Samuel Lévy1, Juha Hartikainen2, Beate Ritz3, Tord Juhlin4, José Carbajosa-Dalmau5, Hans Domanovits6. 1. Marseille School of Medicine, Aix-Marseille University, bd Charles Livon, Marseille Cedex 07, 13284, Marseille, France. samuel@samuel-levy.com. 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.
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.
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.
Authors: Paulus Kirchhof; Stefano Benussi; Dipak Kotecha; Anders Ahlsson; Dan Atar; Barbara Casadei; Manuel Castella; Hans-Christoph Diener; Hein Heidbuchel; Jeroen Hendriks; Gerhard Hindricks; Antonis S Manolis; Jonas Oldgren; Bogdan Alexandru Popescu; Ulrich Schotten; Bart Van Putte; Panagiotis Vardas Journal: Eur Heart J Date: 2016-08-27 Impact factor: 29.983
Authors: A Capucci; G Boriani; G L Botto; T Lenzi; I Rubino; C Falcone; G Trisolino; S Della Casa; N Binetti; M Cavazza Journal: Am J Cardiol Date: 1994-09-01 Impact factor: 2.778
Authors: Peter R Kowey; Paul Dorian; L Brent Mitchell; Craig M Pratt; Denis Roy; Peter J Schwartz; Jerzy Sadowski; Dorota Sobczyk; Andrzej Bochenek; Egon Toft Journal: Circ Arrhythm Electrophysiol Date: 2009-12
Authors: Denis Roy; Craig M Pratt; Christian Torp-Pedersen; D George Wyse; Egon Toft; Steen Juul-Moller; Tonny Nielsen; S Lind Rasmussen; Ian G Stiell; Benoit Coutu; John H Ip; Edward L C Pritchett; A John Camm Journal: Circulation Date: 2008-03-10 Impact factor: 29.690
Authors: Clare L Atzema; Peter C Austin; Eli Miller; Alice S Chong; Lingsong Yun; Paul Dorian Journal: Ann Emerg Med Date: 2013-06-27 Impact factor: 5.721
Authors: Alexander Simon; Jan Niederdoeckl; Ekaterini Skyllouriotis; Nikola Schuetz; Harald Herkner; Christoph Weiser; Anton N Laggner; Hans Domanovits; Alexander O Spiel Journal: Europace Date: 2017-02-01 Impact factor: 5.214