Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience.

International Journal of Cardiology
Giuseppe SantoroGiovanni Di Salvo

Abstract

This perspective, observational study evaluated safety and efficacy of the GORE® Cardioform ASD Occluder (WL Gore & Associates, Flagstaff, AZ), compliant and potentially innovative prosthesis recently approved for closure of ostium secundum atrial septal defects (ASD). Between January and June 2020, 43 unselected patients with -significant ASD were submitted to trans-catheter closure with GORE® Cardioform ASD Occluder at two high-volume Italian Pediatric Cardiology centers. Primary endpoints were procedural success and safety. Secondary endpoints were closure rate and clinical safety at 1-month follow-up. Patients' age and weight were 8.2 ± 3.9 years (range 3-21, median 9.9) and 29.6 ± 15.3 kg (range 16-57, median 33.3), respectively. ASD diameter was 16.6 ± 4.5 mm (median 10), resulting in QP/QS of 1.7 ± 0.7 (median 1.6). Seventeen pts. (39.5%) were considered "surgical" candidates due to challenging septum morphology, ASD rim deficiency or ASD diameter/patient weight ratio ≥ 1.2. Device placement was successfully achieved in all but one patient (97.7%), in whom it embolized early after deployment, resulting in rescue surgical repair. No cross-over with different devices was recorded. Median procedure and fluoroscopy times wer...Continue Reading

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Citations

Feb 3, 2021·International Journal of Cardiology·Pil Hyung Lee, Duk-Woo Park
Oct 16, 2021·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Giuseppe SantoroMassimiliano Cantinotti

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