Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies

Apostolos Tzikas; David R. Holmes; Sameer Gafoor; Carlos E. Ruiz; Carina Blomstrom-Lundqvist; Hans Christoph Diener; Riccardo Cappato; Saibal Kar; Randal J. Lee; Robert A. Byrne; Reda Ibrahim; Dhanunjaya Lakkireddy; Osama I. Soliman; Michael Nabauer; Steffen Schneider; Johannes Brachmann; Jeffrey L. Saver; Klaus Tiemann; Horst Sievert; A. John Camm; Thorsten Lewalter

doi:10.1093/europace/euw141

Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies

Apostolos Tzikas
, David R. Holmes
, Sameer Gafoor
, Carlos E. Ruiz
, Carina Blomstrom-Lundqvist
, Hans Christoph Diener
, Riccardo Cappato
, Saibal Kar
, Randal J. Lee
, Robert A. Byrne
, Reda Ibrahim
, Dhanunjaya Lakkireddy
, Osama I. Soliman
, Michael Nabauer
, Steffen Schneider
, Johannes Brachmann
, Jeffrey L. Saver
, Klaus Tiemann
, Horst Sievert
, A. John Camm

Thorsten Lewalter

AHEPA University Hospital
Mayo Clinic
CardioVascular Center Frankfurt
Joseph M. Sanzari Children's Hospital
Uppsala University
University Clinics
Humanitas Research Hospital
Humanitas Gavazzeni Clinics
Cedars-Sinai Medical Center
University of California San Francisco
Technical University Munich
Université de Montréal
University of Kansas Health System
Erasmus MC
Ludwig-Maximilians-University
Stiftung Institut für Herzinfarktforschung
II. Med. Hospital Klinikum Coburg GmbH
McGill University
St. George’s University of London
Clinic Munich-Thalkirchen

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

228 Citations (Scopus)

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 LAAOamong the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

Original language	English
Pages (from-to)	4-15
Number of pages	12
Journal	Europace
Volume	19
Issue number	1
DOIs	https://doi.org/10.1093/europace/euw141
Publication status	Published - 2017
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Atrial Fibrillation
LAA closure
Prevention
Stroke

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10.1093/europace/euw141

Cite this

Tzikas, A., Holmes, D. R., Gafoor, S., Ruiz, C. E., Blomstrom-Lundqvist, C., Diener, H. C., Cappato, R., Kar, S., Lee, R. J., Byrne, R. A., Ibrahim, R., Lakkireddy, D., Soliman, O. I., Nabauer, M., Schneider, S., Brachmann, J., Saver, J. L., Tiemann, K., Sievert, H., ... Lewalter, T. (2017). Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace, 19(1), 4-15. https://doi.org/10.1093/europace/euw141

@article{9650c9c112cf4b7f9a932d2f34a72162,

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 LAAOamong the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.",

keywords = "Atrial Fibrillation, LAA closure, Prevention, Stroke",

author = "Apostolos Tzikas and Holmes, \{David R.\} and Sameer Gafoor and Ruiz, \{Carlos E.\} and Carina Blomstrom-Lundqvist and Diener, \{Hans Christoph\} and Riccardo Cappato and Saibal Kar and Lee, \{Randal J.\} and Byrne, \{Robert A.\} and Reda Ibrahim and Dhanunjaya Lakkireddy and Soliman, \{Osama I.\} and Michael Nabauer and Steffen Schneider and Johannes Brachmann and Saver, \{Jeffrey L.\} and Klaus Tiemann and Horst Sievert and Camm, \{A. John\} and Thorsten Lewalter",

note = "Publisher Copyright: {\textcopyright} The Author 2016.",

year = "2017",

doi = "10.1093/europace/euw141",

language = "English",

volume = "19",

pages = "4--15",

journal = "Europace",

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publisher = "Oxford University Press",

number = "1",

}

Tzikas, A, Holmes, DR, Gafoor, S, Ruiz, CE, Blomstrom-Lundqvist, C, Diener, HC, Cappato, R, Kar, S, Lee, RJ, Byrne, RA, Ibrahim, R, Lakkireddy, D, Soliman, OI, Nabauer, M, Schneider, S, Brachmann, J, Saver, JL, Tiemann, K, Sievert, H, Camm, AJ & Lewalter, T 2017, 'Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies', Europace, vol. 19, no. 1, pp. 4-15. https://doi.org/10.1093/europace/euw141

TY - JOUR

T1 - Percutaneous left atrial appendage occlusion

T2 - The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies

AU - Tzikas, Apostolos

AU - Holmes, David R.

AU - Gafoor, Sameer

AU - Ruiz, Carlos E.

AU - Blomstrom-Lundqvist, Carina

AU - Diener, Hans Christoph

AU - Cappato, Riccardo

AU - Kar, Saibal

AU - Lee, Randal J.

AU - Byrne, Robert A.

AU - Ibrahim, Reda

AU - Lakkireddy, Dhanunjaya

AU - Soliman, Osama I.

AU - Nabauer, Michael

AU - Schneider, Steffen

AU - Brachmann, Johannes

AU - Saver, Jeffrey L.

AU - Tiemann, Klaus

AU - Sievert, Horst

AU - Camm, A. John

AU - Lewalter, Thorsten

PY - 2017

Y1 - 2017

N2 - 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 LAAOamong the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

AB - 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 LAAOamong the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

KW - Atrial Fibrillation

KW - LAA closure

KW - Prevention

KW - Stroke

UR - https://www.scopus.com/pages/publications/85016183469

U2 - 10.1093/europace/euw141

DO - 10.1093/europace/euw141

M3 - Article

SN - 1099-5129

VL - 19

SP - 4

EP - 15

JO - Europace

JF - Europace

IS - 1

ER -

Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies

Abstract

UN SDGs

Keywords

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