Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label

Stem cells as source for retinal pigment epithelium transplantation

Inherited maculopathies, age related macular degeneration and some forms of retinitis pigmentosa are associated with impaired function or loss of the retinal pigment epithelium (RPE). Among potential treatments, transplantation approaches are particularly promising. The arrangement of RPE cells in a well-defined tissue layer makes the RPE amenable to cell or tissue sheet transplantation. Different cell sources have been suggested for RPE transplantation but the development of a clinical protocol faces several obstacles. The source should provide a sufficient number of cells to at least recover the macula area. Secondly, cells should be plastic enough to be able to integrate in the host tissue. Tissue sheets should be considered as well, but the substrate on which RPE cells are cultured needs to be carefully evaluated. Immunogenicity can also be an obstacle for effective transplantation as well as tumorigenicity of not fully differentiated cells. Finally, ethical concerns may represent drawbacks when embryo-derived cells are proposed for RPE transplantation. Here we discuss different cell sources that became available in recent years and their different properties. We also present data on a new source of human RPE. We provide a protocol for RPE differentiation of retinal stem cells derived from adult ciliary bodies of post- mortem donors. We show molecular characterization of the in vitro differentiated RPE tissue and demonstrate its functionality based on a phagocytosis assay. This new source may provide tissue for allogenic transplantation based on best matches through histocompatibility testing

Profile and progression of cognitive deficits in Progressive Supranuclear Palsy, Multiple System Atrophy and Parkinson's Disease

Objective: This study investigated neuropsychological tests most sensitive in differentiating progressive supranuclear palsy (PSP) from Parkinson’s disease (PD) and multiple system atrophy (MSA), and in detecting cognitive changes at follow-up. Background: Cognitive impairment is frequent in PSP, but its characteristics and progression need to be properly defined. Method: We evaluated 35 PSP with Richardson’s syndrome (PSP-RS), 30 MSA as well as 65 age-, sex-, and education-matched PD with an extensive clinical and neuropsychological assessment, allowing Level II cognitive diagnosis. Eighteen PSP, 12 MSA and 30 PD had a second evaluation 12-18-month (mean 15 months) after the first assessment. Results: In PSP, Montreal Cognitive Assessment (MoCA), verbal fluencies (phonemic and semantic tasks), Stroop test, Digit Span Sequencing (DSS), incomplete letters of Visual Object and Space Perception (VOSP) and Benton’s Judgment of Line Orientation (JLO) performance were significantly impaired at baseline compared to PD and MSA. Executive and visuo-spatial abilities declined longitudinally in PSP, but not in PD and MSA. After 1.5 year, 16% of PSP converted to dementia. Conclusion: Our study provides evidence that cognitive decline is more severe and rapid in PSP than PD and MSA. MoCA, verbal fluency, DSS and Benton’s JLO are valuable tests to detect cognitive progression in PSP and may be proposed as biomarker for research protocols to assess efficacy of disease modification strategies

Prevalence of Lens Opacities in North India: The INDEYE Feasibility Study

PURPOSE: To obtain estimates of the prevalence of lens opacities in an Indian setting by using photographically acquired lens images. METHODS: In 11 randomly sampled villages from a rural district of Haryana, North India, 1443 people (median age 60 years), 52% women, were identified from enumeration of the > or =50-year age group; 87% attended an eye examination. Digital images of cortical and posterior subcapsular opacities and photographs of nuclear opacities were graded using the Lens Opacity Classification System (LOCS) II. The prevalence of opacities was based on a grade of 2 or higher in the worse eye for nuclear, cortical, or posterior subcapsular opacities. RESULTS: Of the participants, 1071 people had gradable images; a further 163 had undergone surgery or had dense opacities. Nuclear opacities were the most common type, with an overall prevalence of 56.9% (95% CI, 53.0-60.6). Posterior subcapsular opacities occurred in 20.6% (95% CI, 17.9-25.8) and cortical opacities in 21.6% (95% CI, 17.9-25.8). Prevalence rose steeply with age for all opacities and was higher in the women than in the men for cortical opacities (P = 0.03). The prevalence of any type of lens opacity including surgical cases and dense opacities was 75.3% (95% CI, 71.4-78.81). CONCLUSIONS: These results highlight the substantial excess of lens opacities in India compared with Western populations

Prevalence and risk factors for vitamin C deficiency in north and south India: a two centre population based study in people aged 60 years and over.

BACKGROUND: Studies from the UK and North America have reported vitamin C deficiency in around 1 in 5 men and 1 in 9 women in low income groups. There are few data on vitamin C deficiency in resource poor countries. OBJECTIVES: To investigate the prevalence of vitamin C deficiency in India. DESIGN: We carried out a population-based cross-sectional survey in two areas of north and south India. Randomly sampled clusters were enumerated to identify people aged 60 and over. Participants (75% response rate) were interviewed for tobacco, alcohol, cooking fuel use, 24 hour diet recall and underwent anthropometry and blood collection. Vitamin C was measured using an enzyme-based assay in plasma stabilized with metaphosphoric acid. We categorised vitamin C status as deficient (28 µmol/L). We investigated factors associated with vitamin C deficiency using multivariable Poisson regression. RESULTS: The age, sex and season standardized prevalence of vitamin C deficiency was 73.9% (95% confidence Interval, CI 70.4,77.5) in 2668 people in north India and 45.7% (95% CI 42.5,48.9) in 2970 from south India. Only 10.8% in the north and 25.9% in the south met the criteria for adequate levels. Vitamin C deficiency varied by season, and was more prevalent in men, with increasing age, users of tobacco and biomass fuels, in those with anthropometric indicators of poor nutrition and with lower intakes of dietary vitamin C. CONCLUSIONS: In poor communities, such as in our study, consideration needs to be given to measures to improve the consumption of vitamin C rich foods and to discourage the use of tobacco

Blood levels of vitamin C, carotenoids and retinol are inversely associated with cataract in a north Indian population

PURPOSE: To examine the association of blood antioxidants with cataract. METHODS: Cross-sectional study of people aged >or=50 years identified from a household enumeration of 11 randomly sampled villages in North India. Participants were interviewed for putative risk factors (tobacco, alcohol, biomass fuel use, sunlight exposure, and socioeconomic status) and underwent lens photography and blood sampling. Lens photographs (nuclear, cortical, and posterior subcapsular) were graded according to the Lens Opacities Classification System (LOCS II). Cataract was defined as LOCS II grade >or=2 for any opacity or ungradable, because of dense opacification or history of cataract surgery. People without cataract were defined as LOCS II or=50 years, 94% were interviewed, 87% attended an eye examination, and 78% gave a blood sample; 1112 (77%) were included in the analyses. Compared with levels in Western populations, antioxidants were low, especially vitamin C. Vitamin C was inversely associated with cataract. Odds ratios (OR) for the highest (>or=15 micromol/L) compared with the lowest (<or=6.3 micromol/L) tertile were 0.64, (95% confidence interval [CI] 0.48-0.85; P < 0.01). Tertiles of zeaxanthin (P < 0.03), alpha-carotene (P < 0.05), and retinol (P < 0.02) were associated with decreased odds of cataract. In analysis of continuous data, significant inverse associations were found for vitamin C, zeaxanthin, lutein, lycopene, alpha- and beta-carotene, and beta-cryptoxanthin, but not for alpha- or gamma-tocopherol. CONCLUSIONS: Inverse associations were found between cataract and blood antioxidants in an antioxidant-depleted study sample

Prevalence of Early and Late Age-Related Macular Degeneration in India: The INDEYE Study

This large, two-center, population-based study provides estimates of the prevalence of age-related macular degeneration in India