| Objective:To investigate the safety and efficacy of "one-step" operation combining catheter ablation and left atrial appendage closure for non-valvular atrial fibrillation.Methods:From November 2015 to December 2018,100 patients with non-valvular atrial fibrillation who underwent catheter ablation combined with left atrial appendage occlusion(one-step group),and 100 patients with non-valvular atrial fibrillation treated with single catheter ablation(single ablation group)in our center were selected.A retrospective cohort study method was adopted.One-step group was used as the study group and the single ablation group was used as the control group.The general data such as gender,age,type of atrial fibrillation,and course of disease were compared between the two groups.The ablation procedure of the two groups was based on the isolation of the pulmonary veins with or without auxiliary line ablation.The operation strategies of one-step group can choose to ablate-first or occlusion-first according to the operator's wishes and patient conditions.Two groups of patients took anticoagulant and antiarrhythmic drugs within 3 months after operation.Electrocardiogram and 24 h Holter examination were performed at 3 months,6 months,1 year,2 years,and 3 years after operation.Patients in the one-step group were required to undergo transesophageal echocardiography(TEE)at 3 months,6 months,and 1 year after operation.The efficacy endpoints of this study were stroke,TIA,systemic thromboembolism,death,and cardiovascular events.The safety endpoints were operation-related and device-related embolization,left atrial esophageal fistula,pericardial effusion requiring treatment,intracranial or gastrointestinal bleeding.Recurrence of atrial fibrillation is defined as atrial tachyarrhythmias(atrial tachycardia,atrial flutter,atrial fibrillation)that persists for more than 30 s after 3 months of operation,with or without antiarrhythmic drugs.Compared the incidence of perioperative complications,recurrence of atrial fibrillation,thromboembolism,hemorrhage,etc.during the follow-up period to evaluate the safety and efficacy of one-step operation relative to single ablation for A.Results:The single ablation group and the one-step group of male patients were all 62(62%),with an average age of 62.8±8.9 years and 68.1±7.1 years(P<0.001).The proportion of patients with persistent atrial fibrillation was 34% vs 61%,P<0.001;the median CHA2DS2-VASc score and HAS-BLED score in the single ablation group were lower than those in the one-step group [2(1,3)vs 4(3.5,5),P<0.001;1(1,2)vs 2(2,3),P <0.001],and ultrasound data showed that the average left anteroposterior diameter of patients in the single ablation group was less than the one-step group(40.3 ± 5.1 vs 42.6 ± 5.9 mm,P=0.025).The mean operation time,intraoperative fluoroscopy time and X-ray exposure time of the one-step group were greater than those of the single ablation group(186.4 ± 30.5 vs 137.5 ± 37.2 minutes,P < 0.001;15.8 ± 7.0 vs 10.5 ± 4.3 minutes,P =0.003;783.2 ± 376.6 vs 344.5 ± 223.0 m Gy,P <0.001).100% ablation success rate in the single ablation group,and 99% of that in the one-step group,P=0.822.No significant difference in ablation and ablation time;one-step group left atrial appendage occlusion success rate was 92%,81%patients had an occluder implant that was completely closed without peri-device leaks,but the rate was found to decrease to 75.4% after 3 months.The incidence of operation complications in the two groups was divided into 4% in the single ablation group vs.6% in the one-step group,P=0.516,and the difference was not statistically significant.At a median follow-up of 24(12,30)months,the total recurrence rates of atrial fibrillation in the single ablation group and the one-step group were 22%,25%,respectively,P = 0.946,no statistical difference;paroxysmal atrial fibrillation recurrence rate of patients in the single ablation group was lower than that in the one-step group [16.7%(11/68)vs 28.2%(11/39),P = 0.02].The difference was statistically significant.The recurrence rate of patients with persistent atrial fibrillation in the single ablation group was higher than that of the one-step group [32.4%(11/34)vs 23.0%(14/61),P=0.326],but the difference was not statistically significant.During follow-up,5 patients(4%)in the simple ablation group had 5 effective outcome endpoints,and 1 patient(1%)in the one-step group had 2 effective outcome endpoints.Kaplan-Meier analysis showed P=0.160.One patient in the single ablation group developed ischemic stroke 3 years after operation and acute myocardial infarction occurred in 3 and a half years after operation,1 patient developed lower extremity venous thromboembolism,2 patients were admitted to hospital due to angina pectoris.One patient in the one-step group developed acute myocardial infarction 4 months after operation and had an ischemic stroke 5 months after opreration.In the case of bleeding events,6 cases(6%)occurred in the single ablation group,5 cases(5%)in the one-step group,P = 0.732,1 case of Intracranial bleeding and 5 cases of minor bleeding in the single ablation group(including 2 gastrointestinal bleeding,1 hematuria,1 epistaxis,1 f gingival bleeding).One patient in the one-step group developed intracranial bleeding 1 month after operation,and 1 patient removed occlusion device and ligated left atrial appendage due to pericardial effusion 8 months after surgery.There were 3 cases of minor bleeding in the one-step group(1 gastrointestinal bleeding,1 nasal bleeding,1 gingival bleeding).Conclusions:Compared with single ablation operation,one-step operation did not significantly increase perioperative complications.There was no significant difference in the recurrence rate of atrial fibrillation,and the incidence rate of thromboembolism and hemorrhagic events after one-step operation was lower. |
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