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Cerebral thromboembolic risk in atrial fibrillation ablation: a direct comparison of vitamin K antagonists versus non-vitamin K-dependent oral anticoagulants

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Adrian Petzl at Universitätsklinikum Sankt Pölten
Adrian Petzl
  • Universitätsklinikum Sankt Pölten
Michael Derndorfer
Michael Derndorfer
Michael Derndorfer
  • This person is not on ResearchGate, or hasn't claimed this research yet.
Georgios Kollias at Evangelismos Hospital
Georgios Kollias
Kgomotso Moroka at University of Alcalá
Kgomotso Moroka
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Abstract and Figures

PurposeCerebral thromboembolic events are well-known complications of pulmonary vein isolation (PVI) and can manifest as stroke or silent cerebral embolic lesions. The aim of this study was to compare the incidence of cerebral embolic lesions (including silent cerebral embolism and stroke) after AF ablation in patients on vitamin K antagonists versus patients on non-vitamin K-dependent oral anticoagulants, and to identify corresponding clinical and procedural risk factors.MethodsA total of 421 patients undergoing PVI were prospectively included into the study. Of these, 43.7% were on VKA and 56.3% on NOAC treatment (dabigatran, rivaroxaban, apixaban, and edoxaban). In the NOAC group, 38% of patients had an interruption of anticoagulation for 24–36 h. All patients underwent pre- and postprocedural cerebral magnetic resonance imaging.ResultsPeriprocedural cerebral lesions occurred in 13.1% overall. Of these, three (0.7%) resulted in symptomatic cerebrovascular accidents and 52 (12.4%) in silent cerebral embolic lesions. Incidence of cerebral lesions was significantly higher in patients on NOAC compared with VKA (16% vs. 9.2%, respectively, p = 0.04), and in patients who had intraprocedural cardioversions compared with no cardivoersions (19.5% vs. 10.4%, respectively, p = 0.03). In multivariate analysis, both parameters were found to be independent risk factors for cerebral embolism. No significant difference between interrupted and uninterrupted NOAC administration could be detected.Conclusions In patients undergoing AF ablation, we identified the use of NOAC and intraprocedural cardioversion as independent risk factors for the occurrence of periprocedural cerebral embolic lesions.
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ORIGINAL RESEARCH
Cerebral thromboembolic risk in atrial fibrillation ablation: a direct
comparison of vitamin K antagonists versus non-vitamin
K-dependent oral anticoagulants
Adrian Petzl
1,2
&Michael Derndorfer
1
&Georgios Kollias
1
&Kgomotso Moroka
1
&Josef Aichinger
1
&
Helmut Pürerfellner
1
&Martin Martinek
1,2
Received: 27 November 2019 /Accepted: 18 February 2020
#Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract
Purpose Cerebral thromboembolic events are well-known complications of pulmonary vein isolation (PVI) and can manifest as
stroke or silent cerebral embolic lesions. The aim of this study was to compare the incidence of cerebral embolic lesions
(including silent cerebral embolism and stroke) after AF ablation in patients on vitamin K antagonists versus patients on non-
vitamin K-dependent oral anticoagulants, and to identify corresponding clinical and procedural risk factors.
Methods A total of 421 patients undergoing PVI were prospectively included into the study. Of these, 43.7% were on VKA and
56.3% on NOAC treatment (dabigatran, rivaroxaban, apixaban, and edoxaban). In the NOAC group, 38% of patients had an
interruption of anticoagulation for 24–36 h.All patientsunderwent pre- and postprocedural cerebral magnetic resonance imaging.
Results Periprocedural cerebral lesions occurred in 13.1% overall. Of these, three (0.7%) resulted in symptomatic cerebrovas-
cular accidents and 52 (12.4%) in silent cerebral embolic lesions. Incidence of cerebral lesions was significantly higher in patients
on NOAC compared with VKA (16% vs. 9.2%, respectively, p= 0.04), and in patients who had intraprocedural cardioversions
compared with no cardivoersions (19.5% vs. 10.4%, respectively, p= 0.03). In multivariate analysis, both parameters were found
to be independent risk factors for cerebral embolism. No significant difference between interrupted and uninterrupted NOAC
administration could be detected.
