Publications by authors named "Simcha Pollack"

53 Publications

The Prognostic Value of Left Atrial Global Longitudinal Strain and Left Atrial Phasic Volumes in Patients Undergoing Transcatheter Valve Implantation for Severe Aortic Stenosis.

Cardiology 2021 Mar 22:1-12. Epub 2021 Mar 22.

Departments of Research and Cardiac Imaging, St. Francis Hospital, The Heart Center, Roslyn, New York, USA,

Introduction: The changes and the prognostic implications of left atrial (LA) volumes (LAV), LA function, and vascular load in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) are less known.

Methods: We enrolled 150 symptomatic patients (mean age 82 ± 8 years, 58% female, and pre-TAVI aortic valve area 0.40 ± 0.19 cm/m2) with severe AS who underwent 2D transthoracic echocardiography and 2D speckle tracking echocardiography at average 21 ± 35 days before and 171 ± 217 days after TAVI. The end point was a composite of new onset of atrial fibrillation, hospitalization for heart failure and all-cause death (major adverse cardiac events [MACE]).

Results: After TAVI, indexed maximal LA volume and minimum volume of the LA decreased by 2.1 ± 10 mL/m2 and 1.6 ± 7 mL/m2 (p = 0.032 and p = 0.011, respectively), LA function index increased by 6.8 ± 11 units (p < 0.001), and LA stiffness decreased by 0.38 ± 2.0 (p = 0.05). No other changes in the LA phasic volumes, emptying fractions, and vascular load were noted. Post-TAVI, both left atrial and ventricular global peak longitudinal strain improved by about 6% (p = 0.01 and 0.02, respectively). MACE was reached by 37 (25%) patients after a median follow-up period of 172 days (interquartile range, 20-727). In multivariable models, MACE was associated with both pre- and post-TAVI LA global peak longitudinal strain (hazard ratio [HR] 0.75, CI 0.59-0.97; and HR 0.77, CI 0.60-1.00, per 5 percentage point units, respectively), pre-TAVI LV global endocardial longitudinal strain (HR 1.37, CI 1.02-1.83 per 5 percentage point units), and with most of the LA phasic volumes.

Conclusion: Within 6 months after TAVI, there is reverse LA remodeling and an improvement in LA reservoir function. Pre- and post-TAVI indices of LA function and volume remain independently associated with MACE. Larger studies enrolling a greater diversity of patients may provide sufficient evidence for the utilization of these imaging biomarkers in clinical practice.
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http://dx.doi.org/10.1159/000514665DOI Listing
March 2021

The Association between Aortic Valve Weight, Echocardiographic Indices, and All-Cause Death in 1,046 Patients Undergoing Surgical Aortic Valve Replacement for Aortic Stenosis.

Cardiology 2020 11;145(4):251-261. Epub 2020 Mar 11.

St. Francis Hospital, The Heart Center, Roslyn, New York, USA,

Background: Aortic valve weight (AVW), a flow independent measure of aortic stenosis (AS) severity, is reported to have heterogeneous associations with the echocardiographic variables used for AS evaluation. Controversy exists regarding its impact on survival after aortic valve replacement (AVR).

Objective: We sought to determine the association between AVW with echocardiographic measures of AS severity and all-cause mortality after surgical AVR.

Methods: One thousand and forty-sixconsecutive patients underwent surgical AVR for AS, the excised valves were weighed, and an echocardiogram was done before surgery.

Results: Males had heavier valves than females, for both absolute and body surface are (BSA)-indexed values (2.78 ± 1.23 vs. 2.08 ± 0.68 g, p < 0.001; and 1.38 ± 0.61 vs. 1.19 ± 0.41 g/m2, p < 0.001, respectively). In a restricted cohort of 634 patients with isolated severe AS and normal ejection fraction, the correlations of AVW with echocardiographic variables of AS were modest, the strongest being with the dimensionless index (r = -0.27 and -0.26 for male and female, both p < 0.01). Stratified by stroke volume index and mean gradient (MG), no associations were found in the low-gradient groups (i.e., MG <40 mmHg). At a median follow-up of 3.5 years, there were only 244 deaths in the entire cohort. Mortality was not related to AVW, except in females who displayed an inverse relationship (HR = 0.67; 95% CI 0.47-0.95) only when it was analyzed as a continuous variable.

Conclusions: The weak correlation between AVW with the echocardiographic indices of AS may reflect its complex pathophysiology, heterogeneous hemodynamics, and possible pitfalls in the current echocardiographic methods used in clinical practice. The prognostic value of AVW after AVR warrants further evaluation.
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http://dx.doi.org/10.1159/000505870DOI Listing
March 2020

Feasibility of integrative games and novel therapeutic game controller for telerehabilitation of individuals chronic post-stroke living in the community.

Top Stroke Rehabil 2020 07 25;27(5):321-336. Epub 2019 Dec 25.

Physical Medicine and Rehabilitation, Kessler Institute for Rehabilitation , West Orange, NJ, USA.

Background: Intensive, adaptable and engaging telerehabilitation is needed to enhance recovery and maximize outcomes. Such services may be provided under early supported discharge, or later for chronic populations. A novel virtual reality game-based telerehabilitation system was designed for individuals post-stroke to enhance their bimanual upper extremity motor function, cognition, and wellbeing.

Objectives: To evaluate the feasibility of novel therapeutic game controller and telerehabilitation system for home use.

Methods: Individuals chronic post-stroke and their caregivers were recruited (n = 8 + 8) for this feasibility study. One was a screen failure and seven completed 4 weeks (20 sessions) of home-based therapy with or without remote monitoring. Standardized clinical outcome measures were taken pre- and post-therapy. Game performance outcomes were sampled at every session, while participant and caregiver subjective evaluations were done weekly.

Results: There was a 96% rate of compliance to protocol, resulting in an average of 13,000 total arm repetitions/week/participant. Group analysis showed significant ( <.05) improvements in grasp strength (effect size [ES] = 0.15), depression (Beck Depression Inventory II, ES = 0.75), and cognition (Neuropsychological Assessment Battery for Executive Function, ES = 0.46). Among the 49 outcome variables, 36 variables (73.5%) improved significantly ( = .001, binomial sign test). Technology acceptance was very good with system rating by participants at 3.7/5 and by caregivers at 3.5/5.

Conclusions: These findings indicate the feasibility and efficacy of the system in providing home-based telerehabilitation. The BrightBrainer system needs to be further evaluated in randomized control trials and with individuals early post-stroke.
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http://dx.doi.org/10.1080/10749357.2019.1701178DOI Listing
July 2020

The Utility of Flow Rate Compared with Left Ventricular Stroke Volume Index in the Hemodynamic Classification of Severe Aortic Stenosis with Preserved Ejection Fraction.

