Vernakalant for Cardioversion of Recent-Onset Atrial Fibrillation in the Emergency Department: The SPECTRUM Study

Abstract

<b><i>Introduction:</i></b> Intravenous vernakalant is a therapeutic option for symptomatic, recent-onset atrial fibrillation (AF). This secondary analysis from the large SPECTRUM study assessed the safety and effectiveness of vernakalant when used in the emergency department setting (ED group) or in an inpatient hospital setting (non-ED group). <b><i>Methods:</i></b> This post hoc analysis of the international, observational, post-authorization SPECTRUM study included 1,289 and 720 recent-onset AF episodes in adults in the ED and non-ED groups, respectively. Safety endpoints included the evaluation of pre-defined health outcomes of interest (HOIs) and other serious adverse events (SAEs) during vernakalant treatment and during the first 24 h after the last infusion. Effectiveness endpoints comprised the rate of successful vernakalant cardioversion, the time from the start of the vernakalant infusion to cardioversion, and the length of hospital stay. Data were analysed using descriptive statistics. <b><i>Results:</i></b> The safety profile of vernakalant was similar in the ED and non-ED groups. In the ED group, 12 pre-defined HOIs were reported in 11 patients (0.9%); all but one occurred within 2 h after start of the first infusion. These events comprised nine significant bradycardia cases, of which one was associated with transient hypotension and three with sinus arrest, and 2 cases of atrial flutter with 1:1 conduction. Five other SAEs were reported. All patients with vernakalant-related events recovered without sequelae. No Torsade de Pointes, ventricular fibrillation, or deaths occurred. Successful cardioversion was reported in 67.8% (95% confidence interval: 65.2–70.4) and 66.4% (62.5–70.1) of episodes, with a median time to conversion of 11.0 and 10.0 min in the ED and non-ED groups, respectively. Patients had a median length of hospital stay of 7.4 h and 17.1 h in the ED and non-ED groups, respectively. <b><i>Conclusion:</i></b> Intravenous vernakalant was well tolerated with similar cardioversion rates in patients treated in the ED or non-ED setting and does not require admission to a coronary care unit or intensive care unit. First-line treatment with vernakalant could allow an early discharge in patients with recent-onset AF treated in the ED.

Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)

“…Vernakalant is a novel agent with a good safety profile and performance in terms of successful cardioversion in a timely fashion. In the recent post-hoc analysis of the large, international, observational SPECTRUM study [ 16 ], IV vernakalant was well-tolerated, albeit with a few (0.9%) adverse events involving significant bradycardia, including sinus arrest. Successful cardioversion was reported in 67.8% of episodes and the median length of hospital stays at the ED was 7.4 h. Vernakalant may be used in patients with a history of coronary artery disease, which is a patient group where amiodarone is typically used.…”

Emergency department management of atrial fibrillation: 2023 consensus from the Spanish Society of Emergency Medicine (SEMES), the Spanish Society of Cardiology (SEC), and the Spanish Society of Thrombosis and Hemostasis (SETH)

“…En ausencia de cardiopatía significativa, pueden usarse tanto los FAA de clase I-C, que asocian una gran efectividad (80-90%) con buena tolerancia, como el más reciente vernakalant, que además de su buena tolerancia asocia una mayor rapidez de acción, permitiendo altas más precoces del SUH y un alivio de los síntomas más temprano 9,110,111 . En pacientes sin cardiopatía, puede considerarse también la cardioversión eléctrica como primera opción, ya que ha demostrado ser la técnica más segura y efectiva para la restauración del ritmo sinusal, y además reducir la duración de la estancia en urgencias 3,7,10,[97][98][99]107 .…”

“…Por otro lado, amiodarona es segura si existe cardiopatía estructural [9][10][11]108 , pero posee muy escasa efectividad en la fase aguda para la restauración del ritmo sinusal en la FA, con un perfil de efectos secundarios a largo plazo no desdeñable 7,97,107,108,112 . Vernakalant presenta una efectividad superior a amiodarona, una gran rapidez de acción (mediana de conversión a los 10-12 minutos) y su uso es seguro en pacientes con cardiopatía estructural (salvo estenosis aórtica o IC grados III-IV de la NYHA) y constituye una alternativa en los pacientes con cardiopatía [9][10][11]14,108,110,111 . En cualquier caso, si existe una cardiopatía estructural significativa, la cardioversión eléctrica aporta una efectividad máxima y un perfil de seguridad más adecuado que el de los FAA, por lo que en general se considera la terapia de elección 10,14,97,98 .…”