Evidence map›Paper›PMID 41372815›Full record

ArticleBMC anesthesiology2025

Use of the impella system in high-risk patients undergoing non-cardiac surgery: a pilot study.

Stefano Guarracini, Lorenzo Mazzocchetti, Andrea Italiano, Leonardo Paloscia, Massimo Di Marco, Fabio Francesco Di Mola, Pierluigi Di Sebastiano, Tommaso Grottola, Gabriele Tovalieri, Giovanni Di Ianni and 3 more

Abstract read
In one paragraph

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

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0citing papers in PubMed
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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

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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

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5 · Who and what money

Authors and funding

13 authors.

Stefano GuarraciniDepartment of Cardiology, Pierangeli Hospital, Pescara, Italy. stefanoguarracini@yahoo.it.
Lorenzo MazzocchettiDepartment of Cardiology, Pierangeli Hospital, Pescara, Italy.
Andrea ItalianoDepartment of Cardiology, Pierangeli Hospital, Pescara, Italy.
Leonardo PalosciaDepartment of Cardiology, Pierangeli Hospital, Pescara, Italy.
Massimo Di MarcoEmergency-Urgency Department, Cardiology with UTIC, Pescara "S. Spirito" Hospital, Pescara, Italy.
Fabio Francesco Di MolaUnit of Surgical Oncology, Casa di Cura Pierangeli, Largo Luigi Pierangeli 1, Pescara, Italy.
Pierluigi Di SebastianoUnit of Surgical Oncology, Casa di Cura Pierangeli, Largo Luigi Pierangeli 1, Pescara, Italy.
Tommaso GrottolaDepartment of Medical, Oral & Biotechnological Sciences, University "G. D'Annunzio" Chieti-Pescara, Chieti, Italy.
Gabriele TovalieriDepartment of Orthopedic department, Pierangeli Hospital, Pescara, Italy.
Giovanni Di IanniDepartment of Orthopedic department, Pierangeli Hospital, Pescara, Italy.
Mirta D'OrazioDepartment of Vascular Surgery, Pierangeli Hospital, Pescara, Italy.
Goffredo LiberatoscioliDepartment of anesthesiology, Pierangeli Hospital, Pescara, Italy.
Michele Di MauroDepartment of Cardiology, Pierangeli Hospital, Pescara, Italy.ORCID http://orcid.org/0000-0003-2611-5626

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with advanced heart failure are often deemed ineligible for non-cardiac surgery (NCS) due to poor hemodynamic reserve and increased perioperative risk. Mechanical circulatory support using the Impella device may stabilize cardiac function during surgery, enabling safe intervention in this population. This pilot study evaluates the feasibility, safety, and hemodynamic performance of SURGELLA, the perioperative use of Impella in high-risk patients undergoing NCS.

methodsThis single-center, single-arm, retrospective pilot study (clinical trial number not applicable) included patients with heart failure and reduced left ventricular ejection fraction (≤ 35%) who underwent major NCS with perioperative Impella support between July 24, 2023, and February 17, 2025. Impella CP with SmartAssist was placed preoperatively. Primary endpoints were safety (30-day major adverse cardiac events) and efficacy (freedom from intraoperative hemodynamic compromise). Secondary endpoints included procedural complications, laboratory changes, and postoperative recovery. Hemodynamic and laboratory parameters were compared pre- and post-Impella support.

resultsA total of 10 patients underwent Impella-supported NCS, including five gastrointestinal, four orthopedic, and one major vascular procedure. Mean duration of Impella support was 131.4 min. None of the patients experienced major adverse cardiac events, deaths from any cause, or Impella device malfunctions. Hemodynamic stability and organ function were maintained throughout the perioperative period, and only one patient experienced bleeding that required transfusion. The average time to hospital discharge following surgery was 8 ± 2 days, and median follow-up was 227 (interquartile range: 100-353) days.

conclusionsThe results of this small pilot study demonstrate that Impella-supported NCS (SURGELLA) in high-risk heart failure patients appears feasible, safe, and effective in maintaining perioperative hemodynamic stability. These early data suggest that temporary mechanical support may expand surgical eligibility for patients with advanced cardiac dysfunction. Prospective studies are warranted to further assess the role of Impella compared to standard perioperative care in this high-risk population.

Indexed as

Heart-Assist DevicesHeart FailurePerioperative CareSurgical Procedures, OperativeAgedFeasibility StudiesFemaleHemodynamicsHumansMaleMiddle AgedPilot ProjectsRetrospective StudiesAdvanced heart failureEnhanced recovery after surgeryHemodynamic optimizationHigh-riskImpellaMechanical circulatory supportNon-cardiac surgeryPercutaneous ventricular assist devicePerioperative supportPilot study

Identifiers

PMID41372815
PMCPMC12853959

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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.