FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions - FDA Press Releases

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

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Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids - FDA Press Releases

FDA is soliciting feedback on the potential use of new authorities under the SUPPORT Act to require certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.

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Antidepressant Treatment for Late‐Life Depression: Considering Risks and Benefits - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Meeting the Behavioral Health Needs of LGBT Older Adults - American Geriatric Society

Lesbian, gay, bisexual, and transgender (LGBT) older adults face an increased risk of adverse behavioral health outcomes compared with the general population of older adults, yet little attention has been given to factors contributing to these disparities or to the ways in which clinicians can address these challenges. We present the case of a 75‐year‐old widowed lesbian woman with depression to illustrate how a lifetime of exposure to discrimination and stigma can produce high levels of stress and isolation while also fostering resilience. We then offer recommendations and resources for promoting psychological health among LGBT older adults by attending to the historical and cultural forces that affect LGBT health, and by implementing inclusive policies and programming. The article concludes with suggestions for advancing research and policy to help achieve greater health equity for LGBT older adults.

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Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults - American Geriatric Society

OBJECTIVES

To assess adverse effects of pharmacologic antidepressants for treatment of major depressive disorder (MDD) in adults 65 years of age or older.

DESIGN

Systematic review and meta‐analysis.

SETTING

Specialist or generalist outpatient setting, rehabilitation facility, and nursing facilities.

PARTICIPANTS

Persons 65 years and older with MDD.

INTERVENTION

Selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), bupropion, mirtazapine, trazodone, vilazodone, or vortioxetine compared with another antidepressant, placebo, or nonpharmacologic therapy.

MEASUREMENTS

Adverse events, arrhythmias, cognitive impairment, falls, fractures, hospitalization, mortality, QTc prolongation, serious adverse events, and withdrawals due to adverse events.

RESULTS

Nineteen randomized controlled trials and two observational studies were included. Most studies evaluated treatment of the acute phase (<12 wk) of MDD of moderate severity. SSRIs led to a statistically similar frequency of overall adverse events vs placebo (moderate strength of evidence [SOE]), but SNRIs caused more overall adverse events vs placebo (high SOE) during the acute treatment phase. Both SSRIs and SNRIs led to more study withdrawals due to adverse events vs placebo (SSRIs low SOE; SNRIs moderate SOE). Duloxetine led to a more falls vs placebo (moderate SOE) during 24 weeks of acute and continuation treatment of MDD.

CONCLUSION

In patients 65 years of age or older with MDD, treatment of the acute phase of MDD with SNRIs, but not SSRIs, was associated with a statistically greater number of overall adverse events vs placebo. SSRIs and SNRIs led to a greater number of study withdrawals due to adverse events vs placebo. Duloxetine increased the risk of falls that as an outcome was underreported in the literature. Few studies examined head‐to‐head comparisons, most trials were not powered to evaluate adverse events, and results of observational studies may be confounded. Comparative long‐term studies reporting specific adverse events are needed to inform clinical decision making regarding choice of antidepressants in this population.

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Physical Performance in Memory Clinic Patients: The Potential Role of the White Matter Network - American Geriatric Society

BACKGROUND/OBJECTIVES

Memory clinic patients commonly also have declined physical performance. This may be attributable to white matter injury, due to vascular damage or neurodegeneration. Quantifying white matter injury is made possible by new magnetic resonance imaging (MRI) techniques, including diffusion‐weighted imaging (DWI) of network connectivity. We investigated whether physical performance in memory clinic patients is related to white matter network connectivity.

DESIGN

Observational cross‐sectional study.

SETTING

Memory clinic.

PARTICIPANTS

Patients referred to a memory clinic with vascular brain injury on MRI (n = 90; average age = 72 years; 60% male; 34% with diagnosis Alzheimer disease).

MEASUREMENTS

We reconstructed structural brain networks from DWI with fiber tractography and used graph theory to calculate global efficiency, fractional anisotropy (FA), and mean diffusivity (MD) of the white matter, and nodal strength (mean FA or MD of all white matter tracts connected to a node). Assessment of physical performance included gait speed, chair stand time, and Short Physical Performance Battery (SPPB) score.

RESULTS

Lower global efficiency, lower FA, and higher MD correlated with poorer gait speed, SPPB scores, and chair stand times (R range = 0.23‐0.42). Global efficiency and FA explained 5% to 16% of the variance in gait speed, chair stand times, and SPPB scores, independent of age and sex. Moreover, global efficiency and FA explained an additional 4% to 5% of variance on top of lacunar infarcts and white matter hyperintensities. Regional analyses showed that, in particular, the connectivity strength of prefrontal, occipital, striatal, and thalamic nodes correlated with gait speed.

CONCLUSION

Poorer physical performance is related to disrupted white matter network connectivity in memory clinic patients with vascular brain injury. The associations of these network abnormalities are partially independent of visible vascular injury.

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Implications of Anemia in the Elderly undergoing Surgery - Geriatrics

Anemia in the elderly is common and is associated with exposure to blood transfusion and higher perioperative morbidity and mortality. These patients would benefit from early diagnosis and work-up of the cause of preoperative anemia systematically. This can be done in preoperative anemia clinics as part of an overall patient blood management program. Iron-deficiency anemia is amenable to treatment with oral or intravenous iron. Intravenous iron leads to a more rapid hemoglobin response, and is devoid of gastrointestinal side effects. More data are needed to determine if preoperative correction of iron-deficiency anemia reduces the morbidity associated with anemia.

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Kidney Disease and Anemia in Elderly Patients - Geriatrics

Anemia is a very common complicating feature of chronic kidney disease (CKD) in the elderly. Noninvasive assessment of renal function in the elderly may include several equations although they may actually underestimate the true glomerular filtration rate (GFR). In summary, anemia in the setting of CKD in the elderly is generally underrecognized and undertreated, leading to associations of increased morbidity and mortality. The likelihood of benefits of treatment of anemia in this rapidly increasing subset of patients with CKD remains very high.

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Anemia in the Long-Term Care Setting - Geriatrics

Anemia has a higher prevalence among residents of long-term care setting. Signs and symptoms of anemia in this group are more insidious and can be overlooked and attributed to other disease manifestations or old age. Available data on the consequences of anemia suggest worse outcomes in heart failure; cognitive and functional decline; and increased rates of falls, hospitalizations, and mortality. Diagnosis and treatment of anemia in long-term care residents should be considered based on cost and benefit to the patient and patient’s and/or caregiver’s preferences.

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Heyde Syndrome - Geriatrics

Heyde described aortic stenosis and gastrointestinal bleeding in the 1950s. Since then, a link with intestinal angiodysplasia and abnormalities of von Willebrand factor (VWF) has been noted. Loss of the highest-molecular-weight multimers of VWF and bleeding also have been described in subaortic stenosis in hypertrophic cardiomyopathy, in isolated mitral and aortic insufficiency, in endocarditis, in patients with prosthetic valve stenosis or regurgitation, and in patients with left ventricular assist devices (LVADs). Bleeding tends to recur with local treatment of angiodysplasias, whereas cardiac repair or removal of LVAD eliminates VWF dysfunction is curative of bleeding in the majority.

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Late Life Vitamin B12 Deficiency - Geriatrics

Vitamin B12 deficiency may present with a wide array of symptoms and, if unrecognized, lead to significant morbidity particularly in terms of the hematologic and neurologic complications. This is of particular concern in the elderly because of its high prevalence with advancing age and the enhanced difficulty of recognizing subtle changes in symptoms and distinguishing those from normal aging.

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Treatment of Iron Deficiency in the Elderly - Geriatrics

Although gene sequencing has elucidated several mutations associated with mild cytopenias in older individuals, iron deficiency remains the most common cause of anemia. Oral iron has remained the frontline standard despite evidence that it is poorly tolerated, often ineffective, and frequently harmful. Studies of different formulations of intravenous iron have shown it effective, with marginal to no toxicity. Serious adverse events have not been described and the failure to address its administration in iron-deficient elderly patients is an unmet clinical need. This article outlines situations in which oral iron should be proscribed and offers an approach to administration of available formulations.

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1980s Camelot - Journal of Antibiotics

The Journal of Antibiotics, Published online: 27 May 2019; doi:10.1038/s41429-019-0174-z

1980s Camelot

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In honor of Professor Samuel J. Danishefsky - Journal of Antibiotics

The Journal of Antibiotics, Published online: 27 May 2019; doi:10.1038/s41429-019-0182-z

In honor of Professor Samuel J. Danishefsky

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Professor Samuel J. Danishefsky, extraordinary synthetic chemist and great mentor - Journal of Antibiotics

The Journal of Antibiotics, Published online: 27 May 2019; doi:10.1038/s41429-019-0173-0

Professor Samuel J. Danishefsky, extraordinary synthetic chemist and great mentor

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A letter from Professor Samuel J. Danishefsky - Journal of Antibiotics

The Journal of Antibiotics, Published online: 27 May 2019; doi:10.1038/s41429-019-0179-7

A letter from Professor Samuel J. Danishefsky

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FDA approves first PI3K inhibitor for breast cancer - FDA Press Releases

FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant.

