Endovascular Aortic Repair Follow up Protocol Based on Contrast Enhanced Ultrasound Is Safe and Effective.

OBJECTIVES: The aim of this study was to define the safety and effectiveness of a contrast enhanced ultrasound (CEUS) based follow up for endovascular aortic repair (EVAR) surveillance at a mid-term period (4 years). METHODS: At the tertiary referral centre EVAR surveillance was based on plain abdominal radiograph and duplex ultrasound (CDU), with computed tomography angiography (CTA) reserved for any non-diagnostic imaging during the period 1999-2011 (Group A). From 2012, CEUS was performed when (a) any endoleak was detected at CDU, (b) sac growth > 5 mm within 6 months, and routinely for (c) patients with renal insufficiency (above Stage 3 chronic kidney disease), or (d) iodine contrast allergy (Group B). RESULTS: A total of 880 patients (mean age 75.6 ± 8.4 years; 824 male) who underwent EVAR between 1999 and 2015 and with a minimum of 1 year follow up were included. Six hundred and nineteen patients were in Group A (70%) and the remaining 261 in Group B (30%). Median follow up was 48 months (interquartile range 24-84). During the study period 318 CEUS scans were performed with no related complications. Indications for CEUS were the following: (a) 160 (50%) endoleak presence, (b) 34 (11%) significant sac expansions, (c) 91 (29%) renal insufficiency (Stage 3 or above CKD), and 33 (10%) iodine contrast allergies. CEUS was compared with CTA, with additional confirmation by angiographic and operative findings in the case of repair in the first 100 patients. CEUS had 100% sensitivity and 100% specificity in classifying endoleaks. No differences in endoleak, re-interventions and sac shrinkage percentage were seen between the two groups at 4 years. A 4 year analysis of CTA use found a 90% reduction with the introduction of CEUS. CONCLUSIONS: The introduction of a CEUS based protocol for EVAR follow up was safe and effective and it was similar to the previous CTA based follow up protocol with regard to identification of endoleaks in a mid-term period. Moreover, CEUS allowed for 90% reduction of CTA, thereby decreasing radiation exposure for patients.

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　- The SCELTA Trial.

BACKGROUND: The therapeutic efficacy of bone marrow mononuclear cells (BM-MNC) autotransplantation in critical limb ischemia (CLI) has been reported. Variable proportions of circulating monocytes express low levels of CD34 (CD14+CD34lowcells) and behave in vitro as endothelial progenitor cells (EPCs). The aim of the present randomized clinical trial was to compare the safety and therapeutic effects of enriched circulating EPCs (ECEPCs) with BM-MNC administration.Methods and Results:ECEPCs (obtained from non-mobilized peripheral blood by immunomagnetic selection of CD14+and CD34+cells) or BM-MNC were injected into the gastrocnemius of the affected limb in 23 and 17 patients, respectively. After a mean of 25.2±18.6-month follow-up, both groups showed significant and progressive improvement in muscle perfusion (primary endpoint), rest pain, consumption of analgesics, pain-free walking distance, wound healing, quality of life, ankle-brachial index, toe-brachial index, and transcutaneous PO2. In ECEPC-treated patients, there was a positive correlation between injected CD14+CD34lowcell counts and the increase in muscle perfusion. The safety profile was comparable between the ECEPC and BM-MNC treatment arms. In both groups, the number of deaths and major amputations was lower compared with eligible untreated patients and historical reference patients. CONCLUSIONS: This study supports previous trials showing the efficacy of BM-MNC autotransplantation in CLI patients and demonstrates comparable therapeutic efficacy between BM-MNC and EPEPCs.

Cranial nerve injury is associated with dual antiplatelet therapy use and cervical hematoma after carotid endarterectomy.

OBJECTIVE: To determine predictors of cranial nerve injury (CNI) after carotid endarterectomy (CEA). METHODS: Consecutive CEAs performed over a 5-year period were enrolled in this study. Outcomes analyzed included 30-day major adverse event rate (composite of stroke, death, and myocardial infarction), death, stroke, disabling stroke, myocardial infarction, cervical hematoma and CNI rate, reoperation, and hospital readmission at 30 days. RESULTS: There were 1258 CEAs were included in the study, 1168 (93%) were performed using an eversion technique. Patients with symptoms comprised 27% of the cohort (n = 340). At 30 days, there were no deaths, 23 major adverse events (1.8%), 11 strokes (0.9%: nine minor, two major), 12 myocardial infarctions (0.9%), 41 cervical hematomas (3.3%), 9 reoperations (0.7%) and 10 hospital readmissions (0.8%). Median duration of stay was 1 day (interquartile range, 1-2 days). CNI rate at discharge was 2.3% (n = 29). Two patients (9%) had more than one cranial nerve affected. The marginal mandibular branch of the facial nerve was most frequently involved (n = 16; 52%), followed by the hypoglossal (n = 9; 29%), the vagus (n = 4; 13%), and the spinal accessory nerve (n = 2; 6%). Horner's syndrome, consistent with an injury to the cervical sympathetic chain, occurred in 13 patients (1%) who had a true cranial nerve affected as well. The vast majority (94%) of these CNIs and all Horner's syndrome neurapraxias were transient; only the two accessory lesions persisted at their follow-up visit (median, 32 months; range, 8-72 months). Significant predictors for CNI included diabetes (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.0-6.2; P = .048), cervical hematoma (OR, 41.7; 95% CI, 13.8-125.4; P < .001), and dual antiplatelet therapy (OR, 4.4; 95% CI, 1.7-11.4; P = .002). CONCLUSIONS: CNI is predominantly a transient complication, but is associated significantly with dual antiplatelet therapy use and the occurrence of a postoperative cervical hematoma. Scrupulous attention to hemostasis might reduce the incidence of CNI.

Use of Tapered Balloons to Recanalize Occluded Below-the-Knee Arteries in Diabetic Patients with Critical Limb Ischemia.

BACKGROUND: The aim of this study was to evaluate the outcome of tapered balloon use in recanalization of long occlusions of below-the-knee (BTK) arteries in diabetic patients with critical limb ischemia (CLI). METHODS: Forty-nine occluded BTK arteries in 35 diabetic patients with CLI were revascularized in our Diabetic Foot Center between January and September 2014 using tapered balloons. Twelve-month outcomes were evaluated in terms of healing of the lesions, survival, limb salvage, primary patency, primary assisted patency, and secondary patency. RESULTS: The patients were predominantly male (27/35, 77.1%) with a mean age of 70.9 years (±10.3 standard deviation [SD]). During the follow-up (mean duration 12.4 months ± 4 SD), healing of the lesions was obtained in 27 of the 35 cases (77.1%). Estimated 12-month survival and limb salvage were 85.7% and 91.1%, respectively. Estimated 12-month primary patency, primary assisted patency, and secondary patency were 78.3%, 79%, and 88.9%, respectively. Univariate analysis demonstrated that the presence of chronic renal failure affected survival (P = 0.005), and assignment to Rutherford class 6 affected limb salvage (P = 0.005), primary patency (P < 0.001), and primary assisted patency (P < 0.001). Furthermore, the presence of coronary artery disease affected primary patency (P = 0.001) and primary assisted patency (P = 0.05). CONCLUSIONS: Tapered balloons are a safe and effective means to recanalize long occlusions of BTK arteries in diabetic patients with CLI. Outcomes are poorer in patients with major tissue loss and with a history of coronary artery disease. Further experience with larger groups is needed to validate these outcomes.

"Thirty-day neurologic improvement associated with early versus delayed carotid endarterectomy in symptomatic patients".

