A. Romanov, V. Beloborodov, V. V. Shabanov, A. Filippenko, D.A. Elesin, V.A. Boboshko, S. Khrushchev, P. Ruzankin
{"title":"心房颤动和左心房扩大患者介入治疗中的远程磁引导导航与手动射频消融方法:倾向分数匹配评估","authors":"A. Romanov, V. Beloborodov, V. V. Shabanov, A. Filippenko, D.A. Elesin, V.A. Boboshko, S. Khrushchev, P. Ruzankin","doi":"10.21688/1681-3472-2024-1-59-72","DOIUrl":null,"url":null,"abstract":"Introduction: Pulmonary vein ostia isolation (PVI) is the main method for catheter ablation (CA) in patients with atrial fibrillation (AF) who are refractory to antiarrhythmic drug therapy (AAD). The data regarding comparison of the remote magnetic-guided navigation (RMN) and manual (MAN) radiofrequency ablation approaches for PVI in patients with AF and enlarged left atrium (LA) are limited.Objective: The study was aimed to comparison of the safety and long-term efficacy of the radiofrequency CA associated with RMN and MAN using in patients with AF and enlarged LA.Methods: The retrospective cohort included 534 patients (mean age 59.2 ± 8.7 years, 41.6% female) with different AF forms and LA >4.5 cm who underwent PVI between 2016 and 2019. The patients were divided into two groups: the RMN group (n = 267) and MAN group (n = 267). The primary safety objective was associated with preventing perisurgical complications, and the primary efficacy objective was disengagement from AF / atrial flutter (AFl) / AT (atrial tachycardia), lasting > 30 seconds, in the 3-month period after the index procedure without AAD. The comparison of the results with 1:1 propensity score matching (PSM) was applied on the basis of 11 covariates. After PSM, 235 patients were selected for each group. The entire cohort was additionally divided into the subgroups of paroxysmal AF (n = 355) and non-paroxysmal AF (n = 179) to increase efficacy assessment. After PSM, 310 and 136 patients with paroxysmal and non-paroxysmal AF were analyzed, respectively.Results: In the entire cohort after PSM (n = 470) patients were balanced completely according to AF forms. The mean values of LA diameter were 4.98 ± 0.61 cm and 4.94 ± 0.58 cm in the RMN and MAN groups, respectively. The long-term efficacy assessment was performed in 448 patients of the both groups excluding 22 (4.7%) patients due to failed contacts. The median follow-up period was 24 months (minimum 3 and maximum 72 months). In the matched cohorts, perisurgical complications were detected in 11 (4.7%) patients of the MAN group and 2 (0.9%) patients of the RMN group (Р = 0.021, OR = 5.7; 95% CI [1.22, 53.5]). The disengagement from AF/AFl/AT after 36 months of the follow up amounted to 62.6% in the RMN group and 47.9% in the MAN group (for entire follow up, P = 0.005, HR = 1.54; 95% CI [1.14, 2.08]). For paroxysmal AF subgroup (n = 310), the disengagement from AF/AFl/AT after 36 months of the follow was 67.1% in the RMN group and 60.6% in the MAN group (for entire follow up, P = 0.15, HR = 1.34; 95% CI [0.90, 1.98]). In the non-paroxysmal AF subgroup (n = 136), the disengagement from AF/AFl/AT after 36 months of the follow up was higher in the RMN group as compared to the MAN group (59.6% and 30.4%, respectively, for entire follow up, P = 0.005, HR = 2.01; 95% CI [1.23, 3.29]) predominantly due to persistent AF.Conclusion: The present propensity-score matching study evidentiated that RMN CA was superior over manual CA for the interventional treatment of patients with AF and enlarged LA with respect to perisurgical complications and long-term disengagement from AF/AFl/AT predominantly due to non-paroxysmal AF. Prospective randomized studies are recommended for the comparison of the outcomes related to RMN and manual CA in patients with AF and enraged LA.\nReceived 24 April 2024. Accepted 8 May 2024.\nFunding: Work by P.S. Ruzankin and S.E. Khrushchev was carried out within the framework of the state assignment of the Sobolev Institute of Mathematics of the Siberian Branch of the Russian Academy of Sciences, project FWNF-2024-0001.\nConflict of interest: The authors declare no conflict of interest.