Page 92 - Journal of Structural Heart Disease Volume 5, Issue 4

Meeting Abstracts
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Canada. 8Edwards Lifesciences, Irvine, CA, USA. 9Cedars-Sinai Medical Center, Los Angeles, CA, USA
Background: Many patients with right ventricular outflow tract (RVOT) dysfunction are not candidates for percuta- neous valve replacement due to RVOT size and geometry. The Edwards self-expanding Alterra Adaptive Prestent internally reduces and reconfigures the RVOT to provide a landing zone for a 29 mm Edwards SAPIEN 3 (S3) transcath- eter heart valve.
Methods: At 4 U.S. investigational sites, eligible patients weighing at least 20 kg, with moderate to severe pulmo- nary regurgitation (PR) were enrolled in an early feasibility study (EFS). Patients were considered suitable candidates for implant if systolic dimension of the RVOT was between 27–38 mm long, and the length of the RVOT from takeoff of the branch pulmonary artery to the contractile portion of the RV was >35 mm long. Anatomical analysis of the RVOT at baseline, including lengths, diameters, and circumfer- ence along the length of the potential deployment zone was performed using a gated CT that covered the entire RVOT and main pulmonary artery (MPA) throughout the entire cardiac cycle. Centerline-based measurements of the RVOT circumference were made from the raw data obtained during peak systole at the time of maximal MPA distension and diastole. The diameter and perimeter plots were created and analyzed in relation to the diameter and perimeter of the unconstrained device. Virtual implants of an unconstrained, fully expanded device were evaluated for device contact with vessel wall in both systole and dias- tole. Table top implants in polyjet models of the RVOT of each patient were performed at peak systole and diastole prior to actual patient implants.
Results: From August 2017 through June 2018, 29 patients were screened and 15 patients were implanted (52%). The primary reason for exclusion was anatomical unsuitabil- ity of the RVOT for the Alterra prestent. Of the 14 patients excluded, 4 had outflow tracts that were too narrow, with RVOT diameter measurements <27 mm (2 of these 4 patients underwent primary S3 implantation; treatment for the other 2 is unknown); 4 patients were excluded for RVOT length measurements <35 mm; 4 patients were excluded for lack of device engagement due to a large outflow tract distally or proximally (>38 mm); 1 patient was excluded due to concern about muscle bundles in the RVOT, which we thought might hinder advancement of the S3; and the final excluded patient consented to treatment, but did not receive the device due to pregnancy.The RVOT mea- surements of patients who did receive the Alterra device, including the minimum and maximum distal dimension
at device engagement, will be available at the time of the presentation. All 15 implantations of Alterra prestent and S3 were successful.
Conclusions: In this EFS of a novel device designed to allow transcatheter pulmonic valve replacement into larger RVOT anatomy, a multimodality screening process allowed identification of suitable candidates who under- went successful Alterra and S3 implant. All implants were successful.
122. CURRENT AND FUTURE APPLICATION OF INTERVENTIONAL CMR IN CONGENITAL HEART DISEASE - RESULTS OF AN ONLINE SURVEY. Surendranath Veeram Reddy1, Peter Ewert2, Kanishka Ratnayaka3, Henry Halperin4, Jennifer Gotto5, Tarique Hussain1, Gerald Greil1, Paul J. A. Borm6
1UT Southwestern Medical Center, Dallas, USA. 2German Heart Center (DHM)., Munich, Germany. 3Rady Children's Hospital, San Diego, USA. 4John Hopkins Medical Institution, Baltimore, USA. 5B Braun Interventional Systems, Bethlehem, USA. 6Nano4Imaging, GmbH, Dusseldorf, Germany
Background: Although first use of cardiovascular mag- netic resonance imaging (CMR) for interventional proce- dures in congenital heart disease (CHD) dates back to 2003, current use is mainly diagnostic, such as for accurate pres- sure/flow measurement in pulmonary hypertension and various forms of CHD.
Objectives: The first objective of the current worldwide survey was to describe current use of CMR in CHD and to further understand future use and application of inter- ventional and diagnostic CMR by current and interested users. A second objective was to make an inventory of the main impediments that apply to interventional cardiovas- cular magnetic resonance imaging (iCMR) and the instru- mental needs for further progression of the field.
Methods: The online survey was sent by email to all phy- sician members of PICS-AICS, CCISC and SCMR community in December of 2018 and answers were gathered until March 5th 2019. All qualifying respondents were pediatric/ adult congenital heart disease providers. A total of 188 responses were obtained, and a sub-group of 112 respond- ers completed all questions, including 102 academic and 10 non-academic centers. Apart from 14 centers that are already active, 72 centers (55%) indicated that they are interested and want to start iCMR procedures at their cen- ters in the near future. The major problems they envisage, or encounter are infrastructure (26 %), lack of medical devices (18 %), training (13 %) and lack of key people on the team
Journal of Structural Heart Disease, August 2019
Volume 5, Issue 4:75-205