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.

Comparison of deep learning, radiomics and subjective assessment of chest CT findings in SARS-CoV-2 pneumonia.

PURPOSE: Comparison of deep learning algorithm, radiomics and subjective assessment of chest CT for predicting outcome (death or recovery) and intensive care unit (ICU) admission in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: The multicenter, ethical committee-approved, retrospective study included non-contrast-enhanced chest CT of 221 SARS-CoV-2 positive patients from Italy (n = 196 patients; mean age 64 ± 16 years) and Denmark (n = 25; mean age 69 ± 13 years). A thoracic radiologist graded presence, type and extent of pulmonary opacities and severity of motion artifacts in each lung lobe on all chest CTs. Thin-section CT images were processed with CT Pneumonia Analysis Prototype (Siemens Healthineers) which yielded segmentation masks from a deep learning (DL) algorithm to derive features of lung abnormalities such as opacity scores, mean HU, as well as volume and percentage of all-attenuation and high-attenuation (opacities >-200 HU) opacities. Separately, whole lung radiomics were obtained for all CT exams. Analysis of variance and multiple logistic regression were performed for data analysis. RESULTS: Moderate to severe respiratory motion artifacts affected nearly one-quarter of chest CTs in patients. Subjective severity assessment, DL-based features and radiomics predicted patient outcome (AUC 0.76 vs AUC 0.88 vs AUC 0.83) and need for ICU admission (AUC 0.77 vs AUC 0.0.80 vs 0.82). Excluding chest CT with motion artifacts, the performance of DL-based and radiomics features improve for predicting ICU admission. CONCLUSION: DL-based and radiomics features of pulmonary opacities from chest CT were superior to subjective assessment for differentiating patients with favorable and adverse outcomes.

Left atrial appendage occlusion in COVID-19 times.

The coronavirus disease 2019 pandemic is having a major impact on healthcare systems worldwide. Several months after the COVID-19 outbreak, waiting lists of non-urgent structural heart (SH) interventions continue to increase. Limitations in terms of ICU beds and anesthesiology represent a major limitation to conduct non-urgent SH interventions and are a valid reason to move towards less invasive approaches. The field of left atrial appendage occlusion (LAAO) reflects this challenging situation perfectly. The aim of this paper is to describe the possibilities for pre-procedural LAA assessment, performance of the LAAO procedure and post-procedural surveillance in these challenging times.