Cardiorenal Syndrome: New Perspectives BOCK, Jeremy S; GOTTLIEB, Stephen S
Circulation (New York, N.Y.),
06/2010, Letnik:
121, Številka:
23
Journal Article
Abstract Background Telemonitoring has been advocated as a way of decreasing costs and improving outcomes, but no study has looked at true Medicare payments and 30-day readmission rates in a ...randomized group of well treated patients. Objective The aim of this work was to analyze Medicare claims data to identify effects of home telemonitoring on medical costs, 30-day rehospitalization, mortality, and health-related quality of life. Methods A total of 204 subjects were randomized to usual-care and monitored groups and evaluated with the SF-36 and Minnesota Living With Heart Failure Questionnaire (MLHF). Hospitalizations, Medicare payments, and mortality were also assessed. Monitored subjects transmitted weight, blood pressure, and heart rate, which were monitored by an experienced heart failure nurse practitioner. Results Subjects were followed for 802 ± 430 days; 75 subjects in the usual-care group (316 hospitalizations) and 81 in the monitored group (327 hospitalizations) were hospitalized at least once ( P = .51). There were no differences in Medicare payments for inpatient or emergency department visits, and length of stay was not different between groups. There was no difference in 30-day readmissions ( P = .627) or mortality ( P = .575). Scores for SF-36 and MLHF improved ( P < .001) over time, but there were no differences between groups. The percentage of patients readmitted within 30 days was lower with telemonitoring for the 1st year, but this did not persist. Conclusions Telemonitoring did not result in lower total costs, decreased hospitalizations, improved symptoms, or improved mortality. A decrease in 30-day readmission rates for the 1st year did not result in decreased total cost or better outcomes.
Heart failure (HF) is a complex syndrome that affects mortality/morbidity and acts at different levels in the patient's life, resulting in a drastic impairment in multiple aspects of daily activities ...(e.g. physical, mental/emotional, and social) and leading to a reduction in quality of life. The definition of disease status and symptom severity has been traditionally based on the physician assessment, while the patient's experience of disease has been long overlooked. The active participation of patients in their own care is necessary to better understand the perception of disease and the multiple aspects of life affected, and to improve adherence to treatments. Patient‐reported outcomes (PROs) aim to switch traditional care to a more patient‐centred approach. Although PROs demonstrated precision in the evaluation of disease status and have a good association with prognosis in several randomized controlled trials, their implementation into clinical practice is limited. This review discusses the modalities of use of PROs in HF, summarizes the most largely adopted PROs in HF care, and provides an overview on the application of PROs in trials and the potential for their transition to clinical practice. By discussing the advantages and the disadvantages of their use, the reasons limiting their application in daily clinical routine, and the strategies that may promote their implementation, this review aims to foster the systematic integration of the patient's standpoint in HF care.
Pros and cons of patient‐reported outcome (PRO) use in clinical practice. EHR, electronic health record; PRS, patient‐reported symptoms; QoL, quality of life.
The term "inotrope" is familiar and intimately connected with pharmaceuticals clinically used for treatment of low cardiac output with cardiogenic shock. Traditional inotropic agents exert their ...effect by modulating calcium signaling in the myocardium. Their use is associated with poor long-term outcomes. Newer molecules in development intend to break from calcium mediation and the associated detrimental long-term effects by targeting distinct mechanisms of action to improve cardiac performance. Thus, "inotropy" does not sufficiently describe the range of potential novel pharmaceutical products. To enhance communication around and evaluation of current, emerging, and potential therapies, this review proposes a novel nuanced and holistic framework to categorize pharmacological agents that improve myocardial performance based on 3 myocardial mechanisms: calcitropes, which alter intracellular calcium concentrations; myotropes, which affect the molecular motor and scaffolding; and mitotropes, which influence energetics. Novel chemical entities can easily be incorporated into this structure, distinguishing themselves based on their mechanisms and clinical outcomes.
Transthyretin amyloidosis (ATTR) is a heterogeneous disorder with multiorgan involvement and a genetic or nongenetic basis.
The goal of this study was to describe ATTR in the United States by using ...data from the THAOS (Transthyretin Amyloidosis Outcomes Survey) registry.
Demographic, clinical, and genetic features of patients enrolled in the THAOS registry in the United States (n = 390) were compared with data from patients from other regions of the world (ROW) (n = 2,140). The focus was on the phenotypic expression and survival in the majority of U.S. subjects with valine-to-isoleucine substitution at position 122 (Val122Ile) (n = 91) and wild-type ATTR (n = 189).
U.S. subjects are older (70 vs. 46 years), more often male (85.4% vs. 50.6%), and more often of African descent (25.4% vs. 0.5%) than the ROW. A significantly higher percentage of U.S. patients with ATTR amyloid seen at cardiology sites had wild-type disease than the ROW (50.5% vs. 26.2%). In the United States, 34 different mutations (n = 201) have been reported, with the most common being Val122Ile (n = 91; 45.3%) and Thr60Ala (n = 41; 20.4%). Overall, 91 (85%) of 107 patients with Val122Ile were from the United States, where Val122Ile subjects were younger and more often female and black than patients with wild-type disease, and had similar cardiac phenotype but a greater burden of neurologic symptoms (pain, numbness, tingling, and walking disability) and worse quality of life. Advancing age and lower mean arterial pressure, but not the presence of a transthyretin mutation, were independently associated with higher mortality from a multivariate analysis of survival.
