Showing papers by "Heart and Diabetes Center North Rhine-Westphalia published in 2015"
University of Dundee1, University of Auckland2, University of Aberdeen3, Emory University4, University of Colorado Denver5, University of Verona6, University of Wisconsin-Madison7, Princess Alexandra Hospital8, SITA9, University of Cambridge10, Spanish National Research Council11, Aarhus University Hospital12, Heart and Diabetes Center North Rhine-Westphalia13
TL;DR: Vitamin D supplementation is ineffective as an agent for lowering BP and thus should not be used as an antihypertensive agent.
Abstract: MAIN OUTCOMES AND MEASURES Difference in SBP and DBP measured in an office setting. RESULTS We included 46 trials (4541 participants) in the trial-level meta-analysis. Individual patient data were obtained for 27 trials (3092 participants). At the trial level, no effect of vitamin D supplementation was seen on SBP (effect size, 0.0 [95% CI, −0.8 to 0.8] mm Hg; P =. 97;I 2 = 21%) or DBP (effect size, −0.1 [95% CI, −0.6 to 0.5] mm Hg; P = .84; I 2 = 20%). Similar results were found analyzing individual patient data for SBP (effect size, −0.5 [95% CI, −1.3 to 0.4] mm Hg; P =. 27;I 2 = 0%) and DBP (effect size, 0.2 [95% CI, −0.3 to 0.7] mm Hg; P = .38; I 2 = 0%). Subgroup analysis did not reveal any baseline factor predictive of a better
255 citations
TL;DR: The Styrian Vitamin D Hypertension Trial as discussed by the authors was a single-center, double-blind, placebo-controlled trial conducted from June 2011 to August 2014 at the endocrine outpatient clinic of the Medical University of Graz, Austria, where 200 participants with arterial hypertension and 25-hydroxyvitamin D levels below 30 ng/mL were randomized to receive either 2800 IU of vitamin D3 per day as oily drops or placebo (n=100) for 8 weeks.
Abstract: Vitamin D deficiency is a risk factor for arterial hypertension, but randomized controlled trials showed mixed effects of vitamin D supplementation on blood pressure (BP). We aimed to evaluate whether vitamin D supplementation affects 24-hour systolic ambulatory BP monitoring values and cardiovascular risk factors. The Styrian Vitamin D Hypertension Trial is a single-center, double-blind, placebo-controlled study conducted from June 2011 to August 2014 at the endocrine outpatient clinic of the Medical University of Graz, Austria. We enrolled 200 study participants with arterial hypertension and 25-hydroxyvitamin D levels below 30 ng/mL. Study participants were randomized to receive either 2800 IU of vitamin D3 per day as oily drops (n=100) or placebo (n=100) for 8 weeks. Primary outcome measure was 24-hour systolic BP. Secondary outcome measures were 24-hour diastolic BP, N-terminal-pro-B-type natriuretic peptide, QTc interval, renin, aldosterone, 24-hour urinary albumin excretion, homeostasis model assessment-insulin resistance, triglycerides, high-density lipoprotein cholesterol, and pulse wave velocity. A total of 188 participants (mean [SD] age, 60.1 [11.3] years; 47% women; 25-hydroxyvitamin D, 21.2 [5.6] ng/mL) completed the trial. The mean treatment effect (95% confidence interval) for 24-hour systolic BP was −0.4 (−2.8 to 1.9) mm Hg ( P =0.712). Triglycerides increased significantly (mean change [95% confidence interval], 17 [1–33] mg/dL; P =0.013), but no further significant effects were observed for secondary outcomes. Vitamin D supplementation in hypertensive patients with low 25-hydroxyvitamin D has no significant effect on BP and several cardiovascular risk factors, but it was associated with a significant increase in triglycerides.
138 citations
TL;DR: Current data highlighting links between SDB and a variety of cardiovascular conditions, the importance of recognising and diagnosing SDB in patients with cardiovascular disease, and the effects of effective SDB treatment on cardiovascular endpoints are presented.
Abstract: Obstructive sleep apnoea and central sleep apnoea/Cheyne-Stokes respiration are collectively referred to as sleep-disordered breathing (SDB). Rapidly accumulating evidence suggests that both forms of SDB, and often a combination of both, are highly prevalent in patients with a wide variety of cardiovascular diseases, including hypertension, heart failure, arrhythmias, coronary artery disease, acute coronary syndrome and stroke. The presence of SDB in these patients is independently associated with worse cardiac function and exercise tolerance, recurrent arrhythmias, infarct expansion, decreased quality of life and increased mortality. Recent data suggest positive effects of positive airway pressure (PAP) therapy on quality of life and cardiovascular function. In addition, ongoing clinical trials may soon provide first definitive data on PAP therapy of SDB on hard outcomes such as mortality. This review presents current data highlighting links between SDB and a variety of cardiovascular conditions, the importance of recognising and diagnosing SDB in patients with cardiovascular disease, and the effects of effective SDB treatment on cardiovascular endpoints.
106 citations
TL;DR: This is the first clinical case report of a highly septic patient treated with the combined use of LVAD, rECMO, CVVH, and CytoSorb and it represents a reasonable approach to improve survival in patients with multiple organ dysfunction necessitating several organ supportive techniques.
Abstract: PurposeA new hemoadsorption device intended as adjunctive treatment for patients with elevated cytokine levels in the setting of SIRS and sepsis has shown promising results. We report on the benefi...
