Use of the novel curved GOKU balloon catheter for acute-angled lesions in palliative surgery for congenital heart disease: comparison with a conventional straight balloon

Obstruction develops commonly at the acute-angled portion of the vessels following palliative surgery, such as systemic-pulmonary shunt (SP shunt), right ventricle-to-pulmonary artery shunt (RV-PA shunt) in the Norwood-Sano procedure for hypoplastic left heart syndrome, and cavopulmonary (Glenn) anastomosis. Although balloon angioplasty is a treatment option, dilation with existing straight balloons is sometimes ineffective and technically complicated because of balloon slippage and target vessel distortion. In this study, we investigated the effectiveness of a curved GOKU balloon catheter for balloon angioplasty in postoperative acute-angled lesions associated with palliative surgery for congenital heart disease. We reviewed patients who underwent balloon angioplasty for angled lesions complicated by SP shunt, RV-PA shunt, or Glenn anastomosis, using the novel curved GOKU or a conventional balloon catheter, such as a Sterling balloon catheter. We evaluated patients' backgrounds, balloon specifications, target lesion anatomical features and angles, and short-term outcomes. We evaluated 45 procedures in 18 patients. A curved GOKU was used in 20 procedures, and a Sterling balloon in 25 procedures. The angulation of the lesions at maximum balloon inflation was significantly smaller using a curved GOKU vs a Sterling balloon [70-120 (mean ± standard deviation, 97 ± 40) degrees vs 110-180 (149 ± 46) degrees, respectively; p < 0.001], while the original angle was similar between the groups. Patients' short-term outcomes with the curved GOKU were excellent, with a significantly better percent increase in minimum lumen diameter of 0-220% (92% ± 66%) vs 0-46% (18% ± 15%) with the Sterling balloon (p < 00.1) and with less frequent balloon slippage. The curved GOKU was more effective in balloon angioplasty for acute-angled lesions compared with a conventional straight balloon, likely because of better conformability to the lesion angle and slip resistance.