Home Sotalol for Arrhythmia Management Using Remote ECG Monitoring

Quick Takes

  • Outpatient initiation of sotalol with use of a personal remote ECG device and pharmacist-led dose adjustments is safe and feasible in carefully selected patients.
  • Compared to inpatient loading regimens, fewer dose adjustments were made using the outpatient protocol but discontinuation rates within 30 days were similar between loading methods.

Study Questions:

Is a pharmacist-led home sotalol loading protocol using an ambulatory electrocardiographic (ECG) device for adverse event monitoring feasible, safe, and efficacious?

Methods:

This is a retrospective review of patients undergoing an outpatient sotalol loading protocol from September 1, 2020 to June 16, 2023 in a pharmacist-led antiarrhythmic clinic. Patients aged 18-85 years with documented atrial or ventricular arrhythmias, normal baseline QTc interval, stable renal function, and optimized serum magnesium and potassium were included. The home sotalol loading protocol consisted of an initial clinic visit, a 3-day outpatient loading period, and a follow-up in-person visit within 1 week of completing sotalol loading. Patients were provided with a Kardia Mobile 6L ECG device and given detailed instructions and training on its use. The pharmacist assessed adverse events and ECG readings after each dose and made dose adjustments according to the protocol. Sotalol dose was decreased if QTc was >500 msec (or 550 msec in patients with an implantable cardioverter-defibrillator). Feasibility of the protocol was measured by the percentage of patients who successfully completed the outpatient loading protocol. A historical cohort of patients who underwent inpatient loading of sotalol was used for comparison.

Results:

A total of 263 patients met the inclusion criteria for the outpatient sotalol loading protocol and 28 patients who underwent inpatient loading were defined as the standard of care group. The most common indication for sotalol initiation was atrial fibrillation (84.4%), of which most were paroxysmal (65.3%). Median starting sotalol doses for outpatients was 120 mg (80-160 mg) twice daily and median doses at the completion of outpatient loading was 120 mg (60-160 mg) twice daily.

The majority of patients completed the outpatient sotalol loading protocol (260/263; 98.9%). Of the three patients who did not complete the protocol, two stopped due to intolerance (dizziness and fatigue) and one patient experienced a mild QTc prolongation. Adherence to the outpatient ECG monitoring remained consistently above 95% throughout the study, except the sixth and final ECG was only transmitted by 91.3% of patients. A total of six patients died during the study period. One died 4 days after starting sotalol but was determined unlikely to be related to the sotalol. The other five deaths were non-arrhythmogenic and occurred >6 months after the initial 90-day follow-up period. Compared to inpatient initiation, sotalol doses were changed less frequently during outpatient loading (5% vs. 21.4%, p = 0.01) but discontinuation rates within 30 days of initiation were similar between groups (8% vs. 7%, p > 0.9).

Conclusions:

Outpatient loading of sotalol through a pharmacist-led, protocol-driven antiarrhythmic clinic is safe and feasible with high adherence rates using personal remote ECG recordings.

Perspective:

Conventional sotalol loading requires a 3-day inpatient hospitalization to carefully monitor patients for adverse events including torsades de pointes. Recently, the Food and Drug Administration approved a shorter 1-day intravenous loading protocol, but this still requires a costly and inconvenient inpatient hospitalization. Several cardiology societies including the American College of Cardiology have noted it would be reasonable to consider outpatient initiation of sotalol for patients in normal sinus rhythm, with QTc <450 msec, and normal electrolytes prior to initiation. This study demonstrates the safety and feasibility of a home sotalol loading protocol using remote ECG recordings and pharmacist-led monitoring and dose adjustments as necessary in carefully selected patients.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Arrhythmias, Cardiac, Electrocardiography, Pharmacists, Sotalol


< Back to Listings