Rotenburg an der Fulda, Germany
Rotenburg an der Fulda, Germany

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Smith V.,Ghent University | Beeckman S.,Ghent University | Herrick A.L.,University of Manchester | Decuman S.,Ghent University | And 69 more authors.
Rheumatology (United Kingdom) | Year: 2016

Objective. To propose simple capillaroscopic definitions for interpretation of capillaroscopic morphologies and to assess inter-rater reliability. Methods. The simple definitions proposed were: normal-hairpin, tortuous or crossing; abnormal-not hairpin, not tortuous and not crossing; not evaluable-whenever rater undecided between normal and abnormal. Based upon an aimed kappa of 0.80 and default prevalences of normal (0.4), abnormal (0.4) and not evaluable (0.2) capillaries, 90 single capillaries were presented to three groups of raters: experienced independent raters, n = 5; attendees of the sixth EULAR capillaroscopy course, n = 34; novices after a 1-h course, n = 11. Inter-rater agreement was assessed by calculation of proportion of agreement and by kappa coefficients. Results. Mean kappa based on 90 capillaries was 0.47 (95% CI: 0.39, 0.54) for expert raters, 0.40 (95% CI: 0.36, 0.44) for attendees and 0.46 (95% CI: 0.41, 0.52) for novices, with overall agreements of 67% (95% CI: 63, 71), 63% (95% CI: 60, 65) and 67% (95% CI: 63, 70), respectively. Comparing only normal vs the combined groups of abnormal and not evaluable capillaries did increase the kappa: 0.51 (95% CI: 0.37, 0.65), 0.53 (95% CI: 0.49, 0.58) and 0.55 (95% CI: 0.49, 0.62). On the condition that the capillaries were classifiable, the mean kappa was 0.62 (95% CI: 0.50, 0.74) for expert raters (n = 65), 0.76 (95% CI: 0.69, 0.83) for attendees (n = 20) and 0.81 (95% CI: 0.74, 0.89) for novices (n = 44). Conclusion. This multicentre, international study showed moderate reliability of simple capillaroscopic definitions for describing morphology of capillaries by rheumatologists with varying levels of expertise. Novices were capable of distinguishing normal from abnormal capillaries by means of a 1-h training session. In future studies, the class not evaluable may be obsolete. © The Author 2015.


Funck-Brentano C.,University Pierre and Marie Curie | Funck-Brentano C.,Pitie Salpetriere Hospital | Funck-Brentano C.,French Institute of Health and Medical Research | Van Veldhuisen D.J.,University of Groningen | And 4 more authors.
European Journal of Heart Failure | Year: 2011

AimsAngiotensin-converting enzyme inhibitors (ACE-Is) and beta-blockers are associated with improved outcome in patients with chronic heart failure (CHF). In this post hoc analysis of the CIBIS III trial, we examined the influence of the order of drug administration on clinical events and achieved dose. We also assessed the relations between dose levels and baseline variables or adverse events.Methods and resultsIn the CIBIS III trial, 1010 patients (mean age: 72.4 years; mean ejection fraction: 28.8; male: 68.2) with stable CHF were randomized to up-titration of monotherapy with either bisoprolol (target dose 10 mg o.d.) or enalapril (target dose 10 mg b.i.d.) for 6 months, followed by their combination for 624 months. Endpoints were mortality or all-cause hospitalization, mortality alone and mortality or cardiovascular hospitalization.The study drug (ACE-I or beta-blocker) was last prescribed at <50 of target dose to significantly more patients for the first initiated drug in both treatment groups (both P< 0.001). Sixty per cent of endpoints were reached during the monotherapy phase and randomized treatment during monotherapy was not a predictor of the three assessed outcomes. Monotherapy phase was the strongest independent predictor of outcome (P< 0.0001 for all endpoints). Older age, NYHA class III, impaired renal function, lower body weight and blood pressure at baseline, and hypotension, bradycardia and heart failure during treatment were associated with the inability to reach high dose of both study drugs.ConclusionThe order of drug administration plays an important role in whether CHF patients reach target doses of bisoprolol and enalapril. For both study drugs, the dose level reached was associated with baseline characteristics and adverse events. In CHF patients not treated with an ACE-I or a beta-blocker, the duration of monotherapy with either type of drug should be shorter than 6 months. © 2011 The Author.