64 citations
TL;DR: Although RPD in patients with PXE occur at a younger age, their distribution and phenotype appear to be similar to RPD associated with age-related macular degeneration, and a pathogenetic role of Bruch membrane alterations for the development of RPD is suggested.
Abstract: Importance Reticular pseudodrusen (RPD) are frequently associated with age-related macular degeneration and considered to be an independent risk factor for disease progression, but the pathophysiologic mechanisms are only incompletely understood. Therefore, it may be helpful to identify the associations of RPD with other diseases that have defined pathophysiologic mechanisms. Objective To describe the phenotype, prevalence, and topographic distribution of RPD in patients with pseudoxanthoma elasticum (PXE) and their association with a diseased Bruch membrane. Design, Setting, and Participants In this single-center, prospective, cross-sectional case series, 57 consecutive patients with PXE from a university referral center whose diagnosis has been confirmed by genetic testing and/or skin biopsy were studied from March 1, 2013, through February 28, 2014. Main Outcomes and Measures Phenotypic characteristics of RPD were evaluated with multiple imaging techniques. The RPD were defined as irregular networks of round to oval lesions that appear hyporeflective on near-infrared reflectance, hypoautofluorescent on fundus autofluorescence, and as subretinal deposits on spectral-domain optical coherence tomographic images. The presence of RPD was judged based on characteristic findings in at least 2 of the 3 imaging modalities. Results A total of 57 patients were examined, and 15 patients were excluded mainly because of large central atrophy or fibrosis. In the remaining 42 patients with PXE, RPD were detected in 22 patients (52%; 95% CI, 38%-67%). Prevalence of RPD was highest in the fifth decade at 67% (10/15; 95% CI, 42%-85%). The RPD were most frequently located within the superior quadrant and least frequently located within the central macula. The RPD were always located central to areas with peau d’orange and within an area of hypofluorescence on late-phase indocyanine green angiographic images. Conclusions and Relevance These data suggest that RPD have a high prevalence in eyes of patients with PXE. Although RPD in patients with PXE occur at a younger age, their distribution and phenotype appear to be similar to RPD associated with age-related macular degeneration. The association with diseased Bruch membrane in PXE suggests a pathogenetic role of Bruch membrane alterations for the development of RPD.
54 citations
TL;DR: Catheter ablation of AF safety and efficacy in DM patients is similar to general population, especially when performed in younger patients with satisfactory glycemic control, and reduces the amount of patients requiring AADs.
Abstract: Aims Diabetes mellitus (DM) and atrial fibrillation (AF) share pathophysiological links, as supported by the high prevalence of AF within DM patients. Catheter ablation of AF (AFCA) is an established therapeutic option for rhythm control in drug resistant symptomatic patients. Its efficacy and safety among patients with DM is based on small populations, and long-term outcome is unknown. The present systematic review and meta-analysis aims to assess safety and long-term outcome of AFCA in DM patients, focusing on predictors of recurrence.
Methods and results A systematic review was conducted in MEDLINE/PubMed and Cochrane Library. Randomized controlled trials, clinical trials, and observational studies including patients with DM undergoing AFCA were screened and included if matching inclusion and exclusion criteria. Fifteen studies were included, adding up to 1464 patients. Mean follow-up was 27 (20–33) months. Overall complication rate was 3.5 (1.5–5.0)%. Efficacy in maintaining sinus rhythm at follow-up end was 66 (58–73)%. Meta-regression analysis revealed that advanced age ( P < 0.001), higher body mass index ( P < 0.001), and higher basal glycated haemoglobin level ( P < 0.001) related to higher incidence of arrhythmic recurrences. Performing AFCA lead to a reduction of patients requiring treatment with antiarrhythmic drugs (AADs) from 55 (46–74)% at baseline to 29 (17–41)% ( P < 0.001) at follow-up end.
Conclusions Catheter ablation of AF safety and efficacy in DM patients is similar to general population, especially when performed in younger patients with satisfactory glycemic control. Catheter ablation of AF reduces the amount of patients requiring AADs, an additional benefit in this population commonly exposed to adverse effects of AF pharmacological treatments.
49 citations
TL;DR: Telemedicine-guided very low-dose INR self-control is comparable with low- dose INR in thrombotic risk, and is superior in bleeding risk.
Abstract: Aim To study in patients performing international normalized ratio (INR) self-control the efficacy and safety of an INR target range of 1.6–2.1 for aortic valve replacement (AVR) and 2.0–2.5 for mitral valve replacement (MVR) or double valve replacement (DVR).
Methods and results In total, 1304 patients undergoing AVR, 189 undergoing MVR and 78 undergoing DVR were randomly assigned to low-dose INR self-control (LOW group) (INR target range, AVR: 1.8–2.8; MVR/DVR: 2.5–3.5) or very low-dose INR self-control once a week (VLO group) and twice a week (VLT group) (INR target range, AVR: 1.6–2.1; MVR/DVR: 2.0–2.5), with electronically guided transfer of INR values. We compared grade III complications (major bleeding and thrombotic events; primary end-points) and overall mortality (secondary end-point) across the three treatment groups.
