Evidence map›Paper›PMID 34992050›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2022

A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes.

Alessandro Spirito, Angelo Quagliana, Marco Coiro, Gebremedhin D Melaku, Stijn Vandenberghe, Gregor Leibundgut, Jonas Häner, Marco Moccetti, Marco Araco, Hector M Garcia-Garcia and 1 more

Abstract read
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Coronary stent retriever-assisted thrombectomy.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  8. Article
  9. Review
  10. Article
  11. Complex Coronary Interventions: Are We Reaching a Plateau?Journal of personalized medicine · 2022
    Article
  12. 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

11 authors.

Alessandro SpiritoDepartment of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.
Angelo QuaglianaCardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Marco CoiroDepartment of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.
Gebremedhin D MelakuGeorgetown University, Washington, DC, USA.
Stijn VandenbergheCardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Gregor LeibundgutKantonsspital Baselland, Liestal, Switzerland.
Jonas HänerDepartment of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.
Marco MoccettiCardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Marco AracoCardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Hector M Garcia-GarciaGeorgetown University, Washington, DC, USA.
Marco ValgimigliCardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is no established technique for managing large thrombus burden (LTB) in patients with acute coronary syndrome (ACS).

aimsThe aim of this study was to assess the safety and efficacy of the NeVa (Vesalio) mechanical thrombectomy device (MTD) in ACS patients with LTB.

methodsConsecutive patients with ACS and LTB were treated with the NeVa MTD as the primary vessel recanalisation and thrombus removal modality, followed by conventional intervention. We further developed a bench model and applied to a subset of patients, a vacuum-assisted aspiration technique, exploiting 6 Fr-compatible conventional guiding catheter extensions, as an adjudicative manoeuvre to the use of stent-based MTD. A core laboratory reviewed the angiographic images for procedural complications, Thrombolysis In Myocardial Infarction (TIMI) flow, myocardial blush grade (MBG) and TIMI thrombus grade (TTG).

resultsBetween November 2019 and March 2021, 61 patients underwent thrombectomy with the NeVa device. Non-flow limiting and reversible coronary spasm occurred in 14 (23%) patients. One patient (#10) suffered from side branch embolisation, which was successfully treated with the NeVa, triggering the development of a vacuum-assisted aspiration technique in a bench model, which was then applied to the subsequent 51 patients. No other device-related complications occurred. After NeVa use, TIMI flow <3 decreased from 68.3% at baseline to 10.3% (p<0.001), MBG <2 from 65% to 27.6% (p<0.001), TTG ≥3 from 96.7% to 43.2% (p<0.001), respectively.

conclusionsIn patients with LTB, the NeVa MTD was safe and associated with high rates of vessel recanalisation and thrombus removal. The concomitant use of vacuum-assisted aspiration has potential to improve the effectiveness and safety of the technique.

Indexed as

Acute Coronary SyndromeCoronary ThrombosisCoronary AngiographyCoronary CirculationHumansProspective StudiesThrombectomyTreatment Outcome

Identifiers

PMID34992050
PMCPMC9912965

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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.