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.

Endovascular treatment of visceral artery aneurysms with Cardiatis multilayer flow modulator: preliminary results at six-month follow-up.

AIM: The aim of this study was to analyze our initial experience with Cardiatis multilayer flow modulator and value its efficacy in the treatment of visceral artery aneurysms (VAA) at one and six months follow up in terms of aneurysms exclusion, patency of collateral vessels (when present) and shrinkage of the lesion. METHODS: Between June 2009 and June 2010, 19 patients (13 men and 6 women, mean age 60 years, range 19-86) with true visceral aneurysms underwent endovascular procedure with Cardiatis multilayer peripheral flow modulator in 12 clinical centers (10 vascular interventional radiology and 2 vascular surgery). The site of aneurysmal lesions was splenic artery in five cases (26.3%), hepatic artery in five cases (26.3%), celiac trunk in three (15.8%), superior mesenteric artery in two cases (10.5%), renal artery in three (15.8%) and gastroduodenal artery in one case (5.3%). The mean size of all the VAAs was 32.75 mm (±21.6). Early results in term of mortality and complications were evaluated. Follow-up consisted of clinical and CT scan examination at 1 and 6 months with particular attention to sac thrombosis, patency of the stent and collateral vessels (when present) and shrinkage/diameter reduction of the lesion. RESULTS: Technical success was achieved in all patients. The one perioperative death was due to pulmonary embolism at 24 hours yielding a perioperative mortality rate of 5.3% (1/19 patients). We had not major or access related complications. In two cases we had stent occlusion (one at 48 hours and another at two weeks) leading to a stent patency rate at one month of 87.5% (14/16 patients). At the CT scan performed at one month follow-up we achieved sac thrombosis in 14/16 patients (87.5%) with patency of collateral vessels; the mean size of all the visceral artery aneurysms was 31.68 mm (±21.9). At six-month follow-up we still had complete sac thrombosis in 14/16 patients (87.5%) and patency of stent and collateral vessels in all cases. The mean size of all the lesions at this scheduled control was 27.6 mm (±21.1) with shrinkage of the lesions in 12/16 cases (75%) (shrinkage range 2-15 mm, mean 5 mm ±4.7, P=0.0006, P<0.05). CONCLUSION: Even if our study has some limitations and longer follow-up is needed, preliminary results showed Cardiatis multilayer flow modulator to be a reliable tool for endovascular aneurysms exclusion of visceral artery aneurysms even in those lesions with collateral vessels arising from the sac or the neck with complete aneurysm thrombosis and shrinkage of the lesion at six-month follow-up. Overcoming limitations of traditional endovascular devices for visceral artery aneurysms exclusion, this new device allows a broaden number of patients, not suitable before for minimally invasive treatment, to undergo exclusion of these lesions with endovascular approach.

Evidence-based medicine in renal artery stenting.

Atherosclerotic renovascular disease is an increasingly recognized cause of severe hypertension and declining kidney function. Patients with atherosclerotic renovascular disease have been demonstrated to have an increased risk of adverse cardiovascular events. Over the course of the last two decades renal artery revascularization for treatment of atherosclerotic renal artery stenosis (RAS) has gained great increase via percutaneous techniques. However the efficacy of contemporary revascularization therapies in the treatment of renal artery stenosis is unproven and controversial. The indication for renal artery stenting is widely questioned due to a not yet proven benefit of renal revascularization compared to best medical therapy. Many authors question the efficacy of percutaneous renal revascularization on clinical outcome parameters, such as preservation of renal function and blood pressure control. None of the so far published randomized controlled trials could prove a beneficial outcome of RAS revascularization compared with medical management. Currently accepted indications for revascularization are significant RAS with progressive or acute deterioration of renal function and/or severe uncontrollable hypertension, renal function decline with the use of agents blocking the renin-angiotensin system and recurrent flash pulmonary edema. The key point for success is the correct selection of the patient. This article summarizes the background and the limitations of the so far published and still ongoing controlled trials.

