[Retinal vascular network: Changes with aging and systemic vascular disease (cardiac and cerebral)]. / Caractéristiques vasculaires rétiniennes : modifications lors du vieillissement et en pathologie vasculaire systémique (cardiaque et cérébrale).

For over 10 years, the description of the retinal microvascular network has benefited from the development of new imaging techniques. Automated retinal image analysis software, as well as OCT angiography (OCT-A), are able to highlight subtle, early changes in the retinal vascular network thanks to a large amount of microvascular quantitative data. The challenge of current research is to demonstrate the association between these microvascular changes, the systemic vascular aging process, and cerebrovascular and cardiovascular disease. Indeed, a pathophysiological continuum exists between retinal microvascular changes and systemic vascular diseases. In the Montrachet study, we found that a suboptimal retinal vascular network, as identified by the Singapore I Vessel Assessment (SIVA) software, was significantly associated with treated diabetes and an increased risk of cardiovascular mortality. In addition, we supplemented our research on the retinal vascular network with the use of OCT-A. In the EYE-MI study, we showed the potential role of quantitative characterization of the retinal microvascular network by OCT-A in order to assess the cardiovascular risk profile of patients with a history of myocardial infarction. A high AHA (American Heart Association) risk score was associated with low retinal vascular density independently of hemodynamic changes. Thus, a better understanding of the association between the retinal microvasculature and macrovascular disease might make its use conceivable for early identification of at-risk patients and to suggest a personalized program of preventative care. The retinal vascular network could therefore represent an indicator of systemic vascular disease as well as an interesting predictive biomarker for vascular events.

[BCG strain shortage from 2012 to 2014: Evaluation of its impact on the management of patients with high-risk NMIBC]. / Pénurie en souche de BCG entre 2012 et 2014 : évaluation de son impact sur la prise en charge des patients présentant une TVNIM de haut risque.

INTRODUCTION: BCG instillations are the gold-standard treatment for high-risk non-muscle-invasive bladder cancer (NMIBC) with a decreased risk of tumor recurrence and muscle infiltration. From 2012 to 2014, a stock shortage of the Connaught strain has led to the cessation of supply for immucyst in France. The objective of this study was to evaluate the potential impact of BCG shortage on the management of patients with NMIBC. PATIENTS AND METHODS: We conducted a retrospective single-center study including patients followed from May 2005 to May 2015 with a high-risk NMIBC (primo-diagnosis). Patients were separated into two groups: not impacted by the shortage (NISG: 56 patients) and impacted by the shortage (ISG: 53 patients). Data on tumour recurrence (RFS), muscle progression (PFS) and overall and specific survival (OS and SS) were also analysed. RESULTS: The BCG induction schedule could not be carried out in 20.8% of cases in the ISG compared to only 5.3% of cases in NISG (P=0.02). Similarly, the maintenance treatment was incomplete for 56.6% of cases versus 37.5% in NISG (P=0.047). Nevertheless, it should be underlined that very high-risk NMIBC received a complete induction BCG schedule. The ISG seems to have benefited with the evolution of the guidelines with the use of diagnosis bladder fluorescence but without significant difference on the rate of second look bladder trans-uretral resection. The cystectomy rate was higher in ISG. No significant difference in RFS, PFS, OS, and SS between the two groups. CONCLUSION: In our experience, RFS, PFS, OS or SS were not impacted by the BCG shortage. These data may be explained by a better selection of very high-risk patients including the recommended BCG schedule and more frequently the use of diagnosis bladder fluorescence. LEVEL OF EVIDENCE: 3.

Serum fructosamine predicts macrosomia in well-controlled hyperglycaemic pregnant women: An observational cross-sectional study.

