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      Loop Recorder Detected High Rate of Atrial Fibrillation Recurrence after a Single Balloon- or Basket-Based Ablation of Paroxysmal Atrial Fibrillation: Results of the MACPAF Study

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          Abstract

          Purpose

          Pulmonary vein isolation (PVI) is an established approach to treat symptomatic non-permanent atrial fibrillation (AF). Detecting AF recurrence after PVI is important, if discontinuation of oral anticoagulation after ablation is considered.

          Methods

          Patients with symptomatic paroxysmal AF were enrolled in the prospective randomized mesh ablator vs. cryoballoon pulmonary vein (PV) ablation of symptomatic paroxysmal AF study, comparing efficacy and safety of the HD Mesh Ablator ® (C.R. Bard, Lowell, MA, USA) and the Arctic Front ® (Medtronic, Minneapolis, MN, USA) catheter. Rhythm status post-PVI was closely monitored for 1 year using the implantable loop recorder (ILR) Reveal XT ® (Medtronic Minneapolis, MN, USA).

          Results

          The study was terminated after the first interim analysis due to the inability of the HD Mesh Ablator ® to achieve the predefined primary study endpoint, an exit block of all PVs. After a 90-day blanking period, 23 (62.2%) out of 37 study patients (median 63.0 years; 41% females) had at least one episode of AF. AF recurrence was associated with AF episodes during the blanking period {hazard ratios (HR) 5.10 [95% confidence interval (CI) 1.21–21.4]; p = 0.038}, and a common left-sided PV ostium [HR 4.17 (95%CI 1.48–11.8); p = 0.039] but not with catheter type, age, gender, cardiovascular risk profile, or left atrial volume. There was a trend toward AF recurrence in patients without complete PVI of all PV ( p = 0.095). Overall, 337 (59.4%) out of 566 ILR-detected episodes represented AF. Comparing patients with AF recurrence to those without, there was no difference in cognitive performance 6 months post-ablation.

          Conclusion

          Using an ILR, in more than 60% of all patients with paroxysmal AF, a recurrence of AF was detected within 12 months after ablation. In patients with a common PV ostium, the first generation balloon-based catheter is obviously less effective.

          Clinical trials

          http://Clinicaltrials.gov NCT01061931.

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          Most cited references23

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          Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg Sequential Ablation Strategy.

          This study describes the 5-year efficacy of catheter ablation for long-standing persistent atrial fibrillation (LS-AF). Long-term outcome data after catheter ablation for LS-AF are limited. Long-term follow-up of 56 months (range 49 to 67 months) was performed in 202 patients (age 61 ± 9 years) who underwent the sequential ablation strategy for symptomatic LS-AF. Initial ablation strategy was circumferential pulmonary vein isolation (PVI). Additional ablation was performed only in acute PVI nonresponder, if direct current cardioversion failed after PVI. After the first ablation procedure, sinus rhythm was documented in 41 of 202 (20.3%) patients. After multiple procedures, sinus rhythm was maintained in 91 of 202 (45.0%) patients, including 24 patients receiving antiarrhythmic drugs. In 105 patients, PVI was the sole ablative therapy, 49 (46.7%) of those patients remained in sinus rhythm during follow-up. Patients with a total AF duration of 2 years (76.5% vs. 42.2%, respectively; p = 0.033). Persistent AF duration (hazard ratio: 1.09 [95% confidence interval: 1.04 to 1.13]; p < 0.001) independently predicted arrhythmia recurrences, and acute PVI responders had a reduced risk of relapse (hazard ratio: 0.57 [95% confidence interval: 0.41 to 0.78]; p < 0.001) after the first ablation. During 5-year follow-up, single- and multiple ablation procedure success was 20% and 45%, respectively, for patients with LS-AF. For patients with a total AF duration of <2 years, the outcomes were favorable. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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            Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial.

            Current methods for detecting atrial fibrillation (AF) have limited diagnostic yield. Continuous monitoring with automatic arrhythmia detection and classification may improve detection of symptomatic and asymptomatic AF and subsequent patient treatment. The study purpose was to quantify the performance of the first implantable leadless cardiac monitor (ICM) with dedicated AF detection capabilities. Patients (n=247) with an implanted ICM (Reveal XT, Medtronic Inc, Minneapolis, Minn) who were likely to present with paroxysmal AF were selected. A special Holter device stored 46 hours of subcutaneously recorded ECG, ICM markers, and 2 surface ECG leads. The ICM automatic arrhythmia classification was compared with the core laboratory classification of the surface ECG. Of the 206 analyzable Holter recordings collected, 76 (37%) contained at least 1 episode of core laboratory classified AF. The sensitivity, specificity, positive predictive value, and negative predictive value for identifying patients with any AF were 96.1%, 85.4%, 79.3%, and 97.4%, respectively. The AF burden measured with the ICM was very well correlated with the reference value derived from the Holter (Pearson coefficient=0.97). The overall accuracy of the ICM for detecting AF was 98.5%. In this ICM validation study, the dedicated AF detection algorithm reliably detected the presence or absence of AF and the AF burden was accurately quantified. The ICM is a promising new diagnostic and monitoring tool for the clinician to treat AF patients independently of symptoms. Long-term studies are needed to evaluate the clinical benefits of the technology.
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              Discerning the incidence of symptomatic and asymptomatic episodes of atrial fibrillation before and after catheter ablation (DISCERN AF): a prospective, multicenter study.