Stenting of transplant renal artery stenosis: outcome in a single center study.

AIM: Transplant renal artery stenosis (TRAS) is the most frequent vascular complication following transplantation and is a potential curable cause of resistant hypertension, allograft dysfunction, and graft loss. Percutaneous angioplasty (PTA) is the treatment of choice, but the incidence of restenosis may be as high as 35%. Alternative treatment option combines the angioplastic procedure with the placement of a stent. The aim of this study was to evaluate retrospectively the clinical outcome of 30 patients with TRAS or post-PTA recurrent TRAS between 1991 and 2006 treated by endoluminal stenting. Primary outcomes of this study were survival rate, percentage of restenosis and lost of the graft. Secondary outcomes were: reduction of blood pressure, creatinine levels and number of antihypertensive medications. METHODS: From May 1991 to May 2006 a retrospective review of stent placement procedures for TRAS was performed. Reviewed parameters included: technical success, arterial blood pressure and number of antihypertension medications, serum creatinine level before and after intervention. Thirty-two interventions in 30 allografts were carried out. Allograft survival rate was estimated using the Kaplan-Meier RESULTS: The technical success rate of stenting was 100% with a single major complication event (a puncture site pseudoaneurysm). Mean follow-up time was 7.1 years; of the 30 allograft that underwent stent placement, all were patent at the last follow-up, with five restenosis (15.6%) of which only one needed to be retreated endoluminally. A reduction of the mean serum creatinine levels and of the number of blood pressure medications was observed. There was no difference in the survival curve of the grafts without TRAS compared to those with stenting treated TRAS. CONCLUSION: The treatment of the TRAS with selective or primary stenting is safe with a long-term patency rate. The efficacy of the stenting in this retrospective study is suggested by a decrease in mean systolic and diastolic blood pressure, serum creatinine levels and number of blood pressure medications.

Should we consider gestational diabetes a vascular risk factor?

Few and contrasting data have reported vascular endothelial dysfunction and increased serum levels of endothelial dysfunction and inflammatory markers in women with previous gestational diabetes mellitus (pGDM). We aimed at evaluating 6.5 years after delivery: intimal medial thickness (IMT), and C-reactive protein (CRP), interleukin-6 (IL-6), E-selectin, intercellular adhesion molecule-1 (ICAM-1), vascular adhesion molecule-1 (VCAM-1) levels in 82 non-pregnant pGDM and 113 control women without pGDM. A subgroup of 21 women, taken from the pGDM group, showing current normal BMI, and no metabolic abnormalities, was separately analysed. All the subjects were free of medication and non-smokers. Women with pGDM, independently by their current BMI and presence of metabolic abnormalities, showed significantly higher E-selectin, ICAM-1 and IMT values than controls. IMT proved to be significantly associated with pGDM in a regression model, after adjustments for BMI, waist circumference, blood pressure, and glucose values (beta=0.046; 95% CI 0.028-0.064). In all pGDM women, E-selectin, ICAM-1, IL-6 and hs-CRP values were significantly associated with IMT in the same model. Post-GDM women, despite being currently free from metabolic abnormalities, showed higher values of markers of endothelial dysfunction and IMT than controls, consistent with an increased future cardiovascular risk.

Diffuse vascular damage in a transplanted kidney: an indication for nuclear magnetic resonance?

