Ashur Carmel, Qin Li, Minges Karl E, Freeman James V, Al-Khatib Sana M, Bradley Steven M, Ho P Michael, Tzou Wendy S, Varosy Paul D, Hess Paul L, Sandhu Amneet
Division of Cardiology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, USA.
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.
Pacing Clin Electrophysiol. 2025 Aug;48(8):859-869. doi: 10.1111/pace.70016. Epub 2025 Jul 31.
Small studies have described the safety of uninterrupted direct oral anticoagulant (DOAC) use in atrial fibrillation (AF) patients undergoing elective, cardiac implantable electronic device (CIED) placement. Real-world practice patterns and associated outcomes remain poorly defined.
Describe DOAC usage trends following uncomplicated, outpatient CIED placement in AF patients and evaluate clinical outcomes based on DOAC status at discharge.
Using data from the National Cardiovascular Data Registry, AF patients with CHADS-VASc ≥ 2 undergoing uncomplicated, outpatient CIED placement from April 2016 to December 2019 were stratified by DOAC prescription at discharge. Short and longer-term temporal trends and post-discharge outcomes were assessed using Centers for Medicare and Medicaid (CMS) claims.
Among 59,169 AF patients with elevated thromboembolic eligible for DOAC therapy who underwent elective, new CIED implant or generator replacement, 32,025 (54.1%) were discharged on a DOAC. Annual rates of DOAC use at discharge increased from 47.0% in 2016 to 62.5% in 2019 (p < 0.0001). Overall, patients discharged on DOAC had higher adjusted rates of pocket hematoma (0.51% vs. 0.33%, p = 0.0007) and lower rates of stroke (2.9% vs. 3.2%, p = 0.05) at 30-days but no significant differences in device infection or need for revision at 30-days or 1-year. Those undergoing new CIED implant had higher rates of pocket hematoma at 30-days (0.53% vs. 0.36%, p = 0.02) and need for device revision at 1-year (1.6% vs. 1.3%, p = 0.04).
In AF patients undergoing CIED implantation, about half were discharged on DOACs, with increasing rates of DOAC resumption immediately following post-CIED implantation over the study period. Those discharged on DOACs had modestly higher rates of pocket hematoma or need for device revision but similar risk of device infection.
小型研究描述了在接受择期心脏植入式电子设备(CIED)植入的心房颤动(AF)患者中持续使用直接口服抗凝剂(DOAC)的安全性。真实世界的实践模式和相关结果仍不明确。
描述AF患者在未发生并发症的门诊CIED植入术后DOAC的使用趋势,并根据出院时的DOAC状态评估临床结果。
利用国家心血管数据注册中心的数据,将2016年4月至2019年12月期间接受未发生并发症的门诊CIED植入术、CHADS-VASc评分≥2的AF患者,按出院时的DOAC处方进行分层。使用医疗保险和医疗补助服务中心(CMS)的索赔数据评估短期和长期的时间趋势以及出院后的结果。
在59169例有血栓栓塞风险升高且适合DOAC治疗、接受择期新CIED植入或发生器更换的AF患者中,32025例(54.1%)出院时使用DOAC。出院时DOAC的年使用率从2016年的47.0%增至2019年的62.5%(p<0.0001)。总体而言,出院时使用DOAC的患者在30天时发生囊袋血肿的校正率较高(0.51%对0.33%,p=0.0007),中风率较低(2.9%对3.2%,p=0.05),但在30天或1年时的装置感染率或翻修需求无显著差异。接受新CIED植入的患者在30天时囊袋血肿发生率较高(0.53%对0.36%,p=0.02),在1年时需要进行装置翻修的比例较高(1.6%对1.3%,p=0.04)。
在接受CIED植入的AF患者中,约一半患者出院时使用DOAC,在研究期间CIED植入术后立即恢复使用DOAC的比例不断增加。出院时使用DOAC的患者囊袋血肿发生率或装置翻修需求略高,但装置感染风险相似。