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nMARQ Ablation for Atrial Fibrillation: Results from a Multicenter Study SAAGAR MAHIDA, M.B.Ch.B.,∗ DARREN A. HOOKS, Ph.D., M.B.Ch.B.,∗ KARIN NENTWICH, M.D.,† G. ANDRE NG, M.B.Ch.B., Ph.D.,‡ MASSIMO GRIMALDI, M.D.,§ DONG-IN SHIN, M.D.,¶ NICOLAS DERVAL, M.D.,∗ FREDERIC SACHER, M.D.,∗ BENJAMIN BERTE, M.D.,∗ ´ EZE ` SEIGO YAMASHITA, M.D., Ph.D.,∗ ARNAUD DENIS, M.D.,∗ MEL HOCINI, M.D.,∗ THOMAS DENEKE, M.D.,† MICHEL HAISSAGUERRE, M.D.,∗ and PIERRE JAIS, M.D.∗ From the ∗ Hˆopital Cardiologique du Haut-L´evˆeque and Universit´e de Bordeaux, Bordeaux, Equipex MUSIC ANR-11-EQPX-0030, IHU LIRYC ANR-10-IAHU-04; †Heart-Center Bad Neustadt, Clinic for Invasive Electrophysiology, Bad Neustadt, Germany; ‡NIHR Leicester Cardiovascular Biomedical Research Unit, Department of Cardiovascular Sciences, Glenfield Hospital, University of Leicester, Leicester, UK; §Francesco Miulli Hospital, Acquaviva delle Fonti, Bari, Italy; and ¶Cardiac Arrhythmia Service, Divison of Cardiology, Pulmonology and Vascular Medicine, University Hospital, Duesseldorf, Germany
nMARQ AF Ablation. Background: nMARQ is a multipolar catheter designed to simultaneously ablate at multiple sites around the pulmonary vein (PV) circumference with a single radiofrequency application. We sought to define the safety and efficacy of atrial fibrillation (AF) ablation with the nMARQ catheter. Methods: In a multicenter study, patients with drug-refractory AF were included. Procedural outcomes were documented at 1 year. Results: 374 patients underwent PV isolation using nMARQ (age 60 ± 10 years, 264 male), of whom 263 patients had paroxysmal AF (PAF), while 111 patients had persistent AF. A total of 1,468 of 1,474 veins (99.6%) were isolated with the nMARQ catheter alone. Thirty-five (13%) PAF patients and 30 (27%) persistent AF patients underwent additional ablation at non-PV sites (2.4 ± 1.4 non-PV sites). Procedure time for PV isolation only was 1.9 ± 0.7 hours (fluoroscopy 24 ± 14 minutes). Procedure time for PV isolation and non-PV ablation was 2.4 ± 1.0 hours (fluoroscopy 30 ± 23 minutes). Major adverse events occurred in two patients (0.5%); one esophago-pericardial fistula and a second, mortality due to sepsis of unknown cause. One-year follow-up data were available in 65 (25%) PAF and 20 (18%) persistent AF patients. Forty-two (65%) PAF and 13 (65%) persistent AF patients were free of arrhythmia at 1 year. In patients undergoing repeat procedures (n = 17) the most frequent points of PV reconnection were: anterior RSPV, inferior RIPV, and superior LSPV. Conclusions: AF ablation with nMARQ is associated with short procedure times and high acute success rates. Further research is necessary to more clearly define long-term outcome. (J Cardiovasc Electrophysiol, Vol. 26, pp. 724-729, July 2015) atrial fibrillation, atrioesophageal fistula, catheter ablation, nMARQ catheter Introduction Pulmonary vein (PV) isolation is an established technique for treatment of patients with drug-refractory paroxysmal atrial fibrillation (AF). PV isolation also forms an important part of the ablation strategy in patients with persistent AF. The most commonly used current approach for PV isolaThe research leading to these results was partly funded by the European Union Seventh Framework Programme (FP7/2007-2013) under Grant Agreement HEALTH-F2-2010-261057. Drs. Jais, Haissaguerre, Hocini, and Sacher have received lecture fees from Biosense Webster for 10,000 USD annually. Dr. Ng has received speaker honorarium and proctorship fees from Biosense Webster. Other authors: No disclosures. Address for correspondence: Saagar Mahida, MB.Ch.B., Service de Rythmologie et Stimulation Cardiaque, Hˆopital Cardiologique du Haut-L´evˆeque, Avenue de Magellan, 33604 Bordeaux-Pessac, France. Fax: +33 05 57 65 65 09; E-mail: [email protected] Manuscript received 16 January 2015; Revised manuscript received 9 March 2015; Accepted for publication 13 March 2015. doi: 10.1111/jce.12698
tion involves delivery of point-by-point lesions around the PV circumference. While effective, this approach is associated with important limitations, which include prolonged procedure times, and in a proportion of cases, failure to achieve durable isolation. As a result, novel ablation catheter designs are required to increase efficacy and efficiency of PV isolation. The nMARQ catheter (Biosense Webster, Inc., Diamond Bar, CA, USA) is a novel technology that allows simultaneous ablation at multiple sites around the circumference of PV with a single radiofrequency (RF) application. Early studies have suggested that the catheter achieves fast and effective PV isolation. However these studies have been restricted to small numbers of patients.1-5 In this large, multicenter study, we sought to more comprehensively define the safety and efficacy of ablation for AF with the nMARQ catheter. Methods Study Population Criteria for inclusion in the study included either paroxysmal or persistent AF, which was refractory to at least 1
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Figure 1. Isolation of LIPV during nMARQ ablation. (A) Fluoroscopic image of nMARQ catheter at the LIPV ostium. (B) Three-dimensional left atrial anatomy demonstrating nMARQ ablation catheter at the LIPV ostium and RF lesions at the ostia of all 4 PVs (red circles). (C) Intracardiac electrograms recorded from nMARQ catheter in LIPV demonstrating PV isolation during RF delivery. PV signals are indicated in red squares. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
antiarrhythmic drug. Exclusion criteria included the presence of left atrial thrombus, inadequate anticoagulation, contraindication to anticoagulation, significant valvular heart disease, and NYHA class III or IV heart failure. Written informed consent was obtained from all patients. The study was approved by the institutional review boards at all respective institutions.
