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Self-expanding transcatheter pulmonary valve feasible at 6 months
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A trial assessing the feasibility of a self-expanding transcatheter pulmonary valve replacement device showed high procedural success and safety rates as well as favorable device performance outcomes, according to new data published in JACC: Cardiovascular Interventions.
“Patients with congenital heart defects such as tetralogy of Fallot often are left with pulmonary regurgitation after their initial surgical repair,” Lisa Bergersen, MD, MPH, from the department of cardiology at Boston Children’s Hospital, and colleagues wrote. “This may progress over time, requiring additional interventions to establish the pulmonary competence necessary for improved long-term quality of life. Transcatheter pulmonary valve replacement is a new, less invasive alternative to surgery for pulmonary valve replacement.”
To obtain in vivo data on device loading conditions and assess procedural feasibility, safety and valve performance at 6 months in patients with severe pulmonary regurgitation who require pulmonary valve replacement, Bergersen and colleagues conducted a nonrandomized, prospective, multicenter study of the self-expanding transcatheter pulmonary valve replacement device (Harmony, Medtronic) between May 2013 and May 2015.
The early feasibility study included 66 patients, 21 of whom were approved for implant and underwent catheterization (median age, 25 years). Of those, 20 were implanted with the device.
According to the researchers, patients who underwent catheterization were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%) and had slight or mild stenosis.
Ninety-five percent of patients had the device delivered to the desired location.
Proximal migration occurred in one patient during delivery system removal. Two devices were surgically explanted during the study.
Three patients had procedure-related premature ventricular contractions, two of which were resolved without treatment.
There was one instance of ventricular arrhythmia that required treatment and was later resolved.
Echocardiography at 1 month revealed little to no pulmonary regurgitation in all patients and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range, 6-31).
“The device was limited to a small group of patients due to anatomical constraints; however, with the development of more implant sizes, the Harmony [transcatheter pulmonary valve] has the potential to serve a larger patient population that currently lacks [transcatheter pulmonary valve replacement] technology,” the researchers wrote. – by Dave Quaile
Disclosures: The study was funded by Medtronic. Bergersen reports she is a consultant for 480 Biomedical. Please see the study for all other authors’ relevant financial disclosures.
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