Atherosclerotic renovascular disease: medical therapy versus medical therapy plus renal artery stenting in preventing renal failure progression: the rationale and study design of a prospective, multicenter and randomized trial (NITER).

BACKGROUND: Many studies suggest a major prevalence of atherosclerotic renovascular disease (ARVD), caused by mono or bilateral renal artery stenosis (RAS). Unfortunately, there is no definite therapy to cure this disease to date; therefore, ARVD is burdened by important clinical complications with high social and economic costs. The last few years have seen important advancements in both medical therapy and in interventional radiology (for example, percutaneous transluminal renal artery stenting (PTRS)). All of them could affect, in some way, the natural history of ARVD, but to date the optimal strategy has not been established. METHODS: The protocol of a prospective, multicenter, randomized trial "Nephropathy Ischemic Therapy (NITER)" is presented. It enrolls patients with stable renal failure (glomerular filtration rate (GFR) >or=30 ml/min) and hypertension, and hemodynamically significant atherosclerotic ostial RAS (>or=70%) diagnosed by duplex Doppler (DD) ultrasonography and confirmed by magnetic resonance angiography (MRA). This study aims to evaluate whether medical therapy plus interventional PTRS is superior to medical therapy alone according to the following combined primary endpoint: death or dialysis initiation or reduction by >20% in estimated GFR after 0.5, 1, and 2 yrs of follow-up and an extended follow-up until the 4th year. Medical therapy means drugs to control hypertension, improve dyslipidemia and optimize platelet anti-aggregant therapy. The sample size is estimated in 50 patients per group to achieve a statistical significance of 0.05 in case of a reduction by 50% in the combined endpoints.

New perspectives for the treatment of thoracic aortic aneurysm with self-expanding endoprostheses. Preliminary experience.

We present our preliminary experience with the application of covered aortic stents to treat aneurysms and dissections of the thoracic artery, a technique that was developed in 1996. Seven selected patients were treated with World Medical Talent bare spring tip endoprostheses and followed up for a total of 67 months. All prostheses were implanted at the Parma General Hospital Cardiovascular Department. Seven patients, average age 57.8 years, range 44-73 years, were treated; a total of 11 prosthetic segments were implanted. Aortic pathologies included: 2 isthmic atherosclerotic aneurysms, 2 chronic dissections, 1 acute dissection, 1 thoracic aneurysm associated with an aneurysm of the abdominal aorta below the renal arteries. Dilation diameters ranged from 6-9 cm, lengths from 4-12 cm. All patients underwent computerized tomography and angiography before stent implantation. The procedure was carried out in an operating room with the patient under general anesthesia and in controlled hypotension. In 2 cases the common iliac artery, prepared for the extraperitoneal route by application of a No. 10 Dacron introducer sheath, was used as the insertion site; in 4 cases the common femoral artery was used, in the case of the double aneurysm the traditional surgical route was used to correct the abdominal aneurysm, and the thoracic aneurysm was repaired through the abdominal prosthesis. All patients were released in good condition; thrombosis of the aneurysm surrounding the graft was immediate in all cases except one which required the application of a second segment shortly after the initial procedure. There were no major complications; one case of iatrogenic dissection of the femoral artery used as the access site required a prosthetic bypass. No implant-related complications were observed during follow-up. Our initial experience has been favorable and demonstrates that stents can be utilized for aortic pathologies of varying etiologies; we had no mortality or major complications, and hospital stays were short. Long term results must be confirmed before the therapeutic potential of this technique can be fully evaluated.

Symptomatic subtotal occlusion of the innominate artery treated with balloon angioplasty and stenting.