All patients were established on anticoagulant therapy for at least 4 weeks prior to the procedure. The procedure was performed on uninterrupted warfarin with a target INR between 2 and 3. A decapolar catheter was positioned in the coronary sinus. Access into the left atrium was gained by means of a transseptal puncture under fluoroscopic guidance (BRK needle, Agilis or SL-1 sheath, St. Jude Medical, St. Paul, MN, USA; Direx sheath, Bard, Lowell, MA, USA). Following transseptal puncture, the activated clotting time was maintained at >320 seconds using heparin boluses. Three-dimensional left atrial geometry was created using the nMARQ catheter and the Carto 3 mapping system (Biosense Webster, Inc. Diamond Bar, CA, USA)
delivery was 15 W per electrode, also with temperature limited to 45 °C. The position of the nMARQ catheter at the PV ostium was optimized using a combination of fluoroscopic imaging and the electroanatomical map (Figs. 1A and B). Real-time power, temperature, and impedance recordings were monitored throughout RF application. The maximum duration per application was 60 seconds. Following each application, bipolar electrograms were recorded at a site distal to the ablation line to demonstrate entrance block (Fig. 1C). Administration of adenosine or pacing of the ablation line was performed at the investigator’s discretion. Among patients with persistent AF, cardioversion following PV isolation or additional ablation at non-PV sites was performed at the investigator’s discretion. Non-PV ablation was performed using the nMARQ catheter or on certain circumstances, with a conventional catheter. Unipolar ablation with power delivery of 25 W was performed at all non-PV sites apart from the posterior wall, where 20 W was used. The aim of non-PV ablation was termination of AF to sinus rhythm. Anticoagulation was continued for a minimum period of 3 months following the index procedure with a target INR of 2–3.
Catheter Ablation
Follow-Up
The nMARQ catheter is an irrigated, circular decapolar catheter that allows both mapping and ablation through the same electrodes. The nMARQ catheter and generator design has previously been described in detail by Zellerhoff et al.4 Unipolar or bipolar ablation modes were used. The irrigation flow rate was set at 60 mL/min. Up to 25 watts (W) of RF energy per electrode was delivered in unipolar mode with the temperature limited to 45 °C. Power delivery during ablation of the posterior wall varied between 20 and 25 W in unipolar mode. In bipolar mode, the maximum power
Antiarrhythmic drug therapy was continued for 3 months following the index ablation. Discontinuation of anticoagulation and antiarrhythmics at the 3-month period was at the investigating physician’s discretion. Follow-up data were collected at a 12-month time point. Recurrences were classified as atrial tachycardias or AF. Patterns of recurrence were further classified as paroxysmal or persistent. Procedure-related serious adverse events were recorded in all patients and were categorized into embolic complications, phrenic nerve damage, vascular complications, PV stenosis, and death.
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TABLE 1 Patient Characteristics 60 ± 10 years 264/110 263/111 60 ± 8%
Age Male/female PAF/pers AF EF
Repeat Procedures In patients who had recurrences of atrial tachycardia of AF and who underwent repeat procedures, ablation were performed with a conventional irrigated ablation catheter (Navistar Thermocool, Biosense Webster, Inc. Diamond Bar, CA, USA). Three-dimensional left atrial geometry was recreated. A high density of points was collected at the PV antra. Points of reconnection were annotated. The veins were subsequently reisolated. Statistical Analysis Continuous variables were expressed as mean ± SD. Analysis of variance (ANOVA) was used to compare per vein ablation times. A P value of 0.0001). RSPV = right superior pulmonary vein; RIPV = right inferior pulmonary vein; LSPV = left superior pulmonary vein; LIPV = left inferior pulmonary vein. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
1.7 non-PV sites were targeted. Among patients with paroxysmal AF, 228 patients (87%) had PV isolation only while 35 patients (13%) had ablation at non-PV sites. In these 35 patients, 1.3 ± 0.6 non-PV sites were targeted. Details of ablation times at non-PV sites are included in Table 2. Of the 65 patients who had ablation at non-PV sites, 48 (74%) patients had ablation with nMARQ only. Eleven (17%) patients had ablation with nMARQ and conventional catheters. Of note, 9 of the 11 (82%) patients who had ablation with nMARQ and conventional catheters required ablation in the coronary sinus. Six (9%) patients had non-PV ablation with a conventional catheter only. Procedure times for patients who underwent PV isolation only (PAF or persistent AF, n = 309) were 1.9 ± 0.7 hours. Fluoroscopy times were 24 ± 14 minutes. Procedure times for patients who underwent additional non-PV isolation (PAF or persistent AF, n = 65), the procedure times were 2.4 ± 1.0 hours. Fluoroscopy times were 30 ± 23 minutes. Safety Outcomes Of the 374 patients who underwent ablation with the nMARQ catheter, major adverse events occurred in 2 patients (0.5%). One patient died due to an esophagopericardial fistula, which occurred 2 weeks following ablation. The case has been described in detail previously.6 Of note, the power was set at 25 W for all available poles during ablation of the main PVs. The patient also had an accessory posterior pulmonary vein, which was ablated with 15 W power. The events surrounding the second patient’s death are less clear. The patient had no complications in the immediate post-procedure period and was discharged from hospital following the initial nMARQ ablation. Four and a half weeks after the procedure,
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TABLE 2 Summary of RF Ablation at Non-PV Sites Non-PV Site Persistent AF (n = 30) CTI LA roof LA mitral isthmus LA (other sites)† RA Coronary sinus PAF (n = 35) CTI LA roof LA mitral isthmus LA (other sites)† RA
nMARQ Only (No.)
nMARQ + Conventional (No.)
Conventional Only (No.)
RF nMARQ (Minutes)
RF Conventional (Minutes)
15 6 3 22 12
1 3 1 3 2
3
6.0 ± 4.9 4.8 ± 2.9 5.7 ± 5.7 8.6 ± 7.0 6.2 ± 4.3
7.4 ± 4.0 7.2 ± 5.1 9.6 ± 5.2 9.9 ± 3.4 3.3 ± 3.8 3.4 ± 2.8
6.8 ± 7.3 1.6 ± 0.1 2.0 3.7 ± 2.4 3.3 ± 3.2
7.9 ± 4.5
3
9 12 2 1 18 3
5
2
† Ablation
at LA sites including anterior LA, posterior LA, LA appendage, LA septum. AF = atrial fibrillation; CTI = cavotricuspid isthmus; LA = left atrium; PAF = paroxysmal AF; PV = pulmonary vein; RA = right atrium.