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FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality - FDA Press Releases

FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality

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Words Matter: The Language of Family Caregiving - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections - FDA Press Releases

FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

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FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies - FDA Press Releases

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

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FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results - FDA Press Releases

FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

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FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea - FDA Press Releases

FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

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A Cluster Randomized Trial of Tai Chi vs Health Education in Subsidized Housing: The MI‐WiSH Study - American Geriatric Society

OBJECTIVES

Tai Chi (TC) may benefit older adults with a variety of diseases and disabilities. We tested the hypothesis that TC improves physical function in older adults living in low‐income housing facilities.

DESIGN

Cluster randomized controlled trial.

SETTING

Subsidized housing facilities in Boston, Massachusetts, and neighboring communities.

PARTICIPANTS

Volunteers were recruited from 15 facilities. The 180 randomized participants were 60 years of age or older, able to understand English and participate in TC, expected to remain in the facility for 1 year, and able to walk independently.

INTERVENTION

TC classes were conducted in the housing facilities twice/week for 1 year and compared with monthly health promotion educational classes and social calls.

MEASUREMENTS

The primary outcome was physical function measured by the Short Physical Performance Battery (SPPB). Secondary outcomes included other aspects of physical and cognitive function, and falls.

RESULTS

An interim analysis revealed less improvement over 12 months in SPPB scores among TC participants (+.20 units; 95% confidence interval [CI] = −.20 to +.60; P = .69) vs control participants (+.51 units; 95% CI = +.15 to +.87; P = .007), a difference of −.31 units (95% CI = −.66 to .04; P = .082). This met the criterion for futility, and the Data Safety Monitoring Board recommended trial termination. No differences were found in 6‐ or 12‐month changes favoring TC in any secondary outcomes or adverse events.

CONCLUSION

In older adults with multiple chronic conditions living in subsidized housing facilities, 6 and 12 months of twice/week TC classes were not associated with improvements in functional health.

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Moderate‐to‐Vigorous Physical Activity Is Associated With Higher Muscle Oxidative Capacity in Older Adults - American Geriatric Society

BACKGROUND

Age‐related decline in muscle oxidative capacity reduces muscle function and physical performance, leading to disability and frailty. Whether age‐related decline in oxidative capacity is modified by exercise and other lifestyle practices is unclear. Therefore, we tested the hypothesis that physical activity is associated with better oxidative capacity, independent of age.

DESIGN

Cross‐sectional study performed in the Baltimore Longitudinal Study of Aging, conducted by the Intramural Research Program (IRP) of the National Institute on Aging (NIA).

SETTING

NIA IRP Clinical Research Unit, Baltimore, MD.

PARTICIPANTS

Participants included 384 adults (54.7% women), aged 22 to 92 years, seen between 2013 and 2017.

MEASUREMENTS

Muscle oxidative capacity was measured in vivo using phosphorous magnetic resonance spectroscopy. We determined the postexercise time constant (τ_PCr; in seconds) for phosphocreatine (PCr) recovery, with lower values of τ_PCr, (ie, more rapid recovery of PCr levels after exercise) reflecting greater oxidative capacity. Time spent in moderate‐to‐vigorous physical activity (MVPA) was assessed using wearable accelerometers that participants wore 5.9 ± 0.9 consecutive days in the free‐living environment.

RESULTS

In linear regression models, higher τ_PCr was associated with older age (standardized β = .39; P < .001) after adjusting for sex, race, height, and weight. After including MVPA as an independent variable, the standardized regression coefficient of age decreased by 40%, but remained associated with τ_PCr (β_age = .22; P < .001) and had a smaller standardized regression coefficient than MVPA (β_MVPA = −.33; P < .001). After adjusting for health status, education, and smoking history, the standardized regression coefficient for age decreased 12% (β_age = .20; P = .003), while the standardized coefficient for MVPA decreased only 3% (β_MVPA = −.32; P < .001).

CONCLUSION

Study findings suggest that MVPA is strongly associated with muscle oxidative capacity, independent of age, providing mechanistic insights into the health benefits of exercise in older age.

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Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities - FDA Press Releases

U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Illinois.

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Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions - FDA Press Releases

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Apixaban Concentrations with Lower than Recommended Dosing in Older Adults with Atrial Fibrillation - American Geriatric Society

OBJECTIVES

Lower than recommended doses of direct‐acting oral anticoagulants are often prescribed to older adults with nonvalvular atrial fibrillation (NVAF). Our goal was to determine the consequences of lower than recommended dosing on plasma apixaban concentrations during the clinical care of older adults with NVAF.

DESIGN

Convenience sample of patients receiving anticoagulation during 2017.

SETTING

Academic medical center.

PARTICIPANTS

Stable adults older than 65 years with NVAF receiving apixaban on a chronic basis.

MEASUREMENTS

Patient age, weight, creatinine, co‐medications, and apixaban concentrations.

RESULTS

A total of 110 older adults with NVAF (mean age = 80.4 y; range = 66‐100 y with 45% women) were studied. Overall, 48 patients received recommended dosing of 5 mg twice/day, and 42 received lower than recommended dosing. One patient in each category had concentrations below the expected 5% to 95% range at time of peak concentrations. Differences in proportion of apixaban concentrations within or outside expected ranges were not significant between patients receiving lower than recommended doses and those dosed as recommended at 5 mg twice/day (P = .35). However, in patients dosed as recommended with 5 mg twice/day, four had concentrations above the 5% to 95% range for peak levels expected at 3 to 4 hours after dosing; in two, this occurred around the midpoint of the dosing interval. Twenty patients received 2.5 mg twice/day as recommended. One‐third had apixaban concentrations higher than expected peak concentrations compared with the clinical trials, and more than two‐thirds had levels above the reported median for peak concentrations.

CONCLUSIONS

Apixaban concentrations in older adults with NVAF seen clinically were higher than expected based on clinical trial data. The findings raise questions about the optimal dosing of apixaban in older adults with NVAF encountered outside of clinical trials and suggest a role for the monitoring of apixaban concentrations during care of patients that differ from those in randomized trials or when considering dosing outside of published guidelines.

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Safe and Effective Anticoagulation: What Does Drug Concentration Add? - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients - American Geriatric Society

OBJECTIVES

Older adult patients are underrepresented in clinical trials comparing non–vitamin K antagonist oral anticoagulants (NOACs) and warfarin. This subgroup analysis of the ARISTOPHANES study used multiple data sources to compare the risk of stroke/systemic embolism (SE) and major bleeding (MB) among very old patients with nonvalvular atrial fibrillation (NVAF) prescribed NOACs or warfarin.

DESIGN

Retrospective observational study.

SETTING

The Centers for Medicare & Medicaid Services and three US commercial claims databases.

PARTICIPANTS

A total of 88 582 very old (aged ≥80 y) NVAF patients newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015.

MEASUREMENTS

In each database, six 1:1 propensity score matched (PSM) cohorts were created for each drug comparison. Patient cohorts were pooled from all four databases after PSM. Cox proportional hazards models were used to estimate hazard ratios (HRs) of stroke/SE and MB.

RESULTS

The patients in the six matched cohorts had a mean follow‐up time of 7 to 9 months. Compared with warfarin, apixaban (HR = .58; 95% confidence interval [CI] = .49‐.69), dabigatran (HR = .77; 95% CI = .60‐.99), and rivaroxaban (HR = .74; 95% CI = .65‐.85) were associated with lower risks of stroke/SE. For MB, apixaban (HR = .60; 95% CI = .54‐.67) was associated with a lower risk; dabigatran (HR = .92; 95% CI = .78‐1.07) was associated with a similar risk, and rivaroxaban (HR = 1.16; 95% CI = 1.07‐1.24) was associated with a higher risk compared with warfarin. Apixaban was associated with a lower risk of stroke/SE and MB compared with dabigatran (stroke/SE: HR = .65; 95% CI = .47‐.89; MB: HR = .60; 95% CI = .49‐.73) and rivaroxaban (stroke/SE: HR = .72; 95% CI = .59‐.86; MB: HR = .50; 95% CI = .45‐.55). Dabigatran was associated with a lower risk of MB (HR = .77; 95% CI = .67‐.90) compared with rivaroxaban.

CONCLUSION

Among very old NVAF patients, NOACs were associated with lower rates of stroke/SE and varying rates of MB compared with warfarin.

