Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts.

Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.

Oliveira-Pinto J ，Oliveira NFG ，Bastos-Gonçalves FM ，Hoeks S ，Rijn MJV ，Raa ST ，Mansilha A ，Verhagen HJM ... -  《-》

Standard endovascular aneurysm repair in patients with wide infrarenal aneurysm necks is associated with increased risk of adverse events.

Endovascular aneurysm repair (EVAR) has progressively expanded to treat more challenging anatomies. Although EVAR in patients with wide infrarenal necks has been reported with acceptable results, there is still controversy regarding the longer-term outcomes. Our aim is to determine the impact of infrarenal neck diameter on midterm outcome following EVAR with a single endograft with suprarenal fixation. A retrospective case-control study was designed using data from a prospective multicenter database. Patients who electively underwent standard EVAR with an Endurant stent graft (Medtronic Ave, Santa Rosa, Calif) for a degenerative abdominal aortic aneurysm from January 2008 to December 2012 in three high-volume centers in The Netherlands were included. All measurements were obtained using dedicated reconstruction software and center-lumen line reconstruction. Patients with an infrarenal neck diameter of ≥30 mm were compared with patients with a neck diameter of <30 mm. The primary end point was freedom from neck-related adverse events (a composite of type Ia endoleak, neck-related secondary intervention, and endograft migration). Secondary end points were primary clinical success, type Ia endoleak, neck-related reinterventions, endoleaks, and aneurysm-related secondary interventions. Four-hundred twenty-seven patients were included. Seventy-four patients (17.3%) with a neck diameter of ≥30 mm were compared with a control group of 353 patients. There were no significant differences at baseline between groups including demographics, comorbidities, baseline aneurysm diameter, infrarenal neck length, suprarenal angulation, or infrarenal neck angulation. Median stent graft oversizing was 12.5% (7.9-16.1) and 16.6% (12.0-23.1) in the ≥30-mm neck-diameter and control groups, respectively (P < .001). Median follow-up was 3.1 years (1.2-4.7) and 4.1 years (2.7-5.6) for the large neck and control groups, respectively (P < .001). Type Ia endoleaks occurred in 17 patients (4.0%) and were significantly more frequent in patients with ≥30-mm neck diameter (9.5% vs 2.8%; P = .005). Neck-related secondary interventions were performed in 20 patients (4.7%) and were also more common among patients with neck diameters of ≥30 mm (9.5% vs 3.7%; P = .04). The 4-year freedom from neck-related adverse events were 75% and 95% for the large neck and control groups, respectively (P < .001). On multivariable regression analysis, infrarenal neck diameter of ≥30 mm was an independent risk factor for neck-related adverse events (odds ratio [OR], 3.8; 95% confidence interval [CI], 1.6-9.1), type Ia endoleak (OR, 2.7; 95% CI, 1.0-8.3), and neck-related secondary interventions (OR, 3.2, 95% CI, 1.1-9.2). EVAR in patients with large diameter necks is associated with an increased risk of neck-related adverse events in midterm follow-up. This may influence the clinical decision regarding choice of repair and toward a more intensive surveillance following EVAR in these patients in the long term.

Oliveira NFG ，Bastos Gonçalves FM ，Van Rijn MJ ，de Ruiter Q ，Hoeks S ，de Vries JPM ，van Herwaarden JA ，Verhagen HJM ... -  《-》

Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results.

