Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.

BACKGROUND: The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. METHODS: We retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE). RESULTS: In 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim; in 11.9%, there was more than one defect; a septum aneurysm was present in 21.5%; and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total = 8, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported. CONCLUSION: ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc.

ASD closure under pressure.

Transcatheter atrial septal defect device implantation in elderly patients may cause acute pulmonary oedema when impaired left ventricular diastolic function causes an abrupt increase in left atrial pressure. Though left atrial pressure is often monitored during test occlusion of a defect, it is not clear at what cut-off value device implantation is contraindicated. We report successful closure of an atrial septal defect in a 73-year-old patient, even though the mean left atrial pressure increased from 18 to 25 mm Hg with device implantation. Although a fenestrated device was used, this did not prevent the rise in left atrial pressure. The patient was supported with mechanical ventilation, milrinone and intravenous diuretics following the procedure and did not develop pulmonary oedema. Her dyspnoea improved and her functional status increased from New York Heart Association (NYHA) III to NYHA II. In conclusion, successful device closure can be accomplished even with high left atrial pressure.