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Antimicrobial Activity of Substituted Benzopentathiepin-6-amines - Journal of Antibiotics

The Journal of Antibiotics, Published online: 22 May 2019; doi:10.1038/s41429-019-0191-y

Antimicrobial Activity of Substituted Benzopentathiepin-6-amines

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Labrenzbactin from a coral-associated bacterium Labrenzia sp. - Journal of Antibiotics

The Journal of Antibiotics, Published online: 22 May 2019; doi:10.1038/s41429-019-0192-x

Labrenzbactin from a coral-associated bacterium Labrenzia sp.

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“Like a Man of 70 Years”: Aging and the Words We Use - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility - FDA Press Releases

FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

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Studies of novel bioprobes isolated from rare natural sources using mutant yeasts - Journal of Antibiotics

The Journal of Antibiotics, Published online: 20 May 2019; doi:10.1038/s41429-019-0189-5

Studies of novel bioprobes isolated from rare natural sources using mutant yeasts

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FDA Warns Against the Use of Unauthorized Devices for Diabetes Management - FDA Press Releases

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

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Frailty Is Related to Subjective Cognitive Decline in Older Women without Dementia - American Geriatric Society

OBJECTIVES

Physical frailty (or loss of physiologic reserve) is associated with cognitive impairment and dementia. Subjective cognitive decline (SCD) may represent early pathologic changes of dementia. The association between these disease markers is unclear.

DESIGN

Cross‐sectional analysis.

SETTING

Community‐based participants from the Vanderbilt Memory & Aging Project.

PARTICIPANTS

A total of 306 older adults with normal cognition (NC; n = 174) or mild cognitive impairment (MCI; n = 132).

MEASUREMENTS

Frailty was measured using standard methods, and a composite frailty score was calculated. SCD was quantified using the Everyday Cognition Scale (ECog; total score and four domain scores). Objective cognition was assessed with the Montreal Cognitive Assessment (MoCA). Proportional odds models, stratified by sex, related the frailty composite to MoCA and total ECog score adjusting for age, education, body mass index, cognitive diagnosis, depressed mood, Framingham Stroke Risk Profile, apolipoprotein E (APOE ε4) carrier status, and height (for gait speed models). Secondary models related individual frailty components to SCD domains and explored associations in NC only.

RESULTS

In women, frailty composite was related to MoCA (odds ratio [OR] = .56; P = .04), a finding attenuated in sensitivity analysis (OR = .59; P = .08). Frailty composite related to ECog total (OR = 2.27; P = .02), planning (OR = 2.63; P = .02), and organization scores (OR = 2.39; P = .03). Increasing gait speed related to lower ECog total (OR = .06; P = .003) and memory scores (OR = .03; P < .001). Grip strength related to lower ECog planning score (OR = .91; P = .04). In men, frailty was unrelated to objective and subjective cognition (P values >.07). Findings were consistent in the NC group.

CONCLUSION

Frailty component and composite scores are related to SCD before the presence of overt dementia. Results suggest that this association is present before overt cognitive impairment. Results suggest a possible sex difference in the clinical manifestation of frailty, with primary associations noted in women. Further studies should investigate mechanisms linking early changes among frailty, SCD, and cognition. J Am Geriatr Soc, 1–9, 2019.

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Indications for β‐Blocker Prescriptions in Heart Failure with Preserved Ejection Fraction - American Geriatric Society

OBJECTIVES

To better understand indications for β‐blocker (BB) prescriptions among older adults hospitalized with heart failure with preserved ejection fraction (HFpEF).

DESIGN/SETTING

Retrospective observational study of hospitalizations derived from the geographically diverse Reasons for Geographic and Racial Differences in Stroke cohort.

PARTICIPANTS

We examined Medicare beneficiaries aged 65 years or older with an expert‐adjudicated hospitalization for HFpEF (left ventricular ejection fraction = 50% or greater).

MEASUREMENTS

Discharge medications and indications for BBs were abstracted from medical records.

RESULTS

Of 306 hospitalizations for HFpEF, BBs were prescribed at discharge in 68%. Among hospitalizations resulting in BB prescriptions, 60% had a compelling indication for BB—44% had arrhythmias, and 29% had myocardial infarction (MI) history. Among the 40% with neither indication, 57% had coronary artery disease (CAD) without MI and 38% had hypertension alone (without arrhythmia, MI, or CAD), both clinical scenarios with little supportive evidence of benefit of BBs. Among hospitalizations resulting in BB prescription at discharge, 69% had geriatric conditions (functional limitation, cognitive impairment, hypoalbuminemia, or history of falls). There were no significant differences in the prevalence of geriatric conditions between hospitalizations of individuals with compelling indications for BBs and hospitalizations of individuals with noncompelling indications.

CONCLUSIONS

BBs are commonly prescribed following a hospitalization for HFpEF, even in the absence of compelling indications. This occurs even for hospitalizations of individuals with geriatric conditions, a subpopulation who may be at elevated risk for experiencing harm from BBs.

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Raw Basics, LLC. Recalls Tucker’s 5lb Pork-Bison Box Because of Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

Raw Basics, LLC. of Pleasant Prairie, WI is recalling 540lb of 5lb Pork-Bison Boxes because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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Hong Lee Trading Inc. Issues Allergen Alert on Undeclared Milk Allergens in Chao Café Vietnamese Instant Coffee Mixed 3 in 1 - FDA Safety Alerts & Drug Recalls

Hong Lee Trading Inc., NY, is recalling its CHAO CAFÉ VIETNAMESE INSTANT COFFEE MIXED 3 IN 1, 384 GRAM, CONTAINER CODE JUNE 06 2018, because they contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.

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FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots - FDA Press Releases

The FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.

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Dean Dairy Conducts Voluntary Recall of Tampico® Brand Tropical Punch in Illinois, Indiana and Wisconsin Because It May Contain Undeclared Allergen (Milk) - FDA Safety Alerts & Drug Recalls

Impacts only the gallon-size Tropical Punch flavor of Tampico® bottled and distributed by Dean Dairy and sold in Illinois, Indiana and Wisconsin. All affected product has the “Best By” date of 12-27-17.

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Health and Daily Functioning of Older Women Religious - American Geriatric Society

OBJECTIVES

Women religious in the United States are aging as a population. These women live in a communal setting, eat from the same kitchen, are nulliparous, and have similar access to healthcare. The purpose of this study was to examine the general health and health practices of a modern sample of older women religious.

DESIGN

Cross‐sectional descriptive study.

SETTING

Cleveland Catholic Diocese, Cleveland, Ohio.

PARTICIPANTS

Older women religious (n = 108), 65 years or older, living independently within the Cleveland Catholic Diocese who could participate in a study interview, undergo a morphometric examination, and complete several questionnaires in English.

MEASUREMENTS

Study participants completed a study interview in which their demographic information, medical history, body mass index (BMI), and blood pressure were obtained. Participants completed several questionnaires including the Tilburg Frailty Indicator, Falls Efficacy Scale‐International, Lawton Instrumental Activities of Daily Living Scale, Geriatric Depression Scale‐Short Form, and the HbL Medication Risk Questionnaire.

RESULTS

The women in our sample were all white with a mean age of 75.6 years (range = 65‐93 y). The vast majority (n = 104 [96%]) had at least a bachelor's degree. Prevalence for chronic diseases was notable for cataracts (60%), hypertension (60%), thyroid disorders (30%), osteoporosis (17%), and diabetes (7%). Nearly half of the sample (n = 48 [44%]) met BMI criteria for obesity, and another 39 women (36%) were overweight. Most women participated in yearly dental examinations (84.5%), eye examinations (79.4%), mammography (84.5%), and pneumovax vaccination (80.4%). Just over half of the women had the recommended colonoscopy (58.8%) and bone density (56.7%) screenings. Twenty women (19%) reported significant frailty, and 38 (35%) reported a significant fear of falling. The majority (80%) would benefit from a discussion about their medications.

CONCLUSION

Older women religious experience health issues that could benefit from targeted preventive health education and screening.

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Coordinated‐Transitional Care for Veterans with Heart Failure and Chronic Lung Disease - American Geriatric Society

OBJECTIVES

Patients with congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) account for most 30‐day hospital readmissions nationwide. The Coordinated‐Transitional Care (C‐TraC) program is a telephone‐based, nurse‐driven intervention shown to decrease readmissions in Veterans Affairs (VA) and non‐VA hospitals. The goal of this project was to assess the feasibility and efficacy of adapting C‐TraC to meet the needs of complex patients with CHF and COPD in a large urban tertiary care VA medical center.