Conclusions In patients undergoing AF ablation, we identified the use of NOAC and intraprocedural cardioversion as indepen-
dent risk factors for the occurrence of periprocedural cerebral embolic lesions.
Keywords Atrial fibrillation ablation .Non-vitamin K-dependent oral anticoagulant .Vitamin K antagonist .Stroke .Silent
cerebral embolism .Cerebral magnetic resonance imaging
1 Introduction
Catheter-based pulmonary vein isolation (PVI) is the corner-
stone of interventional atrial fibrillation (AF) treatment [1].
One of the most severe adverse events of this procedure is
cerebral thromboembolism. The incidence of clinically overt
stroke during PVI is, however, low (approximately 0.1–0.8%)
[2]. Periprocedural silent cerebral embolisms (SCE), on the
other hand, are much more frequent (incidence of about
19%, calculated across different studies) [3]. Although these
lesions are clinically silent, they can be detected by magnetic
resonance imaging (MRI) and may cause long-term adverse
effects, such as neurocognitive decline and depression [2]. It is
therefore critical to understand risk factors of periprocedural
cerebral thromboembolism to reduce risks of PVI.
The currently preferred choice to prevent thromboembolic
events in AF are non-vitamin K-dependent oral anticoagulants
(NOAC) rather than vitamin K antagonists (VKA) [4]. It is
recommended to continue oral anticoagulation with no oronly
minimal interruption during the PVI procedure [1,4]. There
have been trials establishing efficacy of uninterrupted VKA
Adrian Petzl and Michael Derndorfer contributed equally to this work.
*Adrian Petzl
adrian.petzl@stpoelten.lknoe.at; adrian.petzl@gmail.com
1
Department of Internal Medicine 2 with Cardiology, Angiology and
Intensive Care, Ordensklinikum Linz Elisabethinen, Fadingerstraße
1, A-4020 Linz, Austria
2
Department of Internal Medicine 3, University Hospital St. Pölten,
Dunant-Platz 1, A-3100 St. Pölten, Austria
https://doi.org/10.1007/s10840-020-00718-w
/ Published online: 6 March 2020
Journal of Interventional Cardiac Electrophysiology (2021) 60:147–154
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
... 28 There was initial controversy when comparing direct oral anticoagulants (DOACs) to vitamin K antagonists (VKAs), with some studies finding a higher risk of thromboembolic complications with DOACs. 29,30 However, many studies have since demonstrated comparable risk, often with a lower rate of bleeding complications using DOACs. [31][32][33][34][35][36][37] Notably, target ACT may be more difficult to achieve using certain DOACs-specifically dabigatran. ...
... A number of studies have shown that intraprocedural electrical cardioversion is an independent predictor of SCLs. 25,29,42 Mechanistically, this might relate to the dislodgement of thrombotic material from equipment-or from fresh ablation lesions-due to the sudden movement caused by direct current cardioversion or by restoration of atrial contraction. ...
Silent cerebral lesions following catheter ablation for atrial fibrillation: a state-of-the-art review
Article
Full-text available
  • Jun 2023
  • EUROPACE
Atrial fibrillation is associated with neurocognitive comorbidities such as stroke and dementia. Evidence suggests that rhythm control-especially if implemented early-may reduce the risk of cognitive decline. Catheter ablation is highly efficacious for restoring sinus rhythm in the setting of atrial fibrillation; however, ablation within the left atrium has been shown to result in MRI-detected silent cerebral lesions. In this state-of-the-art review article, we discuss the balance of risk between left atrial ablation and rhythm control. We highlight suggestions to lower the risk, as well as the evidence behind newer forms of ablation such as very high power short duration radiofrequency ablation and pulsed field ablation.