PURPOSE: To report the endovascular treatment of a subtotal occlusion of the innominate artery giving rise to subclavian steal syndrome. METHODS AND RESULTS: A 60-year-old man in general good health was admitted to the hospital for sudden onset of amaurosis in the right eye. Thrombosis of the central retinal artery was diagnosed. Physical examination, color flow duplex imaging, and aortic arch angiography showed a subtotal occlusion of the innominate artery with right subclavian steal syndrome. One month later, balloon dilation and stenting of the innominate artery was performed through a right axillary access without cerebral protection. The innominate artery was recanalized with correction of the steal syndrome and restoration of the right radial pulse; no complications occurred. Twelve months later, color flow duplex sonography confirmed innominate stent patency and antegrade flow in the right vertebral artery. CONCLUSIONS: Our experience supports the view that percutaneous endovascular techniques are appropriate and are the preferred treatment for lesions of the supra-aortic vessels. Continued surveillance will determine their long-term durability.

Transjugular intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal bleeding in cirrhosis: a randomized multicenter trial. Gruppo Italiano Studio TIPS (G.I.S.T.).

Transjugular intrahepatic portosystemic shunt (TIPS), a new technique for the treatment of portal hypertension, has been successful in preliminary studies to treat acute variceal hemorrhage and to prevent variceal rebleeding. The purpose of this multicenter, randomized controlled trial is to compare the efficacy of TIPS with that of endoscopic sclerotherapy in the prevention of variceal rebleeding in cirrhosis. Eighty-one cirrhotic patients, with endoscopically proven variceal bleeding, were randomized to either TIPS (38 patients) or endoscopic sclerotherapy (43 patients). Randomization was stratified according to the following: if bleeding occurred < 1 week (stratum I); if bleeding occurred 1 to 6 weeks (stratum II); and if bleeding occurred 6 weeks to 6 months (stratum III) before enrollment. Follow-up included clinical, biochemical, Doppler Ultrasound, and endoscopic examinations every 6 months. During a mean follow-up of 17.7 months, 51% of the patients treated with sclerotherapy and 24% of those treated with TIPS rebled (P = .011). Mortality was 19% in sclerotherapy patients and 24% in TIPS patients (P = .50). Hepatic encephalopathy (HE) developed in 26% and 55%, respectively (P = .006). A separate analysis of the three strata showed that TIPS was significantly more effective than sclerotherapy (P = .026) in preventing rebleeding only in stratum I patients. TIPS is significantly better than sclerotherapy in preventing rebleeding only when it is performed shortly after a variceal bleed; however, TIPS does not improve survival and is associated with a significantly higher incidence of HE. The overall performance of TIPS does not seem to justify the adoption of this technique as a first-choice treatment to prevent rebleeding from esophageal varices in cirrhotic patients.

Is the tantalum Strecker stent suitable for TIPS creation? Short- and mid-term results in 20 consecutive patients.

PURPOSE: To assess the suitability of tantalum Strecker stents for transjugular intrahepatic portosystemic shunt (TIPS) creation. METHODS: TIPS was performed with Strecker balloon-expandable stents in the first 20 patients of our series. A total of 26 prostheses were utilized (average 1.3 per patient). RESULTS: Immediate technical success was achieved in all 20 cases. Nine patients (45%) died during follow-up. The overall average follow-up period was 18.9 months; the 11 survivors were followed for a mean period of 29.8 months. In 4 patients (20%) the stent dislodged towards the hepatic vein during withdrawal of the balloon catheter, and difficulties in recatheterizing the shunt for routine control portal phlebography were frequently encountered. Rebleeding occurred in 5 cases and aggravation of pre-existing encephalopathy occurred in 2 cases. Shunt occlusions or stenosis required further intervention in 4 and 9 patients, respectively. CONCLUSION: In our opinion the tantalum Strecker stent is not particularly suitable for TIPS. Although it has evident advantages, such as high radiopacity and minimal shortening after deployment, the tendency of the device to dislodge and the difficulty in recatheterization during portal phlebography were important drawbacks. Furthermore, the atraumatic ends of the device did not seem to reduce shunt-related complications, which were comparable to those occurring with other types of stent.

Hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. Incidence and risk factors.