\nContribution of the authorsConception and study design: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. FilippenkoData collection and analysis: V.V. Beloborodov, A.B. Romanov, D.A. Elesin, V.A. Boboshko, V.V. Shabanov, A.G. Filippenko Statistical analysis: P.S. Ruzankin, S.Ye. Khrushchev, A.B. RomanovDrafting the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevCritical revision of the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevFinal approval of the version to be published: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. Filippenko, D.A. Elesin, V.A. Boboshko, S.Ye. Khrushchev, P.S. Ruzankin","PeriodicalId":19853,"journal":{"name":"Patologiya krovoobrashcheniya i kardiokhirurgiya","volume":" 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Remote magnetic-guided navigation versus manual radiofrequency ablation approach in the interventional treatment of patients with atrial fibrillation and enlarged left atrium: propensity-score matching assessment\",\"authors\":\"A. Romanov, V. Beloborodov, V. V. Shabanov, A. Filippenko, D.A. Elesin, V.A. Boboshko, S. Khrushchev, P. Ruzankin\",\"doi\":\"10.21688/1681-3472-2024-1-59-72\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction: Pulmonary vein ostia isolation (PVI) is the main method for catheter ablation (CA) in patients with atrial fibrillation (AF) who are refractory to antiarrhythmic drug therapy (AAD). The data regarding comparison of the remote magnetic-guided navigation (RMN) and manual (MAN) radiofrequency ablation approaches for PVI in patients with AF and enlarged left atrium (LA) are limited.Objective: The study was aimed to comparison of the safety and long-term efficacy of the radiofrequency CA associated with RMN and MAN using in patients with AF and enlarged LA.Methods: The retrospective cohort included 534 patients (mean age 59.2 ± 8.7 years, 41.6% female) with different AF forms and LA >4.5 cm who underwent PVI between 2016 and 2019. The patients were divided into two groups: the RMN group (n = 267) and MAN group (n = 267). The primary safety objective was associated with preventing perisurgical complications, and the primary efficacy objective was disengagement from AF / atrial flutter (AFl) / AT (atrial tachycardia), lasting > 30 seconds, in the 3-month period after the index procedure without AAD. The comparison of the results with 1:1 propensity score matching (PSM) was applied on the basis of 11 covariates. After PSM, 235 patients were selected for each group. The entire cohort was additionally divided into the subgroups of paroxysmal AF (n = 355) and non-paroxysmal AF (n = 179) to increase efficacy assessment. After PSM, 310 and 136 patients with paroxysmal and non-paroxysmal AF were analyzed, respectively.Results: In the entire cohort after PSM (n = 470) patients were balanced completely according to AF forms. The mean values of LA diameter were 4.98 ± 0.61 cm and 4.94 ± 0.58 cm in the RMN and MAN groups, respectively. The long-term efficacy assessment was performed in 448 patients of the both groups excluding 22 (4.7%) patients due to failed contacts. The median follow-up period was 24 months (minimum 3 and maximum 72 months). In the matched cohorts, perisurgical complications were detected in 11 (4.7%) patients of the MAN group and 2 (0.9%) patients of the RMN group (Р = 0.021, OR = 5.7; 95% CI [1.22, 53.5]). The disengagement from AF/AFl/AT after 36 months of the follow up amounted to 62.6% in the RMN group and 47.9% in the MAN group (for entire follow up, P = 0.005, HR = 1.54; 95% CI [1.14, 2.08]). For paroxysmal AF subgroup (n = 310), the disengagement from AF/AFl/AT after 36 months of the follow was 67.1% in the RMN group and 60.6% in the MAN group (for entire follow up, P = 0.15, HR = 1.34; 95% CI [0.90, 1.98]). In the non-paroxysmal AF subgroup (n = 136), the disengagement from AF/AFl/AT after 36 months of the follow up was higher in the RMN group as compared to the MAN group (59.6% and 30.4%, respectively, for entire follow up, P = 0.005, HR = 2.01; 95% CI [1.23, 3.29]) predominantly due to persistent AF.Conclusion: The present propensity-score matching study evidentiated that RMN CA was superior over manual CA for the interventional treatment of patients with AF and enlarged LA with respect to perisurgical complications and long-term disengagement from AF/AFl/AT predominantly due to non-paroxysmal AF. Prospective randomized studies are recommended for the comparison of the outcomes related to RMN and manual CA in patients with AF and enraged LA.\\nReceived 24 April 2024. Accepted 8 May 2024.\\nFunding: Work by P.S. Ruzankin and S.E. Khrushchev was carried out within the framework of the state assignment of the Sobolev Institute of Mathematics of the Siberian Branch of the Russian Academy of Sciences, project FWNF-2024-0001.\\nConflict of interest: The authors declare no conflict of interest.\\nContribution of the authorsConception and study design: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. FilippenkoData collection and analysis: V.V. Beloborodov, A.B. Romanov, D.A. Elesin, V.A. Boboshko, V.V. Shabanov, A.G. Filippenko Statistical analysis: P.S. Ruzankin, S.Ye. Khrushchev, A.B. RomanovDrafting the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevCritical revision of the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevFinal approval of the version to be published: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. Filippenko, D.A. Elesin, V.A. Boboshko, S.Ye. Khrushchev, P.S. 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Remote magnetic-guided navigation versus manual radiofrequency ablation approach in the interventional treatment of patients with atrial fibrillation and enlarged left atrium: propensity-score matching assessment
