The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

The objective of this study was to describe a new technique for transcatheter device closure of large atrial septal defects (ASDs) using the Amplatzer septal occluder and our experience with this technique in 14 patients. Transcatheter closure of large (> 25 mm) ASDs is challenging. We have developed a balloon-assisted technique (BAT) to facilitate device closure of large ASDs. The BAT consists of using a balloon catheter to support the left atrial (LA) disk of the Amplatzer septal occluder during device deployment. The balloon support prevents prolapse of the LA disk into the right atrium. Between April 2003 and February 2004, 14 patients with large ASDs (mean age, 25.71 +/- 15.71 years; mean weight, 51.21 +/- 23.78 kg) underwent device closure with the Amplatzer septal occluder using the BAT. The median balloon-stretched diameter of the ASD was 32 (range, 26-40) mm. The median device size used was 33 mm (range, 26-40 mm). All 14 patients had successful deployment of the device using the BAT. The mean follow-up period was 16.5 +/- 11.95 weeks. No major complications were noted during the procedure or on short-term follow-up. The BAT enables predictably successful closure of large ASDs using the Amplatzer septal occluder.

Background: Coronavirus disease 2019 (COVID-19) pandemic has drastically affected global health. Despite several studies, there is yet a dearth of data regarding the mechanisms of cardiac injury, clinical presentation, risk factors, and treatment of COVID-19-associated cardiovascular disease. This systematic review and meta-analysis is aimed at defining the clinical, electrocardiographic, and pathologic spectrum of cardiovascular disease (CVD), frequency of elevated cardiac and inflammatory biomarkers, and their frequency and relationship with severity of the disease and mortality in COVID-19 patients and to develop a triage risk stratification tool (TRST) that can serve as a guide for the timely recognition of the high-risk patients and mechanism-targeted therapy. We conducted an online search in databases of PubMed and Embase to identify relevant studies. Data selection was in concordance with PRISMA guidelines. Results were presented as pooled frequencies, odds ratio, standardized mean difference (SMD), and forest and funnel plots. Results: We gathered a total of 54 studies and included 35 of them in our meta-analysis. Acute cardiac injury occurred in more than 25% of cases, mortality was 20 times higher, and admission to intensive care unit increased by 13.5 times. Hypertension was the most common pre-existing comorbidity with a frequency of 29.2%, followed by diabetes mellitus (13.5%). The deceased group of patients had higher cardiac and inflammatory biomarkers, with statistically significant SMD, compared with survivors. Pediatric patients were predominantly mildly affected. However, less frequently, the presentation was very similar to Kawasaki disease or Kawasaki shock syndrome. This latter presentation hass been called as multisystem inflammatory syndrome in children (MIS-C). Conclusions: There is a wide spectrum of cardiac involvement in COVID-19 patients, and hence a Triage Risk Stratification Tool can serve as a guide for the timely recognition of the high-risk patients and mechanism-targeted therapy.

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Little is known about the efficacy and safety of the 40 mm Amplatzer septal occluder (ASO). Thirty-three patients (22 female, 11 male) with a large secundum atrial septal defect (ASD) underwent attempted device closure using the 40 mm ASO at a median age of 40 years (range, 14-81 years) and median weight of 65 kg (range, 48-98 kg). The median size of the ASD measured on 2D transesophageal echocardiography (27 patients) or intracardiac echocardiography (6 patients) was 30.5 mm (range, 24-39 mm) and the median balloon-stretched diameter was 37.7 mm (range, 32-43.7 mm). The median Qp:Qs ratio was 3.2:1 (range, 1.4-6.2). The attempt was unsuccessful in five patients; two had device embolization and one had left atrial wall perforation due to the sheath; all three required emergent surgery. The attempt was successful in the 28 remaining patients, resulting in complete immediate closure in 14 and a trivial residual shunt in 14. Fluoroscopy time ranged from 8.6 to 37.8 min (median, 12.2 min). At 24-hr follow-up, 2D transthoracic echocardiography with color flow Doppler revealed complete closure in 23 patients, and 5 had a trivial residual shunt. There were no complications encountered in patients who received the device. On follow-up, all patients are doing well. We conclude that the 40 mm ASO is safe and effective in most patients with a large ASD up to a diameter of 39 mm. However, the use of this device requires careful attention as the procedure may be unsuccessful or the device may embolize.