Long-term sac behavior after endovascular abdominal aortic aneurysm repair with the Excluder low-permeability endoprosthesis.

Sac regression is a surrogate marker for clinical success in endovascular aneurysm repair (EVAR) and has been shown to be device-specific. The low porosity Excluder endograft (Excluder low-permeability endoprosthesis [ELPE]; W. L. Gore & Associates Inc, Flagstaff, Ariz) introduced in 2004 was reported in early follow-up to be associated with sac regression rates similar to other endografts, unlike the original Excluder which suffered from sac growth secondary to fluid accumulation in the sac. The purpose of this study was to determine whether this behavior is durable in mid-term to long-term follow-up. Between July 2004 and December 2007, 301 patients underwent EVAR of an abdominal aortic aneurysm (AAA) with the ELPE at two institutions. Baseline sac size was measured by computed tomography (CT) scan at 1 month after repair. Follow-up beyond 1 year was either with a CT or ultrasound scan. Changes in sac size ≥5 mm from baseline were determined to be significant. Endoleak history was assessed with respect to sac behavior using χ(2) and logistic regression analysis. Two hundred sixteen patients (mean age 73.6 years and 76% men) had at least 1-year follow-up imaging available for analysis. Mean follow-up was 2.6 years (range, 1-5 years). The average minor-axis diameter was 52 mm at baseline. The proportion of patients with sac regression was similar during the study period: 58%, 66%, 60%, 59%, and 63% at 1 to 5 years, respectively. The proportion of patients with sac growth increased over time to 14.8% at 4-year follow-up. The probability of freedom from sac growth at 4 years was 82.4%. Eighty patients (37.7%) had an endoleak detected at some time during follow-up with 29.6% (16 of 54) residual endoleak rate at 4 years; 13 of the residual 16 endoleaks were type II. All patients with sac growth had endoleaks at some time during the study compared with only 18% of patients with sac regression (P < .0001). A sustained sac regression after AAA exclusion with ELPE is noted up to 5-year follow-up. Sac enlargement was observed only in the setting of a current or previous endoleak, with no cases of suspected hygroma formation noted.

Hogg ME ，Morasch MD ，Park T ，Flannery WD ，Makaroun MS ，Cho JS ... -  《-》

New results with 100 Excluder cases.

Ghotbi R ，Sotiriou A ，Mansur R 《JOURNAL OF CARDIOVASCULAR SURGERY》

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 ... -  《-》

Ten-year outcome analysis of the Italian Excluder Registry with the Gore Excluder endograft for infrarenal abdominal aortic aneurysms.

The objective of this study was to report the 10-year outcomes of the multicenter Italian Excluder Registry for elective endovascular aneurysm repair (EVAR). A retrospective analysis of all patients who underwent elective EVAR using the Gore Excluder (W. L. Gore & Associates, Flagstaff, Ariz) endograft (EG) at four Italian centers between 1998 and 2006 was carried out. Follow-up consisted of duplex ultrasound scan and computed tomography performed at 1 month, 6 months, and 12 months and yearly thereafter. Long-term outcomes were evaluated according to a life-table analysis. The Excluder EG was used in 461 patients (425 men; mean age, 72.9 ± 9.2 years) with abdominal aortic aneurysm (mean diameter, 52.2 ± 11.9 mm) who underwent elective EVAR. The 10-year cumulative survival was 62.5% ± 3.5% (95% confidence interval [CI], 55.5%-69.1%). During the follow-up, 14 (3.03%) patients were lost to follow-up. Estimated freedom from EG-related complication was 90.5% ± 1.5% (95% CI, 87.4%-92.9%) at 5 years, 89.2% ± 1.6% (95% CI, 85.6%-91.9%) at 7 years, and 88.4% ± 1.8% (95% CI, 84.4%-91.5%) at 10 years. Freedom from reintervention at 5, 7, and 10 years was 87.7% ± 1.8% (95% CI, 83.7%-90.8%), 82.4% ± 2.4% (95% CI, 77.2%-86.6%), and 80.6% ± 2.6% (95% CI, 75.5%-84.9%), respectively. On multivariable analysis, we did not find independent predictors of a higher rate of reintervention. There were 127 (27.5%) endoleaks detected during the follow-up. Only one type I endoleak was identified beyond 5-year follow-up. Cumulative freedom from endoleak rate was significantly different between the two different follow-up intervals (0-5 years, 2.6%; 6-10 years, 0.8%; P < .001). Estimated freedom from aorta-related mortality was 97.2% ± 0.8% (95% CI, 49.7%-99.9%) at 10 years. The Italian Excluder Registry outcomes confirmed sustained EVAR effectiveness at 10-year follow-up using the Gore Excluder EG. Freedom from EG-related complications, endoleaks, and reinterventions was satisfactory and remained acceptable beyond 5 years of follow-up, supporting a reasonable long-term durability of this device.

Pratesi G ，Piffaretti G ，Verzini F ，De Blasis G ，Castelli P ，Pratesi C ... -  《-》

Type II endoleaks after endovascular repair of abdominal aortic aneurysms: fate of the aneurysm sac and neck changes during long-term follow-up.

Nolz R ，Teufelsbauer H ，Asenbaum U ，Beitzke D ，Funovics M ，Wibmer A ，Plank C ，Prusa AM ，Lammer J ，Schoder M ... -  《-》