Catheter ablation for atrial fibrillation on uninterrupted direct oral anticoagulants: A safe approach.

BACKGROUND: Current consensus guidelines suggest direct oral anticoagulants (DOACs) are interrupted periprocedurally for catheter ablation (CA) of atrial fibrillation (AF). However, this may predispose patients to thromboembolic complications. This study investigates the safety of CA for AF on uninterrupted DOACs compared to uninterrupted warfarin. METHODS: This was a single-center, retrospective study of consecutive patients undergoing CA for AF. All patients were heparinized prior to transseptal puncture with a target-activated clotting time (ACT) of 300-350 seconds. Patients who had procedures performed on continuous DOAC were compared to those on continuous warfarin. Clinical, procedural data, and complications occurring up to 3 months were analyzed from a prospective registry with additional review of electronic health records. RESULTS: A total of 1,884 procedures were performed over 28 months: 761 (609 patients) on uninterrupted warfarin and 1,123 (900 patients) on uninterrupted DOAC (rivaroxaban 64%, apixaban 32%, and dabigatran 4%). There was no difference in the composite endpoint of death, thromboembolism, or major bleeding complication (2.2% vs 1.4%, P = 0.20). There was no difference in the complications comprising this, including tamponade, hematoma, pseudoaneurysm, and transfusion (P-values 0.28, 0.13, 0.45, and 0.36). There were no strokes, transient ischemic attacks, or other thromboembolic complications. There was no difference between groups in the proportion of tamponades requiring reversal of oral anticoagulation, the volume of blood lost, the proportion transfused, or the proportion drained percutaneously (P-values 0.50, 0.51, 0.36, and 0.38). CONCLUSION: Catheter ablation for AF can be performed safely and effectively in patients anticoagulated with DOACs and heparinized with a therapeutic ACT. There is no increased risk of periprocedural bleeding when compared to uninterrupted warfarin.

Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboemolic events--European Registry in Atrial Fibrillation (PREFER in AF).

AIMS: We sought to describe the management of patients with atrial fibrillation (AF) in Europe after the release of the 2010 AF Guidelines of the European Society of Cardiology. METHODS AND RESULTS: The PREFER in AF registry enrolled consecutive patients with AF from January 2012 to January 2013 in 461 centres in seven European countries. Seven thousand two hundred and forty-three evaluable patients were enrolled, aged 71.5 ± 11 years, 60.1% male, CHA2DS2VASc score 3.4 ± 1.8 (mean ± standard deviation). Thirty per cent patients had paroxysmal, 24.0% had persistent, 7.2% had long-standing persistent, and 38.8% had permanent AF. Oral anticoagulation was used in the majority of patients: 4799 patients (66.3%) received a vitamin K antagonist (VKA) as mono-therapy, 720 patients a combination of VKA and antiplatelet agents (9.9%), 442 patients (6.1%) a new oral anticoagulant drugs (NOAC). Antiplatelet agents alone were given to 808 patients (11.2%), no antithrombotic therapy to 474 patients (6.5%). Of 7034 evaluable patients, 5530 (78.6%) patients were adequately rate controlled (mean heart rate 60-100 bpm). Half of the patients (50.7%) received rhythm control therapy by electrical cardioversion (18.1%), pharmacological cardioversion (19.5%), antiarrhythmic drugs (amiodarone 24.1%, flecainide or propafenone 13.5%, sotalol 5.5%, dronedarone 4.0%), and catheter ablation (5.0%). CONCLUSION: The management of AF patients in 2012 has adapted to recent evidence and guideline recommendations. Oral anticoagulant therapy with VKA (majority) or NOACs is given to over 80% of eligible patients, including those at risk for bleeding. Rate is often adequately controlled, and rhythm control therapy is widely used.

Three-dimensional localization versus fluoroscopically only guided ablations: a meta-analysis.

