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
... -
《-》
Strategies and outcomes for aortic endograft explantation.
Failure of endovascular aneurysm repairs (EVARs) requiring open conversion remains a major challenge. We analyzed indications for repair, operative strategies, and outcomes with a focus on iliac artery degeneration after endograft removal.
A prospective, institutional database was reviewed to identify patients who underwent explantation of a failed EVAR device. Demographics, reason for failure, operative details including extent of endograft removal, and complications/survival were examined. Postexplantation computed tomography imaging was evaluated for iliac artery degeneration.
There were 32 patients who underwent explantation from 2002 to 2017. Six patients were treated emergently for rupture. The majority were elderly (average age, 76 ± 8.5 years), white (100%) men (91%) who had their EVAR graft inserted 45.5 months (range, 0.3-86 months) before open conversion, usually at an outside institution (75%). Explanted endografts included nine AneuRx (Medtronic, Minneapolis, Minn), nine Excluder (W. L. Gore & Associates, Flagstaff, Ariz), four Endurant (Medtronic), three Zenith (Cook Medical, Bloomington, Ind), three Powerlink/AFX (Endologix, Irvine, Calif), one Aorfix (Lombard Medical, Oxfordshire, United Kingdom), one Talent (Medtronic), and two unknown. Failure was due to endoleak in 91% (type I, 38%; type II, 28%; type III, 13%; type V, 13%), infection in 6%, and occlusion/kinking in 3%. A previous attempt at endovascular salvage of EVAR occurred in 12 (37.5%) patients. Operative approach was transabdominal in 69% and retroperitoneal in 31%. Initial aortic clamp position was supraceliac in 31%, suprarenal in 31%, and infrarenal in 38%. Most patients had complete removal of their endograft (n = 19 [59%]), with 22 (69%) having at least the iliac limbs removed. Grafts with suprarenal fixation were more likely to have the upper main body left in situ (67% vs 17%; P = .029). The 30-day mortality was 6.3% (3.8% elective, 16.7% ruptured), and 31% had a major complication. Of the 23 patients who had follow-up imaging, there was a trend for more iliac degeneration (>5 mm in growth) in those who had the iliac limbs removed (29.4% vs 0%; P = .184). Three patients with iliac limb removal required subsequent iliac endovascular intervention (two for rupture). Patients who presented with a rupture had a decreased 5-year overall survival (33%) compared with those who were converted electively (59%).
Both complete and partial endograft explantation, although morbid procedures, can be performed safely. Postoperative imaging surveillance is important, especially if the endograft has been removed from the iliac arteries, as degeneration can occur.
Arnaoutakis DJ
,Sharma G
,Blackwood S
,Shah SK
,Menard M
,Ozaki CK
,Belkin M
... -
《-》