OBJECTIVES: This study was conducted to establish the safety and performance of a new rate-smoothing pacing algorithm for patients with atrial fibrillation (AF). BACKGROUND: Irregularity of the ventricular response is a hallmark of AF. This irregularity may contribute to symptoms and hemodynamic compromise in patients with AF. Interventions designed to reduce irregularity have not previously been evaluated in a long-term, clinical setting. METHODS: We designed a prospective, double-blind study with randomized crossover. Patients with either paroxysmal or chronic AF whose conditions were medically refractory and who were referred for an atrioventricular node ablation procedure all underwentpacemaker implantation. Subjects were then randomly assigned to either DDD mode with the rate-smoothing algorithm (RSA) on, or to OOO mode. After 2 months they were crossed over to the other arm. RESULTS:Fourteen patients (9 with paroxysmal AF and 5 with chronic AF) were enrolled. There were no significant differences between the group randomly assigned to RSA first versus the group assigned to OOO first. The mean left ventricular ejection fraction with the RSA was not significantly different than it was in OOO mode (45.1 +/- 18.6 vs 51.9 +/- 12.3; P =.11), although some individuals with uncontrolled ventricular rates did have a large decrease in ejection fraction with rate smoothing. One developed overt heart failure. One quality-of-life instrument detected a significant improvement in the "physical limitations" domain with the rate-smoothing mode. Eleven of 14 patients preferred the RSA ON arm, and 6 of those 11 elected to defer the ablation procedure. CONCLUSIONS: Long-term rate-smoothed pacing is feasible. Because of concerns about pacing-induced heart failure in some patients with rapid ventricular rates, rate-smoothed pacing should be reserved for those who remain symptomatic despite adequate control of the ventricular rate. The RSA may help to reduce symptoms in patients with medically refractory AF; more study is required to define its efficacy in reducing symptoms and morbidity in this population.
RCT Entities:
OBJECTIVES: This study was conducted to establish the safety and performance of a new rate-smoothing pacing algorithm for patients with atrial fibrillation (AF). BACKGROUND: Irregularity of the ventricular response is a hallmark of AF. This irregularity may contribute to symptoms and hemodynamic compromise in patients with AF. Interventions designed to reduce irregularity have not previously been evaluated in a long-term, clinical setting. METHODS: We designed a prospective, double-blind study with randomized crossover. Patients with either paroxysmal or chronic AF whose conditions were medically refractory and who were referred for an atrioventricular node ablation procedure all underwent pacemaker implantation. Subjects were then randomly assigned to either DDD mode with the rate-smoothing algorithm (RSA) on, or to OOO mode. After 2 months they were crossed over to the other arm. RESULTS: Fourteen patients (9 with paroxysmal AF and 5 with chronic AF) were enrolled. There were no significant differences between the group randomly assigned to RSA first versus the group assigned to OOO first. The mean left ventricular ejection fraction with the RSA was not significantly different than it was in OOO mode (45.1 +/- 18.6 vs 51.9 +/- 12.3; P =.11), although some individuals with uncontrolled ventricular rates did have a large decrease in ejection fraction with rate smoothing. One developed overt heart failure. One quality-of-life instrument detected a significant improvement in the "physical limitations" domain with the rate-smoothing mode. Eleven of 14 patients preferred the RSA ON arm, and 6 of those 11 elected to defer the ablation procedure. CONCLUSIONS: Long-term rate-smoothed pacing is feasible. Because of concerns about pacing-induced heart failure in some patients with rapid ventricular rates, rate-smoothed pacing should be reserved for those who remain symptomatic despite adequate control of the ventricular rate. The RSA may help to reduce symptoms in patients with medically refractory AF; more study is required to define its efficacy in reducing symptoms and morbidity in this population.
Authors: John Silberbauer; Rick A Veasey; Elizabeth Cheek; Nadeem Maddekar; Neil Sulke Journal: J Interv Card Electrophysiol Date: 2009-07-28 Impact factor: 1.900