DESIGN

We used the Replicating Effective Programs model to guide the implementation. The C‐TraC nurse received intensive training in cardiology and pulmonology and worked closely with both inpatient and outpatient providers to coordinate care. Eligible patients were admitted with CHF or COPD and had at least one additional risk for readmission.

SETTING

The nurse met patients in the hospital, participated in their discharge planning, and then provided intensive case management for up to 4 weeks.

PARTICIPANTS

Over its initial 14 months, the program successfully enrolled 299 veterans with good fidelity to the protocol.

MEASUREMENTS

A total of 43 (15.8%) C‐TraC participants were rehospitalized within 30 days compared with 172 (21.0%) of historical controls matched 3:1 on age, risk of 90‐day hospital admission, and discharge diagnosis.

RESULTS

Participants were 54% less likely to be rehospitalized (odds ratio = .46; 95% CI = .24‐.89).

CONCLUSION

The program was financially sustainable. The total cost of care in the 30‐day postdischarge period was $1842.52 less per C‐TraC patient than per controls, leading the medical center to sustain and expand the program.

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Use of Functional Assessment to Define Therapeutic Goals and Treatment - American Geriatric Society

This article summarizes the presentations and discussions from a workshop, “Using Functional Assessment to Define Therapeutic Goals and Treatment,” which took place on November 30 to December 1, 2017. This workshop brought together transdisciplinary leaders in the fields of function and disability and clinical investigators engaged in research on geriatric populations to outline opportunities and challenges for incorporating measures of function in clinical research. Topics addressed included reliable and clinically feasible measures of function and key domains of health (eg, musculoskeletal, cognitive, and sensory) that are most strongly associated with patients' perceptions of well‐being, independence, and quality of life across a wide array of diseases and interventions. The workshop also focused on the importance of function in medical decision making to inform communications between specialty physicians and patients about prognosis and goals of care. Workshop participants called for more research on the role of function as a predictor of an intervention's effectiveness and an important treatment outcome. Such research would be facilitated by development of a core set of simple, short, functional measures that can be used by all specialties in the clinical setting to allow “big data” analytics and a pragmatic research.

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A Trip to Remember: Perspectives of a Medical Learner as a Caregiver - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Integrated Home‐ and Community‐Based Services Improve Community Survival Among Independence at Home Medicare Beneficiaries Without Increasing Medicaid Costs - American Geriatric Society

OBJECTIVES

To determine the effect of home‐based primary care (HBPC) for frail older adults, operating under Independence at Home (IAH) incentive alignment on long‐term institutionalization (LTI).

DESIGN

Case‐cohort study using HBPC site, Medicare administrative data, and National Health and Aging Trends Study (NHATS) benchmarks.

SETTING

Three IAH‐participating HBPC sites in Philadelphia, PA, Richmond, VA, and Washington, DC.

PARTICIPANTS

HBPC integrated with long‐term services and supports (LTSS) cases (n = 721) and concurrent comparison groups (HBPC not integrated with LTSS: n = 82; no HBPC: n = 573). Cases were eligible if enrolled at one of the three HBPC sites from 2012 to 2015. Independence at Home‐qualified (IAH‐Q) concurrent comparison groups were selected from Philadelphia, PA; Richmond, VA; and Washington, DC.

INTERVENTION

HBPC integrated with LTSS under IAH demonstration incentives.

MEASUREMENTS

Measurements include LTI rate and mortality rates, community survival, and LTSS costs.

RESULTS

The LTI rate in the three HBPC programs (8%) was less than that of both concurrent comparison groups (IAH‐Q beneficiaries not receiving HBPC, 16%; patients receiving HBPC but not in the IAH demonstration practices, 18%). LTI for patients at each HBPC site declined over the three study years (9.9%, 9.4%, and 4.9%, respectively). Costs of home‐ and community‐based services (HCBS) were nonsignificantly lower among integrated care patients ($2151/mo; observed‐to‐expected ratio = .88 [.68‐1.09]). LTI‐free survival in the IAH HBPC group was 85% at 36 months, extending average community residence by 12.8 months compared with IAH‐q participants in NHATS.

CONCLUSION

HBPC integrated with long‐term support services delays LTI in frail, medically complex Medicare beneficiaries without increasing HCBS costs.

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Transitional Care Outcomes in Veterans Receiving Post‐Acute Care in a Skilled Nursing Facility - American Geriatric Society

BACKGROUND

As the veteran population ages, more veterans are receiving post‐acute care in skilled nursing facilities (SNFs). However, the outcomes of these transitions across Veterans Affairs (VA) and non‐VA settings are unclear.

OBJECTIVE

To measure adverse outcomes in veterans transitioning from hospital to SNF in VA and non‐VA hospitals and SNFs.

DESIGN

Retrospective observational study using the 2012 to 2014 Residential History File, which concatenates VA, Medicare, and Medicaid data into longitudinal episodes of care for veterans.

SETTING

VA and non‐VA hospitals and SNFs in four categories: non‐VA SNFs, VA‐contracted SNFs, VA Community Living Centers (CLCs), and State Veterans Homes.

PARTICIPANTS

Veterans, aged 65 years or older, who were acutely hospitalized and discharged to an SNF; one transition was randomly selected per patient.

MEASUREMENTS

Adverse “transitional care” outcomes were a composite of hospital readmission, emergency department visit, or mortality within 7 days of hospital discharge.

RESULTS

More than four in five veteran transitions (81.7%) occurred entirely outside the VA system. The overall 7‐day outcome rate was 10.7% in the 388 339 veterans included. Adverse outcomes were lowest in VA hospital–CLC transitions (7.5%; 95% confidence interval [CI] = 7.1%‐7.8%) and highest in non‐VA hospital to VA‐contracted nursing home transitions (17.5%; 95% CI = 16.0%‐18.9%) in unadjusted analysis. In multivariate analyses adjusted for patient and hospital characteristics, VA hospitals had lower adverse outcome rates than non‐VA hospitals (odds ratio [OR] = 0.80; 95% CI = 0.74‐0.86). In comparison to VA hospital–VA CLC transitions, non‐VA hospital to VA‐contracted nursing homes (OR = 2.51; 95% CI = 2.09‐3.02) and non‐VA hospital to CLC (OR = 2.25; 95% CI = 1.81‐2.79) had the highest overall adverse outcome rates.

CONCLUSION

Most veteran hospital‐SNF transitions occur outside the VA, although adverse transitional care outcomes are lowest inside the VA. These findings raise important questions about the VA's role as a provider and payer of post‐acute care in SNFs.

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Can Home‐Based Primary Care Drive Integration of Medical and Social Care for Complex Older Adults? - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Identifying Palliative Care Champions to Promote High‐Quality Care to Those with Serious Illness - American Geriatric Society

Leading medical authorities advocate for routine integration of palliative care for all major causes of death in the United States. With rapid growth and acceptance, the field of palliative care is tasked with addressing a compelling question of its time: “Who will deliver timely, evidence‐based palliative care to all who should benefit?”

The current number of palliative care specialists will not suffice to meet the needs of persons with serious illness. In 2010, initial estimates quantified the shortage at 6000 to 18 000 additional palliative care physicians needed to fully staff existing programs. Unfortunately, the predicted number of specialty physicians in 2030 will likely not be larger than the workforce in existence today. These findings result in a physician‐to‐serious‐illness‐person ratio of about 1:28 000 in 2030.¹

To address the workforce shortage, stronger alignment is needed between intensity of patient needs and provision of palliative care services. Such an alignment better harnesses the talents of those in a position to deliver core palliative care services (such as discussing goals of care with patients or managing their symptoms) while engaging palliative care specialists to address more complex issues.

We introduce the concept of “Palliative Care Champions,” who sit at the nexus between specialty palliative care and the larger clinical workforce. Acknowledging that the needs of most patients can be met by clinicians who have received basic palliative care training, and that specialty palliative care is not always available for those with more complex needs, there exists an important opportunity for those with additional interest to scale training and quality improvement to fill this void. J Am Geriatr Soc 67:S461–S467, 2019.

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Consensus‐Based Recommendations for an Adequate Workforce to Care for People with Serious Illness - American Geriatric Society

The lack of an adequately prepared workforce is a critical barrier to delivering high‐quality community‐based care for individuals living with serious illness. This article presents 16 consensus‐based recommendations to improve the capacity of the workforce in this area within the next 5 years, focusing on older adults. The recommendations were developed at a summit of 40 national leaders from practice, payment, labor, advocacy, and research arenas. The consensus‐based recommendations include specific steps for geriatrics leaders including curriculum reforms to increase skills in the care of older and seriously ill populations, expanding experiential learning opportunities for students to increase interest in careers in geriatric and palliative care, developing and improving curriculum in interprofessional and cultural competency skills, preparing clinicians to support incorporation of home care aides and family caregivers as healthcare team members, development of skills to support shared decision making with patients, and requiring specific skills related to serious illness care in licensing, accreditation, and continuing education regulations. Together, these recommendations put forward a charge to healthcare leaders to act to ensure a workforce that will optimize support for those with serious illness living in the community. J Am Geriatr Soc 67:S392–S399, 2019.

