title: Cerebral Protection During MitraClip Implantation: Initial Experience at 2 Centers.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. Electronic address: c.frerker@asklepios.com.
authors.forename: Christian
authors.initials: C
authors.lastname: Frerker
authors.affiliation: Asklepios Proresearch, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.affiliation: CVPath Institute, Inc., Gaithersburg, Maryland.
authors.forename: Oscar D
authors.initials: OD
authors.lastname: Sanchez
authors.affiliation: Department of Cardiology, University Hospital of the RWTH Aachen, Aachen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Reith
authors.affiliation: CVPath Institute, Inc., Gaithersburg, Maryland.
authors.forename: Maria E
authors.initials: ME
authors.lastname: Romero
authors.affiliation: CVPath Institute, Inc., Gaithersburg, Maryland.
authors.forename: Elena
authors.initials: E
authors.lastname: Ladich
authors.affiliation: Department of Cardiology, University Hospital of the RWTH Aachen, Aachen, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schröder
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Schmidt
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Kreidel
authors.affiliation: CVPath Institute, Inc., Gaithersburg, Maryland.
authors.forename: Michael
authors.initials: M
authors.lastname: Joner
authors.affiliation: CVPath Institute, Inc., Gaithersburg, Maryland.
authors.forename: Renu
authors.initials: R
authors.lastname: Virmani
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D057505:Embolic Protection Devices / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D020767:Intracranial Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D016015:Logistic Models; D008297:Male; D008944:Mitral Valve Insufficiency / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
keywords: MitraClip; cerebral protection; embolization; mitral regurgitation; transcatheter mitral valve repair