Background Balloon pulmonary angioplasty (BPA), a novel technique initially introduced as a treatment for inoperable chronic thromboembolic pulmonary hypertension, is now increasingly being performed in a broader spectrum of patients. Here, we performed a time-trend analysis of the characteristics and in-hospital outcomes of patients who underwent BPA in Japan, using data extracted from nationwide procedure-based registration system. Methods The Japanese Structural Heart Disease (J-SHD) registry was established and sponsored by the Japanese Association of Cardiovascular Intervention and Therapeutics and aims to provide basic statistics on the performance of structural interventions in Japan. J-SHD registers cases from approximately 200 institutions, representing more than 90% of SHD intervention-performing hospitals in the nation. We analysed the registered BPA data elements from January 2015 to December 2018. Successful BPA was defined as a session in which a physician successfully treated all targeted lesions. Results There were a total of 2512 BPA sessions; the number of institutions and registered sessions increased from 30 to 50 sites and from 479 to 852 sessions during the study period, respectively. The average age of the patients was 66±13 years, and 72.1% were women. In-hospital death was observed in 0.2%, and the total complications rate was 5.3%. The preoperative and postoperative mean pulmonary artery pressure were 32±11 mm Hg and 30±10 mm Hg, respectively. Conclusion The number of BPA sessions increased during the study period, with an acceptable in-hospital complication rate. Data are available upon reasonable request. The data elements were collected from the Japanese Structural Heart Disease (J-SHD) registry, which was established in 2012 and is a prospective Japanese nationwide multicentre registry founded by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) designed to collect clinical variables and short-term outcome data on patients with SHD. The mission of CVIT is to further our understanding of cardiovascular intervention and establish its procedural safety. Today, the database has grown to become one of the largest healthcare procedural database with more than 20 000 SHD intervention cases registered annually (excluding transcatheter aortic valve replacement, which is registered onto J-TVT registry) from approximately 200 institutions in Japan representing more than 90% of all SHD intervention-performing hospitals in the nation. Importantly, case registrations in the J-SHD registry are essential for coronary interventionalist and educating hospital certification. This study protocol was approved by the institutional review board (). The BPA data, which are one of the components of the J-SHD, were collected from 2015. The CVIT registry subcommittee designed a software for a web-based data collection system through the National Clinical Database. Data managers in the participating hospitals submit data through this system annually. Because registration in the J-SHD database is mandatory for board certification and renewal applications, data completeness is high, although participation in the J-SHD is voluntary. This study protocol was approved by the relevant committee and the Board of Directors of the CVIT.

中文翻译：

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接受球囊肺血管成形术治疗慢性血栓栓塞性肺动脉高压患者的特征和住院结果：来自日本全国登记处的时间趋势分析

背景 球囊肺血管成形术 (BPA) 是一种新技术，最初是作为治疗无法手术的慢性血栓栓塞性肺动脉高压而引入的，现在越来越多地在更广泛的患者中进行。在这里，我们使用从全国范围内基于程序的注册系统中提取的数据，对日本接受 BPA 的患者的特征和住院结果进行了时间趋势分析。方法 日本结构性心脏病 (J-SHD) 登记处由日本心血管干预和治疗协会建立和赞助，旨在提供日本结构性干预表现的基本统计数据。J-SHD 登记了大约 200 个机构的病例，占全国执行 SHD 干预的医院的 90% 以上。我们分析了 2015 年 1 月至 2018 年 12 月注册的 BPA 数据元素。成功的 BPA 定义为医生成功治疗所有目标病变的会话。结果 BPA 会话总数为 2512 个；在研究期间，机构和注册会话的数量分别从 30 个站点增加到 50 个站点和从 479 个会话增加到 852 个会话。患者的平均年龄为66±13岁，72.1%为女性。院内死亡发生率为 0.2%，总并发症发生率为 5.3%。术前和术后平均肺动脉压分别为 32±11 mm Hg 和 30±10 mm Hg。结论 在研究期间，BPA 治疗次数增加，院内并发症发生率可接受。可应合理要求提供数据。这些数据元素是从日本结构性心脏病 (J-SHD) 登记处收集的，该登记处成立于 2012 年，是日本心血管干预和治疗协会 (CVIT) 成立的前瞻性日本全国多中心登记处，旨在收集临床变量和SHD 患者的短期结果数据。CVIT 的使命是加深我们对心血管干预的理解并建立其程序安全性。如今，该数据库已发展成为最大的医疗程序数据库之一，每年注册的 SHD 干预病例超过 20 000 例（不包括经导管主动脉瓣置换术、它在 J-TVT 登记处注册）来自日本大约 200 家机构，占全国所有 SHD 干预医院的 90% 以上。重要的是，J-SHD 登记处的病例登记对于冠状动脉介入医师和教育医院认证至关重要。该研究方案得到了机构审查委员会的批准（）。BPA 数据是 J-SHD 的组成部分之一，从 2015 年开始收集。CVIT 注册小组委员会通过国家临床数据库为基于网络的数据收集系统设计了一个软件。参与医院的数据管理人员每年通过该系统提交数据。由于董事会认证和更新申请必须在 J-SHD 数据库中注册，因此数据完整性很高，尽管参与 J-SHD 是自愿的。该研究方案得到了 CVIT 相关委员会和董事会的批准。