Vascular lesions are an increasing challenge after renal transplantation due to the wider indications for recipients and acceptance criteria for donors. Diagnostic approach and prognostic interpretation are still matter of controversy. The case reported herein may summarize some of the issues in this regard. A 54-year-old woman, on renal replacement therapy since 1974, and a kidney graft recipient from 1975 to 1999, received a second graft in 2001. The donor age was 65 years (cold ischemia 22 hours; two mismatches). The early posttransplant follow-up was characterized by delayed graft function, hypertension, and diabetes. During the initial hypertension workup, renal graft ultrasound (US) Doppler demonstrated increased vascular resistances, stable over time (resistance index 0.74 to 0.77); renal scintiscan displayed homogeneously parenchymoa and angio-magnetic resonance imaging (MRI), an homogeneous parenchymal vascularization. Initial immunosuppression with tacrolimus and steroids was modulated by adding mycophenolate mofetil to taper tacrolimus (to reduce nephrotoxicity and hypertension). Despite this, kidney function slowly deteriorated; serum creatinine reached 3 to 3.5 mg/dL by the second year. After a severe hypertensive crisis with unchanged scintiscan and US doppler examinations, angio-MRI revealed the almost complete disappearance of parenchymal enhancement beyond the lobar arteries. A renal biopsy confirmed the severe vascular damage. The patient was switched to rapamycine and a low-dose of an angiotension converting enzyme (ACE) inhibitor. She did relatively well (serum creatinine 2.2 to 3 mg/dL) for 6 months, when rapid functional impairment forced her to restart hemodialysis. This case, almost paradigmatic of the problems occurring when the rigid vasculature of long-term dialysis patients is matched with "marginal kidneys," suggests that MRI may be a sensible good to define vascular damage in the grafted kidney.

Worsening of hypertension in a pregnant woman with renal arteriovenous malformation: a successful superselective embolization after delivery.

A 30-year-old female presented with uncontrolled hypertension due to arteriovenous malformation in the upper third of the right kidney, which worsened during pregnancy. The arteriovenous malformation was detected by color-coded Doppler sonography, confirmed by angiography, and the fistula was sealed by superselective arterial embolization with metallic coils. Superselective embolization is the most effective and safe treatment for this rare and complex pathology.

Duplex scan sonography of renal artery stenosis.

Renal artery stenosis is the most common cause of potentially remediable secondary hypertension. The most common causes include atherosclerosis and fibromuscular dysplasia. Particularly the atherosclerotic form is a progressive disease that may lead to gradual and silent loss of renal functional tissue. Thus, early diagnosis of renal artery stenosis is an important clinical objective since interventional therapy may improve or cure hypertension and preserve renal function. Screening for renal artery stenosis is indicated in the suspicion of renovascular hypertension or ischemic nephropathy in order to identify patients in which an endoluminal or a surgical revascularization is advisable. In the recent years many noninvasive tests have been proposed and evaluated in the clinical practice, in alternative to arteriography. These include nuclear scan, color Doppler sonography, CT angiography and MR angiography. Sonography is usually the first diagnostic modality for the non invasive evaluation of renal vascular disease with 95% sensitivity and 90% specificity when performed in dedicated laboratories. Despite sonography is highly affected by operator dependence, and it takes a lot of time to train good operators, actually is the best screening test because it is not expensive, non invasive and accurate. When a discrepancy exists between the clinical data and the results of US, other tests are mandatory.

[Scabies in a dalysis unit. Mystery and prejudice]. / La scabbia in un centro dialisi. Mistero e pregiudizio.

BACKGROUND: Pruritus is one of the most common symptoms of uremia. The etiology of uremic pruritus is steel incompletely known. Scabies may be a cause of itching in these patients. METHODS: Retrospective analysis of beginning and developing of a scabies outbreak in a Dialysis Unit with 160 patients. RESULTS: Sixteen cases of scabies were observed in the Dialysis Unit from April 1998 and January 1999: in 6 of them the scarification was positive. In 10 the scarification was negative, but itching disappeared after treatment with benzyl benzoate 20%. Many courses were necessary (max 6). Prophylaxis (treatment with benzyl benzoate 20% for 3 days and lingery cleaning) was applied to approximately 400 people. No cases were observed among health care workers of the Dialysis Unit. CONCLUSIONS: In a Dialysis Unit the diagnosis of scabies is difficult because the patients often have generalized itching; moreover some of them are affected by neuropathy that may make the infestation of scabies more difficult to identify. The most important factor to limitate the outbreak seems to be the prophylaxis of people who take care of patients (health-care workers, family members and car-drivers). It seems also necessary to repeat the treatments many times. The most exposed patients seemed to be those with diminished independence, diabetes and malnutrition.

