Modulation transfer function and optical quality after bilateral implantation of a+3.00 D versus a+4.00 D multifocal intraocular lens

PURPOSE: To determine whether the improvement in intermediate vision after bilateral implantation of an aspheric multifocal intraocular lens (IOL) with a +3.00 diopter (D) addition (add) occurs at the expense of optical quality compared with the previous model with a +4.00 D add. SETTING: Department of Ophthalmology, University of Sao Paulo, Sao Paulo, Brazil. DESIGN: Prospective randomized double-masked comparative clinical trial. METHODS: One year after bilateral implantation of Acrysof Restor SN6AD1 +3.00 D IOLs or Acrysof Restor SN6AD3 +4.00 D IOLs, optical quality was evaluated by analyzing the in vivo modulation transfer function (MTF) and point-spread function (expressed as Strehl ratio). The Strehl ratio and MTF curve with a 4.0 pupil and a 6.0 mm pupil were measured by dynamic retinoscopy aberrometry. The uncorrected and corrected distance visual acuities at 4 m, uncorrected and distance-corrected near visual acuities at 40 cm, and uncorrected and distance-corrected intermediate visual acuities at 50 cm, 60 cm, and 70 cm were measured. RESULTS: Both IOL groups comprised 40 eyes of 20 patients. One year postoperatively, there were no statistically significant between-group differences in the MTF or Strehl ratio with either pupil size. There were no statistically significant between-group differences in distance or near visual acuity. Intermediate visual acuity was significantly better in the +3.00 D IOL group. CONCLUSION: Results indicate that the improvement in intermediate vision in eyes with the aspheric multifocal +3.00 D add IOL occurred without decreasing optical quality over that with the previous version IOL with a +4.00 D add.

Metformin versus lifestyle changes in treating women with polycystic ovary syndrome

Objective: To compare the efficacy of metformin with that of lifestyle changes in patients with polycystic ovary syndrome (PCOS). Design: Prospective, randomized clinical trial of 40 women with PCOS to analyze the effects of metformin and lifestyle intervention treatments on menstrual pattern and hormone and metabolic profile. The duration of treatment was 6 months. Statistical analysis was done using Student's t-test. Results: Fifteen women in the metformin group and 12 in the lifestyle changes group completed the study. The menstrual pattern improved by similar to 67% in both groups. There was a significant decrease in waist circumference in the lifestyle changes group (101.8 +/- 3.9 and 95.1 +/- 3.6, at baseline and at 6 months of treatment, respectively; p<0.001) and in body mass index (BMI) in both groups. The predictor of menstrual pattern improvement was BMI. Conclusions: Both metformin and lifestyle changes may increase the number of menstrual cycles in PCOS. This effect was related to a decrease in BMI.

Twelve-month clinical outcomes after coronary stenting with the Genous Bio-engineered R Stent in patients with a bifurcation lesion: from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry

Background The e-Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth (e-HEALING) registry was designed to capture clinical data on the use of the endothelial progenitor cell capture stent (ECS) in routine clinical practice. In this analysis, we investigated the 12-month clinical outcomes in patients treated with an ECS for a bifurcation lesion. Methods The worldwide, prospective, nonrandomized e-HEALING registry aimed to enrol 5000 patients treated for coronary artery disease with one or more ECS between October 2005 and October 2007. Clinical follow-up was obtained at 1, 6, and 12 months. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization at 12 months. Results A total of 573 patients were treated for at least one bifurcation lesion and were assessed in the current analysis. Baseline characteristics showed a median age of 65 years; 21% were diabetic patients and 36% had unstable angina. A total of 63% of the bifurcation lesions were located in the left artery descending and the mean stent length was 20.7 +/- 12.6 mm. At 12 months, TVF was 12.7% and target lesion revascularization was 7.5%. Definite or probable stent thrombosis occurred in 1.7% of the patients. Moreover, one or more stents per lesion [hazard ratio (HR): 2.79, 95% confidence interval (CI): 1.60-4.86, P < 0.001], predilatation (HR: 0.39, 95% CI: 0.17-0.87, P = 0.023), and lesions located in the right coronary artery (HR: 4.56, 95% CI: 1.07-19.5, P = 0.041) were independent predictors of TVF. Conclusion In the e-HEALING registry, coronary bifurcation stenting with the ECS results in favorable clinical outcomes and low incidences of repeat revascularization and stent thrombosis. Coron Artery Dis 23:201-207 (C) 2012 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

