Atrial septal defect (ASD) occlusion in adult patients with advanced age and left or right heart diastolic or systolic heart failure and in patients with pulmonary arterial hypertension bears a considerable risk of deterioration of heart failure. Therefore, we conducted this feasibility trial in 15 ASD patients with pulmonary hypertension and/or right heart failure using a fenestrated Amplatzer septal occluder (AGA Medical Corporation, Golden Valley, MN), allowing an overflow of blood in both directions in case of univentricular diastolic or systolic heart failure. In all patients, the device could be implanted without complications. All symptomatic patients showed an improvement in the New York Heart Association (NYHA) class, and no right or left heart decompensation occurred. On echocardiography, right ventricular end diastolic dimension (RVEDD) and pulmonary artery pressure (PAP) decreased significantly, whereas left ventricular end diastolic dimension (LVEDD) increased. Our series of 15 patients with fenestrated ASD occlusion shows that high-risk ASD occlusion can safely be accomplished with excellent clinical results and without complications by a fenestrated occluder.

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paradoxical embolism as the reason for acute myocardial infarction (AMI) in patients with PFO and normal coronary arteries. 26,28-47 Even fatal outcomes have been convincingly published. 48,49 However, to date there has not been a large scale evaluation of this phenomenon. MethodsOur approach to describing the epidemiology of AMI included a retrospective and a prospective study. We retrospectively analyzed the incidence over 10 years of paradoxical coronary embolism in a tertiary care center and then prospectively undertook an effort to prove this using the same criteria over 39 months in another tertiary care center. Retrospective and Prospective StudiesFor the retrospective study, we searched the database of the hospital's information system over a period of 10 years for cases of MI according to the International Classification of Diseases, searching for AMI, recurrent MI, and acute as well as silent ischemia. Subsequently all angiogram A patent foramen ovale (PFO) is caused by defective fusion of the septum primum coverage of the fossa ovalis area after birth. A PFO is present in approximately 25% of the general population. 1 In most cases it never leads to any health issues, but PFO has been recognized as a possible source of paradoxical (venoarterial) embolism since the late 18 th century, 2 especially in patients with additional risk factors such as large right-to-left shunt, 3 atrial septal aneurysm, 4-7 thrombophilia 8-11 or prominent Eustachian valve. 12 A possible mechanism for PFO-related systemic embolic events is paradoxical embolism from the peripheral venous system 13-17 through the interatrial communication to the systemic circulation. The embolisms have a preference to be transmitted to vascular areas in accordance with the anatomy and the centrifugal force (i.e., primarily into the cerebral arteries and there to the posterior vessels). 18 There are a few small studies and case reports that have reported paradoxical embolism to the non-cerebral circulation causing limb ischemia, splanchnic ischemia, and splenic or renal infarction. 19-28Almost exclusively the case reports suggest suspected Background: Despite several negative prospective randomized trials on the efficacy of patent foramen ovale (PFO) occlusion, the discussion on indications is ongoing. Because the incidence of paradoxical coronary embolism through a PFO is unknown, we investigated the risk of paradoxical embolic myocardial infarction over a period of 13 years.

Background Beneficial effects of placebos are high in double-blind hot flush trials. Studies in various conditions suggest that honestly prescribed placebos may elicit symptom improvement. Objective To determine whether open label placebo (OLP) treatment is efficacious in alleviating hot flushes among peri- and postmenopausal women. Methods/design In this assessor-blinded, randomized-controlled trial, n = 100 women experiencing five or more daily hot flushes of at least moderate severity and bothersomeness are assigned 1:1 to a 4-week OLP treatment or no treatment. To explore the duration and maintenance of placebo effects, the OLP group is randomized a second time to either discontinue or continue the OLP treatment for another 4 weeks. All participants receive a briefing about placebo effects and study visits at baseline, post-treatment (4 weeks), and follow-up (8 weeks, OLP group only). Qualitative interviews about subjective experiences with the OLP treatment are conducted. Primary outcomes are differences between the OLP and the no-treatment group in the hot flush composite score (frequency × severity), and bothersomeness of hot flushes as assessed with the Hot Flush Rating Scale at post-treatment. Secondary outcomes include hot flush frequency, health-related quality of life, global improvement, and the number of responders at post-treatment. Data are analyzed by fitting (generalized) linear mixed models. An exploratory analysis of maintenance and duration is performed including follow-up data. Discussion This trial will contribute to the evaluation of OLP treatments in clinical practice and further our understanding about the magnitude of placebo effects in hot flush treatments. Trial registration Clinicaltrials.gov, NCT03838523 . Retrospectively registered on February 12th, 2019. The first patient was enrolled on October 10th, 2018.