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 ... -  《-》

Results of standard suprarenal fixation endografts for abdominal aortic aneurysms with neck length ≤10 mm in high-risk patients unfit for open repair and fenestrated endograft.

The aim of this study was to evaluate long-term outcomes of endovascular aneurysm repair (EVAR) using a standard suprarenal fixation endograft in abdominal aortic aneurysms (AAAs) with infrarenal neck length ≤10 mm (short-neck AAA [SN-AAA]). From 2005 to 2010, data of high-risk patients with SN-AAA, unfit for open repair (OR) and fenestrated EVAR, were prospectively collected. Follow-up was performed by duplex ultrasound and contrast-enhanced ultrasound or computed tomography angiography at 1 month, 6 months, and 12 months and yearly thereafter. The primary end point was AAA-related mortality. Secondary end points were proximal type I endoleak, freedom from reintervention, and AAA shrinkage (>5 mm). Sixty patients (mean age, 74.9 ± 6.2 years; American Society of Anesthesiologists class 3 [85%] and class 4 [15%]) were enrolled. The mean aneurysm diameter and neck length and diameter were 60.4 ± 12.2 mm, 8.4 ± 1.6 mm, and 23.5 ± 3 mm, respectively. Four (7%) patients were symptomatic and 15 (25%) had rapid AAA enlargement (>5 mm/6 months). Cook Zenith Flex (Cook Medical, Bloomington, Ind) endografts (32) and Medtronic Endurant (Medtronic, Santa Rosa, Calif) endografts (28) were implanted. The mean follow-up was 51 ± 18 months. Survival at 5 years was 70%. There were three (5%) type I endoleaks. One was sealed by endovascular reintervention, and two (3%) underwent conversion to OR for AAA rupture at 8 and 36 months. Both patients died (2/60; 3% AAA-related mortality). Reinterventions were necessary for another five (8%) patients, and they were not proximal neck related. Freedom from reintervention at 5 years was 90%. In 49 (82%) cases, there was AAA shrinkage; the AAA diameter remained stable in nine (15%) and increased in two (3%) cases. Severe proximal angle (α neck angle ≥60 degrees) was associated with type I endoleak (P = .010) and reinterventions (P = .010). The neck length <7 mm (P = .030) was associated with reinterventions (P = .017). Suprarenal fixation EVAR in SN-AAA with a straight, not wide neck and 7- to 10-mm aortic neck length can be considered safe and effective in patients who are unfit for OR and fenestrated EVAR. For these cases, long-term data showed acceptable results in preventing aneurysm rupture and related mortality.

Gallitto E ，Gargiulo M ，Freyrie A ，Bianchini Massoni C ，Pini R ，Mascoli C ，Faggioli G ，Stella A ... -  《-》

Long-term results after endovascular abdominal aortic aneurysm repair using the Cook Zenith endograft.

This study assessed the long-term outcome of patients with abdominal aortic and aortoiliac aneurysms treated with the Cook Zenith endovascular graft (Cook Inc, Bloomington, Ind). Between September 1998 and October 2003, 143 patients underwent elective endovascular aneurysm repair (EVAR) using the Cook Zenith endograft. Data from these patients were reviewed from a prospective database in October 2008. Primary outcome measures were overall survival, intervention-free survival, and freedom from aneurysm rupture. Secondary outcome measures were early and late postoperative complications, including endoleaks. Mean follow-up was 66.4 months (range, 1.9-121.0 months). Overall survival was 72.1% at the 5-year follow-up and 50.9% at the 8-year follow-up. Intervention-free survival was 77.1% at 5 years and 63.8% at 8 years. There were no reintervention-related deaths. Six patients had a late aneurysm rupture, which was fatal in three. Freedom from aneurysm rupture was 98.1% at 5 years and 91.0% at 8 years. Late complications occurred throughout the follow-up period, with a tendency for aneurysm rupture and surgical conversion to occur at a later stage in the follow-up period. Aneurysm sac enlargement during follow-up was associated with late aneurysm rupture and with the need for reintervention. Elective EVAR using the Cook Zenith endograft provides excellent results through a mean follow-up of >5 years. There is a low aneurysm-related mortality and an acceptable rate of postoperative complications and reinterventions. The occurrence of late complications throughout the follow-up period stresses the need for continued postoperative surveillance in EVAR patients.

Mertens J ，Houthoofd S ，Daenens K ，Fourneau I ，Maleux G ，Lerut P ，Nevelsteen A ... -  《-》

Prior endovascular abdominal aortic aneurysm repair provides no survival benefits when the aneurysm ruptures.

