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Stent Implantation for Congenital Heart Diseases in Japan ― Comprehensive Analysis From the Japanese Society of Congenital Interventional Cardiology Registry ―
Circulation Journal ( IF 3.3 ) Pub Date : 2021-08-25 , DOI: 10.1253/circj.cj-20-0915
Hideshi Tomita 1 , Sung-Hae Kim 2 , Ryo Inuzuka 3 , Hikoro Matsui 3 , Hisateru Tachimori 4 , Tohru Kobayashi 5 , Atsuko Kato 6 , Takanari Fujii 1 , Yuji Haishima 7 , Yoshihiro Okamoto 7 , Hideyuki Sakoda 7
Affiliation  

Background:Stent implantation for vascular stenosis associated with congenital heart diseases is commonly performed as an off-label procedure in Japan because there is no officially approved stent for any congenital heart disease.

Methods and Results:We analyzed data from the Japanese Society of Congenital Interventional Cardiology Registry collected from January 2016 to December 2018. Patients who underwent stent implantation were enrolled in the present analysis. During the study period, there were 470 procedures, 443 sessions, and 391 cases. Of 443 sessions, 427 (96.4%) succeeded procedurally. There were no differences in the procedural success rates among age groups. In all, 416 sessions (367 patients; 94%) resulted in survival to 30 days after catheter intervention. Of 392 admissions, 357 patients (91%) survived to discharge. Only 4 deaths were directly related to stent implantation. Some in-hospital complications were observed during 55 of 443 sessions. Both hospital deaths and serious complications were significantly more frequent in the group with various preoperative risk factors.

Conclusions:Although not officially approved for congenital heart diseases in Japan, stent implantation in congenital heart diseases has been widely and routinely performed for many years with safety and efficacy. The aim of stenting was variable and broad because of many different applications and morphological variations. These data may facilitate approval of such an important device in Japan.



中文翻译:

日本先天性心脏病支架植入术 ― 日本先天性介入心脏病学注册学会综合分析 ―

背景:用于先天性心脏病相关血管狭窄的支架植入在日本通常作为标签外手术进行,因为没有官方批准的用于任何先天性心脏病的支架。

方法和结果:我们分析了从 2016 年 1 月至 2018 年 12 月收集的日本先天性介入心脏病学会登记处的数据。接受支架植入的患者被纳入本分析。在研究期间,共有470个程序,443个疗程和391个案例。在 443 次会议中,427 次(96.4%)在程序上成功。不同年龄组的手术成功率没有差异。总共有 416 次治疗(367 名患者;94%)在导管介入后存活至 30 天。在 392 名入院患者中,357 名患者 (91%) 存活出院。只有 4 例死亡与支架植入直接相关。在 443 次治疗中有 55 次观察到一些院内并发症。在具有各种术前危险因素的组中,医院死亡和严重并发症的发生率明显更高。

结论:虽然在日本尚未正式批准用于先天性心脏病,但先天性心脏病的支架植入已被广泛常规进行多年,并且安全有效。由于许多不同的应用和形态变化,支架植入的目的是可变的和广泛的。这些数据可能有助于在日本批准这样一个重要的设备。

更新日期:2021-08-24
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