From the Academic Hospital Maastricht, Maastricht, the Netherlands
(H.J.J.W., C.T.); Queen Mary Hospital, Hong Kong, China (C.-P.L., H.-F.T.);
University of Bonn, Bonn, Germany (B.L., W.J.); St Luke's Medical
Center, Milwaukee, Wis (M.A.); University Hospitals of Cleveland, Cleveland,
Ohio (A.L.W.); St George's Hospital, London, UK (A.J.C.); Academic
Hospital Gent, Gent, Belgium (L.J.); and InControl Inc, Redmond, Calif (G.A.).
Background—During atrial
fibrillation, electrophysiological changes
occur in atrial tissue that favor the maintenance of the
arrhythmia and facilitate recurrence after conversion
to sinus rhythm. An implantable defibrillator connected to right atrial
and coronary sinus defibrillation leads allows prompt
restoration of sinus rhythm by a low-energy shock. The safety and
efficacy of this system, called the Atrioverter, were evaluated in a
prospective, multicenter study.
Methods and Results—The study included 51 patients with recurrent
atrial fibrillation who had not responded to antiarrhythmic drugs, were
in New York Heart Association Heart failure class I or II, and were at
low risk for ventricular arrhythmias. The atrial
defibrillation threshold had to be
Conclusions—With the Atrioverter, prompt and safe restoration of
sinus rhythm is possible in patients with recurrent atrial
fibrillation.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Atrioverter: An Implantable Device for the Treatment of Atrial Fibrillation
240 V during preimplant testing.
Atrial fibrillation detection, R-wave shock synchronization, and
defibrillation threshold were tested at implantation and during
follow-up. Shock termination of spontaneous episodes of atrial
fibrillation was performed under physician observation. Results are
given after a minimum of 3 months of follow-up. During a follow-up of
72 to 613 days (mean, 259±138 days), 96% of 227 spontaneous episodes
of atrial fibrillation in 41 patients were successfully converted to
sinus rhythm by the Atrioverter. In 27% of episodes, several shocks
were required because of early recurrence of atrial
fibrillation. Shocks did not induce ventricular
arrhythmias. Most patients received antiarrhythmic medication
during follow-up. In 4 patients, the Atrioverter was removed: in 1
because of infection, in 1 because of cardiac tamponade, and in 1
because of frequent episodes of atrial fibrillation requiring His
bundle ablation.
Key Words: atrial fibrillation • atrial defibrillation • atrium
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