Avaliação dos exercícios proprioceptivos no tratamento dos distúrbios do manguito rotador em profissionais de enfermagem: um estudo clínico controlado e randomizado

CONTEXTUALIZAÇÃO: A dor no ombro em profissionais de enfermagem pode acarretar limitação das atividades diárias e ocupacionais e interferir na qualidade de vida. OBJETIVO: Comparar o efeito da aplicação de dois programas fisioterapêuticos diferenciados pelos exercícios de propriocepção em trabalhadores de enfermagem com desordem do manguito rotador, segundo indicadores de qualidade de vida, satisfação no trabalho e intensidade da dor. MÉTODO: Trata-se de um estudo experimental, randomizado, prospectivo, comparativo, com análise quantitativa dos dados. A coleta de dados foi realizada no período de junho de 2010 a julho de 2011, por meio de um questionário sociodemográfico e profissional, questionário Western Ontario Rotador Cuff Index (WORC), Escala de Satisfação no Trabalho (Occupational Stress Indicator) e Escala Visual Numérica (EVN) para intensidade da dor. Após randomização, os sujeitos foram alocados em dois grupos. No Grupo 1 (controle), foram aplicados exercícios de alongamento, fortalecimento e crioterapia. No Grupo 2 (experimental), foram realizados os mesmos exercícios que no Grupo 1 acrescidos de exercícios proprioceptivos. Os dados foram analisados por meio do Statistical Package for the Social Science, versão 16.0 para Windows. RESULTADOS: Após os tratamentos fisioterapêuticos, houve melhora significativa da dor nos sujeitos dos dois grupos e da qualidade de vida nos trabalhadores do Grupo 2. Não houve alteração dos indicadores de satisfação no trabalho nos dois grupos. CONCLUSÕES: Os exercícios proprioceptivos foram importantes no tratamento dos distúrbios osteomusculares. No entanto, os resultados não permitiram inferir a melhor efetividade deles em relação ao outro tratamento, pois não houve diferença significativa entre os grupos. Ensaio clínico registrado no ClinicalTrials.gov NCT01465932.

Left cardiac sympathetic denervation for treatment of symptomatic systolic heart failure patients: a pilot study

To evaluate the feasibility, safety, and potential beneficial effects of left cardiac sympathetic denervation (LCSD) in systolic heart failure (HF) patients. In this prospective, randomized pilot study, inclusion criteria were New York Heart Association (NYHA) functional class II or III, left ventricular ejection fraction (LVEF) 40, sinus rhythm, and resting heart rate 65 b.p.m., despite optimal medical therapy (MT). Fifteen patients were randomly assigned either to MT alone or MT plus LCSD. The primary endpoint was safety, measured by mortality in the first month of follow-up and morbidity according to pre-specified criteria. Secondary endpoints were exercise capacity, quality of life, LVEF, muscle sympathetic nerve activity (MSNA), brain natriuretic peptide (BNP) levels and 24 h Holter mean heart rate before and after 6 months. We studied clinical effects in long-term follow-up. Ten patients underwent LCSD. There were no adverse events attributable to surgery. In the LCSD group, LVEF improved from 25 6.6 to 33 5.2 (P 0.03); 6 min walking distance improved from 167 35 to 198 47 m (P 0.02). Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score physical dimension changed from 21 5 to 15 7 (P 0.06). The remaining analysed variables were unchanged. During 848 549 days of follow-up, in the MT group, three patients either died or underwent cardiac transplantation (CT), while in the LCSD group six were alive without CT. LCSD was feasible and seemed to be safe in systolic HF patients. Its beneficial effects warrant the development of a larger randomized trial. Trail registration: NCT01224899.

The Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry

Background The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. Methods A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. Results The randomized cohort was 63.1 +/- 9.1 years old and 29% female, with a median diabetes duration of 10.2 +/- 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 +/- 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 +/- 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 +/- 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts. Conclusions The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD. (Am Heart J 2012;164:591-9.)

