PulseCath. EndNote X9 and Rayyan softwares will be used to aid article selection. Standardized forms will be employed for subsequent data charting and extraction. The ROBINS-I and RoB2 tools will be employed to perform a formal assessment of the risk of bias of included studies. Results: Included studies will be categorized into two groups: preclinical in vivo and clinical. The clinical studies will be further classified according to implantation strategy, either pre-emptive or bail-out. The main findings from the selected studies will be presented through a narrative synthesis. If sufficient homogeneity exists among the studies, the presentation of quantitative data will be conducted. Tables and figures will be used to aid in the illustration of the findings. Conclusion: The planned scoping review will systematically examine the existing evidence on the hemodynamic effects, pathophysiology, and potential complications of PulseCath, ultimately seeking to delineate optimal clinical settings for its use. The findings could highlight research gaps in tMCS support and expand the clinical application of PulseCath, thus improving patient outcomes and enhancing clinicians' understanding of this novel device.

Indexed as

cardiogenic shockhemodynamic instabilityImpellaintra‐aortic balloon pumpiVAC2LiVAC3Lpulsatile ventricular assist devicePulseCathtemporary mechanical circulatory support

Identifiers

PMID40352318
PMCPMC12063065

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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.