Cardiology Division, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Cardiology Division, Pacific Heart Institute, Santa Monica, California.
Heart Rhythm. 2020 Nov;17(11):1848-1855. doi: 10.1016/j.hrthm.2020.06.024. Epub 2020 Jun 27.
Because device-related thrombus (DRT) portends a poor prognosis after left atrial appendage closure with the Watchman device, surveillance transesophageal echocardiography (TEE) is recommended at 45 days and 1 year. However, oral anticoagulants are just discontinued at 45 days, rendering this early TEE unlikely to detect DRT. Indeed, DRT is most likely to occur after instituting aspirin monotherapy.
The purpose of this study was to evaluate the alternative strategy of first TEE imaging (or computed tomography) at 4 months post-Watchman implantation.
After Food and Drug Administration approval, consecutive patients undergoing Watchman implantation at 2 centers received TEE or CT at 4 months and 1 year, along with a truncated drug regimen: 6 weeks of an oral anticoagulant (or clopidogrel in a subset) plus aspirin, then 6 weeks of dual antiplatelet therapy, and finally aspirin monotherapy.
Of the 530-patient cohort (mean age 78.7±7.9 years; 65.5% (n = 347) male; CHADS-VASc score 4.5±1.4), 465 patients (87.7%) received 4-month imaging: 83.0% (440 of 530) TEE and 4.7% (25 of 530) computed tomography. Over a median follow-up of 12 months, 16 ischemic strokes (ISs), 8 transient ischemic attacks, and 1 systemic embolization occurred. Importantly, no IS occurred between 45 days and 4 months; the sole transient ischemic attack in this period (at ∼2 months) occurred 1 week after transcatheter aortic valve replacement. DRT was detected in 2.4% (11 of 465) at 4 months and 0.9% (2 of 214) at 1 year. No IS, but 1 leg embolization, was observed after DRT detection.
Delaying the first imaging post-Watchman implantation to 4 months was associated with no IS between 45 days and 4 months, the "vulnerable" period of this follow-up strategy.
由于 Watchman 装置左心耳封堵术后与器械相关的血栓(DRT)预示着预后不良,因此建议在术后 45 天和 1 年进行经食管超声心动图(TEE)监测。然而,抗凝药物仅在术后 45 天停用,这使得早期 TEE 不太可能发现 DRT。事实上,DRT 最有可能在开始使用阿司匹林单药治疗后发生。
本研究旨在评估 Watchman 植入后 4 个月首次进行 TEE 成像(或计算机断层扫描)的替代策略。
在获得美国食品和药物管理局批准后,在 2 个中心连续进行 Watchman 植入的患者在术后 4 个月和 1 年时接受 TEE 或 CT 检查,并采用简化的药物治疗方案:6 周口服抗凝药物(或部分患者使用氯吡格雷)联合阿司匹林,然后 6 周双联抗血小板治疗,最后改为阿司匹林单药治疗。
在 530 例患者队列中(平均年龄 78.7±7.9 岁;65.5%(n=347)为男性;CHA2DS2-VASc 评分 4.5±1.4),465 例患者(87.7%)接受了 4 个月的影像学检查:83.0%(440/530)行 TEE,4.7%(25/530)行 CT。中位随访 12 个月期间,发生 16 例缺血性卒中(IS)、8 例短暂性脑缺血发作和 1 例系统性栓塞。重要的是,在 45 天至 4 个月之间没有发生 IS;此期间唯一的短暂性脑缺血发作(约在 2 个月时)发生在经导管主动脉瓣置换术 1 周后。在 4 个月时,11 例(465 例的 2.4%)和 1 年时,2 例(214 例的 0.9%)患者发现 DRT。在发现 DRT 后,无 IS 发生,但有 1 例下肢栓塞。
将 Watchman 植入后首次影像学检查推迟至 4 个月与 45 天至 4 个月之间无 IS 发生相关,这是该随访策略的“脆弱”时期。