Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial.

The tolerance of exercise and its effects on quality of life in myasthenia gravis are not currently backed up by strong evidence. The aim of this study was to determine whether exercise as an adjunct therapy is well tolerated and can improve health-related quality of life (HRQoL) in stabilized, generalized autoimmune myasthenia gravis (gMG). We conducted a parallel-group, multi-center prospective RCT using computer-generated block randomization. Adults with stabilized, gMG, and no contra-indication to exercise, were eligible. Participants received usual care alone or usual care and exercise. The exercise intervention consisted of 3-weekly 40 min sessions of an unsupervised, moderate-intensity home rowing program over 3 months. The primary endpoint was the change in HRQoL from randomization to post-intervention. Assessor-blinded secondary endpoints were exercise tolerance and effects on clinical, psychological and immunological status. Of 138 patients screened between October 2014 and July 2017, 45 were randomly assigned to exercise (n = 23) or usual care (n = 20). Although exercise was well tolerated, the intention-to-treat analysis revealed no evidence of improved HRQoL compared to usual care (MGQOL-15-F; mean adjusted between-groups difference of -0.8 points, 95%CI -5.4 to 3.7). Two patients hospitalized for MG exacerbation were from the usual care group.

Secondary findings from next generation sequencing: Psychological and ethical issues. Family and patient perspectives.

Access to active search for actionable secondary findings (SF) in diagnostic practice is a major psychological and ethical issue for genomic medicine. In this study, we analyzed the preferences of patients and their families regarding SF and identified the reporting procedures necessary for informed consent. We interviewed parents of patients with undiagnosed rare diseases potentially eligible for exome sequencing and patients affected by the diseases listed in the ACMG recommendations. Four focus groups (FG) were formed: parents of patients with undiagnosed rare diseases (FG1, n = 5); patients with hereditary cancers (FG2, n = 10); patients with hereditary cardiac conditions (FG3, n = 3); and patients with metabolic diseases (FG4, n = 3). Psychologists presented three broad topics for discussion: 1. Favorable or not to SF access, 2. Reporting procedures, 3. Equity of access. Discussions were recorded and analyzed using simplified Grounded Theory. Overall, 8 participants declared being favorable to SF because of the medical benefit (mainly FG1); 11 were unfavorable because of the psychological consequences (mainly FG2, FG3, FG4); 2 were ambivalent. The possibility of looking for SF in minors was debated. The 4 key information-based issues for participants ranked as follows: explanation of SF issues, autonomy of choice, importance of a reflection period, and quality of interactions between patients and professionals. Examining equity of access to SF led to philosophical discussions on quality of life. In conclusion, individual experience and life context (circumstances) were decisive in participants' expectations and fears regarding access to SF. Additional longitudinal studies based on actual SF disclosure announcements are needed to establish future guidelines.

The Management of Geriatric and Frail HIV Patients. A 2017 Update from the Italian Guidelines for the Use of Antiretroviral Agents and the Diagnostic Clinical Management of HIV-1 Infected Persons.

OBJECTIVE: This article deals with the attempt to join HIV and geriatric care management in the 2017 edition of the Italian guidelines for the use of antiretrovirals and the diagnostic-clinical management of HIV-1 infected persons. METHODS: The outlined recommendations are based on evidence from randomized clinical trials and observational studies published in peer-reviewed journals and/or presented at international scientific conferences in recent years. The principles of starting antiretroviral therapy in elderly patients and the viro-immunological goals are the same as in the general HIV population. However, there are some specificities to consider, related to the host as well as the therapy itself. HIV care in elderly patients must shift from a combined AntiRetroviral Therapy specific approach to a more comprehensive management, and from a disease-based model (list of co-morbidities) to a multi-morbidity and frailty standpoint. The implementation of a geriatric approach, based on the Comprehensive Geriatric Assessment, is essential and consists of a broader evaluation of health status. This multidimensional and multidisciplinary evaluation is focused on the development of a tailored intervention plan. Polypharmacy is a frequent condition in the older population and an independent risk factor for negative health-related outcomes. This can be overcome with a multidisciplinary and cooperative approach involving HIV specialists, geriatricians and primary care physicians. CONCLUSION: The inclusion of geriatric care becomes necessary due to the novel needs of an evolving patient population. It is important to underline that the HIV specialist will continue to lead multidimensional interventions and optimize quality of care for HIV-positive people.

