Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial.

BACKGROUND: The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed. OBJECTIVE: The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA). METHODS AND ANALYSIS: Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up. CONCLUSIONS: The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.

Pulmonary vein isolation using Ablation Index improves outcome in patients with atrial fibrillation.

AIMS: To evaluate the clinical outcome of pulmonary vein isolation (PVI) in radiofrequency ablation of atrial fibrillation (AF) comparing a strategy using Ablation Index (AI) and lesion contiguity with Contact Force (CF) only. METHODS: In a single-center retrospective design, we included 479 patients with AF (n=341 (71.2%) paroxysmal AF (PAF) and n=138 (28.8%) persistent AF (PeAF)) treated with first time radiofrequency ablation. In 2015, 210 patients underwent PVI based on a drag-and-ablate technique using CF only. In 2017, 269 patients underwent point-by-point PVI using AI and a maximum inter-lesion distance of 6 mm ensuring contiguity. Follow-up was performed after 12 months. Outcome was freedom from documented AF/atrial tachycardia (AT) after single procedure without use of anti-arrhythmic drugs at follow-up. RESULTS: There was no significant difference in baseline characteristics between the groups. The median procedure time and mean ablation time were significantly longer in the AI-group compared to the CF-group (131.5[113;156] min vs. 120.0[97;140] min, P < 0.01) and (44.1±10.0 min vs. 37.1±13.3 min, P < 0.01), respectively. Freedom from documented AF/AT was significantly higher in the AI-group compared to the conventional CF -group (71.0% vs. 62.4%, P = 0.046). The improvement in clinical outcome in the AI group is mainly driven by the outcome in patients with PeAF (64.9% vs. 50.0%, P = 0.078) and not PAF. CONCLUSIONS: An ablation strategy combining AI and lesion contiguity improves the clinical outcome after first time PVI in patients with AF compared to a strategy using CF only.

Symptomatic and asymptomatic atrial fibrillation after pulmonary vein ablation and the impact on quality of life.

BACKGROUND: The aim of this prospective study was to evaluate the recurrences of atrial fibrillation (AF) and flutter (AFL) after circumferential pulmonary vein ablation (CPVA) using repetitive long-term Holter recordings, and to evaluate the change in quality of life (QoL), especially in patients with asymptomatic AF recurrences. METHODS: A total of 149 patients with AF were followed up with 7-day Holter monitoring at 3, 6, and 12 months after CPVA. We calculated the burden of AF/AFL defined as the percentage of time in AF/AFL, and patients with documented arrhythmia were divided into isolated symptomatic episodes of arrhythmia, mixed symptomatic/asymptomatic arrhythmia, or isolated asymptomatic arrhythmia. The QoL was analyzed with SF-36 questionnaires in patients with sinus rhythm after CPVA, and in patients with recurrence of symptomatic and asymptomatic arrhythmia, respectively. RESULTS: Asymptomatic arrhythmia was observed in 44% of the patients with documented arrhythmia at 12 months of follow-up. In patients with persistent AF, 63% of the documented arrhythmia at 12 months of follow-up was asymptomatic and often persistent. In the subgroup of patients with asymptomatic arrhythmia, the QoL improved significantly in the physical scores, in contrast to patients with symptomatic arrhythmia who had unchanged or worsened QoL scores. CONCLUSIONS: Asymptomatic arrhythmia is very common after AF ablation. Our data indicate that these patients improve their physical component of the QoL significantly, which may be considered a palliative success of treatment. We suggest that patients with asymptomatic AF recurrences are carefully evaluated before considering reablation. Repetitive rhythm monitoring after AF ablation is very important considering the postablation management of anticoagulant therapy.

[Infrequent arrhythmia episodes diagnosed by a smartphone-based event recorder]. / Paroksystisk atrieflimren påvist ved hjælp af en smartphone

Smartphone-based ECG monitor devices are a new promising tool for rhythm detection in patients with palpitations. We present a case where a young patient with infrequent arrhythmia episodes was diagnosed with atrial fibrillation using this novel smartphone-based event recorder.

The Impact of Atrial Fibrillation Ablation on Quality of Life.

Quality of life (QoL) is a very important endpoint in trials reporting the efficacy of catheter ablation in patients with atrial fibrillation (AF). It has been shown that AF ablation significantly improves the QoL, but recent studies question the usefulness of the most used generic QoL instrument in AF patients. The complexity of the disease makes it mandatory to employ disease specific instruments in the assessment of QoL. This paper reviews the current knowledge of various QoL instruments, including the limitations and pitfalls, and the impact of AF ablation on the QoL.

[Radio frequency of atrial fibrillation: results from 102 consecutive patients--secondary publication]. / Radiofrekvensablation af atrieflimren: resultater fra 102 konsekutive patienter--sekundaerpublikation.

Segmental pulmonary vein isolation (SPVI) and circumferential pulmonary vein isolation (CPVI) are the two main approaches to radiofrequency ablation in patients with atrial fibrillation (AF). The aim of this retrospective study was to investigate the safety level and patient outcome of both approaches. The overall freedom from symptoms was 73% and 25% after CPVI and SPVI, respectively. Our study concludes that CPVI is an effective treatment of highly symptomatic and drug-resistant AF and when used in laboratories by experienced electrophysiologists has a promising and reproducible outcome ratio and safety level.