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Myocardial Infarction Stabilization

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282. Telehealth for Acute and Chronic Care Consultations

department; EMS = emergency medical services; KQ = Key Question; RR = risk ratio; STEMI = ST-elevation myocardial infarction; tPA = tissue plasminogen activator; Outpatient Telehealth Consultations • Clinical outcomes: Clinical outcomes were reported in just over one-quarter of the studies of telehealth consultations and in 7 of 11 clinical topics. In three topics, there is moderate strength of evidence of the benefits of telehealth (better healing in wound care, higher response to treatment

2019 Effective Health Care Program (AHRQ)

283. Atrial Fibrillation (Focused Update)

or thromboembolism (doubled), vascular disease, age 65 to 74 years, sex category CI confidence interval CKD chronic kidney disease CMS U.S. Centers for Medicare & Medicaid Services CrCl creatinine clearance DAPT dual-antiplatelet therapy FDA U.S. Food and Drug Administration HF heart failure HFrEF heart failure with reduced left ventricular ejection fraction HR hazard ratio INR international normalized ratio LAA left atrial appendage LV left ventricular MI myocardial infarction NOAC non–vitamin K oral (...) anticoagulant PCI percutaneous coronary intervention RCT randomized controlled trial MANUSCRIPT ACCEPTED ACCEPTED MANUSCRIPT January CT, et al. 2019 Focused Update on Atrial Fibrillation Page 10 TIMI Thrombolysis in Myocardial Infarction MANUSCRIPT ACCEPTED ACCEPTED MANUSCRIPT January CT, et al. 2019 Focused Update on Atrial Fibrillation Page 11 4. Prevention of Thromboembolism 4.1. Risk-Based Anticoagulant Therapy (Modified From Section 4.1., “Risk- Based Antithrombotic Therapy,” in the 2014 AF Guideline

2019 American College of Cardiology

284. Treatment of Diabetes in Older Adults

the next 3 decades; as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths ( ). Moreover, older adults are susceptible to all of the usual complications of diabetes [reviewed in Refs. ( ) and ( )]. The prevalence rates of end-stage renal disease, loss of vision, myocardial infarction, stroke, peripheral vascular disease, and peripheral neuropathy are increased by the presence of diabetes (...) identified 23 randomized trials. For primary prevention, statins reduced the risk of coronary artery disease and myocardial infarction, but not all-cause or cardiovascular mortality or stroke. These effects were imprecise in patients with diabetes, but there was no significant interaction between diabetes status and the intervention effect. For secondary prevention, statins reduced all-cause mortality, cardiovascular mortality, coronary artery disease, myocardial infarction, and revascularization

2019 The Endocrine Society

285. What is the evidence on the role of the arts in improving health and well-being? A scoping review

can be used to support regeneration programmes: inner-city housing projects incorporating the arts have 11 been found to improve the built environment, enhance social cohesion and decrease levels of violent crime, thus leading to safer places (90). The arts also provide job opportunities and support social mobility, employment and socioeconomic stability for both individuals and communities (91–95). For many of these programmes, the location of arts activities in community or bespoke arts venues

2019 WHO Health Evidence Network

286. Primary Prevention of ASCVD and T2DM in Patients at Metabolic Risk

Heart Attack (ALLHAT) trials. The recommendation for treatment with aspirin in this population has been eliminated due to a lack of sufficient evidence for its benefit. Subsequent data and a systematic review identified a relative risk (RR) reduction in nonfatal myocardial infarction (MI) but not in cardiovascular or all-cause mortality. The effects were modest and could be potentially outweighed by the risk of bleeding and other complications ( ). Dietary and exercise recommendations have been

2019 The Endocrine Society

287. SCAI/ACVP expert consensus statement on cardiovascular catheterization laboratory economics:

$9,669 248 (with MCC) $19,382 249 (w/o MCC) $12,158 92937 Bypass graft PCI (drug‐eluting stent) 10.95 17.24 5193 $9,669 246 (with MCC) $19,787 247 (w/o MCC) $12,690 92941 PCI for acute myocardial infarction 12.31 19.38 5194 $15,355 — — — — 92943 Chronic total occlusion PCI (bare metal stent) 12.31 19.38 5193 $9,669 248 (with MCC) $19,382 249 (w/o MCC) $12,158 92943 Chronic total occlusion PCI (drug‐eluting stent) 12.31 19.38 5194 $15,355 246 (with MCC) $19,787 247 (w/o MCC) $12,690 Abbreviations: RVU (...) ‐DRGv28 definitions manual Diagnosis code Description I2101‐I213 ST elevation myocardial infarction (STEMI) I214 Non‐ST elevation (NSTEMI) myocardial infarction (NSTEMI) I220‐I2209 Subsequent ST elevation MI (STEMI) I234 Rupture of chordae tendineae as current complication following acute MI I235 Rupture of papillary muscle as current complication following acute MI I2542 Coronary artery dissection I468‐469 Cardiac arrest I4901‐4901 Ventricular fibrillation/flutter I5021, I5023 Acute systolic heart

