Objective: To verify the safety and efficacy of the domestic 3D cardiac electrophysiological mapping system for catheter ablation of persistent atrial fibrillation (AF).
Methods: From December 2011 to April 2014, 255 patients (184 male) with persistent AF in 13 centers were enrolled in this multicenter prospective controlled study.The patients were allocated to catheter ablation group (experiment group) and antiarrhythmics drugs cardioversion group (control group) with the ratio 2∶1 according to the patients' intention. Left atria were constructed with 3D cardiac electrophysiology mapping system, magnetic sensored saline irrigated radiofrequency ablation catheter (FireMagic™ Cool 3D) and surface reference (Columbus™). Pulmonary vein isolation and left atrial roof line, mitral annulus isthmus line, three tricuspid annulus isthmus line, superior vena cava, the coronary sinus and complex atrial fragmented potentials were targeted if necessary under the guidance of the 3D mapping system. Antiarrhythmics drugs (except amiodarone) were applied to patients for 2 to 3 months after ablation. The patients were followed up for 9 months after 3 months blanking period. The patients in the control group underwent cardioversion with amiodarone and electrical cardioversion if needed. Patients in the control group were also followed up for 9 months.
Results: Of the 255 patients, 167 cases were in the experiment group and 88 cases were in the control group. In per protocol set (PPS), 155 cases were in the experiment group, 79 cases in the control group. Catheter ablation was successful for all patients in the experiment group under the guidance of the 3D cardiac electrophysiological mapping system. Pumononary veins isolation was achieved in all patients. After 9 months follow-up beyond blanking period, in full analysis set, the success rate was 66.5% (111/167) in the experiment group, which was significantly higher than that in the control group (21.6% (19/88), P<0.001). In PPS, the success rate was also significantly higher in the experiment group than in the control group (67.1% (104/155) vs. 22.8%(18/79), P<0.001). The incidence of adverse events was 19.8% in the experiment group and 13.6% in the control group(P=0.223). The adverse events associated with catheter ablation included 1 case of left subclavian hematoma, 1 case of left subclavian bleeding and 1 case of pericardial effusion, which was alleviated by pericardiocentesis. No pulmonary vein stenosis occurred.
Conclusion: Domestic 3D cardiac electrophysiological mapping system can safely and effectively guide catheter ablation of persistent AF.