Journal of cardiology · 2025
Balloon angioplasty for congenital heart disease in Japan - Comprehensive analysis from the Japanese Society of Congenital Interventional Cardiology Registry.
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Kato Atsuko, Tachimori Hisateru, Inuzuka Ryo, Kim Sung-Hae, Matsui Hikoro, Fujii Takanari, Kise Hiroaki, Fujimoto Kazuto, Kumamaru Hiraku, Kobayashi Tohru, Tomita Hideshi
Аннотация
BACKGROUND: Transcatheter angioplasty is an essential interventional procedure for congenital heart disease. However, in Japan, the lack of large high-pressure balloons and vascular stents limits treatment options. This study analyzes data from the Japanese Society of Congenital Interventional Cardiology registry (JCIC-R) to evaluate outcomes under these constraints and assess the need for device development.
METHODS: This study analyzed transcatheter balloon angioplasty cases recorded in the JCIC-R from 2016 to 2018. Patients were categorized into two groups according to the technique used: single-balloon (SB) and double-balloon (DB). Baseline characteristics, procedural details, effectiveness, and adverse events were compared. Effectiveness was assessed by pressure gradient and minimal lumen diameter (MLD) if recorded. A subgroup analysis focused on SB vs. DB techniques for large pulmonary artery stenosis with limited balloon availability. Propensity score matching was used to adjust for confounders.
RESULTS: There were 4,902 procedures in 2,766 patients (2016-2018) who underwent balloon angioplasty. Most (93.6 %) had SB, while 6.4 % had DB. DB was used in larger patients (22.4 kg vs 9.0 kg, p < 0.001) and larger lesions (39.4 % vs. 6.4 %, p < 0.001), with pulmonary arteries as the main target (66.2 %). Angioplasty balloons were the most used device (83.4 % of procedures); however, suboptimal balloon selection, including under-pressurized or under-sized, occurred in 7.9 % of cases. Serious adverse events were rare (1.3 %) with no significant difference between groups. In pulmonary arteries with pre-procedural MLD >6 mm, DB group showed a larger pre-procedural MLD (8.2 mm vs 7.3 mm, p = 0.003) and more severe stenosis (30 mmHg vs 17 mmHg, p = 0.011), requiring longer procedures (132 vs 108 minutes, p = 0.002). Despite differences, effective balloon dilation remained limited (23 % vs 29 %, p = 0.5).
CONCLUSION: Balloon angioplasty is widely used and relatively safe for congenital heart disease in Japan, but its effectiveness for larger lesions may improve with better access to high-pressure balloons and stents.
METHODS: This study analyzed transcatheter balloon angioplasty cases recorded in the JCIC-R from 2016 to 2018. Patients were categorized into two groups according to the technique used: single-balloon (SB) and double-balloon (DB). Baseline characteristics, procedural details, effectiveness, and adverse events were compared. Effectiveness was assessed by pressure gradient and minimal lumen diameter (MLD) if recorded. A subgroup analysis focused on SB vs. DB techniques for large pulmonary artery stenosis with limited balloon availability. Propensity score matching was used to adjust for confounders.
RESULTS: There were 4,902 procedures in 2,766 patients (2016-2018) who underwent balloon angioplasty. Most (93.6 %) had SB, while 6.4 % had DB. DB was used in larger patients (22.4 kg vs 9.0 kg, p < 0.001) and larger lesions (39.4 % vs. 6.4 %, p < 0.001), with pulmonary arteries as the main target (66.2 %). Angioplasty balloons were the most used device (83.4 % of procedures); however, suboptimal balloon selection, including under-pressurized or under-sized, occurred in 7.9 % of cases. Serious adverse events were rare (1.3 %) with no significant difference between groups. In pulmonary arteries with pre-procedural MLD >6 mm, DB group showed a larger pre-procedural MLD (8.2 mm vs 7.3 mm, p = 0.003) and more severe stenosis (30 mmHg vs 17 mmHg, p = 0.011), requiring longer procedures (132 vs 108 minutes, p = 0.002). Despite differences, effective balloon dilation remained limited (23 % vs 29 %, p = 0.5).
CONCLUSION: Balloon angioplasty is widely used and relatively safe for congenital heart disease in Japan, but its effectiveness for larger lesions may improve with better access to high-pressure balloons and stents.