Background

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.

Objective

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.

Methods

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.

Results

The study cohort comprised 105 patients; 38 (36%) females, mean age ± standard deviation (SD) 73.9 ± 10.36 years, and with a CHA₂DS₂-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.

Conclusions

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.

中文翻译：

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心房颤动患者门诊开始使用索他洛尔：心脏植入式电子设备在治疗监测中的应用

背景

抗心律失常药物常用于治疗心房颤动 (AF) 患者。索他洛尔通常用于住院患者监测疗效和不良反应，包括 QTc 间期延长和尖端扭转型室速 (TdP) 致心律失常。

客观的

我们旨在评估门诊开始使用索他洛尔治疗心房植入式电子设备 (CIED) 患者的有效性和安全性：永久起搏器 (PPM)、植入式心律转复除颤器 (ICD) 和植入式循环记录器(ILR) 能够远程连续监测节奏。

方法

我们在真实世界的实践环境中进行了临床研究，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且患有 CIED 的有症状的阵发性和持续性 AF 的成年患者。已知有索他洛尔禁忌症的患者被排除在外。在与患者做出共同管理决定后，索他洛尔开始作为门诊患者，定期与患者进行临床接触以评估治疗的有效性和安全性，并利用 CIED 利用其远程监测平台监测心律和 QTc 间期。

结果

研究队列包括 105 名患者；38 (36%) 名女性，平均年龄 ± 标准差 (SD) 73.9 ± 10.36 岁，CHA ₂ DS ₂ -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 PPM，10 名 (9.5%) 植入双腔 ICD，69 名 (65.7%) 植入 ILR。在 23 ± 15 个月的随访期内，77 名（73%）维持窦性心律的患者继续以 80 mg 每天两次的稳定中位剂量服用索他洛尔，105 ± 42 mg（平均±标准差），并在28 (27%) 名患者因为无效或出现不良反应。在研究期间未观察到与 QTc 延长和 TdP 或死亡率相关的不良反应。

结论

对于具有持续远程监测和监视能力的 CIED 的特定患者，可以在门诊有效和安全地启动和维持索他洛尔治疗。