Findings Two-year freedom from bleedings in the LOW, VLO, and VLT groups was 96.3, 98.6, and 99.1%, respectively ( P = 0.008). The corresponding values for thrombotic events were 99.0, 99.8, and 98.9%, respectively ( P = 0.258). The risk-adjusted composite of grade III complications was in the per-protocol population (reference: LOW-dose group) as follows: hazard ratio = 0.307 (95% CI: 0.102–0.926; P = 0.036) for the VLO group and = 0.241 (95% CI: 0.070–0.836; P = 0.025) for the VLT group. The corresponding values of 2-year mortality were = 1.685 (95% CI: 0.473–5.996; P = 0.421) for the VLO group and = 4.70 (95% CI: 1.62–13.60; P = 0.004) for the VLT group.
Conclusion Telemedicine-guided very low-dose INR self-control is comparable with low-dose INR in thrombotic risk, and is superior in bleeding risk. Weekly testing is sufficient. Given the small number of MVR and DVR patients, results are only valid for AVR patients.
43 citations
TL;DR: In cardiac surgical patients, deficient but not high 25OHD levels are independently associated with the risk of MACCE and Cohort studies should consider potential interrelationships between kidney function, circulating vitamin D metabolite levels, and clinical outcome.
Abstract: Context: Several cohort studies have reported U-shaped or inverse J-shaped associations between circulating 25-hydroxyvitamin D [25OHD] and clinical outcomes. Objective: We aimed to investigate in cardiac surgical patients the association of preoperative 25OHD and 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] levels with the risk of major adverse cardiac and cerebrovascular events (MACCE). Design: A prospective cohort study of adult cardiac surgical patients in 2012–2013 was used. Setting: The study was conducted at the Heart and Diabetes Center North Rhine-Westphalia, Germany. Patients: A total of 3371 adult patients participated in the study. Intervention: None Measurements: The main outcome measure was MACCE until discharge. We categorized vitamin D metabolite levels into subgroups and performed multivariable-adjusted logistic regression analysis to estimate odds ratios (ORs) of MACCE. Moreover, we performed multiple regression analysis to assess the association of 25OHD and circulating 1,25(OH)2D3 with preop...
36 citations
TL;DR: A sensitive and specific UPLC-MRM MS assay for the quick and specific measurement of dabigatran and rivaroxaban in human plasma has a much better selectivity than classical functional assays measuring activities of various coagulation factors which are susceptible to interference by other coagulant drugs.
Abstract: Introduction
The fast, precise, and accurate measurement of the new generation of oral anticoagulants such as dabigatran and rivaroxaban in patients’ plasma my provide important information in different clinical circumstances such as in the case of suspicion of overdose, when patients switch from existing oral anticoagulant, in patients with hepatic or renal impairment, by concomitant use of interaction drugs, or to assess anticoagulant concentration in patients’ blood before major surgery.
35 citations
TL;DR: Both vitamin D and activated vitamin D significantly increase circulating 1,25(OH)2D concentrations, but in vitamin D users this increase is suppressed by calcium coadministration, which is inversely related to overall mortality.
Abstract: BACKGROUND: Evidence is accumulating that circulating 1,25-dihydroxyvitamin D [1,25(OH)2D] concentrations are inversely related to overall mortality.
METHODS: We searched PubMed, Embase and ISI Web of Science for randomized controlled trials with a control group receiving a placebo instead of vitamin D/activated vitamin D and performed a metaanalysis to evaluate the effect of oral vitamin D/activated vitamin D on circulating 1,25(OH)2D concentrations using a random effects model.
RESULTS: We included 52 vitamin D intervention groups (4796 individuals) and 14 intervention groups with activated vitamin D (668 individuals). Vitamin D supplements increased circulating 1,25(OH)2D by 12.2 pmol/L (95% CI, 7.8–16.5 pmol/L) and 18.8 pmol/L (95% CI, 9.2–28.4 pmol/L) if only studies with a low risk of bias in study design and reporting were considered (n = 18). There was significant heterogeneity among studies (Cohran's Q P < 0.001, I 2 = 91%). The incremental effect was larger in studies using vitamin D alone compared with coadministration of calcium supplements (18.6 pmol/L; 95% CI, 12.7–24.4 pmol/L vs 4.9 pmol/L; 95% CI, −0.4 to 10.2 pmol/L; P = 0.001), and if quantification was performed with RIA vs other methods (17.1 pmol/L; 95% CI, 11.1–23.1 pmol/L vs 6.9 pmol/L; 95% CI, 1.0–12.8 pmol/L; P = 0.02). Activated vitamin D increased the mean circulating 1,25(OH)2D by 20.5 pmol/L (95% CI, 8.3–32.7 pmol/L; P = 0.04). Again, there was evidence for significant heterogeneity among studies (Cochran Q = 85.4; P < 0.001; I 2 = 87%), but subgroup analysis did not identify parameters significantly influencing the increment in 1,25(OH)2D concentrations.
CONCLUSIONS: Both vitamin D and activated vitamin D significantly increase circulating 1,25(OH)2D concentrations, but in vitamin D users this increase is suppressed by calcium coadministration.
33 citations
TL;DR: According to the time status graphs, the use of bovine jugular veins for RVOT in patients younger than 25 years appears to lead to superior results when compared with cryopreserved homografts.
