| Objective:Through systematic evaluation and meta-analysis of previous clinical studies,the efficacy and safety of contact force-sensing radiofrequency catheter ablation(CF-RFA)and second-generation cryoballoon ablation(CB2)for paroxysmal atrial fibrillation were further compared.Method:According to the purpose of the study,the inclusion criteria of the literature needed in this study were formulated based on the research objects,types of research and the effective and safety indicators(operation time,X-ray exposure time,perioperative complications,follow-up success rate,early recurrence rate)of ablation for paroxysmal atrial fibrillation.This study conducted literature retrieval in Pubmed,Embase,Web of science,Cochrance Library,China National Knowledge Internet,Wanfang database,Weipu Chinese Science and Technology Journal database and Chinese Biomedical database.The retrieval time was from the beginning of the establishment of the database to December 31,2018.The language of retrieval literature was limited to English and Chinese.The clinical comparative research literature about CF-RFA and CB2 in the treatment of paroxysmal atrial fibrillation was collected,which included randomized controlled trial(RCT)and non-RCT studies.According to the inclusion criteria,the necessary literature was preliminarily screened.RCT and non-RCT literatures were evaluated by using the RCT bias risk assessment tool and Newcastle-Ottawa Scale scale,respectively.Electronic documents are used to extract data from literatures included in the summary analysis.Revman 5.3 software provided by Cochrane collaboration network was used to analyze the extracted data.Statistics for combined analysis:Continuous variable data are represented by weighted mean difference(WMD)and95%confidence interval(CI),while binary variable data are represented by relative risk(RR)and 95%confidence interval.According to the results of heterogeneity analysis by I~2 test:homogeneity(P>0.1,I~2<50%)or heterogeneity(P<0.1,I~2<50%),meta-analysis was carried out by fixed effect model or random effect model,respectively.The difference was statistically significant with P<0.05.In this study,funnel plots were used to detect publication bias.Result:1.Nine clinical controlled studies were included in this study,including three RCT articles and six non-RCT articles.A total of 1153 patients were enrolled,including 583in CF-RFA group and 570 in CB2 group.The follow-up period was 12 to 30 months.According to the national division,two studies were from France,one from Canada,one from the United States,one from Germany,two from Hungary,one from Japan and one from Italy.According to the year of publication,there are one in 2014,two in 2015,two in 2016 and four in 2018.According to the study index,nine literatures evaluated the operation time,eight literatures evaluated the X-ray exposure time,nine literatures evaluated the perioperative complications,nine literatures evaluated the success rate of follow-up,and three literatures evaluated the early recurrence rate.2.Data were merged for literature taking operation time as index.Heterogeneity test results showed heterogeneity(P<0.001,I~2=94%).Random effect model was used to analyze the results.The combined statistics were WMD=24.33(95%CI:8.91-39.74,P=0.002).The difference between the two groups was statistically significant,suggesting that the operation time of CF-RFA was longer than that of CB2 in the treatment of paroxysmal atrial fibrillation.3.Data were merged for literature taking X-ray exposure time as the index.Heterogeneity test results showed heterogeneity(P<0.001,I~2=91%).Random effect model was used to analyze the results.The combined statistics were WMD=-1.56(95%CI:-4.70-1.57,P=0.33).There was no significant difference between the two groups,suggesting that the X-ray exposure time of CF-RFA was similar to that of CB2 in the treatment of paroxysmal atrial fibrillation.4.Perioperative complications were analyzed in the following four aspects:total complications,phrenic nerve paralysis,severe complications(pericardial tamponade,embolism,esophageal injury),and death.Among the included literature,9 evaluated the total number of complications,8 evaluated phrenic nerve paralysis,and 4 evaluated severe complications.(1)Data were merged for literature taking the total number of complications as the index.The results of heterogeneity test showed no statistical significance(P=0.38,I~2=7%).The combined statistic results were RR=0.60(95%CI:0.38-0.95,P=0.03),however,sensitivity analysis suggests that meta-analysis results were unreliable.(2)Data were merged for literature taking phrenic nerve paralysis as the research index.The results of heterogeneity test showed no statistical significance(P=0.80,I~2=0%).The combined statistic result was RR=0.11(95%CI:0.04-0.30,P<0.01),which indicated that the difference was statistically significant,suggesting that the incidence of perioperative phrenic nerve palsy in CF-RFA was significantly lower than that in CB2in the treatment of paroxysmal atrial fibrillation.Diaphragmatic nerve paralysis was only found in CB2 group,a total of 33 cases,of which 32 cases returned to normal by themselves.(3)Data were merged for literature taking severe complications as indicators.The results of heterogeneity test showed no statistical significance(P=0.90,I~2=0%).The results of combined statistics were RR=4.87(95%CI:1.10-21.64,P=0.04),which indicated that the difference was statistically significant,suggesting that the incidence of severe perioperative complications of CF-RFA was significantly higher than that of CB2in the treatment of paroxysmal atrial fibrillation.(4)No death occurred during the operation in CF-RFA group and CB2 group.5.Subgroup analysis was carried out on 9 literatures which recorded the success rate of follow-up according to the follow-up time of 12 months,18 months and 24months.(1)Eight papers were followed up for 12 months.There was no significant difference in heterogeneity test among the studies in this subgroup(P=0.86,I~2=0%).Meta-analysis showed that the combined effect RR=0.99(95%CI:0.93-1.05,P=0.80).(2).Two papers were followed up for 18 months.There was no significant difference in heterogeneity test among the studies in this subgroup(P=0.44,I~2=0%).Meta-analysis showed that the combined effect RR=1.02(95%CI:0.93-1.13,P=0.63).(3).Two papers were followed up for 24 months.There was no significant difference in heterogeneity test among the studies in this subgroup(P=0.77,I~2=0%).Meta-analysis showed that the combined effect RR=1.00(95%CI:0.85-1.18,P=0.98).(4).There was no significant difference between the two methods,suggesting that the follow-up success rates of 12,18 and 24 months after operation for paroxysmal atrial fibrillation were similar.6.Data were merged for literature taking early recurrence rate as the index.Heterogeneity test results showed no statistical significance(P=0.43,I~2=0%).The combined statistic results were RR=1.05(95%CI:0.52-2.10,P=0.89).There was no significant difference between CF-RFA and CB2 in the early recurrence rate of paroxysmal atrial fibrillation.Conclusion:Compared with CB2,CF-RFA has similar clinical results in the treatment of paroxysmal atrial fibrillation,but CB2 may be safer and more time-saving. |
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