TY - JOUR JO - EuroIntervention TI - A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes AB - <p><strong>Background:</strong> There is no established technique for managing large thrombus burden (LTB) in patients with acute coronary syndrome (ACS).</p> <p><strong>Aims:</strong> 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.</p> <p><strong>Methods:</strong> Consecutive 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).</p> <p><strong>Results:</strong> 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 &lt;3 decreased from 68.3% at baseline to 10.3% (p&lt;0.001), MBG &lt;2 from 65% to 27.6% (p&lt;0.001), TTG &ge;3 from 96.7% to 43.2% (p&lt;0.001), respectively.</p> <p><strong>Conclusions:</strong> 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.</p> AU - Spirito Alessandro AU - Quagliana Angelo AU - Coiro Marco AU - Melaku D. Gebremedhin AU - Vandenberghe Stijn AU - Leibundgut Gregor AU - Häner Jonas D. AU - Moccetti Marco AU - Araco Marco AU - Garcia-Garcia M. Hector AU - Valgimigli Marco VL - 18 IS - 3 Y1 - 24/06/2022 Y1 - 2022 DOI - 10.4244/EIJ-D-21-00741 SP - 242 EP - 252 KW - acs/nste-acs KW - aspiration device KW - thrombectomy KW - thrombus-containing lesion KW - stemi KW - Stent retrievers PB - Europa Digital & Publishing SE - Coronary interventions UR - https://eurointervention.pcronline.com/article/a-prospective-first-in-human-use-of-the-neva-mechanical-thrombectomy-device-for-patients-with-acute-coronary-syndromes SN - 1774-024X ER -