the patient was readmitted to an outside hospital with sepsis. She died during the admission due to progressive sepsis. The impression from the treating physicians was that it was not a procedure related death; however, there are no available details regarding the focus of sepsis, the causative organism, or imaging to exclude an esophagopericardial fistula. There were no incidences of stroke or neurological events, phrenic nerve paralysis, cardiac tamponade, or PV stenosis. In addition to acute procedural safety outcomes, potential procedure related complications were also documented at 90 days in a proportion of patients. A total of 329 of the 374 patients (88%) had 90-day follow-up data. There were no additional major adverse events at this time point. Long-Term Outcome Follow-up data were collected at a 12-month time point. In the PAF group, follow-up data were available in 65 (25%) patients. Forty-two (65%) PAF patients were free of arrhythmia at 1 year. Of the 23 patients who experienced recurrences, 22 had PAF while 1 had an atrial tachycardia (AT) (Fig. 3A). Thirteen (20%) PAF patients were receiving antiarrhythmic drug therapy at follow-up (8 flecainide; 4 sotalol; 1 amiodarone). Thirty-two PAF patients were on β-blockers and a further 5 were on calcium channel blockers. In the persistent AF group, follow-up data were available in 20 (18%) patients. Thirteen (65%) persistent AF patients were free of arrhythmia at 1 year. Of the 7 patients who experienced recurrences, 4 had AF while 3 had atrial tachycardia (Fig. 3B). Six (30%) persistent AF patients were receiving antiarrhythmic drug therapy at follow-up (1 dronedarone; 2 sotalol; 3 amiodarone). Twelve persistent AF patients were on β-blocker therapy. Repeat Procedures Seventeen patients who experienced recurrences of AF following the index nMARQ ablation underwent repeat procedures (15 PAF, 2 persistent AF). Repeat procedures were performed 5.3 ± 3.7 months following the index procedure. All 17 patients had PV reconnections. Data on the specific reconnection points were available in 16 of the 17 (94%) patients. As illustrated in Figure 4, the most frequent points of reconnection were the anterior aspect of the RSPV, the
Figure 3. Outcomes at 1 year after nMARQ ablation. (A) In PAF patients (n = 65), 42 patients (65%) were free of atrial arrhythmias at 1 year. (B) In persistent AF patients (n = 20), 13 patients (65%) were free of arrhythmia at 1 year. Atrial tachycardia was more commonly encountered at follow-up in patients who had been ablated for persistent AF. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
inferior aspect of the RIPV, and the superior aspect of the LSPV. Discussion In this large, multicenter study, we demonstrate that ablation with the nMARQ catheter is associated with short
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Figure 4. Points of reconnection in patients who underwent repeat procedures. Data from repeat PV siolation in 16 patients are presented. PVs are divided into 4 quadrants (anterior [green], posterior [red], superior [grey], and inferior [blue]). The most frequent points of reconnection were the anterior aspect of the RSPV, the inferior aspect of the RIPV and the superior aspect of the LSPV. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
procedure times and a high acute PV isolation success rate. Further, in a large proportion of cases, the nMARQ catheter was effective for ablating non-PV targets without the need for additional ablation with a conventional catheter. There was a 0.5% incidence of procedure-related serious adverse events following nMARQ ablation. Finally, the outcomes at 1 year were comparable to those in AF patients undergoing ablation with conventional catheters. Five recent studies have reported on outcomes following ablation with the nMARQ catheter.1-5 Of note however, these have been single-center studies restricted to small numbers of patients. The largest study involved 43 patients. Consistent with our findings, the studies reported high acute PV isolation rates ranging from 98% to 100%. The complication rates in these studies were also similar. Out of the total of 153 patients in the 5 studies, major complications were observed in 2 patients (1.3%); 1 patient had a cardiac tamponade related to a transseptal puncture while the second had phrenic nerve palsy.3,4 In this study, we describe a third patient with a major complication related to nMARQ ablation, which was an esophagopericardial fistula. The same case has also previously been described in the form of a case report.6 The major complication rate in this study was 0.5%, with 2 mortalities occurring following nMARQ ablation. The first mortality, which occurred due to an esophagopericardial fistula, was clearly related to the ablation. While the exact cause of the second mortality is not clear, in the absence of additional data, it remains a potential procedure related death. The mortality rate is significantly higher than that previously reported for conventional ablation. In an international survey Cappato et al. reported a mortality of 0.1% following conventional ablation.7 It is important to emphasize, however, that the study involved a much larger population of more than 30,000 patients. In order to more clearly define the mortality rate associated with nMARQ ablation, studies in larger cohorts of patients are necessary. The occurrence of an esophagopericardial fistula in our cohort underscores the importance of adjusting power during posterior wall ablation with nMARQ. The optimal power
settings posterior wall ablation has been addressed in 2 recent reports. In a study involving 43 patients, Deneke et al. reported that 25 W unipolar ablation with nMARQ was associated with a 42% incidence of thermal esophageal injury, as evidenced by superficial erythema or superficial ulceration during endoscopy.2 When the power was reduced to 20 W, the incidence of thermal injury decreased to 20%. In a more recent study involving 21 patients, a combination of 20 W unipolar ablation and 10 W bipolar ablation for 60 seconds was associated with a higher incidence of esophageal injury (50%) as compared to ablation for 30 seconds at 15 W unipolar and 10 W for bipolar ablation (6.7%).3 These numbers are comparable to esophageal injury rates with conventional ablation.8,9 Of note, posterior wall ablation in the aforementioned patient with a esophagopericardial fistula was performed with 25 W. We did not observe any complications or symptoms suggestive of esophageal injury in patients who had ablation with 20 W on the posterior wall. Of note, Deneke et al. recently reported the use of an esophageal temperature probe increases the risk of esophageal injury during nMARQ ablation. On the basis of this observation, we did not use a temperature probe in this study.10 Embolic neurological complications have previously been reported with multielectrode ablation catheter designs such as the PVAC catheter (Medtronic Inc.). A previous metaanalysis on PVAC safety and efficacy reported a thromboembolic complication rate of 0.63%.11 Patients were carefully monitored for neurological sequelae in the present study. We did not observe strokes or TIAs following nMARQ ablation. Consistent with our findings, none of the previous smaller studies on nMARQ outcomes have reported