Outpatient Initiation of Sotalol in Patients with Atrial Fibrillation: Utility of Cardiac Implantable Electronic Devices for Therapy Monitoring

Abstract

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. ResultsThe study cohort comprised 105 patients; 38 (36%) females, mean age ± standard deviation (SD) 73.9 ± 10.36 years, and with a CHA 2 DS 2 -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.

Safety of outpatient commencement of sotalol

“…Most importantly, close monitoring for arrhythmic events is paramount to ensure patient safety. Mascarenhas et al 19 used the remote monitoring capabilities of CIEDs for safe outpatient initiation of sotalol in their group of patients. The QT interval was assessed from intracardiac electrograms and ECG tracings obtained via manual transmission from the CIEDs at 2-hour post-sotalol dosing, and patients were seen daily for the first 3 days with 12-lead ECGs.…”

“…16 These requirements result in significant economic implications in using this strategy, with a reported hospitalization cost between US$3278 and US$12,466, mainly because of the cost of the hospital room itself. 17 , 18 More contemporary studies have suggested the safety of outpatient initiation of sotalol therapy in patients with implantable cardiac devices 19 and no excess mortality in patients treated with sotalol compared with β-blockers. 20 Here, we aim to determine the safety aspects of sotalol initiation in outpatient settings without continuous rhythm monitoring.…”

Economics and outcomes of sotalol in‐patient dosing approaches in patients with atrial fibrillation

“…Additionally, some centers, particularly those outside of the United States, have implemented novel protocols for outpatient sotalol loading that employ ambulatory cardiac monitoring (e.g., cardiac event monitors, or implantable electronic pacemaker or defibrillator data) to monitor for ECG abnormalities such as QT prolongation and ventricular ectopy in the outpatient setting while loading patients with sotalol. 19 If these novel approaches for outpatient sotalol loading prove safe and effective, then they may provide viable and cost‐effective alternatives to both oral and IV inpatient loading protocols. Additional studies will be needed on both IV sotalol and these novel outpatient oral sotalol loading strategies to determine the feasibility, efficacy, safety, and costs associated with each to determine the optimal drug formulation and loading protocols for this medication.…”

Catheter Ablation for Atrial Fibrillation in Adult Congenital Heart Disease: An International Multicenter Registry Study

“…Atrial arrhythmias in patients with CHD are associated with increased rates of heart failure, sudden death, stroke, and hospitalization. 5 Rhythm control is preferred over rate control in more complex forms of CHD 6 ; however, the currently available agents either have a poor side effect profile, 7 require intensive monitoring at initiation, or may increase all-cause mortality. 8 Catheter ablation of atrial tachycardia (AT) in patients with CHD is known to be safe and effective.…”