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 ... -  《-》

Midterm results of endovascular aneurysm repair using the Endurant stent-graft according to the instructions for use vs. off-label conditions.

Troisi N ，Torsello G ，Weiss K ，Donas KP ，Michelagnoli S ，Austermann M ... -  《-》

Standard endovascular treatment of abdominal aortic aneurysms in patients with very short proximal necks using the Endurant stent graft.

This study evaluated and compared the midterm results of endovascular aortic aneurysm repair with the Endurant (Medtronic Inc, Santa Rosa, Calif) stent graft system in off-label use in patients with short (<10 mm) proximal aortic necks and in patients treated according to device-specific instructions for use. This was a case-control (2:1) single-center retrospective analysis of prospectively collected data performed between September 2008 and December 2012. Analysis identified 19 elective patients with short (<10 mm) proximal necks and mild angulations (≤45°) treated with the Endurant stent graft and 38 patients matched for age, sex, and aneurysm diameter with proximal aortic necks ≥10 mm in length who met the instructions for use. End points included technical and clinical success and freedom from any secondary intervention, any type of endoleak, and aneurysm-related death. The short-neck group was a mean ± standard deviation age of 71.7 ± 8.9 years, 84% were men, and their mean infrarenal aortic neck length was 6.1 ± 1.2 mm. Mean suprarenal and infrarenal angles were 110° ± 10.4° and 170° ± 15.4°, respectively. Aortic neck diameters were similar between the groups (26.6 ± 3.8 vs 25.7 ± 3.7 mm; P = .36). Primary technical success was achieved in all cases. Off-label patients were more likely to require additional proximal cuff deployment to successfully obtain a seal (21% vs 3%; P = .04). The two patient groups were similar in rates of perioperative mortality, morbidity, and complications. Mean follow-up of 24 ± 12 months revealed no differences in clinical success, freedom from reintervention, and aneurysm-related death. No type I endoleaks were observed in either group during the follow-up period. The Endurant stent graft system applied off-label in patients with very short aneurysm necks (<10 mm) with mild angulation showed acceptable treatment results. These midterm results might suggest its use in carefully selected patients with very short neck anatomy. Long-term data are needed to verify the observed durability of the Endurant stent graft.

Matsagkas M ，Kouvelos G ，Peroulis M ，Avgos S ，Arnaoutoglou E ，Papa N ，Papadopoulos G ... -  《-》

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft.

Recent reports showed that the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) is safe and effective for endovascular repair of abdominal aortic aneurysms (AAAs). However, due to its relatively recent introduction, only short-term follow-up data are available. This study presents the 4-year results using this device. All clinical data, including detailed anatomic information of the first 100 consecutive patients treated with the Endurant stent graft for an infrarenal AAA in three Dutch high-volume hospitals, were prospectively collected. Computed tomography angiography was routinely performed before the procedure, ≤ 1 month, and at 1 year post-endovascular aneurysm repair. Thereafter, the imaging modality during yearly follow-up was individualized (duplex ultrasound imaging or computed tomography angiography). Patients were classified as within or outside the instructions for use (IFU) for analysis. Study end points were primary clinical success, overall and AAA-related mortality, and sac morphology changes and endoleak during follow-up. Estimates were obtained using Kaplan-Meier plots. The study included 100 consecutive patients (88 men) with a median age of 74 years (interquartile range [IQR], 67-79 years) and median AAA diameter of 58 mm (IQR, 55-65 mm), between December 2007 and March 2009. Twenty patients (20%) were treated outside the IFU (18, outside proximal neck IFU, one outside iliac IFU, and one outside both IFUs). Median follow-up was 48 months (IQR, 36-53 months), and no patients were lost. One contained rupture was observed after 1.5 months due to graft infection. No patients had graft migration. Two type Ia endoleaks, 5 type Ib endoleaks, and 15 type II endoleaks were found. Primary clinical success was 97%, 90%, 84% and 77% at 1, 2, 3, and 4 years, respectively. Primary clinical success was comparable for patients treated within or outside IFU (P = .20), although both patients outside iliac IFU needed a secondary iliac intervention. Over time, maximum aneurysm diameter decreased ≥ 5 mm, remained stable, and increased ≥ 5 mm in 58%, 32%, and 10% of the patients, respectively. All-cause mortality was 20% at 4 years, with a 3% AAA-related mortality. The 4-year follow-up data of the Endurant stent graft for AAA treatment shows its use results in a low AAA-related mortality with adequate prevention of rupture or aneurysm growth. Although patients with very challenging anatomy were treated in our series, primary clinical success rates were comparable for patients treated within and outside the IFU. However, both patients outside the iliac IFU needed a secondary iliac intervention. The knowledge of the present results may aid in improving outcomes in the future.

Zandvoort HJ ，Gonçalves FB ，Verhagen HJ ，Werson DA ，Moll FL ，de Vries JP ，van Herwaarden JA ... -  《-》

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 ... -  《-》