A comparison of postprocedural anticoagulation in high‐risk patients undergoing WATCHMAN device implantation

Abstract

Background Left atrial appendage closure (LAAC) is an alternative to long‐term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short‐term Warfarin use following LAAC is well‐studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high‐risk patients is lacking. Objective To compare the safety and efficacy of Warfarin and NOAC use in a high‐risk patient population undergoing LAAC with the WATCHMAN device. Methods From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months. Results Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months. Conclusion For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short‐term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.

A practical approach to the management of cerebral amyloid angiopathy

“…Initial studies of the WATCHMAN device excluded patients with past history of ICH as these studies had a long-term warfarin arm and a short course of warfarin was used for LAAC (typically ∼45 days for the WATCHMAN) to allow for device endothelialization to prevent thrombi formation on the device surface. 93 However, studies have demonstrated noninferiority with NOACs for short-term anticoagulation post LAAC, 93,94 and dual antiplatelet therapy can be used as an alternative to short-term anticoagulation postprocedurally. 95,96 It is important to note the difference between short term (∼six weeks post LAAC) anticoagulation versus lifelong anticoagulation as the risk of ICH increases over years.…”

Meta-analysis of postoperative antithrombotic therapy after left atrial appendage occlusion

“…Four studies 13,14,25,35 used two different antithrombotic regimens after LAAO. Therefore, each of these four studies was considered to include two research groups, and finally, 36 research groups were included in the analysis.…”

NOACs versus VKAs during Watchman implantation in patients with atrial fibrillation: The end of an era

“…Nevertheless, both groups had statistically significant differences in the mean CHADS2 (2.4 vs 2.1), CHA2DS2-VASC (4.1 vs 3.8), and HASBLED (2.7 vs 2.4) scores between the warfarin and NOAC groups, respectively. 5 Cohen et al, 6 in this issue of PACE compared the safety and efficacy of Warfarin and NOAC (mainly apixaban) use in a high-risk patient population undergoing LAAC with the Watchman device. Albeit this is a retrospective study, all patients were well-matched with regard to age, gender, comorbid conditions, prior bleeding events, thromboembolic risk, and bleeding risk, with a significant difference only in the proportion of patients with a history of congestive heart failure, and prior falls.…”

“…At 245 days, there were three patients in the warfarin group and one in the NOAC group that met the criteria for a composite endpoint of stroke or death (event rate 7.0% vs 2.1%; P = .35). 6 This study is limited by a relatively small sample size, which may also lead to the study being underpowered to detect events such as DRT and stroke. As with any nonrandomized, retrospective study without propensity matching, selection bias is possible.…”

“…Remarkably, 95% of patients in the warfarin group and 98% of patients in the NOAC group tolerated at least 6 weeks of OAC with almost all patients discontinuing OAC by 90 days postprocedure. At 245 days, there were three patients in the warfarin group and one in the NOAC group that met the criteria for a composite endpoint of stroke or death (event rate 7.0% vs 2.1%; P = .35) . This study is limited by a relatively small sample size, which may also lead to the study being underpowered to detect events such as DRT and stroke.…”