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Building a Culturally Competent Workforce to Care for Diverse Older Adults: Scope of the Problem and Potential Solutions - American Geriatric Society

The population of minority older adults is going to explode over the next four decades. Older adults from racial and ethnic minorities face persistent and pervasive health disparities. Health disparities exert a huge fiscal burden on the nation. The national financial cost of health disparities for the years 2002 to 2006 was an estimated 1.23 trillion dollars. As the aging population becomes more diverse, these disparity‐related costs are expected to increase. Older adults from racial and ethnic minorities face multiple barriers to accessing health and support services that will help them to age and die in place in the community. Patient‐related barriers include limited English proficiency, low health literacy, varying levels of acculturation, biases about Western healthcare and medications, mistrust of clinicians, inability to navigate the complex healthcare system, and cultural beliefs and taboos. Clinician‐related barriers include ageism (ie, discrimination against older people due to negative and inaccurate stereotypes), conscious and unconscious bias, being deeply entrenched in the culture of biomedicine, and the lack of training in the principles and practice of providing culturally respectful care. Health system–related barriers include lack of culturally tailored services, including access to medical interpreters. We conclude by identifying three specific strategies to facilitate culturally humble and respectful care for diverse patients. J Am Geriatr Soc 67:S423–S432, 2019.

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Connecting Social, Clinical, and Home Care Services for Persons with Serious Illness in the Community - American Geriatric Society

The medical, psychological, cognitive, and social needs of older adults with serious illness are best met by coordinated and team‐based services and support. These services are best provided in a seamless care model anchored by integrated biopsychosocial assessments focused on what matters to older adults and their social determinants of health; individualized care plans with shared goals; care provision and management; and quality measurement with continuous improvement. This model requires (1) racially and ethnically diverse healthcare professionals, including mental health and direct service workers, with training in aging and team collaboration; (2) an integrated network of community‐based organizations (CBOs) providing in‐home services; (3) an electronic communication platform that spans the system of providers and organizations with skilled technology staff; and (4) payment models that incentivize team‐based care across the continuum of services, including CBOs, with adequate salaries and academic loan forgiveness to recruit and retain high‐quality team members. Assuring that this model is effective requires ongoing quality assurance measures that include not only quality of care and utilization data to demonstrate cost offsets of service integration, but also quality of life for both the older adults and the family members caring for them. Although this may seem a lofty ideal in comparison with our current fragmented system, we review models that provide the key elements effectively and cost efficiently. We then propose an Essential Care Model that defines best practice in meeting the needs of older adults with serious illness and their families. J Am Geriatr Soc 67:S412–S418, 2019.

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Addressing the Community‐Based Geriatric Healthcare Workforce Shortage by Leveraging the Potential of Interprofessional Teams - American Geriatric Society

As Americans live longer lives, we will see an increased demand for quality healthcare for older adults. Despite the growth in the number of older adults, there will be a decrease in the supply of a primary care physician workforce to provide adequately for their care and health needs. This article reviews the literature that explores ways to address the primary care workforce shortage in a community‐based geriatric healthcare setting, with special attention to elevating the role of nurses and caregivers and shifting the way we think about delivery of care and end‐of‐life conversations and planning. The shift is toward a more integrated and collaborative approach to care where medical and nonmedical, social services, and community providers all play a role. Several models have demonstrated promising positive benefits and outcomes to patients, families, and providers alike. The goal is to provide high quality care that addresses the unique attributes of older adults, especially those with complex conditions, and to focus more on care goals and priorities. The many barriers to scaling and spreading models of care across varied settings include payment structures, lack of education and training among all stakeholders, and, at the top of the list, leadership resistance. We address these barriers and make recommendations for a path forward where healthcare providers, policymakers, patients, families, and everyone else involved can play a role in shaping the workforce caring for older adults. J Am Geriatr Soc 67:S400–S408, 2019.

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Family Caregiving in Serious Illness in the United States: Recommendations to Support an Invisible Workforce - American Geriatric Society

Family caregivers provide the vast majority of care for individuals with serious illness living in the community but are not often viewed as full members of the healthcare team. Family caregivers are increasingly expected to acquire a sophisticated understanding of the care recipient's condition and new skills to execute complex medical or nursing tasks, often without adequate preparation and support, and with little choice in taking on the role. This review draws on peer‐reviewed literature, government reports, and other publications to summarize the challenges faced by family caregivers of older adults in the context of serious illness and to identify opportunities to better integrate them into the healthcare workforce. We discuss promising approaches such as inclusion of family caregivers in consensus‐based practice guidelines; the “no wrong door” function, directing consumers to needed resources, regardless of where initial contact is made; and caregiver‐friendly workplace policies allowing flexible arrangements. We present specific recommendations focusing on research, clinical practice, and policy changes that promote family‐centered care and improve outcomes for caregivers as well as persons with serious illness. J Am Geriatr Soc 67:S451–S456, 2019.

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Training Clinicians with Communication Skills Needed to Match Medical Treatments to Patient Values - American Geriatric Society

Most clinicians currently in practice did not receive the evidence‐based communication skills training they need to provide high‐quality communication for seriously ill older adults and their families. Clinician communication skills are a critical factor in achieving a patient and family understanding of their illness that enables them to share in decision making that will result in medical treatments and social supports that are aligned with their goals and values. Research demonstrates that existing clinician competence in communication skills is extremely variable, that most clinicians need specific communication training to have an adequate level of skill, and that evidence‐based training is efficacious. A conservative estimate suggests that more than 219,000 physicians and advance practice providers (APPs) (50% of physicians in high‐contact subspecialties and 25% of all APPs) could benefit from training. Combining evidence‐based clinician training with health system workflow redesign would likely maximize the impact of this training. We conclude with recommendations designed to address gaps in communication skills through effective training and health system changes in the service of enabling all patients with serious illness and their families to receive care aligned with their personal priorities. J Am Geriatr Soc 67:S435–S441, 2019.

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The Future of the Home Care Workforce: Training and Supporting Aides as Members of Home‐Based Care Teams - American Geriatric Society

Home health, home care, and personal care aides provide most of the paid hands‐on care delivered to seriously ill, functionally impaired individuals in their homes, assisted living, and other noninstitutional settings. This workforce delivers personal care, assistance with activities of daily living, and emotional support to their patients. They are often the eyes and ears of the health system, observing subtle changes in condition that can provide important information for clinical decision making and therapeutic intervention. Despite this fact, the growing number of team‐based home care initiatives have failed to incorporate this workforce into their programs. Barriers to inclusion of aides into teams include a basic lack of value and understanding on the part of clinical team members and society in general of the complex tasks that these caregivers perform, inadequate investments in training and education of this workforce to develop their knowledge and competencies, and variation in state delegation laws that limit the scope of practice and consequently the ability of aides to work effectively in teams and to advance in their careers. Building on the few programs that have successfully included aides as key members of home care teams, federal and state policymakers, educators, and health systems and providers should standardize competency‐based training requirements, expand nurse delegation consistently across states, and support evaluation, dissemination, and replication of successful programs. J Am Geriatr Soc 67:S444–S448, 2019.

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Connecting Social, Clinical, and Home Care Services: Where Healthcare Needs to Go - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S419-S422, May 2019.

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Palliative Care Champions Are a Promising Solution to Meeting Patient Needs - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S468-S469, May 2019.

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Commentary on the Future of the Home Care Workforce: Training and Supporting Aides as Members of Home‐Based Care Teams - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S449-S450, May 2019.

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175 000 Blue Chairs - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S442-S443, May 2019.

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Why Does Culture and Context Matter for Care That Aims for Quality and Impact? - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S433-S434, May 2019.

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Commentary on the Geriatric Healthcare Workforce: Leveraging the Potential of Interprofessional Teams - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S409-S411, May 2019.

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Whose Responsibility Is It? Balancing Individual, Family, and Societal Needs for Supporting Seriously Ill Older Adults - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S457-S460, May 2019.

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Gordon and Betty Moore Foundation Special Issue Introduction - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S391-S391, May 2019.

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Introduction to the Special Issue on the Workforce for Seriously Ill Older Adults in the Community - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S390-S390, May 2019.

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Issue Information - American Geriatric Society

Journal of the American Geriatrics Society, Volume 67, Issue S2, Page S385-S389, May 2019.