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... This inquires about work composed by Adrian Petzl in 2019. "Symptomatic carotid near-occlusion causes a high risk of recurrent ipsilateral ischemic stroke" is composed by Thomas Gu within the year 2019 [39]. This creator employments CTA pictures of 19 patients. ...
A Comprehensive Review on Medical Imaging Technologies to Detect Brain Stroke
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Brain stroke discovery remains one of the foremost critical investigation zones in restorative imaging. A brain stroke can be classified into two primary categories Ischemic and Haemorrhagic. Imaging technology detects strokes early. When it comes to imaging, the American College of Radiology persistently overhauls its rules for imaging pathways through the ACR Fittingness Criteria. There are a few prevalent restorative imaging methods for brain stroke locations like X-ray, computed tomography, positron outflow tomography, attractive reverberation imaging, and utilitarian attractive reverberation imaging. MRI and fMRI, using radio waves and a magnet, provide a detailed image of the brain, detecting a wide variety of brain tissues and blood vessel anomalies, including those in regions undetectable by CT (Computed tomography) scans. Advanced technology is making medical imaging crucial in emergencies, with faster scans and better stroke detection. Therefore, MRI and/or fMRI remain the best imaging technologies for detecting strokes.
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... In a study of Petzl et al. using conventional RF energy or cryoballoon for PVI, the authors found an increased incidence of SCE for uninterrupted NOAC patients (16%) compared with VKA (9.2%) [20]. However, other trials have failed to show differences in SCE between these groups [12]. ...
Uninterrupted use of direct oral anticoagulants versus vitamin K antagonists for catheter ablation of atrial fibrillation with PVAC gold: incidence of silent cerebral microembolic events
Article
Full-text available
  • Oct 2021
  • J INTERV CARD ELECTR
Background: Silent cerebral microembolic events (SCE) after duty-cycled ablation of atrial fibrillation using PVAC have been detected by cerebral magnet resonance imaging (MRI) in a substantial number of patients. The purpose of this study was to investigate if uninterrupted oral anticoagulation with non-vitamin K antagonists (NOACs) compared with vitamin K antagonists (VKA) affects the incidence of SCE after pulmonary vein isolation (PVI) using PVAC Gold. Methods: Eighty-four consecutive patients (62 ± 15 years, 58% male) undergoing a first PVI were prospectively enrolled. Of these, 42 were on VKA and 42 on uninterrupted NOAC treatment. An activated clotting time (ACT) ≥ 350 s was targeted for ablation. Results: Cerebral MRI the day after PVI revealed acute diffusion-weighted positive lesions in 11/42 (26%) VKA compared with 14/42 (33%) in NOAC patients (p = 0.634). No differences were found for lesion size, number of lesions/patient, and number of lesions indicating cerebral infarction (2.4% for VKA and 4.8% for NOAC patients). Seventy-five percent of NOAC patients with sporadic ACT levels < 300 s during PVI developed SCE compared with 22% of corresponding VKA patients (p = 0.030). VKA and NOAC subgroups with ACT ≥ 350 s had no reduced incidence of SCE compared with ACT 300-350 s. Conclusions: A significant, but comparable, number of patients under uninterrupted anticoagulation with VKA or NOACs still experience SCE after PVAC Gold PVI. NOAC patients with sporadic subtherapeutic ACT levels during PVI are at the highest risk for SCE while permanent ACT levels ≥ 350 s did not further reduce the incidence of SCE in both groups.
