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, H. M. Garcia-Garcia, Marco Valgimigli
Abstract
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 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). 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.