Stent-Assisted Angioplasty (SAA) at the Level of the Common Femoral Artery Bifurcation: Long-Term Outcomes.

BACKGROUND: The objective of this retrospective single-center study was to report the initial and the long-term outcome after stent-assisted angioplasty of occlusive disease at the common femoral artery. MATERIALS AND METHODS: Between 1995 and 2015, 94 limbs in 79 consecutive patients (54 men; mean age 70 ± 8.6 years) underwent angioplasty with self-expanding stent implantation in 94 common femoral arteries. Critical limb ischemia was present in 15 limbs (16%); the other patients had claudication. RESULTS: Technical success was 99%. Complications occurred in 5/94 interventions (5.3%): puncture site hematomas (2), arteriovenous fistula (1), cholesterol embolism (1), and dissection of the access site artery (1). The intervention was outpatient-based in 98%. Median follow-up was 53 months. Ankle-brachial index (ABI) rose from 0.71 ± 0.17 to 1.0 ± 0.2 (p < .001) immediately after the intervention and was 1.03 ± 0.2 after 1 year and 0.96 ± 0.21 at the last follow-up visit (p < .001 compared to pre-interventional ABI). During follow-up, restenosis was found in 23/94 limbs (25%); 15 limbs were treated by angioplasty, 3 by surgery, and 5 conservatively. One limb was amputated below the knee 6 months after stent-assisted angioplasty (SAA). Death rate during follow-up was 35/79 patients (44%). CONCLUSIONS: SAA of the CFA resulted in high immediate success and a low complication rate. Restenosis rate was moderate, and target lesions could easily be retreated by angioplasty. The main hazard was not restenosis, but death during follow-up.

Effect of a single, oral, high-dose vitamin D supplementation on endothelial function in patients with peripheral arterial disease: a randomised controlled pilot study.

OBJECTIVE: Apart from its role in bone metabolism, vitamin D may also influence cardiovascular disease. The objective of this study was: (1) to determine the effect of a single, oral, high-dose vitamin D supplementation on endothelial function and arterial stiffness in patients with peripheral arterial disease (PAD) and (2) to investigate the impact of this supplementation on coagulation and inflammation parameters. METHODS: In this double-blind, placebo-controlled, interventional pilot study, we screened 76 Caucasian patients with PAD for vitamin D deficiency. Sixty-two were randomised to receive a single, oral supplementation of 100,000 IU vitamin D3 or placebo. At baseline and after 1 month, we measured serum vitamin D and parathormone levels, and surrogate parameters for cardiovascular disease. RESULTS: Sixty-five of 76 patients (86%) had low 25-hydroxyvitamin D levels (<30 ng ml(-1)); of those, 62 agreed to participate in the study. At baseline, only parathormone was related to vitamin D. In supplemented patients, vitamin D levels increased from 16.3 ± 6.7 to 24.3 ± 6.2 ng ml(-1) (P < 0.001), with wide variations between single patients; in the placebo group vitamin levels did not change. Seasonal factors accounted for a decrease of vitamin D levels by 8 ng ml(-1) between summer and winter. After 1 month, none of the measured parameters was influenced by vitamin substitution. CONCLUSION: In this pilot study, most patients with PAD were vitamin D deficient. Vitamin D supplementation increased serum 25-hydroxyvitamin D without influencing endothelial function, arterial stiffness, coagulation and inflammation parameters, although the study was underpowered for definite conclusions.

Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome.

OBJECTIVE: Adult height deficit seen in Turner syndrome (TS) originates, in part, from growth retardation in utero and throughout the first 3 years of life. Earlier diagnosis enables earlier therapeutic intervention, such as with recombinant human GH (r-hGH), which may help to prevent growth retardation. In this open-label, multicentre phase III study, we investigated efficacy and safety in r-hGH treatment in young girls with TS. SUBJECTS AND METHODS: Girls (n=61) aged <4 years with TS receiving 0.035-0.05 mg/kg per day r-hGH for 4 years were compared with an historical control group (n=51) comprising untreated, age- and height-matched girls with TS. The main outcome measure was change in height SDS (H-SDS). Other measures included changes in height velocity SDS, IGF1 levels and glucose metabolism. RESULTS: After 4 years, a gain in mean H-SDS of 1.0 SDS (from -2.33±0.73 to -1.35±0.86 SDS) was observed with r-hGH treatment, in contrast to the decrease in mean H-SDS of 0.3 SDS in the control group (from -2.09±0.81 to -2.44±0.73 SDS; P<0.0001). r-hGH treatment was the main predictor of H-SDS gain and accounted for 52% of variability (multivariate analysis). r-hGH was well tolerated. As expected, IGF1 levels rose with treatment. A case of transient glucose intolerance resolved after dietary adaptation. CONCLUSION: Early treatment with r-hGH helps to prevent natural evolution towards short stature in most girls with TS. IGF1 levels and glucose metabolism should be monitored routinely during r-hGH therapy.

