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Objectives: The aims of this study were to explore the relationship of baseline levels of natriuretic peptides (NPs) with outcomes and to test for an interaction between baseline levels of NPs and the effects spironolactone., Background: Plasma NPs are considered to be helpful in the diagnosis of heart failure (HF) with preserved ejection fraction (HFpEF), and elevated levels are associated with adverse outcomes. Levels of NPs higher than certain cutoffs are often used as inclusion criteria in clinical trials of HFpEF to increase the likelihood that patients have HF and to select patients at higher risk for events. Whether treatments have a differential effect on outcomes across the spectrum of NP levels is unclear., Methods: The TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial) trial randomized patients with HFpEF and either prior hospitalization for HF or elevated natriuretic peptide levels (B-type NP [BNP] ≥100 pg/ml or N-terminal proBNP ≥360 pg/ml) to spironolactone or placebo. Baseline BNP (n = 430) or N-terminal proBNP (n = 257) levels were available in 687 patients enrolled from the Americas in the elevated-NP stratum of TOPCAT., Results: Higher levels of NPs were independently associated with an increased risk for TOPCAT's primary endpoint of cardiovascular mortality, aborted cardiac arrest, or hospitalization for HF when analyzed either continuously or grouped by terciles, adjusting for region of enrollment, age, sex, atrial fibrillation, diabetes, renal function, body mass index, and heart rate. There was a significant interaction between the effect of spironolactone and baseline NP terciles for the primary outcome (p = 0.017), with greater benefit of the drug in the lower compared with higher NP terciles., Conclusions: Similar to the effects of irbesartan in the I-PRESERVE (Irbesartan in Heart Failure With Preserved Ejection Fraction) trial, a greater benefit of spironolactone was observed in the group with lower levels of NPs and overall risk in TOPCAT. Elevated NPs in HFpEF identify patients at higher risk for events but who may be less responsive to treatment. The mechanism of this apparent interaction between disease severity and response to therapy requires further exploration. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302)., (Copyright © 2017. Published by Elsevier Inc.)

Objective: To compare the change in potassium concentration (dose-response) using the intravenous versus enteral route for potassium replenishment., Research Methodology/design: Cross-sectional analysis of individual potassium chloride doses with resulting changes in plasma potassium concentrations in intensive care patients. Potassium chloride was administered according to potassium replenishment protocols. For inclusion, doses were required to have pre- and post-dose plasma potassium concentrations obtained within 8hours of administration., Setting: Medical and surgical intensive care units of a United States Veterans Affairs Medical Center., Main Outcome Measures: The primary outcome was the dose-response slope for intravenous versus enteral potassium administration as estimated by linear regression analysis. Multivariable linear regression was employed to adjust for potential confounders., Results: The sample had 278 potassium chloride doses administered to 142 patients. The potassium concentration change per 20mmol of potassium chloride was similar for intravenous and enteral routes, 0.25mmol/L (95% confidence interval 0.16-0.33) versus 0.27mmol/L (0.15-0.39) respectively (p=0.73). Multivariable linear regression did not alter results. The success of achieving a minimum potassium concentration defined by the specific protocol was similar for intravenous (61%) and enteral (59%) administration. Overall, 77% of potassium chloride doses were administered at a time when patients were eligible to receive an enteral dosage form., Conclusion: The enteral route was as effective as the intravenous route in increasing the plasma potassium concentration. The enteral route was widely available for potassium replenishment. Despite enteral route availability and the well-known reliability of potassium chloride absorption, the majority of doses were administered intravenously., (Published by Elsevier Ltd.)

Background: Adverse drug events (ADEs) cause significant morbidity and mortality to patients. A brief questionnaire asking patients how they coped with such problems could be a useful tool for providing timely interventions., Objective: The aim of this study was to develop an adverse-event coping scale (AECS) to measure patients' coping responses to their ADE., Methods: Data were collected from subjects recruited from community pharmacies. Psychometric analyses based on item response theory (IRT) were performed to calibrate items and assess reliability. Convergent validity was evaluated by testing a priori formulated hypotheses about expected correlations between the coping scores and other related scales., Results: A total of 140 patients participated in this study by answering the developed items. Confirmatory factor analysis supported a one-dimensional item bank with 11 items. The developed scale was reliable with the reliability coefficient of 0.82. Coping scores were positively correlated with seriousness of the ADE and health literacy, but not coping self-efficacy. Overall, results suggest that the score reflects problem magnitude and coping effort rather than coping efficacy., Conclusion: A high score on the AECS indicates an ADE serious enough to prompt a patient to invest substantial efforts to cope with it. The final AECS item bank and its short-form can help clinicians better understand their patients' ADE-coping efforts., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Dynamic cardiomyoplasty is an evolving treatment for heart failure that uses an electrically stimulated latissimus dorsi muscle wrapped around the heart to improve cardiac function. Preoperative patient characteristics and deaths after cardiomyoplasty have been recorded during the past 5 years in a cumulative database representing worldwide experience of 42 medical centers., Methods: Statistical models of hazards (monthly death rates) were used to identify risk factors for transiently increased risk of cardiovascular mortality within 2 months after cardiomyoplasty., Results: Actuarial survival (n = 261) was 88%, 80%, and 76% at 1, 3, and 6 months after cardiomyoplasty, respectively. The peak hazard of 6% dying per month occurred during the first month after the surgical procedure. Lower ejection fraction, increased number of major coronary arteries with > or = 70% stenotic lesions, and lower chronotropic responses during exercise were independent risk factors for the transient increase in early cardiovascular mortality. Early risk of cardiovascular mortality was significantly reduced as centers gained experience with more than 3 patients., Conclusion: Early survival after cardiomyoplasty has improved with experience and might be reduced further by preoperative assessments that identify patients at highest risk.

Measures of the effects of health care on patients' lives are being requested to evaluate heart transplantation programs. A relatively short, 36-item, questionnaire (SF-36) designed to measure health status is being evaluated as an outcome measure for a variety of conditions. The SF-36 was sent to all adults awaiting heart transplantation (n = 48) and heart transplant recipients (n = 177) at the University of Minnesota as a pilot study of the SF-36 applied to heart transplantation. Response rates were 88% and 81%, respectively. Heart transplant recipients had significantly (p < 0.0001) better scores for general health perceptions (70 +/- 21 versus 33 +/- 21), vitality (62 +/- 19 versus 39 +/- 2), physical function (71 +/- 22 versus 36 +/- 24), ability to perform roles without physical limitations (62 +/- 41 versus 27 +/- 35), and social function (85 +/- 18 versus 63 +/- 31) compared with patients awaiting heart transplantation. Mental function and ability to perform roles without emotional problems were good in both groups and not significantly different. Mean SF-36 scores for the heart transplant recipients were uniformly not as high as scores for a historical group with only minor medical problems. These preliminary data suggest that the SF-36 is sensitive to the effects of heart transplantation. Additional studies of the SF-36 as an outcome measure for heart transplantation are warranted and should include methods to control for extraneous variability and to provide unbiased data collection.