ENVAST FIRST-IN-HUMAN

PUBLICATION TITLE:

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

Authors:
Alessandro Spirito, MD; Angelo Quagliana, MD; Marco Coiro, MD; Gebremedhin D. Melaku, MD; Stijn Vandenberghe, MD; Gregor Leibundgut, MD, PhD; Jonas Häner, MD; Marco Moccetti, MD; Marco Araco, MD; Hector M. Garcia-Garcia, MD; Marco Valgimigli
Journal:
Eurointervention, Feb 2021
Background:
There is no established technique for managing large thrombus burden (LTB) in patients with acute coronary syndrome (ACS).
Methods:
  • enVast was used for primary vessel recanalization and thrombus removal, followed by conventional intervention
  • A subset of patients received vacuum-assisted aspiration as an adjudicative manoeuvre 
  • Procedural complications, TIMI flow, MBG, and TTG were core-lab reviewed
aim:

Between Nov. 2019 & Mar.2021, 61 consecutive acute coronary syndrome patients with large thrombus burden underwent thrombectomy with the enVast device to assess its safety and efficacy.

Results:

TIMI Flow

  • enVast deployment was associated with immediate reperfusion in 85% and TIMI-3  flow in 74% of the patients with TIMI-0 after wire insertion
  • TIMI-3 flow increased from 31.7% to 90% after enVast (p<.001)

ST ELEVATION RESOLUTION

  • STE Resolution (≥50%) in 71.7% of patients
  • Complete STE REsolution (≥70%) in 43.5% of patients

TIMI THROMBUS GRADE

  • enVast retrieved macroscopic thrombotic material in 53% of the cases
  • enVast use decreased the angiographic thrombus burden to ≤2 in 56.9% of the patients (p<.001)

MYOCARDIAL BLUSH GRADE

  • MGB 0-1 was detected in 65% of patients at baseline and in 27% after enVast use(p<.001)
Safety:
  • Non-flow limiting, reversable coronary spasm: 14 patients (23%)
  • Side branch embolization in 1 successfully treated patient (#10): triggered the development of vacuum-assisted co-aspiration technique, which was then applied to the subsequent 51 patients
  • No other device-related complications occurred
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.