Therapeutic options and patterns of prescription in chronic venous disorders: results of a 3-year survey in Italy.

OBJECTIVES: To assess self-management of chronic venous disorders (CVDs) in a selected Italian population and the pattern of prescription by selected Italian phlebologists. DESIGN: Cross-sectional study carried out between 2003 and 2005. MATERIALS: Non-random, transverse sample of men and women recruited by advertising. METHODS: Assessment of therapeutic habits of respondents, treatment advice given by phlebologists related to socio-demographic variables and severity of the disease. Multivariate odds ratios for sex, age, class, region, family history and severity of the disease. RESULTS: Women undergo CVD therapy more than men (odds ratio (OR): 2.37 for medical treatment; 1.29 for surgical treatment and 5.72 for sclerotherapy). Young people prefer drug treatment to compression stockings. Drug therapy for CVD is 1.5 times more likely in southern Italian respondents, as is compression stockings (OR: 1.91). Surgical therapy is more frequent in Northern Italy (OR for Central Italy: 0.79; Southern Italy and Islands: 0.76). Family history of CVD leads people to early treatment of symptoms. CONCLUSIONS: This study provides insight into self-medication of CVD in Italy and the prescribing patterns of Italian phlebologists in the treatment of CVD. It shows that the population interviewed is able to practise responsible self-medication of their CVD problems.

The burden of constipation on quality of life: results of a multinational survey.

BACKGROUND: The impact of constipation on quality of life (QoL) may vary in different cultural or national settings. AIM: We studied QoL in a multinational survey to compare different social and demographic groups with and without constipation (defined according to Rome III criteria) and to detect country-specific differences among the groups studied. METHODS: Health-related QoL (HRQoL) was assessed with the Short Form 36 (SF-36) questionnaire in 2870 subjects in France, Germany, Italy, UK, South Korea, Brazil and USA. Results Respondents were mainly middle-aged, married or living together and part- or full-time employed. General health status, measured by the SF-36 questionnaire, was significantly worse in the constipated vs. non-constipated populations. RESULTS: were comparable in all countries. QoL scores correlated negatively with age. Constipated women reported more impaired HRQoL than constipated men. Brazilians were most affected by constipation as to their social functioning (35.8 constipated vs. 51.3 non-constipated) and general health perception (29.4 constipated vs. 54.4 non-constipated). CONCLUSIONS: There are significant differences in HRQoL between constipated and non-constipated individuals and a significant, negative correlation between the number of symptoms and complaints and SF-36 scores. The study detected a correlation of constipation with QoL and the influence of social and demographic factors on HRQoL in constipated people.

Demographic factors and their relationship with the presence of CVI signs in Italy: the 24-cities cohort study.

BACKGROUND: Chronic venous insufficiency (CVI) is a common progressive disease, the deterioration rate depending on specific risk factors. Demographic characteristics associated with the prevalence of objective signs of CVI were evaluated in a cross-sectional population study in Italy. METHODS: A sample of 5247 people selected by advertising in television and newspapers in 24 Italian cities underwent a clinical examination of the lower limbs, including colour-coded duplex ultrasonography, to determine the presence and severity of CVI. Of these, 4288 subjects provided demographic data that could be analysed by multiple logistic regression model using sex, age, region and family history as covariates. RESULTS: Women were four or more times as likely as men to develop telangiectasia, whilst males had a two-fold increased risk of trunk varices. Age was the main risk factor for vein varicosis in the female population, with women aged over 50 years being almost five times as likely as those aged 29 or less to show trunk varices. Females living in the southern regions had a two-fold increase in risk of developing CVI signs and the risk increased by at least 1.3 times in multiparous women. A positive familial history of disease increased the risk for varicose veins. CONCLUSIONS: Demographic characters such as sex, advanced age, living in the southern regions, number of pregnancies and a family history of CVI were all contributing risk factors for the development of CVI in Italy.