Cardiology 2018 10;141(1):37-45. Epub 2018 Oct 10.

Objectives: To substitute the stroke volume index (SVi) with flow rate (FR) in the hemodynamic classification of severe aortic stenosis (AS) with preserved ejection fraction (EF), in order to evaluate its prognostic value.

Methods: A total of 529 patients (78.8 ± 9.8 years old, 44.1% males) with isolated severe AS (aortic valve area, AVA < 1 cm2), EF ≥50%, in sinus rhythm, who underwent transthoracic echocardiography, were stratified by FR (≥/< 200 mL/s) and mean pressure gradient (MG) (≥/< 40 mm Hg): FRnormal/MGhigh, FRlow/MGhigh, FRnormal/MGlow, and FRlow/MGlow.

Results: Aortic valve replacement was more frequently performed in the FRnormal/MGhigh than in the FRlow/MGlow group (69.3 vs. 47%, respectively, p < 0.0001), yielding a similar survival benefit across all four groups. Over a median follow-up of 51 ± 29 months, there were 249 deaths. In highly adjusted models, the FRlow/MGlow group had a higher all-cause mortality (HR = 1.7, 95% CI: 1.1-2.6, p = 0.02) than patients with FRnormal/MGhigh. FR had a stronger association with AVA than SVi (r = 0.51 vs. 0.41, respectively, p = 0.0002), and a similar predictive value for death (AUC = 0.57 and 0.58, respectively, p = 0.88).

Conclusions: The FRlow/MGlow subset of AS is associated with the worst prognosis, and FR is not superior to SVi in the hemodynamic classification of severe AS.
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http://dx.doi.org/10.1159/000493165DOI Listing
November 2019

Optimal Same-Day Platelet Inhibition in Patients Receiving Drug-Eluting Stents With or Without Previous Maintenance Thienopyridine Therapy: from the Evaluation of Platelet Inhibition in Patients Having A VerifyNow Assay (EPIPHANY) Trial.

Am J Cardiol 2017 Apr 5;119(7):991-995. Epub 2017 Jan 5.

Cardiology Department, St. Francis Hospital-The Heart Center, Roslyn, New York. Electronic address:

We determined if high on-treatment platelet reactivity (HTPR) can be overcome on the day of percutaneous coronary intervention (PCI) in patients with or without previous maintenance thienopyridine therapy. Patients with HTPR, as defined as P2Y12 reaction units (PRU) >230, were switched to an alternate thienopyridine. Patients with HTPR undergoing PCI are at increased risk for ischemic complications. A total of 429 patients undergoing PCI with drug-eluting stents were enrolled. Patients on maintenance thienopyridine (n = 249) with PRU >230 were loaded with the alternative thienopyridine. Patients who were thienopyridine naïve (n = 180) were randomized to clopidogrel 600 (n = 90) or prasugrel 60 mg (n = 90). Patients with HTPR were loaded with the alternative agent. Patients on maintenance clopidogrel (n = 192) had a higher prevalence of HTPR compared with prasugrel (n = 57; 51% vs 4%, p <0.001). Patients on maintenance clopidogrel with HTPR (n = 98) who were loaded with prasugrel achieved PRU ≤230 in 97%. Thienopyridine-naïve patients loaded with clopidogrel had a higher prevalence of HTPR compared with prasugrel (37% vs 3%, p <0.001). Clopidogrel-loaded patients with HTPR (n = 33) who were reloaded with prasugrel achieved PRU ≤230 in 94%. All 3 prasugrel-loaded patients with HTPR treated with clopidogrel achieved PRU ≤230. Two patients experienced 30-day major adverse clinical events. One patient experienced Thrombolysis In Myocardial Infarction major bleeding. In conclusion, HTPR can be overcome in patients with and without previous maintenance thienopyridine therapy by identifying patients with HTPR and switching to an alternate thienopyridine.
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http://dx.doi.org/10.1016/j.amjcard.2016.11.057DOI Listing
April 2017

Collective impact of conventional cardiovascular risk factors and coronary calcium score on clinical outcomes with or without statin therapy: The St Francis Heart Study.

Atherosclerosis 2016 12 17;255:193-199. Epub 2016 Sep 17.

Saint Francis Hospital, Roslyn, NY, USA; State University of New York at Stony Brook, New York, USA. Electronic address:

Background And Aims: The efficacy of statin therapy remains unknown in patients eligible for statin therapy with and without elevated coronary calcium score (CAC). The study sought to evaluate how cardiovascular risk factors, expressed in terms of statin eligibility for primary prevention, and CAC modify clinical outcomes with and without statin therapy.

Methods: We conducted a post-hoc analysis of the St. Francis Heart Study treatment trial, a double-blind, placebo-controlled randomized controlled trial of atorvastatin (20 mg), vitamin C (1 g), and vitamin E (1000 U) daily, versus placebos in 990 asymptomatic individuals with CAC ≥ 80th percentile for age and gender. Primary cardiovascular outcomes included non-fatal myocardial infarction or coronary death, coronary revascularization, stroke, and peripheral arterial revascularization. We further stratified the treatment and placebo groups by eligibility (eligible when statin indicated) for statin therapy based on 2013 ACC/AHA guidelines and based on CAC categories.

Results: After a median follow-up of 4.8 years, cardiovascular events had occurred in 3.9% of the statin treated but not eligible, 4.6% of the untreated and not eligible, 8.9% of the treated and eligible and 13.4% of the untreated and eligible groups, respectively (p<0.001). Low CAC (<100) occurred infrequently in statin eligible subjects (≤4%) and was associated with low 10-year event rate (<1 per 100 person-years). In contrast, high CAC (>300) occurred frequently in more than 35% of the statin not eligible subjects and was associated with a high 10-year event rate (≥17 per 100 person-years). Risk prediction improved significantly when both clinical risk profile and CAC score were combined (net reclassification index p = 0.002).

Conclusions: Under the current statin treatment guidelines a small number of statin eligible subjects with low CAC might not benefit from statin therapy within 5 years. However, the statin not eligible subjects with high CAC have high event rate attributing to loss of opportunity for effective primary prevention.
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http://dx.doi.org/10.1016/j.atherosclerosis.2016.09.060DOI Listing
December 2016

The Mau-Reverdin Osteotomy: A Short-Term Retrospective Analysis.

J Foot Ankle Surg 2016 Jul-Aug;55(4):794-8. Epub 2016 Apr 14.

Professor, Computer Information Systems and Decision Sciences, St. John's University, Queens, NY.

