Author + information
- Received August 5, 2015
- Revision received September 14, 2015
- Accepted September 24, 2015
- Published online January 25, 2016.
- Christian Frerker, MD∗∗ (, )
- Michael Schlüter, PhD†,
- Oscar D. Sanchez, MD‡,
- Sebastian Reith, MD§,
- Maria E. Romero, MD‡,
- Elena Ladich, MD‡,
- Jörg Schröder, MD§,
- Tobias Schmidt, MD∗,
- Felix Kreidel, MD∗,
- Michael Joner, MD‡,
- Renu Virmani, MD‡ and
- Karl-Heinz Kuck, MD∗
- ∗Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany
- †Asklepios Proresearch, Hamburg, Germany
- ‡CVPath Institute, Inc., Gaithersburg, Maryland
- §Department of Cardiology, University Hospital of the RWTH Aachen, Aachen, Germany
- ↵∗Reprint requests and correspondence:
Dr. Christian Frerker, Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
Objectives This study sought to assess the feasibility and safety of using a filter-based cerebral protection system (CPS) during MitraClip implantation and to report on the histopathologic analysis of the captured debris.
Background Stroke is one of the serious adverse events associated with MitraClip therapy.
Methods Between July 2014 and March 2015, 14 surgical high-risk patients (age 75 ± 7 years; 7 men; median logistic EuroSCORE 21%) underwent MitraClip implantation employing cerebral protection with a dual embolic filter system. All patients had severe mitral regurgitation of predominantly functional origin.
Results All procedures were successfully completed for both CPS deployment/retrieval and MitraClip implantation. A total of 28 filters (2 from each patient) were analyzed. Microscopically, debris was identified in all 14 patients. The most common tissue types were acute thrombus and small fragments of foreign material, which were found in 12 patients (85.7%) each. Organizing thrombus was present in 4 patients (28.6%), valve tissue and/or superficial atrial wall tissue in 9 patients (64.3%), and fragments of myocardium in 2 patients (14.3%). No transient ischemic attacks, strokes, or deaths occurred peri-procedurally or during a median follow-up interval of 8.4 months.
Conclusions In this small study of patients undergoing MitraClip treatment with cerebral protection, embolic debris potentially conducive to cerebrovascular events was found in all patients. Debris was composed most often of acute thrombus, foreign material likely originating from the hydrophilic device coating, and valve/atrial wall tissue. Further studies are warranted to assess the impact of cerebral protection on the incidence of cerebrovascular events after MitraClip therapy.
Dr. Frerker has received lecture honoraria from Abbott Vascular, Inc., and Claret Medical, Inc. Dr. Joner has received honoraria from OrbusNeich, Abbott Vascular, Boston Scientific, and Biotronik; and research grants from OrbusNeich, Abbott Vascular, BioSensors International, SinoMedical, Terumo Corporation, CeloNova, W.L. Gore, Medtronic, Microport, Boston Scientific, and Biotronik. Dr. Virmani has served as a consultant to 480 Biomedical, Abbott Vascular, Medtronic, and W.L. Gore; has received honoraria from 480 Biomedical, Abbott Vascular, Boston Scientific, Cordis J&J, Lutonix Bard, Medtronic, Merck, Terumo Corporation, W.L. Gore, Cardiovascular Systems Inc., Meril Life Sciences, and Spectranetics; and has received institutional grants/research support from 480 Biomedical, Abbott Vascular, Atrium, BioSensors International, Biotronik, Boston Scientific, Cordis Johnson&Johnson, GlaxoSmithKline, Kona, Medtronic, MicroPort Medical, CeloNova, OrbusNeich Medical, ReCore, SINO Medical Technology, Terumo Corporation, W.L. Gore, Spectranetics, Cardiovascular Systems Inc., Lutonix Bard, Surmodics, and Meril Life Sciences. Dr. Kuck has received consultant fees and research grants from St. Jude Medical, Medtronic, and Edwards Lifesciences; and has received research grants from Abbott Vascular, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 5, 2015.
- Revision received September 14, 2015.
- Accepted September 24, 2015.
- American College of Cardiology Foundation