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 ... -  《-》

Predisposing Factors for Migration of the Iliac Limb and Reintervention after Endovascular Abdominal Aortic Aneurysm Repair.

Migration of the iliac limb after endovascular abdominal aortic aneurysm repair (EVAR) can result in type 1b and 3 endoleaks, which are relatively common causes of reintervention after EVAR. The aim of the present study was to investigate the factors influencing migration of the iliac limb and methods of treatment. From April 2012 to September 2017, 4 patients experienced migration of the iliac limb, requiring additional iliac stent graft implantation intraoperatively or at follow-up at our institute. Patient 1 was a 74-year-old man in whom preoperative computed tomography angiography (CTA) revealed a large aneurysm. The patient underwent EVAR with a bifurcated stent graft, and the left iliac stent graft migrated into the aneurysm sac. Patient 2 was a 53-year-old man in whom CTA revealed a large abdominal aortic aneurysm (AAA) involving the bilateral common iliac artery (CIA), with occlusion of the left hypogastric artery. An iliac stent graft was deployed to the right CIA to preserve the hypogastric artery. CTA, at 5 years of follow-up, showed migration of the right iliac limb and impending rupture. Patient 3 was a 61-year-old man with a ruptured AAA, and CTA revealed a large AAA and dilated CIA. The patient underwent EVAR with a bifurcated stent graft. Three years after EVAR, CTA showed that the right iliac limb migrated and kinked, with rupture of the stent graft. Patient 4 was an 80-year-old man with a ruptured AAA and aortocaval fistula. CTA revealed a large aneurysm involving the bilateral CIA. The patient underwent urgent EVAR with a bifurcated stent graft, and a cuff was deployed to seal the landing zone of the left CIA to preserve the hypogastric artery. Type 3 endoleak occurred because of the migration and detachment of the left iliac limb. All 4 patients underwent additional iliac stent graft implantation to connect or reline the iliac limb. The mean diameter of the aneurysms was 85.3 ± 18.9 mm, and 2 patients were diagnosed with ruptured AAAs. The mean diameter, length, and proportional engagement rate of the CIA that experienced migration of the iliac limb were 25.50 ± 11.1 mm, 32.8 ± 6.6 mm, and 72.75% ± 17.88%, respectively. Oversizing of the iliac stent graft was 10-20% in 2 patients and was less than 10% in the other 2 patients. The migrated iliac limbs were bell-bottom stent grafts. All patients underwent additional iliac stent graft implantation successfully, and there were no deaths or complications perioperatively. The patients were followed up from 7 months to 3 years and remained in good condition. Migration of the iliac limb after EVAR was influenced by a complex combination of several factors including a large aneurysm (>60 mm in diameter), dilated or aneurysmal CIA (>18 mm in diameter), short length of fixation (<70%), lower degree of iliac limb oversizing (<10-20%), and bell-bottom of the iliac limb. Patients with these factors require more vigorous surveillance after EVAR. The implantation of an additional stent graft is effective and is the most common reintervention procedure.

Wang Y ，Li C ，Xin H ，Li J ，Wang H ... -  《-》

Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft.

Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience. Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention. Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034). EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.

Verzini F ，Romano L ，Parlani G ，Isernia G ，Simonte G ，Loschi D ，Lenti M ，Cao P ... -  《-》

Midterm single-center results after endovascular aneurysm sealing reveal a high rate of stent graft migration, secondary aneurysm ruptures, and device-related reinterventions.

To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic disease. In this retrospective observational study, all patients treated with EVAS between March 2013 and January 2018 for abdominal aortic aneurysm (AAA) or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, and procedural and clinical surveillance outcomes. Furthermore, patients treated within the original instructions for use (IFU-group) were compared with patients treated outside the IFU (non-IFU-group) with regard to survival, reintervention-free survival, freedom from type I endoleak, and freedom from stent graft migration. Seventy patients were included (67 male; median age, 72.5 years). Sixty-five patients were treated for AAA and 5 patients for abdominal penetrating aortic ulcer. Sixty-nine cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow-up was 50.5 months (interquartile range, 29.3-62.7 months) with a median computed tomography angiographic follow-up of 38.5 months (interquartile range, 17.1-60.2 months). There were five deaths during the study period (7.1%), four of which were aneurysm related (5.7%). Five secondary AAA ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly owing to thrombotic complications (18.6%), stent graft migration (17.1%), and type I endoleak (12.9%). Fifteen patients were treated outside of the IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days and 1, 3, and 5 years was 94.3%, 88.5%, 72%, and 56.9%, respectively. Freedom from stent graft migration at 1, 3, and 5 years was 98.6%, 82.0%, and 47.3%, respectively. The estimated freedom from type I endoleak at 30 days and 1, 3, and 5 years in the IFU-group was 100%, 100%, 94.9% and, 91.1% and significantly different when compared with the non-IFU-group with 79.5%, 72.2%, 72.2%, and 72.2% (P = .012). Although the technical and initial results were satisfying, the mid-term results were disappointing. The enforcement of a close follow-up protocol for all patients treated with EVAS, especially vigilant for stent graft migration to prevent secondary type I endoleak and rupture, is strongly recommended.

Hatzl J ，Peters AS ，Pfeiffer S ，Meisenbacher K ，Bischoff MS ，Böckler D ... -  《-》

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 ... -  《-》