Chronic venous insufficiency in Italy: the 24-cities cohort study.

OBJECTIVE: To assess the relationship between sex, age, geographical region, lower limb symptoms and the presence of trunk varicose veins and venous incompetence. DESIGN: Cross-sectional population study in 24 cities in the North, centre and South of Italy. PARTICIPANTS: Five thousand two hundred and forty-seven people were selected during spring and summer 2003 by advertising on television, in newspapers, and by leaflets in 24 Italian cities. In all 5187 (4457 [85.9%] women and 730 men [14.1%]) volunteers were assessed. The median age was 54 (range: 18-90) years for the women and 61 (range: 18-89) years for the men. METHODS: Self-administered questionnaire on subjective symptoms of chronic venous insufficiency (CVI) in the lower limbs, and clinical examination, including colour duplex ultrasonography to assess the presence and severity of varicose veins. RESULTS: Overall only 22.7% of the subjects examined were free of visible signs of venous disease, with approximately 53% of the population over 50 years of age showing some venous reflux. People living in Southern Italy were more severely affected than those living in the North. Varicosities and telangiectases were the most frequent objective signs in both sexes. Trunk varicosities (27%) and saphenous reflux (41%) increased with age and were more common in men; in contrast, minor objective symptoms such as telangiectases (70%), as well as subjective symptoms such as heavy (79%) and tired legs (78%), were more common in women and were not age-related. CONCLUSIONS: Venous disease is very common in Italy, in particular in people living in the South. A correlation between varicose veins and venous incompetence is more marked in men, while minor objective and subjective symptoms prevail in women. The findings from this non-random sample closely match results from previous studies, in which random sampling was used.

Lack of seasonal variations in fertilization, pregnancy and implantation rates in women undergoing IVF.

BACKGROUND: Several studies have investigated seasonal variations during IVF. Their results are contradictory, especially concerning fertilization and pregnancy rates. The aim of the present study was to re-evaluate these parameters using a large number of IVF cycles. METHODS: A total of 7368 IVF cycles conducted in Switzerland between 1995 and 2003 were retrospectively analysed. To avoid a bias in the evaluation of the fertilization rate, only IVF cycles without ICSI were considered for analysis. Cycles were assigned to seasons according to the date of the beginning of stimulation. RESULTS: There were no statistically significant differences between the seasons concerning the fertilization, the pregnancy and the implantation rates. However, statistically significant variables deciding on the outcome of an IVF cycle are age, centre, aetiology of infertility and day of transfer. CONCLUSIONS: There were no statistically significant seasonal differences in central Europe (Switzerland) that influenced the outcome of IVF treatment. The only statistically significant variables of IVF outcome were age, centre, aetiology of infertility and day of transfer. A change to routine fertility treatment concerning the different seasons should therefore not be taken into account.

Ten years of Swiss National IVF Register FIVNAT-CH. Are we making progress?

In 2001, analysis of Swiss data collected since 1993 included 1001 treatment cycles with IVF, 2217 treatment cycles with intracytoplasmic sperm injection and 2160 treatment cycles with frozen-thawed embryos or zygotes. IVF cycle number has remained constant over the past 10 years, now representing only 18% of the total. ICSI treatment cycles have plateaued since 2001. Altogether, patients receive 1.56 treatment cycles per year, nearly constant since 1995. Mean maternal age has increased from 33.9 to 35.7 years, while mean number of recovered oocytes has increased by 1.3. Considerable improvement was seen in clinical pregnancy rate after 'fresh' treatment cycles since 2000. Mean number of replaced embryos in 'fresh' treatment cycles has fallen to below 2.5 since 1996, long before the legal imposition of the three-embryo transfer limit in 2001, and is still decreasing without affecting the consistent twin pregnancy rate of 19%. The frequency of ovarian hyperstimulation syndrome has increased three-fold. External audits have reduced the mean number of errors per data file by half, and increased the number of correct files by 20%. Data collected over this 10-year period show that despite the introduction of a restrictive law and increasing mean maternal age, the overall clinical pregnancy rate has continued to improve.

Effects of a standardized ginseng extract on quality of life and physiological parameters in symptomatic postmenopausal women: a double-blind, placebo-controlled trial. Swedish Alternative Medicine Group.