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Microembolizations in the Arterial Cerebral Circulation during Atrial Fibrillation Ablation: Cryoballoon Technique Advantages and Neurocognitive Safety - Results of a Prospective Observational Study
Article
  • Aug 2024
  • EUROPACE
Aims The significance of micro-embolic signals (MESs) during atrial fibrillation (AF) ablation is unclear. Previous studies had limitations, and cryoballoon (CB) ablation patients were under-represented. Minimizing MESs is recommended due to their uncertain neurocognitive impact. Methods and results This prospective observational study included AF patients from a German centre between February 2021 and August 2022. Patients were equally divided into paroxysmal (Group A) and persistent (Group B) AF. Group A received cryoballoon-pulmonary vein isolation only, while Group B also had left atrial roof ablation. MESs were detected using transcranial Doppler ultrasonography during ablation. Neurocognitive status was assessed pre- and post-procedure and at 3 months using the CERAD Plus battery. The study analyzed 100 patients with a median age of 65.5 years. A total of 19 698 MESs were observed, with 80% being gaseous and 20% solid in origin, primarily occurring during pulmonary vein angiography and the balloon freeze and thawing phase. The median MES per patient was 130 (IQR: 92–256) in total, 298 (IQR: 177–413) in bilateral (36%), and 110 (IQR: 71–130) in unilateral (64%) recordings. No significant difference in total MES counts was found between the groups. None of the 11 neuropsychological tests showed cognitive decline post-procedure or at 3 months. Conclusion Our observations confirm that neurocognitive abilities are not affected either 24 h or 3 months after AF ablation using the CB technique. However, despite the low MES burden associated with the CB, more work is needed to reduce small embolic events during AF ablation.
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Atrial fibrillation catheter ablation associated silent cerebral emboli: A narrative review
Article
  • Aug 2023
  • PACE
The incidence of silent cerebral emboli (SCE) associated with atrial fibrillation catheter ablation (AFCA) is much higher than that of stroke/transient ischemic attack (TIA). Interventional electrophysiologists have been increasingly alerted to asymptomatic cerebral infarction over the years. Plentiful studies revealed that diagnostic definitions, detection modalities, energy sources, ablation strategies, perioperative anticoagulation regimens, and patient-related factors were associated with the risk of AFCA-associated SCE. Studies related to non-interventional procedures found that SCE may prompt stroke, cognitive decline, and dementia later in life, suggesting a possible role of AFCA-associated SCE in the cognitive function of patients with AF. However, there is no consistent evidence for this view to date. Given that the majority of patients with AF being elderly and the increased risk of cognitive impairment in AF itself, efforts should be made to minimize the occurrence of AFCA-associated SCE.
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Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias
Article
  • Oct 2021
  • COCHRANE DB SYST REV
Background: The management of anticoagulation therapy around the time of catheter ablation (CA) procedure for adults with arrhythmia is critical and yet is variable in clinical practice. The ideal approach for safe and effective perioperative management should balance the risk of bleeding during uninterrupted anticoagulation while minimising the risk of thromboembolic events with interrupted therapy. Objectives: To compare the efficacy and harms of interrupted versus uninterrupted anticoagulation therapy for catheter ablation (CA) in adults with arrhythmias. Search methods: We searched CENTRAL, MEDLINE, Embase, and SCI-Expanded on the Web of Science for randomised controlled trials on 5 January 2021. We also searched three registers on 29 May 2021 to identify ongoing or unpublished trials. We performed backward and forward searches on reference lists of included trials and other systematic reviews and contacted experts in the field. We applied no restrictions on language or publication status. Selection criteria: We included randomised controlled trials comparing uninterrupted anticoagulation with any modality of interruption with or without heparin bridging for CA in adults aged 18 years or older with arrhythmia. Data collection and analysis: Two review authors conducted independent screening, data extraction, and assessment of risk of bias. A third review author resolved disagreements. We extracted data on study population, interruption strategy, ablation procedure, thromboembolic events (stroke or systemic embolism), major and minor bleeding, asymptomatic thromboembolic events, cardiovascular and all-cause mortality, quality of life (QoL), length of hospital stay, cost, and source of funding. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We identified 12 studies (4714 participants) that compared uninterrupted periprocedural anticoagulation with interrupted anticoagulation. Studies performed an interruption strategy by either a complete interruption (one study) or by a minimal interruption (11 studies), of which a single-dose skipped strategy was used (nine studies) or two-dose skipped strategy (two studies), with or without heparin bridging. Studies included participants with a mean age of 65 years or greater, with only two studies conducted in relatively younger individuals (mean age less than 60 years). Paroxysmal atrial fibrillation (AF) was the primary type of AF in all studies, and seven studies included other types of AF (persistent and long-standing persistent). Most participants had CHADS2 or CHADS2-VASc demonstrating a low-moderate risk of stroke, with almost all participants having normal or mildly reduced renal function. Ablation source using radiofrequency energy was the most common (seven studies). Ten studies (2835 participants) were conducted in East Asian countries (Japan, China, and South Korea), while the remaining two studies were conducted in the USA. Eight studies were conducted in a single centre. Postablation follow-up was variable among studies at less than 30 days (three studies), 30 days (six studies), and more than 30 days postablation (three studies). Overall, the meta-analysis showed high uncertainty of the effect between the interrupted strategy compared to uninterrupted strategy on the primary outcomes of thromboembolic events (risk ratio (RR) 1.76, 95% confidence interval (CI) 0.33 to 9.46; I2 = 59%; 6 studies, 3468 participants; very low-certainty evidence). However, subgroup analysis showed that uninterrupted vitamin A antagonist (VKA) is associated with a lower risk of thromboembolic events without increasing the risk of bleeding. There is also uncertainty on the outcome of major bleeding events (RR 1.10, 95% CI 0.59 to 2.05; I2 = 6%; 10 studies, 4584 participants; low-certainty evidence). The uncertainty was also evident for the secondary outcomes of minor bleeding (RR 1.01, 95% CI 0.46 to 2.22; I2 = 87%; 9 studies, 3843 participants; very low-certainty evidence), all-cause mortality (RR 0.34, 95% CI 0.01 to 8.21; 442 participants; low-certainty evidence) and asymptomatic thromboembolic events (RR 1.45, 95% CI 0.85 to 2.47; I2 = 56%; 6 studies, 1268 participants; very low-certainty evidence). There was a lower risk of the composite endpoint of thromboembolic events (stroke, systemic embolism, major bleeding, and all-cause mortality) in the interrupted compared to uninterrupted arm (RR 0.23, 95% CI 0.07 to 0.81; 1 study, 442 participants; low-certainty evidence). In general, the low event rates, different comparator anticoagulants, and use of different ablation procedures may be the cause of imprecision and heterogeneity observed. Authors' conclusions: This meta-analysis showed that the evidence is uncertain to inform the decision to either interrupt or continue anticoagulation therapy around CA procedure in adults with arrhythmia on outcomes of thromboembolic events, major and minor bleeding, all-cause mortality, asymptomatic thromboembolic events, and a composite endpoint of thromboembolic events (stroke, systemic embolism, major bleeding, and all-cause mortality). Most studies in the review adopted a minimal interruption strategy which has the advantage of reducing the risk of bleeding while maintaining a lower level of anticoagulation to prevent periprocedural thromboembolism, hence low event rates on the primary outcomes of thromboembolism and bleeding. The one study that adopted a complete interruption of VKA showed that uninterrupted VKA reduces the risk of thromboembolism without increasing the risk of bleeding. Hence, future trials with larger samples, tailored to a more generalisable population and using homogeneous periprocedural anticoagulant therapy and ablation source are required to address the safety and efficacy of the optimal management of anticoagulant therapy prior to ablation.
