One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft.
The Endurant (Medtronic, Minneapolis, Minn) is a new stent graft specifically designed to make more patients anatomically eligible for endovascular aneurysm (EVAR). This study presents the 1-year results of 100 consecutive patients with abdominal aortic aneurysms (AAAs) treated with the Endurant stent graft in real-life practice.
All clinical preoperative, operative, postoperative, and 1-year follow-up data of patients with the Endurant stent graft from three tertiary centers were prospectively collected. Patients underwent computed tomographic angiography (CTA) preoperatively, at 1 month, and at 1-year post-EVAR. The first 100 patients with an implantation date at least 1 year before our date of analysis and complete information were included. Clinical data, AAA characteristics, presence of endoleaks, graft migration, and other EVAR-related complications were noted. All values are stated as mean ± SD (range).
This study included 100 patients with AAAs (88 men) with a mean age of 73 ± 8 years (47 to 87 years), an AAA size of 61 ± 10 mm (31 to 93 mm), an AAA volume of 210 ± 122 mL (69 to 934 mL), a proximal neck length of 33 ± 14 mm (9 to 82 mm), and an infrarenal angulation of 44 ± 25° (0°-108°). Nineteen of the 100 included patients had at least one anatomic characteristic that was considered a violation of the instructions for use (IFU) of the Endurant stent graft. A primary technical success was achieved in 98% of the patients (one additional stent placement in renal artery was required; one unplanned aorto-uni-iliac device placed), with no primary type I or III endoleaks or conversions. A secondary technical success was achieved in all cases. The 30-day mortality was 2% and the first postoperative CTA documented 16 endoleaks (16%; 16 type II). One-year follow-up showed three iliac limb occlusions (3%), one infected stent graft (causing a type Ia endoleak), and five endovascular reinterventions (5%; three to treat iliac limb occlusions, one proximal extension cuff; and one stent in the renal artery). The 1-year all-cause mortality rate was 12% (12 patients) and the AAA-related mortality was 3%. The mean AAA size was significantly smaller after 1 year (diameter, 54 ± 11.8 [32-80] mm; P < .01; volume, 173 ± 119 [42-1028] mL; P < .01), and one graft migration >5 mm and 13 endoleaks were noted (12 type II, 1 type I [neck dilatation]).
The treatment of patients with AAAs with the Endurant stent graft seems to be successful and durable during the first year after EVAR. Despite the wider inclusion criteria for the Endurant, and with 19% of our patients treated outside the IFU, the AAA-related mortality, number of type I or III endoleaks, and reintervention rates are comparable to the results of other stent grafts.
van Keulen JW
，de Vries JP
，Dekker H
，Gonçalves FB
，Moll FL
，Verhagen HJ
，van Herwaarden JA
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Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair.
This study evaluated the early and intermediate results of endovascular aortic aneurysm repair (EVAR) using the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) in patients treated according to device-specific instructions for use (IFU) for the proximal aortic neck compared with those obtained in patients treated in an off-label (OL) situation.
Between November 2007 and March 2010, 177 consecutive patients with abdominal aortic aneurysms (AAAs) were treated with the Endurant stent graft at our centers. The IFU for the Endurant stent graft included a proximal neck of 15 mm in length and <75° of angulation or 10 mm of neck length and <60° of angulation. The 121 patients (68.4%) operated on according to IFU were compared with 56 (31.6%) who underwent EVAR in OL circumstances to evaluate significant differences in demographics, intraoperative technical factors, and early (30 days) and intermediate outcomes (1 year).
Significantly more patients were aged >80 years in the OL group (37.5% vs 19%, P = .008), and they also had larger aneurysms (59 ± 10.6 vs 55.9 ± 10.8 mm, P = .05) and required a longer procedure time (69.3 ± 27.2 vs 60.8 ± 20.4 minutes, P = .02). At 30 days, the risk of type I endoleak was higher in the OL group (2 patients, 3.6% vs 0 in IFU), but this did not reach statistical significance (P = .09). The two groups were similar in rates of perioperative mortality, major morbidity, technical success, clinical success, complications, and reinterventions. At 1 year, there were no differences between the two groups in survival, freedom from any device-related reinterventions, and freedom from graft thrombosis. Estimated 1-year freedom from type I endoleak was 100% in the IFU group vs 93.3% in the OL group (P = .01).
In patients with both normal and complex anatomy of the proximal aortic neck, the Endurant stent graft obtained acceptable results, with no difference in survival, morbidity, or reinterventions. However, there was a greater risk of type I endoleak when OL indications were applied. Longer term follow-up is required to evaluate the effectiveness of this endograft in preventing late aneurysm-related complications.
Torsello G
，Troisi N
，Donas KP
，Austermann M
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Clinical outcomes for endovascular repair of abdominal aortic aneurysm with the Seal stent graft.
Since 2007, the availability of the Seal (S & G Biotech Inc, Seong-nam, Gyeonggi-do, Korea) stent graft for endovascular aneurysm repair (EVAR) has improved short-term outcomes in Korea. However, midterm outcome data are lacking. This retrospective study evaluated the midterm outcomes of 126 patients who underwent EVAR using the Seal stent graft between 2007 and 2010.
Data regarding use of the Seal stent graft for EVAR were collected from 16 Korean centers, and were analyzed retrospectively using Kaplan-Meier and Cox univariate and multivariate analyses.
The mean patient age was 71 ± 8 years (median, 70; range, 49-87 years). Patients who were treated using a bifurcated graft (113; 90%) were generally symptomatic (56; 44%, which included 13 ruptured abdominal aortic aneurysms [10%]) and male (105; 83%). The primary technical success rate was 99%. Four patients (3%) died within 30 days, 5 patients (4%) died after 30 days, and 12 patients (9%) were lost to follow-up. The survival rates were 97% ± 2% (1 month), 97% ± 2% (3 months), 96% ± 2% (6 months), 96% ± 2% (1 year), 94% ± 3% (3 years), and 81% ± 10% (5 years). During a mean follow-up of 55 ± 22 months (median, 40; range, 0.03-91.2 months), 18 reinterventions were performed for 16 patients (13%). The freedom from reintervention rates were 96% ± 2% (1 month), 96% ± 2% (3 months), 94% ± 2% (6 months), 89% ± 3% (1 year), 84% ± 4% (3 years), and 57% ± 17% (5 years). The mean aneurysm diameter significantly decreased from 69.6 to 46.6 mm during the follow-up (P < .0001). A proximal neck of less than 15 mm, different simultaneous endoleaks, and insufficient bilateral coverage of the iliac aneurysm were associated with significantly higher rates of increased or unchanged aneurysm diameters (all P < .0001). Significantly higher rates of clinical failure were observed in patients who were less than 70 years old (P = .04), had a neck length of less than 15 mm (P = .02), and had a neck diameter of greater than 28 mm (P = .02).
Most Seal stent grafts were implanted successfully (even in cases with a physical status of grade IV or higher or a ruptured abdominal aortic aneurysm), had an appropriate reintervention rate, and were stable during the midterm follow-up. However, there was a high rate of type I endoleak, which may be related to the early device model that we used. Therefore, long-term radiologic follow-up is recommended for the early detection of stent graft migration or endoleaks.
Kim JH
，Cho YK
，Seo TS
，Song MG
，Jeon YS
，Han YM
，Kang MH
，Lim HG
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