Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
University of Colorado Denver School of Medicine, Aurora, Colo.
J Vasc Surg. 2020 Aug;72(2):576-583.e1. doi: 10.1016/j.jvs.2019.10.078. Epub 2020 Jan 19.
To evaluate clinical outcomes from a postmarket registry of the Zenith Spiral-Z abdominal aortic aneurysm iliac leg graft with a continuous, spiral nitinol stent that was designed for improved conformability, kink, and migration resistance.
This prospective, multicenter registry was designed to evaluate physician-reported outcomes of the Spiral-Z leg graft in up to 600 patients who underwent endovascular repair of abdominal aortic or aortoiliac aneurysms at up to 30 investigative sites in the United States and Canada. Study outcomes were focused on iliac limb occlusion, limb-related reintervention, limb-related endoleak, component separation, and device integrity. Short-term data were collected during an interval of 1 to 6 months, with longer term data collected at 12 months.
Between March 2012 and March 2015, 599 patients (mean age 74 ± 8 years; 87% male; 26% with aortoiliac aneurysm) were treated, with Spiral-Z iliac leg grafts placed in 564 left iliac arteries and 559 right iliac arteries. The mean iliac inner diameters (both left and right) were 9 ± 3 mm; moderate/severe occlusive disease, calcification, and vessel tortuosity were present in 14%, 25%, and 36% and 15%, 25%, and 34% of the left and right iliac arteries, respectively. Iliac artery adjunctive procedures (iliac artery angioplasty and/or stent placement) were performed intraoperatively in 112 patients (19%; bilateral in 52 patients). Mortality within 30 days was 1.7% (10/599); cumulative mortality at 1 year was 6.2% (37/599). There were no aortic ruptures and only one open conversion (0.2%). Limb occlusions occurred in 11 of 599 patients (2%; 3 within 30 days and 8 after 30 days, all unilateral, none had received procedural iliac artery adjuncts at implantation); of these, 7 patients underwent reinterventions. Other limb-related reinterventions were performed on eight patients for nonocclusive kink, compression, or thrombus (six within 30 days and three after 30 days). In total, 13 patients (2%) underwent 15 limb-related reinterventions (7 for occlusions and 8 for nonocclusive causes). In one patient, a distal type I endoleak and device migration (>10 mm) involving a right iliac leg was noted at the 12-month follow-up visit. No other limb-related endoleak, migration, component separation, or stent fracture was reported during a mean follow-up of 11 ± 6 months.
The Spiral-Z leg graft demonstrated excellent patency and required infrequent limb-related reinterventions in routine clinical care in a postmarket registry.
评估 Zenith Spiral-Z 腹主动脉瘤髂支移植物的上市后登记处的临床结果，该移植物采用连续螺旋镍钛诺支架，旨在提高顺应性、抗扭结和抗迁移能力。
这项前瞻性、多中心登记研究旨在评估 Spiral-Z 支在 30 个美国和加拿大调查点进行的腹主动脉或腹主动脉瘤腔内修复的多达 600 例患者中，医生报告的结果。研究结果集中在髂支闭塞、与支相关的再介入、与支相关的内漏、组件分离和器械完整性。短期数据在 1 至 6 个月的时间间隔内收集，长期数据在 12 个月时收集。
2012 年 3 月至 2015 年 3 月，599 例患者（平均年龄 74±8 岁；87%为男性；26%为腹主动脉瘤）接受治疗，564 例患者左侧髂支和 559 例患者右侧髂支置入 Spiral-Z 髂支移植物。左右髂内直径的平均值（均为 9±3mm）；中度/重度闭塞性疾病、钙化和血管迂曲在 14%、25%和 36%以及 15%、25%和 34%的左侧和右侧髂支中存在。112 例患者（19%；52 例双侧）术中进行了髂动脉辅助治疗（髂动脉血管成形术和/或支架置入术）。30 天内死亡率为 1.7%（10/599）；1 年累计死亡率为 6.2%（37/599）。无主动脉破裂，仅 1 例转为开放手术（0.2%）。599 例患者中有 11 例（2%；30 天内 3 例，30 天后 8 例，均为单侧，植入时均未接受髂支的程序性辅助治疗）发生支闭塞；其中 7 例患者接受了再介入治疗。其余 8 例患者因非闭塞性扭结、压迫或血栓形成进行了 8 次与支相关的再介入治疗（30 天内 6 次，30 天后 3 次）。共有 13 例（2%）患者进行了 15 次与支相关的再介入治疗（7 例为闭塞，8 例为非闭塞原因）。在 12 个月的随访中，1 例患者出现右侧髂支移植物远端 1 型内漏和器械迁移（>10mm）。在平均 11±6 个月的随访中，未报告其他与支相关的内漏、迁移、组件分离或支架断裂。
Spiral-Z 支移植物在上市后登记处的常规临床护理中表现出极好的通畅性，需要进行较少的支相关再介入治疗。
