The high prevalence of atrial fibrillation (AF) and its clinical complicati
ons, the poor efficacy of medical therapy for preventing recurrences, and d
issatisfaction with alternative modes of therapy stimulated interest in imp
lantable atrial and combined atrioventricular defibrillators.
In a multicenter study, the safety and efficacy of a stand alone implantabl
e atrial defibrillator, the Metrix system, were evaluated. The device was i
mplanted in 51 patients with highly symptomatic episodes of AF refractory t
o pharmacological treatment. During a follow-up of 9 months, 96% of 227 spo
ntaneous AF episodes were successfully converted to sinus rhythm in 41 pati
ents. In 62 episodes (27%), several shocks and/or additional drug treatment
were required to maintain stable sinus rhythm because of early recurrences
of AF. A total of 3719 shocks were delivered and no induction of ventricul
ar proarrhythmia or inaccurately synchronized shocks occurred. The AF detec
tion algorithm exhibited a 100% specificity for the recognition of sinus rh
ythm and a 92.3% sensitivity for the detection of AF.
The combined atrioventricular defibrillator, Jewel AF 7250, was evaluated i
n a multicenter, randomized, cross-over trial. The primary study objectives
included: overall safety as determined by complications-free survival at 6
months, efficacy of tiered atrial pacing and defibrillation therapies for
termination of spontaneous atrial tachycardias (AT) and AF, and relative se
nsitivity of a new dual-chamber detection algorithm. The device was implant
ed in 211 patients with either a history of ventricular tachyarrhythmias (V
T/VF) alone or with a history of both AT/AF and VT/VF. During a mean follow
-up of 4.5 months, it has been shown that the Jewel AF is safe and effectiv
e in treating atrial and ventricular tachyarrhythmias. Pace termination of
85% of AT episodes were achieved with painless delivery of antitachycardia
pacing; additional 35% of AT episodes were terminated by high frequency bur
st pacing.
Conclusions: The stand alone implantable atrial defibrillator may be safe a
nd clinically useful in selected patients for the treatment of highly sympt
omatic, drug resistant recurrences of AF. The combined atrioventricular def
ibrillator may be particularly indicated in patients presenting with both a
history of atrial and ventricular tachyarrhythmias.