Comparison catheter ablation versus permanent pacemaker implantation in patients with tachycardia-bradycardia syndrome: prospective, randomized trial
Abstract Background Clinical outcomes after catheter ablation (CA) or pacemaker (PM) implantation for tachycardia-bradycardia syndrome (TBS) has not been well evaluated. Purpose This randomized controlled study compared the efficacy and safety outcomes of CA and PM implantation as an initial treatment for TBS with paroxysmal atrial fibrillation (AF). Methods A total of 70 patients with paroxysmal AF and TBS (mean 64 years, 64.3% male) underwent randomization, and received CA (CA group, n=35) or PM (PM group, n=35) as an initial treatment. The primary outcome was unexpected emergency room visit or hospitalization from any cardiovascular causes. Results The two groups were well-balanced with respect to the baseline characteristics except for difference in age (61.0±8.0 vs. 66.2±7.2, P=0.005). In the intention-to-treatment analysis, the rate of primary outcome was not significantly different between two groups at 2-years of follow-up (19.8% vs. 24.2%; HR 1.25, 95% CI 0.42–3.73, P=0.684). The same trend was noted when the result was adjusted for age (HR 1.16 95% CI 0.26–2.89, P=0.807). The rate of recurrent AF was significantly lower in CA group compared to PM group (24.0% vs. 100% at 2-yreas, P<0.001). Four patients (11.4%) in CA group finally received PM implantation after CA due to syncope. The rate of major or minor procedure related complications was not significantly different between two groups (14.3% vs. 14.3%, P>0.99). Conclusion In this randomized controlled study, CA was associated with a similar efficacy and safety with higher rate of sinus rhythm maintenance. CA could be considered a preferable treatment option over PM implantation in patients with paroxysmal AF and TBS. Funding Acknowledgement Type of funding source: None