BACKGROUND: Neurologic outcome after early or delayed carotid endarterectomy (CEA) has yet to be fully elucidated. The aim of this study was to determine 30-day neurologic improvement with respect to the timing of CEA in symptomatic patients. METHODS: Single-institution review of consecutive patients who underwent CEA for symptomatic carotid stenosis ≥60% in the period between January 2009 and November 2013. Patients recruited had acute neurologic impairment on presentation, defined as <5 points on the National Institutes of Health Stroke Scale (NIHSS). Patients were grouped according to time between the qualifying event and surgery (0-14 days, early CEA and 15-30 days, delayed CEA). Thirty-day neurologic status improvement was defined as a decrease (≥1) in the 30-day NIHSS score versus NIHSS score immediately before surgery. RESULTS: There were 100 and 222 patients in the early and delayed CEA groups, respectively. The type of qualifying symptoms (stroke versus transient ischemic attack rate) was similar and there were no significant differences in 30-day adverse outcome rates between the 2 cohorts. There were no deaths, 4 strokes (1.2%, 3 vs. 1; P = 0.091), and 4 myocardial infarcts (1.2%, 0 vs. 4; P = 0.315). Thirty-day improvement in neurologic status was associated with early CEA, very early CEA (48 hours), and NIHSS >2 before surgery, with an odds ratio of 4.9 (confidence interval [CI], 0.9-25.7; P = 0.03), 12.9 (CI, 1.4-115.7; P = 0.02), and 2.6 (CI, 1.7-4.1; P < 0.001), respectively. CONCLUSIONS: Our results suggest that reducing the time to intervention in selected (NIHSS <5) symptomatic patients is safe and associated with improved neurologic status.

Simultaneous hybrid treatment of aneurysmal aberrant right subclavian artery.

We review the literature and report our experience on the simultaneous hybrid treatment (open and endovascular) of two symptomatic aneurysms of an aberrant right subclavian artery (ARSA). At follow-up (four years and one year, respectively) both patients were alive and free of symptoms. Hybrid treatment of an aneurysmal ARSA is a safe and effective procedure. However, a larger series of patients with long-term follow-up is necessary to determine the role of this technique.

Staged in situ aorto-iliac hybrid technique: an original technique to treat complex juxtarenal and iliac aneurysms.

BACKGROUND: To report a novel staged hybrid technique to treat complex juxtarenal abdominal aortic aneurysm (JAAA) associated with at least one iliac artery aneurysm (IA) with no adequate distal fixation zone. METHODS: The novel technique herein described has two main "staged" steps. The first step consists in creating an adequate distal fixation zone by endovascular means; after hypogastric embolization an iliac stent-graft has placed from 5 mm above the aortic bifurcation to the external iliac artery. The second step is the surgical resection of the JAAA and graft placement sutured distally to the stent-graft which was always performed the day after. RESULTS: The five cases included (mean age 74 years), were rejected for fenestrated or branched endovascular aortic repair or iliac branch devices. Four tube grafts and one aorto-bi-iliac graft were sutured to one stent-graft (N.=3), two stent-grafts in iliac kissing configuration (N.=1) and to a main body of a bifurcated stent-graft (N.=1). Mean follow-up duration was 14 (4-27) months with no mortality. Technical success was obtained in all cases (2 suprarenal clamping). Postoperative complications included two pleural effusions, two transient gluteal intermittent claudications, and one renal failure. CONCLUSIONS: The technique herein described seems to be a feasible and cost-effective alternative treatment for selected concomitant complex JAAAs and IAs unsuitable for totally endovascular treatment.

Long-term analysis of standard abdominal aortic endovascular repair using different grafts focusing on endoleak onset and its evolution.