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2019 Society for Cardiovascular Angiography and Interventions

291. Pharmacologic and Nonpharmacologic Therapies in Adult Patients With Exacerbation of COPD

with stable COPD or patients who had stabilized after an episode of ECOPD, but in more recent times, a number of trials have explored the role of exercise/early pulmonary rehabilitation during an episode of ECOPD. 27, 28 Chest physiotherapy using airway clearance techniques (including breathing technique, vibration/percussion, and autogenic drainage) are used routinely in many patients hospitalized with ECOPD. A Cochrane review published in 2012 found evidence that airway clearance techniques may reduce

2019 Effective Health Care Program (AHRQ)

292. Chest Pain – Possible Acute Coronary Syndrome

. The principal limitations to this technique are equipment availability and the high level of expertise required of technologists and interpreting physicians. Access to the patient may be more difficult in the magnetic environment if the patient’s stability should deteriorate. However, cardiac MRI with delayed postcontrast imaging and edema-weighted imaging provides definitive assessment of the size, distribution, and transmural extent of acute or remote myocardial infarction. Cine MRI has utility (...) syndromes (ACS) include ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina (UA) [1]. Being able to establish the diagnosis rapidly and accurately may be lifesaving. The immediate cardiac workup consists of an electrocardiogram (ECG) and cardiac biomarkers. In the acute setting, even if there are no ischemic changes on ECG, a cardiac workup is often indicated. Because research has demonstrated that patients having a STEMI have improved outcomes if percutaneous

2019 American College of Radiology

293. Patients Hospitalized with Heart Failure: Risk Assessment, Management, and Clinical Trajectory

. -,NO. -,2019 Hollenberg et al. -,2019:-–- Heart Failure Hospitalization Pathway 9TABLE 4 Key Comorbid Conditions to Consider Comorbidity Management Relevant Guidelines/Pathways Cardiovascular Coronary artery disease/acute coronary syndrome Assess and treat ischemia, and consider revascularization. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction Atrial ?brillation/ ?utter (...) chain; ARB¼ angiotensin receptor blockers; ATTR¼ amyloid transthyretin; GDMT¼ guideline-directed medical therapy; HF¼ heart failure; HFrEF¼ heart failure with reduced ejection fraction; HTN¼ hypertension; RAAS¼ renin-angiotensin-aldosterone system; SGLT2¼ sodium-glucose cotransporter-2; STEMI¼ ST-segment elevation myocardial infarction. JACC VOL. -,NO. -,2019 Hollenberg et al. -,2019:-–- Heart Failure Hospitalization Pathway 11trial databases are continuous variables, while those from administrative

2019 American College of Cardiology

294. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

. Assessment report EMA/CHMP/520007/2018 Page 18/128 Release and periodical retests for both, the primary reference and the working reference standard have been submitted and are considered acceptable. For the primary reference standard a panel of analytical methods for additional characterisation has been presented. Stability The proposed shelf life of Hefiya active substance when stored at the recommended conditions is based on long-term stability data. The results demonstrate that Hefiya active (...) substance is stable under the recommended conditions. Supporting information on accelerated and stress stability data and data from thermal freeze/thaw cycles as well as photo-stability data have been provided. Comparability exercise for Active Substance The development activities include the initial development of the AS manufacturing process, the following scale up and transfer from the pilot scale to the manufacturing scale at different plants and lines. Comparability was demonstrated in data between

2018 European Medicines Agency - EPARs

295. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

standards as well as the concept for introduction of future in-house reference standards has been briefly outlined. Release and periodical retests for both, the primary reference and the working reference standard have been submitted and are considered acceptable. For the primary reference standard a panel of analytical methods for additional characterisation has been presented. Stability The proposed shelf life of Halimatoz active substance when stored at the recommended conditions is based on long (...) -term stability data. The results demonstrate that Halimatoz active substance is stable under the recommended conditions. Supporting information on accelerated and stress stability data and data from thermal freeze/thaw cycles as well as photo-stability data have been provided. Comparability exercise for Active Substance The development activities include the initial development of the AS manufacturing process, the following scale up and transfer from the pilot scale to the manufacturing scale