Long term effectiveness of electrochemotherapy for the treatment of lower lip squamous cell carcinoma.

PURPOSE: Electrochemotherapy (ECT) is a therapeutic approach based on the local application of electrical pulses that permeabilize cell membranes to enhance the uptake of low-permeant chemotherapeutic agents, thus increasing their cytotoxic effects. MATERIALS AND METHODS: Twenty-one patients with SCC of the lower lip were treated according to the European Standard Operating Procedures of Electrochemotherapy. Bleomycin (15,000 IU/m2 body surface area) was administered intravenously over a 1-min period. Eight electrical pulses (amplitude, 1000 V/cm; duration, 100 µs) were generated and delivered at a repetition frequency of 5 kHz. Changes in tumor volume were used to assess treatment response. RESULTS: Objective response (OR), complete response (CR), and partial response (PR) rates of 100%, 71.4%, and 28.6% respectively were demonstrated following a single session of ECT. ECT was well tolerated, and no adverse events occurred. CONCLUSIONS: Intravenous bleomycin-based ECT is a safe and effective therapy for SCC of the lower lip. ECT improves the quality-of-life of patients by preserving the function and the aesthetic appearance of the affected area. ECT provides a therapeutic option for elderly and frail patients who, due to their state of health, are not suitable for, or refuse surgical interventions.

Selective Intra-procedural AAA sac Embolization During EVAR Reduces the Rate of Type II Endoleak.

OBJECTIVE: The pre-treatment presence of at least six efferent patent vessels (EPV) from the AAA sac and/or AAA thrombus volume ratio (VR%) <40% are considered to be positive predictive factors for persistent type II endoleak (ELIIp). The aim of the present study was to evaluate the effectiveness of sac embolization during EVAR in patients with pre-operative morphological risk factors (p-MRF) for ELIIp. METHODS: Patients undergoing EVAR and intra-procedural AAA sac embolization (Group A, 2012-2013) were retrospectively selected and compared with a control group of patients with the same p-MRF, who underwent EVAR without intra-procedural sac embolization (Group B, 2008-2010). The presence of ELIIp was evaluated by duplex ultrasound at 0 and 6 months, and by contrast enhanced ultrasound at 12 months. The association between AAA diameter, age, COPD, smoking, anticoagulant therapy, and AAA sac embolization with ELIIp was evaluated using multiple logistic regression. The primary endpoint was the effectiveness of the intra-procedural AAA sac embolization for ELIIp prevention. Secondary endpoints were AAA sac evolution and freedom from ELIIp and embolization related re-interventions at 6-12 months. RESULTS: Seventy patients were analyzed: 26 Group A and 44 Group B; the groups were homogeneous for clinical/morphological characteristics. In Group A the median number of coils positioned in AAA sac was 4.1 (IQR 1). There were no complications related to the embolization procedures. A significantly lower number of ELIIp was detected in Group A than in Group B (8/26 vs. 33/44, respectively, p < .001) at discharge, and this was confirmed at 6-12 months (7/26 vs. 30/44 respectively, p = .001, and 5/25 vs. 32/44, respectively, p < .001). On multivariate analysis, intra-procedural AAA sac embolization was the only factor independently associated with freedom from ELIIp at 6 (OR 0.196, 95% CI 0.06-0.63; p = .007) and 12 months (OR 0.098, 95% CI 0.02-0.35; p < .001). No differences in median AAA sac diameter shrinkage were detected between the two groups at 6-12 months (p = .42 and p = .58, respectively). Freedom from ELIIp related and embolization related re-interventions was 100% in both groups, at 6 and 12 months. CONCLUSION: Selective intra-procedural AAA sac embolization in patients with p-MRF is safe and could be an effective method to reduce ELIIp. Further studies are mandatory to support these results at long-term follow up.

Could four-dimensional contrast-enhanced ultrasound replace computed tomography angiography during follow up of fenestrated endografts? Results of a preliminary experience.

OBJECTIVE: To evaluate four-dimensional contrast-enhanced ultrasound (4D-CEUS) as an alternative imaging method to computed tomography angiography (CTA) during follow up of fenestrated endovascular aneurysm repair (FEVAR) for juxta- and para-renal abdominal aortic aneurysms (AAA). METHODS: Between October 2011 and March 2012, all consecutive patients who underwent FEVAR follow up were included in the study and evaluated with both 4D-CEUS and CTA. The interval between the two examinations was always ≤ 30 days. Endpoints were the comparison of postoperative AAA diameter, AAA volume, presence of endoleaks, revascularized visceral vessel (RVV) visualization, and patency. Comparative analysis was performed using Bland-Altman plots and McNemar's Chi-square test. RESULTS: Twenty-two patients (96% male, 4% female; mean age 74 ± 7 years; American Society of Anesthesiologists grade III/IV 82%/18%) were enrolled. Seventy-eight RVV (fenestrations: 60; scallops: 17; branches: 1) were analyzed. The mean AAA diameter evaluated by 4D-CEUS and CTA was 45 ± 10 mm (range 30-69 mm) and 48 ± 9 mm (range 32-70 mm), respectively. The mean difference was 3 ± 3 mm. The mean AAA volume evaluated by 4D-CEUS and CTA was 150 ± 7 cc (range 88-300 cc) and 159 ± 68 cc (range 80-310 cc), respectively. The mean difference was 7 ± 4 cc; a Bland-Altman plot revealed agreement in AAA diameter and volume evaluation (p < .01) between 4D-CEUS and CTA. The observed agreement for the detection of endoleaks was 95%. McNemar's Chi-square test confirmed that 4D-CEUS and CTA were equivalent (p > .05) at detecting endoleaks. The first segment of six (8%) RVVs (four renal and two superior mesenteric arteries) was not directly visualized by 4D-CEUS owing to obesity, but the contrast enhancement into the distal part of vessel or into the relative parenchyma gave indirect information about their patency. McNemar's Chi-square test demonstrated the superiority of CTA (p = .031) in visualizing RVVs. The patency of 77/78 RVVs was confirmed with both techniques. McNemar's Chi-square test confirmed that 4D-CEUS and CTA were equivalent in their ability to detect visceral vessel patency. CONCLUSIONS: The data suggest that 4D-CEUS is as accurate as CTA in the evaluation of postoperative AAA diameter and volume, endoleak detection, and RVV patency after FEVAR. Four-dimensional CEUS could provide hemodynamic information regarding RVVs, and reduce radiation exposure and renal impairment during follow up. Obesity limits the diagnostic accuracy of 4D-CEUS.

Biochemical and immunomorphological evaluation of hepatocyte growth factor and c-Met pathway in patients with critical limb ischemia.

