Handa Nobuhiro, Yamashita Masafumi, Takahashi Toshiki, Onohara Toshihiro, Okamoto Minoru, Yamamoto Tsuyoshi, Shimoe Yasushi, Okada Masahiro, Ishibashi Yoshimitsu, Kasashima Fuminori, Kishimoto Jyunji, Mizuno Akihiro, Kei Jyun-ichi, Nakai Mikizou, Suhara Hitoshi, Endo Masamitsu, Nishina Takeshi, Furuyama Tadashi, Kawasaki Masakazu, Ueno Yoichirou
Affiliations of the National Hospital Organization Network Study Group for Abdominal Aortic Aneurysm in Japan are listed as in the Appendix.
Circ J. 2014;78(5):1104-11. doi: 10.1253/circj.cj-14-0131. Epub 2014 Mar 21.
The objective of the present study was to assess the hypothesis that the introduction of endovascular aneurysm repair (EVAR) into Japan has expanded the indication of abdominal aortic aneurysm (AAA) repair without increasing surgical mortality.
From 10 national hospitals, we registered a total of 2,154 consecutive patients (Open surgery [OS]: n=1,577, EVAR: n=577) over 8 years, divided into 4 time periods: Group I (2005-2006: n=522), Group II (2007-2008: n=475), Group III (2009-2010: n=551), Group IV, (2011-2012: n=606). Mean age increased over the 4 time periods (P<0.0001). The incidences of COPD, smoking history, history of abdominal surgery and concomitant malignancy significantly increased as well, while the numbers of patients with preoperative shock or high ASA status reduced over time. The proportion of EVAR in AAA repair increased from: 0% in Group I, 11.6% in Group II, 41.0% in Group III, to 48.8% in Group IV (P<0.0001). Early mortality was 0.8% in the EVAR and 3.4% in the OS (P<0.001) groups. Survival rates among the 4 groups free of all-cause death and aneurysm-related death at 1 year were 92.1-96.3% (P=0.1555) and 95.5-96.8% (P=0.9891), respectively. Multiple logistic regression analysis for surgical death failed to demonstrate survival advantage of EVAR over OS.
Introduction of EVAR expanded the indication of AAA repair without increasing mortality, while high risk for anesthesia and emergency cases reduced over time. UMIN-CTR (UMIN000008345).
本研究的目的是评估以下假设:在日本引入血管内动脉瘤修复术(EVAR)扩大了腹主动脉瘤(AAA)修复的适应症,且未增加手术死亡率。
我们从10家国立医院登记了8年间连续收治的2154例患者(开放手术[OS]:n = 1577,EVAR:n = 577),分为4个时间段:第一组(2005 - 2006年:n = 522),第二组(2007 - 2008年:n = 475),第三组(2009 - 2010年:n = 551),第四组(2011 - 2012年:n = 606)。在这4个时间段内,平均年龄有所增加(P < 0.0001)。慢性阻塞性肺疾病(COPD)、吸烟史、腹部手术史和合并恶性肿瘤的发生率也显著增加,而术前休克或高美国麻醉医师协会(ASA)分级状态的患者数量随时间减少。EVAR在AAA修复中的比例从第一组的0%、第二组的11.6%、第三组的41.0%增加到第四组的48.8%(P < 0.0001)。EVAR组的早期死亡率为0.8%,OS组为3.4%(P < 0.001)。4组在1年时无全因死亡和动脉瘤相关死亡的生存率分别为92.1 - 96.3%(P = 0.1555)和95.5 - 96.8%(P = 0.9891)。对手术死亡进行的多因素逻辑回归分析未能证明EVAR相对于OS具有生存优势。
EVAR的引入扩大了AAA修复的适应症且未增加死亡率,同时麻醉高风险和急诊病例随时间减少。日本大学医学信息网络临床试验注册编号(UMIN000008345)