Forty-seven consecutive patients were prospectively evaluated to study the incidence of hepatic encephalopathy as well as modifications in the PSE index after TIPS. Various clinical, laboratory, and angiographic parameters were also recorded to identify risk factors for the development of post-TIPS hepatic encephalopathy (HE). Mean follow-up was 17 +/- 7 months. During follow-up, six patients died and one underwent transplantation. All other patients were followed for at least a year. Fifteen patients (32%) experienced 20 acute episodes of precipitated HE (hospitalization was necessary in 10 instances), and five patients (11%) presented a continuous alteration in mental status with frequent spontaneous exacerbation during follow-up. Both precipitated and spontaneous HE occurred more frequently during the first three months of follow-up. Moreover the PSE index was significantly worse than basal values one month after TIPS, thereafter returning to near basal values. HE was successfully treated in all patients but one who required a reduction in the stent/shunt diameter. Increasing age (>65 years) and low portacaval gradient (<10 mm Hg) were predictors of HE after TIPS. A gradual dilation of the stent/shunt should be performed to obtain a portacaval gradient >10 mm Hg to avoid an unacceptable rate of HE after TIPS.

TIPS (transjugular intrahepatic portosystemic shunt): state of art and personal experience.

After a brief historical view, we describe the basic technique currently used to create percutaneous portosystemic shunt. Between September 1992 and March 1995, TIPS was achieved in 50 out of 52 patients; main indications included bleeding from esophageal or gastric varices and refractory ascites. The mean portal pressure reduction was 14.9 mmHg and the mean residual portosystemic gradient was 10.5 mmHg. The average follow-up time was 11.8 months; in this period the overall mortality rate was 28%, while rebleeding occurred in 8 patients and new onsets of encephalopathy occurred in 4 cases. The major problems were due to shunt related complications observed in 46% of the patients; close follow-up and reintervention are required to keep the shunt previous. TIPS, developed ad an alternative to surgery and endoscopic sclerotherapy, is an effective and relatively safe procedure for the treatment of symptomatic portal hypertensive patient.

Peripheral arteriography with a new nonionic agent: comparison of iomeprol with iopamidol.

Aim of this randomized, double-blind, parallel group study was to compare the safety, tolerance and diagnostic efficacy of iomeprol and iopamidol, both at iodine concentration of 150 mgI/ml, in 100 adult patients undergoing peripheral intra-arterial digital subtraction angiography (IA-DSA). All patients underwent extensive pre- and post-contrast clinical, instrumental and laboratory evaluation for safety assessments. The tolerance to the test compounds was evaluated in terms of discomfort associated with the injection of the test compounds. Image quality was prospectively graded by two independent readers according to a five-point scale as 1, insufficient; 2, sufficient; 3, good; 4, excellent; or E, excessive. At the end of the study, two experienced radiologists working at institutions other than the study centre and not aware of patients identity, clinical profile or results of other imaging procedures, jointly evaluated study images using the same ordinal scale. The procedure was always well tolerated. None of the studied patients experienced adverse events. All angiographic examinations were rated as diagnostic. The quality of the radiographs was judged as excellent or good in most individual patient studies, without significant differences between the two study groups. No significant differences between the results of prospective on-site assessment and retrospective external assessment were detected. The results of our study show that iomeprol and iopamidol are equally effective, well tolerated and safe contrast agents when used for peripheral IA-DSA.

Variation in hemostatic parameters after intra-arterial and intravenous administration of iodinated contrast media.