Effect of treatment delay on disease severity and need for resuscitation in porcine fecal peritonitis

Objective: Early treatment in sepsis may improve outcome. The aim of this study was to evaluate how the delay in starting resuscitation influences the severity of sepsis and the treatment needed to achieve hemodynamic stability. Design: Prospective, randomized, controlled experimental study. Setting: Experimental laboratory in a university hospital. Subjects: Thirty-two anesthetized and mechanically ventilated pigs. Interventions: Pigs were randomly assigned (n = 8 per group) to a nonseptic control group or one of three groups in which fecal peritonitis (peritoneal instillation of 2 g/kg autologous feces) was induced, and a 48-hr period of protocolized resuscitation started 6 (Delta T-6 hrs), 12 (Delta T-12 hrs), or 24 (Delta T-24 hrs) hrs later. The aim of this study was to evaluate the impact of delays in resuscitation on disease severity, need for resuscitation, and the development of sepsis-associated organ and mitochondrial dysfunction. Measurements and Main Results: Any delay in starting resuscitation was associated with progressive signs of hypovolemia and increased plasma levels of interleukin-6 and tumor necrosis factor-alpha prior to resuscitation. Delaying resuscitation increased cumulative net fluid balances (2.1 +/- 0.5 mL/kg/hr, 2.8 +/- 0.7 mL/kg/hr, and 3.2 +/- 1.5 mL/kg/hr, respectively, for groups.T-6 hrs, Delta T-12 hrs, and.T-24 hrs; p < .01) and norepinephrine requirements during the 48-hr resuscitation protocol (0.02 +/- 0.04 mu g/kg/min, 0.06 +/- 0.09 mu g/kg/min, and 0.13 +/- 0.15 mu g/kg/min; p = .059), decreased maximal brain mitochondrial complex II respiration (p = .048), and tended to increase mortality (p = .08). Muscle tissue adenosine triphosphate decreased in all groups (p < .01), with lowest values at the end in groups Delta T-12 hrs and.T-24 hrs. Conclusions: Increasing the delay between sepsis initiation and resuscitation increases disease severity, need for resuscitation, and sepsis-associated brain mitochondrial dysfunction. Our results support the concept of a critical window of opportunity in sepsis resuscitation. (Crit Care Med 2012; 40:2841-2849)

Influence of Pleural Drain Insertion in Lung Function of Patients Undergoing Coronary Artery Bypass Grafting

Background and objectives: Longitudinal, prospective, randomized, blinded Trial to assess the influence of pleural drain (non-toxic PVC) site of insertion on lung function and postoperative pain of patients undergoing coronary artery bypass grafting in the first three days post-surgery and immediately after chest tube removal. Method: Thirty six patients scheduled for elective myocardial revascularization with cardiopulmonary bypass (CPB) were randomly allocated into two groups: SX group (subxiphoid) and IC group (intercostal drain). Spirometry, arterial blood gases, and pain tests were recorded. Results: Thirty one patients were selected, 16 in SX group and 15 in IC group. Postoperative (PO) spirometric values were higher in SX than in IC group (p < 0.05), showing less influence of pleural drain location on breathing. PaO2 on the second PO increased significantly in SX group compared with IC group (p < 0.0188). The intensity of pain before and after spirometry was lower in SX group than in IC group (p < 0.005). Spirometric values were significantly increased in both groups after chest tube removal. Conclusion: Drain with insertion in the subxiphoid region causes less change in lung function and discomfort, allowing better recovery of respiratory parameters.

Effect of Complete Revascularization on 10-Year Survival of Patients With Stable Multivessel Coronary Artery Disease MASS II Trial

Background-The importance of complete revascularization remains unclear and contradictory. This current investigation compares the effect of complete revascularization on 10-year survival of patients with stable multivessel coronary artery disease (CAD) who were randomly assigned to percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). Methods and Results-This is a post hoc analysis of the Second Medicine, Angioplasty, or Surgery Study (MASS II), which is a randomized trial comparing treatments in patients with stable multivessel CAD, and preserved systolic ventricular function. We analyzed patients who underwent surgery (CABG) or stent angioplasty (PCI). The survival free of overall mortality of patients who underwent complete (CR) or incomplete revascularization (IR) was compared. Of the 408 patients randomly assigned to mechanical revascularization, 390 patients (95.6%) underwent the assigned treatment; complete revascularization was achieved in 224 patients (57.4%), 63.8% of those in the CABG group and 36.2% in the PCI group (P = 0.001). The IR group had more prior myocardial infarction than the CR group (56.2% X 39.2%, P = 0.01). During a 10-year follow-up, the survival free of cardiovascular mortality was significantly different among patients in the 2 groups (CR, 90.6% versus IR, 84.4%; P = 0.04). This was mainly driven by an increased cardiovascular specific mortality in individuals with incomplete revascularization submitted to PCI (P = 0.05). Conclusions-Our study suggests that in 10-year follow-up, CR compared with IR was associated with reduced cardiovascular mortality, especially due to a higher increase in cardiovascular-specific mortality in individuals submitted to PCI.

