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Published on: February 28, 2012
Clinical Outcomes and Characteristics With Dofetilide in Atrial Fibrillation Patients Considered for Implantable
Ryan J Koene1, Vivek Menon1, Daniel J Cantillon1
1Department of Cardiovascular Medicine, Electrophysiology Section, Cleveland Clinic, OH.
Insights
Dofetilide use in atrial fibrillation (AF) with reduced ejection fraction (LVEF ≤35%) led to high discontinuation rates but improved LVEF in most patients, potentially avoiding implantable cardioverter defibrillators.
Area of Science:
- Cardiology
- Electrophysiology
- Pharmacology
Background:
- Dofetilide is a key anti-arrhythmic for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF).
- Limited post-approval data exist on dofetilide's safety and efficacy in this specific patient population (LVEF ≤35%).
- This study evaluates outcomes in AF patients with LVEF ≤35% not previously treated with advanced cardiac devices or ablation.
Purpose of the Study:
- To assess the incidence of LVEF improvement and recovery in AF patients with LVEF ≤35% treated with dofetilide.
- To identify predictors of LVEF improvement and recovery.
- To evaluate the safety, drug continuation, and long-term outcomes, including AF recurrence and need for ablation or device implantation.
Main Methods:
- Retrospective analysis of 168 consecutive AF patients with LVEF ≤35% from 2007-2016.
- Data collected on adverse events, drug continuation, device implantation (ICD, CRT), LVEF changes, AF recurrence, and ablation.
- Multivariable regression analysis used to determine predictors of LVEF improvement/recovery.
Main Results:
- Dofetilide was discontinued in 27% of patients before discharge due to QT prolongation, Torsades de Pointes, or ineffectiveness.
- At 1 year, 43% remained on dofetilide, 42% were free from AF, and 40% underwent AF ablation.
- LVEF improved to >35% in 73% and recovered to ≥50% in 45%; predictors included AF presence during echo, coronary artery disease, left atrial diameter, and baseline LVEF.
Conclusions:
- High rates of dofetilide discontinuation and subsequent AF ablation were observed in AF patients with LVEF ≤35%.
- Despite discontinuation, a majority of patients experienced significant LVEF improvement.
- LVEF improvement may obviate the need for primary prevention implantable cardioverter defibrillators in this cohort.
Background:
Dofetilide is one of the only anti-arrhythmic agents approved for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF). However, postapproval data and safety outcomes are limited. In this study, we assessed the incidence and predictors of LVEF improvement, safety, and outcomes in patients with AF with LVEF ≤35% without prior implantable cardioverter defibrillator, cardiac resynchronization therapy, or AF ablation.
Methods:
An analysis of 168 consecutive patients from 2007 to 2016 was performed. Incidences of adverse events, drug continuation, implantable cardioverter defibrillator and cardiac resynchronization therapy implantation, LVEF improvement (>35%) and recovery (≥50%), AF recurrence, and AF ablation were determined. Multivariable regression analysis to identify predictors of LVEF improvement/recovery was performed.
Results:
The mean age was 64±12 years. Dofetilide was discontinued before hospital discharge in 46 (27%) because of QT prolongation (14%), torsades de pointe or polymorphic ventricular tachycardia/fibrillation (6% [sustained 3%, nonsustained 3%]), ineffectiveness (5%), or other causes (3%). At 1 year, 43% remained on dofetilide. Freedom from AF was 42% at 1 year, and 40% underwent future AF ablation. LVEF recovered (≥50%) in 45% and improved to >35% in 73%. Predictors of LVEF improvement included presence of AF during echocardiogram (odds ratio, 4.22 [95% CI, 1.71-10.4], P=0.002), coronary artery disease (odds ratio, 0.35 [95% CI, 0.16-0.79], P=0.01), left atrial diameter (odds ratio, 0.52 per 1 cm increase [95% CI, 0.30-0.90], P=0.01), and LVEF (odds ratio, per 1% increase, 1.09 [95% CI, 1.02-1.16], P=0.006). The C statistic was 0.78.
Conclusions:
In patients with LVEF ≤35%, who are potential implantable cardioverter defibrillator candidates, treated with dofetilide as an initial anti-arrhythmic strategy for AF, drug discontinuation rates were high, and many underwent future AF ablation. However, most patients had improvement in LVEF, obviating the need for primary prevention implantable cardioverter defibrillator.
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