Savic Z.N.,Institute of Radiology | Davidovic L.B.,Center for Cardiovascular Diseases | Sagic D.Z.,Center for Cardiovascular Diseases Dedinje | Brajovic M.D.,Center for Cardiovascular Diseases Zvezdara | Popovic S.S.,Institute of Endocrinology
TheScientificWorldJournal | Year: 2010

The aim of this paper was to examine the correlation between the Color Doppler ultrasound (CD-US) and multidetector CT angiography (MDCTA) diagnostic methods, and to define the degree and extent of stenosis in patients with internal carotid artery stenosis. This was a cross-sectional study with a consecutive series of patients. All US examinations were always carried out by the same physician-angiologist, while all CT examinations were always carried out by the same physician-radiologist. Both worked independently from each other. The stenosis area was measured at the narrowest point by NASCET criteria for US/CT. Peak systolic velocity (PSV) over 210 cm/sec and end diastolic velocity (EDV) over 110 cm/sec criteria were applied for stenoses with lumen narrowed over 70%, while PSV under 130 cm/sec and EDV under 100 cm/sec criteria were applied for those with lumen narrowed under 70%. A total of 124 carotid arteries were observed; namely, 89 narrowed and 68 surgically treated. All patients were reviewed by US and then by MDCTA; patients with 70-99% stenosis underwent surgery. The correlation coefficient between stenosis degree measured by US and MDCTA was 0.922; p < 0.01. The average difference between US and MDCTA diagnostic methods was 3% (Z = -1.438, p > 0.05). The US and CT matching level for stenoses from 70 to 99% was very high (κ = 0.778, p < 0.01). In conclusion, there is a highly significant statistical correlation among both diagnostic methods when measuring stenosis degree and extent. US is more dependent on the physician, while MDCTA is more objective and independent from the physician. We think it would be appropriate to undertake an MDCTA exam for those patients who are candidates for carotid endarterectomy. ©2010 with author. Published by TheScientificWorld.


Wiemer M.,Ruhr University Bochum | Degenhardt R.,Clinical Research Institute | Vallbracht C.,Center for Cardiovascular Diseases | Horstkotte D.,Ruhr University Bochum | And 5 more authors.
Journal of Interventional Cardiology | Year: 2010

Background and Objectives: Paclitaxel-coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in-stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel-eluting Coroflex™ Please stent in coronary artery lesions. Methods: One-hundred and twenty-nine patients (66.2 ± 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post-PTCA restenotic coronary lesions.The mean reference diameter was 2.84 ± 0.43 mm, the lesion length 12.51 ± 4.6 mm, and the minimal lumen diameter 0.75 ± 0.29 mm. Follow-up was performed clinically in 129129 (100%) after 6 and 12 months and angiographically in 120129 (93%) patients after 6 months. Results: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in-stent late loss and the late-loss index were 0.27 ± 0.59 mm and 0.17 ± 0.40 resulting in binary in-stent restenoses in 16120 (13.3%) subjects and in-segment restenoses in 20120 (16.7%) subjects. Major adverse cardiac events occurred in 23129 (17.8%) during the first 6 months of follow-up with 3129 (2.3%) myocardial infarctions, 1129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2129 (1.6%) nonlesion related PCI were performed. Conclusion: The data of the Paclitaxel-eluting Coroflex™ Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel-eluting stent. © 2010, Wiley Periodicals, Inc.


Kimmelman J.,McGill University | Mogil J.S.,McGill University | Dirnagl U.,Charité - Medical University of Berlin | Dirnagl U.,German Center for Neurodegeneration Research | Dirnagl U.,Center for Cardiovascular Diseases
PLoS Biology | Year: 2014

Preclinical researchers confront two overarching agendas related to drug development: selecting interventions amid a vast field of candidates, and producing rigorous evidence of clinical promise for a small number of interventions. We suggest that each challenge is best met by two different, complementary modes of investigation. In the first (exploratory investigation), researchers should aim at generating robust pathophysiological theories of disease. In the second (confirmatory investigation), researchers should aim at demonstrating strong and reproducible treatment effects in relevant animal models. Each mode entails different study designs, confronts different validity threats, and supports different kinds of inferences. Research policies should seek to disentangle the two modes and leverage their complementarity. In particular, policies should discourage the common use of exploratory studies to support confirmatory inferences, promote a greater volume of confirmatory investigation, and customize design and reporting guidelines for each mode. © 2014 Kimmelman et al.