We reviewed 33 consecutive Mau-Reverdin osteotomies in 23 patients performed for correction of hallux abducto valgus from November 2010 to May 2013. All patients were followed up and evaluated for a mean of 401 days and median of 360 days after surgery. In each foot, the preoperative first intermetatarsal angle, hallux abductus angle, and proximal articular set angle were obtained. The mean correction of these angles was as follows: intermetatarsal angle 10.5° ± 3.31°, hallux abductus angle 24.4° ± 8.8°, and proximal articular set angle 28.39° ± 11.2°. Furthermore, we evaluated for metatarsus elevates, and no statistically significant first metatarsal elevation was present in any of the 33 feet (p < .0001). Additionally, 21 of the 33 feet (63.6%) were available for first metatarsophalangeal joint American Orthopaedic Foot and Ankle Society scale score evaluation. The mean preoperative score was 25.5 ± 16.7. After correction, the mean American Orthopaedic Foot and Ankle Society scale score had increased to 95.4 ± 5.7. All these differences were statistically significant (p < .0001), and the patients had a very high level of satisfaction. In all 33 feet, no deep infection, malunion, nonunion, avascular necrosis of the first metatarsal, or hardware failure developed. One patient developed hallux varus deformity. The Mau-Reverdin osteotomy is a very effective and reproducible procedure that successfully corrects large bunion deformities and provides patients with a high level of satisfaction and a low complication rate.
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http://dx.doi.org/10.1053/j.jfas.2016.03.003DOI Listing
August 2017

How Long Does (S)He Have? Retrospective Analysis of Outcomes After Palliative Extubation in Elderly, Chronically Critically Ill Patients.

Crit Care Med 2016 06;44(6):1138-44

1Division of Geriatrics and Palliative Care Medicine, New York Presbyterian Queens, Flushing, NY. 2Department of Medicine, Weill Cornell Medical College, New York, NY. 3Hospice Care Network. Department of Medicine, Northwell Health, Woodbury, NY. 4Department of Internal Medicine, Wyckoff Heights Medical Center, Brooklyn, NY. 5Department of Decision Sciences, St. John's University, Flushing, NY.

Objective: For chronically critically ill elderly patients on mechanical ventilation, prognosis for significant recovery may be minimal. These individuals, or their surrogates, may decide for "palliative extubation." A common prognostic question arises: "How long does she/he have?" This study describes demographics, mortality, time to death, and factors associated with death after palliative extubation.

Design, Setting, And Patients: Retrospective 3-year study in community hospital with ethnically diverse elderly population. Chronically critically ill patients followed from palliative extubation to death or survival to discharge.

Measures: Mortality/survival following palliative extubation, time to death or discharge, factors associated with death.

Results: Hundred and forty-eight subjects underwent palliative extubation. Mean age: 78 years, 60% female, ethnically diverse with 46% white, and 54% others. Top diagnostic categories: sepsis (47%) and respiratory failure (22%). After extubation, 114 patients (77%) died in hospital and 34 (23%) were discharged. Of those who died, median time to death 8.9 hours (range, 4 min to 7 d). Mortality proportion was 56% at 24 hours and increased with time. Factors associated with early death: Systolic blood pressure less than 90 (p = 0.002) and Charlson Comorbidity Index that is above 6 or 0 (p = 0.002).

Conclusions: Palliative extubation at end of life was an option selected by an ethnically diverse elderly population. Approximately three-fourths of subjects died in hospital, and one-fourth was discharged alive. Over 50% who died did so within 24 hours, making this useful information for counseling and anticipatory planning. Subjects with systolic blood pressure less than 90 and Charlson Comorbidity Index that is very low or very high had higher mortality.
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http://dx.doi.org/10.1097/CCM.0000000000001642DOI Listing
June 2016

Manual Aspiration Thrombectomy in Acute Myocardial Infarction: A Clinical Experience.

Int J Angiol 2016 Mar 23;25(1):20-8. Epub 2015 Mar 23.

Division of Cardiology, New York Hospital Queens/Weill Medical College of Cornell University, New York.

Multiple clinical studies have failed to establish the role of routine use of thrombectomy in ST-elevation myocardial infarction (STEMI) patients. There is a paucity of data on the impact of thrombectomy in unselected STEMI patients outside clinical trials. We sought to evaluate the clinical variables and outcomes associated with the performance of thrombectomy in STEMI patients. We retrospectively examined the clinical outcomes in all STEMI patients who underwent successful percutaneous intervention (PCI) at our center. Patients were divided into two groups, one with patients who underwent conventional PCI and another with patients who had thrombus aspiration in addition to conventional PCI. We compared the baseline clinical characteristics, laboratory investigations, re-infarction rates, and all-cause mortality. Total 477 consecutive STEMI patients were identified. Overall, 29% (139) of the patients underwent conventional PCI and 71% (338) of the patients were treated with aspiration thrombectomy and PCI. In addition to the presence of thrombus, patients with nonanterior infarction, and patients with hemodynamic instability requiring intra-aortic balloon pump support were more likely to undergo thrombectomy. Thrombectomy was associated with higher enzymatic infarction (creatine kinase: 2,796 [2,575] vs. 1,716 [1,662]; p < 0.0001; CK-MB: 210.6 [156.0] vs. 142.0 [121.9], p < 0.0001). However, thrombectomy was not associated with any difference in 30 day reinfarction rate (3.3 vs. 2.9%, p = 0.83), mortality (5.0 vs. 7.2%, p = 0.35), or composite of death and 30 day reinfarction (7.7 vs. 9.4%, p = 0.55). We observed that STEMI patients with anterior infarction and hemodynamic instability were more likely to undergo thrombectomy during primary PCI.
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http://dx.doi.org/10.1055/s-0035-1547515DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4758846PMC
March 2016

Asymptomatic rectal colonization with carbapenem-resistant Enterobacteriaceae and Clostridium difficile among residents of a long-term care facility in New York City.

Am J Infect Control 2016 05 18;44(5):525-32. Epub 2016 Jan 18.

Department of Medicine, NewYork-Presbyterian/Queens, Flushing, NY; The Dr. James J. Rahal Jr. Division of Infectious Diseases, NewYork-Presbyterian/Queens, Flushing, NY. Electronic address:

Background: Residents of long-term care facilities (LTCFs) are at increased risk for colonization and development of infections with multidrug-resistant organisms. This study was undertaken to determine prevalence of asymptomatic rectal colonization with Clostridium difficile (and proportion of 027/NAP1/BI ribotype) or carbapenem-resistant Enterobacteriaceae (CRE) in an LTCF population.

Methods: Active surveillance was performed for C difficile and CRE rectal colonization of 301 residents in a 320-bed (80-bed ventilator unit), hospital-affiliated LTCF with retrospective chart review for patient demographics and potential risk factors.