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Time Is of the Essence: Solving Office Visit Coding Problems - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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A Growing Population of Older Adults with Sickle Cell Disease - Geriatrics

In countries with organized access to health care, survival of patients with sickle cell disease (SCD) has greatly improved, shifting the burden of care from a pediatrician to an internal medicine physician. As a consequence, cumulative disease complications related to chronic vasculopathy are becoming more apparent, adding to organ dysfunction from physiologic aging. The time has come for us to reevaluate the approach to managing the older adult with SCD by putting a greater emphasis on geriatric conditions while proactively considering curative options once previously offered only to younger patients, with comprehensive annual assessments and joint clinics with relevant specialists.

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Inflammatory Pathways to Anemia in the Frail Elderly - Geriatrics

Anemia is a common, yet often overlooked, geriatric syndrome characterized by reduced hemoglobin levels and associated with adverse health outcomes and early mortality. Evidence suggests that anemia is an independent risk factor for frailty in older adults. In this article, the authors review the evidence for the role of chronic inflammation in the pathogenesis of anemia in the frail elderly. Understanding the relationships between anemia, frailty, and chronic inflammation will pave the way for the development of novel interventional strategies for the treatment and prevention of anemia and, likely, also frailty in older adults.

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Unexplained Anemia in the Elderly - Geriatrics

The prevalence of anemia increases with advancing age, and despite thorough investigation, approximately one-third will be classified as “unexplained.” Unexplained anemia (UA) is typically hypoproliferative, normocytic, and with low reticulocyte count. Serum erythropoietin levels are lower than expected for degree of anemia. Chronic inflammation, low testosterone levels, malnutrition, and possibly nascent myelodysplasia are variably contributing factors. No clearly established beneficial treatment strategy has been established, but the association of UA with a wide range of adverse outcomes, including impaired quality of life, physical function, and mortality, is sufficiently compelling to justify expanding clinical research focused on basic and clinical aspects.

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Aging and Hematopoiesis - Geriatrics

In hematopoiesis, mature blood cells, granulocytes, erythrocytes, and megakaryocytes originate from hematopoietic stem cells. With age, changes in hematopoiesis may have clinical consequences: defective immune responses, cytopenias (most commonly anemia and lymphopenia), hematological malignancy, and effects mediated by hematopoietic cells in other organs. Clonal hematopoiesis is commonly seen with aging and has been associated with both blood concerns and atherosclerosis, but further study is required to determine a causative link.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility - FDA Press Releases

The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility.

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Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women - FDA Press Releases

The FDA is issuing two draft guidances, which, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information in drugs used during pregnancy or lactation.

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FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder - FDA Press Releases

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

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FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis - FDA Press Releases

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

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Isolation of depsipeptides and optimization for enhanced production of valinomycin from the North-Western Himalayan cold desert strain Streptomyces lavendulae - Journal of Antibiotics

Isolation of depsipeptides and optimization for enhanced production of valinomycin from the North-Western Himalayan cold desert strain Streptomyces lavendulae

Isolation of depsipeptides and optimization for enhanced production of valinomycin from the North-Western Himalayan cold desert strain <i>Streptomyces lavendulae</i>, Published online: 09 May 2019; doi:10.1038/s41429-019-0183-y

Isolation of depsipeptides and optimization for enhanced production of valinomycin from the North-Western Himalayan cold desert strain Streptomyces lavendulae

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Racial Disparities in Readmission Rates among Patients Discharged to Skilled Nursing Facilities - American Geriatric Society

OBJECTIVES

Prior studies have reported mixed findings about the existence of racial disparities in readmission rates among Medicare Advantage beneficiaries, but these studies used data from one state, focused on black‐white disparities, and did not focus on patients discharged to skilled nursing facilities (SNFs). The objective of the study was to characterize racial and ethnic disparities in rates of 30‐day rehospitalization directly from SNFs among fee‐for‐service and Medicare Advantage patients.

DESIGN

A cross‐sectional study of admissions to SNFs in 2015 was conducted.

SETTING

SNFs across the United States.

PARTICIPANTS

The sample included 1 500 334 white, 213 848 African American, and 99 781 Hispanic Medicare patients who were admitted to 13 375 SNFs.

MEASUREMENTS

The main outcome of interest was readmission, identified as patients sent back to any hospital directly from the SNF within 30 days of admission, as indicated on the Minimum Data Set discharge assessment.

RESULTS

Overall readmission rates for fee‐for‐service patients were 16.7% (95% confidence interval [CI] = 16.7%‐16.8%) for whites, 18.8% (95% CI = 18.7%‐19.0%) for African Americans, and 17.4% (95% CI = 17.1%‐17.7%) for Hispanics. Readmission rates in Medicare Advantage were 14.7% (95% CI = 14.5%‐14.8%) for whites, 16.8% (95% CI = 16.6%‐17.1%) for African Americans, and 15.3% (95% CI = 14.9%‐15.6%) for Hispanics. We also found that African Americans had about 1% higher readmission rates than whites, even when they received care within the same SNF. No statistically significant differences were found in the magnitude of within‐SNF racial disparities in Medicare Advantage compared with Medicare fee‐for‐service.

CONCLUSION

We found racial disparities in readmission rates even within the same facility for both Medicare Advantage and fee‐for‐service beneficiaries. Intervention to reduce disparities in readmission rates, as well as more comprehensive quality measures that incorporate outcomes for Medicare Advantage enrollees, are needed. J Am Geriatr Soc, 1–8, 2019.

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Effectiveness of Ambulatory Telemedicine Care in Older Adults: A Systematic Review - American Geriatric Society

BACKGROUND

Disparities in healthcare access and delivery, caused by transportation and health workforce difficulties, negatively impact individuals living in rural areas. These challenges are especially prominent in older adults.

DESIGN

We systematically evaluated the feasibility, acceptability, and effectiveness in providing telemedicine (TMed), searching the English‐language literature for studies (January 2012 to July 2018) in the following databases: Medline (PubMed); Cochrane Library (Wiley); Web of Science; CINAHL; EMBASE (Ovid); and PsycINFO (EBSCO).

PARTICIPANTS

Older adults (mean age = 65 years or older, and none were younger than 60 years).

INTERVENTIONS

Interventions consisted of live, synchronous, two‐way videoconferencing communication in nonhospital settings. All medical interventions were included.

MEASUREMENTS

Quality assessment, using the Cochrane Collaboration's Risk‐of‐Bias Tool, was applied on all included articles, including a qualitative summary of all articles.

RESULTS

Of 6616 citations, we reviewed the full text of 1173 articles, excluding 1047 that did not meet criteria. Of the 17 randomized controlled trials, the United States was the country with the most trials (6 [35%]), with cohort sizes ranging from 3 to 844 (median = 35) participants. Risk of bias among included studies varied from low to high. Our qualitative analysis suggests that TMed can improve health outcomes in older adults and that it could be used in this population.

CONCLUSIONS

TMed is feasible and acceptable in delivering care to older adults. Research should focus on well‐designed randomized trials to overcome the high degree of bias observed in our synthesis. Clinicians should consider using TMed in routine practice to overcome barriers of distance and access to care.

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Measuring Quality in Home Healthcare - American Geriatric Society

BACKGROUND/OBJECTIVES

Improving quality performance in home health is an increasingly high priority. The objective of this study was to examine trends in industry performance over time using three quality measures: a composite quality metric (Q index), an infection prevention measure (vaccination verification), and an outcome measure (hospital avoidance).

DESIGN/SETTING/PARTICIPANTS/MEASURES

We linked Home Health Compare and Provider of Services data from 2012 to 2016, which included 39 211 observations during the 5‐year study period and 7670 agencies in 2016. The Q index was developed to allow comparability over time, equally weighting the contributions of each element. After examining summary statistics, we developed three regression models stratified by ownership (for‐profit/nonprofit agency) and included two constructs of nurse staffing, in addition to controlling for known confounders.

RESULTS

Most agencies (80.4%) were for‐profit agencies. The Q index and vaccination verification improved substantially over time, but there was no change in hospital avoidance. Ownership status was associated with all three measures (P < .001). Registered nurse staffing (relative to licensed practical nurses and home health aides) was associated with higher Q index and vaccination verification (P < .001).

CONCLUSION

The Q index allows for assessment of trends over time in home healthcare. Ownership and nurse staffing are important factors in the quality of care. The overall home care market is driven by for‐profit agencies, but their characteristics and outcomes differ from nonprofit agencies.

