Literature DB >> 27540038

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

Apostolos Tzikas1, David R Holmes2, Sameer Gafoor3, Carlos E Ruiz4, Carina Blomström-Lundqvist5, Hans-Christoph Diener6, Riccardo Cappato7,8, Saibal Kar9, Randal J Lee10, Robert A Byrne11, Reda Ibrahim12, Dhanunjaya Lakkireddy13, Osama I Soliman14, Michael Nabauer15, Steffen Schneider16, Johannes Brachmann17, Jeffrey L Saver18, Klaus Tiemann19, Horst Sievert3, A John Camm20, Thorsten Lewalter21.   

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. Published on behalf of the European Society of Cardiology. All rights reserved.
© The Author 2016. For permissions please email: journals.permissions@oup.com.

Entities:  

Keywords:  Atrial Fibrillation; LAA closure; Prevention; Stroke

Mesh:

Year:  2016        PMID: 27540038      PMCID: PMC5841559          DOI: 10.1093/europace/euw141

Source DB:  PubMed          Journal:  Europace        ISSN: 1099-5129            Impact factor:   5.214


  43 in total

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Review 2.  Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

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Journal:  J Thromb Haemost       Date:  2009-10-30       Impact factor: 5.824

3.  2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association.

Authors:  A John Camm; Gregory Y H Lip; Raffaele De Caterina; Irene Savelieva; Dan Atar; Stefan H Hohnloser; Gerhard Hindricks; Paulus Kirchhof
Journal:  Europace       Date:  2012-08-24       Impact factor: 5.214

4.  Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

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Journal:  Eur Heart J       Date:  2012-10       Impact factor: 29.983

5.  Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry.

Authors:  Vivek Y Reddy; David Holmes; Shephal K Doshi; Petr Neuzil; Saibal Kar
Journal:  Circulation       Date:  2011-01-17       Impact factor: 29.690

6.  Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation.

Authors:  Robert G Hart; Lesly A Pearce; Maria I Aguilar
Journal:  Ann Intern Med       Date:  2007-06-19       Impact factor: 25.391

7.  Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial.

Authors:  David R Holmes; Saibal Kar; Matthew J Price; Brian Whisenant; Horst Sievert; Shephal K Doshi; Kenneth Huber; Vivek Y Reddy
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8.  Edoxaban versus warfarin in patients with atrial fibrillation.

Authors:  Robert P Giugliano; Christian T Ruff; Eugene Braunwald; Sabina A Murphy; Stephen D Wiviott; Jonathan L Halperin; Albert L Waldo; Michael D Ezekowitz; Jeffrey I Weitz; Jindřich Špinar; Witold Ruzyllo; Mikhail Ruda; Yukihiro Koretsune; Joshua Betcher; Minggao Shi; Laura T Grip; Shirali P Patel; Indravadan Patel; James J Hanyok; Michele Mercuri; Elliott M Antman
Journal:  N Engl J Med       Date:  2013-11-19       Impact factor: 91.245

9.  Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury.

Authors:  Ravindra L Mehta; John A Kellum; Sudhir V Shah; Bruce A Molitoris; Claudio Ronco; David G Warnock; Adeera Levin
Journal:  Crit Care       Date:  2007       Impact factor: 9.097

Review 10.  A clinician's perspective: novel oral anticoagulants to reduce the risk of stroke in nonvalvular atrial fibrillation--full speed ahead or proceed with caution?

Authors:  Eugene Yang
Journal:  Vasc Health Risk Manag       Date:  2014-08-21
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  37 in total

1.  Acute and long-term outcomes of epicardial left atrial appendage ligation with the second-generation LARIAT device: a high-volume electrophysiology center experience.

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Journal:  Clin Res Cardiol       Date:  2018-06-07       Impact factor: 5.460

2.  Left atrial appendage closure using the Watchman device in patients with off-label anatomy: "No man left behind".

Authors:  Linying Xia
Journal:  Cardiol J       Date:  2020       Impact factor: 2.737

Review 3.  Left Atrial Occlusion Device Implantation: the Role of the Echocardiographer.

Authors:  David Altszuler; Alan F Vainrib; Daniel G Bamira; Ricardo J Benenstein; Anthony Aizer; Larry A Chinitz; Muhamed Saric
Journal:  Curr Cardiol Rep       Date:  2019-06-10       Impact factor: 2.931

Review 4.  [Current indications for left atrial appendage occlusion].

Authors:  Clemens Jilek; Thorsten Lewalter
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2017-10-25

Review 5.  Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update.

Authors:  Apostolos Tzikas
Journal:  J Atr Fibrillation       Date:  2017-12-31

6.  Incidence, predictors, and relevance of acute kidney injury in patients undergoing left atrial appendage closure with Amplatzer occluders: a multicentre observational study.

Authors:  Alexander Sedaghat; Vivian Vij; Samuel R Streit; Jan Wilko Schrickel; Baravan Al-Kassou; Dominik Nelles; Caroline Kleinecke; Stephan Windecker; Bernhard Meier; Marco Valglimigli; Fabian Nietlispach; Georg Nickenig; Steffen Gloekler
Journal:  Clin Res Cardiol       Date:  2019-07-05       Impact factor: 5.460

7.  Position Statement of the Brazilian Cardiology Society and the Brazilian Society of Hemodynamics and Interventional Cardiology on Training Centers and Professional Certification in Hemodynamics and Interventional Cardiology - 2020.

Authors:  José Airton de Arruda; Viviana de Mello Guzzo Lemke; José Mariani Júnior; Adriano Henrique Pereira Barbosa; Alexandre Schaan de Quadros; Carlos Augusto Cardoso Pedra; Cristiano de Oliveira Cardoso; Ênio Eduardo Guérios; Henrique Barbosa Ribeiro; Luiz Antonio Gubolino; Maurício Cavalieri Machado; Mauricio Jaramillo Hincapie; Nelson Antonio Moura de Araujo; Raul Ivo Rossi Filho; Ricardo Alves da Costa; Silvio Gioppato
Journal:  Arq Bras Cardiol       Date:  2020-01       Impact factor: 2.000

8.  The NCDR Left Atrial Appendage Occlusion Registry.

Authors:  James V Freeman; Paul Varosy; Matthew J Price; David Slotwiner; Fred M Kusumoto; Chidambaram Rammohan; Clifford J Kavinsky; Zoltan G Turi; Joseph Akar; Cristina Koutras; Jeptha P Curtis; Frederick A Masoudi
Journal:  J Am Coll Cardiol       Date:  2020-04-07       Impact factor: 24.094

9.  Left atrial appendage closure after cryoballoon ablation in patients with atrial fibrillation.

Authors:  Jun Liu; Yu Xia; Hao Zhang; Xiaofeng Li; Shu Zhang; Pihua Fang
Journal:  Herz       Date:  2020-01-30       Impact factor: 1.443

10.  Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure.

Authors:  Roberto Galea; Federico De Marco; Adel Aminian; Nicolas Meneveau; Frederic Anselme; Christoph Gräni; Adrian T Huber; Emmanuel Teiger; Xavier Iriart; Marco Angelillis; Nicolas Brugger; Alessandro Spirito; Noé Corpataux; Anna Franzone; Pascal Vranckx; Urs Fischer; Giovanni Pedrazzini; Francesco Bedogni; Stephan Windecker; Lorenz Räber; Marco Valgimigli
Journal:  J Cardiovasc Transl Res       Date:  2021-04-21       Impact factor: 4.132

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