Results: Over 40% of patients had airway ventilation and received enteral feeding. One-third of these patients had prior C difficile-associated infection (CDI). Asymptomatic rectal colonization with C difficile occurred in 58 patients (19.3%, one-half with NAP1+), CRE occurred in 57 patients (18.9%), and both occurred in 17 patients (5.7%). Recent CDI was significantly associated with increased risk of C difficile ± CRE colonization. Multivariate logistic regression analysis revealed presence of tracheostomy collar to be significant for C difficile colonization, mechanical ventilation to be significant for CRE colonization, and prior CDI to be significant for both C difficile and CRE colonization.

Conclusions: The strong association of C difficile or CRE colonization with disruption of normal flora by mechanical ventilation, enteral feeds, and prior CDI carries important implications for infection control intervention in this population.
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http://dx.doi.org/10.1016/j.ajic.2015.11.021DOI Listing
May 2016

Just ask: hospice familiarity in Asian and Hispanic adults.

J Pain Symptom Manage 2015 May 12;49(5):928-33. Epub 2014 Dec 12.

St. John's University, Queens, New York, USA.

Context: Previous research documents the under-utilization of hospice services by minority ethnic groups, but less data exist for Asian and Hispanic Americans. It is unclear whether these low utilization rates are a result of attitudinal or information barriers, or both.

Objectives: To examine self-reported familiarity and attitudes toward hospice among Asian and Hispanic groups in ethnically diverse Queens County, NY.

Methods: We surveyed diverse adults during health fairs, at senior centers, and church programs directed at ethnic populations. Respondents completed surveys in their preferred language: Spanish, Chinese (Mandarin), and Korean. Analysis of variance was used to compare continuous variables among language groups; Fisher's exact test compared categorical variables.

Results: A total of 604 community adults were surveyed: 99 Chinese, 349 Korean, 156 Spanish. Respondents were mostly female, average age 53 years. Familiarity with hospice varied significantly among the groups (P < 0.001) and was lower in the Hispanic (16%) and higher in the Chinese (45%) and Korean (56%) groups. Personal experiences with hospice were low (8-16%) in all groups. A majority (75-94%) responded they would share hospice information with loved ones, but the Hispanic group was significantly less likely to do so compared with Chinese and Korean Americans. Between 74 and 95% reported willingness to receive future information about hospice, but the Korean group was significantly less likely to want information.

Conclusion: When surveyed in their preferred language, Asian and Hispanic adults reported variable levels of familiarity with hospice services. Most responded positively to receiving future information and would tell friends and family members about hospice.
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http://dx.doi.org/10.1016/j.jpainsymman.2014.09.016DOI Listing
May 2015

Palliative care intervention in the intensive care unit: comparing outcomes among seriously ill Asian patients and those of other ethnicities.

J Palliat Care 2014 ;30(3):151-7

Background: The literature describing the attitude of Asians toward palliative care in the intensive care unit (ICU) is scarce.

Aim: The purpose of this study was to compare outcomes of Asians and people of other ethnicities after palliative care intervention in the ICU.

Methods: A retrospective chart review was conducted of all ICU patients evaluated by palliative care; the outcomes measured were incidence of life-sustaining treatments, institution of advance care directives, and preferences for end-of-life care.

Results: The palliative care team evaluated 119 patients (46.2 percent Caucasian, 27.2 percent Asian, and 26.1 percent other ethnicities). There were no differences in demographics or clinical variables. Thirty-six percent of the Asians, 49 percent of the Caucasians, and 28.6 percent of the patients of other ethnicities (p = 0.19) had healthcare proxies. The palliative care team increased advance care directives by more than 40 percent in all groups (p < 0.001). There were no differences in the use of life-sustaining treatments or preferences for comfort measures among ethnic groups.

Conclusion: Asians are as likely as people of other ethnicities to decide on advance care directives, life-sustaining treatments, and comfort measures after palliative care evaluation in the ICU.
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November 2014

Absence of left ventricular hypertrophy in severe isolated aortic stenosis and preserved left ventricular systolic function.

J Heart Valve Dis 2014 Jan;23(1):1-8

Background And Aim Of The Study: Recent evidence challenges the paradigm that left ventricular hypertrophy (LVH) is required to preserve left ventricular systolic performance in severe aortic stenosis (AS). The study aims were to determine the clinical, echocardiographic and prognostic implications in a cohort of patients with symptomatic severe AS, a preserved left ventricular ejection fraction (LVEF), and an absence of LVH.

Methods: Echocardiographic, clinical, aortic valve replacement (AVR)-related and all-cause death data were analyzed in 512 patients (253 males, 259 females; mean age 78.4 +/- 10.3 years) with severe AS and a preserved LVEF. Of these patients, 21% were enrolled prospectively, and the mean follow up was 40.4 +/- 32.5 months.

Results: By using the American Society of Echocardiography equation for left ventricular mass calculation, LVH was shown to be present in 330 patients (63%) and absent from 182 (36%). Typically, patients without LVH had a larger body surface area, were more often male, had a larger aortic valve area index (AVAi), and had similar LVEFs and rates of AVR as compared to those with LVH. A total of 59 deaths (32.4%) occurred among patients without LVH, and 134 (40.6%) among those with LVH (p = 0.07). When the left ventricular mass index (LVMi) was analyzed as a continuous variable, in both unadjusted and adjusted models for demographics, clinical characteristics, medications, AVAi, LVEF, and systemic vascular resistance, no association was found between LVMi and survival (p = 0.26). However, only patients with a normal LVMi and relative wall thickness had a survival benefit when compared to those with any pattern of abnormal left ventricular geometry (p = 0.01).

Conclusion: LVH was absent in more than one-third of patients with severe AS, and was not associated with worse outcomes. A normal left ventricular geometry was associated with lower mortality rates, while AVR was associated with prolonged survival, regardless of LVMi. Mechanisms other than compensatory hypertrophy appear capable of offsetting the adverse effects of afterload excess in AS.
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January 2014

Feasibility study of the BrightBrainer™ integrative cognitive rehabilitation system for elderly with dementia.

Disabil Rehabil Assist Technol 2015 29;10(5):421-32. Epub 2014 Mar 29.

Bright Cloud International Corp , Highland Park, NJ , USA .

Purpose: To describe the development of BrightBrainer™ integrative cognitive rehabilitation system and determine clinical feasibility with nursing home-bound dementia patients.

Method: BrightBrainer cognitive rehabilitation simulations were first played uni-manually, then bimanually. Participants sat in front of a laptop and interacted through a game controller that measured hand movements in 3D, as well as flexion of both index fingers. Interactive serious games were designed to improve basic and complex attention (concentration, short-term memory, dual tasking), memory recall, executive functioning and emotional well-being. Individual simulations adapted automatically to each participant's level of motor functioning. The system underwent feasibility trials spanning 16 sessions over 8 weeks. Participants were evaluated pre- and post-intervention, using standardized neuropsychological measures. Computerized measures of movement repetitions and task performance were stored on a remote server.