OBJECTIVES: Data regarding efficacy and safety of three-dimensional localization systems (3D) are limited. We performed a meta-analysis of randomized trials comparing combined fluoroscopy- and 3D guided to fluoroscopically-only guided procedures. DESIGN: A systematic search was performed using multiple databases between 1990 and 2010. Outcomes were acute and long-term success, ablation, procedure and fluoroscopic times, radiation dose (RD), and complications. RESULTS: Thirteen studies involving 1292 patients were identified. 3D were tested against fluoroscopic guidance in 666 patients for supraventricular tachycardia (SVT), atrial flutter (AFL), atrial fibrillation (AF), and ventricular tachycardia (VT). Acute and long-term freedom from arrhythmia was not significantly different between 3D and control for AFL (acute success, 97% vs. 93%, p = 0.57; chronic success, 93% vs. 96%, p = 0.90) or for SVT (acute success, 94% vs. 100%, p = 0.36; chronic success, 88% vs. 88%, p = 0.80). A shorter fluoroscopic time was achieved with 3D in AFL (p < 0.001) and in SVT (p = 0.002). RD was significantly less for both AFL (p = 0.002) and SVT (p = 0.01). Ablation and procedure time and complications were not statistically different. CONCLUSIONS: Success, procedure time, and complications were similar between fluoroscopy- and 3D-guided ablations. Fluoroscopic time and RD were significantly reduced for ablation of AFL and SVT with 3D.

Are patients admitted to emergency departments with regular supraventricular tachycardia (SVT) treated appropriately?

Regular supraventricular tachycardia (SVT) is frequently encountered in clinical practice. Guidelines are available from the National Service Framework (NSF) for the treatment of patients attending emergency departments (ED) with SVT. These recommend a thyroid-function test (TFT) and arrhythmia electrocardiography (ECG), and referral to a heart-rhythm specialist on discharge. Hospital admission is rarely required. In our multicentre study, we examined the implementation of these guidelines among patients attending the ED with SVT. Only 34% of patients had specialist referrals, with an average wait of 50.3 days (the majority of delays resulted from referral requests from general practitioners). A history of previous SVT, the mode of tachycardia termination, patient age and/or comorbidities were similar for the 27 (23.5%) patients who were admitted overnight. Of these, 15 (13%) of the total 115 patients who attended ED with regular SVT were referred for Holter monitoring despite having ECGs demonstrating arrhythmia. Low referral rates, unnecessary investigations and admissions indicate a need for improvement for better patient care and to minimise healthcare costs. We have formulated a standard operating procedure, which will be available via the College of Emergency Medicine website.

Impact of Type-2 Diabetes Mellitus on the Outcomes of Catheter Ablation of Atrial Fibrillation (European Observational Multicentre Study).

Type-2 diabetes mellitus (DM) is associated with an increased risk of atrial fibrillation (AF). It is unclear whether DM is a risk factor for arrhythmia recurrence following catheter ablation of AF. We performed a nonrandomised, observational study in 7 high-volume European centres. A total of 2,504 patients who underwent catheter ablation of AF were included, and procedural outcomes were compared among patients with or without DM. Patients with DM (234) accounted for 9.3% of the sample, and were significantly older, had a higher BMI and suffered more frequently from persistent AF. Arrhythmia relapses at 12 months after AF ablation occurred more frequently in the DM group (32.0% vs 25.3%, p = 0.031). After adjusting for type of AF (i.e., paroxysmal vs persistent), during a median follow-up of 17 ± 16 months, atrial arrhythmia free-survival was lower in the diabetics with persistent AF (log-rank p = 0.003), and comparable for paroxysmal AF (log-rank p = 0.554). These results were confirmed in a propensity-matched analysis, and DM was also an independent predictor of AF recurrence on the multivariate analysis (hazard ratio 1.39; 95% confidence interval 95%1.07 to 1.88; p = 0.016). There was no significant difference in the rate of periprocedural complications among DM and non-DM patients (3.8% vs 6.3%, p = 0.128). Efficacy and safety of cryoballoon ablation were comparable to radiofrequency ablation in both DM and no-DM groups. In conclusion, catheter ablation of AF appears to be safe in patients with DM. However, DM is associated with higher rate of atrial arrhythmia relapse, particularly for patients with persistent AF.

Percutaneous permanent pacemaker implantation via the azygous vein in a patient with superior vena cava occlusion.