OBJECTIVES: Hepatocyte growth factor (HGF), the c-Met receptor, and hypoxia-inducible factor (HIF) are crucial for regenerative processes including ischemic wound healing. The aims of the present study are (a) to analyze the tissue c-Met and HIF-1α expression in skin from patients with critical limb ischemia (CLI); (b) to compare the serum HGF levels of CLI and control subjects. METHODS: This is a prospective, controlled, single-center study. Thirty-seven patients were enrolled. A skin sample adjacent to the ischemic lesion was taken from 20 patients with CLI; skin samples were taken from the surgical wounds of 17 patients surgically treated for abdominal aortic aneurysm as healthy controls. Serum samples were taken in all cases. Samples were formalin fixed, paraffin embedded, and routinely processed. Tissue inflammation was histologically assessed. Immunohistochemistry was performed with antibodies against total c-Met receptor, activated Met (p-Met), and HIF-1α. RT-polymerase chain reaction was used to quantify HIF-1α mRNA. The enzyme-linked immunosorbent assay was performed to evaluate serum HGF levels. RESULTS: With immunohistochemistry, while total c-Met was unchanged, different patterns of p-Met positivity were observed between CLI and control cases (p < .001). In particular, CLI skin showed a total negativity or membrane positivity for p-Met (19/20 cases), while control skin mainly showed cytoplasmic positivity in the epidermal basal layer (16/17 cases). HIF-1α was diffusely lost in CLI, but HIF-1α mRNA was threefold higher than in controls. Finally, mean serum HGF levels were 590.5 pg/mL and 2380.0 pg/mL in CLI and control groups respectively (p < .001). CONCLUSIONS: In CLI patients a significant decrease in serum HGF levels, concomitant with a loss of skin HIF-1α stabilization and a lack of c-Met phosphorylation were seen, probably driving a decrease in wound-healing functions. The next hypothesis is that HGF application might reactivate the c-Met receptor, stabilizing the normal wound healing process.

Proximal aortic neck angle does not affect early and late EVAR outcomes: an AnacondaTM Italian Registry analysis.

AIM: The aim of this paper was to evaluate early and 3-year results of the endovascular repair (EVAR) for abdominal aortic aneurysm (AAA) using the AnacondaTM endograft in patients with severe proximal aortic neck angle. METHODS: A retrospective analysis of the AnacondaTM Italian Registry was carried out. Two groups of patients were identified according to the presence of a severe (Group A, GA: ≥ 60°) or an absent (Group B, GB: <45°) proximal aortic neck angle. Preoperative, procedural and follow-up data were evaluated. Mortality, proximal type I endoleak, freedom from iliac leg thrombosis and conversion to open repair were analyzed at 30-day and 3-year follow-up. The results of GA and GB were compared. RESULTS: From 2005 to 2012, 1030 patients were enrolled in the Registry. Sixty-five patients (6.3%) were included in GA and 737 (71.5%) in GB. The mean age and AAA diameter were respectively 76.8 years and 62.7 mm in GA and 77.2 years and 56.5 mm in GB (P=NS). The ASA ≥ 3 was reported in the 95.3% of GA vs. 81% of GB (P=0.005). The endograft main-body was repositioned in 35% of cases in GA and 20.7% in GB (P=0.008); there were no differences in the main-body ballooning and proximal aortic cuff placement. There were no statistical differences in 30-day mortality (GA 1.5% vs. GB 1.3%), proximal type I endoleaks (GA 1.5% vs. GB 0.8%), iliac leg thrombosis (GA 1.5% vs. GB 1.4%) and conversion to open repair (GA 3% vs. GB 0.6%). The 3-year survival was 95.4% in GA and 94.7% in GB (P=NS). Freedom from proximal type I endoleak, iliac leg thrombosis and conversion to open repair were respectively 98.5%, 95.4%, and 95.4% in GA and 97.8%, 96.9%, and 98.5% in GB (P=NS). CONCLUSION: The AnacondaTM Italian Registry reports good results in terms of clinical success at 3-year follow-up. AAA with severe proximal aortic neck can be treated with similar outcomes to AAA with favorable neck anatomy. The endograft repositionability is a benefit in cases with severe neck angle.

Treatment of peripheral arterial disease in diabetes: a consensus of the Italian Societies of Diabetes (SID, AMD), Radiology (SIRM) and Vascular Endovascular Surgery (SICVE).