AIM: While serum fructosamine may be a good marker of glucose control in pregnant women with diabetes, its relationship with macrosomia is still uncertain. METHODS: In 130 hyperglycaemic women with singleton pregnancies (117 gestational diabetes mellitus, 13 pregestational diabetes), serum fructosamine and HbA1c levels were measured at 25±7 weeks of gestation. Levels in mothers of infants with and without macrosomic newborns (birth weight>4000g and/or large-for-gestational-age birth weight>90th percentile) were compared using logistic regression analysis adjusted for macrosomia risk factors. RESULTS: These 130 pregnant women were 33±5 years old; their BMI before pregnancy was 27.7±6.9kg/m2, and they gained 7.5±5.1kg during the first 6 months of gestation. Glucose control was good according to HbA1c levels (5.3±0.3%; 34±2mmol/mol), yet 17/130 (13%) newborns had macrosomia: 3900±227g vs 3057±512g (P<0.001) in the others. These mothers were older and had higher parity, whereas their BMI scores before pregnancy and gestational weight gains did not differ. Fructosamine levels were also higher at 221±40µmol/L vs 192±22µmol/l (P<0.001), respectively, and remained significant even after adjusting for maternal age, BMI, parity, type of diabetes, antecedents of macrosomia and excessive gestational weight gain. By contrast, HbA1c did not differ between the two groups. In fact, nearly two-thirds (64.7%) of the mothers of macrosomic newborns had fructosamine levels>200µmol/l vs 31.9% of mothers with non-macrosomic newborns (P<0.05). CONCLUSION: High fructosamine levels are associated with macrosomia in the newborns of well-controlled hyperglycaemic pregnant women.

Sensory loss and suicide ideation in older adults: findings from the Three-City cohort study.

ABSTRACTObjectives:To examine the longitudinal risk of vision loss (VL) or hearing loss (HL) for experiencing suicidal ideation in older adults. DESIGN: The Three-City study, examining data from three waves of follow-up (2006-2008, 2008-2010, and 2010-2012). SETTING: Community-dwelling older French adults. PARTICIPANTS: N = 5,438 adults aged 73 years and over. MEASUREMENTS: Suicidality was assessed by the Mini-International Neuropsychiatric Interview, Major Depressive Disorder module. Mild VL was defined as Parinaud of 3 or 4 and severe VL as Parinaud >4. Mild HL was self-reported as difficulty understanding a conversation and severe HL as inability to understand a conversation. RESULTS: Severe VL was associated with an increased risk of suicidal ideation at baseline (OR = 1.59, 95% CIs = 1.06-2.38) and over five years (OR = 1.65, 95% CIs = 1.05-2.59). Mild and severe HL were associated with an increased risk of suicidal ideation, both at baseline (OR = 1.29, 95% CIs = 1.03-1.63; OR = 1.78, 95% CIs = 1.32-2.40) and over five years (OR = 1.47, 95% CIs = 1.17-1.85; OR = 1.97, 95% CIs = 1.44-2.70). CONCLUSION: Sensory losses in late life pose a risk for suicidal ideation. Suicidality requires better assessment and intervention in this population.

The association of vision loss and dimensions of depression over 12 years in older adults: Findings from the Three City study.

BACKGROUND: The established relationship between vision impairment and depression is limited by the examination of depression only as a unidimensional construct. The present study explores the vision-depression relationship using a dimensional approach. METHODS: 9036 participants aged 65 years and above enrolled in the Three-City study were included. Relationships between baseline near Vision Impairment (VI) or self-reported distance Visual Function (VF) loss with trajectory of four dimensions of depression - depressed affect, positive affect, somatic symptoms and interpersonal problems - over 12 years were examined using mixed-effects models. Depression dimensions were determined using the four-factor structure of the Centre for Epidemiology Studies-Depression Scale (CESD). RESULTS: In the fully adjustment models, mild near VI predicted poorer depressed affect (b = 0.04, p = .002) and positive affect (b = -0.06, p < 0.001) over time, with evidence of longer term adjustment. Distance VF loss was associated with poorer depressed affect (b = 0.27, p ≤ .001), positive affect (b = -0.15, p = .002), and somatic symptoms (b = 0.18, p ≤ .001) at baseline, although only the association with depressed affect was significant longitudinally (b = 0.01, p = .001). Neither near VI nor distance VF loss was associated with interpersonal problems. LIMITATIONS: This paper uses a well-supported model of depression dimensions, however, there remains no definite depression dimension model. Distance VF loss was self-reported, which can be influenced by depression symptoms. CONCLUSIONS: Vision impairment in older adults is primarily associated with affective dimensions of depression. A reduction in social connectedness and ability to engage in pleasurable activities may underlie the depression-vision relationship. Older adults with vision impairment may benefit from targeted treatment of affective symptoms, and pleasant event scheduling.

