Skip to main content
Erschienen in: Journal of Interventional Cardiac Electrophysiology 1/2021

05.06.2020 | Stroke

Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants

verfasst von: Ethan Fry, Harini Bollempali, Keith Suarez, Javier Banchs, Jeffrey Michel

Erschienen in: Journal of Interventional Cardiac Electrophysiology | Ausgabe 1/2021

Einloggen, um Zugang zu erhalten

Abstract

Purpose

As left atrial appendage occlusion devices (LAAO) implantation rates grow, continued evaluation on best patient practices is important. We report pooled Watchman outcomes at a multicenter Texas healthcare system with an emphasis on clinical outcomes and post-implantation anticoagulation with direct oral anticoagulants (DOACs) versus warfarin.

Methods

Data for 163 patients with atrial fibrillation (AF) undergoing Watchman implantation was collected via retrospective chart review between June 2016 and June 2018. A Fisher’s exact test was utilized to evaluate associations in bivariate comparisons of categorical data. Tests of non-inferiority, applied between DOACs and warfarin, utilized a ratio of 2.

Results

Outcomes were significant for similar rates of stroke, disabling stroke, major bleeds, and all-cause mortality when compared to published clinical trials. Most patients with cerebrovascular events were found to have >5 mm peri-device leaks (PDLs), were on warfarin at the time of the event (75%), and all occurred within the first 6 months post implant. A significant number of patients were discharged on DOACs (42%). DOACs were shown to be non-inferior to warfarin with respect to stroke (p = 0.0048), disabling stroke (p = 0.0383), gastrointestinal bleeding (p = 0.0287), mortality (p = 0.0165), and combined adverse outcomes (p = 0.0040). DOACs were associated with less combined adverse outcomes (p = 0.021).

Conclusion

Our findings suggest that additional imaging or aggressive management of PDLs in Watchman recipients within the initial 6-month follow-up may aid in reducing stroke rates. Additionally, anticoagulation with DOACs’ post Watchman implantation was found non-inferior to warfarin, with some evidence of lower risk for adverse outcomes favoring DOACs.
Literatur
1.
Zurück zum Zitat Wyse DG, Waldo AL, DiMarco JP, et al. Atrial fibrillation follow-up investigation of rhythm management (AFFIRM) investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002;347(23):1825.CrossRef Wyse DG, Waldo AL, DiMarco JP, et al. Atrial fibrillation follow-up investigation of rhythm management (AFFIRM) investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002;347(23):1825.CrossRef
2.
Zurück zum Zitat Ogawa S, Yamashita T, Yamazaki T, J-RHYTHM Investigators, et al. Optimal treatment strategy for patients with paroxysmal atrial fibrillation: J-RHYTHM Study. Circ J. 2009;73(2):242.CrossRef Ogawa S, Yamashita T, Yamazaki T, J-RHYTHM Investigators, et al. Optimal treatment strategy for patients with paroxysmal atrial fibrillation: J-RHYTHM Study. Circ J. 2009;73(2):242.CrossRef
3.
4.
Zurück zum Zitat 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. 2011;123:417–24.CrossRef 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. 2011;123:417–24.CrossRef
5.
Zurück zum Zitat Belgaid DR, Khana Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy - the PREVAIL trial. Int J Cardiol. 2016;219:177–9.CrossRef Belgaid DR, Khana Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy - the PREVAIL trial. Int J Cardiol. 2016;219:177–9.CrossRef
6.
Zurück zum Zitat Bergmann MW, Betts TR, Sievert H, Schmidt B, et al. Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry. EuroIntervention. 2017;13:877–84.CrossRef Bergmann MW, Betts TR, Sievert H, Schmidt B, et al. Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry. EuroIntervention. 2017;13:877–84.CrossRef
15.
Zurück zum Zitat Enomoto Y, Gadiyaram VK, Gianni C, Horton RP, Trivedi C, Mohanty S, et al. Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the watchman device. Heart Rhythm. 2017;14(1):19–24.CrossRef Enomoto Y, Gadiyaram VK, Gianni C, Horton RP, Trivedi C, Mohanty S, et al. Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the watchman device. Heart Rhythm. 2017;14(1):19–24.CrossRef
20.
Zurück zum Zitat Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R, et al. The clinical impact of incomplete left atrial appendage closure with the Watchman device in patients with atrial fibrillation: a PROTECT AF (percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy. J Am Coll Cardiol. 2012;59:923–9.CrossRef Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R, et al. The clinical impact of incomplete left atrial appendage closure with the Watchman device in patients with atrial fibrillation: a PROTECT AF (percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy. J Am Coll Cardiol. 2012;59:923–9.CrossRef
22.
Zurück zum Zitat Pillarisetti J, Reddy YM, Gunda S, Swarup V, Lee R, Rasekh A, et al. Endocardial (watchman) vs epicardial (lariat) left atrial appendage exclusion devices: understanding the differences in the location and type of leaks and their clinical implications. Heart Rhythm. 2015;12(7):1501–7.CrossRef Pillarisetti J, Reddy YM, Gunda S, Swarup V, Lee R, Rasekh A, et al. Endocardial (watchman) vs epicardial (lariat) left atrial appendage exclusion devices: understanding the differences in the location and type of leaks and their clinical implications. Heart Rhythm. 2015;12(7):1501–7.CrossRef
23.
Zurück zum Zitat Granier M, Laugaudin G, Massin F, Cade S, Winum PF, Freitag C, et al. Occurrence of incomplete endothelialization causing residual permeability after left atrial appendage closure. J Invasive Cardiol. 2018;30(7):245–50.PubMed Granier M, Laugaudin G, Massin F, Cade S, Winum PF, Freitag C, et al. Occurrence of incomplete endothelialization causing residual permeability after left atrial appendage closure. J Invasive Cardiol. 2018;30(7):245–50.PubMed
25.
Zurück zum Zitat el Mar Contreras Muruaga M, Vivancos J, Reig G, González A, Cardona P, Ramírez-Moreno J. Satisfaction, quality of life and perception of patients regarding burdens and benefits of Vitamin K antagonists compared with direct oral anticoagulants in patients with nonvalvular atrial fibrillation. J Comp Eff Res. 2017;6. https://doi.org/10.2217/cer-2016-0078. el Mar Contreras Muruaga M, Vivancos J, Reig G, González A, Cardona P, Ramírez-Moreno J. Satisfaction, quality of life and perception of patients regarding burdens and benefits of Vitamin K antagonists compared with direct oral anticoagulants in patients with nonvalvular atrial fibrillation. J Comp Eff Res. 2017;6. https://​doi.​org/​10.​2217/​cer-2016-0078.
Metadaten
Titel
Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants
verfasst von
Ethan Fry
Harini Bollempali
Keith Suarez
Javier Banchs
Jeffrey Michel
Publikationsdatum
05.06.2020
Verlag
Springer US
Erschienen in
Journal of Interventional Cardiac Electrophysiology / Ausgabe 1/2021
Print ISSN: 1383-875X
Elektronische ISSN: 1572-8595
DOI
https://doi.org/10.1007/s10840-020-00790-2

Weitere Artikel der Ausgabe 1/2021

Journal of Interventional Cardiac Electrophysiology 1/2021 Zur Ausgabe

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.