No coin nor oath required. For personal study only.
The Helex septal occluder is composed of ePTFE patch material supported by a single Nitinol frame. The device is low profile and atraumatic. Studies suggest comparative closure rates to other septal occlusion devices and device erosion has never been reported. Data is lacking in small children. Theoretical concerns include distortion of the compliant device by the relatively smaller atrial chamber and greater risk of frame fracture. Methods: Retrospective review of all catheterizations with attempted ASD closure in children 20kg between 03/2006 and 12/2010. Results: Helex device placement was attempted in 34 patients with technical success in 32 patients. Two patients demonstrated unstable device positioning with device retrieval prior to release and subsequent surgical repair. For device closure patients, mean weight was 15.5kg (range 6.8-20kg) and mean age was 48 months (range 5-84 months). ASD morphology included 5 fenestrated defects and 7 defects with deficient (<5mm) aortic rim. ASD stop-flow diameter was 12.4 (range 7-19mm) and Qp:Qs was 1.760.4. Devices used included: 15mm (n¼3), 20mm (n¼7), 25mm (n¼10), 30mm (n¼11), 35mm (n¼1). Device size to stretch diameter ratio was 2.1 (range 1.7-2.5) and device size to total septal length was 0.7560.14. Fluoroscopy time was 26.9612.0 minutes. Residual leaks were seen on post-procedure day #1 in 14/32 patients (44%) and persisted in 1/25 patients with 6 month follow-up. Complications included 1 embolization on post-procedure day #1 with successful percutaneous retrieval and ASD device closure. There were no long term adverse events including no cardiac perforation, obstruction to venous inflow or device related atrioventricular valve insufficiency. There were no known device fractures including 11 patients with repeat fluoroscopy at 1 year post-procedure. During the study period 1 patient <20kg had ASD closure with an alternative device. Conclusion: Exclusive institutional use of the Helex septal occluder for ASD closure in children 20kg resulted in comparable efficacy to other ASD closure devices. Small residual leaks are common in the short term but typically resolve with device endothelialization. In our experience, frame fracture has not been a clinical concern. Device embolization was our only procedural complication and the device design facilitates percutaneous retrieval.
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