Christiane Prettin

Titration to target dose of bisoprolol vs. carvedilol in elderly patients with heart failure: the CIBIS‐ELD trial

Various beta‐blockers with distinct pharmacological profiles are approved in heart failure, yet they remain underused and underdosed. Although potentially of major public health importance, whether one agent is superior in terms of tolerability and optimal dosing has not been investigated. The aim of this study was therefore to compare the tolerability and clinical effects of two proven beta‐blockers in elderly patients with heart failure.

Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial.

IMPORTANCE Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown. OBJECTIVE To determine whether 24 months of treatment with escitalopram improves mortality, morbidity, and mood in patients with chronic systolic heart failure and depression. DESIGN, SETTING, AND PARTICIPANTS The Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients (MOOD-HF) study was a double-blind, placebo-controlled randomized clinical trial conducted at 16 tertiary medical centers in Germany. Between March 2009 and February 2014, patients at outpatient clinics with New York Heart Association class II-IV heart failure and reduced left ventricular ejection fraction (<45%) were screened for depression using the 9-item Patient Health Questionnaire. Patients with suspected depression were then invited to undergo a Structured Clinical Interview based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) to establish the diagnosis. INTERVENTIONS Patients were randomized 1:1 to receive escitalopram (10-20 mg) or matching placebo in addition to optimal heart failure therapy. Study duration was 24 months. MAIN OUTCOMES AND MEASURES The composite primary outcome was time to all-cause death or hospitalization. Prespecified secondary outcomes included safety and depression severity at 12 weeks of treatment (including the titration period), which were determined using the 10-item Montgomery-Åsberg Depression Rating Scale (total possible score, 0 to 60; higher scores indicate more severe depression). RESULTS A total of 372 patients (mean age, 62 years; 24% female) were randomized and had taken at least 1 dose of study medication when the data and safety monitoring committee recommended the trial be stopped early. During a median participation time of 18.4 months (n = 185) for the escitalopram group and 18.7 months (n = 187) for the placebo group, the primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99 [95% CI, 0.76 to 1.27]; P = .92). The mean Montgomery-Åsberg Depression Rating Scale sum score changed from 20.2 at baseline to 11.2 at 12 weeks in the escitalopram group and from 21.4 to 12.5 in the placebo group (between-group difference, -0.9 [95% CI,-2.6 to 0.7]; P = .26). Safety parameters were comparable between groups. CONCLUSIONS AND RELEVANCE In patients with chronic heart failure with reduced ejection fraction and depression, 18 months of treatment with escitalopram compared with placebo did not significantly reduce all-cause mortality or hospitalization, and there was no significant improvement in depression. These findings do not support the use of escitalopram in patients with chronic systolic heart failure and depression. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN33128015.

Evaluation of Transient Elastography, Acoustic Radiation Force Impulse Imaging (ARFI), and Enhanced Liver Function (ELF) Score for Detection of Fibrosis in Morbidly Obese Patients.

Background Liver fibrosis induced by non-alcoholic fatty liver disease causes peri-interventional complications in morbidly obese patients. We determined the performance of transient elastography (TE), acoustic radiation force impulse (ARFI) imaging, and enhanced liver fibrosis (ELF) score for fibrosis detection in bariatric patients. Patients and Methods 41 patients (median BMI 47 kg/m2) underwent 14-day low-energy diets to improve conditions prior to bariatric surgery (day 0). TE (M and XL probe), ARFI, and ELF score were performed on days -15 and -1 and compared with intraoperative liver biopsies (NAS staging). Results Valid TE and ARFI results at day -15 and -1 were obtained in 49%/88% and 51%/90% of cases, respectively. High skin-to-liver-capsule distances correlated with invalid TE measurements. Fibrosis of liver biopsies was staged as F1 and F3 in n = 40 and n = 1 individuals. However, variations (median/range at d-15/-1) of TE (4.6/2.6–75 and 6.7/2.9–21.3 kPa) and ARFI (2.1/0.7–3.7 and 2.0/0.7–3.8 m/s) were high and associated with overestimation of fibrosis. The ELF score correctly classified 87.5% of patients. Conclusion In bariatric patients, performance of TE and ARFI was poor and did not improve after weight loss. The ELF score correctly classified the majority of cases and should be further evaluated.

Carotid-artery stenting in a high-risk patient population--single centre, single operator results.