Abstract: Background Various diseases and diversity in implantation ages, together with evolving diagnostic and therapeutic options, hinder comparative evaluations of long-term outcomes for valved conduits used for reconstruction of the right ventricular outflow tract (RVOT) We combined two common evaluation methods to optimally use information obtained by pooling the raw data from two high volume centers, each with very regular follow-up procedures, with the aim of analyzing durability differences between conventional homografts and bovine jugular veins Patients and Methods In the period 1985 to 2012, a total of 444 bovine jugular veins and 267 homografts were implanted, and 6,738 postoperative examinations took place Evaluations included age-stratified Kaplan–Meier analyses, Cox regression models, and time status graphs, the third showing age-group stratified, time-related frequencies of intact, insufficient, stenotic, both insufficient and stenotic, and postinterventional conduits below the freedom from explantation curve They take into account interventions, explantations, and the nonterminal character of echocardiographic findings Results The durability of intact bovine jugular veins in children and young adults is not inferior to that of homografts Averaged over the first 12 years after implantation, the age groups Conclusion According to the time status graphs, the use of bovine jugular veins for RVOT in patients younger than 25 years appears to lead to superior results when compared with cryopreserved homografts
TL;DR: The role of obstructive sleep apnea and Cheyne-Stokes respiration is highlighted, their clinical effect in supraventricular and ventricular tachyarrhythmias, and in conduction disturbances are addressed, and the role of current treatment options is addressed.
TL;DR: To assess the relevance of Parvovirus B19 (B19V) DNA at low to intermediate concentrations in blood donors for the recipients of their blood components, a large number of patients with confirmed or suspected cases of B19V infection are surveyed.
Abstract: Background and Objectives
To assess the relevance of Parvovirus B19 (B19V) DNA at low to intermediate concentrations in blood donors for the recipients of their blood components.
Material and Methods
We studied recipients of B19V DNA-positive blood components [red blood cell concentrates (RBCs), pooled platelet concentrates and fresh frozen plasma]. This included archived pretransfusion samples as well as follow-up samples investigated by ELISA or NAT and genome sequence analysis.
Results
In 132 out of 424 recipients, we could detect no anti-B19V IgG before transfusion. In 67 out of 132 sero-negative recipients, a follow-up sample was available. Sixty-five of these received blood components from donors with <104 IU B19V DNA/ml plasma and had no evidence of transfusion-transmitted (TT)-B19V infection. Homology in genome sequences in donor and recipient provided evidence for a TT-B19V infection in two recipients. Both patients received RBC containing 3·4 × 106 and 1·8 × 104 IU B19V DNA/ml plasma, respectively. The anti-B19V IgG titres in the donors were 2 and 76 IU/ml plasma, respectively. The antibodies in the second donor were directed against capsid proteins and are thus considered as potential neutralizing antibodies.
Conclusions
TT-B19V infections through blood components with low (<104 IU/ml plasma) B19V DNA concentrations did not occur in our study. One of the TT-B19V infections occurred from RBC with intermediate B19V DNA concentration despite the presence of potential neutralizing antibodies in the donor, but its clinical significance was low.
TL;DR: EMS can improve glucose metabolism and functional performance in T2DM patients and might help patients to overcome their sedentary lifestyle, and data suggest that EMS might emerge as a novel additional therapeutic mode of exercise training.
Abstract: Aims: In patients with type 2 diabetes mellitus (T2DM) exercise training is recommended to improve glycemic control. Electrical myostimulation (EMS) of skeletal muscles is a new method to increase exercise capacity in patients with chronic heart failure. The aim of this study was to investigate the effects of EMS in T2DM on glucose metabolism, body composition, and exercise performance using a newly designed stimulation suit that involves trunk, leg, and arm muscles. Subjects and Methods: Fifteen individuals (nine males; 61.7±14.8 years old) were trained for 10 weeks twice weekly for 20 min with EMS. Effects on glucose, glycosylated hemoglobin (HbA1c), oxygen consumption, and body composition were evaluated. Results: There was a significant increase of oxygen uptake at the aerobic threshold from 12.3±0.8 to 13.3±0.7 mL/kg/min (P=0.003) and of maximal work capacity from 96.9±6.4 to 101.4±7.9 W (P=0.046), with a concomitant trend for improved maximal oxygen uptake (from 14.5±0.9 to 14.7±0.9 mL/kg/m...
TL;DR: If confirmed in clinical trials, preoperative administration of vitamin D or activated vitamin D (in case of chronic kidney disease) would be a promising strategy to prevent anemia in patients scheduled for cardiac surgery.
Abstract: Background
Preoperative anemia is considered an independent risk factor of poor clinical outcome in cardiac surgical patients. Low vitamin D status may increase anemia risk.
Methods
We investigated 3,615 consecutive patients scheduled for cardiac surgery to determine the association between preoperative anemia (hemoglobin [Hb] <12.5 g/dL) and circulating levels of the vitamin D metabolites 25-hydroxyvitamin D (25OHD) and 1,25-dihydroxyvitamin D (1,25[OH]2D).
Results
Of the study cohort, 27.8 % met the criteria for anemia. In patients with deficient 25OHD levels ( 70 pmol/l; P<0.001). In multivariable–adjusted logistic regression analyses, the odds ratios for anemia of the lowest categories of 25OHD and 1,25(OH)2D were 1.48 (95%CI:1.19-1.83) and 2.35 (95%CI:1.86-2.97), compared with patients who had adequate 25OHD levels and 1,25(OH)2D values in the highest category, respectively. Anemia risk was greatest in patients with dual deficiency of 25OHD and 1,25(OH)2D (multivariable-adjusted OR = 3.60 (95%CI:2.40-5.40). Prevalence of deficient 25OHD levels was highest in anemia of nutrient deficiency, whereas low 1,25(OH)2D levels were most frequent in anemia of chronic kidney disease.
