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

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.

The challenges surrounding preclinical testing in transcatheter device development and the implications on the clinic.

INTRODUCTION: Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices. Expert commentary: The lifecycle of a device is complex, but the period of commercialization may be short with little time for manufacturers to recuperate the costs associated with device development and (pre) clinical testing. Regulatory bodies such as the FDA require comprehensive data on pre-clinical testing prior to considering approval of an investigational device exemption to start trials in humans, which should include some data on safety and efficacy of a device. Preclinical testing needs to evaluate a variety of factors, such biocompatibility, material performance, durability, toxicology, particulation, protection against user error and device malfunction, potential hazards, and many more.

Combined prospective United States clinical study data for the GORE(®) HELEX(®) septal occluder device.

OBJECTIVES: Our goal was to summarize the outcome for all subjects evaluated during a prospective clinical study in the United States with the GORE(®) HELEX(®) Septal Occluder for transcatheter repair of secundum atrial septal defects (ASD). BACKGROUND: The GORE(®) HELEX(®) Septal Occluder is currently utilized for repair of secundum ASD. No previous reports are available that summarize the combined clinical trial outcomes for this device. METHODS: In the United States between 1999 and 2009, 435 subjects were enrolled through the Feasibility, Pivotal, Continued Access, and Post-Approval Studies. All subjects enrolled through these studies were collectively reviewed as the "study cohort." Clinical success, defined as a composite evaluation of safety and efficacy, is reported for subjects at the 12-month follow-up period. RESULTS: Of the 435 device subjects enrolled in the four clinical studies, 412 subjects were eligible for follow-up. Device efficacy, as represented by clinical closure at 12 months, was achieved in 98.3% of subjects, and in 99.5% of those receiving a device whose nominal diameter was greater or equal to twice the balloon sized defect diameter. Through 12 months following implantation, freedom from major adverse events was 95.2%. Together, these results yield a 93.0% composite clinical success at 12 months following the index procedure. CONCLUSIONS: The combined clinical study cohort represents the largest prospective, controlled clinical trial data set available for the GORE(®) HELEX(®) Septal Occluder. The clinical data presented in this report reaffirm the safety and efficacy of the GORE(®) HELEX(®) Septal Occluder when utilized for secundum atrial septal defect repair.

Failure of the GORE HELEX atrial septal defect occluder to treat membranous VSDs in swine.

OBJECTIVE: We tested the suitability of the GORE HELEX septal occluder for closure of membranous ventricular septal defect in three Yucatan minipigs that had naturally-occurring membranous ventricular septal defects. METHODS: The animals were studied in the Gore Science Center Laboratory in Flagstaff, Arizona. In all of the device implantations, seating of the right disk along the right ventricular septum was problematic with resultant entanglement of one device in the chordae tendinae during attempted removal, implantation of one device onto the tricuspid valve papillary muscle and unlocking of one device occurring after implantation. CONCLUSIONS: A new occluder design appears to be needed to minimize the risk of disk entanglement with cardiac structures, particularly within the right ventricle. These studies did establish that the Yucatan mini swine are an acceptable and appropriate model for evaluating occluders intended for closure of membranous ventricular septal defects.