Drexel University College of Medicine, Philadelphia, PA, USA.
Cardiovascular and Heart Rhythm Consultants, 30 West 60th Street, Suite 1U, New York, NY, 10023, USA.
Am J Cardiovasc Drugs. 2021 Nov;21(6):693-700. doi: 10.1007/s40256-021-00493-7. Epub 2021 Jul 22.
Antiarrhythmic drugs are often used in the management of patients with atrial fibrillation (AF). Sotalol is conventionally initiated in the inpatient setting for monitoring efficacy and adverse effects, including QTc interval prolongation and torsades de pointes (TdP) proarrhythmia.
We aimed to evaluate the efficacy and safety of outpatient initiation of sotalol for the treatment of AF in a select group of patients with cardiac implantable electronic devices (CIEDs): permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and implantable loop recorders (ILRs) capable of continuous rhythm monitoring remotely.
We conducted our clinical study in a real-world practice setting with longitudinal follow-up of the study cohort. We included adult patients with symptomatic paroxysmal and persistent AF eligible for sotalol for rhythm control strategy and who had CIEDs in our study. Patients with a known contraindication to sotalol were excluded. After making a shared management decision with patients, sotalol was initiated as an outpatient, with regular clinical encounters with patients to assess the efficacy and safety of treatment, and monitoring cardiac rhythm and QTc intervals with CIEDs utilizing their remote monitoring platforms.
The study cohort comprised 105 patients; 38 (36%) females, mean age ± standard deviation (SD) 73.9 ± 10.36 years, and with a CHADS-VASc score of 3.26 ± 1.37 and left ventricular ejection fraction of 60.16 ± 9.10%. Twenty-six (24.8%) patients were implanted with PPMs, 10 (9.5%) with dual-chamber ICDs, and 69 (65.7%) with ILRs. Over a follow-up period of 23 ± 15 months, sotalol was continued at a steady median dose of 80 mg twice daily, 105 ± 42 mg (mean ± SD) in 77 (73%) patients who maintained sinus rhythm, and discontinued in 28 (27%) patients because of inefficacy or development of adverse effects. No adverse effects relating to QTc prolongation and TdP or mortality were observed during the study period.
Effective and safe outpatient initiation and maintenance of sotalol therapy is possible in select patients who have CIEDs for continuous remote monitoring and surveillance capabilities.
抗心律失常药物常用于治疗心房颤动(AF)患者。索他洛尔通常在住院环境中开始使用,以监测疗效和不良反应,包括 QTc 间期延长和尖端扭转型室性心动过速(TdP)致心律失常。
我们旨在评估在一组选择的心脏植入式电子设备(CIED)患者中,门诊起始索他洛尔治疗 AF 的疗效和安全性:永久性起搏器(PPM)、植入式心脏复律除颤器(ICD)和能够远程连续监测节律的植入式环路记录器(ILR)。
我们在真实世界的实践环境中进行了我们的临床研究,并对研究队列进行了纵向随访。我们纳入了符合索他洛尔节律控制策略适应证的有症状阵发性和持续性 AF 且有 CIED 的成年患者。排除了已知对索他洛尔有禁忌症的患者。在与患者共同做出管理决策后,将索他洛尔作为门诊起始药物,定期与患者进行临床接触,以评估治疗的疗效和安全性,并利用 CIED 的远程监测平台监测心脏节律和 QTc 间期。
研究队列包括 105 名患者;38 名(36%)女性,平均年龄 ± 标准差(SD)为 73.9 ± 10.36 岁,CHADS-VASc 评分为 3.26 ± 1.37,左心室射血分数为 60.16 ± 9.10%。26 名(24.8%)患者植入了 PPM,10 名(9.5%)患者植入了双腔 ICD,69 名(65.7%)患者植入了 ILR。在 23 ± 15 个月的随访期间,索他洛尔以稳定的中位数剂量 80 mg 每日两次持续使用,105 ± 42 mg(平均值 ± 标准差)在 77 名(73%)维持窦性心律的患者中,28 名(27%)因疗效不佳或出现不良反应而停止使用。在研究期间,未观察到与 QTc 延长和尖端扭转型室性心动过速或死亡率相关的不良反应。
在具有连续远程监测和监测能力的 CIED 的选择患者中,门诊起始和维持索他洛尔治疗是有效和安全的。