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 Blomström-Lundqvist; Hans Christoph Diener; Riccardo Cappato; Saibal Kar; Randal J. Lee; Robert A. Byrne; Reda Ibrahim; Dhanunjaya Lakkireddy; Osama I. Soliman; Michael Näbauer; Steffen Schneider; Johannes Brachman; Jeffrey L. Saver; Klaus Tiemann; Horst Sievert; A. John Camm; Thorsten Lewalter

doi:10.4244/EIJV12I1A18

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 Blomström-Lundqvist, Hans Christoph Diener, Riccardo Cappato, Saibal Kar, Randal J. Lee, Robert A. Byrne, Reda Ibrahim, Dhanunjaya Lakkireddy, Osama I. Soliman, Michael Näbauer, Steffen Schneider, Johannes Brachman, Jeffrey L. Saver, Klaus Tiemann, Horst Sievert, A. John CammThorsten Lewalter

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

53 Scopus citations

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 patient 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.

Original language	English (US)
Pages (from-to)	103-111
Number of pages	9
Journal	EuroIntervention
Volume	12
Issue number	1
DOIs	https://doi.org/10.4244/EIJV12I1A18
State	Published - May 2016

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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Tzikas, A., Holmes, D. R., Gafoor, S., Ruiz, C. E., Blomström-Lundqvist, C., Diener, H. C., Cappato, R., Kar, S., J. Lee, R., Byrne, R. A., Ibrahim, R., Lakkireddy, D., Soliman, O. I., Näbauer, M., Schneider, S., Brachman, J., Saver, J. L., Tiemann, K., Sievert, H., ... Lewalter, T. (2016). Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies. EuroIntervention, 12(1), 103-111. https://doi.org/10.4244/EIJV12I1A18

Tzikas, A, Holmes, DR, Gafoor, S, Ruiz, CE, Blomström-Lundqvist, C, Diener, HC, Cappato, R, Kar, S, J. Lee, R, Byrne, RA, Ibrahim, R, Lakkireddy, D, Soliman, OI, Näbauer, M, Schneider, S, Brachman, J, Saver, JL, Tiemann, K, Sievert, H, Camm, AJ & Lewalter, T 2016, 'Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies', EuroIntervention, vol. 12, no. 1, pp. 103-111. https://doi.org/10.4244/EIJV12I1A18

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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 patient 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.",

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AU - Holmes, David R.

AU - Gafoor, Sameer

AU - Ruiz, Carlos E.

AU - Blomström-Lundqvist, Carina

AU - Diener, Hans Christoph

AU - Cappato, Riccardo

AU - Kar, Saibal

AU - J. Lee, Randal

AU - Byrne, Robert A.

AU - Ibrahim, Reda

AU - Lakkireddy, Dhanunjaya

AU - Soliman, Osama I.

AU - Näbauer, Michael

AU - Schneider, Steffen

AU - Brachman, Johannes

AU - Saver, Jeffrey L.

AU - Tiemann, Klaus

AU - Sievert, Horst

AU - Camm, A. John

AU - Lewalter, Thorsten

PY - 2016/5

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

Abstract

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