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

Abstract

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.