A clinical comparison between DisCoVisc and 2% hydroxypropylmethylcellulose in phacoemulsification: a fellow eye study

OBJECTIVE: This study sought to compare the effects and outcomes of two ophthalmic viscosurgical devices, 1.6% hyaluronic acid/4.0% chondroitin sulfate and 2.0% hydroxypropylmethylcellulose, during phacoemulsification. METHODS: This prospective, randomized clinical trial comprised 78 eyes (39 patients) that received phacoemulsification performed by the same surgeon using a standardized technique. Patients were randomly assigned to receive either 1.6% hyaluronic acid/4.0% chondroitin sulfate or 2.0% hydroxypropylmethylcellulose on the first eye. The other eye was treated later and received the other viscoelastic agent. Preoperative and postoperative examinations (5, 24 and 48 hours; 7 and 14 days; 3 and 6 months) included measurements of the total volume of the ophthalmic viscosurgical device, ultrasound and washout times to completely remove the ophthalmic viscosurgical device, intraocular pressure, central corneal thickness and best-corrected visual acuity. The corneal endothelial cell count was measured at baseline and at six months postoperatively. ClinicalTrials.gov: NCT01387620. RESULTS: There were no statistically significant differences between groups in terms of cataract density or ultrasound time. However, it took longer to remove 2.0% hydroxypropylmethylcellulose than 1.6% hyaluronic acid/ 4.0% chondroitin sulfate, and the amount of viscoelastic material used was greater in the 2.0% hydroxypropylmethylcellulose group. In addition, the best-corrected visual acuity was significantly better in the hyaluronic acid/ chondroitin sulfate group, but this preferable outcome was only observed at 24 hours after the operation. There were no statistically significant differences between the two ophthalmic viscosurgical devices regarding the central corneal thickness or intraocular pressure measurements at any point in time. The corneal endothelial cell count was significantly higher in the hyaluronic acid/chondroitin sulfate group. CONCLUSION: The ophthalmic viscosurgical device consisting of 1.6% hyaluronic acid/4.0% chondroitin sulfate was more efficient during phacoemulsification and was easier to remove after IOL implantation than 2.0% hydroxypropylmethylcellulose. In addition, the corneal endothelial cell count was significantly higher following the use of hyaluronic acid/chondroitin sulfate than with hydroxypropylmethylcellulose, which promoted an improved level of corneal endothelium protection.

Untersuchung zum Einfluss der ACD-CPR mit während der Dekompressionsphase blockiertem Gasfluss (ITD) im Vergleich zur Standard-Reanimationstechnik auf die Kurzzeit-Überlebensrate von Patienten mit präklinisch aufgetretenem Herzkreislaufstillstand

