Page 101 - Journal of Structural Heart Disease Volume 4, Issue 4

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Meeting Abstracts
The last patient was unlucky to have no false lumen throm- bosis and collapse following supracoronary aortic replace- ment, elephant trunk and TEVAR procedures. The proximal to the stent-graft fenestration was closed with 6 mm AGA ASD device. Six month after CT con rmed complete false lumen thrombosis and collapse in the thoracic aorta.
Conclusion: Pediatric devices are good solution in some patients with aortic diseases.
165. MULTICENTER TRIAL OF CONGENITAL PULMONIC VALVE DYSFUNCTION STUDYING THE SAPIEN 3 INTERVENTIONAL THV WITH THE ALTERRA ADAPTIVE PRESTENT-RESULTS OF THE U.S. EARLY FEASIBILITY STUDY
Shabana Shahanavaz MBBS1; David Balzer MD1; Vasilis Babaliaros MD2; Dennis Kim MD PHD2; Vivian Dimas MD4; Suredranath R; Veeram Reddy4; Evan Zahn MD5
1Division of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO; 2Structural Heart Disease Center, Division of Cardiology, Emory University School of Medicine, Atlanta, GA; 3Division of Pediatric Cardiology, Department of Pediatrics, Children's Healthcare of Atlanta, Emory University, Atlanta, GA; 3Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center, Children's Health System of Texas, Dallas, TX ; 5The Smidt Heart Institute and the Department of Pediatrics, Cedars-Sinai Medical Center, Los Angeles, California
Disclosures: Dr. Shahanavaz and Dr Zahn are consultants for Medtronic Inc. (Minneapolis, MN) and proctors for Edwards Life Sciences LLC. (Irvine, CA). Dr. Balzer is a con- sultant and proctor for Medtronic Inc.
Dr Babaliaros, Dr Kim, Dr Dimas and Dr Reddy do not have any disclosures.
Objectives: This study sought to demonstrate the safety and e ectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the
Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular out ow
tract/pulmonary valve (RVOT/PV) who have an indication for treatment for severe pulmonary regurgitation (PR).
Background: Based upon the large size and irregular topography, many patients with dysfunctional right ven- tricular out ow tracts (RVOT) are currently not candidates for percutaneous balloon-expandable valves. The Alterra Prestent is a unique self-expanding device designed to
internally reduce and recon gure the RVOT and provide a stable landing zone for percutaneous implantation of a 29 mm SAPIEN 3 THV.
Methods: Four U.S. sites participated in an FDA-approved early feasibility study (EFS). Potentially eligible patients underwent extensive non-invasive work-up and review by a screening committee to determine implant eligibility. Inclusion criteria included moderate/severe pulmonary regurgitation and RVOT dimensions > 27 and < 38 mm in diameter and > 35 mm in length. A total of 15 patients were enrolled in the EFS. Pre-procedural characteristics are reported for the rst 6 patients.
Results: Between February 2018 and May 2018, 6 patients were implanted with the Alterra Prestent and Edwards
165. Table 1. Demographics and Baseline Characteristics All treated Population (N=6)
Variable
Summary Statistics
NYHA Class
Class I/II
Class III/IV
Original CHD Diagnosis
Atrial septal defect Coarctation of the Aorta Pulmonary valve stenosis Tetralogy of Fallot Ventricular septal defect Other
Total Number of previous Surgical Cardiothoracic Inter- ventions
Total Number of previous Percutaneous Cardiothoracic Interventions
Total Pulmonary Regurgitation
None/Trace
Mild
Moderate
Severe
Mean RVOT Gradient
5 1
1 1 2 3 3 3 1
1
0
0
0
6
7.8 ± 4.32
Note: Categorical measures – Count; Continuous measures – Median (Range) or Mean ± Std. Dev.
Hijazi, Z
21st Annual PICS/AICS Meeting