Vishal Luther, Sharad Agarwal, Anthony Chow, Michael Koa-Wing, Nuno Cortez-Dias, Luís Carpinteiro, João de Sousa, Richard Balasubramaniam, David Farwell, Shahnaz Jamil-Copley, Neil Srinivasan, Hakam Abbas, James Mason, Nikki Jones, George Katritsis, Phang Boon Lim, Nicholas S Peters, Norman Qureshi, Zachary Whinnett, Nick W F Linton, Prapa Kanagaratnam
{"title":"Ripple-AT研究:一项多中心随机研究,比较心房心动过速消融过程中的3D制图技术。","authors":"Vishal Luther, Sharad Agarwal, Anthony Chow, Michael Koa-Wing, Nuno Cortez-Dias, Luís Carpinteiro, João de Sousa, Richard Balasubramaniam, David Farwell, Shahnaz Jamil-Copley, Neil Srinivasan, Hakam Abbas, James Mason, Nikki Jones, George Katritsis, Phang Boon Lim, Nicholas S Peters, Norman Qureshi, Zachary Whinnett, Nick W F Linton, Prapa Kanagaratnam","doi":"10.1161/CIRCEP.118.007394","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Ripple mapping (RM) is an alternative approach to activation mapping of atrial tachycardia (AT) that avoids electrogram annotation. We tested whether RM is superior to conventional annotation based local activation time (LAT) mapping for AT diagnosis in a randomized and multicenter study.</p><p><strong>Methods: </strong>Patients with AT were randomized to either RM or LAT mapping using the CARTO3v4 CONFIDENSE system. Operators determined the diagnosis using the assigned 3D mapping arm alone, before being permitted a single confirmatory entrainment manuever if needed. A planned ablation lesion set was defined. The primary end point was AT termination with delivery of the planned ablation lesion set. The inability to terminate AT with this first lesion set, the use of more than one entrainment manuever, or the need to crossover to the other mapping arm was defined as failure to achieve the primary end point.</p><p><strong>Results: </strong>One hundred five patients from 7 centers were recruited with 22 patients excluded due to premature AT termination, noninducibility or left atrial appendage thrombus. Eighty-three patients (pts; RM=42, LAT=41) completed mapping and ablation within the 2 groups of similar characteristics (RM versus LAT: prior ablation or cardiac surgery n=35 [83%] versus n=35 [85%], P=0.80). The primary end point occurred in 38/42 pts (90%) in the RM group and 29/41pts (71%) in the LAT group (P=0.045). This was achieved without any entrainment in 31/42 pts (74%) with RM and 18/41 pts (44%) with LAT (P=0.01). Of those patients who failed to achieve the primary end point, AT termination was achieved in 9/12 pts (75%) in the LAT group following crossover to RM with entrainment, but 0/4 pts (0%) in the RM group crossing over to LAT mapping with entrainment (P=0.04).</p><p><strong>Conclusions: </strong>RM is superior to LAT mapping on the CARTO3v4 CONFIDENSE system in guiding ablation to terminate AT with the first lesion set and with reduced entrainment to assist diagnosis.</p><p><strong>Clinical trials registration: </strong>https://www.clinicaltrials.gov. Unique identifier: NCT02451995.</p>","PeriodicalId":10167,"journal":{"name":"Circulation: Arrhythmia and Electrophysiology","volume":"57 1","pages":"e007394"},"PeriodicalIF":0.0000,"publicationDate":"2019-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ripple-AT Study: A Multicenter and Randomized Study Comparing 3D Mapping Techniques During Atrial Tachycardia Ablations.\",\"authors\":\"Vishal Luther, Sharad Agarwal, Anthony Chow, Michael Koa-Wing, Nuno Cortez-Dias, Luís Carpinteiro, João de Sousa, Richard Balasubramaniam, David Farwell, Shahnaz Jamil-Copley, Neil Srinivasan, Hakam Abbas, James Mason, Nikki Jones, George Katritsis, Phang Boon Lim, Nicholas S Peters, Norman Qureshi, Zachary Whinnett, Nick W F Linton, Prapa Kanagaratnam\",\"doi\":\"10.1161/CIRCEP.118.007394\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Ripple mapping (RM) is an alternative approach to activation mapping of atrial tachycardia (AT) that avoids electrogram annotation. 