O-063 IMPROVED LVO FIRST-PASS EFFECT WITH PRECISE CYCLIC ASPIRATION: EARLY EXPERIENCE WITH THE RAPIDPULSE™ SYSTEM
G Gal (1), J Gallego León (2), F Ballenilla (3), C Domínguez Rodríguez (2), G Barbieri (2), E Barcena Ruiz (3), J Munoz Olmedo (3), J Rayón Aledo (2), A Diaz (1), A Sagredo Barra (2), F Sánchez Blanco (2), R Nogueira (4)
(1) Odense University Hospital, Odense, DENMARK; (2) General University Hospital of Alicante, Alicante, SPAIN; (3) Hospital Universitario 12 de Octubre, Madrid, SPAIN; (4) Neurology, University of Pittsburgh School of Medicine, Pittsburgh, PA
First-pass reperfusion effect (FPE) has been shown to be associated with improved clinical outcomes and reduced mortality in mechanical thrombectomy (MT) for patients with large vessel occlusion strokes (LVOS). However, FPE is achieved in less than 30% of patients undergoing MT with the current technology.
Materials and Methods
We report on the prospective, multicenter, first-in-human experience of the RapidPulseTM Cyclic Aspiration System. This novel technology consists of a valve box that precisely and rapidly cycles the vacuum pressure from full vacuum to no vacuum 8 times per second. Patients with acute ischemic stroke (AIS) due to LVO involving the intracranial internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar artery (BA) or vertebral arteries (VA), up to 24 hours from stroke onset (or last known well), without evidence of ICAD and/or tandem occlusions, and target lesion treated with Medtronic React 71 aspiration catheter were considered for inclusion. A single-use tubing set was used in conjunction with the Medtronic React 71 catheter and a commercially available pump. The primary outcome was the rate of FPE success with complete/near reperfusion, as defined by mTICI ≥ 2c after one pass. Secondary outcomes included frontline technical success, as defined by mTICI ≥2b after final pass with no rescue therapy, and incidence of vessel injury and/or vasospasm. Outcomes were compared against historical controls from a recent meta-analysis (n=9,082).
A total of 29 patients were included (table 1). The rate of FPE (mTICI ≥2c after one-pass) was significantly higher in the RapidPulse-cohort than in the historical cohort (69% [20/29] vs. 28%; p<0.0001). Minor transient vasospasm was observed in one patient. No vessel injury was observed.
In this early experience, the RapidPulseTM Aspiration System was shown to be safe, and effective, resulting in one of the highest rates of FPE reported to date. This novel technology may allow clinicians to reduce reliance on more complex techniques and significantly reduce the disposable device costs associated with treating LVOS. Additional studies are currently underway.
The RapidPulse™ System is not yet cleared for marketing by the US Food & Drug Administration. It is not available for commercial sale.
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