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Response to “Potentially Inappropriate Medication Prescriptions for Older Adults with Painful Conditions and Association with Return Emergency Department Visits” - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Reply to Comment on Potentially Inappropriate Medication Prescriptions for Older Adults With Painful Conditions and Association With Return Emergency Department Visits - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Nursing Home Residents by Human Immunodeficiency Virus Status: Characteristics, Dementia Diagnoses, and Antipsychotic Use - American Geriatric Society

OBJECTIVES

Given an aging human immunodeficiency virus (HIV) population, we aimed to determine the prevalence of HIV for long‐stay residents in US nursing homes (NHs) between 2001 and 2010 and to compare characteristics and diagnoses of HIV‐positive (HIV+) and negative (HIV‐) residents. Also, for residents with dementia diagnoses, we compared antipsychotic (APS) medication receipt by HIV status.

DESIGN

A cross‐sectional comparative study.

SETTING

NHs in the 14 states accounting for 75% of persons living with HIV.

PARTICIPANTS

A total of 9 245 009 long‐stay NH residents.

MEASUREMENTS

Using Medicaid fee‐for‐service claims data in the years 2001 to 2010, together with Medicare resident assessment and Chronic Condition Warehouse data, we identified long‐stay (more than 89 days) NH residents by HIV status and dementia presence. We examined dementia presence by age groups and APS medication receipt by younger (aged younger than 65 years) vs older (aged 65 years or older) residents, using logistic regression.

RESULTS

Between 2001 and 2010, the prevalence of long‐stay residents with HIV in NHs increased from 0.7% to 1.2%, a 71% increase. Long‐stay residents with HIV were younger and less often female or white. For younger NH residents, rates of dementia were 20% and 16% for HIV+ and HIV‐ residents, respectively; they were 53% and 57%, respectively, for older residents. In adjusted analyses, younger HIV+ residents with dementia had greater odds of APS medication receipt than did HIV‐ residents (AOR = 1.3; 95% confidence interval [CI] = 1.2‐1.4), but older HIV residents had lower odds (AOR = 0.9; 95% CI = 0.8‐0.9).

CONCLUSION

The prevalence of long‐stay HIV+ NH residents has increased over time, and given the rapid aging of the HIV population, this increase is likely to have continued. This study raises concern about potential differential quality of care for (younger) residents with HIV in NHs, but not for those aged 65 years and older. These findings contribute to the evidence base needed to ensure high‐quality care for younger and older HIV+ residents in NHs.

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What Does Aging with HIV Mean for Nursing Homes? - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Fractures and Subsequent Graft Loss and Mortality among Older Kidney Transplant Recipients - American Geriatric Society

OBJECTIVES

Older adults who undergo kidney transplantation (KT) are living longer with a functioning graft and are at risk for age‐related adverse events including fractures. Understanding recipient, transplant, and donor factors and the outcomes associated with fractures may help identify older KT recipients at increased risk. We determined incidence of hip, vertebral, and extremity fractures; assessed factors associated with incident fractures; and estimated associations between fractures and subsequent death‐censored graft loss (DCGL) and mortality.

DESIGN

This was a prospective cohort study of patients who underwent their first KT between January 1, 1999, and December 31, 2014.

SETTING

We linked data from the Scientific Registry of Transplant Recipients to Medicare claims through the US Renal Data System.

PARTICIPANTS

The analytic population included 47 815 KT recipients aged 55 years or older.

MEASUREMENTS

We assessed the cumulative incidence of and factors associated with post‐KT fractures (hip, vertebral, or extremity) using competing risks models. We estimated risk of DCGL and mortality after fracture using adjusted Cox proportional hazards models.

RESULTS

The 5‐year incidence of post‐KT hip, vertebral, and extremity fracture for those aged 65 to 69 years was 2.2%, 1.0%, and 1.7%, respectively. Increasing age was associated with higher hip (adjusted hazard ratio [aHR] = 1.37 per 5‐y increase; 95% confidence interval [CI] = 1.30‐1.45) and vertebral (aHR = 1.31; 95% CI = 1.20‐1.42) but not extremity (aHR = .97; 95% CI = .91‐1.04) fracture risk. DCGL risk was higher after hip (aHR = 1.34; 95% CI = 1.12‐1.60) and extremity (aHR = 1.30; 95% CI = 1.08‐1.57) fracture. Mortality risk was higher after hip (aHR = 2.31; 95% CI = 2.11‐2.52), vertebral (aHR = 2.80; 95% CI = 2.44‐3.21), and extremity (aHR = 1.85; 95% CI = 1.64‐2.10) fracture.

CONCLUSION

Our findings suggest that older KT recipients are at higher risk for hip and vertebral fracture but not extremity fracture; and those with hip, vertebral, or extremity fracture are more likely to experience subsequent graft loss or mortality. These findings underscore that different fracture types may have different underlying etiologies and risks, and they should be approached accordingly. J Am Geriatr Soc, 1–9, 2019.

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Ethical Challenges in Caring for Unrepresented Adults: A Qualitative Study of Key Stakeholders - American Geriatric Society

The decision‐making process on behalf of unrepresented adults (ie, those who lack capacity to make medical decisions and have no identifiable surrogate) is at risk for not incorporating their interests, raising ethical concerns. We performed semistructured interviews with key stakeholders across multiple sectors in an urban county who participate in the care of or decision‐making process for unrepresented adults. This included a safety net healthcare system, social services, and legal services. Participants were healthcare, social service, and legal professionals who worked with unrepresented adults (n = 25). Our interview questions explored the current process for proxy decision making in cases of unrepresented adults and potential alternatives. We recorded, transcribed, and analyzed interviews using the constant comparative method to identify major themes related to ethical challenges if they were raised. Participants grappled with multiple ethical challenges around the care of unrepresented adults. Themes described by participants were: (1) prioritizing autonomy; (2) varying safety thresholds; (3) distributing resources fairly; and (4) taking a moral toll on stakeholders. In conclusion, all stakeholders identified ethical challenges in caring for unrepresented adults. An applied ethical framework that takes these dilemmas into account could improve ethical practice for unrepresented adults and lessen the emotional toll on stakeholders. J Am Geriatr Soc, 1–6, 2019.

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Nurse Practitioners and Physician Assistants: An Underestimated Workforce for Older Adults with Cancer - American Geriatric Society

OBJECTIVES

To describe the composition of the US provider workforce for adults with cancer older than 65 years and to determine whether there were differences in patients who received care from different providers (eg, nurse practitioners [NPs], physician assistants [PAs], and specialty physicians).

DESIGN

Observational, cross‐sectional study.

SETTING

Adults within the 2013 Surveillance, Epidemiology, and End Results cancer registries linked to the Medicare claims database.

PARTICIPANTS

Medicare beneficiaries who received ambulatory care for any solid or hematologic malignancies.

MEASUREMENTS

International Classification of Diseases, Ninth Revision (ICD‐9), diagnosis codes were used to identify Medicare patient claims for malignancies in older adults. Providers for those ambulatory claims were identified using taxonomy codes associated with their National Provider Identifier number.

RESULTS

A total of 2.5 million malignancy claims were identified for 201, 237 patients, with 15, 227 providers linked to claims. NPs comprised the largest group (31.5%; n = 4,806), followed by hematology/oncology physicians (27.7%; n = 4,222), PAs (24.7%; n = 3767), medical oncologists (10.9%; n = 661), gynecological oncologists (2.6%; n = 403), and hematologists (2.4%; n = 368). Rural cancer patients were more likely to receive care from NPs (odds ratio [OR] = 1.84; 95% confidence interval [CI] = 1.65‐2.05) or PAs (OR = 1.57; 95% CI = 1.40‐1.77) than from physicians. Patients in the South were more likely to receive care from NPs (OR = 1.36; 95% CI = 1.24‐1.49).

CONCLUSIONS

A large proportion of older adults with cancer receive care from NPs and PAs, particularly those who reside in rural settings and in the southern United States. Workforce strategies need to integrate these provider groups to effectively respond to the rising need for cancer care within the older adult population.

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Evidence‐Based Community Fall Prevention Programs at Senior Centers Near 10 US Academic Centers - American Geriatric Society

BACKGROUND/OBJECTIVES

The Centers for Disease Control and Prevention recommends that patients at risk of falling engage in evidence‐based community fall prevention programs (EBCFPPs). EBCFPPs are often delivered in senior centers (SCs). This is the first independent assessment of availability of EBCFPPs in SCs.

DESIGN

Cross‐sectional study of four types of EBCFPPs in the 25‐mile radius of 10 US academic centers (ACs).

SETTING

SCs.

PARTICIPANTS

SCs.

INTERVENTION

None.

MEASUREMENTS

Number and types of EBCFPPs offered at SCs.