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MRI-detected brain lesions in AF patients without further stroke risk factors undergoing ablation - A retrospective analysis of prospective studies
Article
Full-text available
  • Mar 2019
  • BMC Cardiovasc Disord
Background Atrial fibrillation (AF) without other stroke risk factors is assumed to have a low annual stroke risk comparable to patients without AF. Therefore, current clinical guidelines do not recommend oral anticoagulation for stroke prevention of AF in patients without stroke risk factors. We analyzed brain magnetic resonance imaging (MRI) imaging to estimate the rate of clinically inapparent (“silent”) ischemic brain lesions in these patients. Methods We pooled individual patient-level data from three prospective studies comprising stroke-free patients with symptomatic AF. All study patients underwent brain MRI within 24–48 h before planned left atrial catheter ablation. MRIs were analyzed by a neuroradiologist blinded to clinical data. Results In total, 175 patients (median age 60 (IQR 54–67) years, 32% female, median CHA2DS2-VASc = 1 (IQR 0–2), 33% persistent AF) were included. In AF patients without or with at least one stroke risk factor, at least one silent ischemic brain lesion was observed in 4 (8%) out of 48 and 10 (8%) out of 127 patients, respectively (p > 0.99). Presence of silent ischemic brain lesions was related to age (p = 0.03) but not to AF pattern (p = 0.77). At least one cerebral microbleed was detected in 5 (13%) out of 30 AF patients without stroke risk factors and 25 (25%) out of 108 AF patients with stroke risk factors (p = 0.2). Presence of cerebral microbleeds was related to male sex (p = 0.04) or peripheral artery occlusive disease (p = 0.03). Conclusion In patients with symptomatic AF scheduled for ablation, brain MRI detected silent ischemic brain lesions in approximately one in 12 patients, and microbleeds in one in 5 patients. The prevalence of silent ischemic brain lesions did not differ in AF patients with or without further stroke risk factors. Electronic supplementary material The online version of this article (10.1186/s12872-019-1035-1) contains supplementary material, which is available to authorized users.
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Non–Vitamin K Antagonist Oral Anticoagulants for Mechanical Heart Valves: Is the Door Still Open?
Article
Full-text available
  • Sep 2018
The estimated prevalence of mitral or aortic valvular heart disease is ≈2.5% in the general population of Western countries, and is expected to rise with population aging. A substantial proportion of patients with valvular heart disease undergoes surgical valve replacement. Mechanical heart valves are much more durable than bioprostheses, and are thus preferentially implanted in patients with a longer life expectancy, but have the major drawback of requiring lifelong anticoagulation to prevent valve thrombosis because of their higher thrombogenicity. The non-vitamin K antagonist oral anticoagulants (NOACs) are replacing vitamin K antagonists in many settings, including bioprostheses, because of their favorable safety and efficacy profiles. However, mechanical heart valves currently pose an absolute contraindication to NOACs based on the results of a single phase II study comparing dabigatran and warfarin (RE-ALIGN [Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement]). That trial was stopped prematurely because of an excess of both stroke and bleeding with the dabigatran doses tested. Because of such negative findings, research in this area has been halted. We believe that several aspects of both the preclinical studies and the RE-ALIGN trial should be critically reevaluated. In our opinion, 1 single trial with a single NOAC does not represent sufficient evidence for dismissing a therapeutic strategy, anticoagulation with NOACs, that has shown better safety and at least similar efficacy as warfarin in the setting of atrial fibrillation and venous thromboembolism,. Herein, we reevaluate this topic to identify the patient profile that has the greatest likelihood of benefit from some of the NOACs, with a focus on factor Xa inhibitors, thus providing some perspectives for basic and translational research.
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The 2018 European Heart Rhythm Association Practical Guide on the use of non-Vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Executive summary
Article
Full-text available
  • Mar 2018
The current manuscript is the Executive Summary of the second update to the original Practical Guide, published in 2013. Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF), and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. The European Heart Rhythm Association (EHRA) set out to co-ordinate a unified way of informing physicians on the use of the different NOACs. A writing group identified 20 topics of concrete clinical scenarios for which practical answers were formulated, based on available evidence. The 20 topics are (i) eligibility for NOACs; (ii) practical start-up and follow-up scheme for patients on NOACs; (iii) ensuring adherence to prescribed oral anticoagulant intake; (iv) switching between anticoagulant regimens; (v) pharmacokinetics and drug–drug interactions of NOACs; (vi) NOACs in patients with chronic kidney or advanced liver disease; (vii) how to measure the anticoagulant effect of NOACs; (viii) NOAC plasma level measurement: rare indications, precautions, and potential pitfalls; (ix) how to deal with dosing errors; (x) what to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a potential risk of bleeding; (xi) management of bleeding under NOAC therapy; (xii) patients undergoing a planned invasive procedure, surgery or ablation; (xiii) patients requiring an urgent surgical intervention; (xiv) patients with AF and coronary artery disease; (xv) avoiding confusion with NOAC dosing across indications; (xvi) cardioversion in a NOAC-treated patient; (xvii) AF patients presenting with acute stroke while on NOACs; (xviii) NOACs in special situations; (xix) anticoagulation in AF patients with a malignancy; and (xx) optimizing dose adjustments of VKA. Additional information and downloads of the text and anticoagulation cards in different languages can be found on an EHRA web site (www.NOACforAF.eu).
