Multicenter midterm follow‐up results using the gore septal occluder for atrial septal defect closure in pediatric patients

Objectives To assess the structural integrity of the patch‐like Gore Septal Occluder (GSO) used for device closure of secundum‐type atrial septal defects (ASD II) in pediatric patients. Background GSO has shown to be effective and safe for ASD device closure in children and adolescents. Methods Single‐center, retrospective mid‐ to long‐term follow‐up of all children and adolescents with a GSO in situ (≥12 months). Periprocedural data and follow‐up data were evaluated, including chest X‐rays to assess the GSO's wire‐frame morphology. Results Ninety‐one consecutive patients were enrolled with a median age and weight of 5 years (range 2–18) and 20 kg (range 11–95) at implantation. ASD anatomy included 64 single and 27 multi‐fenestrated defects, with 39 patients having small retro‐aortic rims (≤4 mm). Median follow‐up period was 42.5 months (range 12–74). Chest X‐rays were available in 80 children: in 74 of them, the GSO's visualization on X‐ray enabled us to reliably assess the wire‐frame structure. Wire‐frame fracture (WFF) was ultimately detected in five of the 74 patients (6.8%); however, those occluders appeared stably anchored and well aligned to both sides of the septum, and no free wire fragments had escaped the GSO matrix. Thus, no further treatment was required. Conclusions Our data confirm that the GSO is safe and effective for ASD closure. Despite its lightweight construction, the GSO seems to offer reliable mechanical durability. Wire‐frame fractures occur, but the free wire‐ends appear to have remained stable within the GSO matrix without any clinical sequelae so far.

Section: Methodssupporting

confidence: 78%

Section: Introductionmentioning

confidence: 99%

Wire‐frame integrity of patch‐like Gore devices following atrial septal defect closure

Kubicki

Fingerhut

Uhl

et al. 2019

“…They did note that the incidence of residual leaks at implantation were more significant in patients with larger defects, smaller retro‐aortic rims, and with multiple fenestrations. These results are similar to the previous reviews for ASD device closure by a Prieto, 2 Grohmann, 3 and Jalal 4 which noted complete closure by ASO (Amplatz, St. Jude Medical, Inc., Saint Paul, MN) at 97.5%; Helex (W. L. Gore, Flagstaff, AZ) at 96.2%, and GSO (Europe) at 95.4%. In general, the mid‐term results have been reported with standard transthoracic echocardiographic imaging.…”

supporting

confidence: 90%

Not to worry (most of the time)

Hagler

2020

Key Points• Most (87.6%) of residual atrial L-R shunts after Gore Cardioform septal occluder implant disappear by 12 months.• Residual leaks at implantation were more common in larger defects with smaller retro-aortic rims, and multiple fenestrations.• While most residual defects close in 12 months, we unfortunately do not yet have a clear idea why or which of the 13% do not close.The current report by Gordon et al. 1 describes the mid-term multi center results of secundum atrial septal defect closure with the Gore Cardioform septal occluder. The manuscript is very positive in its presentation to document the closure of residual leaks in patients included in the Gore pivotal and continued access study for the Gore Cardioform septal occluder. Of the 370 total ASD closure patients included, 17.56% had a residual leak define by echocardiography at the time of implantation. A total of 87.6% of these disappeared by 12 months follow-up. Thus, in this group of 370 patients, the total closure rate at 12 months was 97.8%. They did note that the incidence of residual leaks at implantation were more significant in patients with larger defects, smaller retro-aortic rims, and with multiple fenestrations. These results are similar to the previous reviews for ASD device closure by a Prieto, 2 Grohmann, 3 and Jalal 4 which noted complete closure by ASO (Amplatz, St. Jude Medical, Inc., Saint Paul, MN) at 97.5%; Helex (W. L. Gore, Flagstaff, AZ) at 96.2%, and GSO (Europe) at 95.4%. In general, the mid-term results have been reported with standard transthoracic echocardiographic imaging. The authors discuss the greater use of transesophageal echocardiography in patients with residual leaks observed in this study but unfortunately there is no clear discussion of what type of echocardiographic study was used to clearly define the late results at 12 months, although, again, it would seem to have been transthoracic echocardiography (TTE).

“…Review of the GSO pivotal and continued access cohort demonstrates a similar leak rate at 1‐year follow up as compared to other retrospective studies of ASD closure with the GSO . Unlike the current review, the population from the European study had a majority of defects consisting of multi‐fenestrated ASDs, which would explain a higher leak rate at 1 year . Another possibility is the higher frequency of transesophageal echocardiography utilization in the leak group versus intracardiac echocardiography.…”

Section: Discussionmentioning

confidence: 75%

“…The GSO has been previously shown to be a safe and effective device for use in the closure of small‐ to medium‐sized secundum ASDs . Our review of the North American GSO pivotal and continued access cohort noted a residual leak at implantation in 17.56% of patients, the vast majority (87.6%) of which disappeared over the first year of follow‐up.…”

Section: Discussionmentioning

confidence: 81%

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

Gordon

Abudayyeh

Goble

et al. 2019

Objective: To assess the outcomes and potential predictors of residual leak after implantation of the GORE CARDIOFORM Septal Occluder (GSO) in secundum atrial septal defects (ASDs). Background:The non-self-centering design of the GSO could lead to residual leak at the edge of the device. Outcomes of residual leak are poorly understood.Methods: Retrospective, multicenter review of patients treated with the GSO for the pivotal and continued access study. Procedural, echocardiographic, and follow up data were reviewed. Multivariate analysis was performed to determine predictors of leak at implant and outcomes of these leaks.Results: There were 370 total ASD device closures with the GSO, 65 (17.56%) of which were found to have residual leak at implantation. Patients with residual leak had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006) and smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), as compared to those without leak. Larger devices were implanted (p = .008) and more devices per case (p = .007) were utilized in the residual leak cohort as compared to those without leak. Overall, among patients with residual leak, there was a significant decrease in leak size over 1 year, from 1.55 ± 0.75 mm to 0.25 ± 0.74 mm (p < .001), with the majority (87.6%) disappearing by 12-month follow-up. Conclusions:Residual leak at implantation can be seen after ASD device closure with the GSO, more commonly in larger defects with smaller retroaortic rims. The vast majority of these leaks completely resolve by 1 year follow up.