Occlusion of the superior vena cava (SVCO) makes implantation of permanent pacemakers challenging and difficult. We describe an extended application of a Medtronic Attain (Medtronic Inc., Minneapolis, MN, USA) guide catheter (a tool designed for delivery of left ventricular pacing leads into the coronary sinus) for delivery of a right ventricular pacing lead via the azygous vein in a 72-year-old woman with SVCO secondary to long-term central venous hemodialysis catheters. This approach allowed the use of an endocardial pacing lead, implantation under local anesthesia, and conventional positioning of the pacemaker generator in the pectoral region in a patient with SVCO.

Quality of life and patient satisfaction in patients with atrial fibrillation on stable vitamin K antagonist treatment or switched to a non-vitamin K antagonist oral anticoagulant during a 1-year follow-up: A PREFER in AF Registry substudy.

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are being introduced for stroke prevention in non-valvular Atrial Fibrillation (AF), and promise to be accepted better than Vitamin K Antagonists (VKAs) by patients, improving their Quality of Life (QoL). AIM: To assess to what extent patient-related factors influence decisions to switch from a VKA to a NOAC. METHODS: The PREFER in AF Registry collected data at baseline in 2012 - at the beginning of NOAC prescriptions - and at 1-year follow-up, in 6412 patients in seven Western European countries. QoL and patient satisfaction questionnaires (EQ-5D-5L and/or PACT-Q2) were completed in 3777 patients at both visits. Data were compared across categories of patients on stable treatment with a VKA (i.e. continuously over the previous 12 months) (n=2102) or recently switched (within 12 months) from a VKA to a NOAC (n=213) during a 1-year follow-up, allowing a snapshot of factors influencing the switch at a time when NOACs were being introduced into the market. RESULTS: Compared to patients on stable treatment with a VKA, switched patients were similar in terms of age, sex, body mass index and other risk factors, but had lower prevalences of hypertension and heart valve dysfunction, and a lower rate of use of concomitant treatment with antiplatelet/anti-inflammatory agents; they also had a lower CHA2DS2-VASc score. Among 25 features investigated, switched patients more often reported bruising or bleeding, complained about bruising, were dissatisfied with the anticoagulant treatment, and reported mobility problems and anxiety/depressive traits. CONCLUSIONS: At the beginning of NOAC prescriptions, European doctors tended to switch from VKAs to NOACs those patients at lower risk than "non-switchers". Complaints about bruising or bleeding, dissatisfaction with treatment, mobility problems and anxiety/depression traits appear to be related to - and may have influenced - the choice to switch from a VKA to a NOAC.

Characteristics and outcomes of atrial fibrillation patients with or without specific symptoms: results from the PREFER in AF registry.

Aims: Atrial fibrillation (AF) is a common condition that is a major cause of stroke. A significant proportion of patients with AF are not classically symptomatic at diagnosis or soon after diagnosis. There is little information comparing their characteristics, treatment, and outcomes of patients with symptoms, which predominate in clinical trials to those without. Methods and results: We analysed data from the Prevention of Thromboembolic Events-European Registry in Atrial Fibrillation. This was a prospective, real-world registry with a 12-month follow-up that included AF patients aged 18 years and over. Patients were divided into those with and without AF symptoms using the European Heart Rhythm Association (EHRA) score (Category I vs. Categories II-IV). Of the 6196 patients (mean age 72 years) with EHRA scores available, 501 (8.1%) were asymptomatic. A lower proportion of asymptomatic patients was female (22.8 vs. 41.2%), with less noted to have heart failure and coronary artery disease (P < 0.01 for all). There were no differences in terms of the prevalence of diabetes, obesity, or prior stroke. Asymptomatic patients had a lower CHA2DS2-VASc score (2.9 ± 1.7 vs. 3.4 ± 1.8; P < 0.01) and HAS-BLED score (1.8 ± 1.1 vs. 2.1 ± 1.2; P < 0.01). During the 1-year follow-up, adverse events occurred at similar frequencies in asymptomatic and symptomatic patients (1.6 vs. 0.8% for ischaemic stroke; P = 0.061; 1.4 vs. 1.3% for transient ischaemic attack; P = 0.840). Patients with higher CHA2DS2-VASc and HAS-BLED scores experienced more events, independent of symptoms. Antithrombotic therapy was comparable for both groups at baseline and at follow-up. Conclusions: The similar clinical characteristics and frequency of adverse events between asymptomatic and symptomatic AF patients revives the question of whether screening programmes to detect people with asymptomatic AF are worthwhile, particularly in those aged 65 and over potentially likely to have clinical and economic benefits from anticoagulants. This evidence may be informative if clinicians may not be comfortable participating in future clinical trials, leaving asymptomatic patients with AF and high stroke risk without anticoagulation.

