Transcatheter Closure of Patent Ductus Arteriosus with the Amplatzer Piccolo Occluder
Presenter
Brian H. Morray, M.D., FSCAI, Seattle Children's Hospital, Seattle, WA
Brian H. Morray, M.D., FSCAI, Seattle Children's Hospital, Seattle, WA
Keywords: Structural Non-Valvular Interventions
Background:
Patent ductus arteriosus (PDA) is a persistence of the fetal connection (ductus arteriosus) between the pulmonary artery and aorta that may result in a pathological left-to-right shunt and produce symptoms of heart failure. The Amplatzer Piccolo Occluder is a device with features uniquely suited to treat PDA in premature infants.
Methods:
A single arm, prospective, investigational study was conducted to test the efficacy and safety in patients ≥ 700 g with PDA ≤ 4 mm in diameter. The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus (defined by echocardiography as a grade 0 or grade 1 shunt) at the 6-month follow-up visit. The primary safety endpoint is the rate of major complications through 180 days after device implant.
Results:
One hundred and twenty-four (50 pivotal IDE and 74 continued access) patients were enrolled at 9 centers, with 58 patients weighing ≤ 2 kg. Enrollment is currently ongoing in the continued access protocol. Implant success was 95% (118/124) overall and 98% in patients ≤ 2 kg (57/58). All subjects ≤ 2 kg were implanted via an anterograde (venous) implant approach. All 6 procedural failures underwent alternative successful PDA closure. Effective closure of the ductus was observed in all patients that completed the 6-month follow-up visit. In patients ≤ 2 kg there was no left pulmonary artery (LPA) stenosis and no aortic coarctation at 6 months. No major complications were reported. Serious adverse events that did not meet the definition of the primary safety endpoint occurred in 5 subjects (4%).
Conclusions:
The low rate of device and procedure related serious adverse events and the high rate of PDA closure observed in this study supports the safety and effectiveness of this device in pediatric patients, particularly those < 2 kg where there is currently a significant unmet need.