Author + information
- Published online December 4, 2017.
- Amr F. Barakat, MD,
- Oussama M. Wazni, MD,
- Walid I. Saliba, MD,
- Bilal Saqi, MD,
- Karim Abdur Rehman, MD,
- Khaldoun Tarakji, MD,
- Mohammed Bassiouny, MD,
- Mohamed Kanj, MD,
- Bruce D. Lindsay, MD and
- Ayman A. Hussein, MD∗ ()
- ↵∗Cardiac Pacing and Electrophysiology, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Avenue, J2-2, Cleveland, Ohio 44195
Left atrial appendage closure has been increasingly accepted as an alternative to long-term oral anticoagulation (OAC) for stroke prevention in atrial fibrillation patients who are at increased bleeding risk (1). PROTECT-AF (The Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (2) and PREVAIL (Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device In Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy) (3) trials have led to the recent U.S. Food and Drug Administration approval of the Watchman device for the purpose of left atrial appendage closure to reduce the risk of thromboembolism in atrial fibrillation. In both trials, warfarin was used for at least 45 days following device implantation to prevent device-related thrombosis until effective left atrial appendage occlusion occurs (2,3). The evidence on the safety and effectiveness of non-vitamin K antagonist oral anticoagulants (NOAC) in this setting is lacking. In this study, we describe our initial experience with the periprocedural use of NOAC for Watchman device implantation.
All consecutive patients referred for Watchman device implantation between April 1, 2015 and September 30, 2016 at Cleveland Clinic were enrolled in a prospectively maintained data registry. Only patients who received NOAC in the periprocedural period were included. All patients were planned to receive NOAC for at least 45 days post-implantation. Vascular access hemostasis was achieved with manual compression. The primary outcome was the occurrence of bleeding or thrombotic complications while receiving NOAC periprocedurally and on follow-up after device implantation. Major bleeding was defined in concordance with the International Society on Thrombosis and Hemostasis definition (4). Statistical analyses were performed using JMPpro version. 10.0 (SAS Institute, Cary, North Carolina). Numbers are presented as median (interquartile range [IQR]) for continuous variables and as proportions for categorical variables.
Watchman device was successfully implanted in 119 patients. NOAC were used in 37 patients (31.1%); those were included in the current study. Baseline characteristics of the study population are summarized in Table 1. The median duration of NOAC therapy after device implantation was 48 (IQR: 45 to 60) days. During that period, 4 bleeding events occurred in 3 patients (8.1%): 2 patients had a minor gastrointestinal bleed (1 and 20 days post-procedure), and 1 had initially a groin hematoma followed by subcutaneous arm and leg hematomas (1 and 30 days post-procedure, respectively), the latter requiring premature discontinuation of OAC (rivaroxaban). As for the patients who had gastrointestinal bleeding, 1 was on rivaroxaban that had to be stopped for 2 days immediately post-procedure before resuming and safely completing the 45-day course, and 1 received 20 days of dabigatran, which was then held for 5 days before the patient was switched to warfarin and completed the intended course of OAC. There were no bleeding complications with apixaban. Major bleeding events did not occur in any of the patients. All but 2 patients (94.6%) completed the planned 45-day course of NOAC post-implantation: 1 discontinued OAC after 30 days of rivaroxaban and the other was able to complete the 45-day course after switching from dabigatran to warfarin. None of the patients experienced device-related thrombosis, procedure- or device-related stroke, procedure-related pericardial effusion, device embolization, or death. In all patients, transesophageal echocardiogram at 45 days post-implantation showed effective occlusion of the left atrial appendage, so OAC was switched to clopidogrel and aspirin for 6 months and then aspirin only thereafter.
Of note, in the remaining patients in our prospective registry who received warfarin for periprocedural anticoagulation (n = 82), we have not observed any device-related thrombosis, procedure- or device-related stroke, procedure-related pericardial effusion, device embolization, or death.
The findings are important for clinical practice as NOAC are being increasingly used due to their efficacy, safety profiles, no need for therapeutic monitoring, and lower likelihood of drug and food interactions compared with warfarin. This case series describes our initial experience with the safety and efficacy of NOAC for periprocedural anticoagulation at the time of Watchman device implantation. The study suggests that in this setting, a short course of NOAC, mainly apixaban, in the periprocedural period is associated with low incidence of bleeding or thrombotic complications and may be a viable alternative to warfarin therapy, which currently remains the OAC recommended for that purpose.
Please note: Dr. Wazni has received speaking fees from Boston Scientific. Dr. Tarakji has received consulting fees from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- 2017 American College of Cardiology Foundation
- Camm A.J.,
- Lip G.Y.,
- De Caterina R.,
- et al.,
- for the ESC Committee for Practice Guidelines
- Holmes D.R. Jr..,
- Kar S.,
- Price M.J.,
- et al.
- Schulman S.,
- Kearon C.,
- Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis