Suitability study of current endovascular aortic repair devices based on real-life anatomic data.

BACKGROUND: There are a number of stent-grafts in the market, designed to handle difficult anatomies during endovascular aortic repair. The aim of this study is to determine which stent-graft is the most appropriate to accommodate the majority of infra-renal aortic aneurysms cases. An additional aim is to determine what stent-graft characteristics influence the suitability of the stent-graft. RESEARCH DESIGN AND METHODS: Retrospective cohort study on the suitability of available stent-grafts for infrarenal aneurysm (AAA) repair based on real-life anatomic data. The anatomical characteristics of 235 AAA were measured manually using specialized software. All measurements were compared to the official instructions-for-use (IFU) using a purpose-specific server-side script. The proper function of the script was additionally confirmed. RESULTS: The highest suitability rate was achieved by Medtronic Endurant. The majority of stent-grafts failed to meet the respective AAA anatomy by one IFU characteristic. Stent-grafts that failed by only one IFU characteristic by ≥80% of unsuitable cases tend to have higher suitability rates. Neck dimensions and CIA diameter are the two characteristics significantly influencing the suitability rate. CONCLUSIONS: Any stent-graft with high suitability rates should be available off-the-shelf in any vascular department in order to cover the majority of cases. For challenging cases, special advantages of the stent-grafts should be taken under consideration.

Prospective evaluation of postimplantation syndrome evolution on patient outcomes after endovascular aneurysm repair for abdominal aortic aneurysm.

OBJECTIVE: This study prospectively investigated the association of postimplantation syndrome (PIS) with the clinical outcome during the first year after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm and assessed the evolution of the inflammatory response as outlined from specific inflammatory markers. METHODS: The study prospectively included 182 consecutive patients treated electively by EVAR for abdominal aortic aneurysm from January 2010 to January 2013. PIS was defined according to systemic inflammatory response syndrome criteria. Patients were monitored for 1 year. Adverse events included any major adverse cardiovascular events (MACE), acute renal failure, readmission, and death from any cause. RESULTS: PIS was diagnosed in 65 patients (35.7%). White blood cell count, high-sensitivity C-reactive protein, and interleukin 6 were significantly higher in the PIS group during the postoperative period (P < .001). At the 1-year follow-up, high-sensitivity C-reactive protein (P = .99) and interleukin 6 (P = .17) were attenuated toward the values of the non-PIS group. The white blood cell count (P = .02) remained higher in the PIS group, although within the normal reference range. During the follow-up period, MACE and adverse events occurred, respectively, in 17.2% and in 18.8% of patients in the PIS group and in 4.3% and 5.1% of the non-PIS group. The occurrence of PIS was the only independent predictor of a MACE (P = .007) or an adverse event (P = .005) during the follow-up period. CONCLUSIONS: The inflammatory response after EVAR is attenuated after the first postoperative month, as shown by the kinetics of several inflammatory biomarkers. However, PIS seems to correlate with the presence of a cardiovascular or any other adverse event during the first year after EVAR. Further studies should focus on whether a change in care is needed to ameliorate the higher cardiovascular risk of PIS patients.

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.

Standard endovascular treatment of abdominal aortic aneurysms in patients with very short proximal necks using the Endurant stent graft.

OBJECTIVE: This study evaluated and compared the midterm results of endovascular aortic aneurysm repair with the Endurant (Medtronic Inc, Santa Rosa, Calif) stent graft system in off-label use in patients with short (<10 mm) proximal aortic necks and in patients treated according to device-specific instructions for use. METHODS: This was a case-control (2:1) single-center retrospective analysis of prospectively collected data performed between September 2008 and December 2012. Analysis identified 19 elective patients with short (<10 mm) proximal necks and mild angulations (≤45°) treated with the Endurant stent graft and 38 patients matched for age, sex, and aneurysm diameter with proximal aortic necks ≥10 mm in length who met the instructions for use. End points included technical and clinical success and freedom from any secondary intervention, any type of endoleak, and aneurysm-related death. RESULTS: The short-neck group was a mean ± standard deviation age of 71.7 ± 8.9 years, 84% were men, and their mean infrarenal aortic neck length was 6.1 ± 1.2 mm. Mean suprarenal and infrarenal angles were 110° ± 10.4° and 170° ± 15.4°, respectively. Aortic neck diameters were similar between the groups (26.6 ± 3.8 vs 25.7 ± 3.7 mm; P = .36). Primary technical success was achieved in all cases. Off-label patients were more likely to require additional proximal cuff deployment to successfully obtain a seal (21% vs 3%; P = .04). The two patient groups were similar in rates of perioperative mortality, morbidity, and complications. Mean follow-up of 24 ± 12 months revealed no differences in clinical success, freedom from reintervention, and aneurysm-related death. No type I endoleaks were observed in either group during the follow-up period. CONCLUSIONS: The Endurant stent graft system applied off-label in patients with very short aneurysm necks (<10 mm) with mild angulation showed acceptable treatment results. These midterm results might suggest its use in carefully selected patients with very short neck anatomy. Long-term data are needed to verify the observed durability of the Endurant stent graft.

The effect of adding ezetimibe to rosuvastatin on renal function in patients undergoing elective vascular surgery.

We compared the effects of lipid lowering with rosuvastatin (RSV) monotherapy versus intensified treatment by combining RSV with ezetimibe (EZT) on kidney function in patients undergoing vascular surgery. Patients were randomly assigned to either 10 mg/d RSV (n = 136) or RSV 10 mg/d plus EZT 10 mg/d (RSV/EZT, n = 126). At 12 months, a similar decrease in estimated glomerular filtration rate (eGFR) was noted. Patients who achieved a low-density lipoprotein cholesterol (LDL-C) of <100 mg/dL had less eGFR decrease than those patients having an LDL-C limit of more than 100 mg/dL. There were no significant changes in the urinary total protein to creatinine ratio in either group. Significant microalbuminuria was evident in both the groups. Patients undergoing vascular surgery show deterioration in their renal function during the first year, despite statin therapy. Intensified lipid-lowering therapy by adding EZT does not appear to have any renoprotective effect.

Bridging endovascular therapy and subsequent surgical repair for the treatment of infected aneurysms after percutaneous cardiac intervention.

Bridging endovascular therapy, accompanied by a second stage open surgical repair was used to treat a rare case of infected aneurysms alongside external iliac artery after a percutaneous cardiac intervention. Because these aneurysms require early treatment, we suggest this approach, in order to avoid immediate, major surgery in a recently symptomatic cardiac and bacteremic patient receiving dual antiplatelet therapy. The approach seems to be safe and durable.

Endovascular treatment for isolated acute abdominal aortic dissection.

BACKGROUND: Isolated acute abdominal aortic dissection (IAAAD) is considered an unusual clinical entity and is traditionally treated by open surgical repair. We report our single-center experience during the last 9 years, evaluating the outcomes after endovascular repair in this patient population. METHODS: All patients with a diagnosis of IAAAD treated in our institute were included in this retrospective review. Between January 2004 and December 2012, 38 patients suffering from an acute aortic dissection were referred regionally for intervention to our department: 24 (63.2%) with a thoracic aortic dissection type B and 14 patients (36.8%, all male; median age, 65 years) with an IAAAD. Demographics, perioperative, procedure-specific, and follow-up data were prospectively aggregated in an electronic database. RESULTS: Patients suffering from IAAAD presented with acute abdominal pain (n = 13) and acute lumbar pain (n = 1). Insufferable pain and enlargement of the aorta were the main indications for treatment. Mean (± standard deviation) maximal abdominal aortic diameter at presentation was 3.5 ± 0.94 cm (range, 2.6-5.1 cm). None of these patients had a concomitant thoracic aortic dissection. All patients were treated by endovascular means, with a primary technical success rate of 100%. Two patients (14%) died perioperatively from cardiac causes. Median hospital stay was 4.5 days (range, 3-16 days). During a mean follow-up period of 37.41 ± 23.56 months (range, 8-82 months; median, 32.5 months), two patients experienced primary treatment failure needing reintervention that led to a successful outcome. The cumulative free-from-reintervention rate was estimated 90.9% at 58 months (standard error, 8.7%). A full aortic remodeling without any events was noted in all other patients during the follow-up period. CONCLUSIONS: Based on our series, IAAAD may represent a not so rare clinical entity as generally thought, suggesting that it may be underdiagnosed. Endovascular treatment of IAAAD appears to be a feasible and efficient therapeutic approach and might be considered as the first-line treatment in all patients with suitable anatomy.

Analysis of effects of fixation type on renal function after endovascular aneurysm repair.

PURPOSE: To report a prospective nonrandomized study comparing the effects of suprarenal (SR) vs. infrarenal (IR) stent-graft fixation on renal function in patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). METHODS: Patients with AAA undergoing elective EVAR between June 2008 and June 2010 were eligible for the comparative study of fixation method on renal function. Patients with impaired renal function [estimated creatinine clearance (eCrCl) <30 mL/min] or a history of renal impairment were not eligible. Renal function was assessed by measuring serum creatinine (SCr) and total proteins and microalbumin in the urine preoperatively, on postoperative day 1, and at 1, 6, and 12 months. The eCrCl was calculated using the Cockcroft-Gault formula. A standard preoperative hydration protocol was followed in all patients, and stent-graft choice was at the operator's discretion. Of 116 patients undergoing elective EVAR in the study period, 16 were ineligible, leaving 100 patients (95 men; median age 74 years) enrolled in the study (49 SR and 51 IR). RESULTS: There was no statistically significant difference between the groups in the prevalence of any risk factor, the baseline SCr and eCrCl values, contrast usage, or procedure duration. At the postoperative measurement, there was no significant deterioration of renal function in either group, although total urinary proteins increased significantly in both groups (IR p=0.01, SR p<0.001). At the 12-month follow-up, patients in the IR group had no significant alteration in any marker vs. baseline, while patients in the SR group had significant alterations in SCr (p=0.001), eCrCl (p<0.001), and microalbumin (p=0.04) in urine. The number of patients with a >20% decrease in eCrCl was not significantly different between the groups. No patient had an adverse renal event. CONCLUSION: Deterioration in renal function was observed 12 months after EVAR in patients receiving a stent-graft with suprarenal fixation, even though this did not seem to increase the likelihood of postoperative renal impairment. Furthermore, suprarenal fixation may be responsible for progressively significant proteinuria. Further studies are needed to determine the long-term impact of suprarenal fixation on renal function and investigate the potential risk of progressive renal disease in relation to type of fixation.

One-stage hybrid repair of multiple degenerative aneurysms.

The development of multiple aneurysms in different segments of the arterial tree requiring treatment is a challenge for the vascular surgeon as their management often demands more than one surgical procedure. We report a case of a 71-year-old male suffering from multiple aneurysms in four different segments of the arterial tree in combination with disabling claudication of his left leg. The patient was managed in a single session with a combination of classic open surgical and endovascular techniques in order to treat his aneurysms and revascularize his leg. This case illustrates the prospect to combine classic open surgical and endovascular techniques for the optimal management of multileveled arterial pathology. Combined therapy simplifies management and allows the one-stage treatment of these patients, while minimizing the overall operative risk.

Limb-shaking transient ischemic attacks successfully treated with external carotid artery stenting.

The external carotid artery (ECA) is one of the most important extracranial-to-intracranial sources of collateral circulation, contributing significantly to the cerebral blood flow especially when perfusion through the internal carotid artery (ICA) is compromised. Most of the endovascular studies so far have been dedicated to ICA, with little focus on the ECA. Limb-shaking transient ischemic attacks (TIAs) are a relatively rare manifestation of carotid artery disease that may present with repetitive shaking movements of the affected limbs. We report a case of an 80-year-old male with bilateral internal and contralateral external carotid artery occlusion who developed limb-shaking TIAs as a result of significant stenosis of the right ECA. Percutaneous revascularization of the ECA was performed by angioplasty and stenting. At the follow-up 12 months later, the patient remained neurologically intact with complete resolution of his symptoms. Stenting of the ECA should be considered as a reasonable alternative to conventional open repair especially in patients with contralateral carotid stenosis, insufficient circle of Willis, and significant comorbidities.

Hybrid procedures for patients with critical limb ischemia and severe common femoral artery atherosclerosis.