clinical strokes.1-5 It is important to note, however, that in the study by Deneke et al. discussed above, 14 of the 43 (33%) of patients had silent cerebral lesions following nMARQ ablation.2 While the study was limited to a small cohort, the findings emphasize the importance of uninterrupted oral anticoagulation, and maintenance of higher activated clotting times during nMARQ ablation. One of the major drivers for development of “one shot” catheter designs is to reduce procedure times for PV isolation and to make the procedure easier. In this study, procedure time to achieve PV isolation with nMARQ (mean 114 minutes) compared favorably with other novel catheter ablation designs. For instance, in a meta-analysis of 23 cryoablation studies, the mean procedure time was 206 minutes.11 In the recent STOP-AF cryoablation trial, procedure time was 371 minutes.12 In a meta-analysis of 42 studies relating to the AF ablation with the PVAC catheter, average procedure times were reported as 117 minutes.11 To date, most of the research relating to the nMARQ catheter has focused on its role as a tool for PV isolation. However, our results suggest that the technology is also effective for ablation of non-PV sites. In a significant number of persistent AF cases in our cohort, nMARQ ablation alone effectively blocked CTI and roof lines with a limited number of RF applications. The nMARQ catheter was also effective for simultaneously targeting multiple left and right atrial sites with high-frequency fractionated signals. In the majority of cases, the need for an additional conventional catheter was determined by a need to ablate within the coronary sinus. It is important to note, however, that the numbers of persistent AF patients who underwent non-PV isolation in this study
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were relatively small. Larger studies are necessary define the role of nMARQ in persistent AF. Our data suggest that the outcomes of nMARQ ablation could potentially be comparable to conventional ablation. The single procedure success rate in PAF patients in our cohort was 65%. In comparison, in a meta-analysis of 11 studies in PAF patients ablated with conventional catheters, Ganesan et al. reported a 1-year success rate of 66.6%.13 In the same study, a meta-analysis of 6 studies reporting outcomes of persistent AF ablation with conventional catheters, 1-year success rates were 52%.13 In our persistent AF cohort, 65% of patients were free of AF at 1 year. However, these results should be interpreted with caution for a number of reasons. First, there was significant heterogeneity in the ablation strategy in persistent AF patients in our cohort. Second, in a proportion of persistent AF patients, conventional ablation was used in addition to nMARQ ablation. Third, and most importantly, follow-up data were only available in a small subset of patients from our cohort. Overall, further data are needed before long-term outcome following nMARQ can be defined.
3.
4.
5.
6.
7.
Limitations 8.
Patients were recruited from 5 different centers. Therefore, there were subtle differences in the approach used for PV isolation between centers. More importantly, there were significant differences in the strategy for ablation of patients with persistent AF. The study investigated a mixed population of PAF and persistent AF patients. The study also has the inherent limitations of a non-randomized study with no control arm. Conclusions AF ablation with the nMARQ catheter is associated with short procedure times and high acute success rates. The question of long-term outcome needs to be addressed further, although our preliminary data suggest that they are favorable. Finally, complication rates associated with nMARQ ablation merit further investigation.
9.
10.
11.
12.
References 1. Shin DI, Kirmanoglou K, Eickholt C, Schmidt J, Clasen L, Butzbach B, Rassaf T, Merx M, Kelm M, Meyer C: Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. Heart Rhythm 2014;11:375-383. 2. Deneke T, Schade A, Muller P, Schmitt R, Christopoulos G, Krug J, Szollosi G, Mugge A, Kerber S, Nentwich K: Acute safety and efficacy
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of a novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation. J Cardiovasc Electrophysiol 2014;25:339345. Rillig A, Lin T, Burchard A, Kamioka M, Heeger C, Makimoto H, Metzner A, Wissner E, Wohlmuth P, Ouyang F, Kuck KH, Tilz RR: Modified energy settings are mandatory to minimize oesophageal injury using the novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation. Europace 2015;17:396-402. Zellerhoff S, Daly M, Lim HS, Denis A, Komatsu Y, Jesel L, Derval N, Sacher F, Cochet H, Knecht S, Yiem S, Hocini M, Haissaguerre M, Jais P: Pulmonary vein isolation using a circular, open irrigated mapping and ablation catheter (nMARQ): a report on feasibility and efficacy. Europace 2014;16:1296-1303. Scaglione M, Caponi D, Anselmino M, Di Clemente F, Blandino A, Ferraris F, Di Donna P, Ebrille E, Halimi F, Leclercq JF, Iunco C, Vaudagna C, Cesarani F, Gaita F: Pulmonary vein isolation with a new multipolar irrigated radiofrequency ablation catheter (nMARQ): Feasibility, acute and short-term efficacy, safety, and impact on postablation silent cerebral ischemia. J Cardiovasc Electrophysiol 2014;25:12991305. Deneke T, Schade A, Diegeler A, Nentwich K: Esophago-pericardial fistula complicating atrial fibrillation ablation using a novel irrigated radiofrequency multipolar ablation catheter. J Cardiovasc Electrophysiol 2014;25:442-443. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A: Prevalence and causes of fatal outcome in catheter ablation of atrial fibrillation. J Am Coll Cardiol 2009;53:1798-1803. Singh SM, d’Avila A, Doshi SK, Brugge WR, Bedford RA, Mela T, Ruskin JN, Reddy VY: Esophageal injury and temperature monitoring during atrial fibrillation ablation. Circ Arrhythm Electrophysiol 2008;1:162-168. Kuwahara T, Takahashi A, Takahashi Y, Okubo K, Takagi K, Fujino T, Kusa S, Takigawa M, Watari Y, Yamao K, Nakashima E, Kawaguchi N, Hikita H, Sato A, Aonuma K: Incidences of esophageal injury during esophageal temperature monitoring: A comparative study of a multithermocouple temperature probe and a deflectable temperature probe in atrial fibrillation ablation. J Interv Card Electrophysiol 2014;39:251257. Deneke T MP, Halbfaß P, Sz¨oll¨osi A, Roos M, Krug J, Fochler F, Schade A, Schmitt R, Christopoulos G, Nentwich K: Single center experience using a novel irrigated multipolar radiofrequency ablation catheter—Acute and long-term data. International Symposium of Catheter Ablation Techniques Paris, 2014. Andrade JG, Dubuc M, Rivard L, Guerra PG, Mondesert B, Macle L, Thibault B, Talajic M, Roy D, Khairy P: Efficacy and safety of atrial fibrillation ablation with phased radiofrequency energy and multielectrode catheters. Heart Rhythm 2012;9:289-296. Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; Investigators SAC: Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: First results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol 2013;61: 1713-1723. Ganesan AN, Shipp NJ, Brooks AG, Kuklik P, Lau DH, Lim HS, Sullivan T, Roberts-Thomson KC, Sanders P: Long-term outcomes of catheter ablation of atrial fibrillation: A systematic review and metaanalysis. J Am Heart Assoc 2013;2:e004549.