The utilisation rate of endovascular aortic aneurysm repair has increased continuously over the past 2 decades. Endovascular aortic aneurysm repair is still performed frequently in patients with an unfavourable proximal seal zone, despite the associated late complications. We aimed to evaluate the mid-term durability of the GORE® EXCLUDER® AAA Endoprosthesis, featuring the C3 delivery system, in patients with a proximal neck anatomy outside the instructions for use (IFU). A retrospective sub-analysis of the Global Registry for Endovascular Aortic Treatment including patients treated for abdominal aortic aneurysms with the GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) was performed. A "challenging neck" was defined as those treated outside the IFU with an aortic neck length <15 mm and/or aortic neck angle >60°. Cox proportional analyses were used to test for time-to-event differences between those treated within and outside the IFU while accounting for covariates, specifically proximal neck length and neck angle. The main outcomes assessed were 5-year all-cause mortality, 5-year endoleak development (type I or III), and 5-year device-related reinterventions. Of the 3,324 patients included in the analysis, 411 (12.4%) had a challenging neck and 2,913 (87.6%) did not. The patients in the challenging neck group were significantly older (74.9 years vs. 73.2 years, p≤0.0001) and had a significantly larger aortic aneurysm diameter at the time of the intervention than those treated within the IFU (61.2 mm vs. 56.4 mm, P< 0.0001), shorter proximal neck length (18 mm vs. 30 mm, P< 0.0001) and larger infrarenal neck angle (60.8° vs. 25.8°, P< 0.0001). In the multivariate analysis, brachial access site and challenging neck were not independent risk factors; increased age was associated with a shorter time to mortality (hazard ratio 1.051, 95% confidence interval 1.039-1.062, P< 0.0001), as was the use of tobacco (hazard ratio 1.329, 95% confidence interval 1.124-1.571, P= 0.0009). The 5-year all-cause mortality (36.2% vs. 27.5%, P= 0.002) and aorta-related mortality (3.8% vs. 1.1%, P= 0.002) were significantly higher in the challenging neck group. The risk of death within 5 years also increased significantly at 1.1% per millimetre increase in the abdominal aortic aneurysm diameter (P= 0.0005). Furthermore, the rates of type Ia endoleak development (7% vs. 1.2%, P< 0.001) and requirement for reintervention (13.3% vs. 9.7%, P< 0.001) were higher in those treated outside the IFU (challenging neck group). Treatment with the Excluder AAA Endograft outside the IFU was associated with higher 5-year mortality values, increased type Ia endoleak development rates, and a greater need for reintervention compared with treatment within the IFU. This reiterates that fenestrated and open treatments should be strongly considered in cases with aortic neck anatomies outside the IFU. Infrarenal endovascular intervention outside the IFU should only be used when there is no alternative, with meticulous procedural planning and intervention to promote satisfactory outcomes.

Barry IP ，Barns M ，Verhoeven E ，Wong J ，Dubenec S ，Heyligers JM ，Milner R ，Shutze WP ，Bachoo P ，Vlaskovky P ，Mwipatayi BP ，GREAT participants ... -  《-》

Long-term outcomes of standard endovascular aneurysm repair in patients with severe neck angulation.

Severe neck angulation is associated with complications after endovascular aneurysm repair (EVAR). Newer endografts may overcome this limitation, but the literature lacks long-term results. We studied the long-term outcomes of EVAR in patients with severe neck angulation. A retrospective case-control study of a prospective multicenter database was performed. All measurements were made with dedicated software with center lumen line reconstruction. A study group including patients with neck length >15 mm, infrarenal angle (β) >75 degrees or suprarenal angle (α) >60 degrees, and neck length 10 to 15 mm with β >60 degrees or α >45 degrees was compared with a control group matched for demographics and other morphologic neck features. The primary end point was type IA endoleak (EL1A). Secondary end points were freedom from neck-related secondary interventions, primary clinical success, and overall survival. Forty-five patients were included in the angulated neck group and compared with 65 matched patients. Median follow-up was 7.4 years (interquartile range, 4.8-8.5 years). In the angulated neck group, mean α was 51.4 degrees (±21.1 degrees) and the mean β was 80.8 degrees (±15.6 degrees); in the nonangulated group, these were 17.9 degrees (±17.0 degrees) and 35.4 degrees (±20.0 degrees), respectively. At 7 years, five patients in the angulated neck group and two nonangulated patients developed EL1A, yielding a freedom from EL1A of 86.1% (n = 14; standard error [SE], 0.069) and 96.6% (n = 34; SE, 0.023), respectively (P = .056). After exclusion of a patient who developed an EL1A secondary to an endograft infection, this difference was significant: 86.1% (n = 14; SE, 0.069) in the angulated neck group and 98.2% (n = 34; SE, 0.018) in the nonangulated group (P = .016). At 7 years, freedom from neck-related secondary interventions was 91.7% (n = 14; SE, 0.059) and 91.6% (n = 29; SE, 0.029), respectively. The 7-year primary clinical success estimates were 41.2% (n = 11; SE, 0.085) and 56.6% (n = 20; SE, 0.072) for the angulated neck and nonangulated groups, respectively (P = .12). The 7-year survival rates were 44.3% (n = 18; SE, 0.076) vs 66.7% (n = 42; SE, 0.059) for the angulated neck and nonangulated groups, respectively (P = .25). Device integrity failure was not observed. Despite satisfactory results early and in the midterm, a higher rate of EL1A was identified among patients with severely angulated necks in the long term. However, mortality was not affected by this difference. These findings suggest that EVAR should be used judiciously in patients with extreme angulation of the proximal neck and highlight the need for close follow-up of EVAR, especially in the long term and in patients treated outside instructions for use.

Oliveira NFG ，Gonçalves FB ，Hoeks SE ，Josee van Rijn M ，Ultee K ，Pinto JP ，Raa ST ，van Herwaarden JA ，de Vries JPM ，Verhagen HJM ... -  《-》

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 ... -  《-》