Cerebral Protection during Transcatheter and Surgical Heart Valve Procedures Using a Novel Endovascular Filter Device

B. Vogel; L. Conradi; M. Seiffert; J. Schirmer; E. Lubos; S. Blankenberg; H. Reichenspurner; U. Schäfer; H. Treede

doi:10.1055/s-0035-1544429

The Thoracic and Cardiovascular Surgeon, Table of Contents

Cerebral Protection during Transcatheter and Surgical Heart Valve Procedures Using a Novel Endovascular Filter Device

B. Vogel ¹, L. Conradi ¹, M. Seiffert ², J. Schirmer ², E. Lubos ², S. Blankenberg ², H. Reichenspurner ¹, U. Schäfer ², H. Treede ¹

¹Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herzzentrum Hamburg, Hamburg, Germany
²Klinik und Poliklinik für Allgemeine und Interventionelle Kardiologie, Universitäres Herzzentrum Hamburg, Hamburg, Germany

Abstract

Objectives: Embolic protection by dual filtration of cerebral blood flow potentially reduces intraprocedural distal embolization by capturing liberated embolic debris. We aimed to describe our early experience with the Claret^TM Filtration System cerebral protection device (Claret Medical, Inc. Santa Rosa, CA, USA) in patients undergoing transcatheter or surgical valve procedures at our center. Primary endpoints were technical success, procedural and 30-day stroke rates, as well as device-related complications.

Methods: From 2013 through 2014, 28 patients at high-risk for embolic complications scheduled for TAVI, MitraClip, minimally-invasive surgical aortic valve replacement or valvulopasty were included. High-risk criteria were valve-in-valve procedures (8/28), left atrial appendage (LAA) thrombus (7/28), severely calcified aortic valves (10/28) or mobile valvular atheroma (2/28). Once, the device was used after thrombus formation on the implant catheter during a MitraClip procedure. The device was placed percutaneously via the right radial or brachial artery with proximal and distal filters placed in the brachiocephalic trunk and left common carotid artery immediately preceeding procedures.

Results: In patients treated by TAVI, the device was used for transfemoral implantation of Sapien XT/3 (14/24), St. Jude Portico (2/20), Medtronic CoreValve (5/24), Symetis Acurate (1/24), Boston Scientific Lotus (1/24) or for transapical implantation of Symetis Acurate (1/24) transcatheter heart valves. No procedural technical complications occurred associated with positioning or removal of the device (mean positioning time: 3.2 minute, radiation dose: 275,49 µGµm²; mean removal time: 20 second, radiation dose 200 µGµm²). No procedural transient ischemic attacks (TIA), minor or major strokes were observed. Thirty-day follow-up showed one TIA at day 8 following TAVI (1/28, 5.6%).

One patient died after an inraprocedural type A dissection and endovascular stenting, one of an intracerebral hemorrhage, and one patient with a known LAA thrombus died after mesenteric embolization.

Conclusion: This device offers the possibility for effective cerebral embolic protection during transcatheter as well as surgical valve procedures. However, there is a potential risk to induce an embolic stroke due to positioning of the device itself. Larger patient numbers and comparative studies are needed to determine a possible clinical benefit which would justify routine clinical application.