A randomized, multicenter, double-blind, parallel group study was performed to assess the effects of a standardized ginseng extract compared with those of a placebo on quality of life (QoL) and on physiological parameters in symptomatic postmenopausal women. Validated questionnaires [Psychological General Well-Being (PGWB) index, Women's Health Questionnaire (WHQ)] and Visual Analogue (VA) scales were used to assess the effects of the extract on QoL at baseline and after 16 weeks' treatment with either the ginseng extract or placebo. To assess the efficacy of ginseng on postmenopausal symptoms, physiological parameters [follicle-stimulating hormone (FSH) and estradiol levels, endometrial thickness, maturity index and vaginal pH] were recorded at the same time points. Of the 384 randomized patients (mean age 53.5 +/- 4.0 years), the questionnaires were completed by 193 women treated with ginseng and 191 treated with placebo. With regard to the primary endpoint (total score of the PGWB index) the extract showed only a tendency for a slightly better overall symptomatic relief (p < 0.1). Exploratory analysis of PGWB subsets, however, reported p-values < 0.05 for depression, well-being and health subscales in favor of ginseng compared with placebo. No statistically significant effects were seen for the WHQ and the VA scales or the physiological parameters, including vasomotor symptoms (hot flushes). The positive effects of ginseng on health-related QoL in menopausal women should be further investigated. This study shows, however, that the beneficial effects of ginseng are most likely not mediated by hormone replacement-like effects, as physiological parameters such as FSH and estradiol levels, endometrial thickness, maturity index and vaginal pH were not affected by the treatment.

Prediction factors in the determination of final height in subjects born small for gestational age.

The aim of this study was to identify factors predictive of individual final height (FH) in subjects born small for gestational age (SGA). All full-term singleton subjects born SGA (birth weight and/or length <3rd percentile) during the period 1971-1978, matched with appropriate birth weight for gestational age (AGA) subjects (birth weight between 25th and 75th percentile) were followed from birth to FH and evaluated before puberty at a mean age +/- SD of 6.1 +/- 0.7 y and after puberty at a mean age of 20.8 +/- 2.0 y (subjects born SGA, n = 213; born AGA, n = 272). When adjusted for target height, a significant deficit in final height (p < 0.0001) was found in SGA as compared with AGA subjects for both male subjects (-3.99 cm with 95% confidence interval from -5.6 to -2.4) and female subjects (-3.64 cm with 95% confidence interval from -5.0 to -2.3), with 13.6% of subjects in the SGA population presenting short final stature. In a multiple regression analysis, target height and studied group (SGA or AGA) were found to be the strongest predictors of individual FH (p < 0.0001, r2 = 0.35 for male subjects, p < 0.0001, r = 0.40 for female subjects). For SGA subjects and according to a multiple stepwise linear regression model, 31% of the variability of individual FH [SD score (SDS)] and 58% of the variability of individual height gain SDS could be explained at birth from mother's height, father's height, and birth length SDS. No other variables were found to be predictive such as sex, gestational age (from 37 to 42 wk), birth weight SDS, ponderal index at birth, or risk factors during pregnancy associated with intrauterine growth retardation such as pregnancy-induced hypertension, smoking, or a history of SGA in offspring. Although a significant increase of body mass index SDS was documented before and after puberty in SGA subjects, puberty was not found to have any influence on growth outcome.

Prediction of the outcome of growth at 2 years of age in neonates with intra-uterine growth retardation.