2018 European Medicines Agency - EPARs

296. Allopurinol / lesinurad (Duzallo) - Gout

are within the specifications and consistent from batch to batch and demonstrated the equivalence of the two processes. Stability Stability data on three pilot scale batches of lesinurad stored in the intended commercial packaging from the first manufacturer and three commercial scale batches from the second manufacturer were provided. In addition data from two pilot batches from the first manufacturer using process II were also provided as supportive data. Results for up to 36 months under long term (...) conditions (25.0 ± 2.0 °C / 60.0 % RH ± 5.0 %) and for up to 6 months under accelerated conditions (40.0 ± 2.0 °C / 75.0 % RH ± 5.0 %) were provided according to the ICH guidelines. Samples were tested for appearance, assay, organic impurities, water content, physical form by XRPD, thermal analysis by DSC and particle size distribution. The test methods are stability indicating. All tested parameters consistently meet the specifications under both accelerated and long-term conditions. No significant

2018 European Medicines Agency - EPARs

297. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia

are usually between 3.5 and 5.0 mmol/L, which is considered the normal range for adults. However, a number of recent retrospective studies have shown the risk of mortality is increased even with only modest elevations of S-K. Mortality risk has been shown to be significantly higher in chronic kidney disease (CKD) patients with S-K levels > 5.0 mmol/L. In acute myocardial infarction patients, a mean postadmission S-K = 5.5 mmol/L during hospitalisation corresponded to a 12-fold increase in death compared (...) of the active substance are provided. The results are within the specifications and consistent from batch to batch. The active substance specifications are based on the active substance critical quality attributes (CQA). Stability Stability data on six commercial scale batches of the active substance from the proposed manufacturer stored in a container closure system representative of that intended for commercial production were provided. Data on three batches was provided for 24 months under long term

2018 European Medicines Agency - EPARs

298. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

through extensive form screening experiments and crystallization studies and is the only form of ertugliflozin L-PGA. All batches of ertugliflozin L-PGA have been consistent. In addition, confirmation of form has been evaluated as part of the supportive and primary stability programs (36 months & 12 months at 25 °C/60% RH; respectively) using powder x-ray diffraction (PXRD) with no changes being observed. Ertugliflozin L-PGA is a white to off-white powder. Ertugliflozin is very slightly soluble (...) testing has been presented. Batch analysis data from full scale batchesof the active substance are provided. The results are within the specifications and consistent from batch to batch. Stability Stability data from full scale batches of active substance from the proposed manufacturer, stored in the intended commercial package for up to 12 months under long term conditions (25 ºC / 60% RH) and for up to 6 months under accelerated conditions (40 ºC / 75% RH) according to the ICH guidelines were

2018 European Medicines Agency - EPARs

299. 2019 HRS expert consensus statement on evaluation, risk stratification, and management of arrhythmogenic cardiomyopathy

exercise for desmosomal mutation carriers. Heart Rhythm . 2016 ; 13 : 199–207 | | | | | , x 255 Saberniak, J., Hasselberg, N.E., Borgquist, R. et al. Vigorous physical activity impairs myocardial function in patients with arrhythmogenic right ventricular cardiomyopathy and in mutation positive family members. Eur J Heart Fail . 2014 ; 16 : 1337–1344 | | | , x 258 Ruwald, A.C., Marcus, F., Estes, N.A. 3rd et al. Association of competitive and recreational sport participation with cardiac events (...) hypertrophy, whereas troponin I variants may cause a restrictive phenotype in which the dominant clinical presentation is atrial fibrillation. x 13 McKenna, W.J., Stewart, J.T., Nihoyannopoulos, P., McGinty, F., and Davies, M.J. Hypertrophic cardiomyopathy without hypertrophy: two families with myocardial disarray in the absence of increased myocardial mass. Br Heart J . 1990 ; 63 : 287–290 | | | , x 14 Watkins, H., Ashrafian, H., and Redwood, C. Inherited cardiomyopathies. N Engl J Med . 2011 ; 364

2019 International Society for Heart and Lung Transplantation

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