Ichihashi Shigeo, Takahara Mitsuyoshi, Fujimura Naoki, Yamaoka Terutoshi, Banno Hiroshi, Shingaki Masami, Shimamura Kazuo, Kimura Fumiaki, Kurimoto Yoshihiko, Nakazawa Ken, Yasuhara Kiyomitsu, Toya Naoki, Kobayashi Yutaka, Saito Yoshiaki, Shibata Tsuyoshi, Kaneko Kenjiro, Kotani Shinsuke, Tamura Yamato, Onitsuka Seiji, Bolstad Francesco, Iwakoshi Shinichi, Sakaguchi Shoji, Tanaka Toshihiro, Kichikawa Kimihiko
Department of Diagnostic and Interventional Radiology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8521, Japan.
Department of Laboratory Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Cardiovasc Intervent Radiol. 2025 Apr;48(4):438-446. doi: 10.1007/s00270-025-03996-x. Epub 2025 Mar 17.
Proximal neck dilatation (PND) is a common issue after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs), being a potential cause of stent graft migration or type Ia endoleak. The ALTO stent graft, featuring a unique polymer sealing mechanism, has been reported to exhibit less PND. This study aims to compare PND and clinical outcomes between the ALTO stent graft and alternative self-expanding stent grafts.
The CustomSEAL study is a multi-center retrospective observational study involving 18 institutions in Japan. It compares EVAR outcomes using the ALTO stent graft and alternative self-expanding stent grafts for fusiform AAAs. The primary outcome measure was the difference in PND at 12 months post-EVAR. Secondary outcome measures included aneurysm sac diameter changes, reintervention rates, and mortality outcomes during the follow-up.
After propensity score matching, 111 patient pairs were extracted. Baseline characteristics, including proximal neck length/diameter and stent graft oversizing, were comparable between groups. The ALTO stent graft was associated with significantly less PND at 12 months (2.3% vs. 26.7%, P < 0.001). There were no significant differences in perioperative outcomes, aneurysm sac diameter changes, reintervention rates, or overall survival between the groups.
The ALTO stent graft demonstrated significantly less PND at 12 months post-EVAR compared to alternative self-expanding stent grafts, highlighting its potential advantage in exerting less chronic expanding force on the proximal aortic neck. Long-term follow-up is needed to validate the clinical benefits of the ALTO stent graft over the alternative self-expanding stent grafts.
Non-randomized controlled cohort/follow-up study.
近端颈部扩张（PND）是腹主动脉瘤（AAA）血管内动脉瘤修复术（EVAR）后常见的问题，是支架移植物迁移或Ia型内漏的潜在原因。据报道，具有独特聚合物密封机制的ALTO支架移植物PND较少。本研究旨在比较ALTO支架移植物与其他自膨式支架移植物的PND及临床结果。
CustomSEAL研究是一项多中心回顾性观察研究，涉及日本的18个机构。该研究比较了使用ALTO支架移植物和其他自膨式支架移植物治疗梭形AAA的EVAR结果。主要结局指标是EVAR术后12个月时PND的差异。次要结局指标包括随访期间动脉瘤囊直径变化、再次干预率和死亡率结局。
经过倾向评分匹配后，提取了111对患者。两组之间的基线特征，包括近端颈部长度/直径和支架移植物尺寸过大情况，具有可比性。ALTO支架移植物在12个月时的PND明显较少（2.3%对26.7%，P<0.001）。两组之间的围手术期结局、动脉瘤囊直径变化、再次干预率或总生存率无显著差异。
与其他自膨式支架移植物相比，ALTO支架移植物在EVAR术后12个月时的PND明显较少，突出了其在对近端主动脉颈部施加较小慢性扩张力方面的潜在优势。需要长期随访以验证ALTO支架移植物相对于其他自膨式支架移植物的临床益处。
非随机对照队列/随访研究。
