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导管消融与永久性心脏起搏器植入作为心动过速-心动过缓综合征患者初始治疗的比较:一项前瞻性、随机试验。

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

机构信息

Department of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.

Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.

出版信息

BMC Cardiovasc Disord. 2024 May 10;24(1):246. doi: 10.1186/s12872-024-03920-0.

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.

摘要

背景

对于心动过速-心动过缓综合征(TBS),导管消融(CA)或起搏器(PM)植入后的临床结果尚未得到充分评估。我们试图比较 CA 和 PM 植入作为阵发性心房颤动(AF)患者 TBS 的初始治疗选择的疗效和安全性结果。

方法

68 例阵发性 AF 和 TBS 患者(平均 63.7 岁,63.2%为男性)被随机分组,分别接受 CA(n=35)或 PM(n=33)作为初始治疗。主要终点为归因于心血管原因的意外急诊就诊或住院。

结果

意向治疗分析中,两组在 2 年随访时主要结局的发生率无显著差异(19.8% vs. 25.9%;风险比(HR)0.73,95%置信区间(CI)0.25-2.20,P=0.584),无论结果是否调整年龄(HR 1.12,95% CI 0.34-3.64,P=0.852)。与 PM 组相比,CA 组的 2 年复发 AF 率明显较低(33.9% vs. 56.8%,P=0.038)。4 例(11.4%)CA 组患者因反复晕厥发作最终在 CA 后接受了 PM。两组间主要或次要手术相关并发症的发生率无显著差异。

结论

CA 的疗效和安全性与 PM 相似,窦律维持率更高。对于阵发性 AF 和 TBS 患者,CA 可作为 PM 植入的首选初始治疗选择。

试验注册

KCT0000155。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/53d8/11088091/066c8cac9f62/12872_2024_3920_Fig1_HTML.jpg

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