Page 28 - Journal of Structural Heart Disease - Volume 1 Issue 2

57
Meeting Abstracts
degree of respiratory support, at 7 days nearly 75% of patients re- quired less support than prior to the procedure. There was no mortal- ity, but blood transfusions were more frequent than expected.
#0059
U.S. MULTI-CENTERED PIVOTAL TRIAL OF THE NOVEL GORE® CARDIOFORM SEPTAL OCCLUDER FOR PERCUTANEOUS CLOSURE OF SECUNDUM ATRIAL SEPTAL DEFECTS
Scott Lim1, John Rhodes2, Joseph Paolillo3, Alex Javois4, Mark Hoyer5, Thomas Forbes1
1University of Virginia, Charlottesville, VA, USA
2Miami Children's Health System, Miami, FL, USA
3Carolinas Healthcare System, Charlotte, NC, USA
4Advocate Health System, Oak Lawn, IL, USA
5Indiana University, Indianapolis, IN, USA
6Wayne State University, Detroit, MI, USA
Objectives: We evaluated the safety and efficacy of the Gore Septal Occluder to percutaneous close secundum atrial septal defects.
Background: The Gore® CARDIOFORM Septal Occluder (GSO) is low profile, double-disc occluder composed of a nitinol 5-wire frame and covered with expanded polytetrafluoroethelene, designed for percu- taneous closure of defects in the atrial septum.
Methods: Patients were enrolled prospectively in a single arm trial from 10 U.S. sites and followed up for the 6 month post-procedure protocol endpoint (and up to 3 years longitudinal follow-up). Core lab measured outcomes were evaluated, with the primary endpoint for a composite clinical success (successful device implant, clinical closure at 6 months, no serious adverse events at 30 days, no device events at 6 months).
Results: Between October, 2012 and June, 2013, 50 patients (age range 3.4 to 68.3 years) with static sized atrial septal defects between 4 and 17mm (mean 10+/-3mm) underwent attempts to implant a sin- gle GSO. Multiple defects were present in 20%, and 26% had a defi- cient retro-aortic rim. Implantation with GSO was successful in 47/50 (94%), with 30 day serious adverse event rate of 0%. The primary endpoint was met in 93.0%, with clinical closure success of 100% at 6 months. There were no device embolizations or need for reinterven- tions at time of last follow-up.
The most common minor adverse events were anesthesia-related in 14%.
Conclusions: Closure of defects in the atrial septum with the novel Gore® CARDIOFORM Septal Occluder is safe and effective. (U.S. Mul- ticenter Pivotal Study of the Gore Septal Occluder for Percutaneous Closure of Secundum Atrial Septal Defects; ClinicalTrials.gov Iden- tifier: NCT01711983).
#0060
THE USE AND OUTCOMES OF SMALL, MEDIUM AND LARGE PREMOUNTED STENTS IN PEDIATRIC AND CONGENITAL HEART DISEASE
Brian Boe, Jeffery Zampi, Kurt Schumacher, Sunkyung Yu,
Aimee Armstrong
University of Michigan, Ann Arbor, MI, USA
Background: Premounted stents (PS) have a lower profile than tradi- tional stents, allowing for delivery through smaller sheaths and place- ment within small patients. These PS require future dilation, given the somatic growth of the patients. Our aim was to evaluate the use and outcomes of small, medium and large PS in pediatric and congenital heart disease patients.
Methods: All small, medium and large PS placed in our catheterization laboratory from 2006 to 2014 were retrospectively reviewed. Patient, vessel and PS characteristics were collected at the time of implanta- tion and at each subsequent catheterization or surgical intervention.
Results: PS were placed in 69 vessels within 58 patients in our study cohort with a 97% success rate. The median age at implant was 1.9 years (interquartile range [IQR] 0.7-8.3) with a median weight of 11.5 kg (IQR 8.1-27.4). PS were placed in 52 pulmonary arteries, 12 major veins and 5 aortas resulting in significant improvements in vessel size and pressure gradient (p<0.0001). Over a median follow-up duration of 3.1 years (IQR 1.3-5.2), 25 patients (43%) required re-interven- tion (18 catheter-based, 3 surgical and 4 both) at a median time of 1.4 years (IQR 0.9-3.0) from implant. Factors associated with earlier re-intervention included age ≤1.9 years (HR 2.42, p=0.03) and weight ≤11.5 kg (HR 2.48, p=0.03) at the time of stent implant, and bare-met- al PS compared to covered PS (HR 4.16, p=0.001). Patients receiving bare-metal PS were younger and smaller than those receiving cov- ered PS (p=0.0002). In-stent stenosis (ISS) was seen in 12 patients on follow up catheterization with an incidence of ISS was 46% in the 26 patients who received follow-up angiographic evaluation. No identi- fied characteristics were associated with ISS development, including “oversizing” the PS. ISS was seen in 25% of covered PS compared to 52% of bare-metal PS, but this difference was not statistically signif- icant (p=0.13).
Conclusions: Small, medium and large PS are effective in treating le- sions in the congenital catheterization laboratory. Younger patients, smaller patients and bare-metal PS are at risk for requiring earlier re-intervention. ISS is seen frequently within PS, and larger studies are needed to identify risk factors. Frequent follow-up is required in this patient population.
#0061
SURGICAL
TRANSCATHETER INTERVENTIONS IN CONGENITAL HEART DISEASE: A SINGLE CENTER REVIEW
Gerson Valencia, Nicole Sutton, Samuel Weinstein, Robert Pass
Children's Hospital at Montefiore, Bronx, NY, USA
Introduction: Surgical access to the heart or great vessels may al- low for diagnostic or interventional catheterization procedures that would otherwise be less safe, extremely challenging or simply not feasible due to either poor vascular access or unfavorable anatomy and/or physiology. We hypothesized that hybrid surgical access to the heart, aorta or pulmonary arteries may, in certain clinical scenar- ios, allow for improved outcomes with low morbidity. We review our single center 8-year experience with surgical hybrid access in con- genital heart disease.
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