Long-term outcome of combined catheter ablation and left atrial appendage closure in atrial fibrillation patients
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)
- et al.
Epidemiology, management, and outcomes of atrial fibrillation among 30 million citizens in Shanghai, China from 2015 to 2020: a medical insurance database study
Lancet Reg. Health West Pac.
(2022) - et al.
Recurrence of atrial fibrillation after catheter ablation or antiarrhythmic drug therapy in the CABANA trial
J. Am. Coll. Cardiol.
(2020) - et al.
Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial
Lancet
(2009) - et al.
Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial
J. Am. Coll. Cardiol.
(2014) - et al.
Left atrial appendage closure versus direct Oral anticoagulants in high-risk patients with atrial fibrillation
J. Am. Coll. Cardiol.
(2020) - et al.
The NCDR left atrial appendage occlusion registry
J. Am. Coll. Cardiol.
(2020) - et al.
Use of deep intravenous sedation with propofol and the laryngeal mask airway during transesophageal echocardiography
J. Cardiothorac. Vasc. Anesth.
(2003) - et al.
Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score
J. Am. Coll. Cardiol.
(2011) - et al.
Adding six short lines on pulmonary vein isolation circumferences reduces recurrence of paroxysmal atrial fibrillation: results from a multicenter, single-blind, randomized trial
Heart Rhythm.
(2022) - et al.
Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the United States
JACC Cardiovasc. Interv.
(2022)
Peridevice leak after left atrial appendage closure: incidence, risk factors, and clinical impact
Can. J. Cardiol.
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.
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.
Ablation versus antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation: a meta-analysis of randomized trials
Circ. Arrhythm. Electrophysiol.
Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical trial
JAMA
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These authors contributed equally.