Results: Group analysis for 10 participants showed statistically significant improvement in decision making (p < 0.01), with trend improvements in depression (p < 0.056). Improvements were also seen in processing speed (p < 0.13) and auditory attention (p < 0.17); however, these were not statistically significant (partly attributable to the modest sample size). Eight of nine neuropsychological tests showed changes in the improvement direction indicating an effective rehabilitation (p < 0.01). BrightBrainer technology was well tolerated with mean satisfaction ratings of 4.9/5.0 across participants.

Conclusions: Preliminary findings demonstrate utility within an advanced dementia population, suggesting that it will be beneficial to evaluate BrightBrainer through controlled clinical trials and to investigate its application in other clinical populations. Implications for Rehabilitation It is possible to improve cognitive function in older low-functioning patients. Integrative rehabilitation through games combining cognitive (memory, focusing, executive function) and physical (bimanual whole arm movement, grasping, task sequencing) elements is enjoyable for this population. The severity of depression in these elderly can be reduced through virtual reality bimanual games. The number of upper extremity active repetitions performed in the process of solving cognitive problems with the BrightBrainer™ system is 600. This number is 18 times (1875%) larger than those observed by other researchers in conventional physical or occupational rehabilitation sessions.
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http://dx.doi.org/10.3109/17483107.2014.900575DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4942847PMC
April 2016

The relationship between faculty performance assessment and results on the in-training examination for residents in an emergency medicine training program.

J Grad Med Educ 2013 Dec;5(4):582-6

Background: Medical knowledge (MK) in residents is commonly assessed by the in-training examination (ITE) and faculty evaluations of resident performance.

Objective: We assessed the reliability of clinical evaluations of residents by faculty and the relationship between faculty assessments of resident performance and ITE scores.

Methods: We conducted a cross-sectional, observational study at an academic emergency department with a postgraduate year (PGY)-1 to PGY-3 emergency medicine residency program, comparing summative, quarterly, faculty evaluation data for MK and overall clinical competency (OC) with annual ITE scores, accounting for PGY level. We also assessed the reliability of faculty evaluations using a random effects, intraclass correlation analysis.

Results: We analyzed data for 59 emergency medicine residents during a 6-year period. Faculty evaluations of MK and OC were highly reliable (κ  =  0.99) and remained reliable after stratification by year of training (mean κ  =  0.68-0.84). Assessments of resident performance (MK and OC) and the ITE increased with PGY level. The MK and OC results had high correlations with PGY level, and ITE scores correlated moderately with PGY. The OC and MK results had a moderate correlation with ITE score. When residents were grouped by PGY level, there was no significant correlation between MK as assessed by the faculty and the ITE score.

Conclusions: Resident clinical performance and ITE scores both increase with resident PGY level, but ITE scores do not predict resident clinical performance compared with peers at their PGY level.
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http://dx.doi.org/10.4300/JGME-D-12-00240.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3886455PMC
December 2013

Clinical and echocardiographic correlates of mortality in medically treated patients with severe isolated aortic stenosis and normal left ventricular ejection fraction.

Circ J 2014 30;78(1):232-9. Epub 2013 Oct 30.

St. Francis Hospital, Heart Center/State University of New York at Stony Brook, Department of Research and Education.

Background: Many symptomatic patients with severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF) are denied surgery and have a grim prognosis with medical management.

Methods And Results: Between 2003 and 2012, among 550 patients with severe isolated AS and preserved LVEF on transthoracic echocardiography, 241 did not undergo aortic valve replacement (mean age, 83.2±7.6 years; 54% female; aortic valve area index, 0.40±0.13cm(2)/m(2); mean LVEF, 64.8±7.6%) and 67% presented with cardiac symptoms. At a mean follow-up of 25.5±25.1 months, 134 patients (56%) had died. Survival at 1, 5 and 9.5 years was 71%, 28% at 12%, respectively. Median survival was 36.3 months (95% confidence interval [CI]: 27.2-42.4 months). In unadjusted analyses, age, heart failure, hypertension, renal insufficiency, left atrial size, pulmonary artery systolic pressure (PASP), relative wall thickness and LV mass/LV end diastolic volume ratio were associated with mortality. On multivariate analysis adjusted for all significant univariate predictors, age ≥78 years, history of hypertension, left atrial diameter ≥40mm and PASP ≥42mmHg gave a joint area under the curve of 0.80 (95% CI: 0.73-0.86) for mortality.

Conclusions: In medically treated patients with severe isolated AS and preserved LVEF, older age, history of hypertension, and echo-Doppler variables reflecting LV diastolic dysfunction are independent predictors of death.
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http://dx.doi.org/10.1253/circj.cj-13-0821DOI Listing
August 2014

Pillcam ESO(®) is more accurate than clinical scoring systems in risk stratifying emergency room patients with acute upper gastrointestinal bleeding.

Therap Adv Gastroenterol 2013 May;6(3):193-8

Division of Gastroenterology, New York Hospital Queens Weill Cornell Medical College, 56-45 Main Street, Flushing, NY 11355, USA.

Background: Upper gastrointestinal bleeding (UGIB) accounts for 400,000 hospital admissions in the US each year. Despite advances, mortality rates remain high and are estimated to be 5-10%. Early therapeutic endoscopy is widely recommended as a means of reducing morbidity and mortality. The Rockall and Blatchford scores are clinical scoring systems devised to assist in risk stratifying patients with UGIB. In a prior study we found that rapid live bedside video capsule endoscopy (VCE) utilizing Pillcam ESO(®) correctly identified patients with high-risk stigmata of bleeding seen on upper endoscopy. In this study, we compare the accuracy of the Rockall and Blatchford scores with Pillcam ESO(®) in predicting high-risk endoscopic stigmata.

Methods: Pre-endoscopy Blatchford and Rockall scores were calculated for 25 patients (14 males, 11 females) presenting to the emergency room with acute UGIB. The average patient was 66 years of age. A total of 24 out of 25 patients underwent upper endoscopy within 24 hours. One patient did not undergo endoscopy due to clinical instability. The timing of endoscopy was based on clinical parameters in 12 patients, and on live view VCE with Pillcam ESO(®) in the other 13 patients. Positive VCE was defined as red blood, clot or coffee grounds. Mean Rockall and Blatchford scores for all 24 patients were compared to determine potential differences between high- and low-risk patients. Rockall and Blatchford scores were also compared with VCE findings.

