Elsevier

International Journal of Cardiology

Volume 368, 1 December 2022, Pages 41-48
International Journal of Cardiology

Long-term outcome of combined catheter ablation and left atrial appendage closure in atrial fibrillation patients

https://doi.org/10.1016/j.ijcard.2022.08.007Get rights and content

Highlights

  • The safety of the combined procedure of catheter ablation and left atrial appendage closure was acceptable.

  • Despite a longer fluoroscopy time, the fluoroscopy-guided process had lower risks of respiratory depression and a shorter procedure time and required less workers than the transesophageal echocardiography-guided process.

  • Long-term event rates of the combined procedure were low, including mortality, thromboembolic events, and major bleeding events.

Abstract

Background

The combined procedure of catheter ablation and left atrial appendage closure (LAAC) aims to simultaneously control the heart rhythm and reduce the risk of strokes in patients with atrial fibrillation (AF). The study aims to evaluate the procedural safety and long-term outcome of the combined procedure in a large patient cohort.

Methods

Clinical data of AF patients who underwent the combined procedure was retrospectively analyzed. Procedural and imaging follow-up parameters were compared between the transesophageal echocardiography-guided standard process and fluoroscopy-guided modified process, and between the single-seal WATCHMAN and dual-seal LACBES devices. Long-term outcomes included all-cause mortality, thromboembolic events, major bleeding, and recurrence of atrial tachyarrhythmias.

Results

A total of 1114 patients were included. The rates of procedure-related major complications were comparable between the standard and modified processes (3.7% vs. 2.2%, p = 0.219), except for a higher incidence of respiratory depression in standard process group (0.9% vs 0%, p = 0.037), and between WATCHMAN and LACBES devices (2.4% vs. 3.3%, p = 0.535). The follow-up imaging evaluation revealed a high rate of satisfactory seals (99.7%) and a low rate of device related thrombus (1.9%), which were similar between two process groups and devices. The follow-up of over 1960 patient-years revealed low rates of mortality, thromboembolism, and nonprocedural major bleeding (1.8, 3.2, and 0.9 per 100 patient-years, respectively). Recurrent atrial tachyarrhythmias was observed in 23.9% patients.

Conclusions

The results supported the safety and long-term efficacy of the combined procedure of catheter ablation and LAAC. Fluoroscopy-guided LAAC device implantation may be considered in experienced centers.

Introduction

Rhythm control and stroke prophylaxis have been recognized as two major approaches in the comprehensive management of atrial fibrillation (AF) [1,2]. Catheter ablation is recommended for symptomatic AF patients to restore sinus rhythm and improve quality of life [1,[3], [4], [5]]. The “local” therapy of left atrial appendage (LAA) closure (LAAC) recapitulates the benefits in stroke prevention observed not only in randomized trials comparing with warfarin and non-vitamin K antagonist oral anticoagulants (NOAC) [[6], [7], [8]], but also in real-world practices [9,10]. The combined procedure of the two left atrial intervention, i.e., catheter ablation and LAAC, has been proposed to simultaneously control the heart rhythm and reduce the risk of strokes. Despite remaining controversial, previous studies have reported the safety and effectiveness of this combined procedure, although in small cohorts [[11], [12], [13]].

As one of the largest electrophysiological centers in China, our center has performed the combined procedure of radiofrequency catheter ablation and LAAC since 2017. In real world scenarios, approaches have varied for both procedural phases, which has raised concerns about procedural safety and long-term effectiveness. During the ablation phase, comprehensive and highly individualized approaches were applied according to the temporal patterns of AF, severity of atrial substrate and discretion of physicians. These ablation strategies included pulmonary vein isolation (PVI), extra-PV trigger elimination, various linear ablations, complex fractionated atrial electrogram (CFAE) modification, vein of Marshall (VOM) ethanol infusion, ganglionated plexi ablation, and posterior wall BOX and LAA electrical isolation, etc. During the subsequent LAAC phase, anesthetic modes, modalities of intraprocedural imaging guidance, and device types also varied. In this study, we report promising results regarding procedural safety, post-procedural imaging follow-ups, and long-term outcomes in 1114 AF patients treated with the combined procedure. In addition, this study evaluates the feasibility and safety of fluoroscopy-guided LAAC device implantation without transesophageal echocardiography (TEE) guidance and results of the LAAC device developed based on the dual-seal mechanism.

Section snippets

Methods

This study was approved by the ethics board of Xinhua Hospital, Shanghai, China, and complies with the Declaration of Helsinki. Written informed consent was provided by all participants. The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.

Patient demographics

A total of 1114 AF patients (mean age 70.1 ± 8.0 years; female 485, 43.5%) who underwent the combined procedure were enrolled and analyzed (Table 1). The mean CHA2DS2-VASc score was 3.6 ± 1.5, and the mean HAS-BLED score was 2.4 ± 1.0. The AF temporal pattern was paroxysmal in 44.6% of cases, and persistent or long-standing persistent in 55.4% of cases. Patients were commonly comorbid with hypertension (837, 75.1%), diabetes mellites (246, 24.8%) and heart failure or left ventricular

Main findings

Results from this large cohort provided promising safety levels and long-term outcomes of combined intervention of catheter ablation and LAAC in patients with AF. The main findings were as follows. (1) The procedural safety was acceptable (with a major complication rate of 2.5%), despite various and complex approaches in both the ablation and LAAC phases. (2) Results regarding procedural complications and post-procedural imaging evaluation were generally similar between the TEE-guided and

Conclusions

Results from this large cohort verified the procedural safety of the combined procedure, even with complex and highly individualized approaches of ablation and TEE-free LAAC device implantation. Long-term follow-ups revealed the benefit of the combined procedure of catheter ablation and LAAC in reducing risks of thromboembolic and bleeding events, as well as in restoring sinus rhythm. The dual-seal LACBES device demonstrated comparable results with the single-seal Watchman device regarding

Author statement

All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation

Funding

This study was supported by the National Natural Science Foundation of China (No. 81900288, No. 82170383, No. 82130009 and No. 82070515).

CRediT authorship contribution statement

Mu Chen: Writing – review & editing, Formal analysis, Funding acquisition, Conceptualization. Jian Sun: Writing – review & editing, Formal analysis, Funding acquisition, Conceptualization. Qun-Shan Wang: Data curation, Project administration, Writing – review & editing. Peng-Pai Zhang: Data curation, Validation, Investigation. Wei Li: Data curation, Validation, Investigation, Resources. Rui Zhang: Data curation, Resources. Bin-Feng Mo: Data curation, Formal analysis. Yi-Chi Yu: Data curation,

Declaration of Competing Interest

None.

References (31)

  • A. Nguyen et al.

    Peridevice leak after left atrial appendage closure: incidence, risk factors, and clinical impact

    Can. J. Cardiol.

    (2019)
  • J. Saw et al.

    Incidence and clinical impact of device-associated thrombus and peri-device leak following left atrial appendage closure with the amplatzer cardiac plug

    JACC Cardiovasc. Interv.

    (2017)
  • G. Hindricks et al.

    2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the task force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) developed with the special contribution of the European heart rhythm association (EHRA) of the ESC

    Eur. Heart J.

    (2021)
  • B. Kheiri et al.

    Ablation versus antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation: a meta-analysis of randomized trials

    Circ. Arrhythm. Electrophysiol.

    (2021)
  • D.B. Mark et al.

    Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical trial

    JAMA

    (2019)
  • Cited by (0)

    1

    These authors contributed equally.

    View full text