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Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation
Article
Full-text available
  • Jun 2018
  • CLIN RES CARDIOL
IntroductionThe aim of this study was to compare second-generation cryoballoon and contact-force radiofrequency point-by-point pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients with regard to pulmonary vein reconnection and arrhythmia-free survival. Methods and resultsAltogether, 269 consecutive patients with drug-refractory AF undergoing PVI were included and randomly allocated to second-generation cryoballoon or contact-force point-by-point radiofrequency ablation. Median follow-up duration was 389 days (interquartile range 219–599). Mean age was 59 years (71% male); 136 patients underwent cryoballoon and 133 patients underwent radiofrequency ablation. Acute electrical PVI was 100% for both techniques. Procedure duration was significantly shorter in cryoballoon vs radiofrequency (166.5 vs 184.13 min P = 0.016). Complication rates were similar (6.0 vs 6.7%, P = 1.00). Single procedure freedom of atrial arrhythmias was significantly higher in cryoballoon as compared to radiofrequency (75.2 vs 57.4%, P = 0.013). In multivariate analysis, persistent AF, AF duration, and cryoballoon ablation were associated with freedom of atrial tachyarrhythmias. The number of repeat ablation procedures was significantly lower in the cryoballoon compared to radiofrequency (15.0 vs 24.3%, P = 0.045). At repeat ablation, pulmonary vein reconnection rate was significantly lower after cryoballoon as compared to radiofrequency ablation (36.8 vs 58.1%, P = 0.003). Conclusions Improved arrhythmia-free survival and more durable pulmonary vein isolation is seen after PVI using second-generation cryoballoon as compared to contact-force radiofrequency, in patients with drug-refractory paroxysmal AF. Complication rates for both ablation techniques are low.
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Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events
Article
  • Jun 2018
Aims This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF). Methods and results We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428). Conclusion Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.
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Continuous and minimally-interrupted direct oral anticoagulant are both safe compared with vitamin K antagonist for atrial fibrillation ablation: An updated meta-analysis
Article
  • Mar 2018
  • INT J CARDIOL
Background The appropriate and safe peri-procedural anticoagulation schedule for patients on a direct oral anticoagulant (DOAC) undergoing AF ablation is not known. We aimed to evaluate the safety and efficacy of both continuous and minimally-interrupted novel oral anticoagulant (DOAC) strategies compared with uninterrupted vitamin K antagonist (VKA) for atrial fibrillation (AF) ablation. Methods We searched electronic databases for randomized or prospective controlled observational studies comparing DOAC (continuous or interrupted) versus uninterrupted VKA. The primary endpoint was major bleeding. Secondary endpoints were total bleeding (composite of major and minor bleeding) and symptomatic thromboembolism. Data were analyzed by random-effects modeling and sensitivity analyses performed according to study design and peri-procedural DOAC schedule. Results Thirteen studies (4 randomized, 9 observational) with 5463 patients were included in final analysis (45% on DOAC). DOAC was associated with less major bleeding compared with VKA in pooled randomized studies (odds ratio [OR] 0.27, 95% confidence interval [CI] 0.09–0.80, p = 0.03, I² = 0%), however there was no difference on overall analyses (OR 0.70, 95% CI 0.39–1.24, p = 0.22, I² = 27%). When stratified by DOAC dose schedule, there was no difference in major bleeding for continuous DOAC (OR 0.48, 95% CI 0.21–1.11, p = 0.09, I² = 6%) or minimally-interrupted DOAC (OR 0.81, 95% CI 0.37–1.76, p = 0.60, I² = 43%) compared with VKA. There was no difference between DOAC and VKA for risk of total bleeding (p = 0.20) or symptomatic thromboembolism (p = 0.78). Conclusion Continuous and minimally-interrupted DOAC are both safe and non-inferior peri-procedural anticoagulation strategies compared with uninterrupted VKA for AF ablation. DOAC in general is associated with reduced major bleeding as demonstrated in pooled randomized studies.