Results: Of 24 patients, 13 had high-risk stigmata on upper endoscopy. The mean Rockall and Blatchford scores were 3 and 13, respectively. In the 11 patients without stigmata, the mean Rockall and Blatchford scores were 2 and 11, respectively. There was no statistically significant difference between the Blatchford scores of the two groups (95% confidence interval [CI] -5.1 to 1.3; p = 0.22). There was no statistically significant difference between the Rockall scores of the two groups (95% CI -2.3 to 0.3; p = 0.11). In the subgroup of 12 patients who underwent VCE prior to endoscopy, 8/12 had positive findings, which were all confirmed at endoscopy. All 4 patients with negative VCE had no high-risk stigmata at endoscopy.

Conclusion: In emergency room patients with acute UGIB, neither the Rockall nor the Blatchford scores were able to differentiate high- and low-risk patients identified at endoscopy. Live view VCE, however, was accurate in predicting high-risk endoscopic stigmata, and may be better suited as a risk stratification tool. Additional studies with a larger cohort will be required to validate these findings.
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http://dx.doi.org/10.1177/1756283X13481020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3625024PMC
May 2013

Prevalence of Adenomas Found on Colonoscopy in Patients With HIV.

Gastroenterology Res 2012 Apr 20;5(2):52-56. Epub 2012 Mar 20.

New York Hospital Queens Weill Cornell Medical College, 56-45 Main Street, Flushing, NY, USA.

Background: The life expectancy of patients with HIV has increased significantly since the introduction of highly active antiretroviral therapy in 1995. Although this population of patients now carries less risk for the development of AIDS defining illnesses and malignancies, they are still at risk for non-AIDS defining cancers, such as colon, prostate, and breast. Several studies have shown that HIV infected patients have a higher prevalence of advanced colonic neoplasia which occur at a younger age. Our aim is to examine the prevalence of adenomas and adenocarcinoma in HIV patients undergoing colonoscopy.

Methods: HIV patients seen in our gastroenterology clinic and inpatient service undergoing colonoscopy were identified from 2010 - 2011. Indication was screening in 27 patients and diagnostic in 23 patients. Significant lesions were defined as adenomas, serrated polyps, and adenocarcinoma.

Results: Total 50 patients were included in the study, 32 male and 18 female (mean age: 53.6; range 37 - 72 years), 25 patients were African American, 21 were Hispanic, 3 were Caucasian, and one was Indian, 39 patients had undetectable HIV RNA, 30 patients had CD4 lymphocyte counts greater than 500, 20 had CD4 lymphocyte counts less than 500, and 4 patients had CD4 lymphocyte counts less than 200, 52% (26/50) of patients had polyps. Significant lesions (adenomas and serrated polyps) were seen in 34% (17/50) of patients, 39% in diagnostic and 30% in screening procedures (P = 0.56). Males were found to have significant lesions 28% of the time as compared to 44% of females (P = 0.35), 43% of Hispanics had significant lesions versus 24% of African Americans (P = 0.22), 25% of the patients under age 50 were found to have significant lesions, 45% of the patients with detectable HIV RNA levels were found to have significant lesions vs 31% (P = 0.48). Surprisingly, patients with CD4 counts > 500 had significantly more adenomas than those with CD4 counts < 500, 47% vs 15% (P = 0.03). No adenocarcinomas were seen in our patient population.

Conclusion: In our case series of HIV patients the adenoma detection rate was 34% overall, 45% in the patients with detectable HIV RNA levels, and 47% in patients with CD4 counts > 500. Additionally, there was a 25% adenoma detection rate in patients less than fifty years of age. This data reinforces the need for aggressive colon cancer screening in the HIV population.
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http://dx.doi.org/10.4021/gr433wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5051166PMC
April 2012

Integrative rehabilitation of elderly stroke survivors: the design and evaluation of the BrightArm™.

Disabil Rehabil Assist Technol 2012 Jul 22;7(4):323-35. Epub 2011 Nov 22.

Bright Cloud International Corp, Highland Park, NJ 08904-2035, USA.

Purpose: To describe the development of the BrightArm upper extremity rehabilitation system, and to determine its clinical feasibility with older hemiplegic patients.

Method: The BrightArm adjusted arm gravity loading through table tilting. Patients wore an arm support that sensed grasp strength and communicated wirelessly with a personal computer. Games were written to improve cognitive, psychosocial and the upper extremity motor function and adapted automatically to each patient. The system underwent feasibility trials spanning 6 weeks. Participants were evaluated pre-therapy, post-therapy, and at 6 weeks follow-up using standardized clinical measures. Computerized measures of supported arm reach and game performance were stored on a remote server.

Results: Five participants had clinically significant improvements in their active range of shoulder movement, shoulder strength, grasp strength, and their ability to focus. Several participants demonstrated substantially higher arm function (measured with the Fugl-Meyer test) and two were less-depressed (measured with the Becks Depression Inventory, Second Edition). The BrightArm technology was well-accepted by the participants, who gave it an overall subjective rating of 4.1 on a 5 point Likert scale.

Conclusions: Given these preliminary findings, it will be beneficial to evaluate the BrightArm through controlled clinical trials and to investigate its application to other clinical populations.
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http://dx.doi.org/10.3109/17483107.2011.629329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3358470PMC
July 2012

Left ventricular torsional mechanics in uncomplicated pregnancy.

Clin Cardiol 2011 Sep 1;34(9):543-8. Epub 2011 Sep 1.

Division of Cardiology, Department of Medicine, University of Southern California, Los Angeles, California, USA.

Background: Alterations in left ventricular (LV) twist (torsion) and untwist have been described for a variety of physiologic and pathologic conditions. Little information is available regarding changes in these parameters during normal pregnancy.

Hypothesis: Pregnancy is associated with significant changes in LV torsional mechanics.

Methods: Left ventricular twist and untwist was measured in 32 pregnant females (mean gestation 199 ± 48 d) and 23 nonpregnant controls using speckle-tracking echocardiography.

Results: Left ventricular ejection fraction (68 ± 5% vs 66 ± 5%) was similar between the groups (P not significant). There was a significant increase in peak LV twist from nonpregnant controls (9.4 ± 3.7 degrees) to second-trimester (12.0 ± 4.2 degrees) and third-trimester subjects (12.6 ± 5.9 degrees, all P<0.05). Peak LV twist velocity was also increased in second- and third-trimester groups compared with controls (94 ± 24 degrees/sec and 93 ± 30 vs 64 ± 21 degrees/sec, respectively, both P<0.05). Both peak untwist velocity and time to peak untwist velocity were not significantly different between groups (P not significant). Multiple regression analysis indicate that only systolic blood pressure (r = 0.394, P = 0.005) was an independent predictor for increased LV torsion.

Conclusions: There are significant changes in LV torsional indices during the course of pregnancy, whereas untwist parameters remain unchanged. Blood pressure is independently associated with increased torsion during pregnancy.
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http://dx.doi.org/10.1002/clc.20942DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6652494PMC
September 2011

Vitamin d and serum cytokines in a randomized clinical trial.

Int J Endocrinol 2010 12;2010. Epub 2010 Aug 12.

Winthrop University Hospital, Bone Mineral Research Center, 222 Station Plaza North, Suite 350A, Mineola, NY 11501, USA.

Background. The role of vitamin D in the body's ability to fight influenza and URI's may be dependent on regulation of specific cytokines that participate in the host inflammatory response. The aim of this study was to test the hypothesis that vitamin D can influence intracellular signaling to regulate the production of cytokines. Subjects and Methods. This study was a 3-month prospective placebo-controlled trial of vitamin D3 supplementation in ambulatory adults [Li-Ng et al., 2009]. 162 volunteers were randomized to receive either 50 μg/d (2000 IU) of vitamin D3 or matching placebo. 25(OH)D and the levels of 10 different cytokines (IL-2, 4, 5, 6, 8, 10, 13, GM-CSF, IFN-γ, TNF-α) were measured in the serum of participants at baseline and the final visit. There were 6 drop-outs from the active vitamin D group and 8 from the placebo group. Results. In the active vitamin D group, we found a significant median percent decline in levels of GM-CSF (-62.9%, P < .0001), IFN-γ (-38.9%, P < .0001), IL-4 (-50.8%, P = .001), IL-8 (-48.4%, P < .0001), and IL-10 (-70.4%, P < .0001). In the placebo group, there were significant declines for GM-CSF (-53.2%, P = .0007) and IFN-γ (-34.4%, P = .0011). For each cytokine, there was no significant difference in the rate of decline between the two groups. 25(OH)D levels increased in the active vitamin D group from a mean of 64.3 ± 25.4 nmol/L to 88.5 ± 23.2 nmol/L. Conclusions. The present study did not show that vitamin D3 supplementation changed circulating cytokine levels among healthy adults.
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http://dx.doi.org/10.1155/2010/305054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2943086PMC
July 2011

The relative influence of calcium intake and vitamin D status on serum parathyroid hormone and bone turnover biomarkers in a double-blind, placebo-controlled parallel group, longitudinal factorial design.

J Clin Endocrinol Metab 2010 Jul 12;95(7):3216-24. Epub 2010 May 12.

Bone Mineral Research Center, Winthrop University Hospital, Mineola, NY 11501, USA.

Background: Adequate calcium and vitamin D are needed to maintain calcium balance.

Objective: Our objective was to examine the influence of calcium intake and vitamin D exposure separately and their interaction on biomarkers of calcium sufficiency.

Design: Healthy men and women, age 20-80 yr, were randomly allocated to four groups: 1) double placebo, 2) calcium (1200 mg daily) plus placebo, 3) vitamin D(3) (100 microg) plus placebo, and 4) vitamin D(3) and calcium. Fasting serum and urine as well as serum and urine 2 h after a calcium load (600 mg of calcium carbonate) were obtained at baseline and 3 months.

Results: Ninety-nine participants were randomized; 78 completed the study. Baseline demographics, protein intake and laboratory studies did not differ among the four groups. Study medication compliance was 90%. Fasting bone turnover markers declined after 3 months only in the two groups given calcium supplements and increased in the vitamin D(3) plus placebo calcium group. The calcium load resulted in a decrease in PTH and in bone turnover markers that did not differ among groups. Urinary calcium excretion increased in the combined group. Mean serum 25-hydroxyvitamin D increased from a baseline of 67 (18 sd) nmol/liter to 111 (30 sd) nmol/liter after vitamin D supplementation.

Conclusion: Increased habitual calcium intake lowered markers of bone turnover. Acute ingestion of a calcium load lowered PTH and bone turnover markers. Additional intake of 100 microg/d vitamin D(3) did not lower PTH or markers of bone turnover.
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http://dx.doi.org/10.1210/jc.2009-1294DOI Listing
July 2010

Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988-2004.

Clin J Am Soc Nephrol 2009 Jan 5;4(1):57-61. Epub 2008 Nov 5.

Winthrop University Hospital, Mineola, NY 11501, USA.

Background And Objectives: Anemia is a common and early complication of nondialysis chronic kidney disease (CKD). One contributing factor is iron deficiency, which may be particularly problematic during erythropoietin replacement therapy. The aim of this study was to examine the prevalence of iron deficiency in nondialysis CKD.

Design, Setting, Participants, & Measurements: The National Health and Nutritional Examination Survey (NHANES) data for NHANES III (1988 to 1994) and subsequent NHANES 2-yr datasets, 1999 to 2000, 2001 to 2002, and 2003 to 2004 were analyzed for individuals >18 yr old.

Results: It was found that low levels of iron tests [either serum ferritin < 100 ng/ml or transferrin saturation (TSAT) < 20%] were present in most patients with reduced creatinine clearance (CrCl). The percentage of low iron tests was higher among women than men, present in 57.8 to 58.8% of men and 69.9 to 72.8% of women (P < 0.001). With declining levels of CrCl, in women, TSAT levels decreased, whereas, surprisingly, serum ferritin tended to progressively increase. The percentage of anemic subjects increased progressively with declining quartiles of TSAT but was unrelated to serum ferritin quartiles.

Conclusions: It was found that low levels of iron tests, following National Kidney Foundation/Kidney Disease Outcomes Quality Initiative guidelines (either serum ferritin < 100 ng/ml or TSAT < 20%) were present in most patients with reduced CrCl.
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http://dx.doi.org/10.2215/CJN.01670408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2615715PMC
January 2009

Association between parapneumonic effusion and pericardial effusion in a pediatric cohort.

Pediatrics 2008 Dec 4;122(6):e1231-5. Epub 2008 Nov 4.

Department of Pediatrics, Winthrop-University Hospital, 120 Mineola Blvd, Suite 210, Mineola, NY 11501, USA.

Objective: Associations between pleural and pericardial effusions have been described in malignancy and autoimmune disorders. Bacterial pneumonia is the most frequent cause of parapneumonic effusion; however, knowledge of the relationship between parapneumonic effusion and the presence of pericardial fluid in children is limited. We examined this relationship.

Methods: We performed a retrospective chart review of pediatric patients who were admitted to our institution during a 6-year period with a diagnosis of either parapneumonic effusion or empyema and who had undergone an echocardiogram, a computed tomography scan of the thorax, or both. All demographic, clinical, radiographic, and laboratory data of these patients were collected, and statistical analysis was done with Student's t tests and chi2 analyses.