Conclusion
This cross-sectional study demonstrates an independent inverse association between vitamin D status and anemia risk. If confirmed in clinical trials, preoperative administration of vitamin D or activated vitamin D (in case of chronic kidney disease) would be a promising strategy to prevent anemia in patients scheduled for cardiac surgery.
TL;DR: Standard CSWT has the potential to improve myocardial perfusion of the therapy zone and clinical CAD symptomatology without affecting global myocardian perfusion, according to a threshold of increased perfusion.
Abstract: Background
Ultrasound guided cardiac shock wave therapy (CSWT) is a noninvasive therapeutic option in the treatment of chronic-refractory angina. Clinical trials have shown that CSWT reduces angina symptoms, improves regional systolic function, LV ejection fraction, myocardial perfusion and quality of life parameters. Absolute measurements of myocardial perfusion before and after CSWT have not been performed so far.
TL;DR: This study suggests that MDR1 is of less importance for drug resistance in PC cells than in other types of solid cancer, and in contrast to YB-1 properties in other malignancies, MDR 1 regulation through Yb-1 seems to be unlikely.
Abstract: The development of a drug-resistant phenotype is the major challenge during treatment of castration-resistant prostate cancer (PC). In solid cancer entities, one of the major contributors to chemoresistance is the multidrug resistance 1 (MDR1) protein. Believed to be involved in the induction of MDR1 expression is the presence of anticancer drugs as well as the Y box binding protein 1 (YB-1).
Basal as well as drug-induced expression of MDR1 in established PC cell lines was assessed by Western blotting and mass spectrometry. Subsequently, the influence of YB-1 on MDR1 expression was examined via transient overexpression of YB-1. While LNCaP and PC-3 cells showed no detectable amounts of MDR1, the resistance factor was found to be expressed in 22Rv1 cells. Despite this difference, all three cell lines demonstrated similar growth behavior in the presence of the first-line chemotherapeutic agent docetaxel. Incubation of 22Rv1 cells with docetaxel, cabazitaxel, and abiraterone did not significantly alter MDR1 expression levels. Furthermore, overexpression of the MDR1 controlling factor YB-1 showed no impact on MDR1 expression levels. MDR1 was detectable in the PC cell line 22Rv1. However, this study suggests that MDR1 is of less importance for drug resistance in PC cells than in other types of solid cancer. Furthermore, in contrast to YB-1 properties in other malignancies, MDR1 regulation through YB-1 seems to be unlikely.
TL;DR: The Nobori DES performed well in patients with diabetes mellitus, however, the absence of late, and very late stent thrombosis in IDDM patients merits further investigation, as this finding might have significant clinical value.
Abstract: OBJECTIVE This study investigates the safety and efficacy of a third-generation drug-eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus (DM). CLINICAL TRIAL REGISTRATION ISRCTN81649913. BACKGROUND Percutaneous coronary interventions in patients with DM are associated with a higher incidence of death, restenosis, and stent thrombosis as compared to non-diabetic patients. The use of a DES has been shown to improve outcomes in diabetic patients. METHODS Out of 3,067 patients, enrolled in 126 centers worldwide in the NOBORI 2 registry, 888 patients suffered from DM, 213 of them (14%) being insulin-dependent DM (IDDM). Two years' follow-up has been completed in this study. RESULTS At 1- and 2-year follow-up, 97% and 95% of the patients, respectively, were available. The reported target lesion failure (TLF) rates at 1- and 2-year follow-up were 6.0% and 7.2% in the DM group, respectively, and 3.0% and 4.2% in the non-DM group, respectively (P<0.001 for both years). Inside the DM group, the TLF rates of 9.9% and 11.7% at the 1- and 2-year follow-ups, respectively, in patients with IDDM were significantly higher than the TLF rates of 4.7% and 5.8%, respectively, in the non-IDDM subgroup (P<0.01 for both years). The rate of stent thrombosis at the 2-year follow-up was 1.0% in the DM group and 0.7% in non-DM patients. There were no cases of late, or very late stent thrombosis in IDDM patients. CONCLUSION The Nobori DES performed well in patients with DM. As expected, patients with DM, particularly those with IDDM, had worse outcomes. However, the absence of late, and very late stent thrombosis in IDDM patients merits further investigation, as this finding might have significant clinical value.
TL;DR: Sleep-disordered breathing (SDB) represents a highly prevalent comorbidity in heart failure patients and moderate to severe obstructive sleep apnea (OSA) or preserved ejection fraction is a major concern.
Abstract: Sleep-disordered breathing (SDB) represents a highly prevalent comorbidity in heart failure (HF) patients. Approximately 45% of stable patients with either heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction have moderate to severe obstructive sleep apnea (OSA) or
TL;DR: In this article, the authors measured circulating 25-hydroxyvitamin D (25OHD), 1,25-dihydroxyv vitamin D3 (1,25[OH]2D3), parathyroid hormone (PTH), and fibroblast growth factor (FGF)-23 shortly before LVAD implantation and investigated their association with stroke and mortality risk during 1-year follow-up.
Abstract: Stroke and mortality risk in patients with left ventricular assist device (LVAD) implants continue to be high. Whether nonclassical cardiovascular risk markers such as vitamin D metabolites and fibroblast growth factor (FGF)-23 contribute to this risk remains to be studied, and this was the objective of our work.