RESULTS

Across the 10 ACs, 249 SCs were sampled. Of the SCs, 35% offered zero, 54% offered at least one, 9% offered at least two, and 2% offered at least three EBCFPPs. Tai Chi of any type was offered in 59.8%, A Matter of Balance was offered in 8.9%, Stepping On was offered in 8.0%, and Staying Active and Independent for Life was offered in 1.2% of SCs sampled. SCs near Columbia University offered all four of the programs, while those near the University of Utah, Johns Hopkins University, and Seattle University only offered three of the programs. In univariate analysis, the number of local SCs was significantly associated with quantity of EBCFPPs (odds ratio [OR] = 2.2; 95% confidence interval [CI] = 1.9‐2.6; P < .001), but not with diversity of EBCFPPs (OR = 1.0; 95% CI = 1.0‐1.1; P = .13). In multivariate regression, city, sex distribution, and average household income did not correlate with the overall number or the diversity of EBCFPPs, whereas locales with more SCs offered more EBCFPPs (OR = 2.2; 95% CI = 1.7‐2.9; P < .001).

CONCLUSIONS

A significant number of SCs still do not offer any EBCFPPs. From those that do, few offer a diversity of these programs. Opportunities exist to increase access to EBCFPPs in SCs.

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Predicting 1‐Year Mortality in Older Hospitalized Patients: External Validation of the HOMR Model - American Geriatric Society

OBJECTIVES

Accurate prognostic information can enable patients and physicians to make better healthcare decisions. The Hospital‐patient One‐year Mortality Risk (HOMR) model accurately predicted mortality risk (concordance [C] statistic = .92) in adult hospitalized patients in a recent study in North America. We evaluated the performance of the HOMR model in a population of older inpatients in a large teaching hospital in Ireland.

DESIGN

Retrospective cohort study.

SETTING

Acute hospital.

PARTICIPANTS

Patients aged 65 years or older cared for by inpatient geriatric medicine services from January 1, 2013, to March 6, 2015 (n = 1654). After excluding those who died during the index hospitalization (n = 206) and those with missing data (n = 39), the analytical sample included 1409 patients.

MEASUREMENTS

Administrative data and information abstracted from hospital discharge reports were used to determine covariate values for each patient. One‐year mortality was determined from the hospital information system, local registries, or by contacting the patient's general practitioner. The linear predictor for each patient was calculated, and performance of the model was evaluated in terms of its overall performance, discrimination, and calibration. Recalibrated and revised models were also estimated and evaluated.

RESULTS

One‐year mortality rate after hospital discharge in this patient cohort was 18.6%. The unadjusted HOMR model had good discrimination (C statistic = .78; 95% confidence interval = .76‐.81) but was poorly calibrated and consistently overestimated mortality prediction. The model's performance was modestly improved by recalibration and revision (optimism corrected C statistic = .8).

CONCLUSION

The superior discriminative performance of the HOMR model reported previously was substantially attenuated in its application to our cohort of older hospitalized patients, who represent a specific subset of the original derivation cohort. Updating methods improved its performance in our cohort, but further validation, refinement, and clinical impact studies are required before use in routine clinical practice. J Am Geriatr Soc 1‐6, 2019.

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Opioid Misuse in Older Women - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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Moving Frailty Toward Clinical Practice: NIA Intramural Frailty Science Symposium Summary - American Geriatric Society

Frailty has long been an important concept in the practice of geriatric medicine and in gerontological research, but integration and implementation of frailty concepts into clinical practice in the United States has been slow. The National Institute on Aging (NIA) Intramural Research Program and the Johns Hopkins Older Americans Independence Center sponsored a symposium to identify potential barriers that impede the movement of frailty into clinical practice and to highlight opportunities to facilitate the further integration of frailty into clinical practice. Primary and subspecialty care providers, and investigators working to integrate and translate new biological aging knowledge into more specific preventive and treatment strategies for frailty provided the meeting content. Recommendations included a call for more specific language that clarifies conceptual differences between frailty definitions and measurement tools; the development of randomized controlled trials to test whether specific intervention strategies for a variety of conditions differently affect frail and non‐frail individuals; development of implementation studies and therapeutic trials aimed at tailoring care as a function of pragmatic frailty markers; the use of deep learning and dynamic systems approaches to improve the translatability of findings from epidemiological studies; and the incorporation of advances in aging biology, especially focused on mitochondria, stem cells, and senescent cells, toward the further development of biologically targeted intervention and prevention strategies that can be used to treat or prevent frailty.

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Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of One Lot of ThermaCare® Back Pain Therapy HeatWraps, up to 16HR pain relief, Due To Out of Specification Results for High Cell Temperature - FDA Safety Alerts & Drug Recalls

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of ThermaCare® Back Pain Therapy HeatWraps, up to 16HR pain relief, to the consumer level.

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Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP - FDA Safety Alerts & Drug Recalls

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (

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Allergen Alert Expansion: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Peanuts or Almonds - FDA Safety Alerts & Drug Recalls

Kwik Trip, Inc. located in La Crosse, WI has expanded their recall of Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of peanuts or almonds

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Bee International issues Allergy Alert on Undeclared Milk in “Plastic Heart Tubes with Chocolate Lentils” - FDA Safety Alerts & Drug Recalls

Bee International, Inc. of Chula Vista, CA is recalling its 1.7oz. Plastic Heart Tubes with Chocolate Lentils because they may contain undeclared milk protein

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Beyond Better Foods, LLC Issues Allergy Alert on Undeclared Peanuts in Mislabeled Ice Cream - FDA Safety Alerts & Drug Recalls

Beyond Better Foods, LLC is recalling select cases from a single production run of Enlightened brand Peanut Butter Chocolate Chip ice cream because they may have been packaged in Mint Chocolate Chip ice cream containers and thus contain undeclared peanuts

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Licata Enterprises Asks For Volunary Recall of Multiple Vitamin Because of A Possible Fish Allergen Health Risk - FDA Safety Alerts & Drug Recalls

Licata Enterprieses of Huntington Beach, California is recalling its The Supreme One / Theravits 100 multiple vitamin (all lots) due to the discovery of a confusing labeling issue which could cause cause individuals allergic to fish oils to ingest the product in error.

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New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice - FDA Safety Alerts & Drug Recalls

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites

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Chlorofields Recalls Asian MIicrogreens Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

ChloroFields of Lawrence, KS is recalling 20 cases of Asian Microgreens,because they have potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened
immune systems.

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Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been fou

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ConAgra Foods Expands Recall of P.F. Chang’s Home Menu Brand Meals Available in Grocery Retailers Due to Potential Presence of Foreign Material ConAgra Foods Does Not Make Meals for P.F. Chang’s Restaurants - FDA Safety Alerts & Drug Recalls

ConAgra Foods is expanding a voluntary recall of P.F. Chang’s Home Menu Brand products due to the potential presence of small metal fragments (2-9mm) in the sugar used in the sauce. This voluntary action is being undertaken because of impacted sugar from a supplier.

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Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens - FDA Safety Alerts & Drug Recalls

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to

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Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade - FDA Safety Alerts & Drug Recalls

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-thr

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Mitral Regurgitation and Prognosis After Non‐ST‐Segment Elevation Myocardial Infarction in Very Old Patients - American Geriatric Society

Background/Objetctives

Mitral regurgitation (MR)after an acute coronary syndrome is associated with a poor prognosis. However,the prognostic impact of MR in elderly patients with non‐ST‐segment elevation myocardialinfarction (NSTEMI) has not been well addressed.

Design

Prospective registry.

Setting and participants

The multicenter LONGEVO‐SCA prospective registry included 532 unselected NSTEMI patients aged ≥80 years.

Measurements

MR was quantified using echocardiography during admission in 497 patients. They were classified in two groups: significant (moderate or severe) or not significant MR (absent or mild). We evaluated the impact of MR status on mortality or readmission at 6 months.

Results

Mean age was 84.3±4.1 years, and 308 (61.9%) were males. A total of 108 patients (21.7%) had significant MR. Compared with those without significant MR, they were older and showed worse baseline clinical status, with higher frailty, disability, and risk of malnutrition. They also had lower systolic blood pressure, higher heart rate, worse Killip class, lower left ventricular ejection fraction, and higher pulmonary pressure on admission, as well as more often new onset atrial fibrillation (all p values = 0.001). Patients with significant MR also had higher in‐hospital mortality (4.6% vs. 1.3%, p = 0.04), longer hospital stay (median 8 [5‐12] vs. 6 [4‐10] days, p = 0.002), and higher mortality/readmission at 6 months (hazard ratio 1.54, 95% confidence interval 1.09‐2.18, p = 0.015). However, after adjusting for potential confounders, this last association was not significant.

Conclusions

Significant MR is seen in one fifth of octogenarians with NSTEMI. Patients with significant MR have a poor prognosis, mainly determined by their baseline clinical characteristics.

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Erratum - American Geriatric Society

Journal of the American Geriatrics Society, EarlyView.

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