PubMed | B. Braun Melsungen AG, Charité - Medical University of Berlin, Universitares Herz und Gefasszentrum Hamburg, Center for Cardiovascular Diseases and 3 more.
Type: Journal Article | Journal: Clinical research in cardiology : official journal of the German Cardiac Society | Year: 2016

We set out to investigate the benefit of distal main or side branch treatment with a DCB compared to POBA in coronary bifurcation lesions.The standard treatment of bifurcation lesions is application of a DES to the main branch with provisional side branch stenting. While this resulted in considerable improvement in overall MACE rate suboptimal side branch results remained a problem.The study was performed from 2011 to 2013 in six German centers. Native bifurcation lesions were included if side branch vessel diameter was 2 and 3.5mm and no proximal main branch lesions was found. After successful predilatation randomization was performed to either DCB application or no further treatment. Follow-up angiograms for QCA analysis were done after 9months. Primary endpoint was late lumen loss (LLL).64 patients were successfully randomized. Minimal lumen diameter and grade of stenosis were equal in both groups. Only five stents were used as bail out. Angiographic follow-up was achieved in 75% of patients. No patient died. There was one NSTEMI in the POBA group. Restenosis rate was 6% in the DCB group vs 26% in the POBA group (p=0.045). TLR was necessary in one patient of the DCB group vs three patients of the POBA. The primary endpoint LLL was 0.13mm in the DCB vs 0.51mm in the POBA group (p=0.013).In bifurcation lesions that show only class A or B dissection and recoil not beyond 30% the use of DCBs is a sound strategy.


Shimazaki N.,Keio University | Hayashi T.,Keio University | Kunio M.,Keio University | Igami Y.,Keio University | And 2 more authors.
2010 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC'10 | Year: 2010

We proposed a novel laser-driven short-term heating angioplasty to realize restenosis-suppressive angioplasty for peripheral artery disease. In this study, we investigated the chronic intimal hyperplasia formation after the short-term heating dilatation in vivo, as well as the thermal damage calculation on arterial smooth muscle cells (SMCs). The prototype short-term heating balloon catheter with 5.0, 5.5, 6.0 mm φ in balloon diameter and 25mm in balloon length were employed. The short-term heating dilatation was performed in porcine iliac arteries with dilatation conditions of 75° (N=4) and 65° (N=5) as peak balloon temperature, 18± 4s as heating duration, 3.5atm as balloon dilatation pressure. Four weeks after the balloon dilatation, the balloon-dilated artery segments were extracted and were stained with HE and picrosirius red for histological observation. In the case of 75° as the peak balloon temperature, neointimal hyperplasia formation was significantly reduced. In this case, the SMCs density in the artery media measured from the HE-stained specimen was 20% lower than that in the reference artery. According to the thermal damage calculation, it was estimated that the SMCs lethality in artery media after the short-term heating angioplasty was 20% in the case of 75° as the peak balloon temperature. We demonstrated that the short-term heating dilatation reduced the number of SMCs in artery media. We think this SMCs reduction might contribute to the suppression of chronic neointimal hyperplasia. © 2010 IEEE.


Kunio M.,Keio University | Shimazaki N.,Keio University | Arai T.,Keio University | Sakurada M.,Center for Cardiovascular Diseases
Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS | Year: 2011

We investigate the relation between the influences on smooth muscle cells and the chronic performances of our novel short-duration heating balloon dilatation to reveal the heating conditions which can suppress the neo-intimal hyperplasia after our heating dilatations. The temperature of prototype balloon catheter surface was measured during short-duration heating balloon dilatation ex vivo. There existed 2C temperature variations in the long direction of prototype balloon catheter at a maximum. The neo-intimal hyperplasia occupancy rate after our short-duration heating dilatations were measured in vivo porcine study. The neo-intimal hyperplasia was suppressed most at 75C in balloon peak temperature in vivo. The estimated dead rate of smooth muscle cells at this condition was about 13% by the Arrhenius equation. We think that the suppression of neo-intimal hyperplasia was obtained after our short-duration heating dilatation due to the proper decrease of smooth muscle cells by heating and no thermal damages to the adventitia and surrounding tissues. © 2011 IEEE.


PubMed | Center for Cardiovascular Diseases
Type: Case Reports | Journal: Acta chirurgica Belgica | Year: 2012

Implantable cardioverter defibrillator (ICD) placement in young children remains a challenge due to device-patient size mismatch and the important choice between an endovenous or an epicardial approach for lead implantation. We treated three children, with respectively Long QT-syndrome, Brugada syndrome and Brugada syndrome with sick sinus syndrome, ranging from 9 months to 7 years with a subxyphoidal ICD and extracardiac lead implantation by minimally invasive techniques. In all cases the thresholds were excellent. The devices could be properly placed in the preperitoneal space without discomfort to the patients. The clinical course was uneventful and results were excellent.

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