Bayer Pharma AG

Essence of this Article

Catheter ablation is a minimally invasive technique performed to re-establish a normal sinus rhythm in patients with atrial fibrillation by destroying the cardiac tissue responsible for the arrhythmia. Due to the periprocedural risk of stroke or transient ischaemic attack, current guidelines recommend catheter ablation under low-level anticoagulation with a vitamin K antagonist. Minimal evidence regarding the use of novel oral anticoagulants during AF ablation is available, but current data suggest no differences between novel oral anticoagulants and standard therapy in terms of the periablative risk of bleeding or thromboembolic complications. Phase III clinical trials investigating novel oral anticoagulants in this setting are ongoing and will provide more evidence on the optimal periprocedural management of patients undergoing catheter ablation.

Atrial Fibrillation Ablation

Ablation procedures are performed on patients with atrial fibrillation (AF) to attempt to restore a normal sinus rhythm by destroying the cardiac tissue responsible for the arrhythmia516

  • Traditional surgical ablation has reported efficacy rates of >90%; however, this procedure is technically difficult and involves open heart surgery517
  • More recently, minimally invasive surgical procedures that make use of energy sources, such as cryoablation and radiofrequency ablation with pulmonary vein isolation, have yielded success rates of up to approximately 80%517
  • Catheter ablation, another commonly employed and minimally invasive technique, is reported to be effective in approximately 80% of patients518

Catheter ablation is now the most popular of these techniques. However, the procedure is associated with an approximately 1% risk of stroke or transient ischaemic attack.518 Therefore, current guidelines recommend catheter ablation under low-level anticoagulation with a vitamin K antagonist (VKA).519

European Society of Cardiology recommendations for left atrial ablation4

Recommendation Grade of evidence
Catheter ablation is recommended in patients with symptomatic paroxysmal AF who experience symptomatic, recurrent AF on antiarrhythmic drug therapy and who instead prefer further rhythm-control therapy. This should be performed by an appropriately trained electrophysiologist at an experienced centre. IA
Catheter ablation of AF should target isolation of the pulmonary veins. IIA
Catheter ablation of AF should be considered as first-line therapy in selected patients with symptomatic paroxysmal AF as an alternative to antiarrhythmic drug therapy, taking into consideration patient choice, benefit and risk. IIB
When catheter ablation of AF is planned, continuation of oral anticoagulation with a vitamin K antagonist should be considered during the procedure, with a view to maintaining an international normalized ratio close to 2.0. IIB
When AF recurs within the first 6 weeks after catheter ablation, a watch-and-wait rhythm-control therapy should be considered. IIB

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AF, atrial fibrillation.

To date, there have been few studies regarding the use of novel oral anticoagulants during AF ablation. A single-centre retrospective study and a prospective registry found no difference between dabigatran and warfarin in terms of the periablative risk of bleeding or thromboembolic complications;520,521 however, patients receiving dabigatran took longer to reach the target activated clotting time compared with patients receiving uninterrupted warfarin.521

In a post hoc analysis of the phase III ROCKET AF study, outcomes associated with catheter ablation in 79 patients treated with warfarin and rivaroxaban were described.523 The authors noted that long-term outcomes (>30 days) were not statistically different between the treatment groups before and after ablation.523

The safety of rivaroxaban in patients with AF undergoing catheter ablation is being investigated in the prospective, randomized, open-label, active-controlled VENTURE-AF study (NCT01729871), which is expected to complete in December 2014

  • Up to 250 patients with paroxysmal or persistent non-valvular AF will receive rivaroxaban 20 mg once daily or dose-adjusted VKA (international normalized ratio 2.0–3.0) before and after ablation
  • During the catheter ablation procedure, patients will receive intravenous heparin. Patients in the rivaroxaban arm will receive their first post-procedure dose on the evening of the same day as the catheter ablation procedure, no sooner than 6 hours and no later than 12 hours after the establishment of adequate haemostasis. Patients in the VKA arm will receive their first post-procedure dose in accordance with usual care and as determined by the principal investigator or the patient’s physician.
  • The primary endpoint is the incidence of major bleeding during the 30±5 days after ablation. Secondary endpoints include the incidence of thromboembolic events

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