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Course Instructor
Abby Massey
Capstone Semester
Fall 2020
Date of Graduation
12-18-2020
Abstract
Objective: To determine if the WATCHMAN device is as efficacious as warfarin for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) using a systematic review. Methods: Pubmed and Google Scholar databases were used to evaluate clinical trials using the search terms atrial fibrillation, watchman, warfarin, and stroke prevention. Results: Three studies met inclusion criteria, with 2 being randomized control trials (RCT), and 1 being a prospective cohort study. Reddy et al found that after 3.8 years of follow-up, patients with percutaneous closure of Left atrial appendage (LAA) met criteria for both non-inferiority and superiority, compared with warfarin for preventing combined outcome for stroke. Holmes et al showed at 18 months follow-up that the WATCHMAN device and warfarin therapy groups had similar efficacy endpoints. The device group was shown to be non-inferior to the control group in late-ischemic stroke 7 days post procedure, and was found to be equally as safe. Boresma et al showed that at the 1-year follow-up there was a lower risk of stroke in the device group, and that the earliest discontinuation of anticoagulant therapy had the lowest risk of bleeding. Conclusion: This systematic review shows evidence that the WATCHMAN implantable LAA device may be a suitable alternative to prevent thromboembolism in patients with NVAF who may have a contraindication for long-term warfarin or anticoagulation use. Due to the novel technology of the WATCHMAN implant, more studies should be completed to determine its long-term efficacy and adverse events.
Document Type
Capstone
Recommended Citation
1. Stroke Facts. CDC.gov. https://www.cdc/gov/stroke/facts.htm. Published March 15, 2019. Accessed 18 September 2019. 2. Atrial fibrillation fact sheet|data & statistics|dhdsp|cdc. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm. Published November 2, 2018. Accessed 18 September 18 2019 3. What medicines treat afib? WebMD. https://www.webmd.com/heart-disease/atrial-fibrillation/what-medicines-treat-afib. Accessed 18 September 2019. 4. Tideman PA, Tirimacco R, St John A, Roberts GW. How to manage warfarin therapy. Aust Prescr. 2015;38(2):44-48. doi:10.18773/austprescr.2015.016. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4653986/. Accessed 18 September 2019. 5. About the watchman procedure for physicians. https://www.watchman.com/en-us-hcp/about-the-procedure.html. Accessed 21 September 2019 6. Protect AF trial Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998. doi:10.1001/jama.2014.15192. https://www.ncbi.nlm.nih.gov/pubmed/25399274. Accessed 12 September 2019 7. PREVAIL trial Holmes DR, 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):1-12. doi:10.1016/j.jacc.2014.04.029r. https://www.ncbi.nlm.nih.gov/pubmed/24998121. Accessed 12 September 2019. 8. EWOLUTION STUDY Boersma LV, Hueseyin I, Kische S, Pokushalov E, Schmitz T, Schmidt B, GoriT, Meincke F., Protopopov AV, Bettst, Mazzone P, Foley D, Grygier M, Sievert H, De Potter, Vireca E., Stein K., BergmannMW. Evaluating real-world clinical outcomes in atrial fibrillation patients receiving the watchman left atrial appendage closure technology. Circulation: Arrhythmia and Electrophysiology. 2019;12(4): e006841. doi:10.1161/CIRCEP.118.006841. https://www.ahajournals.org/doi/10.1161/CIRCEP.118.006841’. Accessed 15 September 2019.
