Piccolo in transcatheter PDA closure multi-centre study from premature to adolescent children
Osman Baspinar1, Nazmi Narin2, Ali Baykan3
1Pediatric Cardiology, Gaziantep University Medical Faculty, Gaziantep, Turkey.
Insights
The Amplatzer Piccolo Occluder is safe and effective for closing patent ductus arteriosus in infants and children. This device demonstrates a high success rate with minimal complications, making it ideal for various age groups.
Area of Science:
- Cardiology
- Pediatric Cardiology
- Interventional Cardiology
Background:
- Patent ductus arteriosus (PDA) is a common congenital heart defect.
- Timely closure of PDA is crucial for infant health.
- The Amplatzer Piccolo Occluder is a device designed for PDA closure.
Purpose of the Study:
- To evaluate the mid- to long-term efficacy and safety of the Amplatzer Piccolo Occluder.
- To assess the device's performance across different age groups, including premature infants.
- To analyze procedural success rates and complication profiles.
Main Methods:
- A multi-center study involving 645 patients (152 < 1 month old) from 2016-2021.
- Patients underwent PDA closure using the Amplatzer Piccolo Occluder.
- Data collected included patient demographics, ductal anatomy, procedural details, follow-up duration (mean 20.4 months), and outcomes.
Main Results:
- Procedure success rate was 99.1%.
- Low rates of complications: device embolisation (2%), left pulmonary artery stenosis (0.4%), and descending aorta stenosis (0.5%).
- The device showed efficacy in all age groups, including premature and newborn infants, with a low residual shunt rate.
Conclusions:
- The Amplatzer Piccolo Occluder is a safe and effective option for PDA closure in infants and children.
- Its low-profile design and small delivery catheter facilitate use in premature neonates.
- The device's symmetry allows for both venous and arterial approaches, positioning it as a near-ideal occluder.
Abstract:
In this multi-centre study, the mid- to long-term efficacy and safety of the Amplatzer Piccolo Occluder in patent ductus arteriosus closure in premature and term infants as well as children were discussed. Methods. Between 2016 and 2021, 645 patients, 152 of whom were less than 1 month old, underwent ductus closure with the Piccolo device from five different centres in Turkey. The median age of the patients was 2.2 years, and the mean narrowest point of duct diameter was 1.8 mm. Sixty-two patients weighed ≤ 1.5 kg, 90 patients 1.5-3 kg, and the mean follow-up was 20.4 months. In 396, the duct was closed by the retrograde route. Ductal anatomy was Type A in 285, C in 72, E in 171, and F in 64 patients. Fluoroscopy duration was 6.2 min. The procedure success rate was 99.1%. Device embolisation occurred in 13 patients (2%), and 11 were retrieved with a snare. Cardiac perforation and death developed in one premature baby. The left pulmonary artery and the descending aorta stenosis were observed in 3 (0.4%) and in 5 patients (0.5%). Results. Piccolo device is safe and effective in closing ductus in all age groups. It has low profile for use in premature and newborn babies, a small embolisation risk, and a low residual shunt rate after closure. Conclusion. The Piccolo device can be considered as close an ideal occluder. The lower profile, smaller delivery catheter size, and symmetry of this device allow for a venous or arterial approach.