Diabetic foot (DF) is a chronic and highly disabling complication of diabetes. The prevalence of peripheral arterial disease (PAD) is high in diabetic patients and, associated or not with peripheral neuropathy (PN), can be found in 50% of cases of DF. It is worth pointing out that the number of major amputations in diabetic patients is still very high. Many PAD diabetic patients are not revascularised due to lack of technical expertise or, even worse, negative beliefs because of poor experience. This despite the progress obtained in the techniques of distal revascularisation that nowadays allow to reopen distal arteries of the leg and foot. Italy has one of the lowest prevalence rates of major amputations in Europe, and has a long tradition in the field of limb salvage by means of an aggressive approach in debridement, antibiotic therapy and distal revascularisation. Therefore, we believe it is appropriate to produce a consensus document concerning the treatment of PAD and limb salvage in diabetic patients, based on the Italian experience in this field, to share with the scientific community.

Bypass to the ankle and foot in the era of endovascular therapy of tibial disease. Results and factors influencing the outcome.

AIM: Endovascular therapy (ET) is the treatment of choice for critical limb ischemia (CLI) and tibial arteries disease (TAD) in focal lesions with restorable run-off; ankle and foot bypass (BPG) is indicated in patients unfit for ET with foot or ankle arteries suitable for surgery. The aim of this study was to evaluate limb salvage (LS), primary patency (PP) and survival (S) of patients underwent BPG in the era of ET for TAD and to define the correlated prognostic factors. METHODS: Between February 2000 and November 2008, patients with CLI and TAD were collected prospectively in a data-base (demographics, Fontaine's stage, Texas University Wound Classification [TUC]of ulcers, risk-factors, TAD, techniques of foot revascularization and surgical factors). BPG was performed in tibial arteries occlusion longer than 4 cm or focal occlusion without line-flow to pedal arteries. Clinical and Duplex-ultrasound follow-up was performed at discharge, 1, 3, 6 months and every 6 months. LS, PP, and S rates were assessed with Kaplan-Meier method; factors influencing outcomes were sought by multivariate Cox proportional hazards model analysis. RESULTS: A total of 410 revascularizations were performed in patients with CLI and TAD; BPG in 153 patients (mean age: 69.3±10.6, male/female=117/36, diabetes mellitus=75.2% hyperlypidemia=54.9%, hypertension=87.6%, renal disease=32.7%, coronary arteries disease=51.6%, Fontaine stage IV=96.1%, TUC grade-III=65.4%, TUC stage-D=51%). All autologous grafts in 96.7% (non-reversed saphenous vein=74.5%, reversed=7.2%, composite vein graft=12.4%, arm's veins=2.6%). LS and S after 1 month were 88.2% and 97.1%, respectively. Mean follow-up was 23 months. At 12 and 36 months: LS 76.7% and 70.9%, PP 62.3% and 52.9%, S 91.5% and 74.6%. LS was negatively associated with age (HR=1.041 [95%CI=1.005-1.079]), infected ulcers (HR=3.377 [95%CI=1.571-7.258]), run-off arteries diameter <1.8 mm (HR=5.854[95% CI=2.274-15.070]). PP was negatively associated with hyperlipidemia (HR=2.555 [95% CI=1.418-4.603]), female gender (HR=2.125[95% CI=1.182-3.823]), run-off arteries diameter <1.8 mm (HR=6.165 [95% CI=2.774-13.699]), reversed saphenous graft (HR=3.105 [95% CI=1.166-8.272]), composite vein graft (HR=2.930 [95% CI=1.406-6.107]) and homograft (HR=2.762 [95% CI=1.040-7.333]); instead it is positively related with hypertension (HR=4.229 [95% CI=2.089-8.563]). S was negatively correlated with renal disease (HR=3.035 [95% CI=1.363-6.756]). CONCLUSION: BPG may be a reasonable first treatment for CLI patients with TAD unfit for ET; female gender, hyperlipidemia, use of reversed saphenous, composite vein or alternative grafts, foot infection and renal disease are associated with worse outcome.

