Initial experience with IntraTherapeutics IntraStent DoubleStrut LD stents in patients with congenital heart defects

Limitations of the currently available balloon-expandable stainless steel (BE-SS) stents for use in patients with congenital heart defects (CHD) include inflexibility, significant shortening with expansion, sharp ends, and limited sizes. These limitations increase risk and greatly effect success of stent placement in these patients. The recently approved IntraStent DoubleStrut LD (IS-LD) stents are BE-SS stents designed to address such limitations. We report our initial experience with IS-LD stents in patients with CHD. Using standard techniques, 36 stents were implanted in 22 patients whose median age was 11 years (range, 1.4-35 years) and weight was 33 kg (range, 9-96.8 kg). Lesions stented included aortic coarctation (4), branch pulmonary arteries (19), inferior or superior vena cava (11), Mustard baffle (1), and Fontan baffle (1). All attempts at stent placement were successful. Hemodynamic assessment and angiography was performed pre- and post-stent placement in all patients. Intravascular ultrasound was performed in four patients. Stenosis diameter increased from 5.7 +/- 0.6 mm (mean +/- SD) to 11.6 +/- 0.5 mm (P < 0.001). Stents did not shorten significantly with dilation (median percent shortening, 3.8%; P > 0.1). Complications included stent recoil (2), stent migration (1), and stent distortion (1). IS-LD stents are a safe and effective treatment for the majority of vascular stenoses in patients with CHD. Stent recoil at large diameters may limit its usefulness in selected lesions. Follow-up studies are required to determine the long-term performance of IS-LD stents.