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OBJECTIVES: The aim of this study was to assess the incidence of persistently positive results on agitated saline contrast injection after patent foramen ovale (PFO) closure, the underlying mechanism, and management. BACKGROUND: Transcatheter intervention to close a PFO is reasonable in highly selected patients younger than 60 years, after a thorough cardioneurological investigation following a cryptogenic stroke, particularly in the presence of thromboembolic disease or in patients at high risk for venous thrombosis. The U.S. Food and Drug Administration approved the Amplatzer PFO Occluder in October 2016 for such an indication. Confirmation of PFO closure is usually verified by an agitated saline contrast injection during an echocardiographic examination. The appearance of bubbles in the left atrium raises the concern of incomplete closure or other sources of shunting. METHODS: The medical records and echocardiograms of patients who were treated with transcatheter closure of a PFO for cryptogenic stroke were reviewed. RESULTS: From January 1998 through December 2015, 880 patients were taken to the catheter laboratory for PFO closure, of whom 568 patients, 320 men (56.3%), underwent transcatheter closure of a PFO using an Amplatzer PFO Occluder, at a mean age of 48.1 ± 12.9 years. The incidence of right-to-left shunting (RLS) was 19.5% at a mean of 4 months' follow-up, which reduced to 8.4% at 11 ± 2 months. Sources of RLS were identified in 10 (1.8%); pulmonary arteriovenous malformation (n = 4) was the most common etiology, followed by leak through the device (n = 3). All patients with additional sources of RLS were treated percutaneously. At 2-year follow-up, 16 patients (2.8%) persisted with only mildly positive results on agitated saline contrast injection, without an apparent additional source of shunting. CONCLUSIONS: Coexistence of a PFO and an additional lesion responsible for RLS is uncommon, but not rare; the majority are amenable to transcatheter or surgical intervention. ispartof: JACC-CARDIOVASCULAR INTERVENTIONS vol:11 issue:11 pages:1095-1104 ispartof: location:United States status: published

OBJECTIVES The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF).BACKGROUND Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce.METHODS A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used.RESULTS During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated.CONCLUSIONS In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding. (C) 2016 by the American College of Cardiology Foundation.