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

Background: This perspective, observational study evaluated safety and efficacy of the GORE (R) Cardioform ASD Occluder (WL Gore & Associates, Flagstaff, AZ), compliant and potentially innovative prosthesis recently approved for closure of ostium secundum atrial septal defects (ASD). Methods: Between January and June 2020, 43 unselected patients with-significant ASD were submitted to trans catheter closure with GORE (R) 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. Results: 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 were 40 and 6.8 min, respectively. Major adverse events were recorded in 7.0% (3 pts). Complete closure rate was 78.5% at discharge, rising to 92.9% (39/42 pts) at 1 month evaluation, without cardiac or extra-cardiac adverse events. Challenging procedures were more time-consuming but as effective and safe as the simple ones. Conclusions: The GORE (R) Cardioform ASD Occluder device was highly effective and versatile in closure of ASDs with different anatomy and size, even in challenging settings. (c) 2020 Elsevier B.V. All rights reserved.

Automated summary

This observational study evaluated the safety and efficacy of the GORE (R) Cardioform ASD Occluder in closing atrial septal defects, showing a high success rate and versatility in patients with different anatomical structures and sizes of ASD. The device had a low rate of major adverse events during the procedure, and patients did not experience any cardiac or extra-cardiac adverse events during the 1-month follow-up.