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      Incidence of complications related to catheter ablation of atrial fibrillation and atrial flutter: a nationwide in-hospital analysis of administrative data for Germany in 2014

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          Abstract

          Aims

          Risks of catheter ablation for atrial fibrillation and flutter assessed in retrospective studies, registries, and controlled trials may underestimate ‘real world’ conditions.

          Methods and results

          To assess complications in a nationwide approach, we included all cases undergoing catheter ablation for atrial fibrillation and atrial flutter in Germany in 2014, using ICD-10-GM-based German Diagnosis Related Group (G-DRG) codes and the well differentiated German Operation and Procedure Classification (OPS) analysing 33 353 in-hospital cases. For left atrial ablations (19 514 cases), the overall complication rate ranged from a mean of 11.7% to 13.8% depending on type and site of applied energy, including major complications ranging from 3.8% to 7.2%. Whereas overall complication rates were lower for atrial flutter ablations (13 871 cases, 10.5%; P < 0.001), interestingly, major complications occurred more frequently (7.4%; P < 0.001). Particularly, in-hospital death was four-times more common following right than following left atrial ablations (47 vs. 18 cases, 0.34% vs. 0.09%; P < 0.001). Stratified by centre ablation volume, significantly fewer overall complications occurred in centres performing >100 vs. ≤100 left atrial ablations annually (12.7% vs. 16.4%; P < 0.002).

          Conclusion

          Administrative data of all atrial fibrillation ablations in Germany in 2014 revealed higher overall and major complication rates than previously reported. Few patients were treated in low volume centres, but were exposed to a higher overall complication risk. Atrial flutter ablations were associated with surprisingly high rates of life-threatening complications. Advanced age combined with highly prevalent cardiac, pulmonary and, vascular comorbidities likely play a major role. In addition, individual-level clinical studies need to address the safety and benefits of catheter ablation in an elderly, diseased population.

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          Most cited references22

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          Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.

          Riccardo Cappato, Hugh Calkins, Shih-Ann Chen … (2010)
          The purpose of this study was to provide an updated worldwide report on the methods, efficacy, and safety of catheter ablation of atrial fibrillation (AF). A questionnaire with 46 questions was sent to 521 centers from 24 countries in 4 continents. Complete interviews were collected from 182 centers, of which 85 reported to have performed 20,825 catheter ablation procedures on 16,309 patients with AF between 2003 and 2006. The median number of procedures per center was 245 (range, 2 to 2715). All centers included paroxysmal AF, 85.9% also included persistent and 47.1% also included long-lasting AF. Carto-guided left atrial circumferential ablation (48.2% of patients) and Lasso-guided ostial electric disconnection (27.4%) were the most commonly used techniques. Efficacy data were analyzed with centers representing the unit of analysis. Of 16,309 patients with full disclosure of outcome data, 10 488 (median, 70.0%; interquartile range, 57.7% to 75.4%) became asymptomatic without antiarrhythmic drugs and another 2047 (10.0%; 0.5% to 17.1%) became asymptomatic in the presence of previously ineffective antiarrhythmic drugs over 18 (range, 3 to 24) months of follow-up. Success rates free of antiarrhythmic drugs and overall success rates were significantly larger in 9590 patients with paroxysmal AF (74.9% and 83.2%) than in 2800 patients with persistent AF (64.8% and 75.0%) and 1108 patients with long-lasting AF (63.1% and 72.3%) (P<0.0001). Major complications were reported in 741 patients (4.5%). When analyzed in a large number of electrophysiology laboratories worldwide, catheter ablation of AF shows to be effective in approximately 80% of patients after 1.3 procedures per patient, with approximately 70% of them not requiring further antiarrhythmic drugs during intermediate follow-up.
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            Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation.

            Jens Cosedis Nielsen, Arne Johannessen, Pekka Raatikainen … (2012)
            There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation. We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis. There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P=0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P=0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P=0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P=0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation. In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years. (Funded by the Danish Heart Foundation and others; MANTRA-PAF ClinicalTrials.gov number, NCT00133211.).
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              Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.

