Thrombectomy aspiration post-market study in acute stroke with the Q aspiration catheter: the TAPAS study

Mariano Espinosa de Rueda, Federico Ballenilla Marco, Eñaut Garmendia Lopetegui, Jose M Pumar, Joaquin Zamarro, Blanca García-Villalba, Jose Díaz-Pérez, Antonio Mosqueira, Alex Lüttich, Jose-Angel Larrea, Guillermo Parrilla, Mariano Espinosa de Rueda, Federico Ballenilla Marco, Eñaut Garmendia Lopetegui, Jose M Pumar, Joaquin Zamarro, Blanca García-Villalba, Jose Díaz-Pérez, Antonio Mosqueira, Alex Lüttich, Jose-Angel Larrea, Guillermo Parrilla

Abstract

Background: The Q Aspiration Catheter (MIVI Neuro) has demonstrated greater aspiration flow rates and ingestion forces compared with conventional catheters in vitro. The safety and performance of the Q Catheter was assessed using a direct aspiration first pass technique in patients with acute ischemic stroke at four neurointerventional centers in Spain.

Methods: We included adult patients who underwent mechanical thrombectomy between March 2019 and March 2020 using the Q Catheter as first-line therapy. Performance endpoints included final successful revascularization of the target vessel (defined as modified thrombolysis in cerebral infarction (mTICI) grade 2B/3), first pass revascularization, and overall Q Catheter revascularization. Safety endpoints were symptomatic intracranial hemorrhage (sICH), embolization to new territory (ENT), and procedural complications. Modified Rankin Scale (mRS) score and all-cause mortality were also assessed.

Results: Forty-five subjects were enrolled. The Q Catheter successfully navigated to the lesion in 95.5% (43/45) of patients. Final successful mTICI 2B/3 revascularization was achieved in 93.3% (42/45), first pass mTICI 2B/3 revascularization with the Q Catheter was 55.3% (21/38), and overall with Q Catheter mTICI 2B/3 revascularization was 65.8% (25/38). Favorable clinical outcome of mRS 0-2 was achieved in 55.6% (25/45). There were no cases of ENT. sICH and mortality rates were 2.2% (1/45) and 13.3% (6/45), respectively.

Conclusion: In this multicenter, observational study, the Q Aspiration Catheter used as first-line therapy demonstrated a good and safe profile in terms of navigation, revascularization, and safety in patients with acute ischemic stroke.

Keywords: Catheter; Device; Stroke; Thrombectomy.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.

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