The aim of the study was to identify at birth, in infants showing intra-uterine growth retardation (IUGR), any parameters correlative with the increase in height SDS during the first 2 years of life and with short stature at 2 years of age, and to determine whether the sensitivity and specificity of such parameters would permit their use as predictors of short stature at 2 years of age. Two cohorts of children born with IUGR with birth weight < 3rd percentile, were studied. In the first group of 317 children selected at birth, 224 were effectively followed up to 2 years of age (group 1) and the second group of 48 children was evaluated at 2 years of age for short stature related to IUGR (group 2). Perinatal history, auxological data at birth and parental height were monitored in a prospective study for the group 1 children and in a retrospective study for the group 2 children. By 2 years of age, 8% of the 224 children followed (group 1), presented short stature (< or = 2 SDS). In a multiple linear regression model, gestational age, birth length (SDS), target height (SDS) and maternal tobacco consumption were found to be the strongest predictors of the magnitude of the height gain (SDS) during the first 2 years of life. Using these parameters 47% of the variability of the height gain (SDS) during the first 2 years of life could be explained at birth. Moreover, logistic regression analysis showed three risk factors at birth for short stature by 2 years of age: reduced gestational age due to premature birth (adjusted odd ratio (O.R.) = 2.10; 95% C.I. = 1.06-4.14), the greater the difference (for each S.D.) between birth length (SDS) and target height (SDS) (O.R. = 1.93; 95% C.I. = 1.40-2.66) and although as a borderline significant factor, maternal tobacco consumption (O.R. = 1.58; C.I. 95% = 0.81-3.07). Non-parametric discriminant analysis was used to investigate whether short (< or = -2 SDS) or normal stature (> -2 SDS) at 2 years could be predicted at birth using gestational age (weeks), birth length (SDS), target height (SDS) and maternal tobacco consumption as discriminant variables. We found that this discriminant model correctly predicted at birth the short stature of 57 of 59 children at 2 years of age (sensitivity 97%) and the normal stature of 142 of 159 children at 2 years of age (specificity 89%). In conclusion, an accurate prediction of short stature by 2 years of age is feasible at birth in the IUGR neonate.

A 5-year prospective study of growth hormone (GH)-deficient children treated with GH before the age of 3 years. French Serono Study Group.

The aim of the study was to assess the efficacy of GH therapy in GH-deficient children treated before the age of 3 yr. A noncomparative multicenter prospective study included 49 children (22 girls and 27 boys) with isolated GH deficiency (n = 19) or multiple pituitary hormone deficiency (n = 30) treated with daily s.c. injections (0.6 U/kg.week) for 3-5 yr. They were divided into two groups according to their height SD score for chronological age (CA) at the initiation of therapy: group A consisted of 8 patients presenting an initial height within the normal range (< 2 SD below the mean) followed for 2-5 yr, and group B consisted of 25 children followed for 5 yr among 41 patients with initial growth retardation. In group A, the mean height SD score increased from -1.1 +/- 0.6 to 0.35 +/- 1.0 SD (P < 0.001) in the first year and remained in the normal range throughout the following 4 yr. In group B after 4 yr of treatment, the mean height SD score for age had increased from -3.6 +/- 1.0 SD (time zero) to -0.9 +/- 1.2 SD. During the fourth year of therapy, the mean height gain of 0.2 +/- 0.2 SD was significant (P < 0.001). After 5 yr of treatment, a plateau was reached with a corresponding height SD score (CA) of -0.8 +/- 1.2 SD (95% confidence interval between -1.3 and -0.2 SD). This value remained significantly below normal for age (P < 0.001), indicating that catch-up growth was incomplete. Only four patients (16%) remained below -2SD for CA. The 5-yr height gain was negatively correlated with the height SD score at the start of treatment (r = -0.6; P < 0.005) and the first year height gain was the most predictive parameter. There was no significant influence of intrauterine growth retardation, body mass index and age at the start of treatment, or parental target height. Bone maturation was significantly retarded over CA by a mean value of 1.1 +/- 0.9 yr (P < 0.0001), with a mean bone age/CA ratio of 0.8 +/- 0.2 after a mean treatment duration of 5.1 +/- 1.1 yr. In conclusion, the rapid and almost complete return to normal height obtained in this study supports the need for GH treatment in early diagnosed GH-deficient children. The present dosage may be considered the minimum to obtain satisfactory catch-up growth ensuring a favorable outcome for these children. In addition, it allowed growth at a rate normal for age in patients diagnosed before growth retardation.

Growth curves in untreated Ullrich-Turner syndrome: French reference standards 1-22 years.

UNLABELLED: In this retrospective study spanning 22 years, 167 untreated females with Ullrich-Turner syndrome were identified and their case records followed throughout their growth period. Information on total and segmental height and weight was retrieved from the case records and used to plot growth curves. Centiles from birth to adulthood were calculated which showed that the normal pubertal growth spurt was absent. Compared with normal French reference standards, the adult total height deficit was about 21 cm and the adult upper body height deficit was about 15 cm. CONCLUSION: Reference curves for untreated Ullrich-Turner syndrome are provided, which should form a basis for assessing the impact of growth-promoting treatment in this disorder.