BACKGROUND: To evaluate the immediate and midterm results of hybrid (combined open surgical and endovascular) lower extremity revascularization procedures in patients with critical limb ischemia (CLI). MATERIAL AND METHODS: Thirty-seven consecutive patients (44 limbs) were treated for CLI using hybrid techniques during a single procedure. The CFA was involved in all limbs and was uniformly treated with endarterectomy and patch angioplasty. Hemodynamically significant atherosclerotic lesions proximal to the CFA were present in 13 limbs, distal to the CFA in 23 limbs, and both above and below the CFA in 8 limbs, and all were treated with endovascular techniques. All patients underwent a detailed clinical assessment and color duplex ultrasonography at 1, 6, and 12 months after the procedure and annually thereafter. RESULTS: The technical success rate was 96.6%, and the limb salvage rate was 95.5%. All patients except three remained free of symptoms without the need for any secondary interventions at the time of the last follow-up. Three patients presented with SFA thrombosis during the first 6 months after the procedure, and two of them had to be amputated. The median follow-up period was 17 months (range: 3-32), and the primary and secondary patency rates at 24 months were 93.2% and 95.5%, respectively. CONCLUSION: Hybrid lower extremity revascularization procedures can be used to treat CLI with low perioperative morbidity and mortality and good immediate and midterm patency and limb salvage, thus providing an attractive alternative to larger open surgical interventions.

Postoperative levels of cardiac troponin versus CK-MB and high-sensitivity C-reactive protein for the prediction of 1-year cardiovascular outcome in patients undergoing vascular surgery.

OBJECTIVE: This study evaluated comparatively the predictive value of postoperative cardiac troponin I (cTnI), creatinine kinase (CK)-MB, and high-sensitivity C-reactive protein (hs-CRP) in 1-year cardiovascular mortality and morbidity in patients undergoing elective vascular surgery. METHODS: A total of 295 consecutive patients undergoing elective noncardiac vascular surgery were prospectively followed-up over a period of 12 months. The levels of cTnI, CK-MB, and hs-CRP were measured preoperatively and 24 h after operation. The primary endpoint was the composite of cardiovascular death, nonfatal acute myocardial infarction, ischemic stroke, and unstable angina. RESULTS: The primary endpoints occurred in 11 patients (3.8%). Receiver operating characteristic curve analysis showed that postoperative cTnI was a strong predictor of a cardiovascular event during 1-year follow-up (area under the curve, 0.852; P<0.001). Areas under the curve for hs-CRP and for CK-MB were 0.734 (P=0.008) and 0.494 (P=0.947). A threshold cTnI value of 0.4 ng/ml was highly associated with the occurrence of a cardiovascular event, with a sensitivity of 80% and specificity of 81%. Furthermore, cTnI levels provided a significantly better prediction than CK-MB levels (P=0.009) and tended to be superior to hs-CRP (P=0.2). CONCLUSION: Postoperative cTnI levels seem to be superior to CK-MB and hs-CRP levels for the prediction of 1-year cardiovascular mortality and morbidity in patients undergoing elective vascular surgery.

Spinal cord ischemia after endovascular repair of infrarenal abdominal aortic aneurysm: a rare complication.

Neurologic deficit secondary to spinal cord ischemia after elective infrarenal, endovascular aneurysm repair (EVAR), consists a rare and rather disastrous complication. The etiology of such neurologic complication seems to be multifactorial, making this event unpredictable and foremost unpreventable. We report a case of paraparesis and bladder dysfunction that occurred immediately after the EVAR procedure. Prompt management by conservative or invasive methods seems to be important for the reversal of the neurologic deficit and the optimization of patient's outcome.

Post-implantation syndrome following endovascular abdominal aortic aneurysm repair: preliminary data.

OBJECTIVES: Endovascular aneurysm repair (EVAR), may elicit an unexpected systemic inflammatory response, which has been named post-implantation syndrome (PIS). The aim of this study was to prospectively evaluate the association of PIS with clinical and laboratory parameters in patients who underwent EVAR for abdominal aortic aneurysms (AAA). METHODS: Forty consecutive patients who underwent EVAR for AAA were studied. Complete blood count, fibrinogen, high sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, IL-1, tumor necrosis factor-alpha were determined before and after surgery. Several parameters regarding the operation, as well as the hospitalization days were recorded. RESULTS: PIS was diagnosed in 35% of the patients. Patients with PIS showed significant greater changes of inflammation marker levels, including hs-CRP and IL-6, as compared with the non-PIS group. PIS was associated with longer hospitalization. CONCLUSION: PIS is a relatively common complication of EVAR used to treat AAAs and it is associated with features of a systemic inflammatory response and prolongation of hospitalization. Further studies are necessary towards understanding the underlying pathophysiology and evaluating effective preventive strategies.