We report our experience with the use of covered stents for the management of coarctation of the aorta. From December 2001 to March 2004, nine patients (seven males; median age, 31 years; mean weight, 65 +/- 15 kg) underwent implantation. Indications included critical or atretic native coarctation (n = 4), patients >50 years of age (n = 2), associated patent ductus arteriosus (n = 1) or adjacent aneurysm (n = 1), and the presence of a circumferential fracture within a previously implanted stent (n = 1). The covered balloon-expandable Cheatham-Platinum stent and the self-expandable stent graft Braile were employed. Adequate implantation was observed in all patients. Gradients were reduced from 54 +/- 14 to 3 +/- 8 mmHg and the coarctation site increased from 2.4 +/- 2.9 to 15.9 +/- 4.3 mm. The patent ductus arteriosus was immediately closed and the aneurysm excluded. Two patients >35 years with aneurysmal ascending aorta and metallic aortic prosthesis had aneurysm formation at follow-up, with one undergoing aneurysm exclusion using a Braile stent. Although covered stents are useful in the management of selected patients with coarctation, aneurysm formation may still occur in patients with markers of aortic wall weakness. Refinements in the deployment technique and/or the stent design are needed to eliminate this risk.

Objectives: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. Background: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. Methods: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. Results: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. Conclusions: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier:

The cardiac catheterization laboratory plays an important role in the management of children with congenital heart disease by not only enabling diagnosis but, in many cases, providing definitive therapy. The goal of the ALARA (As Low as Reasonably Achievable) concept as it applies to cardiac catheterization is to provide maximal diagnostic and therapeutic benefit while requiring the lowest possible radiation dose. A number of specific challenges unique to the setting of pediatric cardiac catheterization, such as higher heart rates, smaller cardiovascular structures, smaller body size, and wider variety of unusual anatomic variants with the potential need for relatively lengthy and complex studies, result in relatively high radiation doses (to the patient and, consequently, to laboratory personnel). In addition, the improved survival of patients with complex anatomy (e.g., palliated single ventricle anatomies) implies that many such children with chronic cardiac disease require frequent catheterizations within the first few years of life. These factors, coupled with the increased radiosensitivity of children and a longer lifespan ahead of them in which to possibly develop radiation-related sequelae, converge to create potentially ominous consequences. Attention to basic rules of radiation safety is, therefore, of tremendous importance in the pediatric cardiac catheterization laboratory. This review focuses on the importance of adequate planning of the study, optimizing image formation, management of fluoroscopy and cine angiography parameters, and the use of certain equipment features that might allow the cardiologist to lower the radiation dose without sacrificing image quality.

Percutaneous closure of PDA should be considered even in infants ≤6 kg.