Skin autofluorescence predicts major adverse cardiovascular events in patients with type 1 diabetes: a 7-year follow-up study.

BACKGROUND: Advanced glycation end-products play a role in diabetic vascular complications. Their optical properties allow to estimate their accumulation in tissues by measuring the skin autofluorescence (SAF). We searched for an association between SAF and major adverse cardiovascular events (MACE) incidence in subjects with Type 1 Diabetes (T1D) during a 7 year follow-up. METHODS: During year 2009, 232 subjects with T1D were included. SAF measurement, clinical [age, sex, body mass index (BMI), comorbidities] and biological data (HbA1C, blood lipids, renal parameters) were recorded. MACE (myocardial infarction, stroke, lower extremity amputation or a revascularization procedure) were registered at visits in the center or by phone call to general practitioners until 2016. RESULTS: The participants were mainly men (59.5%), 51.5 ± 16.7 years old, with BMI 25.0 ± 4.1 kg/m2, diabetes duration 21.5 ± 13.6 years, HbA1C 7.6 ± 1.1%. LDL cholesterol was 1.04 ± 0.29 g/L, estimated Glomerular Filtration Rates (CKD-EPI): 86.3 ± 26.6 ml/min/1.73 m2. Among these subjects, 25.1% were smokers, 45.3% had arterial hypertension, 15.9% had elevated AER (≥ 30 mg/24 h), and 9.9% subjects had a history of previous MACE. From 2009 to 2016, 22 patients had at least one new MACE: 6 myocardial infarctions, 1 lower limb amputation, 15 revascularization procedures. Their SAF was 2.63 ± 0.73 arbitrary units (AU) vs 2.08 ± 0.54 for other patients (p = 0.002). Using Cox-model, after adjustment for age (as the scale time), sex, diabetes duration, BMI, hypertension, smoking status, albumin excretion rates, statin treatment and a previous history of MACE, higher baseline levels of SAF were significantly associated with an increased risk of MACE during follow-up (HR = 4.13 [1.30-13.07]; p = 0.02 for 1 AU of SAF) and Kaplan-Meier curve follow-up showed significantly more frequent MACE in group with SAF upper the median (p = 0.001). CONCLUSION: A high SAF predicts MACE in patients with T1D.

Bidirectional associations of vision and hearing loss with anxiety: prospective findings from the Three-City Study.

OBJECTIVE: the aim of this study was to examine the bidirectional association of vision loss (VL) and hearing loss (HL) with anxiety over a 12-year period. DESIGN: this was a prospective population-based study. SETTING: community-dwelling French adults. PARTICIPANTS: the study included 3,928 adults aged 65 and above from the Three-City study. METHODS: the relationships of VL, as assessed by near visual acuity and self-reported HL to a diagnosis of generalised anxiety disorder (GAD) were assessed over 12 years. A further objective was to explore whether sensory loss has a differential relationship with GAD than with anxiety symptoms, assessed by the Spielberger's State-Trait Anxiety Inventory. RESULTS: at baseline, HL [odds ratio (OR) = 1.41, 95% confidence interval (CI) 1.02-1.96, P = 0.04], but not mild or moderate to severe VL, was associated with self-reported anxiety symptoms (OR = 1.07 95% CI 0.63-1.83, P = 0.80; OR = 0.66 95% CI 0.12-2.22, P = 0.50, respectively). Neither vision nor HL was significantly associated with incident GAD. Baseline GAD was related to increased risk of incident HL (OR = 1.17, 95% CI 1.07-1.28, P < 0.001), but not mild or moderate to severe vision loss (OR = 1.01, 95% CI 0.96-1.06, P = 0.81; OR = 0.97, 95% CI 0.89-1.05, P = 0.45, respectively). CONCLUSIONS: increased anxiety symptoms were observed in older adults with HL, whereas we found no evidence for an association between VL and anxiety. Anxiety was prospectively associated with increased risk of reporting HL. Improved detection of anxiety in older adults with HL may improve quality of life.

