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Randomized Controlled Trial
. 2024 May 10;24(1):246.
doi: 10.1186/s12872-024-03920-0.

Comparison between catheter ablation versus permanent pacemaker implantation as an initial treatment for tachycardia-bradycardia syndrome patients: a prospective, randomized trial

Min Soo Cho  1 , Ji Hyun Lee  2 , Gi-Byoung Nam  3 , Ki Won Hwang  4 , Myung-Jin Cha  1 , Jun Kim  1 , Kee-Joon Choi  1
Affiliations
Randomized Controlled Trial

Comparison between catheter ablation versus permanent pacemaker implantation as an initial treatment for tachycardia-bradycardia syndrome patients: a prospective, randomized trial

Min Soo Cho et al. BMC Cardiovasc Disord. .

Abstract

Background: Clinical outcomes after catheter ablation (CA) or pacemaker (PM) implantation for the tachycardia-bradycardia syndrome (TBS) has not been evaluated adequately. We tried to compare the efficacy and safety outcomes of CA and PM implantation as an initial treatment option for TBS in paroxysmal atrial fibrillation (AF) patients.

Methods: Sixty-eight patients with paroxysmal AF and TBS (mean 63.7 years, 63.2% male) were randomized, and received CA (n = 35) or PM (n = 33) as initial treatments. The primary outcomes were unexpected emergency room visits or hospitalizations attributed to cardiovascular causes.

Results: In the intention-to-treatment analysis, the rates of primary outcomes were not significantly different between the two groups at the 2-year follow-up (19.8% vs. 25.9%; hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.25-2.20, P = 0.584), irrespective of whether the results were adjusted for age (HR 1.12, 95% CI 0.34-3.64, P = 0.852). The 2-year rate of recurrent AF was significantly lower in the CA group compared to the PM group (33.9% vs. 56.8%, P = 0.038). Four patients (11.4%) in the CA group finally received PMs after CA owing to recurrent syncope episodes. The rate of major or minor procedure related complications was not significantly different between the two groups.

Conclusion: CA had a similar efficacy and safety profile with that of PM and a higher sinus rhythm maintenance rate. CA could be considered as a preferable initial treatment option over PM implantation in patients with paroxysmal AF and TBS.

Trial registration: KCT0000155.

Keywords: Artificial pacemaker; Atrial fibrillation; Catheter ablation; Sick sinus syndrome.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flow diagram. Of the 105 patients with tachycardia-bradycardia syndrome, 35 were excluded from the study for the following reasons; 21 refused consent, 10 < 40 years or ≥ 75 years, 2 previous percutaneous coronary intervention or coronary artery bypass grafting, 1 previous catheter ablation, and 1 valvular heart disease. Of the 70 patients who underwent randomization, 35 patients were assigned to catheter ablation and 35 to the pacemaker group. Two patients in the pacemaker group withdrew consent immediately after the randomization and asked for their data to be deleted. The remaining 68 patients were included in the intention-to-treat analysis
Fig. 2
Fig. 2
(A) Rate of unexpected emergency room visits or rehospitalizations, and (B) age-adjusted rate of unexpected emergency room visits or rehospitalizations
Fig. 3
Fig. 3
Rate of (A) clinical atrial fibrillation or tachycardia recurrence, and (B) clinical or subclinical atrial fibrillation or tachycardia recurrence
See this image and copyright information in PMC

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