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  • Anker, Stefan D, et al. (författare)
  • Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency.
  • 2009
  • Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793. ; 361, s. 2436-2448
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (ferric carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia. METHODS: We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 mug per liter or between 100 and 299 mug per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (ferric carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life. RESULTS: Among the patients receiving ferric carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to ferric carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups. CONCLUSIONS: Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780.) Copyright 2009 Massachusetts Medical Society.
  • Anker, Stefan D., et al. (författare)
  • Rationale and design of Ferinject((R)) Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia
  • 2009
  • Ingår i: European Journal of Heart Failure. - : Elsevier. - 1879-0844 .- 1388-9842. ; 11:11, s. 1084-1091
  • Tidskriftsartikel (refereegranskat)abstract
    • Iron deficiency (ID) and anaemia are common in patients with chronic heart failure (CHF). The presence of anaemia is associated with increased morbidity and mortality in CHF, and ID is a major reason for the development of anaemia. Preliminary studies using intravenous (i.v.) iron supplementation alone in patients with CHF and ID have shown improvements in symptom status. FAIR-HF (Clinical Trials.gov NCT00520780) was designed to determine the effect of i.v. iron repletion therapy using ferric carboxymaltose on self-reported patient global assessment (PGA) and New York Heart Association (NYHA) in patients with CHF and ID. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF < 40% (NYHA II) or < 45% (NYHA III), ID [ferritin < 100 ng/mL or ferritin 100-300 ng/mL when transferrin saturation (TSAT) < 20%], and haemoglobin 9.5-13.5 g/dL. Patients were randomized in a 2:1 ratio to receive ferric carboxymaltose (Ferinject((R))) 200 mg iron i.v. or saline i.v. weekly until iron repletion (correction phase), then monthly until Week 24 (maintenance phase). Primary endpoints are (i) self-reported PGA at Week 24 and (ii) NYHA class at Week 24, adjusted for baseline NYHA class. This study will provide evidence on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anaemia.
  • Bergenzaun, Lill, et al. (författare)
  • Assessing left ventricular systolic function in shock: evaluation of echocardiographic parameters in intensive care
  • 2011
  • Ingår i: Critical Care. - : BioMed Central (BMC). - 1364-8535 .- 1466-609X. ; 15:4
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: Assessing left ventricular (LV) systolic function in a rapid and reliable way can be challenging in the critically ill patient. The purpose of this study was to evaluate the feasibility and reliability of, as well as the association between, commonly used LV systolic parameters, by using serial transthoracic echocardiography (TTE). Methods: Fifty patients with shock and mechanical ventilation were included. TTE examinations were performed daily for a total of 7 days. Methods used to assess LV systolic function were visually estimated, "eyeball" ejection fraction (EBEF), the Simpson single-plane method, mean atrioventricular plane displacement (AVPDm), septal tissue velocity imaging (TDIs), and velocity time integral in the left ventricular outflow tract (VTI). Results: EBEF, AVPDm, TDIs, VTI, and the Simpson were obtained in 100%, 100%, 99%, 95% and 93%, respectively, of all possible examinations. The correlations between the Simpson and EBEF showed r values for all 7 days ranging from 0.79 to 0.95 (P < 0.01). the Simpson correlations with the other LV parameters showed substantial variation over time, with the poorest results seen for TDIs and AVPDm. The repeatability was best for VTI (interobserver coefficient of variation (CV) 4.8%, and intraobserver CV, 3.1%), and AVPDm (5.3% and 4.4%, respectively), and worst for the Simpson method (8.2% and 10.6%, respectively). Conclusions: EBEF and AVPDm provided the best, and Simpson, the worst feasibility when assessing LV systolic function in a population of mechanically ventilated, hemodynamically unstable patients. Additionally, the Simpson showed the poorest repeatability. We suggest that EBEF can be used instead of single-plane Simpson when assessing LV ejection fraction in this category of patients. TDIs and AVPDm, as markers of longitudinal function of the LV, are not interchangeable with LV ejection fraction.