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Silent Cerebral Events after Atrial Fibrillation Ablation – Overview and Current Data
Article
  • Feb 2014
Silent cerebral lesions (SCL) have been identified on brain magnetic resonance imaging (MRI) in apparently asymptomatic patients after cardiovascular procedures. After atrial fibrillation (AF) ablation incidences range from 1 to over 40% depending upon different factors. MRI definition should include diffusion weighted imaging (DWI) to detect hyperintensities (bright spots) due to acute brain ischemia correlated with a hypointensity in the apparent diffusion coefficient mapping (ADC-map) to rule out artifacts. The genesis of SCL appears to be multifactorial and appears to be a result of embolic events either from gaseous or solid particles. The MRI pattern appears to be comparable not hinting towards a specific mechanism. One may distinguish two different MRI definition: one, more sensitive, for silent ischemic events (SCE) not proven to be related to cell death (DWI positive but FLAIR negative); and one for SCL that are due to edema caused by cell death which will lead to glial cell scar formation (DWI positive and FLAIR positive). For ease of data interpretation, future studies should ensure both definitions, and that DWI and FLAIR data is acquired using identical slice thickness and orientation. Risk factors associated with increased SCL-incidences involve patient-specific, technology-associated and procedural determinants. When using a high-sensitive MRI definition differences in SCE-rates in between technologies appear to be less prominent. Further studies on the effects of different periprocedural anticoagulation regimen, different steps of the ablation procedure and new technologies are needed. For now, SCL incidence may determine the thrombogenic potential of an ablation technology and further studies to reduce or avoid SCL generation are desirable. It appears reasonable, that any SCE should be avoided.
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Incidence and predictors of silent cerebral thromboembolic lesions after catheter ablation for atrial fibrillation in patients treated with direct oral anticoagulants
Article
  • May 2017
There are few reports about the incidence and predictors of silent cerebral thromboembolic lesions (SCLs) after atrial fibrillation (AF) ablation in patients treated with direct oral anticoagulants (DOACs). The purpose of this study is to evaluate the incidence and predictors of SCLs after AF ablation with cerebral magnetic resonance imaging (C-MRI) in patients treated with DOACs. We enrolled 117 consecutive patients who underwent first AF ablation and received DOACs, including apixaban, dabigatran, edoxaban, and rivaroxaban. DOACs were discontinued after administration 24 h before the procedure, and restarted 6 h after the procedure. During the procedure, activated clotting time (ACT) was measured every 15 min, and intravenous heparin infusion was performed to maintain ACT at 300–350 s. All patients underwent C-MRI the day after the procedure. SCLs were detected in 28 patients (24%) after AF ablation. Age, female sex, the presence of persistent AF, left atrial volume, procedure time, radiofrequency energy, electrical cardioversion, and mean ACT showed no correlations with the incidence of SCLs. Multivariate analysis revealed independent predictors of SCLs were CHA2DS2VASc scores ≥3, left atrial appendage (LAA) emptying velocity ≤39 cm/s, and minimum ACT ≤260 s. Patients with both CHA2DS2VASc scores ≥3 and LAA flow velocity ≤39 cm/s had the highest incidence of SCLs 15 of 26 patients (58%). In patients treated with DOACs, CHA2DS2VASc score ≥3, minimum ACT ≤260 s, and LAA emptying velocity ≤39 cm/s were independent risk factors for the SCLs after AF ablation.
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