Demiraj Francis, Benrubi Michael S, Babici Denis, Muharremi Eti, Pachon Ronald, Osman Ahmed
Department of Neurology, Florida Atlantic University Charles E. Schmidt College of Medicine, Marcus Neuroscience Institute, Boca Raton, USA.
Department of Neurology, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Boca Raton, USA.
Cureus. 2023 Oct 21;15(10):e47444. doi: 10.7759/cureus.47444. eCollection 2023 Oct.
Background The WATCHMAN™ device is a Food and Drug Administration (FDA)-approved device that reduces the risk of stroke from atrial fibrillation (AF) in those who have a contraindication to taking oral anticoagulation. A key aspect of this device implantation is the choice of medical therapy in the months after device implantation with Vitamin K antagonist oral anticoagulants (OAC) being the mainstay of therapy but dual antiplatelet therapy (DAPT) poses as a potential alternative to patients who have a contraindication to OAC use. Methods Our single-center study retroactively followed 150 patients post-WATCHMAN™ implantation and evaluated outcomes at 12 months post-implantation in two cohorts, those treated with OAC or DAPT. Our results were obtained via chart review of a single-center electronic medical records system. Results In our study, 67.33% of study patients were males and 49.33% were on OAC compared to 36.00% that were on DAPT. Ten patients were not able to undergo device implantation. With this analysis, we found similarly low rates of complications such as stroke and device-associated thrombosis (DAT) in both groups. Our DAPT cohort did have a higher number of gastrointestinal (GI) bleeding but this was not significant in our analysis. Discussion Our study compares to larger trials that show similar outcomes between OAC and DAPT post-implantation of the WATCHMAN™ device. The increased number of GI bleeding in our DAPT cohort could be the result of the underlying advanced age and comorbidity of that patient cohort. Conclusion Our results suggest that DAPT is a safe alternative to OAC for patients undergoing WATCHMAN™ implantation.
WATCHMAN™ 装置是一种经美国食品药品监督管理局(FDA)批准的装置,可降低有口服抗凝禁忌的心房颤动(AF)患者的中风风险。该装置植入的一个关键方面是在植入后的几个月内选择药物治疗,维生素K拮抗剂口服抗凝剂(OAC)是主要治疗方法,但双重抗血小板治疗(DAPT)对有OAC使用禁忌的患者而言是一种潜在替代方案。方法:我们的单中心研究对150例植入WATCHMAN™ 装置后的患者进行回顾性随访,并在植入后12个月评估两个队列(接受OAC或DAPT治疗的患者)的结局。我们的结果通过对单中心电子病历系统的病历审查获得。结果:在我们的研究中,67.33%的研究患者为男性,49.33%接受OAC治疗,而接受DAPT治疗的患者为36.00%。10例患者未能进行装置植入。通过该分析,我们发现两组中风和装置相关血栓形成(DAT)等并发症发生率同样较低。我们的DAPT队列胃肠道(GI)出血的患者数量较多,但在我们的分析中这并不显著。讨论:我们的研究与更大规模的试验相比,这些试验表明在植入WATCHMAN™ 装置后OAC和DAPT的结局相似。我们DAPT队列中GI出血患者数量增加可能是该患者队列潜在的高龄和合并症所致。结论:我们的结果表明,对于接受WATCHMAN™ 植入的患者,DAPT是OAC的一种安全替代方案。