nMARQ Ablation for Atrial Fibrillation: Results from a Multicenter Study SAAGAR MAHIDA, M.B.Ch.B.,∗ DARREN A. HOOKS, Ph.D., M.B.Ch.B.,∗ KARIN NENTWICH, M.D.,† G. ANDRE NG, M.B.Ch.B., Ph.D.,‡ MASSIMO GRIMALDI, M.D.,§ DONG-IN SHIN, M.D.,¶ NICOLAS DERVAL, M.D.,∗ FREDERIC SACHER, M.D.,∗ BENJAMIN BERTE, M.D.,∗ ´ EZE ` SEIGO YAMASHITA, M.D., Ph.D.,∗ ARNAUD DENIS, M.D.,∗ MEL HOCINI, M.D.,∗ THOMAS DENEKE, M.D.,† MICHEL HAISSAGUERRE, M.D.,∗ and PIERRE JAIS, M.D.∗ From the ∗ Hˆopital Cardiologique du Haut-L´evˆeque and Universit´e de Bordeaux, Bordeaux, Equipex MUSIC ANR-11-EQPX-0030, IHU LIRYC ANR-10-IAHU-04; †Heart-Center Bad Neustadt, Clinic for Invasive Electrophysiology, Bad Neustadt, Germany; ‡NIHR Leicester Cardiovascular Biomedical Research Unit, Department of Cardiovascular Sciences, Glenfield Hospital, University of Leicester, Leicester, UK; §Francesco Miulli Hospital, Acquaviva delle Fonti, Bari, Italy; and ¶Cardiac Arrhythmia Service, Divison of Cardiology, Pulmonology and Vascular Medicine, University Hospital, Duesseldorf, Germany
nMARQ AF Ablation. Background: nMARQ is a multipolar catheter designed to simultaneously ablate at multiple sites around the pulmonary vein (PV) circumference with a single radiofrequency application. We sought to define the safety and efficacy of atrial fibrillation (AF) ablation with the nMARQ catheter. Methods: In a multicenter study, patients with drug-refractory AF were included. Procedural outcomes were documented at 1 year. Results: 374 patients underwent PV isolation using nMARQ (age 60 ± 10 years, 264 male), of whom 263 patients had paroxysmal AF (PAF), while 111 patients had persistent AF. A total of 1,468 of 1,474 veins (99.6%) were isolated with the nMARQ catheter alone. Thirty-five (13%) PAF patients and 30 (27%) persistent AF patients underwent additional ablation at non-PV sites (2.4 ± 1.4 non-PV sites). Procedure time for PV isolation only was 1.9 ± 0.7 hours (fluoroscopy 24 ± 14 minutes). Procedure time for PV isolation and non-PV ablation was 2.4 ± 1.0 hours (fluoroscopy 30 ± 23 minutes). Major adverse events occurred in two patients (0.5%); one esophago-pericardial fistula and a second, mortality due to sepsis of unknown cause. One-year follow-up data were available in 65 (25%) PAF and 20 (18%) persistent AF patients. Forty-two (65%) PAF and 13 (65%) persistent AF patients were free of arrhythmia at 1 year. In patients undergoing repeat procedures (n = 17) the most frequent points of PV reconnection were: anterior RSPV, inferior RIPV, and superior LSPV. Conclusions: AF ablation with nMARQ is associated with short procedure times and high acute success rates. Further research is necessary to more clearly define long-term outcome. (J Cardiovasc Electrophysiol, Vol. 26, pp. 724-729, July 2015) atrial fibrillation, atrioesophageal fistula, catheter ablation, nMARQ catheter Introduction Pulmonary vein (PV) isolation is an established technique for treatment of patients with drug-refractory paroxysmal atrial fibrillation (AF). PV isolation also forms an important part of the ablation strategy in patients with persistent AF. The most commonly used current approach for PV isolaThe research leading to these results was partly funded by the European Union Seventh Framework Programme (FP7/2007-2013) under Grant Agreement HEALTH-F2-2010-261057. Drs. Jais, Haissaguerre, Hocini, and Sacher have received lecture fees from Biosense Webster for 10,000 USD annually. Dr. Ng has received speaker honorarium and proctorship fees from Biosense Webster. Other authors: No disclosures. Address for correspondence: Saagar Mahida, MB.Ch.B., Service de Rythmologie et Stimulation Cardiaque, Hˆopital Cardiologique du Haut-L´evˆeque, Avenue de Magellan, 33604 Bordeaux-Pessac, France. Fax: +33 05 57 65 65 09; E-mail: [email protected] Manuscript received 16 January 2015; Revised manuscript received 9 March 2015; Accepted for publication 13 March 2015. doi: 10.1111/jce.12698
tion involves delivery of point-by-point lesions around the PV circumference. While effective, this approach is associated with important limitations, which include prolonged procedure times, and in a proportion of cases, failure to achieve durable isolation. As a result, novel ablation catheter designs are required to increase efficacy and efficiency of PV isolation. The nMARQ catheter (Biosense Webster, Inc., Diamond Bar, CA, USA) is a novel technology that allows simultaneous ablation at multiple sites around the circumference of PV with a single radiofrequency (RF) application. Early studies have suggested that the catheter achieves fast and effective PV isolation. However these studies have been restricted to small numbers of patients.1-5 In this large, multicenter study, we sought to more comprehensively define the safety and efficacy of ablation for AF with the nMARQ catheter. Methods Study Population Criteria for inclusion in the study included either paroxysmal or persistent AF, which was refractory to at least 1
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Figure 1. Isolation of LIPV during nMARQ ablation. (A) Fluoroscopic image of nMARQ catheter at the LIPV ostium. (B) Three-dimensional left atrial anatomy demonstrating nMARQ ablation catheter at the LIPV ostium and RF lesions at the ostia of all 4 PVs (red circles). (C) Intracardiac electrograms recorded from nMARQ catheter in LIPV demonstrating PV isolation during RF delivery. PV signals are indicated in red squares. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
antiarrhythmic drug. Exclusion criteria included the presence of left atrial thrombus, inadequate anticoagulation, contraindication to anticoagulation, significant valvular heart disease, and NYHA class III or IV heart failure. Written informed consent was obtained from all patients. The study was approved by the institutional review boards at all respective institutions.