Untersuchung zum Einfluss der ACD-CPR (Aktive Kompressions- Dekompressions-Reanimation) mit während der Dekompressionsphase blockiertem Gasfluss (Impedance-Threshold-Device) im Vergleich zur Standardreanimationsrechnik auf die Kurzzeit-Überlebensrate von Patienten mit präklinisch aufgetretenem Herzkreislaufstillstand. Die Studie vergleicht die ACD-ITD-CPR gegen die Standard-CPR bei Patienten mit präklinischem Herkreislaufstillstand. Primär untersuchter Parameter war die Ein-Stunden-Überlebensrate nach Krankenhausaufnahme. Sekundär wurden die Tastbarkeit eines Pulses unter CPR, die Wiederkehr des Spontankreislaufs (ROSC), die Rate an Krankenhausaufnahmen, 24-Stunden-Überleben und Krankenhausentlassungen untersucht. Außerdem wurde das neurologische Outcome evaluiert. Die Studie fand in Mainz statt; Mainz bietet sich für die Durchführung notfallmedizinischer Studien in besonderem Maße an. Der Rettungsdienst der Stadt arbeitet nach dem in Deutschland üblichen zweigliedrigen System mit RA/RS auf RTWs und NA auf NAW/NEF. Die Studie wurde nach einer fünfmonatigen Pilotphase und extensivem Training beider Verfahren durchgeführt. Zusätzlich bestanden bei einigen der Beteiligten schon Erfahrungen mit ACD-CPR. Es ergaben sich signifikante Vorteile der ACD-ITD-CPR gegenüber der Standard-CPR hinsichtlich des primär untersuchten Parameters (51% vs. 32% p=0,006), außerdem statistisch auffällige Vorteile hinsichtlich der Pulstastbarkeit unter CPR (85% vs. 69%, p=0,008), der Wiederkehr des Spontankreislaufs (55% vs. 37%, p=0,016), der Rate der Krankenhausaufnahmen (52% vs. 36%, p=0.023) und des 24-Stunden-Überlebens (37% vs. 22%, p=0,033). Es ergaben sich keine statistisch auffälligen Unterschiede hinsichtlich der Rate an Krankenhausentlassungen und im neurologischen Outcome. Die Ergebnisse lassen den Schluss zu, dass die ACD-ITD die Kurzzeitüberlebensrate der Patienten mit außerklinischem Herzkreislaufstillstand verbessern kann. Eine Voraussetzung hierfür ist eine ausreichende und andauernde Ausbildung der beteiligten Helfer und/oder die Verfügbarkeit technisch verbesserter Lösungen. Weitere Untersuchungen zum Einfluss auf die Langzeitüberlebensraten und das neurologische Outcome scheinen angezeigt.

EPITHET: Positive Result After Reanalysis Using Baseline Diffusion-Weighted Imaging/Perfusion-Weighted Imaging Co-Registration

the Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) was a prospective, randomized, double-blinded, placebo-controlled, phase II trial of alteplase between 3 and 6 hours after stroke onset. The primary outcome of infarct growth attenuation on MRI with alteplase in mismatch patients was negative when mismatch volumes were assessed volumetrically, without coregistration, which underestimates mismatch volumes. We hypothesized that assessing the extent of mismatch by coregistration of perfusion and diffusion MRI maps may more accurately allow the effects of alteplase vs placebo to be evaluated.

Performance of the pediatric-sized i-gel compared with the Ambu AuraOnce laryngeal mask in anesthetized and ventilated children

This prospective, randomized, controlled trial compares the performance of the pediatric i-gel (Intersurgical Ltd., Wokingham, United Kingdom) with the Ambu AuraOnce laryngeal mask (Ambu A/S, Ballerup, Denmark) in anesthetized and ventilated children.

Spot drug-eluting stenting for long coronary stenoses: long-term results of a randomized clinical study

Preliminary results of a randomized trial have suggested that total lesion coverage with drug-eluting stents (DES) is not necessary in the presence of diffuse disease of nonuniform severity. In the present study, we report long-term results of this trial.

Autologous peripheral blood stem cell transplantation for acute myeloid leukemia

We report the results of a prospective, randomized phase 3 trial evaluating autologous peripheral blood stem cell transplantation (ASCT) versus intensive consolidation chemotherapy in newly diagnosed AML patients in complete remission (CR1). Patients with AML (16-60 years) in CR1 after 2 cycles of intensive chemotherapy and not eligible for allogeneic SCT were randomized between intensive chemotherapy with etoposide and mitoxantrone or ASCT ater high-dose cyclophosphamide and busulfan. Of patients randomized (chemotherapy, n = 259; ASCT, n = 258), more than 90% received their assigned treatment. The 2 groups were comparable with regard to prognostic factors. The ASCT group showed a markedly reduced relapse rate (58% vs 70%, P = .02) and better relapse-free survival at 5 years (38% vs 29%, P = .065, hazard ratio = 0.82; 95% confidence interval, 0.66-1.1) with nonrelapse mortality of 4% versus 1% in the chemotherapy arm (P = .02). Overall survival was similar (44% vs 41% at 5 years, P = .86) because of more opportunities for salvage with second-line chemotherapy and stem cell transplantation in patients relapsing on the chemotherapy arm. This large study shows a relapse advantage for ASCT as postremission therapy but similar survival because more relapsing patients on the chemotherapy arm were salvaged with a late transplantation for relapse. This trial is registered at www.trialregister.nl as #NTR230 and #NTR291.