RATIONALE AND OBJECTIVES: A few case reports have suggested a possible thrombogenic effect of nonionic contrast media. In vitro investigations have lead to conflicting results. The authors performed three ex vivo studies to evaluate the influence of an ionic, ioxaglate, and a nonionic, iopamidol, low-osmolality contrast medium on a series of clotting and fibrinolytic parameters, after intravenous or intra-arterial administration, during routine diagnostic procedures. METHODS: In the first study, iopamidol was given to 20 consecutive patients through an arterial catheter for digital subtraction arteriography (DSA). In the second study, iopamidol was compared with ioxaglate. The media were randomly and blindly administered intravenously to 21 consecutive patients undergoing brain computed tomography (CT). Finally, ioxaglate was administered intra-arterially to 20 consecutive patients, in a situation comparable with that of the first study. RESULTS: In the first study, a weak anticoagulant effect and an activation of fibrinolysis were found, associated with indirect markers of thrombin generation, such as increased plasma levels of fibrinopeptide A (FpA) and thrombin-antithrombin III complexes (TAT). In the second study, no significant changes were seen with either contrast medium, for thrombin or fibrinolysis activation parameters. In the third study, the intra-arterially administered contrast medium elicited a marked increase of FpA and TAT, together with an anticoagulant effect. CONCLUSION: Both ionic and nonionic contrast media are able to interfere with the clotting/fibrinolytic system in the general circulation when they are administered to patients at the usual dosages. Ioxaglate shows more marked anticoagulant and thrombin-generating effects than iopamidol. The procedure (ie, arterial catheter versus intravenous infusion) seems to be more important than the category of contrast medium in conditioning the magnitude of these effects.

Iomeprol vs iopamidol in intraarterial peripheral digital subtraction angiography.

The aim of this research was to compare the efficacy and tolerability of iomeprol, 150 mg iodine/mL, a new nonionic contrast medium, and iopamidol, 150 mg iodine/mg in intraarterial (IA) peripheral digital subtraction angiography (DSA) in 100 patients; a group of 40 patients were also submitted to a complete coagulation screening to check the influence of contrast media on blood clotting. The study was a comparative, double-blind clinical trial. The compound was assigned to each patient according to a randomization list. Small size (4-5 French) catheters were used in all patients to minimize arterial trauma and bedding time and to assess the quality of x-ray pictures in this condition. Vital signs, EKG tracings and laboratory parameters were monitored before and after the angiographic procedure; the coagulation screening included: thrombin time, prothrombin time, partial thromboplastin time, euglobulin lysis time, plasma thromboplastin antecedent, and plasminogen activator inhibitor (PAI). Both contrast media did not produce any adverse reaction or clinically significant alteration of studied parameters; in the 40-patient group subjected to massive coagulative screening, no important alteration after contrast media administration was reported. The score for contrastographic efficacy was very good with both media with a prevalence of better results in the iomeprol group.

Duplex ultrasound diagnosis of symptomatic proximal deep vein thrombosis of lower limbs.

Real time ultrasound (US) was used to examine 165 consecutive inpatients with clinically suspected deep vein thrombosis of lower limbs. In order to evaluate accuracy, the results of non-invasive techniques were compared with ascending venography, performed in all patients. Assessment included only femoro-popliteal veins, because of difficulty in visualizing calf vein with US. Diagnosis of thrombosis was based on noncompressibility of the examined veins; pulsed Doppler provided further information by evaluating blood flow. In our series Duplex ultrasound was very accurate in detecting acute thrombosis of the proximal veins, sensitivity being 97% and specificity 98%. With US it is also possible to detect conditions that mimic deep vein thrombosis, such as muscular rupture, hematoma, popliteal cyst or compressive tumors. In conclusion US is considered a valid alternative to contrast venography in the diagnosis of proximal vein thrombosis of lower limbs.

[Recanalization with laser and angioplasty of atherosclerotic lesions of the legs. Personal experience with 31 treated lesions]. / Ricanalizzazione mediante laser ed angioplastica nelle lesioni aterosclerotiche degli arti inferiori. Esperienza personale su 31 lesioni trattate.

