The effect of spironolactone on diastolic function in haemodialysis patients.

Heart failure with preserved ejection fraction (HFpEF) is highly prevalent in patients on maintenance haemodialysis (HD) and lacks effective treatment. We investigated the effect of spironolactone on cardiac structure and function with a specific focus on diastolic function parameters. The MiREnDa trial examined the effect of 50 mg spironolactone once daily versus placebo on left ventricular mass index (LVMi) among 97 HD patients during 40 weeks of treatment. In this echocardiographic substudy, diastolic function was assessed using predefined structural and functional parameters including E/e'. Changes in the frequency of HFpEF were analysed using the comprehensive 'HFA-PEFF score'. Complete echocardiographic assessment was available in 65 individuals (59.5 ± 13.0 years, 21.5% female) with preserved left ventricular ejection fraction (LVEF > 50%). At baseline, mean E/e' was 15.2 ± 7.8 and 37 (56.9%) patients fulfilled the criteria of HFpEF according to the HFA-PEFF score. There was no significant difference in mean change of E/e' between the spironolactone group and the placebo group (+ 0.93 ± 5.39 vs. + 1.52 ± 5.94, p = 0.68) or in mean change of left atrial volume index (LAVi) (1.9 ± 12.3 ml/m2 vs. 1.7 ± 14.1 ml/m2, p = 0.89). Furthermore, spironolactone had no significant effect on mean change in LVMi (+ 0.8 ± 14.2 g/m2 vs. + 2.7 ± 15.9 g/m2; p = 0.72) or NT-proBNP (p = 0.96). Treatment with spironolactone did not alter HFA-PEFF score class compared with placebo (p = 0.63). Treatment with 50 mg of spironolactone for 40 weeks had no significant effect on diastolic function parameters in HD patients.The trial has been registered at clinicaltrials.gov (NCT01691053; first posted Sep. 24, 2012).

Performance of cone beam computed tomography in comparison to conventional imaging techniques for the detection of bone invasion in oral cancer.

Detecting bone invasion in oral cancer is crucial for therapy planning and the prognosis. The present study evaluated cone beam computed tomography (CBCT) for detecting bone invasion in comparison to standard imaging techniques. A total of 197 patients with diagnoses of oral cancer underwent CBCT as part of preoperative staging between January 2007 and April 2013. The sensitivity, specificity, and accuracy of CBCT were compared with panoramic radiography (PR), multi-slice computed tomography (CT) or magnetic resonance imaging (MRI), and bone scintigraphy (BS) using McNemar's test. Histopathology and clinical follow-up served as references for the presence of bone invasion. CBCT and BS (84.8% and 89.3%, respectively), as well as CBCT and CT/MRI (83.2%), showed comparable accuracy (P = 0.188 and P = 0.771). CBCT was significantly superior to PR, which was reconstructed based on a CBCT dataset (74.1%, P = 0.002). In detecting bone invasion, CBCT was significantly more accurate than PR and was comparable to BS and CT/MRI. However, each method has certain advantages, and the best combination of imaging methods must be evaluated in prospective clinic trials.

[Rivermead assessment of somatosensory performance: validation of a German version (RASP-DT)]. / Rivermead Assessment of Somatosensory Performance : Validierung einer deutschen Version (RASP DT).

BACKGROUND: Sensory deficits after stroke are common and impact motor regeneration and the total length of hospital stay as well as quality of life factors including the independence to conduct daily life activities. There is currently no existing reliable and standardized assessment tool to measure somatosensory performance in the German language. The aim of our study was to translate the original version of the Rivermead assessment for somatosensory performance (RASP) into German and to study its reliability in a German-speaking population sample. METHODS: The translation of the English original version followed the protocol of the Medical Outcomes Trust. The German version was assessed with 60 patients with first time presentation of subacute stroke and AC1 coefficients were calculated to measure interrater reliability for the different subtests. RESULTS: The mean AC1 value was 0.75 (range 0.58-0.81). The interrater reliability was good to excellent for all subtests. CONCLUSION: The German version of the RASP (RASP-DT) developed in this study is a reliable assessment instrument for sensory deficits after stroke.

Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study.

AIMS: Catheter ablation of the pulmonary veins (PVs) is a promising therapeutic approach for symptomatic atrial fibrillation (AF). The prospective randomized single-centre study 'Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation' (MACPAF; clinicaltrials.gov NCT01061931) compared the efficacy and safety of two balloon-based PV ablation systems. METHODS AND RESULTS: Thirty-two patients underwent PV ablation for symptomatic paroxysmal AF using the Arctic Front® or the HD Mesh Ablator® catheter according to study protocol. The primary endpoint was complete PV isolation (PVI) at the end of the ablation procedure, determined by exit block after achieving entrance block. Long-term follow-up data are not included in this publication. Patients' mean age was 61.7 ± 8.9 years, 43.2% were female, and median CHA2DS2-VASc score was 2.0. In the intention-to-treat analysis, the rate of the primary endpoint was 56.5% in patients randomized to the Arctic Front® and 9.5% in patients randomized to the HD Mesh Ablator® catheter (P = 0.001). In the per-protocol analysis, complete PVI was achieved in 13 (76.5%) of 17 Arctic Front® patients but in none of the 15 HD Mesh Ablator® patients (P < 0.0001). There were one major and two minor complications in each study arm but no clinically evident stroke. Post-procedural AF recurrence was detected within hospital stay in two (11.8%) Arctic Front® patients and in seven (46.7%) HD Mesh Ablator® patients (P = 0.049). CONCLUSION: The MACPAF study revealed a superiority of the Arctic Front® catheter concerning complete PVI. Owing to the insufficient efficacy of the HD Mesh Ablator® catheter, the safety board decided to stop MACPAF prematurely.

