Novel Curved Balloon Catheter for Dilating Postoperative Angled Lesions Associated with Congenital Heart Disease

Abstract

Although further clinical evaluation is necessary, this novel curved balloon may be a reasonable alternative in angled lesions, providing better conformability and preventing excessive stress to the vessel wall adjacent to the stenosis.

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

“…We previously assessed the wall stress distribution in a curved vessel model, and found that the curved GOKU naturally curved to the lesser curvature and generated uniform stress on both the greater and lesser curvatures, whereas the straight balloons caused disproportionate stress on each side of the wall [12] . In the initial report evaluating the curved GOKU, all procedures were completed because the curved balloon naturally conformed well to the angled lesion without slipping, while the authors speculated that the curved GOKU may reduce the risk of vessel damage associated with disproportionate stress caused by straight balloons [12] . In the current study, our findings suggested that the curved GOKU is advantageous not only in reducing complications but also in contributing to better short-term outcomes.…”

“…In our patients, the original angles of the lesions ranged from 70 to 110 (mean, 85) degrees in the groups. In bench testing, the curved angle of the curved GOKU is 90°, 88°, and 80° at 10, 13, and 18 atmospheres, respectively [12 , 13] . Given this property of the balloon and the patients’ lesion angles, we consider the curved GOKU may be particularly useful for lesions more acute than approximately 90°.…”

“…In SP shunt and RV–PA shunt, we selected a balloon diameter 1–2-mm larger than the diameter of the expanded polytetrafluoroethylene (ePTFE) graft used for the previous surgery, while in the Glenn anastomosis, we used a balloon measuring either 1–3 times to than the minimal lumen diameter, or not exceed 1.5 times of the reference vessel diameter. The curved GOKU was selected by operator’s preference based on the initial clinical experience [12] .…”

“…The nominal and burst pressures are 13 atm and 18 atm for the 2-cm and 4-cm lengths, respectively. We previously reported the results of an in vitro study evaluating vessel wall stress caused by an inflated curved GOKU in a curved vessel model and our initial clinical experience in five cases [12] . The results suggested that this balloon may be a reasonable alternative in angled lesions, providing better conformability and preventing excessive stress to the vessel wall adjacent to the stenosis.…”

Stenting for curved lesions using a novel curved balloon: Preliminary experimental study

“…Materials and methods: In vitro experiments: A Palmaz Genesis 1 stent (Johnson & Johnson, Cordis Co, Bridgewater, NJ, USA) mounted on the Goku 1 curve (Tokai Medical Co. Nagoya, Japan) was dilated in vitro to observe directly the behavior of the stent and balloon assembly during expansion. Animal experiment: A short Express 1 Vascular SD (Boston Scientific Co, Marlborough, MA, USA) stent and a long Express 1 Vascular LD stent (Boston Scientific) mounted on the curved balloon were deployed in the curved vessel of a pig to observe the effect of stenting in vivo. Results: In vitro experiments: Although the stent was dilated in a curved fashion, stent and balloon assembly also rotated conjointly during expansion of its curved portion.…”