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Novel Size-Adjustable Pediatric Pulmonary Valve: 6-month Outcomes In The First 50 Patients
Oliver M. Barry, MD1, Stephanie Fuller, MD2, Matthew Gillespie, MD2, Mark Galantowicz, MD3, Aimee Armstrong, MD3, Luke Wiggins, MD4, Darren Berman, MD4, Christopher Baird, MD5, Diego Porras, MD5, James Jaggers, MD6, Gareth Morgan, MD6, Jennifer Romano, MD7, Jeffrey Zampi, MD7, Joseph Turek, MD8, Gregory Fleming, MD8, Christina L. Greene, MD9, Brian Morray, MD9, Paul Chai, MD10, Dennis Kim, MD10, David Winlaw, MD11, Alan Nugent, MBBS11, Adil Husain, MD12, Mary Hunt Martin, MD12, Emile Bacha, MD1.
1Columbia University Irving Medical Center, New York, NY, USA, 2Children's Hospital of Philadelphia, Philadelphia, PA, USA, 3Nationwide Children's Hospital, Columbus, OH, USA, 4Children's Hospital Los Angeles, Los Angeles, CA, USA, 5Boston Children's Hospital, Boston, MA, USA, 6Children's Colorado, Denver, CO, USA, 7C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA, 8Duke Children's Hospital, Durham, NC, USA, 9Seattle Children's Hospital, Seattle, WA, USA, 10Children's Healthcare of Atlanta, Atlanta, GA, USA, 11Lurie Children's Hospital, Chicago, IL, USA, 12Primary Children's Hospital, University of Utah, Salt Lake City, UT, USA.
Objective(s): The Autus Size-Adjustable Valve (ASAV) is the first surgically implanted synthetic, balloon-expandable pulmonary valve designed for pediatric patients with native or repaired right ventricular outflow tracts. Primary safety and effectiveness in the first 50 patients are assessed.
Methods: This prospective, single-arm, multicenter Investigational Device Exemption study enrolled patients from 18 months to 16 years of age from both Early Feasibility and Pivotal Studies (NCT05006404). The primary safety endpoint at 30 days was freedom from device-related complications including death, valve thrombosis requiring intervention, and symptomatic thromboembolism. The primary effectiveness endpoint at 6 months was mean RVOT gradient ≤40 mmHg, and <moderate pulmonary regurgitation by transthoracic echocardiogram, and no reintervention except for valve expansion to address prosthesis-patient mismatch.
Results: Twelve U.S. centers enrolled 50 patients, with median age, weight, and body surface area at implant of 9 years (range 1.9-16.2 years), 25.9 kg (range, 10.2-71.7 kg)
, and 0.96 m
2 (range, 0.48-1.73 m
2), respectively. Tetralogy of Fallot with pulmonary stenosis was the primary diagnosis in 29 (58%) patients. We will report primary safety and effectiveness endpoints to complete 6-month follow-up (n=11 Early Feasibility Study and n=39 Pivotal Study). This abstract is promissory since these data are embargoed secondary to FDA review.
Conclusions: The primary safety and efficacy outcomes in this combined IDE cohort will provide insights into safety and early clinical performance of the novel pediatric ASAV. Patients will be followed through 10 years.
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