LB13. Novel Size-Adjustable Pulmonary Valve U.S. Early Feasibility Study: 1-year Outcomes

Objective: This size-Adjustable Valve(AV) is a novel surgically implanted expandable synthetic pulmonary valve. Mimicking the geometric profile of the human femoral venous valve, the bileaflet AV features a size-adjustable frame with expanded polytetrafluorethylene (ePTFE) leaflets that maintain competency over a functional diameter range of 12.7mm to 22mm (internal diameter, ID), Figure 1. The AV is designed to be size-adjusted at implant to match the patient's body surface area (BSA). The AV may be size-adjusted post-implant via transcatheter balloon dilation to accommodate somatic growth. We report 1-year results of the first-in-human size-Adjustable Valve Early Feasibility IDE study.

Methods: This was a prospective, single-arm, multi-center study to evaluate safety and preliminary effectiveness of the AV in pediatric patients aged 18 months to 16 years requiring pulmonary valve replacement. Primary endpoints were freedom from a device-related complication (death, valve thrombosis, thromboembolism) as adjudicated by an independent Clinical Events Committee; and clinically acceptable hemodynamic performance (defined as < moderate pulmonary regurgitation (PR) on transthoracic echocardiogram) as assessed by an independent Echo Core Lab, at 1-year post-valve implant.

Results: Eleven patients (nine male) were enrolled at 3 centers. Median age at implant was 8.2 (range, 2.7-13.6) years and BSA ranged from 0.6-1.3m2. Primary diagnoses included tetralogy of Fallot (N=8), double outlet right ventricle (N=2) and pulmonary atresia/intact ventricular septum (N=1). All had prior right ventricular outflow tract surgery. The AV was size-adjusted at implant in all patients, ranging from 14mm to 20mm ID (z-score -1 to +1). Acute procedural success (defined as RV to PA peak gradient <40 mmHg, none/trivial PR, no paravalvular leak) was achieved in all patients. Median hospital length of stay was 4 days (range, 3-5). At 1-year follow-up, 100% of patients were alive and free from device-related complications. Ten (91%) had ≤mild pulmonary stenosis and all had ≤trivial PR. One developed moderate AV stenosis due to marked somatic growth and underwent subsequent transcatheter balloon dilation without complications.

Conclusions: One-year results from this novel size-Adjustable Pulmonary Valve EFS demonstrated no significant valve insufficiency, no device-related adverse events and no thrombotic or infectious complications. The AV is now under evaluation in a Pivotal IDE study.

Mark Galantowicz (1), Corey A. Stiver (2), Oliver Barry (3), Emile Bacha (4), Kanwal Farooqi (3), Gerald Marx (5), Diego Porras (5), Christopher Baird (6), Aimee K. Armstrong (2), (1) Dept. of Cardiothoracic Surgery, Nationwide Children's Hospital, The Ohio State University, Columbus, OH, (2) The Heart Center, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, (3) Division of Pediatric Cardiology, New York-Presbyterian Hospital/ Columbia University Medical Center, New York, NY, (4) Division of CardioVascular Surgery, New York-Presbyterian Hospital/ Columbia University Medical Ctr, New York, NY, (5) Dept. of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, (6) Dept. of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA

James Quintessenza

Commentator

Dr. Quintessenza is the co-director of the Heart Institute and Professor and chief of cardiovascular surgery at Johns Hopkins All Children’s Hospital. 

Mark Galantowicz

Abstract Presenter

Mark Galantowicz, MD, is the first recipient of the Murray D. Lincoln endowed Chair of Cardiothoracic Surgery.  He is the Chief of the Department of Cardiothoracic Surgery and Co-Director of The Heart Center at Nationwide Children’s Hospital.  Dr. Galantowicz is also a Professor of Surgery at The Ohio State University College of Medicine. After receiving his undergraduate degree from the University of Pennsylvania, Dr. Galantowicz was awarded the Fulbright Scholarship to conduct molecular biology research at the University of Geneva, Switzerland. He received his medical degree from Cornell University Medical College and completed his surgical training, including fellowships in adult and pediatric cardiothoracic surgery, at Columbia-Presbyterian Medical Center.

Dr. Galantowicz joined Nationwide Children’s Hospital in 2002 to head up the Department of Cardiothoracic Surgery where he also serves as the Surgical Director of the Heart, Lung and Heart-Lung Transplantation Programs.  His clinical interests are in the areas of the surgical treatment and repair of newborns with complex congenital heart defects and cardiopulmonary transplantation. In his tenure at Nationwide Children’s he completed the hospital’s first successful heart, lung, and heart-lung transplants including some of the youngest and smallest patients in the world.  His work has helped expand the hospital’s Blood Conservation Program for congenital heart surgery, making The Heart Center an international treatment center for patients coming from all over the world.  Additionally, he helped design the country’s first Hybrid Congenital Cardiac Operating Suite, allowing the technology first developed in the Hybrid Catheterization Suites to translate into a state-of-the-art operating suite. His research interests focus on the development of innovative, less invasive strategies for the management of cardiopulmonary disease. 

Specialties: Congenital