              The DISCERN AF study (Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation) monitored atrial fibrillation (AF) using an implantable cardiac monitor (ICM) to assess the incidence and predictors of asymptomatic AF before and after catheter ablation. Patients with symptomatic AF underwent implantation of an ICM with an automated AF detection algorithm 3 months before and 18 months after ablation. Patients kept a standardized diary to record symptoms of arrhythmia, and ICM data were downloaded every 3 months. All episodes were blindly adjudicated and correlated with the diary. Asymptomatic recurrences were ICM episodes of 2 minutes or longer with no associated diary symptoms. Fifty patients had 2355 ICM episodes. Of these, 69.0% were true AF/atrial flutter (AFL)/atrial tachycardia (AT); 16.0%, sinus with extrasystoles; 11.0%, artifact; and 4.0%, sinus arrhythmia. Total AF/AFL/AT burden was reduced by 86% from a mean (SD) of 2.0 (0.5) h/d per patient before to 0.3 (0.2) h/d per patient after ablation (P < .001), and 56.0% of all episodes were asymptomatic. The ratio of asymptomatic to symptomatic AF episodes increased after ablation from 1.1 to 3.7 (P = .002). By symptoms alone, 29 of 50 patients (58%) were free of AF/AFL/AT after ablation compared with 23 of 50 (46%) using ICM-detected AF/AFL/AT recurrence. Asymptomatic episodes were more likely AFL/AT and were significantly shorter and slower, with lower heart rate variability. However, the postablation state was the strongest independent predictor of asymptomatic AF. The ratio of asymptomatic to symptomatic AF episodes increased from 1.1 before to 3.7 after ablation. Postablation state is the strongest predictor of asymptomatic AF. Symptoms alone underestimate postablation AF burden, with 12% of patients having asymptomatic recurrences only. clinicaltrials.gov Identifier: NCT00745706.
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                Author and article information

                Contributors
                URI : http://frontiersin.org/people/u/403454
                URI : http://frontiersin.org/people/u/380202
                URI : http://frontiersin.org/people/u/9750
                URI : http://frontiersin.org/people/u/13773
                Journal
                Front Cardiovasc Med
                Front Cardiovasc Med
                Front. Cardiovasc. Med.
                Frontiers in Cardiovascular Medicine
                Frontiers Media S.A.
                2297-055X
                13 February 2017
                2017
                : 4
                : 4
                Affiliations
                [1] 1Department of Cardiology, Sana Clinic Lichtenberg , Berlin, Germany
                [2] 2Department of Neurology, Charité – Universitätsmedizin Berlin , Berlin, Germany
                [3] 3Center for Stroke Research Berlin, Charité – Universitätsmedizin Berlin , Berlin, Germany
                [4] 4Department of Cardiology and Pneumology, Charité – Universitätsmedizin Berlin , Berlin, Germany
                [5] 5German Center for Neurodegenerative Diseases (DZNE), Partner Site , Berlin, Germany
                [6] 6German Center for Cardiovascular Diseases (DZHK), Partner Site , Berlin, Germany
                Author notes

                Edited by: Mehdi Namdar, Hôpitaux Universitaires de Genève, Switzerland

                Reviewed by: Antonio Sorgente, Cleveland Clinic Abu Dhabi, United Arab Emirates; Cheryl Teres, Hôpitaux Universitaires de Genève, Switzerland

                *Correspondence: Alexander Schirdewan, a.schirdewan@ 123456sana-kl.de

                These authors have contributed equally to this work.

                Specialty section: This article was submitted to Cardiac Rhythmology, a section of the journal Frontiers in Cardiovascular Medicine

                Article
                10.3389/fcvm.2017.00004
                5303896
                28243592
                0882ded0-94c0-48ab-b738-441d2c22f1f9
                Copyright © 2017 Schirdewan, Herm, Roser, Landmesser, Endres, Koch and Haeusler.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 23 September 2016
                : 18 January 2017
                Page count
                Figures: 2, Tables: 2, Equations: 0, References: 39, Pages: 8, Words: 6270
                Funding
                Funded by: Bundesministerium für Bildung und Forschung 10.13039/501100002347
                Award ID: 01 EO 0801
                Funded by: Deutsche Forschungsgemeinschaft 10.13039/501100001659
                Award ID: SFB TR 43, KFO 247, KFO 213
                Categories
                Cardiovascular Medicine
                Original Research

                catheter ablation,pulmonary veins,atrial fibrillation,arctic front®,hd mesh ablator®,ecg monitoring

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