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Eighty-three patients (pts; RM=42, LAT=41) completed mapping and ablation within the 2 groups of similar characteristics (RM versus LAT: prior ablation or cardiac surgery n=35 [83%] versus n=35 [85%], P=0.80). The primary end point occurred in 38/42 pts (90%) in the RM group and 29/41pts (71%) in the LAT group (P=0.045). This was achieved without any entrainment in 31/42 pts (74%) with RM and 18/41 pts (44%) with LAT (P=0.01). Of those patients who failed to achieve the primary end point, AT termination was achieved in 9/12 pts (75%) in the LAT group following crossover to RM with entrainment, but 0/4 pts (0%) in the RM group crossing over to LAT mapping with entrainment (P=0.04).</p><p><strong>Conclusions: </strong>RM is superior to LAT mapping on the CARTO3v4 CONFIDENSE system in guiding ablation to terminate AT with the first lesion set and with reduced entrainment to assist diagnosis.</p><p><strong>Clinical trials registration: </strong>https://www.clinicaltrials.gov. 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引用次数: 0
摘要
背景:纹波映射(RM)是一种替代心房心动过速(AT)激活映射的方法,避免了电图注释。我们在一项随机多中心研究中测试了RM是否优于传统的基于注释的局部激活时间(LAT)映射用于AT诊断。方法:使用CARTO3v4 confidence系统将AT患者随机分为RM组和LAT组。操作人员仅使用指定的3D绘图臂确定诊断,然后在需要时允许进行单个确认夹带操作。确定计划消融病灶组。主要终点是AT终止和计划消融病灶组的交付。无法在第一个病变组终止AT,使用多个夹带手法,或需要切换到另一个测绘臂被定义为未能达到主要终点。结果:从7个中心招募了105例患者,其中22例因AT过早终止、不可诱导或左心耳血栓而被排除。83例患者;RM=42, LAT=41)在两组具有相似特征的患者中完成了定位和消融(RM vs LAT:既往消融或心脏手术n=35 [83%] vs n=35 [85%], P=0.80)。主要终点发生在RM组的38/42(90%)和LAT组的29/41 (71%)(P=0.045)。RM组的31/42分(74%)和LAT组的18/41分(44%)在没有任何干扰的情况下实现了这一目标(P=0.01)。在未能达到主要终点的患者中,LAT组中有9/12(75%)的患者在转入RM伴夹带后终止了AT,而RM组中有0/4(0%)的患者转入LAT伴夹带后终止了AT (P=0.04)。结论:在引导消融时,RM优于在CARTO3v4 confense系统上的LAT定位,以第一个病变集和减少夹带终止AT,以辅助诊断。临床试验注册:https://www.clinicaltrials.gov。唯一标识符:NCT02451995。
Ripple-AT Study: A Multicenter and Randomized Study Comparing 3D Mapping Techniques During Atrial Tachycardia Ablations.
Background: Ripple mapping (RM) is an alternative approach to activation mapping of atrial tachycardia (AT) that avoids electrogram annotation. We tested whether RM is superior to conventional annotation based local activation time (LAT) mapping for AT diagnosis in a randomized and multicenter study.
Methods: Patients with AT were randomized to either RM or LAT mapping using the CARTO3v4 CONFIDENSE system. Operators determined the diagnosis using the assigned 3D mapping arm alone, before being permitted a single confirmatory entrainment manuever if needed. A planned ablation lesion set was defined. The primary end point was AT termination with delivery of the planned ablation lesion set. The inability to terminate AT with this first lesion set, the use of more than one entrainment manuever, or the need to crossover to the other mapping arm was defined as failure to achieve the primary end point.
Results: One hundred five patients from 7 centers were recruited with 22 patients excluded due to premature AT termination, noninducibility or left atrial appendage thrombus. Eighty-three patients (pts; RM=42, LAT=41) completed mapping and ablation within the 2 groups of similar characteristics (RM versus LAT: prior ablation or cardiac surgery n=35 [83%] versus n=35 [85%], P=0.80). The primary end point occurred in 38/42 pts (90%) in the RM group and 29/41pts (71%) in the LAT group (P=0.045). This was achieved without any entrainment in 31/42 pts (74%) with RM and 18/41 pts (44%) with LAT (P=0.01). Of those patients who failed to achieve the primary end point, AT termination was achieved in 9/12 pts (75%) in the LAT group following crossover to RM with entrainment, but 0/4 pts (0%) in the RM group crossing over to LAT mapping with entrainment (P=0.04).
Conclusions: RM is superior to LAT mapping on the CARTO3v4 CONFIDENSE system in guiding ablation to terminate AT with the first lesion set and with reduced entrainment to assist diagnosis.