Prospective evaluation to characterize the real-world performance of the EMBOVAC aspiration catheter for neurothrombectomy: a post-market clinical follow-up trial

Once again the wrong endpoint; reperfusion! You incompetently don't realize survivors don't give a shit about reperfusion; that's only the first step to 100% recovery! What are the followon steps to GET THERE?

 Prospective evaluation to characterize the real-world performance of the EMBOVAC aspiration catheter for neurothrombectomy: a post-market clinical follow-up trialMariangela Piano1,

1. Olav Jansen2,
2. http://orcid.org/0000-0002-7611-7753Gaultier Marnat3,
3. Benjamin Gory4,
4. http://orcid.org/0000-0002-8049-1203Hannes Nordmeyer5,6,
5. Bernd Eckert7,
6. Alessandro Pedicelli8,
7. http://orcid.org/0000-0003-4287-2627Christophe Cognard9,
8. Christian Loehr10,
9. http://orcid.org/0000-0002-5847-3316Matteo Zanoni11,
10. Axel Schaefer12,
11. Antonio Macera13,
12. Jens Fiehler14,15,
13. Karen Doyle16,
14. http://orcid.org/0000-0001-5093-9751Kyriakos Lobotesis17

1. Correspondence to Dr Kyriakos Lobotesis, Imaging Department, Imperial College Healthcare NHS Trust, London, UK; k.lobotesis@nhs.net

Abstract

Background A direct aspiration first pass technique (ADAPT) is an effective alternative to stent retriever thrombectomy for patients with large vessel occlusion (LVO). The PERFECT study evaluated direct aspiration with the EMBOVAC large bore aspiration catheter in patients with LVO strokes.

Methods PERFECT was a prospective, post-market, single-arm, multicenter, observational study of patients enrolled across 11 European centers between October 2020 and July 2022. Three direct aspiration passes with EMBOVAC were mandated before switching strategy. The primary endpoint was core-lab assessed successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) post-procedure. Other outcomes included first pass mTICI ≥2c, independent 90-day modified Rankin Scale (mRS) evaluation, and symptomatic intracerebral hemorrhage (sICH) at 24 hours by a clinical events committee.

Results EMBOVAC was used in 100 patients (mean age 70.4±14.0 years, 59.0% (59/100) female). Final mTICI ≥2b was achieved in 98.0% (97/99), final mTICI ≥2b with no change in frontline therapy or thrombolytics use during the procedure was achieved in 87.9% (87/99), final mTICI ≥2c in 86.9% (86/99), and first pass mTICI ≥2c in 53.5% (53/99). sICH at 24 hours was 0%. The 90-day mRS ≤2 rate was 56.6% (56/99) and all-cause mortality was 12.9%. One device-related serious adverse event occurred within 90 days (1.0%).

Conclusions PERFECT demonstrates that EMBOVAC achieves successful reperfusion rates and favorable clinical outcomes when used in the endovascular treatment of acute ischemic stroke (AIS) using a direct aspiration technique as first line therapy in a real-world setting in patients with AIS secondary to large vessel occlusion.

Trial registration www.clinicaltrials.gov Unique identifier: NCT04531904.

Data availability statement

Data are available upon reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/jnis-2023-021407