Introduction
Atrial fibrillation (AF) is the most common rhythm disturbance, with lifetime risk estimates between 20-30% in the United States.1The disease is complex and often difficult to treat for clinicians. It represents a considerable cost burden with an estimated incremental cost of $26 billion in 2010.2Antiarrhythmic drugs (AAD) remain a cornerstone of therapy for management of atrial fibrillation (AF). The class III AAD sotalol has QT-prolonging effects that necessitate multiple days of inpatient hospitalization for observation during oral loading. This has been estimated to cost more than $10,000 per patient for a standard three-day admission, with the greatest proportion of cost coming from room and board.3The use of inpatient beds for these drug loads can also significantly impact hospital capacity to accept and manage other patients, given staffing and bed shortages.4
Intravenous (IV) sotalol was first approved for use by the FDA as a substitute for oral therapy in patients with supraventricular arrhythmias, life-threatening ventricular arrhythmias, and atrial fibrillation/flutter, but with recommendations for infusion over 5 hours.5In March 2020, the IV formulation of the drug received FDA approval for use in expedited loading of oral sotalol.6This approval was based on the Model-Informed Drug Development regulatory path, with simulated data showing that an initial one hour loading dose of IV sotalol followed by two oral doses in 24 hours reflected maximum QT prolongation over a one-day observation period.7The newly approved use case can reduce loading time by two days or more, with even greater reductions for those with impaired renal function. Despite the higher drug cost of IV sotalol, the anticipated reduction in hospital length of stay with intravenous sotalol is expected to lead to significant cost savings when compared to oral sotalol initiation.3
Thus far, available data supporting the use of one-day IV sotalol initiation has been limited to model-informed simulation data.7 A single center experience with a one-day sotalol loading protocol for atrial arrhythmias has been briefly described, but there are no studies comparing IV versus oral sotalol load in a clinical context.8This study aims to describe implementation of a one-day IV sotalol initiation protocol for atrial and ventricular arrhythmias at a learning health system, and to provide initial feasibility and safety outcomes compared to oral sotalol initiation.