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Secundum ASD closure has been performed with Amplatzer and Helex Septal Occluder, Figulla-Occlutech and Cera Lifetech devices. The aim of this study was to evaluate efficacy of Coccoon Septal occluder (CSO- Vascular Innovation, Thialand) for ASD closure as immediate and long term results.
Between March 2013 to July 2015, 122 patients (22 Male, 100 Female; mean age-23.8 years) underwent attempted transcatheter closure of haemodynamically significant ASD (signs of RV volume overload) with suitable anatomic features and/or who have experienced sequelae of paradoxical emboli such as stroke or recurrent transient ischaemic attack under transoesophageal echo. Exclusion criteria were defect >40 mm, unsuitable anatomy, Eisenmenger syndrome and anomalous pulmonary venous return. Balloon assisted technique (BAT) was done in devices >38 mm. Optimal device position was ensured by TEE, and fluoroscopy in antero-posterior and left anterior oblique position. Follow-up evaluation was performed with echo-doppler within 24 h and at 6, 12 months and yearly thereafter. Mean diameter of ASD in long axis on TEE was 28.6±4.1 mm and implanted device was 32.8±8.2 mm. Mean difference in size was 4.9±2.4 mm. Aortic rim was deficient in 36(29.5%) patients. Devices were delivered using 8-14F long sheath. 12(14.8%) cases were performed with help of BAT from contralateral venous access. Aspirin was started preprocedure and 75 mg for six months later on. Local haemostasis was acheived by z-suture technique.
Primary success was achieved in 120(98.1%) while 2(1.9%) patients had immediate embolization to right atrium, requiring surgery. Both were 44 mm device attempted for defect of 40 mm and retro-aortic rim were deficient. Transient atrial fibrillation, immediate postprocedural pericardial effusion, local site haematoma and residual shunt were reported in 5(4%), 2(1.9%), 49(3.3%) and 18(14.8%) patients respectively. After mean follow up of 31.2 months in 118 of 122 patients (95% CI 89%-100%), there were no erosion, thromboembolism, late embolization, arrhythmia and death.
TCC of the secundum ASD by CSO (upto 38 mm) is safe and feasible with favourable immediate and long term results.
STRUCTURAL: Congenital and Other Structural Heart Disease