A poster presented at the 43rd Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery (Freiburg, Germany, February 9–12) has shown that vernakalant (Brinavess, Cardiome) successfully cardioverted 74% atrial fibrillation patients to sinus rhythm at 90 minutes.
The study, “Medical conversion with vernakalant on postoperative cardio-surgical patients” was an independent, investigator-led investigation that demonstrated real-world cardioversion experience with vernakalant IV in patients who developed post-cardiac surgery atrial fibrillation. This was a prospective, non-randomised, single-arm study in 50 patients with a variety of cardiac surgical procedures, ranging from coronary artery bypass graft alone to complicated combination surgeries such as aortic valve and mitral valve replacement.
From October 2011 to October 2013, 50 patients (64% males) with new onset atrial fibrillation received vernakalant according to the labelled indication and dosing schedule. The patients (mean age 72 years old) underwent the following interventions: coronary artery bypass graft (n=30); mitral valve replacement surgery (n=6); aortic valve replacement surgery (n=8); coronary artery bypass graft + mitral valve replacement surgery (n=2); coronary artery bypass graft + aortic valve replacement surgery (n=3); aortic valve replacement surgery + mitral valve replacement surgery (n=1). The primary outcome was the conversion of atrial fibrillation to sinus rhythm at 90 minutes post infusion. The secondary outcome was the proportion of those responders in whom sinus rhythm was maintained post-operation day eight.
In the poster, it was indicated that vernakalant successfully cardioverted 74% of the patients at 90 minutes. Within the initial non-responders, six additional patients had returned to sinus rhythm at day eight (spontaneous conversion (n=1), electric cardioversion (n=1) and conversion by additional amiodarone administration (n=4). At the time of discharge, a total of 43 patients (86%) were successfully converted to sinus rhythm.
There were no serious adverse events or deaths reported in the study group.
The authors concluded that vernakalant with a conversion rate of 74% appears to be well-tolerated and is a promising option compared to current methods.
“We are extremely pleased with the real-world effectiveness that Brinavess demonstrated in cardioverting post-cardiac surgery patients,” says Steen Juul-Möller, Cardiome’s medical director. “This real-world experience of cardioverting 74% of atrial fibrillation patients is similar to what was demonstrated in Malmö, where 70% of non-cardiac surgery patients were effectively cardioverted with Brinavess. The high cardioversion efficacy coupled with its long term durability through patient discharge up to eight days later makes Brinavess a valuable option for the management of post-cardiac surgery atrial fibrillation.”