Cinical outcomes of Endurant II stent-graft for infrarenal aortic aneurysm repair: comparison of on-label versus off-label use.

PURPOSE: We aimed to compare the outcomes of the Endurant II (Medtronic) stent-graft used under instructions for use versus off-label in high-risk patients considered unfit for conventional surgery. METHODS: Data from patients treated with the Endurant II stent-graft between December 2012 and March 2015 were retrospectively analyzed. Sixty-four patients were included. Patients were assigned to group A if treated under instructions for use (n=34, 53%) and to group B if treated off-label (n=30, 47%). Outcome measures included perioperative mortality and morbidity, survival, freedom from reintervention, endoleak incidence, in-hospital length of stay, and mean stent-graft component used. Mean follow-up was 22.61±12 months (median, 21.06 months; range, 0-43 months). RESULTS: One perioperative mortality (1.6%) and one perioperative complication (1.6%) occurred in group B. At two months follow-up, one iliac limb occlusion (1.6%) occurred in group A. No type I/III endoleaks were recorded. A type II endoleak was identified in three cases (4.7%). Overall survival at three years was 89% (97% for group A, 82% for group B; P = 0.428). Reintervention-free survival at three years was 97% for both groups (P = 0.991). A longer in-hospital stay was observed in group B (P = 0.012). CONCLUSION: The Endurant II (Medtronic) new generation device was safe in off-label setting at mid-term follow-up. The off-label use of the Endurant II (Medtronic) is justified in patients considered unfit for conventional surgery. Larger studies are required in this subgroup of patients.

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.

Spontaneous symptomatic common carotid artery pseudoaneurysm: case report and literature review.

Spontaneous common carotid artery pseudoaneurysm (CCAP) is rare but potentially lethal disease. A 78-year-old man presented with pain in correspondence of right neck side and slight right eye ptosis. No previous surgery, trauma, or venous catheterizations in the neck region were reported. The computed tomographic angiography (CTA) showed a 4-cm saccular CCAP. The patient was managed emergently with surgical CCAP excision. At 6-month follow-up, the patient is neck pain-free with complete ptosis regression, and the CTA shows no pathologic findings. The literature review reported 7 cases of pseudoaneurysm of carotid district. All these cases were managed by surgical approach, and in 1 case, an endovascular embolization procedure was associated before. The CTA was used in all cases but angiography in only one. In these cases, the surgical repair with pseudoaneurysm evacuation is still the treatment of choice.

Late Complication after Superficial Femoral Artery (SFA) Aneurysm: Stent-graft Expulsion Outside the Skin.

A 78-year-old man presented with a 7-cm aneurysm in the left superficial femoral artery, which was considered unfit and anatomically unsuitable for conventional open surgery for multiple comorbidities. The patient was treated with stent-graft [Viabhan stent-graft (WL Gore and Associates, Flagstaff, AZ)]. Two years from stent-graft implantation, the patient presented a purulent secretion and a spontaneous external expulsion through a fistulous channel. No claudication symptoms or hemorrhagic signs were present. The pus and device cultures were positive for Staphylococcus aureus sensitive to piperacillin/tazobactam. Patient management consisted of fistula drainage, systemic antibiotic therapy, and daily wound dressing. At 1-month follow-up, the wound was closed. To our knowledge, this is the first case of this type of stent-graft complication presenting with external expulsion.

Endovascular treatment of abdominal aortic anastomotic pseudoaneurysm. The experience of two centers.

INTRODUCTION: Abdominal aortic pseudoaneurysms are a rare but serious complication of aortic surgery. Treatment with traditional open surgery is associated with a high rate of perioperative mortality and morbidity. Endovascular treatment is less invasive and guarantees lower mortality and morbidity rates. The aim of this study was to evaluate the role of short-, medium- and long-term endovascular treatment of these pseudoaneurysms. MATERIALS AND METHODS: Over the past 10 years, 14 patients with abdominal aortic aneurysms, which developed after prior aortic surgery, underwent endovascular treatment involving implantation of an endoprosthesis at our institutions. Exclusion criteria were emergency treatment and suspicion of an infected prosthesis. A Cheatham-platinum covered stent mounted on a balloon catheter was implanted in one patient and self-expandable stent-graft in the other 13. No fenestrated or custom-made prostheses were used. RESULTS: The procedure had a 100% technical success rate. There was no postoperative mortality. Two type I endoleaks, observed at aortography at the end of the procedure, were not seen on the CT scan taken one month later. Three patients (21.4%) had major perioperative complications which consisted of early occlusion of a branch of the endoprosthesis, (treated with a femoro-femoral crossover bypass graft), a transient ischemic attack, and jaundice. The long-term mortality rate, at an average follow-up of 37.4 months, was 21.4%. None of the deaths was related to the procedure. CONCLUSIONS: Endovascular treatment of patients who develop anastomotic pseudoaneurysm after surgery of the abdominal aorta is safe and effective both in the short and long term. In our opinion it is the treatment of choice for this category of patients.

Basal cerebral computed tomography as diagnostic tool to improve patient selection in asymptomatic carotid artery stenosis.

One-hundred patients were included to evaluate the role of cerebral computed tomography (CT) to improve patient selection in asymptomatic internal carotid stenosis. Symptomatic patients were assigned to group A, asymptomatic patients to group B. A cerebral CT pattern A was observed in groups A and B in 60% and 20%, respectively (P < .0001). Between A and B groups, type 6 plaques were found, respectively, in 26.7% and 7.5% of patients (P = .01); a type 5 in 51.7% and 45% (P = .32) of patients; and a type 4 in 21.7% and 47.5% of patients, respectively (P = .006). Within B group, the association of CT pattern A and histological plaque level 4, 5, and 6 was, respectively, 25% (P = .15), 50% (P = .53), and 25% (P = .16). In group B, a 7-fold risk increase in CT pattern A was found in patients with level 6 plaque. In asymptomatic patients with high-risk plaque, a basal cerebral CT scan can be used as diagnostic tool to improve patient selection for intervention.

Surgical repair of popliteal artery aneurysms remains a safe treatment option in the endovascular era: a 10-year single-center study.

INTRODUCTION: Endovascular popliteal artery aneurysm repair has emerged recently as a feasible alternative to standard surgical repair. However, the evidence from the literature is still limited, with only case reports, case series and one small randomized trial. Currently, the available data suggests that stent-grafts should be used in patients at very high surgical risk. The purpose of this study is to present our surgical experience in popliteal artery aneurysm repair in an endovascular era. MATERIALS AND METHODS: Data from 36 consecutive patients, who were admitted to our hospital from January 2000 to April 2010, was analyzed retrospectively. Twenty-six patients underwent surgical treatment through medial or posterior access. The posterior approach was used preferentially. The medial approach was adopted in patients with large aneurysms or aneurysms involving the superficial femoral artery. RESULTS: Twelve patients (Group A; 46.1%) were operated on via medial access followed by femoropopliteal bypass. In the remaining fourteen patients (Group B; 53.9%) an interposition graft was performed via a posterior approach. The 30-day overall mortality rate was 3.8% (1/26). The 30-day amputation rate was 0% in both groups. The primary patency rate was 83.3% in Group A at 78.8-month average follow-up (range: 18-128 months) and was 100% in Group B at 46.3-month average follow-up (range: 5-121 months). CONCLUSION: Notwithstanding the extensive use of stent-grafts worldwide, surgical repair remains the gold standard for the management of popliteal artery aneurysms. In our experience open repair using either a medial or posterior approach is associated with low mortality and morbidity rates.