Rutger A. Stokmans

Early Results from the ENGAGE Registry: Real-world Performance of the Endurant Stent Graft for Endovascular AAA Repair in 1262 Patients

OBJECTIVE The ENGAGE registry was undertaken to examine the real-world outcome after endovascular abdominal aortic aneurysm (AAA) repair (EVAR) with the Endurant Stent Graft in a large, contemporary, global series of patients. METHODS From March 2009 to April 2011, 1262 AAA patients (89.6% men; mean age 73.1 years, range 43-93 years) were enrolled from 79 sites in 30 countries and treated with Endurant. Results are described following the reporting standards for EVAR. Follow-up data were tabulated for all 1262 patients at a 30-day follow-up and for the first 500 patients at a 1-year follow-up. RESULTS Intra-operative technical success was achieved in 99.0% of cases. Within 30 days, adverse events were reported in 3.9% of patients, including a 1.3% mortality rate. Type-I or -III endoleaks were identified in 1.5% of cases. Estimated overall survival, aneurysm-related survival and freedom from secondary interventions at 1 year were 91.6%, 98.6% and 95.1%, respectively. At 1 year, aneurysm size increased ≥ 5 mm in 2.8% and decreased ≥ 5 mm in 41.3% of cases. CONCLUSION Early results from this real world, global experience are promising and indicate that endovascular AAA repair with the Endurant Stent Graft is safe and effective across different geographies and standards of practice. Longer-term follow-up is necessary to assess durability of these results.

Challenging the Evidence for Pre-emptive Coil Embolisation of the Internal Iliac Artery during Endovascular Aneurysm Repair

OBJECTIVES We retrospectively analysed the results of a strategy in which coverage of the internal iliac artery (IIA) during endovascular aneurysm repair (EVAR) was routinely performed without coil embolisation. METHODS From January 2010 until May 2012, 32 patients (96.9% men; mean age 73.0 years, range 52-89 years) underwent EVAR with stent grafts extended into the external iliac artery (EIA), all without prior coil embolisation. Aneurysm morphology was determined on preoperative computed tomography (CT) images. During follow-up, patients were interviewed about buttock claudication, and the occurrence of endoleaks and evolution of aneurysm diameter were recorded. RESULTS At baseline, the mid-common iliac artery (CIA) diameter was 33.5 ± 16.8 mm and seven patients presented with ruptured aneurysms. Mean follow-up was 14.3 ± 7.4 months. There were eight deaths, none related to IIA coverage. Buttock claudication occurred in seven (22.6%) patients, which persisted after 6 months in two cases of bilateral IIA coverage. No Type-I or -II endoleaks occurred related to IIA coverage. Aneurysm growth was not observed. CONCLUSION Endovascular treatment of aortoiliac and iliac aneurysm without pre-emptive coil embolisation of the IIA appears safe and effective. No IIA-related endoleaks or re-interventions occurred in our series. This approach saves operating time, contrast load and costs and may reduce complications. However, a larger population and longer follow-up is required to confirm our findings.

Performance of the Endurant stent graft in challenging anatomy

OBJECTIVE This study aimed to compare perioperative and postoperative outcomes after endovascular repair of abdominal aortic aneurysms (AAAs) in patients with various neck morphologic features. METHODS Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) were used for the analyses. Patients were categorized into three different groups according to proximal aortic neck anatomy: regular (REG), intermediate (INT), and challenging (CHA). REG was defined as AAAs with a proximal neck ≥15 mm combined with a suprarenal angulation (α) ≤45 degrees and an infrarenal neck angulation (ß) ≤60 degrees. INT was defined as AAAs with a proximal neck of 10 to 15 mm combined with α ≤45 degrees and ß ≤60 degrees or with a proximal neck of >15 mm combined with α ≤60 degrees and ß = 60 to 75 degrees or α = 45 to 60 degrees and ß ≤75 degrees. CHA was defined as infrarenal necks that exceed at least one of the three defining factors. RESULTS Overall, 925 patients (75.9%) had REG anatomy, 189 patients (15.5%) had INT anatomy, and 104 patients (8.5%) had CHA anatomy. Patient demographics and risk factors were similar. There was a significant difference in AAA diameter between the REG and CHA groups (59.4 mm vs 65.2 mm; P < .001). Technical success was similar among groups (REG 99.1% vs INT 99.5% vs CHA 97.1%). There were no differences in mortality or the need for secondary procedures within 30 days or at 1 year. A significantly higher rate of type I endoleaks within 30 days was seen in CHA compared with REG (adjusted odds ratio, 0.15; 95% confidence interval, 0.05-0.46) and INT (adjusted odds ratio, 0.08; 95% confidence interval, 0.01-0.70), but there was no difference at 1-year follow-up. CONCLUSIONS This real-world, global experience shows promising results and indicates that endovascular AAA repair with the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) is safe and effective in patients with challenging aortic neck anatomy. However, long-term follow-up of patients is required to confirm results.

Effects of Anesthesia Type on Perioperative Outcome After Endovascular Aneurysm Repair.