OBJECTIVE: To report long-term results of standard EVAR focusing on endoleak onset (ELo) and its evolution. METHODS: 880 EVARs using different stentgrafts (1999-2015) were included. Primary outcomes were all-cause mortality and AAA-related mortality. Timing of ELo after EVAR was categorized as follows: ELo1 = 0-2 years, ELo2 = 2-4 years, ELo3 = 4-6 years, ELo4 = 6-8 years, and ELo5 ≥ 8 years. The rate of sac shrinkage/sac expansion and the need to re-intervene were the variables considered to determine EL evolution. RESULTS: Median follow-up was 60 months (IQR: 36-84). Summary follow-up index was 0.99. Survival rate was 94.5% at 2 years, 57.7% at 10 years, 33.3% at 14 years. Freedom from AAA-related-death rate was 99.3% at 14 years. Freedom from endoleak was 86.4% at 2 years, 68.3% at 10 years, and 48.6% at 14 years. EL rate was 1.9% (n = 19),16.6% (n = 146), 0.8% (n = 7), and 0.4% (n = 4) for type I, II, III and IV, respectively. Only type II EL showed a significant difference in the ELo (Elo1 = 31%; ELo2 = 12.8%; ELo3 = 9.4%; Elo4 = 10.2%; Elo5 = 11.4%; P < .001). Sac shrinkage occurred in 791 (90%) patients while 89 (10%) had a persistent sac expansion at the last follow-up. Freedom from reintervention was 95.6% at 2 years, 86.4% at 10 years, and 80% at 14 years. 48 out of 176 (27.2%) patients with EL underwent reintervention. The re-intervention rate was significantly higher within the first two years of follow-up if compared to the following years (17.6% vs. <10%; P < .001). CONCLUSIONS: An active lifelong surveillance follow-up can guarantee good long-term EVAR outcomes. Reinterventions and type II EL were more frequent in the first two-year of follow-up.

Intra-arterial injection of iloprost reduces the risk of early recoil after balloon angioplasty of below-the-knee vessels in patients with critical limb ischemia.

BACKGROUND: Previous studies demonstrated that early recoil is frequently observed in patients undergoing balloon angioplasty. The aim of this study was to evaluate the impact of intra-arterial administration of iloprost (Endoprost®, Italfarmaco S.p.A., Milan, Italy) on early elastic recoil after balloon angioplasty of below-the-knee (BTK) vessels in patients with critical limb ischemia (CLI). METHODS: Between January 2015 and December 2015 32 patients with CLI underwent balloon angioplasty of at least one BTK vessel followed by intra-arterial administration of iloprost. Early elastic recoil was defined as residual lumen compromise >10%. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after BTK balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). RESULTS: Patients were predominantly female (18/32, 56.2%) with a mean age of 79.6 years (range 68-87). Most of the patients were diabetics (25/32, 78.1%). An occlusion was present in 24 cases (75%). Mean BTK lesion length was 144.1 mm (range 22-320). Mean MLD measurements were 0.1 mm (range 0-0.5; MLDbaseline), 2.5 mm (range 1.9-3; MLDpostdilation), and 1.9 mm (range 0.7-3; MLD15min). Early elastic recoil was recorded in 14 patients (43.8%). The mean percentage of elastic recoil after 15 minutes was 21.4%. CONCLUSIONS: In our experience intra-arterial administration of iloprost reduces the risk of early elastic recoil after balloon angioplasty of BTK vessels in patients with CLI. Further analyses with larger population studies and randomized trials are needed to validate this therapeutic option.

Prevalence, predictors and prognostic significance of microalbuminuria in acute cardiac patients: a single center experience.

The objective of this study was to prospectively assess the prevalence, predictors and prognostic significance of microalbuminuria in a large cohort of consecutive acute cardiac patients, admitted to an intensive cardiac care unit from 1 January 2008 to 30 June 2009. In 815 acute cardiac patients, microalbuminuria is detectable in 39.3%. Microalbuminuria shows a significant negative correlation with left ventricular ejection fraction (Spearman's ρ = -0.228; p < 0.001), while it is positively correlated with C-reactive protein (Spearman's ρ = 0.239; p < 0.001), NT-pro-BNP (Spearman's ρ = 0.306; p < 0.001) and glycemia (Spearman's ρ = 0.191; p < 0.001). Microalbuminuria is an independent predictor for in-hospital mortality (1 µg/min step) (OR 1.015; 95% CI 1.008-1.023; p < 0.001). In the acute phase of cardiac patients, microalbuminuria is a common finding, and it represents an independent predictor for early mortality. It is strictly linked to the inflammatory activation (as indicated by C-reactive protein) and to acute glucose values, thus suggesting that it may be part of the acute response to stress.