Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder

Gordon BM, Abudayyeh I, Goble J, Collado NA, Paolillo J.Catheter Cardiovasc Interv. 2020 Apr 1;95(5):932-936. doi: 10.1002/ccd.28666. Epub 2019 Dec 26.PMID: 31876383

Take Home Points:


  • Residual leaks following device closure of secundum atrial septal defects, particularly when using the GORE CARDIOFORM Septal Occluder, are poorly understood.
  • Patients with larger defects, smaller aortic rims, and with the presence of multiple fenestrations are more likely to have residual leaks following ASD device closure with the GSO.
  • Residual leaks following ASD device closure with the GSO frequently disappear within the first year following implantation.



Commentary from Dr. Arash  Salavitabar (Ann Arbor, MI), section editor of Congenital Heart Disease Interventions Journal Watch:  In this retrospective, multicenter study, the authors aimed to review experiences with outcomes of residual leaks following device closure of secundum atrial septal defects (ASD) with the GORE CARDIOFORM Septal Occluder (GSO) during the pivotal and continued access study. This is a well-known potential issue post-device closure of ASDs and the expectant course is not well-described, particularly with this device. One important characteristic of the GSO device is that it is not “self-centering”, and so it has the ability to shift as it conforms to the septal anatomy. This can lead to potential small leaks around the edge of the device. The authors sought to characterize the medium-term outcomes of residual leaks noted with the GSO and to report on potential risk factors associated with eventual closure rates.


This study included 69 patients who had a residual leak following device implantation, out of 374 total patients who underwent ASD closure with the GSO for the pivotal and continued access U.S. trials. Sixty-five (17.5%) patients met inclusion criteria following retrospective review of their echocardiograms. When comparing those with and without residual leak, those with residual leaks had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006), larger stop flow balloon sizes (12.91 ± 3.02 mm vs. 11.43 ± 2.89 mm, p < .001), smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), the presence of multiple fenestrations (43.08% vs. 18.69%, p < .001), and increased fluoroscopic time (16.02 ± 9.65 min vs. 13.17 ± 9.03 min, p = .004). Larger devices tended to be implanted and more devices per case were utilized in the residual leak cohort as compared to those without leak. There was no significant differences between procedural time, device- to-defect ratio, or type of anesthesia among groups.


Importantly, there was a significant decrease in the leak size over 1 year in those patients with residual leak, from 1.55 ± 0.75mm to 0.25 ± 0.74mm (p < 0.001), with the majority disappearing by that 1 year follow-up (Figure 1).


The authors postulate that residual shunts adjacent to ASD closure devices disappear over time due to remodeling of the right atrium with subsequent normalization of right atrial size following removal of the volume load caused by the ASD. This is thought to augment the endothelialization that occurs from adjacent tissue.


While this study is limited by its retrospective nature, it provides important information regarding risk factors for residual leak following ASD device closure, particularly with the GSO. It is also valuable to understand that these residual leaks frequently completely disappear over the first year following implantation, which can affect patient counseling, frequency of follow-up, and potential need for future interventions.