Purpose: To examine outcomes of endovascular aortic aneurysm repair (EVAR) using general, regional, or local anesthesia. Methods: From March 2009 to April 2011, patients were enrolled from 79 sites in 30 countries worldwide and treated with an Endurant Stent Graft System. Data were compared among 3 groups based on the method of anesthesia: general anesthesia (GA) was used in 785 (62%) patients, regional anesthesia (RA) in 331 (27%) patients, and local anesthesia (LA) in 145 (11%) patients. Multivariate logistic regression analysis was performed to adjust for possible confounding factors; outcomes are presented as the odds ratio and 95% confidence interval. Results: There were intercontinental differences in the distribution of type of anesthesia used for EVAR. Higher ASA (American Society of Anesthesiologists) classification was associated with predominant use of GA. Procedure time was reduced in LA (80.4±40.0 minutes) compared with RA (94.2±41.6 min, adjusted p=0.001) and GA (105.3±46.0 minutes, adjusted p<0.001). Intensive care unit (ICU) admission was less frequent for RA than for GA (adjusted OR 0.71, 95% CI 0.53 to 0.97, p=0.030) and LA (adjusted OR 0.51, 95% CI 0.33 to 0.79, p=0.002). Postoperative hospital stay was significantly shorter for RA and LA compared with GA (adjusted p=0.003 and p=0.010, respectively). There were no significant differences in systemic and surgical complications. Mortality rates within 30 days did not differ among the groups. Conclusion: Type of anesthesia used during EVAR has no influence on perioperative mortality and morbidity. The use of local or regional anesthesia during EVAR appeared to be beneficial concerning procedure time, ICU admission, and postoperative hospital stay.

A 15-Year Single-Center Experience of Endovascular Repair for Elective and Ruptured Abdominal Aortic Aneurysms

Purpose: To evaluate the differences in technical outcomes and secondary interventions between elective endovascular aneurysm repair (el-EVAR) procedures and those for ruptured aneurysms (r-EVAR). Methods: Of the 906 patients treated with primary EVAR from September 1998 until July 2012, 43 cases were excluded owing to the use of first-generation stent-grafts. Among the remaining 863 patients, 773 (89.6%) patients (mean age 72 years; 697 men) with asymptomatic or symptomatic abdominal aortic aneurysms (AAAs) were assigned to the el-EVAR group; 90 (10.4%) patients (mean age 73 years; 73 men) were assigned to the r-EVAR group based on blood outside the aortic wall on preoperative imaging. The primary study outcome was technical success; secondary endpoints, including freedom from secondary interventions and late survival, were examined with Kaplan-Meier analyses. Results: At baseline, r-EVAR patients had larger aneurysms on average (p<0.001) compared to el-EVAR patients. Technical success was comparable (p=0.052), but there were more type Ia endoleaks at completion angiography in the r-EVAR group (p=0.038). As anticipated, more patients died in the first month in the r-EVAR group (18.9% vs 2.2% el-EVAR, p<0.001). At 5 years, there was an overall survival of 65.1% for the el-EVAR patients vs 48.1% in the r-EVAR group (p<0.001). The freedom from AAA-related mortality was 95.7% for el-EVAR and 71.0% for r-EVAR (p<0.001). Five-year freedom from type I/III endoleaks was significantly lower in the r-EVAR group (78.7% vs 90.0%, p=0.003). Five-year freedom from secondary intervention estimates were not significantly different (el-EVAR 84.2% vs r-EVAR 78.2%, p=0.064). Conclusion: Within our cohort of primary EVAR patients, r-EVAR cases showed comparable stent-graft–related technical outcome. Although there was a higher incidence of type Ia endoleaks on completion angiography in the r-EVAR group, the overall secondary intervention rate was comparable to el-EVAR.

Overstenting the hypogastric artery during endovascular aneurysm repair with and without prior coil embolization: A comparative analysis from the ENGAGE Registry

Background Endovascular aneurysm repair of aortoiliac or iliac aneurysms is often performed with stent graft coverage of the origin of the hypogastric artery (HA) to ensure adequate distal seal. It is considered common practice to perform adjunctive coiling of the HA to prevent a type II endoleak. Our objective was to question the necessity of pre‐emptive coiling by comparing the outcomes of HA coverage with and without prior coil embolization. Methods Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE), which prospectively enrolled 1263 endovascular aneurysm repair patients between March 2009 and April 2011 from multiple centers worldwide, were used for this study. We identified patients in whom the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) covered one or both HAs and grouped them into cases in which prior HA embolization—coils or plugs—was performed (CE) and cases in which HA embolization was not performed (NE). The occurrence of covered HA‐related endoleak and secondary interventions were compared between groups. Results In 197 patients, 225 HAs were covered. Ninety‐one HAs were covered after coil embolization (CE group), and 134 HAs were covered without prior coil embolization (NE group). Both groups were similar at baseline and had comparable length of follow‐up to last image (665.2 ± 321.7 days for CE patients; 641.6 ± 327.6 days for NE patients; P = .464). Importantly, both groups showed equivalent iliac morphology concerning common iliac artery proximal, mid, and distal dimensions and tortuosity, making them suitable for comparative analysis. During follow‐up, HA‐related endoleaks were sparse and occurred equally often in both groups (CE 5.5% vs NE 3.0%; P = .346). Secondary intervention to resolve an HA‐related endoleak was performed twice in the CE group and three times in the NE group. Late non‐HA‐related endoleaks occurred more often in the CE group compared with the NE group, (25.0% vs 15.0%; P = .080). Secondary interventions for other reasons than HA‐related endoleaks occurred in 7.5% of NE cases and 15.4% of CE cases (P = .057), mostly for occlusions in the ipsilateral iliac limb. During follow‐up, 19 NE patients and 9 CE patients died, which is not significantly different (P = .225), and no deaths were related directly or indirectly to HA coverage. Also, no reports of gluteal necrosis and bowel ischemia were made. Conclusions This study shows that HA coverage with the Endurant endograft without prior coil embolization does not increase the incidence of endoleak or related secondary interventions. These findings together with the already available evidence suggest that omission of coil embolization may be a more resource‐effective strategy whenever HA coverage is required.