Urethral pressure controlled balloon refilling or balloon change for artificial sphincter secondary procedure?

OBJECTIVES: To report our experience of inflating or changing pressure balloon to treat recurrent urinary incontinence after AMS800® implantation instead of changing all the devices. PATIENTS AND METHODS: A retrospective study was conducted in a tertiary reference center between 2005 and 2015. All patients, treated by AMS800® implantation for post-prostatectomy urinary incontinence and whom balloon was subsequently changed or inflated, were included. Main clinical end point was the need for another surgery. Secondary end points were urethral erosion, infection, and efficacy on pad test and pad use. RESULTS: Thirty-one patients were included. All had had a 61-70cm H20 balloon implanted, with a single cuff (13 with transcorporeal placement). Twenty-one patients had their balloon changed for a 71-80cm H20 type, while 10 patients had their balloon refilled (median 3mL [range 2-7]). Median follow-up was 23 months (range 1-129). Overall rate of another subsequent surgery was 48.3% (n=15). Erosion and atrophy occurred more frequently after balloon repressurizing than after balloon replacement (80% vs 33%, P=0.024). At last follow-up, median pad use was higher in repressurizing group (2 vs 1, P=0.033). CONCLUSION: Balloon repressurizing is associated with a higher erosion and reoperation rate than changing pressure balloon. Continence results seem better when PRB is changed. It could be an alternative instead of changing all devices in patients with frail urethra. LEVEL OF EVIDENCE: 4.

The association amongst visual, hearing, and dual sensory loss with depression and anxiety over 6 years: The Tromsø Study.

OBJECTIVE: To examine the longitudinal association of dual and single (vision and hearing) sensory loss on symptoms of depression and anxiety in older adults. METHODS: Two thousand eight hundred ninety adults aged 60 years or over who participated in the longitudinal population-based Tromsø Study, Norway, were included. The impact of objective vision loss, self-report hearing loss, or dual sensory loss on symptoms of depression and anxiety, as assessed by the Hopkins Symptom Checklist 10, was examined at baseline and 6-year follow-up using linear mixed models. RESULTS: Hearing loss had a cross-sectional relationship with increased depression (b = 0.1750, SE = 0.07, P = .02) and anxiety symptoms (b = 0.1765, SE = 0.08, P = .03); however, these relationships were not significant at the 6-year follow-up. Both vision loss only and dual sensory loss predicted increased depression scores at follow-up (b = 0.0220, SE = 0.01, P = .03; and b = 0.0413, SE = 0.02, P = .01, respectively). Adjustment for social isolation did not attenuate the main depression results. CONCLUSION: Dual sensory loss resulted in increased depression symptomatology over time and posed an additional long-term risk to depression severity beyond having a single sensory loss only. Only hearing loss is associated with anxiety symptoms. Older adults with vision, hearing, and dual sensory loss have different mental health profiles. Therefore, management and intervention should be tailored to the type of sensory loss.

Sequential treatment with ProACT™ device implantation after male sling failure for male urinary incontinence.

OBJECTIVES: There is no strong evidence for second line therapy after male sling failure for post-prostatectomy urinary incontinence (PPUI). We report the outcomes after periurethral balloons implantation for persistence or recurrence of mild PPI symptoms after male sling implantation. METHODS: All patients implanted of a ProACT™ device (Uromedica, Inc., MN, USA) following I-STOP transobturator male sling (TOMS) failure, in a tertiary reference center between 2009 and 2016, were included. Patients were evaluated by 24-hour pad-test before and after implantation, and after each balloon repressurizing procedure. PGI-I and Likert scale patient satisfaction were estimated during a telephone interview conducted in 2016. Objective and subjective cure of urinary incontinence were defined by a 24-hour pad-test<8g and the use of zero or one pad per day, respectively. RESULTS: Fourteen patients were included. Median follow-up was 34months [4-89]. Objective and subjective cure were 29% (n=4) and 57% (n=8), respectively. Median pad-test decreased from 95g [IQR: 130] to 34g [IQR: 83] (P=0.022). ProACT™ significantly decreased median pad-test by a factor 2.73 [1.19-6.29]. Eighty-eight percent patients were feeling a little better, much better or very much better and 77% were satisfied or very satisfied at the end of follow-up. Reoperation rate was 28% (n=4): 3 balloons were changed for caudally migration (n=2) or deflation (n=1) and 1 had a urinary sphincter implanted for severe UI. CONCLUSIONS: ProACT™ is a safe and efficient treatment that can be used in second line therapy after TOMS failure for PPUI. LEVEL OF EVIDENCE: 4.

