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

DOI: 10.4244/EIJ-D-21-00741

Alessandro Spirito
Alessandro Spirito1, MD; Angelo Quagliana2, MD; Marco Coiro1, MD; Gebremedhin D. Melaku3, MD; Stijn Vandenberghe2,4, MD; Gregor Leibundgut5, MD, PhD; Jonas Häner1, MD; Marco Moccetti2, MD; Marco Araco2, MD; Hector M. Garcia Garcia3, MD; Marco Valgimigli2
1. Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland; 2. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland; 3. Georgetown University, Washington, DC, USA; 4. Università della Svizzera italiana, Lugano, Switzerland; 5. Kantonsspital Baselland, Liestal, Switzerland

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

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

Methods: Consecutive patients with ACS and LTB were treated with the NeVa MTD as 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).

Results: Between 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.

Conclusions: In 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.

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acs/nste-acsaspiration devicethrombectomythrombus-containing lesionstemiStent retrievers
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