Mid-term results of endovascular repair for abdominal aortic aneurysm, with loco-regional anesthesia, in high-risk patients.

BACKGROUND: Aim of this study was to evaluate the results of endovascular repair of abdominal aortic aneurysm (AAA) in patients considered not suitable for traditional open surgical repair because of the high anesthesiological risk. METHODS: We have retrospectively evaluated the result of the endovascular treatment of 11 patients with AAA of more than 6 cm diameter and high surgical risk due to cardiac hypokinesia and/or respiratory insufficiency. Patients were selected by a team composed of vascular surgeons and vascular radiologists who decided to implant the graft according to anatomical features of the AAA and of the iliac arteries. The treatment was performed in loco-regional anesthesia. The main end-points were: implantation success, mortality, morbidity, the absence of endoleak during the follow up that lasted two years. RESULTS: All the grafts were successfully implanted. There were no complications caused by anesthesiological manouvres. We had a minor intra-operative vascular complication and we performed three adjunctive endovascular procedures. A patient died of acute myocardial infarction, in the post operative period. Mean stay was six days. Pre-discharge scan showed 3 endoleaks (type I), two of these healed spontaneously and one sealed by percutaneous endovascular treatment. During follow-up (3-24 months) no patient died. One endoleak (type II) still persists. CONCLUSIONS The use of loco-regional anaesthesia allows us to treat high risk patients. Following strictly the criteria of patient selection, the surgical high risk seems not to influence significantly the mid term results that are almost equal to the ones obtained in low-risk patients.

[Evaluation of patient doses in interventional radiology]. / Valutazioni di dose al paziente in radiologia interventistica.

PURPOSE: To verify the suitability of indicative quantities to evaluate the risk related to patient exposure, in abdominal and vascular interventional radiology, by the study of correlations between dosimetric quantities and other indicators. MATERIAL AND METHODS: We performed in vivo measurements of entrance skin dose (ESD) and dose area product (DAP) during 48 procedures to evaluate the correlation among dosimetric quantities, and an estimation of spatial distribution of exposure and effective dose (E). To measure DAP we used a transmission ionization chamber and to evaluate ESD and its spatial distribution we used radiographic film packed in a single envelope and placed near the patient's skin. E was estimated by a calculation software using data from film digitalisation. RESULTS: From the data derived for measurements in 27 interventional procedures on 48 patients we obtained a DAP to E conversion factor of 0.15 mSv / Gy cm2, with an excellent correlation (r=.99). We also found a good correlation between DAP and exposure parameters such as fluoroscopy time and number of images. The greatest effective dose was evaluated for a multiple procedure in the hepatic region, with a DAP value of 425 Gy cm2. The greatest ESD was about 550 mGy. For groups of patients undergoing similar interventional procedures the correlation between ESD and DAP had conversion factors from 6 to 12 mGy Gy-1 cm-2. CONCLUSION: The evaluation of ESD and E by slow films represents a valid method for patient dosimetry in interventional radiology. The good correlation between DAP and fluoroscopy time and number of images confirm the suitability of these indicators as basic dosimetric information. All the ESD values found are lower than threshold doses for deterministic effects.

The Erasme study: a multicenter study on the safety and technical results of the Palmaz stent used for the treatment of atherosclerotic ostial renal artery stenosis.

