講演情報
[III-P01-1-02]JCIC-Rを用いた本邦における先天性心疾患のバルーン拡張術の実態
○加藤 温子1, 立森 久照2,6, 犬塚 亮3, 金 成海4, 松井 彦郎3, 藤井 隆成5, 喜瀬 広亮5, 藤本 一途8, 隈丸 拓6, 小林 徹7, 富田 英5 (1.大阪大学大学院 医学系研究科 小児科学, 2.慶應義塾大学医学部 医療政策・管理学教室, 3.東京大学医学部附属病院 小児科, 4.静岡県立こども病院 循環器科, 5.昭和大学病院 小児循環器・成人先天性心疾患センター, 6.東京大学大学院 医学系研究科 医療品質評価学講座, 7.国立成育医療研究センター 臨床研究センター データサイエンス部門, 8.国立循環器病研究センター 小児循環器内科)
キーワード：
nationwide registry、balloon dilation、device lag
Background: Balloon angioplasty plays a vital role in managing congenital heart disease. However, in Japan, the unavailability of large high-pressure balloons and vascular stents limits treatment options. This study leverages data from the Japanese Society of Congenital Interventional Cardiology registry (JCIC-R) to evaluate outcomes of balloon dilation under these constraints and assess the clinical need of device development.Methods and Results: A total of 4,902 procedures in 2766 patients who underwent balloon angioplasty from 2016 to 2018 in JCIC-R were analyzed between those who had single-balloon dilation (SB, 94.0%) and the others who had double-balloon dilation (DB, 6.4%). DB was utilized in larger patients (9.0 kg vs 22.4 kg, p＜0.001) in larger lesions (6.4% vs 39.4%, p＜0.001) with pulmonary arteries (PA) being the main target in both groups (66.2%). Serious adverse events were 1.3% without significant difference between groups. Subgroup analysis of PA with pre-procedural minimal lumen diameter (MLD)＞6 mm showed larger MLD (8.2 mm vs 7.3 mm, p=0.003) and higher stenosis (30 mmHg vs 17 mmHg, p=0.011) in DB, requiring longer procedure time (132 vs 108 minutes, p=0.002). Despite these differences, procedural effectiveness was similar and unsatisfactory (23% vs 29%, p=0.5). Conclusion: Balloon angioplasty is a commonly performed but somewhat limited in efficacy, highlighting the urgent need for advanced approved devices like large high-pressure balloons and vascular stents to improve outcomes for patients with congenital heart disease in Japan.