All patients were established on anticoagulant therapy for at least 4 weeks prior to the procedure. The procedure was performed on uninterrupted warfarin with a target INR between 2 and 3. A decapolar catheter was positioned in the coronary sinus. Access into the left atrium was gained by means of a transseptal puncture under fluoroscopic guidance (BRK needle, Agilis or SL-1 sheath, St. Jude Medical, St. Paul, MN, USA; Direx sheath, Bard, Lowell, MA, USA). Following transseptal puncture, the activated clotting time was maintained at >320 seconds using heparin boluses. Three-dimensional left atrial geometry was created using the nMARQ catheter and the Carto 3 mapping system (Biosense Webster, Inc. Diamond Bar, CA, USA)
delivery was 15 W per electrode, also with temperature limited to 45 °C. The position of the nMARQ catheter at the PV ostium was optimized using a combination of fluoroscopic imaging and the electroanatomical map (Figs. 1A and B). Real-time power, temperature, and impedance recordings were monitored throughout RF application. The maximum duration per application was 60 seconds. Following each application, bipolar electrograms were recorded at a site distal to the ablation line to demonstrate entrance block (Fig. 1C). Administration of adenosine or pacing of the ablation line was performed at the investigator’s discretion. Among patients with persistent AF, cardioversion following PV isolation or additional ablation at non-PV sites was performed at the investigator’s discretion. Non-PV ablation was performed using the nMARQ catheter or on certain circumstances, with a conventional catheter. Unipolar ablation with power delivery of 25 W was performed at all non-PV sites apart from the posterior wall, where 20 W was used. The aim of non-PV ablation was termination of AF to sinus rhythm. Anticoagulation was continued for a minimum period of 3 months following the index procedure with a target INR of 2–3.
Catheter Ablation
Follow-Up
The nMARQ catheter is an irrigated, circular decapolar catheter that allows both mapping and ablation through the same electrodes. The nMARQ catheter and generator design has previously been described in detail by Zellerhoff et al.4 Unipolar or bipolar ablation modes were used. The irrigation flow rate was set at 60 mL/min. Up to 25 watts (W) of RF energy per electrode was delivered in unipolar mode with the temperature limited to 45 °C. Power delivery during ablation of the posterior wall varied between 20 and 25 W in unipolar mode. In bipolar mode, the maximum power
Antiarrhythmic drug therapy was continued for 3 months following the index ablation. Discontinuation of anticoagulation and antiarrhythmics at the 3-month period was at the investigating physician’s discretion. Follow-up data were collected at a 12-month time point. Recurrences were classified as atrial tachycardias or AF. Patterns of recurrence were further classified as paroxysmal or persistent. Procedure-related serious adverse events were recorded in all patients and were categorized into embolic complications, phrenic nerve damage, vascular complications, PV stenosis, and death.
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TABLE 1 Patient Characteristics 60 ± 10 years 264/110 263/111 60 ± 8%
Age Male/female PAF/pers AF EF
Repeat Procedures In patients who had recurrences of atrial tachycardia of AF and who underwent repeat procedures, ablation were performed with a conventional irrigated ablation catheter (Navistar Thermocool, Biosense Webster, Inc. Diamond Bar, CA, USA). Three-dimensional left atrial geometry was recreated. A high density of points was collected at the PV antra. Points of reconnection were annotated. The veins were subsequently reisolated. Statistical Analysis Continuous variables were expressed as mean ± SD. Analysis of variance (ANOVA) was used to compare per vein ablation times. A P value of 0.0001). RSPV = right superior pulmonary vein; RIPV = right inferior pulmonary vein; LSPV = left superior pulmonary vein; LIPV = left inferior pulmonary vein. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
1.7 non-PV sites were targeted. Among patients with paroxysmal AF, 228 patients (87%) had PV isolation only while 35 patients (13%) had ablation at non-PV sites. In these 35 patients, 1.3 ± 0.6 non-PV sites were targeted. Details of ablation times at non-PV sites are included in Table 2. Of the 65 patients who had ablation at non-PV sites, 48 (74%) patients had ablation with nMARQ only. Eleven (17%) patients had ablation with nMARQ and conventional catheters. Of note, 9 of the 11 (82%) patients who had ablation with nMARQ and conventional catheters required ablation in the coronary sinus. Six (9%) patients had non-PV ablation with a conventional catheter only. Procedure times for patients who underwent PV isolation only (PAF or persistent AF, n = 309) were 1.9 ± 0.7 hours. Fluoroscopy times were 24 ± 14 minutes. Procedure times for patients who underwent additional non-PV isolation (PAF or persistent AF, n = 65), the procedure times were 2.4 ± 1.0 hours. Fluoroscopy times were 30 ± 23 minutes. Safety Outcomes Of the 374 patients who underwent ablation with the nMARQ catheter, major adverse events occurred in 2 patients (0.5%). One patient died due to an esophagopericardial fistula, which occurred 2 weeks following ablation. The case has been described in detail previously.6 Of note, the power was set at 25 W for all available poles during ablation of the main PVs. The patient also had an accessory posterior pulmonary vein, which was ablated with 15 W power. The events surrounding the second patient’s death are less clear. The patient had no complications in the immediate post-procedure period and was discharged from hospital following the initial nMARQ ablation. Four and a half weeks after the procedure,
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TABLE 2 Summary of RF Ablation at Non-PV Sites Non-PV Site Persistent AF (n = 30) CTI LA roof LA mitral isthmus LA (other sites)† RA Coronary sinus PAF (n = 35) CTI LA roof LA mitral isthmus LA (other sites)† RA
nMARQ Only (No.)
nMARQ + Conventional (No.)
Conventional Only (No.)
