Kimura Yuki, Ohtsu Hiroshi, Yonemoto Naohiro, Azuma Nobuyoshi, Sase Kazuhiro
Clinical Pharmacology and Regulatory Science, Juntendo University School of Medicine Graduate School of Medicine, Bunkyo-ku, Japan.
Leading Center for the Development and Research of Cancer Medicine, Juntendo University, Bunkyo-ku, Japan.
BMJ Surg Interv Health Technol. 2022 Jul 29;4(1):e000131. doi: 10.1136/bmjsit-2022-000131. eCollection 2022.
Endovascular aortic repair (EVAR) evolved through competition with open aortic repair (OAR) as a safe and effective treatment option for appropriately selected patients with abdominal aortic aneurysm (AAA). Although endoleaks are the most common reason for post-EVAR reintervention, compliance with lifelong regular follow-up imaging remains a challenge.
Retrospective data analysis.
The Japan Medical Data Center (JMDC), a claims database with anonymous data linkage across hospitals, consists of corporate employees and their families of ≤75 years of age.
The analysis included participants in the JMDC who underwent EVAR or OAR for intact (iAAA) or ruptured (rAAA) AAA. Patients with less than 6 months of records before the aortic repair were excluded.
Overall survival and reintervention rates.
We identified 986 cases (837 iAAA and 149 rAAA) from JMDC with first aortic repairs between January 2015 and December 2020. The number of patients, median age (years (IQR)), follow-up (months) and post-procedure CT scan (times per year) were as follows: iAAA (OAR: n=593, 62.0 (57.0-67.0), 26.0, 1.6, EVAR: n=244, 65.0 (31.0-69.0), 17.0, 2.2), rAAA (OAR: n=110, 59.0 (53.0-59.0), 16.0, 2.1, EVAR: n=39, 62.0 (31.0-67.0), 18.0, 2.4). Reintervention rate was significantly higher among EVAR than OAR in rAAA (15.4% vs 8.2%, p=0.04). In iAAA, there were no group difference after 5 years (7.8% vs 11.0%, p=0.28), even though EVAR had initial advantage. There were no differences in mortality rate between EVAR and OAR for either rAAA or iAAA.
Claims-based analysis in Japan showed no statistically significant difference in 5-year survival rates of the OAR and EVAR groups. However, the reintervention rate of EVAR in rAAA was significantly higher, suggesting the need for regular post-EVAR follow-up with imaging. Therefore, international collaborations for long-term outcome studies with real-world data are warranted.
血管内主动脉修复术（EVAR）是在与开放主动脉修复术（OAR）的竞争中发展起来的，对于经过适当选择的腹主动脉瘤（AAA）患者而言，它是一种安全有效的治疗选择。尽管内漏是EVAR术后再次干预的最常见原因，但坚持终身定期进行随访成像仍是一项挑战。
回顾性数据分析。
日本医疗数据中心（JMDC）是一个跨医院匿名数据链接的索赔数据库，由75岁及以下的企业员工及其家属组成。
分析纳入了JMDC中因完整（iAAA）或破裂（rAAA）AAA接受EVAR或OAR治疗的参与者。排除主动脉修复术前记录少于6个月的患者。
总生存率和再次干预率。
我们从JMDC中识别出986例首次主动脉修复的病例（837例iAAA和149例rAAA），时间跨度为2015年1月至2020年12月。患者数量、中位年龄（岁（四分位间距））、随访时间（月）和术后CT扫描次数（每年）如下：iAAA（OAR：n = 593，62.0（57.0 - 67.0），26.0，1.6；EVAR：n = 244，65.0（31.0 - 69.0），17.0，2.2），rAAA（OAR：n = 110，59.0（53.0 - 59.0），16.0，2.1；EVAR：n = 39，62.0（31.0 - 67.0），18.0，2.4）。在rAAA中，EVAR的再次干预率显著高于OAR（15.4%对8.2%，p = 0.04）。在iAAA中，5年后两组无差异（7.8%对11.0%，p = 0.28），尽管EVAR最初具有优势。对于rAAA或iAAA，EVAR和OAR的死亡率均无差异。
日本基于索赔的分析显示，OAR组和EVAR组的5年生存率无统计学显著差异。然而，rAAA中EVAR的再次干预率显著更高，这表明EVAR术后需要定期进行成像随访。因此，开展基于真实世界数据的长期结局研究的国际合作很有必要。