  • Bergenzaun, Lill, et al. (författare)
  • High-sensitive cardiac Troponin T is superior to echocardiography in predicting 1-year mortality in patients with SIRS and shock in intensive care
  • 2012
  • Ingår i: BMC Anesthesiology. - : BioMed Central (BMC). - 1471-2253. ; 12
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Left ventricular (LV) dysfunction is well documented in the critically ill. We assessed 1-year mortality in relation to cardiac biomarkers and LV function parameters by echocardiography in patients with shock. Methods: A prospective, observational, cohort study of 49 patients. B-natriuretic peptide (BNP), high-sensitive troponin T (hsTNT) and transthoracic echocardiography (TTE) were assessed within 12 h of study inclusion. LV systolic function was measured by ejection fraction (LVEF), mean atrioventricular plane displacement (AVPDm), peak systolic tissue Doppler velocity imaging (TDIs) and velocity time integral in the LV outflow tract (LVOT VTI). LV diastolic function was evaluated by transmitral pulsed Doppler (E, A, E/A, E-deceleration time), tissue Doppler indices (e, a, E/e) and left atrial volume (La volume). APACHE II (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment) scores were calculated. Results: hsTNT was significantly higher in non-survivors than in survivors (60 [17.0-99.5] vs 168 [89.8-358] ng/l, p = 0.003). Other univariate predictors of mortality were APACHE II (p = 0.009), E/e (p = 0.023), SOFA (p = 0.024) and age (p = 0.031). Survivors and non-survivors did not differ regarding BNP (p = 0.26) or any LV systolic function parameter (LVEF p = 0.87, AVPDm p = 0.087, TDIs p = 0.93, LVOT VTI p = 0.18). Multivariable logistic regression analysis identified hsTNT (p = 0.010) as the only independent predictor of 1-year mortality; adjusted odds ratio 2.0 (95% CI 1.2-3.5). Conclusions: hsTNT was the only independent predictor of 1-year mortality in patients with shock. Neither BNP nor echocardiographic parameters had an independent prognostic value. Further studies are needed to establish the clinical significance of elevated hsTNT in patients in shock.
  • Bergenzaun, Lill, et al. (författare)
  • Mitral annular plane systolic excursion (MAPSE) in shock: a valuable echocardiographic parameter in intensive care patients
  • 2013
  • Ingår i: Cardiovascular Ultrasound. - : BioMed Central (BMC). - 1476-7120. ; 11
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Assessing left ventricular (LV) dysfunction by echocardiography in ICU patients is common. The aim of this study was to investigate mitral annular plane systolic excursion (MAPSE) in critically ill patients with shock and its relation to LV systolic and diastolic function, myocardial injury and to outcome. Methods: In a prospective, observational, cohort study we enrolled 50 patients with SIRS and shock despite fluid resuscitation. Transthoracic echocardiography (TTE) measuring LV function was performed within 12 hours after admission and daily for a 7-day observation period. TTE and laboratory measurements were related to 28-day mortality. Results: MAPSE on day 1 correlated significantly with LV ejection fraction (LVEF), tissue Doppler indices of LV diastolic function (e, E/e) and high-sensitive troponin T (hsTNT) (p< 0.001, p= 0.039, p= 0.009, p= 0.003 respectively) whereas LVEF did not correlate significantly with any marker of LV diastolic function or myocardial injury. Compared to survivors, non-survivors had a significantly lower MAPSE (8 [IQR 7.5-11] versus 11 [IQR 8.9-13] mm; p= 0.028). Other univariate predictors were age (p= 0.033), hsTNT (p=0.014) and Sequential Organ Failure Assessment (SOFA) scores (p=0.007). By multivariate analysis MAPSE (OR 0.6 (95% CI 0.5- 0.9), p= 0.015) and SOFA score (OR 1.6 (95% CI 1.1-2.3), p= 0.018) were identified as independent predictors of mortality. Daily measurements showed that MAPSE, as sole echocardiographic marker, was significantly lower in most days in non-survivors (p<0.05 at day 1-2, 4-6). Conclusions: MAPSE seemed to reflect LV systolic and diastolic function as well as myocardial injury in critically ill patients with shock. The combination of MAPSE and SOFA added to the predictive value for 28-day mortality.