RF nMARQ (Minutes)
RF Conventional (Minutes)
15 6 3 22 12
1 3 1 3 2
3
6.0 ± 4.9 4.8 ± 2.9 5.7 ± 5.7 8.6 ± 7.0 6.2 ± 4.3
7.4 ± 4.0 7.2 ± 5.1 9.6 ± 5.2 9.9 ± 3.4 3.3 ± 3.8 3.4 ± 2.8
6.8 ± 7.3 1.6 ± 0.1 2.0 3.7 ± 2.4 3.3 ± 3.2
7.9 ± 4.5
3
9 12 2 1 18 3
5
2
† Ablation
at LA sites including anterior LA, posterior LA, LA appendage, LA septum. AF = atrial fibrillation; CTI = cavotricuspid isthmus; LA = left atrium; PAF = paroxysmal AF; PV = pulmonary vein; RA = right atrium.
the patient was readmitted to an outside hospital with sepsis. She died during the admission due to progressive sepsis. The impression from the treating physicians was that it was not a procedure related death; however, there are no available details regarding the focus of sepsis, the causative organism, or imaging to exclude an esophagopericardial fistula. There were no incidences of stroke or neurological events, phrenic nerve paralysis, cardiac tamponade, or PV stenosis. In addition to acute procedural safety outcomes, potential procedure related complications were also documented at 90 days in a proportion of patients. A total of 329 of the 374 patients (88%) had 90-day follow-up data. There were no additional major adverse events at this time point. Long-Term Outcome Follow-up data were collected at a 12-month time point. In the PAF group, follow-up data were available in 65 (25%) patients. Forty-two (65%) PAF patients were free of arrhythmia at 1 year. Of the 23 patients who experienced recurrences, 22 had PAF while 1 had an atrial tachycardia (AT) (Fig. 3A). Thirteen (20%) PAF patients were receiving antiarrhythmic drug therapy at follow-up (8 flecainide; 4 sotalol; 1 amiodarone). Thirty-two PAF patients were on β-blockers and a further 5 were on calcium channel blockers. In the persistent AF group, follow-up data were available in 20 (18%) patients. Thirteen (65%) persistent AF patients were free of arrhythmia at 1 year. Of the 7 patients who experienced recurrences, 4 had AF while 3 had atrial tachycardia (Fig. 3B). Six (30%) persistent AF patients were receiving antiarrhythmic drug therapy at follow-up (1 dronedarone; 2 sotalol; 3 amiodarone). Twelve persistent AF patients were on β-blocker therapy. Repeat Procedures Seventeen patients who experienced recurrences of AF following the index nMARQ ablation underwent repeat procedures (15 PAF, 2 persistent AF). Repeat procedures were performed 5.3 ± 3.7 months following the index procedure. All 17 patients had PV reconnections. Data on the specific reconnection points were available in 16 of the 17 (94%) patients. As illustrated in Figure 4, the most frequent points of reconnection were the anterior aspect of the RSPV, the
Figure 3. Outcomes at 1 year after nMARQ ablation. (A) In PAF patients (n = 65), 42 patients (65%) were free of atrial arrhythmias at 1 year. (B) In persistent AF patients (n = 20), 13 patients (65%) were free of arrhythmia at 1 year. Atrial tachycardia was more commonly encountered at follow-up in patients who had been ablated for persistent AF. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
inferior aspect of the RIPV, and the superior aspect of the LSPV. Discussion In this large, multicenter study, we demonstrate that ablation with the nMARQ catheter is associated with short
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Figure 4. Points of reconnection in patients who underwent repeat procedures. Data from repeat PV siolation in 16 patients are presented. PVs are divided into 4 quadrants (anterior [green], posterior [red], superior [grey], and inferior [blue]). The most frequent points of reconnection were the anterior aspect of the RSPV, the inferior aspect of the RIPV and the superior aspect of the LSPV. For a high quality, full color version of this figure, please see Journal of Cardiovascular Electrophysiology’s website: www.wileyonlinelibrary.com/journal/jce
procedure times and a high acute PV isolation success rate. Further, in a large proportion of cases, the nMARQ catheter was effective for ablating non-PV targets without the need for additional ablation with a conventional catheter. There was a 0.5% incidence of procedure-related serious adverse events following nMARQ ablation. Finally, the outcomes at 1 year were comparable to those in AF patients undergoing ablation with conventional catheters. Five recent studies have reported on outcomes following ablation with the nMARQ catheter.1-5 Of note however, these have been single-center studies restricted to small numbers of patients. The largest study involved 43 patients. Consistent with our findings, the studies reported high acute PV isolation rates ranging from 98% to 100%. The complication rates in these studies were also similar. Out of the total of 153 patients in the 5 studies, major complications were observed in 2 patients (1.3%); 1 patient had a cardiac tamponade related to a transseptal puncture while the second had phrenic nerve palsy.3,4 In this study, we describe a third patient with a major complication related to nMARQ ablation, which was an esophagopericardial fistula. The same case has also previously been described in the form of a case report.6 The major complication rate in this study was 0.5%, with 2 mortalities occurring following nMARQ ablation. The first mortality, which occurred due to an esophagopericardial fistula, was clearly related to the ablation. While the exact cause of the second mortality is not clear, in the absence of additional data, it remains a potential procedure related death. The mortality rate is significantly higher than that previously reported for conventional ablation. In an international survey Cappato et al. reported a mortality of 0.1% following conventional ablation.7 It is important to emphasize, however, that the study involved a much larger population of more than 30,000 patients. In order to more clearly define the mortality rate associated with nMARQ ablation, studies in larger cohorts of patients are necessary. The occurrence of an esophagopericardial fistula in our cohort underscores the importance of adjusting power during posterior wall ablation with nMARQ. The optimal power
settings posterior wall ablation has been addressed in 2 recent reports. In a study involving 43 patients, Deneke et al. reported that 25 W unipolar ablation with nMARQ was associated with a 42% incidence of thermal esophageal injury, as evidenced by superficial erythema or superficial ulceration during endoscopy.2 When the power was reduced to 20 W, the incidence of thermal injury decreased to 20%. In a more recent study involving 21 patients, a combination of 20 W unipolar ablation and 10 W bipolar ablation for 60 seconds was associated with a higher incidence of esophageal injury (50%) as compared to ablation for 30 seconds at 15 W unipolar and 10 W for bipolar ablation (6.7%).3 These numbers are comparable to esophageal injury rates with conventional ablation.8,9 Of note, posterior wall ablation in the aforementioned patient with a esophagopericardial fistula was performed with 25 W. We did not observe any complications or symptoms suggestive of esophageal injury in patients who had ablation with 20 W on the posterior wall. Of note, Deneke et al. recently reported the use of an esophageal temperature probe increases the risk of esophageal injury during nMARQ ablation. On the basis of this observation, we did not use a temperature probe in this study.10 Embolic neurological complications have previously been