Ethan Fry1, Harini Bollempali2, Keith Suarez3, Javier Banchs3, Jeffrey Michel3. 1. Department of Medicine, Division of Cardiology, Baylor Scott & White Health, Scott & White Memorial Hospital, 2401 S 31st Street, Temple, TX, 76508, USA. Ethan.fry@uky.edu. 2. Department of Medicine, Baylor Scott & White Round Rock, Round Rock, TX, USA. 3. Department of Medicine, Division of Cardiology, Baylor Scott & White Health, Scott & White Memorial Hospital, 2401 S 31st Street, Temple, TX, 76508, USA.
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.
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.
Authors: Martin W Bergmann; Hüseyin Ince; Stephan Kische; Thomas Schmitz; Felix Meincke; Boris Schmidt; David Foley; Timothy R Betts; Marek Grygier; Alexey V Protopopov; Kenneth M Stein; Lucas V A Boersma Journal: EuroIntervention Date: 2018-04-20 Impact factor: 6.534
Authors: Vivek Y Reddy; Ronald L Akehurst; Stacey L Amorosi; Meghan B Gavaghan; Deanna S Hertz; David R Holmes Journal: Stroke Date: 2018-05-08 Impact factor: 7.914