Introduction: Pulmonary vein ostia isolation (PVI) is the main method for catheter ablation (CA) in patients with atrial fibrillation (AF) who are refractory to antiarrhythmic drug therapy (AAD). The data regarding comparison of the remote magnetic-guided navigation (RMN) and manual (MAN) radiofrequency ablation approaches for PVI in patients with AF and enlarged left atrium (LA) are limited.Objective: The study was aimed to comparison of the safety and long-term efficacy of the radiofrequency CA associated with RMN and MAN using in patients with AF and enlarged LA.Methods: The retrospective cohort included 534 patients (mean age 59.2 ± 8.7 years, 41.6% female) with different AF forms and LA >4.5 cm who underwent PVI between 2016 and 2019. The patients were divided into two groups: the RMN group (n = 267) and MAN group (n = 267). The primary safety objective was associated with preventing perisurgical complications, and the primary efficacy objective was disengagement from AF / atrial flutter (AFl) / AT (atrial tachycardia), lasting > 30 seconds, in the 3-month period after the index procedure without AAD. The comparison of the results with 1:1 propensity score matching (PSM) was applied on the basis of 11 covariates. After PSM, 235 patients were selected for each group. The entire cohort was additionally divided into the subgroups of paroxysmal AF (n = 355) and non-paroxysmal AF (n = 179) to increase efficacy assessment. After PSM, 310 and 136 patients with paroxysmal and non-paroxysmal AF were analyzed, respectively.Results: In the entire cohort after PSM (n = 470) patients were balanced completely according to AF forms. The mean values of LA diameter were 4.98 ± 0.61 cm and 4.94 ± 0.58 cm in the RMN and MAN groups, respectively. The long-term efficacy assessment was performed in 448 patients of the both groups excluding 22 (4.7%) patients due to failed contacts. The median follow-up period was 24 months (minimum 3 and maximum 72 months). In the matched cohorts, perisurgical complications were detected in 11 (4.7%) patients of the MAN group and 2 (0.9%) patients of the RMN group (Р = 0.021, OR = 5.7; 95% CI [1.22, 53.5]). The disengagement from AF/AFl/AT after 36 months of the follow up amounted to 62.6% in the RMN group and 47.9% in the MAN group (for entire follow up, P = 0.005, HR = 1.54; 95% CI [1.14, 2.08]). For paroxysmal AF subgroup (n = 310), the disengagement from AF/AFl/AT after 36 months of the follow was 67.1% in the RMN group and 60.6% in the MAN group (for entire follow up, P = 0.15, HR = 1.34; 95% CI [0.90, 1.98]). In the non-paroxysmal AF subgroup (n = 136), the disengagement from AF/AFl/AT after 36 months of the follow up was higher in the RMN group as compared to the MAN group (59.6% and 30.4%, respectively, for entire follow up, P = 0.005, HR = 2.01; 95% CI [1.23, 3.29]) predominantly due to persistent AF.Conclusion: The present propensity-score matching study evidentiated that RMN CA was superior over manual CA for the interventional treatment of patients with AF and enlarged LA with respect to perisurgical complications and long-term disengagement from AF/AFl/AT predominantly due to non-paroxysmal AF. Prospective randomized studies are recommended for the comparison of the outcomes related to RMN and manual CA in patients with AF and enraged LA.
Received 24 April 2024. Accepted 8 May 2024.
Funding: Work by P.S. Ruzankin and S.E. Khrushchev was carried out within the framework of the state assignment of the Sobolev Institute of Mathematics of the Siberian Branch of the Russian Academy of Sciences, project FWNF-2024-0001.
Conflict of interest: The authors declare no conflict of interest.
Contribution of the authorsConception and study design: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. FilippenkoData collection and analysis: V.V. Beloborodov, A.B. Romanov, D.A. Elesin, V.A. Boboshko, V.V. Shabanov, A.G. Filippenko Statistical analysis: P.S. Ruzankin, S.Ye. Khrushchev, A.B. RomanovDrafting the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevCritical revision of the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevFinal approval of the version to be published: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. Filippenko, D.A. Elesin, V.A. Boboshko, S.Ye. Khrushchev, P.S. Ruzankin