Contralateral carotid occlusion in endovascular and surgical carotid revascularization: a single centre experience with literature review and meta-analysis.

OBJECTIVE/BACKGROUND: The influence of contralateral carotid occlusion (CCO) on the outcome of carotid endarterectomy (CEA) and stenting (CAS) is debated. This study aims to evaluate CEA and CAS results in patients with CCO. METHODS: All carotid revascularizations from 2005 to 2011 were analyzed, focusing on the role of CCO on 30-day cerebral events and death (CED). A meta-analysis was performed to evaluate the results of the literature by random effect. RESULTS: Of the 1,218 carotid revascularizations performed in our institution, 706 (57.9%) were CEA and 512 (42.1%) were CAS. CED occurred in 3.6% of the CEAs and 8.2% of the CASs (p = .001). CCO was present in 37 (5.2%) CEAs and 38 (7.4%) CASs. In CEA, CCO patients had a higher CED compared with the non-CCO patients (16.2% vs. 2.9%, p = .001), as confirmed by multiple regression analysis (OR [odds ratio]: 5.1[1.7-14.5]). In CAS, CED was not significantly different in the CCO and non-CCO patients (2.6% vs. 8.7%, p = 0.23). The comparative analysis of the CCO patients showed a higher CED in CEA compared with that in CAS (16.2% vs. 2.6%, p = 0.04). Meta-analysis of 33 papers (27 on CEA and 6 on CAS) revealed that CCO was associated with a higher CED in CEA, but not in CAS (OR: 1.82 [1.57-2.11]; OR: 1.22 [0.60-2.49], respectively). CONCLUSION: CCO can be considered as a risk factor for CED in CEA, but not in CAS. CAS appears to be associated with lower CED than CEA in CCO patients.

BRAVISSIMO: 12-month results from a large scale prospective trial.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Pancreatic injury during AAA repair: a comparison between EVAR and open repair.

OBJECTIVES: Enzymatic pancreatic injury (EPI) in abdominal aortic aneurysm (AAA) treatment has been scarcely studied in the literature. Aim of this work was to compare perioperative EPI in AAA patients treated by endovascular repair (EVAR) or open repair (OR). METHODS: Forty AAA patients consecutively treated with either EVAR (GI, 20 pts) or OR (GII, 20 pts) were prospectively evaluated in terms of epidemiology, comorbidities and technical details. Serum levels of amylase, lipase and pancreatic isoamylase were assessed before treatment (T0), before aortic clamping/endograft deployment (T1), 1, 2, and 6 hours after aortic declamping/endograft deployment (T2, T3, T4) and 24, 48, and 72 hours after the procedure (T5, T6, T7). GI and GII were compared by Mann Whitney test with significance set at p < 0.05. RESULTS: GI patients were significantly older and with higher frequency of preoperative renal insufficiency than GII ones (p = 0.001 and 0.047 respectively). Other characteristics were not significantly different. Pancreatic enzymes values at T0 were within normal parameters in all patients. Total serum amylase was significantly greater at T4 (p = 0.003), T5 (p = 0.010), T6 (p = 0.003), T7 (p = 0.011) and isoamylase at T3 (p = 0.052), T4 (p = 0.037), T5 (p = 0.016) and T6 (p = 0.014) in GII compared with GI. Amylase and isoamylase peak occurred 24 hours after the procedure. Lipase was significantly different in the two groups only in T4 (p = 0.028). No acute pancreatitis occurred in the whole study group. CONCLUSIONS: EVAR significantly reduces EPI compared with OR in the AAA treatment.

Abdominal aortic aneurysms with short proximal neck: comparison between standard endograft and open repair.

