| Part I:Safety and effectiveness of anticoagulation for Elderly patients with atrial fibrillation undergoing cry oballoon ablationBACKGROUND:Anticoagulation is of great significance in cryoballoon ablation for atrial fibrillation(AF).The differences in CHA2DS2-VASc score and HAS-BLED scores between elderly and younger patients with AF may lead to the inconsistence of anticoagulation-related risks.OBJECTIVE:This section of the study compared the incidence rate of hemorrhage and thromboembolic events between elderly and younger patients with AF who underwent the second generation cryoballoon ablation(2G-CBA),aiming to investigate the safety and efficacy of anticoagulation for elderly AF patients in 2G-CBA.METHODS:We retrospectively analyzed the medical history,surgical and follow-up information of patients with AF who underwent 2G-CBA from a single center,and assigned into two groups by age of admission:elderly group with 65 years and older,younger group with 65 years old below.Groups were compared for differences in the effectiveness and safety endpoints between the two groups from the first vascular puncture to 3 months after ablation.The safety endpoint is defined as the bleeding event that occurred during the observation period,and the effectiveness endpoint refers to the thromboembolic event that occurred during the above period.The Kaplan-Meyer application analysis predicts the time interval(in days)from the first vascular puncture to the first bleeding event.RESULTS:319 patients were involved in this study,137 in the elderly group and 182 in the younger group.The age of the elderly group was significantly higher than the younger group(68.9±3.8 vs.54.0±8.0 years,P<0.001).The CHA2DS2-VASc score was significantly higher than the younger group(3.3± 1.3 and 1.6 ±1.0 points,P<0.001),HAS-bleeding score was also significantly higher than the younger group(2.2 ± 0.9 and 0.9 ±0.9 points,P<0.001).There was no significant difference in the effective endpoint between the elderly group and the younger group during the observation period(2.2%vs 0.5%,95%CI,P=0.318).The incidence of ischemic stroke in the two groups was 0.7%and 0.5%with no significant difference.The incidence of safety endpoints was higher in the elderly group than in the younger group(hazard ratio 2.78,95%CI,1.15 to 6.72,P=0.024),but the incidence of major bleeding events was not significantly different between the elderly and younger groups(5.1%vs 1.6%.95%CI,P=0.079).The incidence of procedure-related bleeding in the elderly group was significantly higher than in the younger group(8.0%vs.2.7%,95%CI,P=0.032);there was no significant difference in the incidence of non-procedure bleeding(2.2%vs 1.1)%,95%CI,P=0.655).Conclusion:Anticoagulant therapy is safe and effective in patients with elderly AF patients undergoing second-generation cryoballoon ablation,but there is still a need to be alert to bleeding events,especially procedure-related bleeding.Part II:Perioperation safety and long-term efficacy of cryoballoon ablation for elderly patients with atrial fibrillationBACKGROUND:There is a lack of relevant research data on whether elderly patients can withstand cryoballoon ablation as well as AF recurrence when compared with younger patients.OBJECTIVE:To evaluate the safety and long-term efficacy of elderly patients with AF.METHODS:The clinical data of patients with AF who underwent 2G-CBA from a single center continuous treatment were analyzed.After preoperative evaluation and screening criteria were excluded for patients who were not suitable for 2G-CBA,participants were assigned into two groups by age of admission:elderly group with 65 years and older,younger group with 65 years old below.All patients were followed up for at least 12 months.The procedure and follow-up data were retrospectively analyzed.The incidence of perioperative safety events(except thromboembolism and hemorrhagic events)and the recurrence rate of long-term AF were compared between the two groups.The Kaplan-Meier survival analysis was used to assess the length of time for the first recurrence of AF after the "blank period".Cox binary regression was used to evaluate independent risk factors affecting recurrence of atrial fibrillation.RESULTS:263 patients were involved in this study,93 in the elderly group and 170 in the younger group.The incidence of combined safety events during the perioperative period of cryoballoon ablation was 20.5%and 14.2%(P=0.142)in the elderly and younger groups respectively,with no significant difference,and the incidence of complications such as phrenic nerve injury/paralysis(3.2%vs.3.5%.P=0.601).severe vagal response(2.2%vs.1.8%,P=0.580).and temporary pacemaker implantation(3.2%vs.1.2%,P=0.239)were not significantly different.There was no significant difference in the total success rate between the elderly group and the younger group during the follow-up period(75.2%vs.77.6%,Log-Rank test,95%CI,P=0.626).There was no significant difference in the success rate of patients with paroxysmal atrial fibrillation between the two groups(81.7%vs.84.2%,Log-Rank test,95%CI,P=0.626),but the success rate of persistent atrial fibrillation in the elderly group was significantly lower than in the same group(54.5%vs.81.7%,Log-Rank test,95%CI,P=0.011),also lower than the persistent atrial fibrillation in the younger group(54.5%vs.64.3%,Log-Rank test,95%CI,P=0.440),but there was no significance.In the elderly group,23 patients had recurrence of AF within 1 year after ablation.The proportion of persistent atrial fibrillation in patients with recurrence was higher than patients without recurrence(43.5%vs.17.1%,P=0.010),the left atrium was larger(43±5mm vs.39±5mm,P<0.001),the proportion of AF occurrence during the blanking period was higher(43.5%vs.10.0%,P=0.001),and also a higher HAS-BLED score(2.5± 1.0 points vs.1.7±0.9 points,P=0.011).Cox regression analysis showed that persistent atrial fibrillation,enlarged left atrium and AF occurrence during the blanking period were independent risk factors for predicting recurrence of atrial fibrillation within 1 year after ablation in the elderly patients.Conclusion:The 2G-CBA is safe and effective in elderly patients 65 years and older.The recurrence rate of patients with paroxysmal atrial fibrillation in the elderly group was no different from that of the younger patients.Persistent atrial fibrillation,enlarged left atium and AF occurrence during the blanking period were independent risk factors for recurrence of atrial fibrillation within 1 year after 2G-CBA in elderly patients. |
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