AIM OF THE STUDY: 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. STUDY DESIGN: 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.
RCT Entities:
AIM OF THE STUDY: 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. STUDY DESIGN: 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.
Authors: G Stabile; G Senatore; A De Simone; P Turco; F Coltorti; P Nocerino; D F Vitale; M Chiariello Journal: J Cardiovasc Electrophysiol Date: 1999-01
Authors: C Timmermans; S Lévy; G M Ayers; W Jung; L Jordaens; M Rosenqvist; B Thibault; J Camm; L M Rodriguez; H J Wellens Journal: J Am Coll Cardiol Date: 2000-05 Impact factor: 24.094
Authors: M Santini; R Ricci; A Puglisi; S Mangiameli; A Proclemer; C Menozzi; G De Fabrizio; G Leoni; F Lisi; F De Seta Journal: G Ital Cardiol Date: 1997-09