reported with multielectrode ablation catheter designs such as the PVAC catheter (Medtronic Inc.). A previous metaanalysis on PVAC safety and efficacy reported a thromboembolic complication rate of 0.63%.11 Patients were carefully monitored for neurological sequelae in the present study. We did not observe strokes or TIAs following nMARQ ablation. Consistent with our findings, none of the previous smaller studies on nMARQ outcomes have reported clinical strokes.1-5 It is important to note, however, that in the study by Deneke et al. discussed above, 14 of the 43 (33%) of patients had silent cerebral lesions following nMARQ ablation.2 While the study was limited to a small cohort, the findings emphasize the importance of uninterrupted oral anticoagulation, and maintenance of higher activated clotting times during nMARQ ablation. One of the major drivers for development of “one shot” catheter designs is to reduce procedure times for PV isolation and to make the procedure easier. In this study, procedure time to achieve PV isolation with nMARQ (mean 114 minutes) compared favorably with other novel catheter ablation designs. For instance, in a meta-analysis of 23 cryoablation studies, the mean procedure time was 206 minutes.11 In the recent STOP-AF cryoablation trial, procedure time was 371 minutes.12 In a meta-analysis of 42 studies relating to the AF ablation with the PVAC catheter, average procedure times were reported as 117 minutes.11 To date, most of the research relating to the nMARQ catheter has focused on its role as a tool for PV isolation. However, our results suggest that the technology is also effective for ablation of non-PV sites. In a significant number of persistent AF cases in our cohort, nMARQ ablation alone effectively blocked CTI and roof lines with a limited number of RF applications. The nMARQ catheter was also effective for simultaneously targeting multiple left and right atrial sites with high-frequency fractionated signals. In the majority of cases, the need for an additional conventional catheter was determined by a need to ablate within the coronary sinus. It is important to note, however, that the numbers of persistent AF patients who underwent non-PV isolation in this study
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were relatively small. Larger studies are necessary define the role of nMARQ in persistent AF. Our data suggest that the outcomes of nMARQ ablation could potentially be comparable to conventional ablation. The single procedure success rate in PAF patients in our cohort was 65%. In comparison, in a meta-analysis of 11 studies in PAF patients ablated with conventional catheters, Ganesan et al. reported a 1-year success rate of 66.6%.13 In the same study, a meta-analysis of 6 studies reporting outcomes of persistent AF ablation with conventional catheters, 1-year success rates were 52%.13 In our persistent AF cohort, 65% of patients were free of AF at 1 year. However, these results should be interpreted with caution for a number of reasons. First, there was significant heterogeneity in the ablation strategy in persistent AF patients in our cohort. Second, in a proportion of persistent AF patients, conventional ablation was used in addition to nMARQ ablation. Third, and most importantly, follow-up data were only available in a small subset of patients from our cohort. Overall, further data are needed before long-term outcome following nMARQ can be defined.
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7.
Limitations 8.
Patients were recruited from 5 different centers. Therefore, there were subtle differences in the approach used for PV isolation between centers. More importantly, there were significant differences in the strategy for ablation of patients with persistent AF. The study investigated a mixed population of PAF and persistent AF patients. The study also has the inherent limitations of a non-randomized study with no control arm. Conclusions AF ablation with the nMARQ catheter is associated with short procedure times and high acute success rates. The question of long-term outcome needs to be addressed further, although our preliminary data suggest that they are favorable. Finally, complication rates associated with nMARQ ablation merit further investigation.
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of a novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation. J Cardiovasc Electrophysiol 2014;25:339345. Rillig A, Lin T, Burchard A, Kamioka M, Heeger C, Makimoto H, Metzner A, Wissner E, Wohlmuth P, Ouyang F, Kuck KH, Tilz RR: Modified energy settings are mandatory to minimize oesophageal injury using the novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation. Europace 2015;17:396-402. Zellerhoff S, Daly M, Lim HS, Denis A, Komatsu Y, Jesel L, Derval N, Sacher F, Cochet H, Knecht S, Yiem S, Hocini M, Haissaguerre M, Jais P: Pulmonary vein isolation using a circular, open irrigated mapping and ablation catheter (nMARQ): a report on feasibility and efficacy. Europace 2014;16:1296-1303. Scaglione M, Caponi D, Anselmino M, Di Clemente F, Blandino A, Ferraris F, Di Donna P, Ebrille E, Halimi F, Leclercq JF, Iunco C, Vaudagna C, Cesarani F, Gaita F: Pulmonary vein isolation with a new multipolar irrigated radiofrequency ablation catheter (nMARQ): Feasibility, acute and short-term efficacy, safety, and impact on postablation silent cerebral ischemia. J Cardiovasc Electrophysiol 2014;25:12991305. Deneke T, Schade A, Diegeler A, Nentwich K: Esophago-pericardial fistula complicating atrial fibrillation ablation using a novel irrigated radiofrequency multipolar ablation catheter. J Cardiovasc Electrophysiol 2014;25:442-443. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A: Prevalence and causes of fatal outcome in catheter ablation of atrial fibrillation. J Am Coll Cardiol 2009;53:1798-1803. Singh SM, d’Avila A, Doshi SK, Brugge WR, Bedford RA, Mela T, Ruskin JN, Reddy VY: Esophageal injury and temperature monitoring during atrial fibrillation ablation. Circ Arrhythm Electrophysiol 2008;1:162-168. Kuwahara T, Takahashi A, Takahashi Y, Okubo K, Takagi K, Fujino T, Kusa S, Takigawa M, Watari Y, Yamao K, Nakashima E, Kawaguchi N, Hikita H, Sato A, Aonuma K: Incidences of esophageal injury during esophageal temperature monitoring: A comparative study of a multithermocouple temperature probe and a deflectable temperature probe in atrial fibrillation ablation. J Interv Card Electrophysiol 2014;39:251257. Deneke T MP, Halbfaß P, Sz¨oll¨osi A, Roos M, Krug J, Fochler F, Schade A, Schmitt R, Christopoulos G, Nentwich K: Single center experience using a novel irrigated multipolar radiofrequency ablation catheter—Acute and long-term data. International Symposium of Catheter Ablation Techniques Paris, 2014. Andrade JG, Dubuc M, Rivard L, Guerra PG, Mondesert B, Macle L, Thibault B, Talajic M, Roy D, Khairy P: Efficacy and safety of atrial fibrillation ablation with phased radiofrequency energy and multielectrode catheters. Heart Rhythm 2012;9:289-296. Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; Investigators SAC: Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: First results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol 2013;61: 1713-1723. Ganesan AN, Shipp NJ, Brooks AG, Kuklik P, Lau DH, Lim HS, Sullivan T, Roberts-Thomson KC, Sanders P: Long-term outcomes of catheter ablation of atrial fibrillation: A systematic review and metaanalysis. J Am Heart Assoc 2013;2:e004549.