SummaryAimsThe aim of this study was to assess the outcome of carotid-artery stenting (CAS) in high-risk patients in routine clinical settings while excluding the impact of multiple operators and the learning curve of individual operators on the outcome, and to determine the impact of individual risk factors, including vascular multimorbidity, on the outcome.Methods and resultsA total of 143 consecutive patients, 100 (69.9%) males and 43 (30.1%) females, mean age 68.7±8 years treated between February 1999 and May 2004 in the Heart Centre Coswig by a single operator for a symptomatic (n=37) and asymptomatic (n=106) on average greater than 70% (82.3±10.7%) or 80% (85.0±9.1%) NASCET carotid-artery stenosis, respectively, were studied. At least one NASCET exclusion criteria was present in 140 patients (97.9%), and vascular multimorbidity was present in 94 (65.7%) patients. In 28 (19.6%) patients there was a complete occlusion of the contralateral internal carotid artery and in 12 (8.4%) patients the procedure was performed prior to emergency coronary bypass surgery. In all, 47 (32.9%) procedures were performed without and 96 (67.1%) were performed with thromboembolic protection. Technical success was achieved in all patients. Combined neurological complications, TIA, PRIND and stroke, occurred in 5 (3.5%) patients, of which 3 (2.1%) were PRIND and 2 (1.4%) were strokes. The neurological complications were more frequent and more severe in symptomatic patients compared to asymptomatic patients (PRIND 2.7% vs 1.9%; stroke 0% vs 5.4%). In patients in whom thromboembolic protection was used, the rate of neurological complications was lower compared to those without protection (PRIND 1.0% vs 4.3%; stroke 1.0% vs. 2.1%). There was no death related to the procedure. Neurological complications were more frequent and more severe in patients with vascular multimorbidity compared to those with an isolated carotid-artery stenosis (4.2% vs 2.0%). The rate of neurological complications was similar in type II diabetics and nondiabetics (2.9% vs 4.1%). In 4.2%, minor complications related to the arterial puncture site were observed (3.5% hematoma not requiring blood transfusion, 0.7% pseudoaneurysm). At follow-up after a minimum of 6 months, 9 (6.3%) patients had died, the majority of whom had died of cardiovascular disease (3.5%).ConclusionsCAS can be performed with an acceptable risk in high-risk patients in routine clinical settings when it is performed by an experienced operator. The use of thromboembolic protection devices reduces the risk of neurological complications. Presence of vascular multimorbidity, but not diabetes, appears to increase the risk of all causes and of neurological complications.

Exercise training in Diastolic Heart Failure (Ex‐DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial

Heart failure with preserved ejection fraction (HFpEF) is a common disease with high incidence and increasing prevalence. Patients suffer from functional limitation, poor health‐related quality of life, and reduced prognosis. A pilot study in a smaller group of HFpEF patients showed that structured, supervised exercise training (ET) improves maximal exercise capacity, diastolic function, and physical quality of life. However, the long‐term effects of ET on patient‐related outcomes remain unclear in HFpEF. The primary objective of the Exercise training in Diastolic Heart Failure (Ex‐DHF) trial is to investigate whether a 12 month supervised ET can improve a clinically meaningful composite outcome score in HFpEF patients. Components of the outcome score are all‐cause mortality, hospitalizations, NYHA functional class, global self‐rated health, maximal exercise capacity, and diastolic function. After undergoing baseline assessments to determine whether ET can be performed safely, 320 patients at 11 trial sites with stable HFpEF are randomized 1:1 to supervised ET in addition to usual care or to usual care alone. Patients randomized to ET perform supervised endurance/resistance ET (3 times/week at a certified training centre) for 12 months. At baseline and during follow‐up, anthropometry, echocardiography, cardiopulmonary exercise testing, and health‐related quality of life evaluation are performed. Blood samples are collected to examine various biomarkers. Overall physical activity, training sessions, and adherence are monitored and documented throughout the study using patient diaries, heart rate monitors, and accelerometers. The Ex‐DHF trial is the first multicentre trial to assess the long‐term effects of a supervised ET programme on different outcome measures in patients with HFpEF.

Gelatine-Thrombin-Matrix zur Blutstillung

BACKGROUND To assess the feasibility of omitting thermal coagulation following cold knife tonsillectomy, we compared the use of a local thrombin hemostat (FloSeal®, FS) to bipolar electrocautery (EK). PATIENTS AND METHODS A total of 181 patients with chronic tonsillitis or tonsillar hypertrophy were stratified in terms of patient characteristics and randomized before undergoing tonsillectomy. The follow-up period continued until postoperative day 20. RESULTS FS-treated patients reported lower postoperative pain intensity scores (p = 0.011) and significantly reduced pain duration (p < 0.001). Whilst wound healing appeared to be improved in FS patients, the rates of postoperative hemorrhage remained unchanged. Use of an FS enabled inexperienced surgeons (< 100 procedures) to reduce their operating time by 8 min (p = 0.05), although no effect was observed for experienced surgeons. CONCLUSION Hemostasis is effectively mediated by an FS and its application reduces postoperative pain intensity and duration. Although we observed accelerated wound healing and reduced operating times owing to a more calculable rate of hemostasis, this did not influence the rates of postoperative hemorrhage.

Intentional single-stage revascularization of two different vascular beds in patients with vascular multimorbidity; a feasibility study.

