Abstract 208: Optimal Catheter Position and Aspiration Technique Improves Safety and Efficacy Using Next Generation Funnel Catheter
Authors: Tomasello Alejandro , Zamarro Joaquin , Terceño Mikel , Requena Manuel , Bashir Samia , Diaz Jose , Laguarta Aina , Sanchez Sonia , Ribo Marc 
Published: March 2024

Introduction

The Advanced Neurovascular Access (ANA5, Anaconda Biomed) is a novel stroke thrombectomy catheter comprising a distal self‐expanding covered funnel designed to locally restrict blood flow in the Internal Carotid Artery (ICA) and, when used in conjuction with available stent retreiver, reduce clot fragmentation during clot ingestion. The ANAIS study aimed to investigate the safety and efficacy of the ANA5 device (‘Funnel’) in different deployment locations and aspiration conditions.

Methods

Prospective, single‐arm, multi‐center study to assess the safety and performance of ANA5 in combination with a stent retriever in patients with Acute Ischemic Stroke (ANAIS). An independent imaging corelab and Clinical Events Committee assessed the different predefined outcomes. Patients with anterior circulation vessel occlusion admitted within 24 hours from symptom onset were eligible. The primary efficacy endpoint was successful recanalization, defined as mTICI ≥2b in the target vessel within three passes of the Funnel device. The primary safety endpoint was a composite of symptomatic Intracranial Hemorrhage within 24 hours and any device related severe adverse event.

The impact of the funnel deployment location in the different ICA segments (C1 to C4 or above) and the condition of the aspiration on angiographical outcome was also evaluated.

Results

A total of 39 subjects who complied with all inclusion/exlusion criteria were treated by 10 different physicians in 3 stroke centers. Mean age was 69.9 ±13.2 years, 52.5% women, and the median National Institutes of Health Stroke Scale on admission was 16.0 [12.5‐19.5]. Initial occlusion location was: TICA 25.0%, M1‐MCA 52.5% and M2‐MCA 22.5%. The rate of succesful reperfusion within 3 passes was 74.4% (29/39) (primary efficacy endpoint). First pass effect (FPE) mTICI 2b‐3 and 2c‐3 was 56.4% (22/39) and 48.7% (19/39), respectively. Zero sICHs at 24h or SADE at 5 days were reported (primary safety endpoint). At 90 days, the rate of modified Rankin Scale score 0‐2 was: 57.9% (22/38).

The efficacy of the thrombectomy procedure using the Funnel increases when:

1. The funnel was deployed in the higher ICA segments (below ophtalmic artery) with diameter between 3.5‐5.0mm, ensuring full apposition of the funnel to the vessel wall: C1(n=10): 40.0% vs. C2 or higher (n=29): 86.2% (p < 0.002).

2. Continuous aspiration was applied during the full retrieval of the stentriever in the Funnel (89.3% (n=28) vs. 36.4% (n=11), p < 0.0005).

3. When both continuous aspiration and appropriate ICA location were achieved, the Clinical efficacy endpoint improved to 95.5% (n=22), and FPE mTICI 2b‐3 and 2c‐3 were 72.7% and 59.1% respectively.

Conclusion

The use of the next generation Funnel Device in the ANAIS study results in a high rate of successful recanalization with an optimal safety profile and favorable 90 days clinical outcomes. The performance improved when the Funnel was deployed above the C1 cervical segment of the ICA, and continuous aspiration was applied during the full stent retrieval.