Thrombophilia screening in young patients with cryptogenic stroke. Prevalence of gene polymorphisms compared to healthy blood donors and impact on secondary stroke prevention.

UNLABELLED: The clinical relevance of thrombophilia screening in stroke patients is still a matter of debate, and descriptions of larger patterns of genetic variability are rare. We assessed the frequency of hereditary hypercoagulability in young patients with cryptogenic stroke (n = 44) and in healthy blood donors (n = 282) without prior cardiovascular event. Furthermore, we focused on the impact of thrombophilia screening on secondary stroke prevention. RESULTS: Compared to the control group (19-67 years; median 38.5 years; 64% women), there was a lower prevalence of the FVII-R353Q mutation (p = 0.033) in stroke patients (17-52 years; median 36 years; 59.1% women). Of note, the FVII-R353Q mutation lowers FVII plasma levels, probably reducing the risk of cardiovascular events. The prevalence of the remaining 13 gene polymorphisms did not differ significantly. However, the prevalence of FV Leiden mutation tended to be higher among stroke patients. CONCLUSION: Overall, extended screening for inherited thrombophilia had an impact on medical stroke prevention in every sixth patient with cryptogenic stroke.

Fast 3D Near-infrared breast imaging using indocyanine green for detection and characterization of breast lesions.

PURPOSE: To evaluate fast 3D near-infrared breast imaging using the optical contrast agent indocyanine green (ICG) for the detection and characterization of breast lesions. MATERIALS AND METHODS: 30 patients with suspicious breast lesions on mammography and/or ultrasound underwent fast 2 Hz 3D optical mammography before, during, and after administration of a 25 mg ICG bolus prior to needle biopsy. The bolus kinetics is analyzed using two perfusion parameters and a derived parameter: "peak amplitude" (PA), "time-to-peak" (TTP) and "peak-time grouped amplitude" (PTA). A receiver operating characteristic curve (ROC) analysis was performed to define a PTA cut-off for reader-independent differentiation of benign and malignant lesions. 8 patients had to be excluded from data analysis. Overall 14 breasts bearing a malignant lesion, 8 breasts bearing a benign lesion and 3 healthy breasts were analyzed. RESULTS: The cut-off-based PTA analysis allowed correct detection for 12 of 14 malignant lesions (tumor size: 8 - 80 mm; sensitivity = 85.7 %). Two malignant lesions were missed. In the benign study group only one fibroadenoma was detected (specificity = 87.5 %). The PTA values differed significantly between the benign group and the malignant group (Mann-Whitney U-test, p < 0.05). Breasts with malignant lesions showed higher peaks at early time-points in ICG perfusion. CONCLUSION: Early perfusion analysis of ICG-enhanced 3D fast optical mammography revealed different enhancement patterns for benign and malignant lesions. This approach might help with the detection of malignant breast lesions and the differentiation from benign lesions.

[The German version of the satisfaction with stroke care questionnaire (SASC) for stroke patients]. / Entwicklung der deutschen Version der Patientenzufriedenheits-Skala (SASC) für den Einsatz bei Patienten nach Schlaganfall.

BACKGROUND AND PURPOSE: Patient satisfaction is an important objective to achieve in all parts of the health-care system. Patient satisfaction probably effects adherence to therapy. Until now, German-speaking countries were lacking a reliable instrument to investigate patient satisfaction. The aim of this study was to translate the English Satisfaction with Stroke Care Questionnaire (SASC), validated and created specifically for patients who had a stroke, and to assess the test-retest reliability of the German version. METHODS: The translation of the satisfaction questionnaire followed the protocol of the Medical Outcome Trust. The validation was carried out with continuously admitted inpatients who had suffered an acute stroke and were able to give written consent. Patients received two questionnaires for self-administration three months after hospital admission. The two questionnaires were compared for test-retest reliability. Reliability was measured using AC 1 values. RESULTS: Out of 202 patients continuously admitted to our hospital with the diagnosis of stroke, 33 could not give written informed consent due to aphasia (N = 29) or foreign-language (N = 4) or refused written consent (N = 8) or died during the following 3 months after the event (N = 14). Recall rate at three months was 71 % with 104 of the remaining 147 patients sending both questionnaires back. (Characteristics of responders: NIHSS = 3 [0 - 26], age = 71.5 [31 - 89] years, 40 % female, 48 % with five or more years of secondary school, 66 % paretic, 17 % with aphasia, 26 % with atrial fibrillation). The test-retest reliability of the German version of the self-administered satisfaction questionnaire was substantial (mean AC 1 = 0.612; range from 0.307 to 0.789). CONCLUSION: The German version of the SASC is a reliable tool to test patient satisfaction in stroke patients in the German language.