[HoLEP learning curve: Toward a standardised formation and a team strategy]. / Apprentissage de l'HoLEP : vers une formation standardisée et une stratégie d'équipe.

AIM: Holmium laser enucleation of prostate (HoLEP) is renowned for the difficulty of its learning curve. Our aim was to evaluate the interest of a three-step tutorial in the HoLEP learning curve, in a university center. METHODS: It is a retrospective, monocentric study of the 82 first procedures done consecutively by the same operator with a proctoring in early experience and after 40 procedures. For all patients were noted: enucleation efficiency (g/min), morcellation efficiency (g/min), percentage of enucleated tissue (enucleated tissue/adenome weigth evaluated by ultrasonography. g/g), perioperative morbidity (Clavien), length of hospital stay, length of urinary drainage, functional outcomes at short and middle term (Qmax, post-void residual volume [PVR], QOL scores and IPSS at 3 and 6months). RESULTS: Enucleation and morcellation efficiency were significantly higher after the second proctoring (0.87 vs 0.44g/min; P<0.0001 and 4.2 vs 3.37g/min, P=0.038, respectively) so as the prostatic volume (43.5 vs 68.1mL, P=0.0001). Percentage of enucleated tissue was higher in the second group, however, the difference was not significant (69.5% vs 80.4%, P=0.03). Per- and postoperative complications, hospital length of stay, urinary drainage length and functional results at 3 and 6months were not significantly different. CONCLUSION: The learning curve did not interfere with functional results. The second proctoring was essential to us in order to grasp the technique. These data underlined the necessity of a pedagogic reflexion in order to built a standardized formation technique to the HoLEP. LEVEL OF EVIDENCE: 4.

[External sphincterotomy in neurological patients: A monocentric experience]. / Sphinctérotomie laser chez le patient porteur d'une vessie neurologique : une expérience monocentrique.

AIM: The aim of this study was to assess the feasibility, efficacy and tolerance of Greenlight™ and Holmium sphincterotomy for treating detrusor-sphincter dyssynergia. METHODS: All men treated with this two techniques between may 2012 and june 2015 were analyzed. Preoperative evaluation included kidney ultrasound scan, urodynamic, retrograde and voiding urethrocystography. Postoperative assessment was composed of a post-void residual volume measurement when the urethral catheter was removed and 1 year after the procedure, a retrograde and voiding urethrocystography at 3 months and telephonic Likert scale questionnaire. RESULTS: Twelve patients were operated with Greenlight™ and 12 with Holmium. Eleven had a memocath urethral stent preoperatively. Post-void residual volume median for both techniques was 285 cc preoperatively vs 137.5 cc postoperatively (P<0.001). Likert scale global satisfaction was 75%. Five stenosis (20.8%) were observed within a median of 4 months. CONCLUSION: Greenligth™ and Holmium procedures are efficient techniques with low morbidity. However, superiority toward monopolar incision remains to be demonstrated through complementary studies. LEVEL OF EVIDENCE: 4.

[Does urinary sacral neuromodulation improve bowel symptoms other than fecal incontinence: A systematic review]. / La neuromodulation sacrée urinaire a-t-elle un effet sur les troubles digestifs autre que l'incontinence fécale : revue de la littérature.

