Evidence map›Paper›PMID 38926145›Full record

ArticleBMJ open2024

Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

Vittoria Ardito, Carla Rognoni, Marina Pieri, Alessandro Barbone, Carlo Briguori, Emanuele Cigala, Gino Gerosa, Mario Iannaccone, Antonio Loforte, Marco Marini and 12 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

22 authors.

Vittoria ArditoCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy.ORCID 0000-0003-2034-716X
Carla RognoniCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy carla.rognoni@unibocconi.it.ORCID 0000-0002-6330-0591
Marina PieriDepartment of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milano, Italy.
Alessandro BarboneIRCCS Humanitas Research Hospital, Rozzano, Italy.
Carlo BriguoriMediterranea Cardiocentro, Clinica Mediterranea SpA, Napoli, Italy.
Emanuele CigalaUOC Cardiologia Interventistica, Ospedale Monaldi, Napoli, Italy.
Gino GerosaCardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Mario IannacconeDivision of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Torino, Italy.
Antonio LoforteDipartimento di Scienze Chirurgiche, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Marco MariniDipartimento di Scienze Cardiovascolari, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy.
Andrea MontaltoAzienda Ospedaliera di Caserta Sant'Anna e San Sebastiano, Caserta, Italy.
Jacopo OregliaNiguarda Hospital, Milano, Italy.
Davide PaciniUniversity of Bologna, Bologna, Italy.
Mauro PennacchiDipartimento Cardio Toraco Vascolare, U.O. Cardiologia Interventistica, Azienda Ospedaliera San Camillo Forlanini, Roma, Italy.
Vincenzo PestrichellaDivision of Cardiology, Ospedale Mater Dei, Bari, Italy.
Italo PortoDICATOV-CardioThoracic and Vascular, Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l'Oncologia, Genova, Italy.ORCID 0000-0002-9854-5046
Pierluigi StefanoAzienda Ospedaliero Universitaria Careggi, Firenze, Italy.
Giuseppe TarantiniDepartment of Cardiac, Thoracic, Vascular Sciences and Public Health, Università degli Studi di Padova, Padova, Italy.
Serafina ValenteAzienda Ospedaliera Universitaria Senese, Siena, Italy.
Pietro VandoniFondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Rosanna TarriconeCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy.
Anna Mara ScandroglioDepartment of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milano, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Indexed as

Cost-Benefit AnalysisExtracorporeal Membrane OxygenationHeart-Assist DevicesShock, CardiogenicBudgetsHumansItalyMulticenter Studies as TopicObservational Studies as TopicProspective StudiesQuality of LifeRetrospective Studiescardiologyhealth economicsobservational study

Identifiers

PMID38926145
PMCPMC11216050

What OpenQuestion holds

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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.