In 154 LVAD patients (91 HeartWare and 63 HeartMate II implants), we measured circulating 25-hydroxyvitamin D (25OHD), 1,25-dihydroxyvitamin D3 (1,25[OH]2D3), parathyroid hormone (PTH) and FGF-23 shortly before LVAD implantation and investigated their association with stroke and mortality risk during 1-year follow-up. Of the study cohort, 34.4 and 92.2 %, respectively, had deficient 25OHD ( 6.7 pmol/l) and FGF-23 values above the reference range (100 RU/ml). One-year freedom from stroke was 80.9 %, and 1-year survival was 64.3 %. The multivariable-adjusted hazard ratio of stroke was 2.44 (95 % CI: 1.09–5.45; P = 0.03) for the subgroup of 25OHD levels <25 nmol/l (reference group: 25OHD levels ≥25 nmol/l). The multivariable-adjusted hazard ratio of 1-year mortality was 2.78 (95 % CI: 1.52–5.09; P = 0.001) for patients with 25OHD levels <25 nmol/l compared with patients with 25OHD levels ≥25 nmol/l. PTH, FGF-23 and 1,25(OH)2D3 were not associated with stroke or mortality risk. In LVAD patients, deficient 25OHD levels are independently associated with high stroke and mortality risk. If confirmed in randomized controlled trials, preoperative correction of deficient vitamin D status could be a promising measure to reduce stroke and mortality risk in LVAD patients.
TL;DR: In patients with HCM, leMDCT provides volumetric assessment of LE mass—absolutely and by percent LV-MM as well as late enhancement (LE) in late-enhanced multislice computed tomography (leMDCT).
Abstract: INTRODUCTION With subgroups of patients with hypertrophic cardiomyopathy (HCM) confers a 4% to 5% risk for adverse prognosis. Besides left-ventricular muscle mass (LV-MM) myocardial fibrosis (MF) assessable by late gadolinium enhancement in cardiovascular magnetic resonance (LGE-CMR) has been related to that. Myocardial fibrosis can also be demonstrated by late enhancement (LE) in late-enhanced multislice computed tomography (leMDCT). This analysis investigates leMDCT whether to enable quantification of LE load in terms of LE mass by percent LV-MM in HCM. METHODS In a prospective validation study, we included 30 consecutive patients with HCM who underwent leMDCT (64 slice) and LGE-CMR (1.5 T). The leMDCT scan was performed 7 minutes after injection of iodine contrast (Iopromid). Endocardial and epicardial planimetry served for the assessment of LV-MM. Visually detectable LE was quantified using the manual quantification method resulting in LE by percent LV-MM (%LE). The LGE-CMR data served for validation. RESULTS Mean (SD) age was 64.1 (13.9) years. Myocardial fibrosis prevalence was 63.3% (19/30 patients indentified by both leMDCT and LGE-CMR). In leMDCT, tissue density in LE areas compared with normal myocardium was higher (138.2 [23.9] HU vs 98.4 [16.5] HU, P < 0.001) but lower than in the LV cavity (138.2 [23.9] HU vs 169.2 [35.9] HU, P < 0.001). Late enhancement mass in leMDCT seemed to be 7.9 (8.5) g LE versus 8.6 [11] g LGE in CMR (P = 0.497, r = 0.95) resulting in a leMDCT/LGE-CMR relation of 1.2. Referring LE mass to LV-MM gave an LE proportion measured by leMDCT of 4 (3.9) %LE versus 3.9 (4.1) %LGE in LGE-CMR (r = 0.88, P = 0.75). Intraobserver/interobserver reliability of LE mass assessment showed an intraclass correlation coefficient of 0.99 and 0.97. CONCLUSIONS In patients with HCM, leMDCT provides volumetric assessment of LE mass-absolutely and by percent LV-MM.
TL;DR: This proficiency panel facilitates the verification of the analytical sensitivity of rapid and cultural bacterial detection systems under controlled routine conditions.
Abstract: Background: The most frequent infectious complication in transfusion therapy in developed countries is related to the bacterial contamination of platelet concentrates (PCs). Rapid and cultural screening methods for bacterial detection in platelets are available, but external performance evaluation, especially of rapid methods, has been difficult to realize so far. Here we summarize the results of three individual collaborative trials using an external quality assessment program (EQAP) for the application of current rapid and cultural screening methods. Methods: Three different modules were available for the detection of bacterial contamination: module 1: rapid methods, module 2: culture methods, module 3: bacterial identification methods. The sample set-up included up to six different bacterial strains, 1-2 negative samples and 4-6 positive samples with stabilized bacterial cell counts (approximately 103/104/105 CFU/ml). Time schedule for testing was limited (module 1: 6 h, module 2 and 3: 7 days). Results: Samples of module 1 were analyzed with two different rapid methods (BactiFlow, NAT). The results of the three individual collaborative trials showed that all participants detected the negative samples with both assays correctly. Samples spiked with 104 to 105 CFU/ml of bacteria obtained positive results with both rapid screening methods, whereas samples spiked with only 103 CFU/ml disclosed a lower number of correctly identified positive results by NAT (86.6-93.8% sensitivity) compared to BactiFlow (100% sensitivity). The results for modules 2 and 3 revealed a 100% diagnostic sensitivity and specificity in all three collaborative trials. Conclusion: This proficiency panel facilitates the verification of the analytical sensitivity of rapid and cultural bacterial detection systems under controlled routine conditions. The concept of samples provided in this EQAP has three main advantages: i) samples can be examined by both rapid and culture methods, ii) the provided material is matrix-equivalent, and iii) the sample material is ready-to-use.
