Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study.

PURPOSE: The newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder. MATERIALS AND METHODS: A retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death. RESULTS: Primary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18-26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34). CONCLUSION: The initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.

The effect of increasing operator experience on procedure-related characteristics in patients undergoing carotid artery stenting.

Objectives To evaluate the efficacy and safety of carotid artery stenting for the treatment of severe carotid artery disease in our department and to investigate the effect of increasing operator experience on perioperative and procedure-related characteristics. Methods From January 2007 to February 2015 200 patients underwent 207 endovascular procedures for carotid artery stenosis. Of all, 113 arteries (56.5%) were symptomatic. Significant changes across time were calculated with the use of Change Point analysis using bootstrap and mean squared error estimates. Results The technical success was 98.6% (204/207 cases). Thirty-day neurological events included stroke in four patients (2%) and transient ischemic attack in two (1%). None of the patients died during the first 30 days. The most significant change of radiation duration occurred after the 33rd patient with a decrease from 25.31 min to 12.31 min, while for the total operative time that change occurred between the 31st and 33rd patient where mean operation time decreased from 88.89 min to 49.22 min. The most significant change of contrast media used occurred at the 40th patient with a decrease from 91.58 ml to 62 ml. During a mean follow-up period of 42 ± 20.02 months none of the patients experienced any cerebrovascular event. There was one case of significant recurrent stenosis, which was successfully treated by endovascular means. Conclusions Endovascular treatment of carotid artery stenosis performed in a single center with the use of a cerebral protection device seems to consist a safe therapeutic choice with acceptable results, within the referenced benchmarks proposed in the latest guidelines. Certain perioperative parameters such as the amount of contrast media used, the fluoroscopy and operation time, seem to decline overtime indicating increasing operator's experience. A number of performed cases above 40 was related to the significant decrease of those parameters and may represent the learning curve of the procedure.

Relationship between normal preoperative white blood cell count and major adverse events after endovascular repair for abdominal aortic aneurysm: results of a pilot study.

STUDY OBJECTIVE: To examine the association between preoperative white blood cell (WBC) count within the reference range and major adverse events (MAEs) following endovascular repair of abdominal aortic aneurysms (AAA). DESIGN: Prospective observational study. SETTING: Vascular surgery clinic in a tertiary university hospital. PATIENTS: One hundred fifty-three consecutive patients. INTERVENTION: Endovascular repair of AAA. MEASUREMENTS: All patients had normal preoperative WBC count (3.5-10.3 K/µL). Postoperative MAE was defined as death, stroke, and myocardial infarction. The prognostic value of preoperative WBC was determined by receiver operating characteristic curves, whereas χ2 test and Cochran-Armitage trend test were used to assess the association between MAE and different values of WBC. MAIN RESULTS: A preoperative WBC cutoff value of 7.3 Κ/µL could predict MAE with 62% sensitivity and 62% specificity (area under the curve, 0.62). Patients with higher preoperative WBC experienced more events compared with patients with lower values (P=.027). A linear relationship was observed between an increasing preoperative WBC count within the reference range and the risk of postoperative events (P=.004). Logistic regression analysis showed that preoperative normal WBC count was an independent predictor of MAE and revealed that for every 1-K/µL increase, patients had a 32.8% increase in their relative odds of developing postoperative MAE (P=.035). CONCLUSIONS: This pilot study demonstrates a linear correlation between an increasing preoperative WBC count within the reference range and an increased risk for postoperative MAEs following endovascular repair for AAA. Identification of high-risk patients at an early stage by using WBC count could prove useful in implementing measures to improve their clinical outcome.

Endovascular repair of blunt axillo-subclavian arterial injuries as the first line treatment.

AIM: To report and analyse our results regarding the endovascular management of blunt axillo-subclavian arterial injuries as the first line treatment. METHODS: During an eight-year period, seven patients (mean age 56.4±14.1 years, all males) with blunt traumatic axillo-subclavian arterial injuries were presented to the emergency department. All patients suffered also from concomitant other injuries and had a supraclavicular haematoma along with diminished or absent upper limb peripheral pulses, while computed tomography angiography set the diagnosis. RESULTS: The endovascular procedure was technically successful in all patients. No procedure-related complication was encountered during the in-hospital stay, while none of the patients died. The median hospital stay was 22 days (range 12-46). During a follow-up period spanning an average of 27 months (range 6-44 months) there was one stent-graft thrombosis at 12 months in an otherwise asymptomatic patient that required no further intervention. CONCLUSION: Endovascular technique seems to constitute a reliable approach for treating blunt axillo-subclavian arterial injuries in the emergent setting. Despite uncertainties in patient selection and optimal management algorithms, it seems that endovascular approach could be the first line treatment for such injuries. Accumulation of data on larger number of patients with longer follow-up is warranted to further define the value of this therapeutic modality in the trauma setting.

Platelet activation after endovascular repair of abdominal aortic aneurysm.

AIM: To investigate the effect of endovascular aneurysm repair (EVAR) on platelet (PLT) function and reveal possible associated factors. METHODS: Fifty consecutive patients were included. PLT count and activation (CD62P-CD36), white blood cell (WBC) count, and high sensitivity C-reactive protein (hs-CRP) were measured preoperatively, at the first and third postoperative day. RESULTS: EVAR elicited a significant reduction in PLT count from baseline to first day after EVAR (p < 0.001), while no significant difference was noted between the first and third day. Furthermore, CD62P expression was markedly elevated at the first day after EVAR (median % positive PLTs from 13.7 at baseline to 22.1, p = 0.05), but returned to baseline levels by the third day. Maximum abdominal aortic aneurysm diameter was the only factor that significantly affected the CD62P values (p = 0.005). Postoperative CD36 values were significantly correlated with total aneurysm volume (p = 0.05) and were higher in endografts made from polyester (p = 0.01). There were no correlation between PLT activation and hs-CRP, WBC, maximum temperature, and 30-day morbidity. CONCLUSION: EVAR has elucidated a significant reduction in PLT count and increase in PLT activation at the immediate postoperative period. The type of the endograft material and the aneurysm maximum diameter and volume appear to play an important role in PLT activation.