First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement

EuroIntervention 2023;19:e-e. DOI: 10.4244/EIJ-D-23-00465

Haim Danenberg
Haim D. Danenberg1,2, MD; Hana Vaknin-Assa2,3, MD; Rajendra Makkar4, MD; Renu Virmani5, MD; Lisa Manevich1,2, MD; Pablo Codner2,3, MD; Vivek Patel4, MD; Aloke V. Finn5, MD; Uri Landes1,2, MD; Ronen Rubinshtein1,2, MD; Alon Bar1,2, MD; Rani Barnea2,3, MD; Yoav Mezape6, MS, BSc; Eyal Teichman6, MS, BSc; Sigal Eli6; Giora Weisz6,7, MD; Ran Kornowski2,3, MD
1. Wolfson Medical Center, Holon, Israel; 2. The Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel; 3. Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel; 4. Cedars-Sinai Medical Center, Los Angeles, CA, USA; 5. CVPath Institute, Gaithersburg, MD, USA; 6. Filterlex Medical Ltd, Caesarea, Israel; 7. NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA

Background: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain’s circulation, capturing the debris and thus avoiding systemic embolisation.

Aims: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR.

Methods: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours.

Results: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients.

Conclusions: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.

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