Successful Implantation of the Alterra Adaptive Prestent At NewYork-Presbyterian Morgan Stanley Children's Hospital
In July, the pediatric interventional cardiologists at NewYork-Presbyterian Morgan Stanley Children’s Hospital were among the first in the US to successfully implant the Edwards Alterra Adaptive Prestent in two congenital heart disease (CHD) patients as part of a FDA pivotal trial of the novel device.
“The Alterra Adaptive Prestent is a self-expanding, partially covered stent designed to reduce the size of large right ventricular outflow tracts (RVOTs) and provide a landing zone for the Edwards SAPIEN 3 transcatheter heart valve,” explains Dr. Alejandro Torres, Director of Pediatric Cardiac Catheterization Laboratories at NewYork-Presbyterian Morgan Stanley Children’s Hospital, who performed the two procedures with Dr. Mariel Turner, Associate Director of the Cardiac Catheterization Laboratory. “If proven safe and effective, transcatheter pulmonary valve therapy with the Alterra device can be lifechanging for patients with dysfunctional RVOTs that are too large in diameter for current transcatheter valves. By being able to implant a transcatheter valve in patients with large RVOTs, we reduce the total number of surgeries they may need over their lifetime.”
Patients who have undergone previous surgery on the RVOT, such as those born with Tetralogy of Fallot, a congenital heart condition, often experience significant pulmonary regurgitation that requires multiple sequential pulmonary valve replacements. “The mean life span of a prosthetic valve is about ten years,” says Dr. Torres. “This means a 20-year-old patient would need to undergo five or six pulmonary valve replacements over his/her lifetime. This procedure enables us to interventionally place a valve, and then another valve within the valve, allowing these patients to gain possibly another 20 to 30 years before they might need to undergo open heart surgery again.”
NewYork-Presbyterian Morgan Stanley is one of only few centers in the country selected to participate in the Multi-Center, Pivotal Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Heart Valve with the Alterra Adaptive Prestent. According to study protocol, the procedure is appropriate for patients who are 20 kilos or more and meet other specific study criteria.
“Most of these procedures are performed in adolescents and adults,” says Dr. Torres. “At our center, our patients were ages 19 and 31. Both did extremely well, went home the following day, and resumed their normal lives within three to four days.”
At the NewYork-Presbyterian Pediatric Heart Valve Center, over 200 transcatheter pulmonary valves have been implanted, placing our institution among the ones with the largest experience in the US. The Interventional Cardiology Team within the Pediatric Heart Valve Center is one of the few teams in the US with a dedicated congenital cardiac catheterization laboratory and a team of fully trained interventional pediatric cardiologists with vast experience in all areas of CHD transcatheter interventions, including balloon valvuloplasty of the pulmonary, aortic and mitral valves.
“As pediatric cardiologists, we understand the complex medical needs of people who were born with congenital heart defects, which often require follow up for life,” says Dr. Torres. “Because of the complexities of CHD which fall under our area of expertise, we continue to perform procedures in grown up patients after they have transitioned to adult cardiology care.”
“Our team is extremely encouraged by the success of these two cases,” says Dr. Torres. “We look forward to our continuing evaluation of this novel approach to enhance the lives of this complex group of patients.”