Objective Assess clinical performance of a new device for transcatheter closure of atrial septal defect (ASD). Background Previously‐approved ASD Closure devices have known limitations. Device erosion has been associated with the AMPLATZER® septal occluder in patients with retro‐aortic rim deficiency (<5 mm), while defects ≥18 mm are too large for the GORE® CARDIOFORM septal occluder. The GORE® CARDIOFORM ASD occluder (GCA), a hybrid of the approved devices, was designed to expand the eligible ASD population. Methods One‐hundred and twenty‐five ASD patients were enrolled in a prospective, multicenter registry. Descriptive clinical endpoints included: technical implant success, closure success, serious adverse events (SAE), clinically significant new arrhythmia, and wire frame fracture. Procedural outcomes and adverse events were adjudicated by an Echocardiography Core Lab and Independent Data Review Board, respectively. Results Median subject age was 12.3 years (range 2.9–84.7), with 72% of patients ≤18 years old. Median ASD stop‐flow diameter was 17.0 mm (8.0–30.0), with 43% ≥18 mm. Deficient retro‐aortic rim occurred in 57% of subjects, and 30% had both diameter ≥ 18 mm and deficient rim. Technical Implant Success was achieved in 120/125 (96%), though three devices were removed within 24 hr. At the scheduled 6‐month evaluation, 112/117 returned for evaluation. All 112 had closure success. SAE occurred in 6/125 (4.8%) and 6/125 (4.8%) had clinically significant new arrhythmia. Wire frame fractures occurred in 37/104 (36%), without any associated clinical sequelae, residual shunt, or device instability. Conclusion The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.

Diabetes mellitus is a common complication in pediatric thoracic transplant patients receiving tacrolimus-based immunosuppression. Insulin dependence in our population rarely resolved, even after lowering tacrolimus and steroid doses. Discontinuation of steroids did not guarantee resolution of diabetes.

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Objective To evaluate safety and efficacy of the GORE® CARDIOFORM Septal Occluder for percutaneous transcatheter closure of ostium secundum atrial septal defects. Background The GORE® CARDIOFORM septal occluder is a double‐disc, low profile, soft, conformable device, with distinct advantages over the GORE® HELEX® Septal Occluder. Methods Subjects were enrolled in this single arm prospective study from 21 U.S. sites, and followed for 3 years. Primary endpoint was 6 month composite clinical success, comprised of technical success (implantation and retention of device), closure success (normalization of right heart size), no 30 day serious adverse events, and no device embolization or reintervention. Secondary endpoints included technical success, procedure success (technical success and ≤ 2 mm residual shunt at procedure conclusion), closure success (clinically insignificant or no residual shunt), and safety (freedom from 30 day serious adverse events and 6‐month device events). Results Between October 2012 and May 2015, 50 pivotal and 350 continued access subjects underwent attempted transcatheter GORE® CARDIOFORM Septal Occluder implantation. Median age was 6.9 years, and mean static defect diameter 9.7 ± 3.1 mm. Device placement was achieved in 93.5% (374/400). Composite clinical success was 90.2% and clinical closure success was 98.8% at 6 months. Freedom from serious adverse events was 98.3% at 30 days, with no device embolizations or reinterventions through 6 months. Conclusions The GORE® CARDIOFORM Septal Occluder has high composite clinical success and safety, performing well in defects ≤17 mm by stop flow stretched diameter. Single, multifenestrated, and deficient retroaortic tissue defects were well represented and successfully treated.

Because pediatric cardiologists can accurately diagnose innocent murmurs by physical exam alone, the authors developed a system for remote cardiac auscultation. They hypothesized that their system could accurately classify auscultatory findings as normal/innocent or pathologic. Patients undergoing evaluation underwent examination, echocardiography, and heart sound recording. Pediatric cardiologists evaluated the heart sounds and classified the case as either normal/innocent or pathologic. They reviewed103 heart sound data sets; 85% of the cases were accurately classified as either normal/innocent or pathologic, with a sensitivity of 82% and specificity of 86%. However, when accounting for clinical diagnosis, reviewer uncertainty, and ECG abnormalities, the sensitivity and specificity improved to 91% and 88% (accuracy 89%), respectively. Degree of certainty with the telecardiology diagnosis correlated with correct interpretation (P < .005). Digital heart sound recordings evaluated via telemedicine can distinguish normal/innocent murmurs from pathologic ones. Such a system could improve the use of pediatric cardiology services.