Cryo-balloon angioplasty for pulmonary vein stenosis in pediatric patients.

This study sought to determine the safety and effectiveness of cryo-balloon angioplasty (CbA) for pulmonary vein stenosis (PVS) in pediatric patients. Current therapy options for PVS are less than satisfactory due to recurrent progressive restenosis and neointimal proliferation. Catheterization database, hospital records, imaging studies, and pathologic specimens were reviewed for procedural-related and outcomes data in all patients who underwent pulmonary vein (PV) CbA using the Boston Scientific PolarCath Peripheral Dilation System between August 2006 and June 2009. Thirteen patients (19 PVs; median age 13 months [range 3.5 months to 18.5 years] and weight 7.9 kg [range 3.8 to 47.7]) underwent CbA. Mean PVS diameter after CbA increased from 2.19 (± 0.6) to 3.77 (± 1.1) mm (p < 0.001). Mean gradient decreased from 14 (± 7.4) to 4.89 (± 3.2) mm Hg (p < 0.001). Mean stenosis-to-normal vein diameter ratio increased from 0.52 (± 0.15) to 0.89 (± 0.33) (p < 0.001). Eight patients underwent repeat catheterization a mean of 5.6 months (± 3.66) later. Improved PVS diameter was maintained in 2 PVs. Four veins had restenosis but maintained diameters greater than that before initial CbA. In 11 PVs, the diameter decreased from 4.28 (± 1.14) to 2.53 (± 0.9) mm (p = 0.001). Mean gradient increased from 3.55 (± 3.0) to 14.63 (± 9.6) mm Hg (p = 0.011). All vessels underwent repeat intervention with acute relief of PVS. Stroke occurred within 24 h of CbA in 1 patient. CbA of PVS is safe and results in acute relief of stenosis. However, CbA appears minimally effective as the sole therapy in maintaining long-term relief of PVS.