              Wyn Davies, Riccardo Cappato, You Wang Kim … (2005)
              The purpose of this study was to conduct a worldwide survey investigating the methods, efficacy, and safety of catheter ablation (CA) of atrial fibrillation (AF). A detailed questionnaire was sent to 777 centers worldwide. Data relevant to the study purpose were collected from 181 centers, of which 100 had ongoing programs on CA of AF between 1995 and 2002. The number of patients undergoing this procedure increased from 18 in 1995 to 5050 in 2002. The median number of procedures per center was 37.5 (range, 1 to 600). Paroxysmal AF, persistent AF, and permanent AF were the indicated arrhythmias in 100.0%, 53.0%, and 20.0% of responding centers, respectively. The most commonly used techniques were right atrial compartmentalization between 1995 and 1997, ablation of the triggering focus in 1998 and 1999, and electrical disconnection of multiple pulmonary veins between 2000 and 2002. Of 8745 patients completing the CA protocol in 90 centers, of whom 2389 (27.3%) required >1 procedure, 4550 (52.0%; range among centers, 14.5% to 76.5%) became asymptomatic without drugs and another 2094 (23.9%; range among centers, 8.8% to 50.3%) became asymptomatic in the presence of formerly ineffective antiarrhythmic drugs over an 11.6+/-7.7-month follow-up period. At least 1 major complication was reported in 524 patients (6.0%). The findings of this survey provide a picture of the variable and evolving methods, efficacy, and safety of CA for AF as practiced in a large number of centers worldwide and may serve as a guide to clinicians considering therapeutic options in patients suffering from this arrhythmia.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Eur Heart J
                Journal ID (iso-abbrev): Eur. Heart J
                Journal ID (publisher-id): eurheartj
                Title: European Heart Journal
                Publisher: Oxford University Press
                ISSN (Print): 0195-668X
                ISSN (Electronic): 1522-9645
                Publication date (Print): 01 December 2018
                Publication date (Electronic): 01 August 2018
                Publication date PMC-release: 01 August 2018
                Volume: 39
                Issue: 45 , Focus Issue on Atrial Fibrillation
                Pages: 4020-4029
                Affiliations
                [1 ]University Hospital Munich, Ludwig Maximilians University, Marchioninistr. 15, Munich, Bavaria, Germany
                [2 ]Department of Medicine I, University Hospital Munich, Ludwig Maximilians University Munich, Marchioninistr. 15, Munich, Bavaria, Germany
                [3 ]German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Biedersteiner Str. 29, Munich, Bavaria, Germany
                [4 ]Institute of Genetic Epidemiology, Helmholtz Zentrum München—German Research Center for Environmental Health, Ingolstaedter Landstr. 1, Neuherberg, Bavaria, Germany
                [5 ]Division of Vascular Medicine, Department of Cardiology and Angiology, University Hospital Münster, Albert-Schweitzer-Campus 1, Munster, North Rhine-Westphalia, Germany
                Author notes
                Corresponding author. Tel: +49 8151 44774 0, Fax: +49 8151 44774 20, Email: g.steinbeck@ 123456kardiozentrum-starnberg.de

                The Stefan Kääb and Holger Reinecke authors share senior authorship.

                Article
                Publisher ID: ehy452
                DOI: 10.1093/eurheartj/ehy452
                PMC ID: 6269631
                PubMed ID: 30085086
                SO-VID: 975b8753-194d-48fd-8dac-efdca5c8ac73
                Copyright © © The Author(s) 2018. Published by Oxford University Press on behalf of the European Society of Cardiology.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Date received : 08 January 2018
                Date revision received : 17 May 2018
                Date accepted : 10 July 2018
                Page count
                Pages: 11
                Categories
                Subject: Clinical Research
                Subject: Atrial Fibrillation

                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: atrial fibrillation ,atrial flutter ,catheter ablation ,complication ,administrative data
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: atrial fibrillation , atrial flutter , catheter ablation , complication , administrative data

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