TL;DR: Data indicate that in patients with high cardiovascular risk profile medication use does not substantially contribute to 25OHD levels <50 nmol/l.
Abstract: Background and aim Low vitamin D status, i.e. circulating 25-hydroxyvitamin D (25OHD) levels Methods and results A total of 11,256 patients were included in this cross-sectional study. We compared 25OHD levels of medication users (18 groups of continuously used and 5 groups of intermittently used medications) with levels of non-users. Moreover, we assessed variables (medications, demographic and clinical parameters) that were independently associated with 25OHD levels Conclusion Data indicate that in patients with high cardiovascular risk profile medication use does not substantially contribute to 25OHD levels
TL;DR: The prevalence and presentation of Nocardiosis in HT recipients in a retrospective cross-sectional analysis found that heart transplant recipients initially had an especially high rate of N Cardia infection, but this could be reduced by the routine use of cyclosporine.
Abstract: Nocardia has emerged as an important opportunistic pathogen, especially in organ transplant recipients. Heart transplant (HT) recipients initially had an especially high rate of Nocardia infection, but this could be reduced by the routine use of cyclosporine. Our objective was to clarify the prevalence and presentation of Nocardiosis in HT recipients in a retrospective cross-sectional analysis.
01 Apr 2015
TL;DR: A growing body of evidence that treating SDB in patients with heart failure, particularly using adaptive servoventilation (ASV) for CSA/CSR, improves functional outcomes such as HF symptoms, cardiac function, cardiac disease markers, exercise tolerance and quality of life.
Abstract: Sleep-disordered breathing (SDB), either obstructive sleep apnoea (OSA) or central sleep apnoea (CSA)/Cheyne-Stokes respiration (CSR) and often a combination of the two, is highly prevalent in patients with heart failure (HF), is associated with reduced functional capacity and quality of life, and has a negative prognostic impact. European HF guidelines identify that sleep apnoea is of concern in patients with HF. Continuous positive airway pressure is the treatment of choice for OSA, and adaptive servoventilation (ASV) appears to be the most consistently effective therapy for CSA/CSR while also being able to treat concomitant obstructive events. There is a growing body of evidence that treating SDB in patients with HF, particularly using ASV for CSA/CSR, improves functional outcomes such as HF symptoms, cardiac function, cardiac disease markers, exercise tolerance and quality of life. However, conflicting results have been reported on 'hard' outcomes such as mortality and healthcare utilisation, and the influence of effectively treating SDB, including CSA/CSR, remains to be determined in randomised clinical trials. Two such trials (SERVE-HF and ADVENT-HF) in chronic stable HF and another in post-acute decompensated HF (CAT-HF) are currently underway.
Journal Article•
TL;DR: Although stenting may be a good solution, self-expanding transcatheter aortic valves should be preferred in patients with ascending aorta grafts to avoid the described complication.
Abstract: An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.
TL;DR: The history and actual developments of standardization of NAT for blood-borne pathogens, including the current WHO International Standards (IS) for NAT and the International Reference Panels for different genotypes are described here in detail.
Abstract: The implementation of nucleic acid amplification techniques (NAT) over the last two decades has totally revolutionized the field of transfusion medicine and blood safety. Several blood services started to screen for viral pathogens (HIV-1, HCV, HBV) with NAT on a voluntary basis in Germany in 1997. Later, the Paul-Ehrlich Institut (PEI) required that from April 1, 1999, NAT testing for HCV RNA is performed on all donations for the release of therapeutic blood components. The routine application of NAT required validation using appropriate standard reagents. In order to address this area scientifically, the WHO (World Health Organization) International Working Group on the Standardization of Gene Amplification Techniques (SoGAT) for the Virological Safety Testing of Blood and Blood Products was established at the National Institute for Biological Standards and Control (NIBSC), UK, in 1995. The purpose of this group is to promote the standardization of amplification methods through the exchange of information on scientific aspects of the technology, exchange of data on its evaluation for the testing of products, and the organization of international collaborative studies for the development, evaluation and provision of reference materials and working standards. Numerous in-house working reagents and reference panels existed in the pre-SoGAT era that used a variety of units, e.g. genome equivalents/ml, copies/ml or PCR-detectable units/ml. The solution was to establish internationally accepted standards against which all working reagents could be calibrated [1,2,3].
Baylis et al. [4] give a fine overview on the history and actual developments of standardization of NAT for blood-borne pathogens in this issue of Transfusion Medicine and Hemotherapy. The current WHO International Standards (IS) for NAT and the International Reference Panels for different genotypes are described here in detail. The great advantage of the development of IS is the physically defined International Unit (IU), which allows the worldwide comparability of NAT test results and the replacement of standard preparations under maintenance of this measurement unit for the first time. Today, IS are widely used for the validation of newly developed NAT assays, e.g. by in vitro diagnostic (IVD) manufacturers, and for the calibration of secondary standards which are commonly used as run controls or in quality assurance proficiency panels.
