title: Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies.
abstract: The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patients groups, comparisons with pharmacological stroke prophylaxis, surgical approaches, and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies, and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.
authors.affiliation: Department of Cardiology, AHEPA University Hospital, Asklipiou 10, 57001 Thessaloniki, Greece th.lewalter@uni-bonn.de aptzikas@yahoo.com.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tzikas
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Sameer
authors.initials: S
authors.lastname: Gafoor
authors.affiliation: Hackensack UMC Heart and Vascular Hospital and The Joseph M. Sanzari Children's Hospital, Hackensack, NJ, USA.
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ruiz
authors.affiliation: Department of Cardiology, Institution of Medical Science, Uppsala University, Uppsala, Sweden.
authors.forename: Carina
authors.initials: C
authors.lastname: Blomström-Lundqvist
authors.affiliation: Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.affiliation: Arrhythmia and Electrophysiology Research Center, IRCCS Humanitas Research Hospital, Milan, Italy.|Arrhythmia and Electrophysiology II Center, Humanitas Gavazzeni Clinics, Bergamo, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cappato
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.affiliation: Cardiovascular Research Institute and Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Randal J
authors.initials: RJ
authors.lastname: Lee
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.affiliation: Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
authors.forename: Reda
authors.initials: R
authors.lastname: Ibrahim
authors.affiliation: Bloch Heart Rhythm Center @ University of Kansas Hospital, KU Cardiovascular Research Institute, Kansas City, KS, USA.
authors.forename: Dhanunjaya
authors.initials: D
authors.lastname: Lakkireddy
authors.affiliation: Cardialysis and Department of Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Osama I
authors.initials: OI
authors.lastname: Soliman
authors.affiliation: Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität, Munich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Nabauer
authors.affiliation: Stiftung Institut für Herzinfarktforschung (Foundation IHF), Ludwigshafen, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.affiliation: II. Med. Hospital Klinikum Coburg GmbH, Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.affiliation: Comprehensive Stroke Center and Department of Neurology, David Geffen School of Medicine at the University of California, Los Angeles, CA, USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Saver
authors.affiliation: Department of Nuclear Medicine, Technical University of Munich,Munich, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiemann
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Cardiovascular and Cell Sciences Research Institute, St. George's University of London, London, UK.
authors.forename: A John
authors.initials: AJ
authors.lastname: Camm
authors.affiliation: Department of Medicine-Cardiology and Intensive Care, Peter Osypka Heart Center, Clinic Munich-Thalkirchen, Am Isarkanal 36, 81379 Munich, Germany th.lewalter@uni-bonn.de aptzikas@yahoo.com.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Lewalter
mesh_terms: D020517:Atrial Appendage / Q000503:physiopathology*; D001281:Atrial Fibrillation / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002545:Brain Ischemia / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D032921:Consensus; D003299:Cooperative Behavior; D003625:Data Collection; D023381:Endpoint Determination; D006801:Humans; D033183:Interdisciplinary Communication; D007391:International Cooperation; D018579:Patient Selection; D012107:Research Design; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome
keywords: Atrial Fibrillation; LAA closure; Prevention; Stroke