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.

Early failure rates of arterovenous fistulas for hemodialysis: evaluation of six-year activity.

Maintenance and complications of vascular access (VA) for hemodialysis (HD) represent the leading cause of morbidity and health care cost among end stage renal disease population. To define the reasons for the use of a particular VA at the beginning of replacement treatment, we prospectively evaluated the early failure rate and survival of arterovenous fistula (AVF) in 183 patients. These patients had high prevalence of cardiovascular risk factors and co-morbid conditions, and began HD in our renal unit from the 1st of January 1995. As a part of this study the present analysis focuses on potential predictors of early failure of the first AVF (within the first 7 days after the operation). Overall, 279 AVF were prepared: 193 at the wrist and 86 at the upper arm, including 11 prosthetic grafts; 150 patients (82%) were given a distal AVF in the first operation. Our conservative policy resulted in a relatively high prevalence of native AVF in use among our prevalent HD patients (84.3%). Early failure of the first VA was 10.4%. Multivariate analysis showed that this event was neither significantly associated with all traditional risk factors and co-morbids tested, nor with the operating surgeon. We conclude that in this prospectively studied cohort, the high rate of native AVF created in order to preserve the vascular bed, though associated with a high early failure rate unaffected by traditional cardiovascular risk factors, resulted in a low proportion of permanent catheters and arterovenous grafts in use among prevalent HD patients. (The Journal of Vascular Access 2001; 2: 154-160).

Urotensin II is an inverse predictor of death and fatal cardiovascular events in chronic kidney disease.

Urotensin II (UTN), a cyclic vasoactive peptide expressed in multiple organs, had higher plasma levels that was previously shown to predict longer survival in dialysis patients. We sought to determine if this association exists in earlier stages of chronic kidney disease (CKD) by studying a cohort of 122 incident clinically stable pre-dialysis patients. Linear models were used to determine associations of UTN with baseline characteristics such as renal function and traditional and nontraditional cardiovascular risk factors. We used Cox regression analysis to model time-to-death as a function of UTN and the same variables for adjustment including a time-varying covariate that indicated progression to end-stage renal disease. No correlation was found between baseline glomerular filtration rate and plasma UTN. In adjusted analysis, UTN correlated directly with serum albumin and, inversely, with history of previous coronary events. During a mean follow-up of 41 months, 43 patients died - 29 from cardiovascular events. After adjusting for potential confounding factors, increased UTN predicted lower risk of death from all-cause and cardiovascular causes. In patients with moderate-to-severe CKD, plasma UTN was found to be an inverse predictor of overall and cardiovascular mortality.

Non-A, non-B hepatitis in patients on dialysis: retrospective evaluation of measures taken to limit the diffusion of the virus.

329 patients were evaluated from 1978 to 1990. 40 new cases of non-A non-B hepatitis were observed, all regarding patients on hemodialysis. Since the beginning of 1989, we introduced measures to limit the diffusion of the virus: reduction to a minimum of blood transfusions and a new disinfection protocol for monitors, instruments and surroundings. Of the 40 new cases, 30 took place between January 1985 and March 1989, only 2 later. If we consider the annual incidence before and after the introduction of preventive measures, we can observe a significant reduction in NANB hepatitis incidence in the last 2 years.

Non-A, non-B hepatitis: clinical laboratory course in patients on hemodialysis and its correlation with the presence of anti-hepatitis C virus antibodies.

136 patients on hemodialysis, 89 males and 47 females, were studied; we evaluated the index of hepatic function (SGOT and SGPT) and antibodies against HCV. We observed 42 cases of increased transaminases classified as non-A, non-B (NANB) hepatitis. Antibodies against HCV were present in 40 patients. Among 42 patients with NANB hepatitis. 31 (73.8%) presented anti-HCV antibodies. No significant clinical or laboratory difference exists between anti-HCV-positive and -negative patients with NANB hepatitis. The distribution of patients who present anti-HCV antibodies is similar in post-transfusional and sporadic forms.

[Risk factors for cystic kidney disease in hemodialysis patients]. / Fattori di rischio nella malattia cistica renale dell'emodializzato.

Acquired bilateral cystic transformation of kidneys in patients on chronic dialysis has been increasingly noted by morphological and clinical studies. Our study aims to identify a group of high-risk patients for incidence and extent of such disease. We studied with ultrasonography 87 patients on maintenance hemodialysis (60 men and 27 women), median age 58 years (range 18 to 81), mean duration of hemodialysis 75 months (range 2-256). The presence of cysts was divided into five grades from 0 no cysts to 4 more than 15 cysts detected for each kidney. 74 patients 85% of our dialytic population had acquired cystic disease; cysts varied in size from 0.5 to 4.5 cm in diameter. The cysts were found in 97% of patients dialyzed for more than 8 years and in 73% of patients on hemodialysis for less than 3 years. The incidence of cystic disease was highly and significantly correlated with the duration of dialysis, the grade correlated with duration of chronic renal failure and hemodialysis. The extent of disease appears to be increased in males. Because of high incidence of disease in long term dialysis patients ultrasonography monitoring is recommended for patients on dialysis for more than 3 years with more attention for males.