AimsThe aim of this retrospective study was to assess the feasibility of catheter-based interventions in two different vascular beds performed in a single stage in patients with vascular multimorbidity.Methods and resultsFifty patients, 28 males, mean age 68.6 (±9.2) years and 22 females, mean ages 72.2 (±6.4) years were studied. At least one major cardiovascular risk factor was present in 48 (94%) of all patients. The most frequent combination of interventions was coronary artery disease (CAD) and renovascular disease (RVD) (20 patients, 40%) followed by CAD and peripheral artery disease (PAD) (17 patients, 34%). In all patients technical success, defined as residual stenosis ≤30% diameter, and procedural success, defined as lack of major adverse cardiac and cerebrovascular events (MACCE) during the in-hospital period, were achieved. In two patients surgical revision of the access site was required and in two additional patients minor local bleeding was observed.ConclusionsSequential vascular interventions in different vascular beds may be performed in a single stage with high success rates, however, compared to historical controls possibly at a higher rate of access site complications. A larger study using controls is needed to assess the medical benefits and cost efficacy of a single stage approach in patients with clinically relevant vascular multimorbidity.

[Gelatin-thrombin matrix-mediated hemostasis: application in tonsillectomy].

BACKGROUND To assess the feasibility of omitting thermal coagulation following cold knife tonsillectomy, we compared the use of a local thrombin hemostat (FloSeal®, FS) to bipolar electrocautery (EK). PATIENTS AND METHODS A total of 181 patients with chronic tonsillitis or tonsillar hypertrophy were stratified in terms of patient characteristics and randomized before undergoing tonsillectomy. The follow-up period continued until postoperative day 20. RESULTS FS-treated patients reported lower postoperative pain intensity scores (p = 0.011) and significantly reduced pain duration (p < 0.001). Whilst wound healing appeared to be improved in FS patients, the rates of postoperative hemorrhage remained unchanged. Use of an FS enabled inexperienced surgeons (< 100 procedures) to reduce their operating time by 8 min (p = 0.05), although no effect was observed for experienced surgeons. CONCLUSION Hemostasis is effectively mediated by an FS and its application reduces postoperative pain intensity and duration. Although we observed accelerated wound healing and reduced operating times owing to a more calculable rate of hemostasis, this did not influence the rates of postoperative hemorrhage.

Gelatine-Thrombin-Matrix zur Blutstillung@@@Gelatin-thrombin matrix-mediated hemostasis: Einsatz bei der Tonsillektomie@@@Application in tonsillectomy

BACKGROUND To assess the feasibility of omitting thermal coagulation following cold knife tonsillectomy, we compared the use of a local thrombin hemostat (FloSeal®, FS) to bipolar electrocautery (EK). PATIENTS AND METHODS A total of 181 patients with chronic tonsillitis or tonsillar hypertrophy were stratified in terms of patient characteristics and randomized before undergoing tonsillectomy. The follow-up period continued until postoperative day 20. RESULTS FS-treated patients reported lower postoperative pain intensity scores (p = 0.011) and significantly reduced pain duration (p < 0.001). Whilst wound healing appeared to be improved in FS patients, the rates of postoperative hemorrhage remained unchanged. Use of an FS enabled inexperienced surgeons (< 100 procedures) to reduce their operating time by 8 min (p = 0.05), although no effect was observed for experienced surgeons. CONCLUSION Hemostasis is effectively mediated by an FS and its application reduces postoperative pain intensity and duration. Although we observed accelerated wound healing and reduced operating times owing to a more calculable rate of hemostasis, this did not influence the rates of postoperative hemorrhage.

Recruiting and Baseline of the HIV-HEART Study: A Prospective, Multicenter Trial to Analyze Cardiac Diseases in HIV-Infected Patients

Background: An increased life span and the amount of cardiovascular risk factors necessitate a closer look on cardiac diseases in the population of human immunodeficiency virus (HIV) - infected subjects. Therefore, we launched a cardiology driven study analyzing HIV-associated diseases supported by the federal ministry of research. Methods: The HIV-HEART (HIV-infection and HEART disease) study is a prospective and multicenter cohort study performed in an urban area. The study comprehends standardized non-invasive cardiology tests of cardiac diseases, such as laboratory parameter, electrocardiogram, echocardiography and an endurance testing by a six-minute walk test. Results: In a 20 month recruiting period 802 HIV-infected patients (age: 44,2 ± 10,3 years; male: 83,4%) were included into the HIV-HEART Study. Duration of HIV-infection since initial diagnosis was 7,6 ± 5,8 years. Virus load was in 65,6% less than 50 copies/ml and CD4 - cell count (508,8 ± 300,6 cells/� l) was more than 500 cells/� l in 42,6%. A reduced CD4 - cell count between 200 and 499 cells/� l or less than 200 cells/� l was present in 45% and 12, 4%, respectively. Of all participants, 85,2% received antiretroviral therapy, most of these patients NRTIs (96,8%), followed by PIs (48,5%), and NNRTIs (45,7%). Conclusions: The characteristics of the HIV-HEART Study cohort are comparable to other national or international cohort registers on HIV-infected persons, performed in industrialized countries. Therefore, the HIV-HEART Study will be able to yield reliable data on the performance of HIV-associated diseases. (Clinical Trials NCT01119729).