Vernakalant for Rapid Cardioversion of Recent-Onset Atrial Fibrillation: Results from the SPECTRUM Study
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ORIGINAL ARTICLE
Vernakalant for Rapid Cardioversion of Recent-Onset Atrial Fibrillation: Results from the SPECTRUM Study Samuel Lévy 1
&
Juha Hartikainen 2 & Beate Ritz 3 & Tord Juhlin 4 & José Carbajosa-Dalmau 5 & Hans Domanovits 6
Accepted: 19 October 2020 # The Author(s) 2020
Abstract Aims Rapid restoration of sinus rhythm using pharmacological cardioversion is commonly indicated in patients with symptomatic recent-onset atrial fibrillation (AF). The objectives of this large, international, multicenter observational study were to determine the safety and effectiveness of intravenous (IV) vernakalant for conversion of AF to sinus rhythm in daily practice. Methods and Results Consenting patients with symptomatic recent-onset AF (< 7 days) treated with IV vernakalant were enrolled and followed up to 24 h after the last infusion or until discharge, in order to determine the incidence of predefined serious adverse events (SAEs) and other observed SAEs and evaluate the conversion rate within the first 90 min. Overall, 2009 treatment episodes in 1778 patients were analyzed. The age of patients was 62.3 ± 13.0 years (mean ± standard deviation). Median AF duration before treatment was 11.1 h (IQR 5.4–27.0 h). A total of 28 SAEs occurred in 26 patients including 19 predefined SAEs, i.e., sinus arrest (n = 4, 0.2%), significant bradycardia (n = 11, 0.5%), significant hypotension (n = 2, 0.1%), and atrial flutter with 1:1 conduction (n = 2, 0.1%). There were no cases of sustained ventricular arrhythmias or deaths. All patients who experienced SAEs recovered fully (n = 25) or with sequelae (n = 1). Conversion rate to sinus rhythm was 70.2%, within a median of 12 min (IQR 8.0–28.0 min). Conclusions This large multicenter, international observational study confirms the good safety profile and the high effectiveness of vernakalant for the rapid cardioversion of recent-onset AF in daily hospital practice. Keywords Atrial Arrhythmias . Atrial fibrillation . Pharmacological cardioversion . Vernakalant
Introduction and Purpose of the Study Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with an estimated 33.5 million people affected worldwide [1]. One in four adults over 55 years of age in Europe and the USA develop AF, with greater prevalence in * Samuel Lévy [email protected] 1
Marseille School of Medicine, Aix-Marseille University, bd Charles Livon, Marseille Cedex 07, 13284 Marseille, France
2
Kuopio University Hospital, Kuopio, Finland
3
Correvio International Sàrl, Geneva, Switzerland
4
Skåne University Hospital, Lund, Sweden
5
ISABIAL-Fundación FISABIO, Hospital General Universitario de Alicante, Alicante, Spain
6
Vienna General Hospital, Medical University of Vienna, Vienna, Austria
older populations [1, 2]. Patients with AF are at increased risk of stroke and heart failure [3, 4]. A significant number of patients with recent-onset AF seen in the emergency departments (EDs) undergo commonly in Europe pharmacological cardioversion. Vernakalant is a partial atrial-selective an
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