Is dual defibrillator better than conventional DDD pacing in brady-tachy syndrome? Results of the ICARUS Trial (Internal Cardioversion Antitachypacing and Prevention: Resource Utilization Study).
OBJECTIVE
To compare the impact of dual defibrillator versus conventional DDD pacing on quality of life and hospitalizations in patients with sinus node disease and recurrent symptomatic atrial fibrillation.


METHODS
Prospective, parallel, controlled trial.


METHODS
Sixty-three patients (41 M, mean age 71 +/- 8 years) with sinus node disease and at least three symptomatic episodes of atrial fibrillation during the last year were enrolled. Thirty-one consecutive patients received a dual defibrillator (group A) and 32 standard DDD pacing (group B). In group A, 12 patients received an external remote-control device in order to shock themselves in case of atrial fibrillation, while 19 were scheduled for early in-hospital manual shock. Seventy-five percent had been hospitalized during the last year and 57% had required electrical cardioversion. Atrial fibrillation was persistent in 63.5% and paroxysmal in 37.5%. The follow-up lasted 1 year.


RESULTS
Atrial fibrillation recurred in 83.3% in group A and 79.3% in group B (p = ns). Electrical cardioversion was applied in 54.8% in group A and in 21.9% in group B (p < 0.05). On the whole, 89.5% of electrical cardioversions were delivered in the defibrillator group (p < 0.0001). In the whole population 27.0% patients had cardiac-related hospitalization (31.2% in the pacemaker group and 22.6% in the defibrillator group, p = n.s.). In patients with persistent atrial fibrillation, cardiac-related hospitalization rate was significantly lower in the group A (0% vs. 30%, p < 0.05). Considering Symptom Check List, symptoms significantly improved in the whole population, but symptom number and frequency improved significantly only in the group A. Similarly, SF-36 questionnaire scores showed a little higher quality of life improvement in the group A.


CONCLUSIONS
Dual defibrillator showed consistent trends toward a higher effectiveness when compared with standard DDD pacing. Dual defibrillator was associated to reduced in-patient cardioversions and to better quality of life. All-cause hospitalizations were reduced only in patients with persistent atrial fibrillation.
Santini
Massimo
M
Department of Cardiology, S. Filippo Neri Hospital, Via Martinotti, 20, Rome, 00135, Italy. m.santini@rmnet.it
Ricci
Renato
R
Pignalberi
Carlo
C
Russo
Maurizio
M
Magris
Barbara
B
Grovale
Nicoletta
N
De Santo
Tiziana
T
D000368:Aged; D001281:Atrial Fibrillation / Q000628:therapy*; D001919:Bradycardia / Q000628:therapy*; D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D013577:Syndrome; D013610:Tachycardia / Q000628:therapy*