It has been proposed that prior endovascular abdominal aortic aneurysm (AAA) repair (EVAR) confers protective effects in the setting of ruptured AAA (rAAA). This study was conducted to compare outcomes of rAAA repairs in patients with and without prior EVAR. A retrospective review identified 18 patients with (group 1) and 233 patients without (group 2) antecedent EVAR who presented with rAAA from January 2001 to December 2008. Patient characteristics and perioperative variables were noted and the outcomes were compared. Multiple logistic regression was used to identify factors contributing to morbidity and mortality and Kaplan-Meier analyses to estimate late survival rates. Baseline characteristics were similar between groups. Mean age was 78 years in group 1 and 74.8 years in group 2 (P=.17). Men comprised 83.3% of patients in group 1 and 77.3% in group 2 (P=.77). Hemodynamic instability at rAAA was noted with similar frequency between groups, 55.6% vs 52.6%, respectively (P=.99). Mean time from EVAR to rAAA was 4.0 years and from last follow-up computed tomography (CT) 1.2 years. The devices involved were Ancure (Guidant, Menlo Park, Calif) (9), AneuRx (Medtronic, Minneapolis, Minn) (5), Zenith (Cook Medical Inc, Bloomington, Ind) (3), and Excluder (W.L Gore, Flagstaff, Ariz) (1). Mean preoperative AAA size was 6.4 cm in group 1. All but 1 patient had an endoleak at the time of rupture. Of 14 patients with CT follow-up, only 3 patients had a known increase in size (≥5 mm) and only 3 were known to have an endoleak. Fifteen patients were treated by a single intervention, whereas 3 patients underwent multiple procedures. In group 2, open repair was performed in 218 patients and EVAR in 15. Morbidity (66.7% vs 56.7%) and in-hospital mortality (38.9% vs 36.9%) were nearly identical between groups. One-year survival rates (27.8% vs 48.2%; P=.15) were also similar. The mortality rates for EVAR for primary rAAA was 20% as compared to 38.1% for open repair for rAAAs (P=.27). rAAA remains a lethal problem in patients with and without prior EVAR alike. An existing endograft provides neither acute nor 1-year survival benefits after rAAA repairs. Prediction of patients at risk for rupture post-EVAR is difficult, as only a minority of patients had a known prior endoleak or sac enlargement.

Cho JS ，Park T ，Kim JY ，Chaer RA ，Rhee RY ，Makaroun MS ... -  《-》

Failure mode analysis of the Endologix endograft.

Type III (T-III) endoleaks following endovascular aneurysm repair (EVAR) remain a major concern. Our center experienced a recent concentration of T-III endoleaks requiring elective and emergency treatment and prompted our review of all EVAR implants over a 40-month period from April 2011 until August 2014. This report represents a single center experience with T-III endoleak management with analysis of factors leading to the T-III-related failure of EVAR. A retrospective review of all the operative reports, medical records, and computed tomography scans were reviewed from practice surveillance. Using Society for Vascular Surgery aneurysm reporting standards, we analyzed the morphology of the aneurysms before and after EVAR implant using computed tomography. Index procedure and frequency of reinterventions required to maintain aneurysm freedom from rupture were compared across all devices using SAS v 9.4 (SAS Institute, Inc, Cary, NC). Major adverse events (MAEs) requiring secondary interventions for aneurysm treatment beyond primary implant were analyzed for methods of failure. Aneurysm morphology of patients requiring EVAR was compared across all endograft devices used for repair. For purposes of MAE analysis, patients receiving Endologix (ELX) endograft were combined into group 1; Gore, Cook, and Medtronic endograft patients were placed into group 2. Overall, technical success and discharge survival were achieved in 97.3% and 98% of patients regardless of device usage. There was no significant device related difference identified between patient survival or freedom from intervention. MAEs involving aneurysm treatment were over seven-fold more frequent with ELX (group 1) vs non-ELX (group 2) endografts (P < .01). Group 1 patients with aneurysm diameters larger than 65 mm were associated with a highly significant value for development of a T-III endoleak (odds ratio, 11.16; 95% confidence interval, 2.17, 57.27; P = .0038). While EVAR technical success and survival were similar across all devices, ELX devices exhibited an unusually high incidence of T-III endoleaks when implanted in abdominal aortic aneurysms with a diameter of more than 65 mm. Frequent reinterventions were required for Endologix devices for prevention of aneurysm rupture due to T-III endoleaks.

Lemmon GW ，Motaganahalli RL ，Chang T ，Slaven J ，Aumiller B ，Kim BJ ，Dalsing MC ... -  《-》