PURPOSE: To evaluate literature data about urinary sacral neuromodulation and its effects on bowel symptoms other than fecal incontinence. METHOD: A systematic review was conducted using PubMed/Medline with the following keywords: sacral neuromodulation, urinary incontinence, voiding symptoms, intestinal bowel syndrome, constipation, epidemiology. RESULTS: Urinary SNS seems to improve intestinal bowel symptoms scores (level of evidence 4). However, for constipation, there are more contrasting results. If symptoms scores seem to improve, QOL scores are not significantly changed. Furthermore, some people reported an aggravation of their constipation symptoms (level of evidence 4). Those contrasted results could be explained by the various causes of constipation which implies various pathophysiological pathways. CONCLUSIONS: A better evaluation of digestive symptoms in patient candidate to urinary SNS could help identifying patients able to be improve by SNS. LEVEL OF EVIDENCE: 4.

[The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): protocol and baseline characteristics of patients included in France]. / La seconde phase d'une étude randomisée, multicentrique évaluant en ouvert l'effet de la réduction intensive de la pression artérielle dans l'hémorragie cérébrale (INTERACT2) : protocole et caractéristiques des patients inclus en France.

RATIONALE AND AIM: The INTERACT pilot study demonstrated the feasibility of the protocol, safety of early intensive blood pressure (BP) lowering, and effects on hematoma expansion within 6hours of onset of intracerebral hemorrhage (ICH). This article describes the design of the second, main phase, INTERACT2. INTERACT2 aims to compare the effects of a management strategy of early intensive BP lowering with a more conservative guideline-based BP management policy in patients with acute ICH. This article also compares the baseline characteristics of the patients included in France with the baseline characteristics of the patients included in the pilot study INTERACT1. DESIGN OF THE STUDY: INTERACT2 is an international, prospective, multicentre, open, assessor-blinded outcome (PROBE), randomised, controlled trial. Patients with a systolic BP greater than 150mmHg are centrally randomised to either to an intensive BP lowering treatment (Systolic BP≤140mmHg within 1hour) or to a conservative treatment strategy (target systolic BP of 180mmHg). A projected 2800 subjects are to be enrolled from approximately 140 centres worldwide to provide 90% power (α 0.05) to detect a beneficial effect of early treatment on the primary outcome. STUDY OUTCOMES: The primary outcome is the combined endpoint of death and dependency according to the modified Rankin Scale (mRS) at 90 days. The key secondary outcome is the primary endpoint in those patients treated within 4hours of ICH. Other predefined secondary outcomes are the separate components of the primary endpoint, grades of physical function on the mRS, health-related quality of life on the EuroQoL, recurrent stroke and other vascular events, days of hospitalisation, requirement for permanent residential care, and unexpected serious adverse events. The study is registered under NCT00716079, ISRCTN73916115, and ACTRN12608000362392. POPULATION: As of early July, 152 patients have been included in France. When compared with the patients randomised in the INTERACT1 pilot study, these patients are older, less likely to have had a previous ICH, more often on antiplatelet or warfarin therapy, have a lower diastolic BP, arere more severe clinically (higher NIHSS) and experience their first ICH.

Nutrition and age-related eye diseases: the Alienor (Antioxydants, Lipides Essentiels, Nutrition et maladies OculaiRes) Study.

BACKGROUND: Worldwide, degenerative eye diseases (age-related maculopathy (ARM), cataract, glaucoma) are the main causes of visual impairment and blindness, which contribute to disability in the elderly. Mainly three types of nutritional factors are investigated for their potential protection against eye ageing: antioxidants; lutein and zeaxanthin (carotenoids which accumulate specifically in the eye); omega 3 polyunsaturated fatty acids. Few epidemiological studies have been conducted in this field, particularly in Europe. OBJECTIVE: The Alienor (Antioxydants, Lipides Essentiels, Nutrition et maladies OculaiRes) Study aims at assessing the associations of eye diseases with nutritional factors, determined from plasma measurements and estimation of dietary intakes. DESIGN, SETTING AND PARTICIPANTS: Subjects were recruited in Bordeaux (France) from the ongoing population-based 3C study. In 2006-2008, 963 subjects from the 3C Study, aged 73 years or more, had an eye examination and will have follow-up eye examinations every 2 years. MEASUREMENTS: Vascular, genetic and nutritional factors were assessed at baseline (1999-2001) and follow-up examinations of the 3C Study. Eye diseases were classified according to international classifications. RESULTS: Nutritional status and vascular disease and risk factors were similar between participants and non participants, except for a slight difference in plasma triglycerides and HDL-cholesterol. As expected, the prevalence of eye diseases was high: early and late ARM (28.4 % and 5.6 %, respectively), open-angle glaucoma and treated ocular hypertension (4.8 % and 10.0 %, respectively), cataract extraction (45.2 %), retinopathy (8.4 %), retinal vein occlusion (1.1 %), epiretinal membrane (3.9 %), current use of artificial tears (17.3 %). CONCLUSIONS: This study confirms the high prevalence of eye diseases in the elderly. Its main strength is the combination of nutritional, vascular and genetic information, collected over a 7 year period of time before the first eye examination. It may help design future interventional studies, which might be common with other age-related disorders, because of common nutritional factors.