In the THAOS registry, ATTR in the United States is overwhelmingly a disorder of older adult male subjects with a cardiac-predominant phenotype. Val122Ile is the most common transthyretin mutation, and neurologic phenotypic expression differs between wild-type disease and Val122Ile, but survival from enrollment in THAOS does not. (Transthyretin-Associated Amyloidoses Outcome Survey THAOS; NCT00628745).
BACKGROUND:Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of ...these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown.
METHODS:DEFINE-HF (Dapagliflozin Effects on Biomarkers, Symptoms and Functional Status in Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate ≥30 mL/min/1.73m, and elevated natriuretic peptides. In total, 263 patients were randomized to dapagliflozin 10 mg daily or placebo for 12 weeks. Dual primary outcomes were (1) mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score, or a ≥20% decrease in NT-proBNP.
RESULTS:Patient characteristics reflected stable, chronic HF with reduced ejection fraction with high use of optimal medical therapy. There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036–1238) vs 1191 pg/dL (95% CI 1089–1304), P=0.43). For the second dual-primary outcome of a meaningful improvement in Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP, 61.5% of dapagliflozin-treated patients met this end point versus 50.4% with placebo (adjusted OR 1.8, 95% CI 1.03-3.06, nominal P=0.039). This was attributable to both higher proportions of patients with ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary score (42.9 vs 32.5%, adjusted OR 1.73, 95% CI 0.98–3.05), and ≥20% reduction in NT-proBNP (44.0 vs 29.4%, adjusted OR 1.9, 95% CI 1.1–3.3) by 12 weeks. Results were consistent among patients with or without type 2 diabetes mellitus, and other prespecified subgroups (all P values for interaction=NS).
CONCLUSIONS:In patients with heart failure and reduced ejection fraction, use of dapagliflozin over 12 weeks did not affect mean NT-proBNP but increased the proportion of patients experiencing clinically meaningful improvements in HF-related health status or natriuretic peptides. Benefits of dapagliflozin on clinically meaningful HF measures appear to extend to patients without type 2 diabetes mellitus.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT 02653482.
Tafamidis is approved in many countries for the treatment of transthyretin amyloid cardiomyopathy. This study reports data on the long-term efficacy of tafamidis from an ongoing long-term extension ...(LTE) to the pivotal ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial).
Patients with transthyretin amyloid cardiomyopathy who completed ATTR-ACT could enroll in an LTE, continuing with the same tafamidis dose or, if previously treated with placebo, randomized (2:1) to tafamidis meglumine 80 or 20 mg. All patients in the LTE transitioned to tafamidis free acid 61 mg (bioequivalent to tafamidis meglumine 80 mg) following a protocol amendment. In this interim analysis, all-cause mortality was assessed in patients treated with tafamidis meglumine 80 mg in ATTR-ACT continuing in the LTE, compared with those receiving placebo in ATTR-ACT transitioning to tafamidis in the LTE.
Median follow-up was 58.5 months in the continuous tafamidis group (n=176) and 57.1 months in the placebo to tafamidis group (n=177). There were 79 (44.9%) deaths with continuous tafamidis and 111 (62.7%) with placebo to tafamidis (hazard ratio, 0.59 95% CI, 0.44-0.79;
<0.001). Mortality was also reduced in the continuous tafamidis (versus placebo to tafamidis) subgroups of: variant transthyretin amyloidosis (0.57 0.33-0.99;
=0.05) and wild-type transthyretin amyloidosis (0.61 0.43-0.87;
=0.006); and baseline New York Heart Association class I and II (0.56 0.38-0.82;
=0.003) and class III (0.65 0.41-1.01;
=0.06).
In the LTE, patients initially treated with tafamidis in ATTR-ACT had substantially better survival than those first treated with placebo, highlighting the importance of early diagnosis and treatment in transthyretin amyloid cardiomyopathy. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01994889 and NCT02791230.
We analyzed multiwavelength observations of the previously identified Galactic center X-ray binary CXO 174528.79-290942.8 (XID 6592) and determine that the near-infrared counterpart is a red ...supergiant based on its spectrum and luminosity. Scutum X-1 is the only previously known X-ray binary with a red supergiant donor star and closely resembles XID 6592 in terms of X-ray luminosity (LX), absolute magnitude, and IR variability (LIR,var), supporting the conclusion that XID 6592 contains a red supergiant donor star. The XID 6592 infrared counterpart shows variability of ∼0.5 mag in the Wide-field Infrared Survey Explorer-1 band (3.4 m) on timescales of a few hours. Other infrared data sets also show large-amplitude variability from this source at earlier epochs but do not show significant variability in recent data. We do not expect red supergiants to vary by ∼50% in luminosity over these short timescales, indicating that the variability should be powered by the compact object. However, the X-ray luminosity of this system is typically ∼1000× less than the variable luminosity in the infrared and falls below the Chandra detection limit. While X-ray reprocessing can produce large-amplitude fast infrared variability, it typically requires LIR,var to do so, indicating that another process must be at work. We suggest that this system may be a supergiant fast X-ray transient (SFXT), and that a large (∼1038 ergs s−1), fast (102-4 s) X-ray flare could explain the rapid IR variability and lack of a long-lasting X-ray outburst detection. SFXTs are normally associated with blue supergiant companions, so if confirmed, XID 6592 would be the first red supergiant SFXT, as well as the second X-ray red supergiant binary.
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