AIM: Comparing the results of the treatment of abdominal aortic aneurysms (AAA) with infra-renal neck length ≤1 cm with open repair (OR) and with endovascular treatment (EVAR) with standard endograft. METHODS: Patients treated from January 2005 to December 2009 for infra-renal AAA with neck length ≤1 cm, were prospectively included. The choice of treatment was made up on anatomical and clinical criteria. Cases treated with OR (G1) and EVAR (G2) were compared. Primary end-points were: peri-operative mortality/morbidity and re-interventions, renal function worsening at discharge, mortality and re-interventions during follow-up. Secondary end points were: procedure time, need and time of intensive unit care (IUC) hospitalization, need for blood transfusions and hospital days. The comparison between groups was estimated by the Long-rank test. RESULTS: Eighty-two patients were treated (76 males and 6 females); the mean age was 71.4 years (range 56-86) and the mean AAA diameter was 6.2 cm. Forty-four patients were enrolled in G1 and 38 in G2. The two groups were clinically homogeneous, except for: age (G1

AnacondaTM: the Italian Registry. Study protocol and preliminary perioperative results.

AIM: AnacondaTM is an infrarenal stent-graft for the endovascular treatment (EVAR) of abdominal aortic aneurysms (AAA). The AnacondaTM Italian Registry is an observational multicentre registry that started in Italy on March 2009. The aim of this study is to present the registry protocol and to evaluate the interim perioperative results. METHODS: Patient data collected covered both retrospective and new cases. The case record forms are divided into preoperative data (population characteristics and clinical data), preoperative morphological data, intraoperative data, perioperative data (30-days from AnacondaTM implant) and follow-up record forms. The inclusion criteria are: AAA with a maximum sac diameter ≥ 5 cm, AAA with rapid expansion, symptomatic AAA or with a contained rupture, aorto-iliac aneurysms, proximal neck length ≥ 15 mm and diameter of the proximal aortic neck between 16 and 31.5 mm. No exclusion criteria were considered regarding aorto-iliac tortuosity, wall calcification or thrombosis and no exclusion criteria were considered regarding the patients age, comorbidities or life expectancy. Seven postoperative follow-up controls (visit and imaging) were required: at 30-days from the AnacondaTM implant, 6 months, 1 year and then annually up to 5 years. The registry is still open to new case enrollment. RESULTS: The reported results reflect the registry cases as at March 15, 2011. At this date, 787 cases were present in the database: 722 (91.7%) were male and 65 (8.3%) female. The mean patient age was 76.6 years with a range between 50 and 94 years. The ASA class was ≥ 3 in 635 patients (80.6%). The mean aneurysmal sac diameter was 55.73 ± 9.5 mm. The mean proximal aortic neck length was 26.52 ± 12.31 mm. Of the 787 patients treated, 11 cases of immediate surgical conversion were reported (1.3%). The overall 30-day mortality rate was 1.2% (10 cases): but 30-day death occurred in 0.9% of successful endograft implants and in 27.2% of surgical conversions (p<0.001). In fourteen cases (1.7%) an iliac leg thrombosis occurred and a native iliac artery thrombosis occurred in only five cases (0.5%). The 30-day overall occurrence of endoleaks was observed in 95 cases (12%): 5 cases of type I proximal endoleak (0.6%), 89 cases of type II endoleak (11.3%) and 1 case of type III endoleak (0.1%). No cases of endograft dislocation were reported. CONCLUSION: This is an interim report on the study protocol and on the preliminary early results. Presently there are no definitive conclusions, however the perioperative results show that the AnacondaTM endograft seems to be safe and effective in the treatment of AAA, even in a high risk cohort of patients. Definitive and long-term results are needed.

Spinal cord ischemia after endovascular treatment of infrarenal aortic aneurysm. Case report and literature review.

Spinal cord ischemia is a rare but catastrophic complication after endovascular treatment of infrarenal aortic aneurysm: only 14 cases are reported in the literature. A patient with a 6 cm infrarenal aortic aneurysm extending to both common iliac arteries and high surgical risk was submitted to endovascular repair with exclusion of both hypogastric arteries and surgical revascularization of the right hypogastric artery. The patient presented paraplegia, apallesthesia and superficial hyposensitivity immediately after the procedure. A spinal cord drainage was positioned with little improvement of superficial sensitivity. We undertook a systematic review of the literature on this topic.

