EWOLUTION: Design of a registry to evaluate real-world clinical outcomes in patients with AF and high stroke risk-treated with the WATCHMAN left atrial appendage closure technology

Catheterization and Cardiovascular Interventions

Volumn 88, Issue 3, 2016, Pages 460-465

  Boersma, Lucas V A ^a   Schmidt, Boris ^b   Betts, Tim R ^c   Sievert, Horst ^d   Tamburino, Corrado ^e   Teiger, Emmanuel ^f   Stein, Kenneth M ^g   Bergmann, Martin W ^h  

^a ST ANTONIUS HOSPITAL   (Netherlands)

^b Department of Cardiology   (Germany)

^c JOHN RADCLIFFE HOSPITAL   (United Kingdom)

^d Department of Cardiology   (Germany)

^e Ospedale Ferrarotto Catania   (Italy)

^f HENRI MONDOR HOSPITAL   (France)

^g BOSTON SCIENTIFIC CORPORATION   (United States)

^h Herzkatheter Asklepios Wandsbek ^*  (Germany)

Author keywords

cardiac embolus; cerebrovascular accident; prevention

Indexed keywords

ADULT; ANTICOAGULATION; ARTICLE; ATRIAL FIBRILLATION; BRAIN EMBOLISM; BRAIN HEMORRHAGE; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DEVICE SAFETY; FOLLOW UP; HUMAN; INFORMED CONSENT; LEFT ATRIAL APPENDAGE CLOSURE DEVICE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OBSERVATIONAL STUDY; PREOPERATIVE PERIOD; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME;

EID: 84986922217     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.26358     Document Type: Article

References (26)

1. Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with AF—Executive summary: A report of the American college of cardiology/American heart association task force on practice guidelines and the European society of cardiology committee for practice guidelines (writing committee to revise the 2001 guidelines for the management of patients with AF). J Am Coll Cardiol 2006;48:854–906.
2. Hart RG, Pearce LA, McBride R, Rothbart RM, Asinger RW. Factors associated with ischemic stroke during aspirin therapy in AF: Analysis of 2012 participants in the SPAF I-III clinical trials. The stroke prevention in AF (SPAF) investigators. Stroke 1999;30:1223–1229.
3. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J 2012;33:2719–2747.
4. White HD, Gruber M, Feyzi J, Kaatz S, Tse HF, Husted S, Albers GW. Comparison of outcomes among patients randomized to VKA therapy according to anticoagulant control: Results from SPORTIF III and V. Arch Intern Med 2007;167:239–245.
5. Connolly SJ, Pogue J, Eikelboom J, Flaker G, Commerford P, Franzosi MG, Healey JS, Yusuf S; ACTIVE W Investigators. Benefit of oral anticoagulant over antiplatelet therapy in AF depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range. Circulation 2008;118:2029–2037.
6. Lopes RD, Shah BR, Olson DM, Zhao X, Pan W, Bushnell CD, Peterson ED. Antithrombotic therapy use at discharge and 1 year in patients with AF and acute stroke: Results from the AVAIL registry. Stroke 2011;42:3477–3483.
7. Pugh D, Pugh A, Mead G. Attitudes of physicians regarding anticoagulation for atrial fibrillation: A systematic review. Age Ageing 2011;40:675–683.
8. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883–891.
9. Connolly SJ, Ezekowitz MD., Yusuf S, Eikelboom J, Oldgren J, et al. Dabigatran versus VKA in patients with AF. N Engl J Med 2009;361: 1139–1151.
10. Connolly SJ, Ezekowitz MD., Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139–1151.
11. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011;364:806–817.
12. Blackshear J, Odell J. Appendage obliteration to reduce stroke in cardiac surgical patients with AF. Ann Thorac Surg 1996;61:755–759.
13. Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs. warfarin for atrial fibrillation: A randomized clinical trial. JAMA 2014;312:1988–1998.
14. Price M, Valderrabano M, Huber K, et al. Avoidance of major bleeding with WATCHMAN left atrial appendage closure compared with long-term oral anticoagulation: A pooled analysis of randomized trials. J Am Coll Cardiol 2014;64:B50–B51.
15. Hastie T, Tibshirani R, Friedman J. The Elements of Statistical Learning: Data Mining, Inference, Prediction. New York: Springer; 2009.
16. Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: A consensus report from the Valve Academic Research Consortium. Eur Heart J 2011;32:205–217.
17. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the bleeding academic research consortium. Circulation 2011;123:2736–2747.
18. Baker WL, Cios DA, Sander SD, Coleman CI. TTR in US community practice: Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm 2009;15:244–252.
19. Skeppholm M, Friberg L. Adherence to warfarin treatment among patients with atrial fibriallation. Clin Res Cardiol 2014;103:998–1005.
20. Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with a 2.3-year follow-up of the PROTECT AF (watchman left atrial appendage system for embolic protection in patients with AF) trial. Circulation 2013;127:720–729.
21. Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. 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. Circulation 123:417–424.
22. Meier B, Blaauw Y, Khattab AA, Lewalter T, Sievert H, Tondo C, Glikson M. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. EuroIntervention 2014;16:1397–1416.
23. Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 2014;64:1–12.
24. Chun KR, Bordignon S, Urban V, Perrotta L, Dugo D, Fürnkranz A, Nowak B, Schmidt B. Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: A prospective single-center experience. Hearth Rhythm 2013;10:1792–1799.
25. Meincke F, Schmidt-Salzmann M, Kreidel F, Kuck KH, Bergmann MW. New technical and anticoagulation aspects for left atrial appendage closure using the WATCHMAN device in patients not taking VKA. EuroIntervention 2013;9:463–468.
26. Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation. The ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol 2013;61:2551–2556.