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 ... -  《-》

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 ... -  《-》

Outcomes of endovascular aneurysm repair performed in abdominal aortic aneurysms with large infrarenal necks.

The aim of this study was to evaluate midterm clinical and morphologic outcomes after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) with large (≥28 mm) infrarenal neck. From 2009 to 2012, we prospectively collected and retrospectively analyzed clinical, morphologic, and intraoperative and postoperative data of patients undergoing EVAR for wide-neck AAA at three European vascular surgery units. All patients had computed tomography angiography follow-up of ≥24 months. The early end points were technical success and proximal type I endoleak at 30 days. The midterm end points were type Ia endoleak, freedom from reintervention (FFR), survival, AAA-related mortality, and infrarenal and suprarenal aortic diameter progression. The aortic diameters were measured on three-dimensional workstation center lumen line reconstructions, 1 cm below the lowest renal artery, at the level of the renal arteries, at the superior mesenteric artery, and at the celiac trunk. Preoperative and 24-month aortic diameters were compared by paired t-test. Survival and FFR were evaluated by Kaplan-Meier analysis. During the study period, 118 patients (74 ± 8 years) were enrolled. The mean aneurysm diameter was 61 ± 10 mm. Suprarenal and infrarenal fixation endografts were implanted in 102 (86%) and 16 (14%) patients, respectively. The mean main body oversizing was 17% ± 9%. Technical success rate was 98% (three type Ia endoleaks at 30 days). The mean follow-up was 38 ± 12 months. Fourteen type Ia endoleaks (12%) were detected during follow-up. Survival at 3 years and 5 years was 89% and 70%, respectively. Four deaths (3.4%) were type Ia endoleak related. FFR at 1 year, 3 years, and 5 years was 96%, 83%, and 82%, respectively. Eight reinterventions (7%) were proximal neck related. All infrarenal and suprarenal aortic diameters increased at 24 months. The mean increase was 11% for the lowest renal artery (29.1 ± 1.1 mm preoperatively vs 32.3 ± 4.5 mm at 24 months; P < .001), 3% to 5% at the level of the renal arteries, and <3% for the superior mesenteric artery and the celiac trunk. Neck length <15 mm (P = .032), stainless steel endograft (P = .003), and type Ia endoleak at 24 months (P = .001) were associated with infrarenal neck enlargement on multivariate logistic regression. EVAR performed in AAAs with large necks is associated with a significant infrarenal aortic neck enlargement at 24 months as well as with a high risk of proximal type I endoleak and proximal neck-related reinterventions. In this subgroup of patients, main body oversizing >15% and suprarenal sealing should be considered.

Gargiulo M ，Gallitto E ，Wattez H ，Verzini F ，Bianchini Massoni C ，Loschi D ，Freyrie A ，Haulon S ... -  《-》

Long-term results of Talent endografts for endovascular abdominal aortic aneurysm repair.

Since the introduction of endovascular aneurysm repair (EVAR), long-term follow-up studies reporting single-device results are scarce. In this study, we focus on EVAR repair with the Talent stent graft (Medtronic, Santa Rosa, Calif). Between July 2000 and December 2007, 365 patients underwent elective EVAR with a Talent device. Patient data were gathered prospectively and evaluated retrospectively. By American Society of Anesthesiologists category, 74% were categories III and IV. Postoperative computed tomography (CT) scanning was performed before discharge, at 3, 12 months, and yearly thereafter. Data are presented according to reporting standards for EVAR. The mean proximal aortic neck diameter was 27 mm (range, 16-36 mm), with a neck length <15 mm in 31% (data available for 193 patients). Deployment of endografts was successful in 361 of 365 patients (99%). Initially, conversion to laparotomy was necessary in four patients. Primary technical success determined by results from computed tomography (CT) scans before discharge was achieved in 333 patients (91%). Proximal type I endoleaks were present in 28 patients (8%) during follow-up, and 14 of these patients needed additional treatment for type I endoleak. The 30-day mortality for the whole Talent group was 1.1% (4 of 365). Follow-up to 84 months is reported for 24 patients. During follow-up, 122 (33%) patients died; in nine, death was abdominal aortic aneurysm (AAA)-related (including 30-day mortality). Kaplan-Meier estimates revealed primary clinical success rates of 98% at 1 year, 93% at 2 years, 88% at 3 years, 79% at 4 years, 64% at 5 years, 51% at 6 years, and 48% at 7 years. Secondary interventions were performed in 73 of 365 patients (20%). Ten conversions for failed endografts were performed. Life-table yearly risk for AAA-related reintervention was 6%, yearly risk for conversion to open repair was 1.1%, yearly risk for total mortality was 8.9%, and yearly risk for AAA-related mortality was 0.8%. Initially, technical success of endovascular aneurysm repair (EVAR) using the Talent endograft is high, with acceptable yearly risk for AAA-related mortality and conversion. However, a substantial amount of mainly endovascular reinterventions is necessary during long-term follow-up to achieve these results.

Verhoeven BA ，Waasdorp EJ ，Gorrepati ML ，van Herwaarden JA ，Vos JA ，Wille J ，Moll FL ，Zarins CK ，de Vries JP ... -  《-》

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft.

Recent reports showed that the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) is safe and effective for endovascular repair of abdominal aortic aneurysms (AAAs). However, due to its relatively recent introduction, only short-term follow-up data are available. This study presents the 4-year results using this device. All clinical data, including detailed anatomic information of the first 100 consecutive patients treated with the Endurant stent graft for an infrarenal AAA in three Dutch high-volume hospitals, were prospectively collected. Computed tomography angiography was routinely performed before the procedure, ≤ 1 month, and at 1 year post-endovascular aneurysm repair. Thereafter, the imaging modality during yearly follow-up was individualized (duplex ultrasound imaging or computed tomography angiography). Patients were classified as within or outside the instructions for use (IFU) for analysis. Study end points were primary clinical success, overall and AAA-related mortality, and sac morphology changes and endoleak during follow-up. Estimates were obtained using Kaplan-Meier plots. The study included 100 consecutive patients (88 men) with a median age of 74 years (interquartile range [IQR], 67-79 years) and median AAA diameter of 58 mm (IQR, 55-65 mm), between December 2007 and March 2009. Twenty patients (20%) were treated outside the IFU (18, outside proximal neck IFU, one outside iliac IFU, and one outside both IFUs). Median follow-up was 48 months (IQR, 36-53 months), and no patients were lost. One contained rupture was observed after 1.5 months due to graft infection. No patients had graft migration. Two type Ia endoleaks, 5 type Ib endoleaks, and 15 type II endoleaks were found. Primary clinical success was 97%, 90%, 84% and 77% at 1, 2, 3, and 4 years, respectively. Primary clinical success was comparable for patients treated within or outside IFU (P = .20), although both patients outside iliac IFU needed a secondary iliac intervention. Over time, maximum aneurysm diameter decreased ≥ 5 mm, remained stable, and increased ≥ 5 mm in 58%, 32%, and 10% of the patients, respectively. All-cause mortality was 20% at 4 years, with a 3% AAA-related mortality. The 4-year follow-up data of the Endurant stent graft for AAA treatment shows its use results in a low AAA-related mortality with adequate prevention of rupture or aneurysm growth. Although patients with very challenging anatomy were treated in our series, primary clinical success rates were comparable for patients treated within and outside the IFU. However, both patients outside the iliac IFU needed a secondary iliac intervention. The knowledge of the present results may aid in improving outcomes in the future.

Zandvoort HJ ，Gonçalves FB ，Verhagen HJ ，Werson DA ，Moll FL ，de Vries JP ，van Herwaarden JA ... -  《-》