It is difficult to cross-reference molecular assays or to validate novel NAT assays without well characterized reference materials. The lack of an IS for West Nile virus (WNV) RNA, for example, hindered the determination of the analytical sensitivity (95% limit of detection). Therefore, the German authority PEI required the use of the Health Canada WNV Reference Reagent or similarly calibrated secondary standards for the quantification of assays. These standards are expressed in copies/ml and make comparison of results more difficult.
In addition to the standardization of NAT by the use of IS, the periodic review of the actual performance of methods is the second main pillar of quality assurance and quality control. Moreover, participation in external quality assurance programs is necessary. Several programs for proficiency testing for infectious diseases have been established in molecular diagnostics in Europe, including EQUALqual, a project proposed under the auspices of the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) and funded by the European Commission, and several commercially available programs provided by, for example, Quality Control for Molecular Diagnostics (QCMD, UK), the United Kingdom National External Quality Assessment Service (NEQAS, UK), the Reference Institute for Bioanalytics (RfB, Germany), and the Institute for Standardization and Documentation in Medical Laboratory (INSTAND, Germany) [5]. Recently, a novel format for a personalized external quality assurance program (EQAP) was described that provides a collaborative trial for genomic detection of eight viruses simultaneously: HAV, HBV, HCV, HIV-1, HIV-2, parvovirus B19 (B19V), WNV and human cytomegalovirus (HCMV) [6]. The so-called MultiVir NAT is organized by the RfB, Germany. This EQAP enables flexible participation regarding the testing of 1-8 different transfusion-relevant viruses, qualitatively and/or quantitatively, and provides result reporting within 4 weeks. Barcoded samples can be processed as routine samples in an automated PCR workflow.
Compared to viral pathogens, the transfusion-relevant bacteria have been neglected regarding quality assurance and quality control. Bacterial contamination of platelet concentrates (PC) remains a persistent problem in transfusion medicine. The residual risk of transfusion-related bacterial infections is currently 8- to 200-fold higher than the residual risk of virus infections (e.g. HIV-1, HCV or HBV). Platelets are the main focus of bacterial contamination, due to the storage temperature of 22 °C providing optimal growth conditions for a broad range of bacteria. Nevertheless, fatal septic reactions have also been reported after transfusion of contaminated red cell concentrates. The maximum shelf life for platelets was reduced from 5 to 4 days in Germany to increase blood safety. Alternatively, rapid screening methods for bacterial detection in platelets have been optimized over the last decade and are now available for routine screening [7].
The validation and head-to-head comparison of these rapid bacterial detection methods, however, represent a complicated process. An important criterion for the evaluation of an analytical method is the determination of the lower detection limit, requiring defined standards. However, standards are not yet available for microbiological diagnostics and are, thus, produced by each laboratory individually. Ascertaining the target values of these standards is extremely problematic because no metrologically correct measuring system for these parameters exists. Additionally, reference methods for bacterial quantification are not available. Target values for the so-called standards are, therefore, attained using either the routine methods biologically characterizing the standard or the same method used to screen the sample material. The routine methods used in microbiology are less reliable (incorrect and imprecise). The current practice is quantification via either i) bacterial titer expressed as colony-forming units (CFU) or ii) the nucleic acid molecule for detection expressed in copies or genome equivalents. Currently, defined, qualified microbiological standards are not yet available, with the exception of the WHO Repository of Platelet Transfusion Relevant Bacteria Reference Strains, which were designed for the low-titer spiking of blood components with a guaranteed ability to multiply in PC. The International Society of Blood Transfusion (ISBT) Working Party Transfusion-Transmitted Infectious Diseases (WP-TTID), Subgroup Bacteria, organized an international study on bacteria standards to be used as a tool for development, validation, and comparison of both bacterial screening and pathogen reduction methods [8].
Vollmer et al. [9] present data in this issue on the first three individual collaborative trials for the detection of bacterial contamination in PC. The problems of standardization of bacterial detection methods with cultural and rapid methods were described in this study. Compared to viral parameters, an EQAP for the detection of bacterial contamination in PC has some special requirements: i) bacteria are supposed to have the ability to proliferate because some test principles are dependent on cell viability, but ii) titers have to be constant between sample setup and execution of analysis to obtain the highest reproducibility of results. This promising approach enables the head-to-head comparison of rapid and cultural bacterial detection systems for the first time. A special challenge is that the bacterial titer (expressed as CFU) is not static in samples or blood components, because microorganisms have the ability to proliferate during storage. By contrast, there is a direct correlation between viral load and copy number determined by NAT for viral approaches. For viral NAT assays, standardization was achieved by using well characterized reference material, i.e. calibrated material using a common standard unit (IU). For bacteria, there are several problems and questions regarding the establishment of a standard preparation. Bacteria are living organisms and, in contrast to viruses, are changeable regarding their metabolism.
Altogether, this issue of Transfusion Medicine and Hemotherapy provides an insight into the history and new developments of the standardization of diagnostics, and challenges and difficulties concerning the improvement of blood safety.
TL;DR: This meta-analysis is based on several observational and a few randomized studies in which the incidence of the recorded outcomes are reported, as correctly reported, in several studies.
Abstract: We thank Petretta1 for his appreciation of our recent meta-analysis published in Circulation: Arrhythmia Electrophysiology 2 and for giving us the ability to clarify some aspects concerning the statistical analysis.
Our meta-analysis is based on several observational and a few randomized studies in which the incidence of the recorded outcomes are reported, as correctly …