BACKGROUND: Uncontrolled studies have suggested that atrioventricular junction ablation and pacemaker implantation have beneficial effects on quality of life in patients with chronic atrial fibrillation (AF). METHODS AND RESULTS: We performed a multicenter, controlled, randomized, 12-month evaluation of the clinical effects of atrioventricular junction ablation and VVIR pacemaker (Abl+Pm) versus pharmacological (drug) treatment in 66 patients with chronic (lasting >6 months) AF who had clinically manifest heart failure and heart rate >90 bpm on 3 standard ECGs recorded at rest during stable clinical conditions on different days. Before completion of the study, withdrawals occurred in 8 patients of the drug group and in 4 patients of the Abl+Pm group. At the end of the 12 months, the 28 Abl+Pm patients who completed the study showed lower scores in palpitations (-78%; P=0.000) and effort dyspnea (-22%; P=0.05) than the 26 of the drug group. Lower scores, although not significant, were also observed for exercise intolerance (-20%), easy fatigue (-17%), chest discomfort (-50%), Living with Heart Failure Questionnaire (-14%), New York Heart Association functional classification (-4%), and Activity scale (-12%). The intrapatient comparison between enrollment and month 12 showed that in the Abl+Pm group, all variables except easy fatigue improved significantly from 14% to 82%. However, because an improvement was also observed in the drug group, the difference between the 2 groups was significant only for palpitations (P=0.000), effort dyspnea (P=0.01), exercise intolerance (P=0.005), easy fatigue (P=0.02), and chest discomfort (P=0.02). Cardiac performance, evaluated by means of standard echocardiogram and exercise test, did not differ significantly between the 2 groups and remained stable over time. CONCLUSIONS: In patients with heart failure and chronic AF, Abl+Pm treatment is effective and superior to drug therapy in controlling symptoms, although its efficacy appears to be less than that observed in uncontrolled studies because some improvement can also be expected in medically treated patients. Cardiac performance is not modified by the treatment.
RCT Entities:
BACKGROUND: Uncontrolled studies have suggested that atrioventricular junction ablation and pacemaker implantation have beneficial effects on quality of life in patients with chronic atrial fibrillation (AF). METHODS AND RESULTS: We performed a multicenter, controlled, randomized, 12-month evaluation of the clinical effects of atrioventricular junction ablation and VVIR pacemaker (Abl+Pm) versus pharmacological (drug) treatment in 66 patients with chronic (lasting >6 months) AF who had clinically manifest heart failure and heart rate >90 bpm on 3 standard ECGs recorded at rest during stable clinical conditions on different days. Before completion of the study, withdrawals occurred in 8 patients of the drug group and in 4 patients of the Abl+Pm group. At the end of the 12 months, the 28 Abl+Pm patients who completed the study showed lower scores in palpitations (-78%; P=0.000) and effort dyspnea (-22%; P=0.05) than the 26 of the drug group. Lower scores, although not significant, were also observed for exercise intolerance (-20%), easy fatigue (-17%), chest discomfort (-50%), Living with Heart Failure Questionnaire (-14%), New York Heart Association functional classification (-4%), and Activity scale (-12%). The intrapatient comparison between enrollment and month 12 showed that in the Abl+Pm group, all variables except easy fatigue improved significantly from 14% to 82%. However, because an improvement was also observed in the drug group, the difference between the 2 groups was significant only for palpitations (P=0.000), effort dyspnea (P=0.01), exercise intolerance (P=0.005), easy fatigue (P=0.02), and chest discomfort (P=0.02). Cardiac performance, evaluated by means of standard echocardiogram and exercise test, did not differ significantly between the 2 groups and remained stable over time. CONCLUSIONS: In patients with heart failure and chronic AF, Abl+Pm treatment is effective and superior to drug therapy in controlling symptoms, although its efficacy appears to be less than that observed in uncontrolled studies because some improvement can also be expected in medically treated patients. Cardiac performance is not modified by the treatment.
Authors: E Hoffmann; P Nimmermann; S Janko; C Reithmann; K Finkner; T Remp; A Gerth; U Dorwarth; G Steinbeck Journal: Herz Date: 1999-10 Impact factor: 1.443
Authors: S Saskena; M J Domanski; E J Benjamin; A J Camm; M D Ezekowitz; B J Gersh; J Jalife; G V Naccarelli; R E Vlietstra; D G Wyse Journal: J Interv Card Electrophysiol Date: 2001-09 Impact factor: 1.900
Authors: Gerald V Naccarelli; John Hynes; Deborah L Wolbrette; Luna Bhatta; Mazhar Khan; Jerry Luck Journal: Curr Cardiol Rep Date: 2002-09 Impact factor: 2.931