From January to November 1989, 31 iliac and femoro-popliteal atherosclerotic lesions were treated in 29 patients (age range: 33-80 years) by means of percutaneous laser-assisted angioplasty. The lesions were 6 iliac tubular stenoses, 6 iliac occlusions and 19 femoro-popliteal occlusions, 2-20 cm long. The laser equipment employed was in 10 cases a Cardiolase 4000 Nd:YAG "hot tip" unit, and in 21 cases a Nd:YAG "sapphire contact probe" unit. Initial success was achieved in 23/31 lesions (74%); the follow-up, by clinical examination, Doppler US, and ankle-arm pressure index performed every 4th month, showed 1-year actuarial patency of 80% for femoro-popliteal occlusion and 100% for iliac lesion, with 87% cumulative patency. Overall complication rate was 22.5%. There were 6 local complications, 4 of which were hematomas at the arterial puncture site, and 2 were performation of the superficial femoral artery, all without any clinical sequelae; one patient developed rethrombosis within 72 hours from treatment, which needed amputation after an emergency bypass. Our preliminary results show no significant improvement when compared with conventional balloon angioplasty results both in immediate success rate and in short-to-midterm patency; furthermore, laser therapy was burdened by a higher complication rate. We believe that laser angioplasty should be employed only in arterial occlusion uncrossable with angiographic guidance alone.

[An unusual case of a double location of arteriosclerotic aneurysms of the ulnar artery and anterior tibial artery]. / Un caso insólito de doble localización de aneurismas arterioscleróticos: arteria ulnar y arteria tibial anterior.

Multiple peripheral arteriosclerotic aneurysms are relatively rare. This is a report of a case of two arteriosclerotic aneurysms in unusual sites: ulnar artery and anterior tibial artery. Surgical treatment was: simple resection for the ulnar aneurysm; resection with restoration of arterial continuity for the tibial aneurysm.

[Ultrasonography in the diagnosis of deep venous thrombosis of the legs]. / Gli ultrasuoni nella diagnosi di trombosi venosa profonda dell'arto inferiore.

One hundred consecutive inpatients with clinically suspected deep venous thrombosis (DVT) were examined by US; the last 19 cases were studied also by means of color-Doppler US. In order to evaluate the method reliability, US results were compared with those obtained with contrast venography, which was performed on all patients. The studied region included the femoro-popliteal vein, while no attempt was made to image the calf veins, which are difficult to evaluate with US. In our series, venographic results were in substantial agreement with US findings, with 99% and 100% sensitivity and specificity, respectively. Diagnosis was based only on noncompressibility of the thrombotic vein, despite the absence of visible clots; pulsed Doppler information supported diagnosis by evaluating blood flow. Further diagnostic progress was provided by color-Doppler US, which allows flow lumen to be defined in color. US also allowed the detection of the conditions mimicking DVT, such as muscular ruptures, hematomas, popliteal cysts, or compressive tumors. In conclusion, US and color-Doppler US prove to be valid alternatives to contrast venography in the diagnosis of proximal DVT of the lower limbs.

[Renal oncocytoma. Ultrasonographic study of 4 cases]. / L'oncocitoma renale. Studio ultrasonografico di 4 casi.

The authors report four cases of renal oncocytoma investigated by echography and proved by histology after surgery. Describing the clinical cases, after a brief review of the literature, the radiologic findings are analysed with particular regard to the sonographic signs that can preoperatively differentiate oncocytomas from carcinomas. The authors conclude that the only sonographic distinguishing feature is a quite characteristic central hyperechoic streak corresponding to the fibrous scar, frequently found in this benign tumor.

[Hepatic abscesses secondary to peritonitis: puncture and ultrasonically guided transparieto-hepatic drainage]. / Ascessi epatici secondari a peritonite: puntura e drenaggio transparietoeopatico ecoguidato.

The Authors describe one case of duplex and separated hepatic abscesses secondary to perforated appendicitis and peritonitis. A contemporary literature review confirms the actual rarity of this entity. The patient was treated by percutaneous and transhepatic puncture and drainage of abscesses under sonographic control in two different stages. Material and methods of this technique are herein reported, in particular those concerning the management of the smaller of the two abscesses, located posteriorly into the lower segment of the right lobe of the liver, having a more difficult approach. The therapeutic results were excellent: either few days later percutaneous treatment than two months later after the patient was discharged, the clinical and sonographic controls confirmed a successful recovery.