Ring-stents supported infrarenal aortic endograft fits well in abdominal aortic aneurysms with tortuous anatomy.

AIM: Abdominal aortic aneurysms (AAA) with severe angulation of the neck or of the iliac arteries are often unsuitable for endovascular repair with conventional endografts. We evaluated the performance of a ring-stent abdominal endograft (AnacondaTM Vascutek, Terumo, Scotland) in a consecutive series of infrarenal AAA. METHODS: Preoperative, procedural and follow-up data of patients treated with AnacondaTM endograft between September 2005 and September 2009 were prospectively enrolled. Patients were divided in Group A (proximal neck angle > or =60 degrees or iliac arteries angle > or =90 degrees ) and Group B (all others). Main endpoints were technical and clinical success (primary and assisted) and late outcome in the two groups. Results were compared by Kaplan-Meier life table analysis with log-rank test (Mantel-Cox). RESULTS: One hundred twenty-seven patients, with a mean age of 73.5+/-6.9 years, have been included in this series. Mean aneurysm size was 56.7+/-10.4 mm. A severe angulation of the proximal aortic neck or/and of the iliac arteries was present in 44 cases (Group A), absent in 83 cases (Group B). The mean follow-up was 18.2+/-16.3 months. Overall primary technical success was achieved in 100% of the patients. At twenty-four months survival, primary and assisted clinical success were 94.2%, 88.2% and 91.3% in Group A and 80.3%, 83.7% and 95.2% in Group B respectively. No significant differences were found between the two groups. The only factor significantly associated with decreased survival was preoperative renal insufficiency. Iliac limb patency 24 months after EVAR in severely and non-severely angulated iliac axis was 96.7% and 98.1% respectively, with no significant difference between the groups. Only one proximal type I endoleak was detected in a patient with severe angulation of proximal aortic neck. No significant correlation between proximal type I endoleak and severe neck angulation was found. CONCLUSION: Aneurysms with severe neck or iliac arteries angulation can be treated by a ring-stent endograft with results similar to those of AAA with more favourable anatomy.

Dysfunctional vasa vasorum in diabetic peripheral artery obstructive disease with critical lower limb ischaemia.

OBJECTIVES AND DESIGN: To establish whether in diabetic patients with peripheral artery obstructive disease (PAOD) vasa vasorum (vv) neoangiogenesis is altered with increased arterial damage. MATERIALS: Thirty-three patients with PAOD and critical lower limb ischaemia, 22 with type II diabetes. METHODS: Immunohistochemistry for endothelial cell markers (CD34 and von Willebrand Factor); real-time reverse transcription polymerase chain reaction (RT-PCR) to quantify arterial wall expression of vascular endothelial growth factor (VEGF); enzyme-linked immunosorbent assay (ELISA) to assess blood VEGF; flow cytometry to detect circulating endothelial cells (CECs). RESULTS: Patients with PAOD and diabetes have a higher frequency (60% vs. 45%) of advanced atherosclerotic lesions and a significant reduction (p = 0.0003) in CD34(+) capillaries in the arterial media. Adventitial neoangiogenesis was increased equally (CD34(+) and vWF(+)) in all patients. Likewise, all patients have increased CEC and VEGF concentration in the blood as well as in-situ VEGF transcript expression. CONCLUSIONS: Patients with PAOD have remarkable arterial damage despite increased in-situ and circulating expression of the pro-angiogenic VEGF; a dysfunctional vv angiogenesis was seen in diabetics which also showed a higher frequency of parietal damage; it is suggested that in diabetic arterial wall, injury is worsened by vv inability to finalise an effective VEGF-driven arterial wall neoangiogenesis.