BACKGROUND: One third of chronic heart failure patients have major intraventricular conduction and uncoordinated ventricular contraction. Non-controlled studies suggest that biventricular pacing may improve haemodynamics and well-being by reducing ventricular asynchrony. The aim of this trial was to assess the clinical efficacy and safety of this new therapy in patients with chronic atrial fibrillation. METHODS:Fifty nine NYHA class III patients with left ventricular systolic dysfunction, chronic atrial fibrillation, slow ventricular rate necessitating permanent ventricular pacing, and a wide QRS complex (paced width >or=200 ms), were implanted with transvenous biventricular-VVIR pacemakers. This single-blind, randomized, controlled, crossover study compared the patients' parameters, as monitored during two 3-month treatment periods of conventional right-univentricular vs biventricular pacing. The primary end-point was the 6-min walked distance, secondary end-points were peak oxygen uptake, quality-of-life, hospitalizations, patients' preferred study period and mortality. RESULTS: Because of a higher than expected drop-out rate (42%), only 37 patients completed both crossover phases. In the intention-to-treat analysis, we did not observe a significant difference. However, in the patients with effective therapy the mean walked distance increased by 9.3% with biventricular pacing (374+/-108 vs 342+/-103 m in univentricular;P =0.05). Peak oxygen uptake increased by 13% (P=0.04). Hospitalizations decreased by 70% and 85% of the patients preferred the biventricular pacing period (P<0.001). CONCLUSION: As compared with conventional VVIR pacing, effective biventricular pacing seems to improve exercise tolerance in NYHA class III heart failure patients with chronic atrial fibrillation and wide paced-QRS complexes. Further randomized controlled studies are required to definitively validate this therapy in such patients. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.
RCT Entities:
BACKGROUND: One third of chronic heart failurepatients have major intraventricular conduction and uncoordinated ventricular contraction. Non-controlled studies suggest that biventricular pacing may improve haemodynamics and well-being by reducing ventricular asynchrony. The aim of this trial was to assess the clinical efficacy and safety of this new therapy in patients with chronic atrial fibrillation. METHODS: Fifty nine NYHA class III patients with left ventricular systolic dysfunction, chronic atrial fibrillation, slow ventricular rate necessitating permanent ventricular pacing, and a wide QRS complex (paced width >or=200 ms), were implanted with transvenous biventricular-VVIR pacemakers. This single-blind, randomized, controlled, crossover study compared the patients' parameters, as monitored during two 3-month treatment periods of conventional right-univentricular vs biventricular pacing. The primary end-point was the 6-min walked distance, secondary end-points were peak oxygen uptake, quality-of-life, hospitalizations, patients' preferred study period and mortality. RESULTS: Because of a higher than expected drop-out rate (42%), only 37 patients completed both crossover phases. In the intention-to-treat analysis, we did not observe a significant difference. However, in the patients with effective therapy the mean walked distance increased by 9.3% with biventricular pacing (374+/-108 vs 342+/-103 m in univentricular;P =0.05). Peak oxygen uptake increased by 13% (P=0.04). Hospitalizations decreased by 70% and 85% of the patients preferred the biventricular pacing period (P<0.001). CONCLUSION: As compared with conventional VVIR pacing, effective biventricular pacing seems to improve exercise tolerance in NYHA class III heart failurepatients with chronic atrial fibrillation and wide paced-QRS complexes. Further randomized controlled studies are required to definitively validate this therapy in such patients. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.
Authors: P Kiès; C Leclercq; G B Bleeker; C Crocq; S G Molhoek; C Poulain; L van Erven; M Bootsma; K Zeppenfeld; E E van der Wall; J-C Daubert; M J Schalij; J J Bax Journal: Heart Date: 2005-09-13 Impact factor: 5.994
Authors: Michael L Alosco; Mary Beth Spitznagel; Lawrence H Sweet; Richard Josephson; Joel Hughes; John Gunstad Journal: Pacing Clin Electrophysiol Date: 2014-12-10 Impact factor: 1.976