PURPOSE: To assess, in a multicenter setting, safety, technical results, and restenosis rate of the Palmaz stent for treatment of atherosclerotic ostial renal artery stenosis. METHODS: Ten centers enrolled 106 patients (120 treated renal artery stenoses) in the study. Patient selection was based on unsuccessful percutaneous transluminal renal angioplasty (residual stenosis >/= 20%) performed for treatment of ostial stenosis >/= 50%, in patients with hypertension and/or impaired renal function. Safety was assessed by means of the complication rate, and technical results by the number of successful stent placements and occurrence of restenosis (>50%) at intraarterial angiographic follow-up. RESULTS: Stent placement was successful (n = 112) or partially successful (n = 5) in 117 (98%) arteries. Complications occurred in 19 procedures; seven were of serious clinical significance. Angiographic follow-up was performed in 89 of 117 (76%) cases, at a mean of 8 months (range 2. 5-18 months). Fifteen stents (16.9%) showed restenosis (at a mean of 8.5 months), of which 10 were successfully redilated. CONCLUSION: Renal artery stenting has a high technical success rate, a complication rate comparable to percutaneous transluminal renal angioplasty, and a low rate of restenosis at 8 months angiographic follow-up.

Arteriovenous fistulas induced by femoral arterial catheterization: percutaneous treatment.

PURPOSE: To evaluate the use of stent-grafts for the percutaneous closure of arteriovenous fistulas that develop after cardiac catheterization. MATERIALS AND METHODS: From January 1994 to November 1997, 14 arteriovenous fistulas in 13 patients (eight men, five women; age range, 46-65 years; mean age, 53.5 years) were treated. Eleven fistulas were situated between the deep femoral artery and the common femoral vein, and three fistulas were between the superficial femoral artery and the common femoral vein. All fistulas were closed with stent-grafts positioned in the artery at the level of the fistula. RESULTS: The percutaneous treatment of arteriovenous fistulas was successful in all cases. The findings at angiography performed after the procedure demonstrated the closure of the fistulas and the correct positioning of the prostheses; veins were no longer visible. One complication occurred--a partial thrombosis of the common femoral vein at the puncture site after manual compression. CONCLUSION: On the basis of the preliminary data, the authors believe that the percutaneous closure of arteriovenous fistulas with stent-grafts is a safe and effective alternative to conventional surgery.

Experience with the Stentor endograft at four Italian centers.

PURPOSE: To report the outcome of an Italian multicenter trial of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device. METHODS: Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting the inclusion criteria were enrolled. The average diameter of the aneurysm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anastomotic aneurysms. RESULTS: Sixteen (25%) tubular and 50 (76%) bifurcated endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated graft's second limb. One tube graft was too short and failed to exclude an anastomotic aneurysm. Sixty (91%) endograft procedures were completed successfully. Six (9.1%) vascular complications occurred, three in one patient who subsequently died of pulmonary embolism 72 hours postoperatively (1.5% mortality). There were four (6.1%) proximal endoleaks; two sealed spontaneously in < 1 month, and a third was converted (7.6% conversion rate). The fourth is being observed. Clinical success (aneurysm exclusion with no death or endoleak) at 30 days was 86.3% (57/66). In the 23-month follow-up of 57 eligible patients, 2 patients died of unrelated causes and 1 graft limb thrombosed, requiring a crossover femoral bypass. One patient was converted to surgical repair at 5 months postoperatively when increasing aneurysm size signaled an undisclosed endoleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques. CONCLUSIONS: The Stentor was technically feasible in 10% to 40% of AAA candidates in this study, although deployment of the second limb was problematic in the bifurcated device. Introduction of the second-generation Vanguard endograft brought this study to an end.

Percutaneous endoluminal bypass of iliac aneurysms with a covered stent.

To evaluate the feasibility of percutaneous treatment of iliac aneurysms, a covered stent was inserted in nine men suffering from common iliac artery aneurysms (six cases), external iliac aneurysms (one case), or pseudoaneurysms (two cases). Placement of the stent was successful in all patients. In one patient, an endoprosthesis thrombosed after 15 days, but was successfully treated by thrombolysis and additional stent placement. At the follow-up examinations (mean period 22 months) all stent-grafts had remained patent. No late leakage or stenosis was observed.