ABSTRACT - ESOC 2023

IMPROVED LVO FIRST-PASS EFFECT WITH PRECISE CYCLIC ASPIRATION: EARLY EXPERIENCE WITH THE RAPIDPULSE™ SYSTEM

Raul Nogueira (1), Gyula Gal (2), José Ignacio Gallego (3), Francisco Mont'alverne (4), Serdar Geyik (5), Karlis Kupcs (6), Federico Ballenilla (7), Carlos Domínguez Rodríguez (3), Giorgio Barbieri (3), Eduardo Barcena (7), José Muñoz Olmedo (7), Jose Carlos Rayon-Aledo (3), Anabel Diaz (2), Fernando Sánchez Blanco (3), Arsida Bajrami (5), Eren Erdem (5), Özgür Zülfükar Ertuğrul (5), Fabrício Oliveira Lima (4), Felipe Rocha (4), George Mendes (4), Alessandra Braga Cruz Guedes de Morais (4), Henrique Silva (4), Hellen Homem (4), Diego Bandeira (4), José Bezerra (4), Lidemarcks Irineu Andrade (4), Anderson de Lucena (4), Carmen Serna Candel (3), Helmuts Kidikas (6), Jānis Vētra (6), Antonio Sagredo (3)

(1) Univ of Pittsburgh, Neurology, Pittsburgh, United States, (2) Odense University Hospital, Neuroradiology, Odense, Denmark, (3) General University Hospital of Alicante, Neuroradiology, Alicante, Spain, (4) Hospital Geral de Fortaleza (HGF), Neuroradiology, Fortaleza, Brazil, (5) Istanbul Aydin University VM Medical Park Florya Hospital, Neuroradiology, Istanbul, Turkey, (6) P. Stradins Clinical University Hospital, Neurosurgery, Riga, Latvia, (7) Hospital Universitario 12 de Octubre, Neuroradiology, Madrid, Spain

Background and aims:

First-pass effect (FPE) is associated with improved clinical outcomes in mechanical thrombectomy (MT) for large vessel occlusion strokes (LVOS). However, FPE is achieved in only 30-40% of patients with the current devices. The RapidPulseTM Cyclic Aspiration System (RP) is a novel technology consisting of a valve box that precisely cycles pressure from full to no vacuum multiple times per second adding kinetic energy to the suction forces. Initial clinical evaluation suggests that the system can achieve FPE rates in the 70% range. We aim to evaluate the RP as a frontline approach in LVOS.

Methods:

Prospective, multicenter, open-label, core lab adjudicated, early experience of the RapidPulseTMSystem. Patients with LVOS involving anterior and/or posterior circulations within 24 hours from stroke onset, without evidence of ICAD and/or tandem occlusions, and amenable to treatment with the Medtronic React-71 aspiration catheter were eligible. The primary outcome was the rate of FPE (mTICI ≥2c after one pass). Secondary outcomes included frontline technical success (mTICI ≥2b after final pass with no rescue therapy), and incidence of vessel injury and/or vasospasm. The study will enroll up to 100 participants at 6 centers across Spain, Turkey, Denmark, Latvia and Brazil. 

Results:

As of December 2022, about two-thirds of the target enrollment has been achieved. Final results will be presented at the ESOC.

Conclusions:

RapidPulseTM is a novel cyclic aspiration technology designed to achieve faster and better reperfusion in LVOS while significantly reducing disposable device costs. Additional larger studies are currently underway.