Differences among western European countries in anticoagulation management of atrial fibrillation. Data from the PREFER IN AF registry.

Due to improved implementation of guidelines, new scoring approaches to improve risk categorisation, and introduction of novel oral anticoagulants, medical management of patients with atrial fibrillation (AF) is continuously improving. The PREFER in AF registry enrolled 7,243 consecutive patients with ECG-confirmed AF in seven European countries in 2012-2013 (mean age: 71.5 ± 10.7 years; 60.1% males; mean CHA2DS2-VASc score: 3.4). While patient characteristics were generally homogeneous across countries, anticoagulation management showed important differences: the proportion of patients taking vitamin K antagonists (VKAs) varied between 86.0% (in France) and 71.4% (in Italy). Warfarin was used predominantly in the UK and Italy (74.9% and 62.0%, respectively), phenprocoumon in Germany (74.1%), acenocoumarol in Spain (67.3%), and fluindione in France (61.8 %). The major sites for international normalised ratio (INR) measurements were biology laboratories in France, anticoagulation clinics in Italy, Spain, and the UK, and physicians' offices or self-measurement in Germany. Temporary VKA discontinuation and bridging with other anticoagulants was frequent (at least once in the previous 12 months for 22.9% of the patients, on average; ranging from 29.7% in Germany to 14.9% in the UK). Time in therapeutic range (TTR), defined as at least two of the last three available INR values between 2.0-3.0 prior to enrolment, ranged from 70.3% in Spain to 81.4% in Germany. TTR was constantly overestimated by physicians. While the type and half-lives of VKA as well as the mode of INR surveillance differed, overall quality of anticoagulation management by TTR was relatively homogenous in AF patients across countries.

Frequent and possibly inappropriate use of combination therapy with an oral anticoagulant and antiplatelet agents in patients with atrial fibrillation in Europe.

PURPOSE: Combined oral anticoagulant (OAC) and antiplatelet (AP) therapy is generally discouraged in atrial fibrillation (AF) outside of acute coronary syndromes or stenting because of increased bleeding. We evaluated its frequency and possible reasons in a contemporary European AF population. METHODS: The PREvention oF thromboembolic events-European Registry in Atrial Fibrillation (PREFER in AF) prospectively enrolled AF patients in France, Germany, Austria, Switzerland, Italy, Spain and the UK from January 2012 to January 2013. We evaluated patterns of combined VKA-AP therapy in this population. RESULTS: Out of 7243 patients enrolled, 5170 (71.4%) were treated with OAC alone, 808 (11.2%) with AP alone and 791 (10.9%) with a combination of OAC and one (dual) or two AP (triple combination therapy). Compared with patients only prescribed OAC, patients on combination treatment had similar Body Mass Index, but more frequently diabetes (p<0.05), dyslipidaemia (p<0.01), coronary heart disease (54.2 vs 18.6%; p<0.01) or peripheral arterial disease (10.2 vs 3.7%; p<0.01). Accordingly, they had a higher mean CHA2DS2VASc (3.7 vs 3.4), and HAS-BLED (2.7 vs 1.9) scores (for both, p<0.01). Of the 660 patients on dual AP+OAC combination therapy, 629 (95.3%) did not have an accepted indication. Out of the 105 patients receiving triple combination therapy, 67 (63.8%) did not have an accepted indication. CONCLUSIONS: The combined use of OAC and AP therapy is not uncommon in AF, largely inappropriate, explained by the coexistence of coronary or peripheral arterial disease, and not influenced by considerations on the risk of bleeding.