Extracts from Butcher's broom rhizome (Ruscus aculeatus) have been widely used in the oral treatment of lower leg edema in patients with chronic venous insufficiency. The aim of the present multi-center, double-blind, randomized, placebo-controlled trial was to confirm the efficacy and safety of a ruscus extract (Fagorutin Ruscus Kapseln) according to the latest scientific standards. 166 women suffering from chronic venous insufficiency (Widmer grade I and II, CEAP (Clinical signs, Etiological classification, Anatomic distribution, Pathophysiology) 3-4) were included. The data of 148 patients (30-89 years, 150-182 cm height, 49-97 kg body weight) with a mean disease duration of 14.6 years in the ruscus extract group and 15.1 years in the placebo group were eligible for the intent-to-treat-analysis. The primary parameter was the area under baseline of the leg volume changes over 12 weeks (AUB0-12). Secondary parameters were the changes in circumference of the lower leg and the ankle, changes in subjective symptoms and quality of life, the overall efficacy and tolerability and safety parameters. The study was carried out according to the guidelines for testing drugs for chronic venous insufficiency. There were significant differences between the treatment groups ruscus and placebo for the AUB0-12 (-827 ml x day), for the change of leg volume after 8 and 12 weeks of treatment (-16.5 ml and -20.5 ml), for changes in ankle and leg circumferences after 8 and 12 weeks of treatment, and for the changes in subjective symptoms, heavy tired legs and sensation of tension (week 12). For the changes in the symptoms heavy lower legs, sensation of tension, and tingling sensation a significant positive correlation with the changes in leg volume was shown. Overall assessment of efficacy was significantly better for ruscus extract compared to placebo. Overall tolerability for both treatments was assessed as good and very good. Of all 48 adverse events occurring in both treatment groups, 22 were reported in the ruscus group, one of them was considered to be related to the study medication (unlikely). Considering the study duration of three months it is concluded, that ruscus extract, in the recommended daily dosage according to the German monograph, is a safe and effective treatment for patients suffering from chronic venous insufficiency.

ObjectivesTransfusion of allogeneic blood is still common in orthopedic surgery. This analysis evaluates from the perspective of a German hospital the potential cost savings of Epoetin alfa (EPO) compared to predonated autologous blood transfusions or to a nobloodconservationstrategy (allogeneic blood transfusion strategy)during elective hip and knee replacement surgery.MethodsIndividual patients (N = 50,000) were simulated based on data from controlled trials, the German DRG institute (InEK) and various publications and entered into a stochastic model (Monte-Carlo) of three treatment arms: EPO, preoperative autologous donation and nobloodconservationstrategy. All three strategies lead to a different risk for an allogeneic blood transfusion. The model focused on the costs and events of the three different procedures. The costs were obtained from clinical trial databases, the German DRG system, patient records and medical publications: transfusion (allogeneic red blood cells: €320/unit and autologous red blood cells: €250/unit), pneumonia treatment (€5,000), and length of stay (€300/day). Probabilistic sensitivity analyses were performed to determine which factors had an influence on the model's clinical and cost outcomes.ResultsAt acquisition costs of €200/40,000 IU EPO is cost saving compared to autologous blood donation, and cost-effective compared to a nobloodconservationstrategy. The results were most sensitive to the cost of EPO, blood units and hospital days.ConclusionsEPO might become an attractive blood conservation strategy for anemic patients at reasonable costs due to the reduction in allogeneic blood transfusions, in the modeled incidence of transfusion-associated pneumonia andthe prolongedlength of stay.

Postoperative, new-onset atrial fibrillation (POAF) is one of the most common complications after cardiosurgical procedures. Vernakalant has been reported to be effective in the conversion of POAF. The aim of this study was to evaluate the efficacy and safety of vernakalant for atrial fibrillation after cardiac operations, and to investigate predictors for the success of vernakalant treatment. Patients and Methods: Post-cardiac surgery patients with new-onset of atrial fibrillation (AF) were consecutively enrolled in this study. Demographic data as well as intraoperative and postoperative parameters were analyzed. Vernakalant administration was primarily started 5.5 hours after new-onset POAF: 3 mg/kg intravenously over 10 min, and in case of non-conversion, a second dose of 2 mg/kg intravenously over 10 min. Results: 129 consecutive patients (70.2 ± 9.1 years) were included: 61 patients with coronary artery bypass graft (CABG) surgery, 49 patients with isolated valve procedures, and 19 patients with combined procedures (CABG and valve). Conversion in sinus rhythm was achieved after the first vernakalant dose in 57 patients (44%), and after the second dose in 41 patients (32%). The mean time to conversion was 13.7 ± 14.1 min. The patients receiving valve procedures depicted a significantly lower conversion rate. The following variables lowered conversion rate: no preoperative beta blocker, postoperative troponin levels >500 ng/L, and systolic blood pressure >140 mmHg. At the first follow-up, 92% of the converted patients showed sinus rhythm, while 80% of the non-responders showed sinus rhythm (P < .01). Conclusions: The POAF was effectively converted by vernakalant. The conversion rate of POAF after valve surgery was lower when compared to isolated CABG.

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Background: The CADScor®System is a noninvasive and radiation-free technology that searches for stenosis induced by turbulent coronary blood flow. A CADSscore represents the acoustic detection results of coronary stenoses. We assessed consecutive patients with stable symptoms without known coronary artery disease (CAD) to define a low risk for obstructive CAD based on a low CAD score than a standard approach of clinical assessment using noninvasive and invasive diagnostic measurements. Methods: Overall, 214 consecutive patients aged ˃40 years in a German cardiological outpatient unit were included. Patients underwent an initial clinical assessment, a double-blinded CAD score, standard examinations, and a national guidance-based diagnostic cascade. They underwent a 6-month telephone follow-up to capture future CAD events. A CAD score of ≤20 was defined as low risk. Results: Overall, 196 patients completed the planned diagnostic workup after their initial visit, and 187 had a valid CAD score. All 196 patients underwent an electrocardiogram (ECG) and echocardiography, and 178 patients underwent a stress ECG. According to the initial standard evaluation, 41 patients were considered to be low-risk without further diagnosis. A CAD score of ≤20 was found in 51 patients. According to clinical standards, 85 and 77 patients underwent noninvasive testing and invasive angiography, respectively. The obstructive CAD was invasively diagnosed in 25 patients, of whom 4 had a CAD score of ≤20. No additional CAD was detected at the 6-month follow-up. Overall, 41 of the 165 noninvasive and invasive diagnostic procedures could have been avoided with a CAD score of ≤20 as the exclusion criterion for further diagnosis after the standard initial diagnosis. Furthermore, 10 of the 52 invasive procedures without evidence of obstructive CAD could have been prevented. Conclusions: The obstructive CAD was confirmed in 12.8% of patients with stable symptoms and suspected CAD. Therefore, advanced noninvasive testing was mainly used for further CAD exclusion. The diagnostic yield of invasive angiography was low, and approximately a quarter of further diagnostic procedures could have been avoided with the CAD score, which showed an acceptable false-negative rate compared with the standard diagnostic tools. Trial registration: Deutsches Register Klinischer Studien (DRKS): DRKS00016986 (22/03/2019)