  • Birgander, Mats, et al. (författare)
  • Cardiac Structure and Function Before and After Parathyroidectomy in Patients With Asymptomatic Primary Hyperparathyroidism
  • 2009
  • Ingår i: The Endocrinologist. - : Lippincott Williams & Wilkins. - 1539-9192. ; 19:4, s. 154-158
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Primary hyperparathyroidism (PHPT) is associated with cardiac disease and increased risk of all-cause and cardiovascular mortality. We investigated cardiac structural and functional parameters before and after successful parathyroidectomy in asymptomatic PHPT patients. Methods and Results: Forty-nine PHPT patients (age: 62.9 +/- 11 years, 5 men) and 48 healthy control subjects, matched for age, sex and smoking status were enrolled in the study. PHPT patients were examined preoperatively and 6 and 12 months postoperatively. Structural and functional cardiac parameters were assessed by transthoracic echocardiography. One year after parathyroidectomy left ventricular (LV) mass, left atrial size, LV enddiastolic and endsystolic diameters, LV posterior wall and interventricular septum diameter, and right ventricular enddiastolic diameter were all increased in PHPT patients, although not significantly. As an indication of worsened LV diastolic function, the heart rate adjusted Doppler-derived deceleration time of the transmittal E-wave increased among PHPT patients (276 +/- 82-303 +/- 54 milliseconds, P = 0.004). There was also deterioration of LV ejection fraction (from 62.7 +/- 7 to 59.9 +/- 7.8%, P = 0.868) and mean atrioventricular plane displacement (from 13.2 +/- 2 to 12.6 +/- 2 mm, P = 0.029). Conclusion: There were no significant differences in heart function between hyperparathyroid and control subjects, and 6 months after parathyroidectomy, there was no change in heart function in hyperparathyroid subjects.
  • Birgander, Mats, et al. (författare)
  • Postexercise Cardiac Performance Among Patients With Mild Primary Hyperparathyroidism
  • 2009
  • Ingår i: The Endocrinologist. - : Lippincott Williams & Wilkins. - 1539-9192. ; 19:6, s. 263-266
  • Tidskriftsartikel (refereegranskat)abstract
    • Primary hyperparathyroidism (pHPT) is associated with cardiac disease. This prospective study was designed to investigate changes in cardiac function before and after parathyroidectomy. Resting and post exercise cardiac function was compared with matched control subjects. Fifty patients (mean age 62.9 +/- 11 years, 45 women) and 50 healthy control subjects, matched for age and sex were studied. Resting and postmaximum exercise echocardiography/Doppler examination were performed at baseline and 6 months after parathyroidectomy. pHPT patients were tested at baseline and 6 months postoperatively. Control subjects were tested only at baseline. Patients were divided into 4 subgroups based on median preoperative levels of PTH and calcium (Ca): high (up arrow) PTI4/ up arrow Ca, up arrow PTH/low (down arrow) Ca, up arrow Ca/ down arrow PTH, and down arrow PTH/ down arrow Ca. No significant difference between pHPT patients and control subjects regarding post exercise systolic function were detected, There was a tendency of lowed E/A among pHPT patients which was significant in subgroup down arrow PTH/ down arrow Ca (1.07 +/- 0.3). Subgroup up arrow PTH/ up arrow Ca showed a lower S/D compared with control subjects at baseline (1.28 +/- 0.3 vs. 1.48 +/- 0.3, P = 0.029). No significant changes regarding post exercise echocardiographic parameters reflecting cardiac function were detected 6 months after parathyriodectomy. Patients with asymptomatic pHPT showed a tendency of elevated filling pressures and signs of impaired diastolic function during exercise.
  • Birgander, Mats, et al. (författare)
  • Relationship Between Mild Primary Hyperparathyroidism and Left Ventricular Structure and Diastolic Performance
  • 2009
  • Ingår i: The Endocrinologist. - : Lippincott Williams & Wilkins. - 1539-9192. ; 19:4, s. 187-191
  • Forskningsöversikt (refereegranskat)abstract
    • Aim: This study aims to investigate cardiac structure and function in patients with asymptomatic primary hyperparathyroidism (pHPT) and if there is any relation to severity regarding serum levels of calcium (Ca) and parathyroid hormone. Methods and Results: We consecutively included 50 patients (mean age 62.9 +/- 11 years, 45 women) with clinically diagnosed pHPT. We prospectively recruited 50 healthy control subjects, matched for age and sex. Standard transthoracic echocardiographic examination was performed using the 4 standard views and structural parameters as well as left ventricular (LV) systolic and diastolic function was determined. Mean LV ejection fraction and atrioventricular plane displacement were on average normal and did not differ between patients and controls. However, pHPT patients had significantly greater LV mass (148 +/- 37 vs. 127 +/- 29 g, P = 0.002), LV end diastolic area (81 +/- 20 vs. 68 +/- 18 cm(2), p = 0.003), LV posterior wall diameter (8.9 +/- 1 vs. 8.1 +/- 1 min, P = 0.006), and LA size (21 +/- 3 vs. 19 +/- 2 mm, P < 0.001). A moderate to severe LV diastolic filling impairment was present in substantially more pHPT patients, compared with control subjects (36% vs. 4%, P < 0:001). Conclusion: Patients with asymptomatic pHPT showed LV structural changes and impaired LV diastolic function.
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