The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2).

RATIONALE: The INTERACT pilot study demonstrated the feasibility of the protocol, safety of early intensive blood pressure lowering and effects on haematoma expansion within 6 h of onset of intracerebral haemorrhage. This article describes the design of the second, main phase, INTERACT2. AIMS: To compare the effects of a management strategy of early intensive blood pressure lowering with a more conservative guideline-based blood pressure management policy in patients with acute intracerebral hemorrhage. DESIGN: INTERACT2 is a prospective, randomized, open label, assessor-blinded end-point (PROBE). Patients with a systolic blood pressure greater than 150 mmHg and no definite indication for or contraindication to blood pressure-lowering treatment are centrally randomised to either of two treatment groups within 6 h onset of intracerebral haemorrhage. Those allocated to intensive blood pressure lowering will receive primarily intravenous, hypotensive agents to achieve a systolic blood pressure target of <140 mmHg within 1 h of randomisation and to maintain this level for up to 7 days in hospital. The control group will receive blood pressure-lowering treatment to a target systolic blood pressure of <180 mmHg. Both groups are to receive similar acute stroke unit care, therapy and active management. Oral antihypertensive therapy is recommended in patients before hospital discharge with a long-term systolic blood pressure goal of 140 mmHg according to secondary stroke prevention guidelines. A projected 2800 subjects are to be enrolled from approximately 140 centres worldwide to provide 90% power (alpha 0.05) to detect a 14% difference in the risk of death and dependency between the groups, which equates to one or more cases of a poor outcome prevented in every 15 patients treated. STUDY OUTCOMES: The primary outcome is the combined end-point of death and dependency according to the modified Rankin Scale at 90 days. The secondary outcomes are the separate components of the primary end-point in patients treated <4 hours of ICH onset, grades of physical function on the modified Rankin Scale, health-related quality of life on the EuroQoL, recurrent stroke and other vascular events, days of hospitalisation, requirement for permanent residential care and unexpected serious adverse events.

Epidemiology of diabetic retinopathy: expected vs reported prevalence of cases in the French population.

AIM AND METHODS: Impaired eyesight and vision loss due to retinopathy are among the most feared complications in diabetic patients. As the number of diabetic patients is predicted to increase, a corresponding increase in the number of patients with diabetic retinopathy (DR) is also to be expected. This review is an update of the published literature pertaining to the epidemiology of DR. RESULTS: Over the past 20 years, eight population-based studies have been conducted in Western countries using photographic evidence of DR. Their results have consistently suggested that the prevalence of DR is close to 28.7%, whereas proliferative DR and macular oedema account for 9% and 17%, respectively, of all diagnosed cases. Various longitudinal studies indicate an annual incidence of DR of 2-6%. However, in France, the epidemiology of DR has mostly been investigated by observational studies. The recorded prevalence of DR, based on physicians' reports, is estimated to be 10%, suggesting that DR is underdiagnosed in the French diabetic population. The discrepancy between the expected and reported prevalences of DR could be explained by the number of patients whose retinal status is unknown. DR screening with non-mydriatic fundus photography is effective for identifying early and advanced DR. Screening programmes carried out over the past 5 years in different regions of France indicate that 10-20% of diabetic patients with previously unknown retinal status have retinopathy. CONCLUSION: Further implementation of screening programmes is the key to improving DR diagnosis and preventing vision loss in the French diabetic population.