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.