Results: We reviewed the charts of 59 children with parapneumonic effusions. Forty-eight underwent 2-dimensional echocardiography, chest computed tomography scan, or both. Of these 48 patients, 54.2% (n=26) were found to have a concomitant pericardial effusion. The majority of patients with pericardial effusions had left-sided pleural disease. Patients with pericardial effusions had more symptomatic days before hospitalization, lower pleural fluid albumin levels, elevated serum white blood cell counts, elevated pleural fluid white blood cell and absolute neutrophil counts, and an increased incidence of surgical intervention. One patient had evidence of hemodynamic compromise that required pericardiocentesis.

Conclusions: We found a high incidence of pericardial effusions in pediatric patients with parapneumonic effusions. Leukocytosis, higher pleural fluid leukocyte and neutrophil counts, and a propensity for surgical intervention suggest a prognostic relationship between pericardial effusions and more severe parapneumonic disease. The majority of these pericardial collections resolve with treatment of the underlying pleural disease.
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http://dx.doi.org/10.1542/peds.2008-0171DOI Listing
December 2008

Superoxide dismutase attenuates hyperoxia-induced interleukin-8 induction via AP-1.

Free Radic Biol Med 2008 Oct 22;45(8):1143-9. Epub 2008 Jul 22.

CardioPulmonary Research Institute, Department of Medicine, Winthrop University Hospital, State University of New York Stony Brook School of Medicine, Mineola, NY 11501, USA.

Exposure of lung epithelial cells to hyperoxia results in the generation of excess reactive oxygen species (ROS), cell damage, and production of proinflammatory cytokines (interleukin-8; IL-8). Although activation of the NF-kappaB and c-Jun N-terminal kinase (JNK)/activator protein (AP)-1 transcription pathways occurs in hyperoxia, it is unclear whether activation of the AP-1 pathway has a direct impact on IL-8 production and whether overexpression of superoxide dismutase (SOD) can mitigate these proinflammatory processes. A549 cells were exposed to 95% O(2), and ROS production, AP-1 activation, and IL-8 levels were determined. Experimental groups included cells transduced with a recombinant adenovirus encoding CuZnSOD or MnSOD (two- to threefold increased activity) or transfected with a JNK1 small interfering RNA (RNAi). Hyperoxia resulted in significant increases in ROS generation, AP-1 activation, and IL-8 production, which were significantly attenuated by overexpression of either MnSOD or CuZnSOD. JNK1 RNAi also moderated IL-8 induction. The data indicate that activation of JNK1/AP-1 and subsequent IL-8 induction in hyperoxia are mediated by intracellular ROS, with SOD having significant protective effects.
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http://dx.doi.org/10.1016/j.freeradbiomed.2008.07.006DOI Listing
October 2008

Vitamin D intake to attain a desired serum 25-hydroxyvitamin D concentration.

Am J Clin Nutr 2008 Jun;87(6):1952-8

Bone Mineral Research Center, Winthrop University Hospital, Mineola, NY, USA.

Background: Indirect evidence suggests that optimal vitamin D status is achieved with a serum 25-hydroxyvitamin D [25(OH)D] concentration >75 nmol/L.

Objective: We aimed to determine the intake of vitamin D(3) needed to raise serum 25(OH)D to >75 nmol/L.

Design: The design was a 6-mo, prospective, randomized, double-blinded, double-dummy, placebo-controlled study of vitamin D(3) supplementation. Serum 25(OH)D was measured by radioimmunoassay. Vitamin D(3) intake was adjusted every 2 mo by use of an algorithm based on serum 25(OH)D concentration.

Results: A total of 138 subjects entered the study. After 2 dose adjustments, almost all active subjects attained concentrations of 25(OH)D >75 nmol/L, and no subjects exceeded 220 nmol/L. The mean (+/-SD) slope at 9 wk [defined as 25(OH)D change/baseline dose] was 0.66 +/- 0.35 (nmol/L)/(microg/d) and did not differ statistically between blacks and whites. The mean daily dose was 86 microg (3440 IU). The use of computer simulations to obtain the most participants within the range of 75-220 nmol/L predicted an optimal daily dose of 115 microg/d (4600 IU). No hypercalcemia or hypercalciuria was observed.

Conclusions: Determination of the intake required to attain serum 25(OH)D concentrations >75 nmol/L must consider the wide variability in the dose-response curve and basal 25(OH)D concentrations. Projection of the dose-response curves observed in this convenience sample onto the population of the third National Health and Nutrition Examination Survey suggests a dose of 95 microg/d (3800 IU) for those above a 25(OH)D threshold of 55 nmol/L and a dose of 125 microg/d (5000 IU) for those below that threshold.
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http://dx.doi.org/10.1093/ajcn/87.6.1952DOI Listing
June 2008

Dose response to vitamin D supplementation among postmenopausal African American women.

Am J Clin Nutr 2007 Dec;86(6):1657-62

Bone Mineral Research Center, Winthrop University Hospital, Mineola, NY 11501, USA.

Background: Reports on the dose response to vitamin D are conflicting, and most data were derived from white men and women.

Objective: The objective was to determine the response of serum 25-hydroxyvitamin D [25(OH)D] to oral vitamin D(3) supplementation in an African American population.

Design: Healthy black postmenopausal women (n = 208) participated in a vitamin D(3) supplementation trial for a period of 3 y. Analyses were done in the vitamin D supplementation arm (n = 104) to quantify the response in serum 25-hydroxyvitamin D concentrations at a steady state vitamin D input. The participants received 20 microg/d (800 IU) oral vitamin D(3) for the initial 2 y and 50 microg/d (2000 IU) for the third year.

Results: Supplementation with 20 microg/d (800 IU/d) vitamin D(3) raised the mean serum 25(OH)D concentration from a baseline of 46.9 +/- 20.6 nmol/L to 71.4 +/- 21.5 nmol/L at 3 mo. The mean (+/-SD) concentration of serum 25(OH)D was 87.3 +/- 27.0 nmol/L 3 mo after supplementation increased to 50 microg/d (2000 IU/d). All participants achieved a serum 25(OH)D concentration >35 nmol/L, 95% achieved a concentration >50 nmol/L, but only 60% achieved a concentration >75 nmol/L. All patients had concentrations <153 nmol/L. On the basis of our findings, an algorithm for prescribing vitamin D so that patients reach optimal serum concentrations was developed. The algorithm suggests a dose of 70 microg (2800 IU/d) for those with a concentration >45 nmol/L and a dose of 100 microg (4000 IU/d) for those with a concentration <45 nmol/L.

Conclusions: Supplementation with 50 microg/d (2000 IU/d) oral vitamin D(3) is sufficient to raise serum 25-hydroxyvitamin D concentrations to >50 nmol/L in almost all postmenopausal African American women. However, higher doses were needed to achieve concentrations >75 nmol/L in many women in this population.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2581841PMC
http://dx.doi.org/10.1093/ajcn/86.5.1657DOI Listing
December 2007