Circulation, Vol 86, 363-374, Copyright © 1992 by American Heart Association
M Fromer, J Brachmann, M Block, J Siebels, E Hoffmann, J Almendral, OJ Ohm, K den Dulk, P Coumel and AJ Camm
BACKGROUND. Third-generation implantable cardioverter-defibrillators are
devices designed to treat ventricular tachycardia (VT) and ventricular
fibrillation (VF) by means of overdrive pacing, cardioversion, or
defibrillation. So far, the efficacy of tiered therapy has been documented
only in small series. Therefore, a European multicenter clinical evaluation
study of a new tachyarrhythmia control device, the Medtronic PCD
pacer-cardioverter-defibrillator with epicardial patch-lead configuration,
was undertaken. METHODS AND RESULTS. We report on 102 patients (mean age,
55 +/- 13 years) from 11 European centers. PCD devices implanted between
May 1989 and February 1991 were included. The patients suffered from
hemodynamically significant ventricular tachyarrhythmias not suppressed by
antiarrhythmic drug therapy and unrelated to acute myocardial infarction;
one patient had nonsustained VT and severely depressed left ventricular
function. Seventy patients had coronary artery disease with old myocardial
infarctions, 23 had cardiomyopathies of various etiologies, and nine
patients had no detectable heart disease. Mean ejection fraction was 36 +/-
14% (range, 10-76%). Mean intraoperative defibrillation threshold (51
patients) was 10.6 +/- 5.1 J (range, 2-18 J). The documented follow-up
ranged from 1 to 21 months (mean, 9.4 +/- 5.8 months), or 79.9 cumulative
patient-years. Perioperative mortality was 3.9%. The actuarial survival
rate at 12 months was 91%. One sudden arrhythmic death occurred. Sixty
patients (58%) received device therapy. Seventeen patients had therapies
only for "VF" episodes, 16 patients only for VT, and 28 patients for VT and
"VF" episodes. Based on device memory data, 1,235 spontaneous VT episodes
were detected and treated in 43 patients. Twelve hundred four of these VT
episodes received painless initial antitachycardia pacing therapy,
restoring sinus rhythm in 91%. The 108 ongoing episodes received 209
multiple therapeutic attempts. Eighty-five additional overdrive pacing
therapies restored sinus rhythm in 30%. Initial ineffective antitachycardia
pacing therapies received 51 cardioversion pulses. The success rate was
61%. Seventy-three additional cardioversion pulses were delivered to backup
ineffective pacing therapy as well as ineffective secondary cardioversion
pulses. Their success rate was only 40%. Two hundred eighty-six spontaneous
episodes were detected in 44 patients as "VF." Overall defibrillation
efficacy was 97.6%. CONCLUSIONS. The implanted device nearly eliminates
sudden arrhythmic death in patients with documented, potentially fatal
ventricular tachyarrhythmias. Automatic tiered therapy is highly effective
to restore sinus rhythm, provided that an integrated two-zone tachycardia
detection algorithm is used, assigning lower tachycardia rates to overdrive
pacing and/or cardioversion and higher tachycardia rates to defibrillation.
In general, spontaneous VTs can be terminated by automatic overdrive
pacing, and painful or disturbing countershock therapies are not required
to terminate the majority of spontaneous VT episodes.
ARTICLES
Efficacy of automatic multimodal device therapy for ventricular tachyarrhythmias as delivered by a new implantable pacing cardioverter- defibrillator. Results of a European multicenter study of 102 implants
Division de Cardiologie, CHUV, Lausanne, Switzerland.
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