Unterkrozingen, Germany
Unterkrozingen, Germany

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Scheinert D.,Park Krankenhaus Leipzig Sudost GmbH | Katsanos K.,University of Patras | Zeller T.,Herz Zentrum Bad Krozingen | Koppensteiner R.,Medical University of Vienna | And 9 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease. Background: Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES. Methods: Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography. Results: Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA. Conclusions: SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease. © 2012 American College of Cardiology Foundation.


Migliorini A.,Careggi Hospital | Stabile A.,Ospedale Civico | Rodriguez A.E.,Otamendi Hospital | Gandolfo C.,Ospedale Civico | And 6 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter <2.5 mm. Coprimary end points were early ST-segment resolution and 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990) © 2010 American College of Cardiology Foundation.


Kristensen S.D.,Aarhus University Hospital | Wurtz M.,Aarhus University Hospital | Grove E.L.,Aarhus University Hospital | de Caterina R.,University of Chieti Pescara | And 3 more authors.
Thrombosis and Haemostasis | Year: 2012

Platelet glycoprotein IIb/IIIa inhibitors (GPI) are antithrombotic agents preventing the binding of fibrinogen to GP IIb/IIIa receptors. Thus, GPI interfere with interplatelet bridging mediated by fibrinogen. Currently, three generic GPI with different antithrombotic properties are available for intravenous administration: abciximab, eptifibatide, and tirofiban. The development of oral GPI was abandoned, whereas intravenous GPI were introduced in various clinical settings during the 1990s, yielding substantial benefit in the treatment of acute coronary syndromes, particularly during percutaneous coronary interventions. Results of the many randomised trials evidenced the efficacy of this drug class, though these trials were conducted prior to the emergence of modern oral antiplatelet therapy with efficient P2Y 12 inhibitors. Subsequent trials failed to consolidate the strongly favourable impression of GPI, and indications for their use have been more restricted in recent years. Nonetheless, GPI may still be beneficial during coronary interventions among high-risk patients including acute ST-elevation and non-ST-elevation myocardial infarctions, particularly in the absence of adequate pretreatment with oral antiplatelet drugs or when direct thrombin inhibitors are not utilised. Intracoronary GPI administration has been suggested as adjunctive therapy during primary percutaneous coronary intervention, and the results of larger ongoing trials are expected to elucidate its clinical potential. The present review outlines the key milestones of GPI development and provides an up-to-date overview of the clinical applicability of these drugs in the era of refined coronary stenting, potent antithrombotic drugs, and novel thrombin inhibiting agents. © Schattauer 2012.


Rogge B.P.,University of Bergen | Cramariuc D.,University of Bergen | Lonnebakken M.T.,University of Bergen | Gohlke-Barwolf C.,Herz Zentrum Bad Krozingen | And 3 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives This study investigated whether overweight and obesity impacted outcome in patients with aortic valve stenosis (AS). Background Increased body mass index (BMI) is a strong predictor of higher cardiovascular (CV) morbidity and mortality in the general population but not among patients undergoing heart surgery. Methods Cardiovascular events in 1,664 patients with initially asymptomatic AS were recorded during a mean of 4.3 years of follow-up in the SEAS (Simvastatin Ezetimibe in Aortic Stenosis) study. Patients were grouped according to baseline BMI class. Results Overweight (n = 737) and obese patients (n = 334) had higher prevalence of hypertension, more abnormal left ventricular geometry, and lower stress-corrected midwall shortening throughout the study compared with normal weight patients (all p < 0.01). The AS progression rate did not differ between BMI classes. In univariate Cox regression, overweight was associated with a 17% to 22% lower rate of AS-related (p = 0.04) and ischemic CV events (p = 0.05). In multivariate analyses, adjusting for AS severity and differences in baseline characteristics, overweight had no significant influence on the rate of ischemic CV or AS-related events, whereas overweight and obesity had 46% and 67% higher rate of total mortality and 42% and 69% higher rate of combined hospital stay for heart failure and death from any cause, respectively, compared with normal weight patients (all p < 0.05). Conclusions In patients with initially asymptomatic AS participating in the SEAS study, overweight and obesity did not influence AS progression or rate of AS-related or ischemic CV events but were both associated with increased mortality. © 2013 by the American College of Cardiology Foundation Published by Elsevier Inc.


Bahlmann E.,Asklepios Clinic St. Georg | Gerdts E.,University of Bergen | Cramariuc D.,University of Bergen | Gohlke-Baerwolf C.,Herz Zentrum Bad Krozingen | And 6 more authors.
Circulation | Year: 2013

Background-: Aortic valve area index adjusted for pressure recovery (energy loss index [ELI]) has been suggested as a more accurate measure of aortic stenosis (AS) severity, but its prognostic value has not been determined in a prospective study. Methods and Results-: The relation between baseline ELI and rate of aortic valve events and combined total mortality and hospitalization for heart failure resulting from the progression of AS was assessed by multivariate Cox regression and reclassification analysis in 1563 patients with initial asymptomatic AS in the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. During 4.3 years follow-up, a total of 498 aortic valve events and 181 combined total mortalities and hospitalizations for heart failure caused by the progression of AS occurred. In Cox regression analyses, 1-cm2/m 2 lower baseline ELI predicted a 2-fold higher risk both for aortic valve events and for combined total mortality and hospitalization for heart failure independently of baseline peak aortic jet velocity or mean aortic gradient and independently of aortic root size (all P<0.05). In reclassification analysis, ELI improved the prediction of aortic valve events by 13% (95% confidence interval, 5-19), whereas the prediction of combined total mortality and hospitalization for heart failure resulting from the progression of AS did not improve significantly. Conclusions-: In asymptomatic AS patients without known atherosclerotic disease or diabetes mellitus, ELI provides independent and additional prognostic information to that derived from conventional measures of AS severity, suggesting that ELI should be measured in such patients. Clinical Trial Registration Information-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00092677. © 2013 American Heart Association, Inc.


Herrera Siklody C.,Herz Zentrum Bad Krozingen | Deneke T.,Krankenhaus Porz Am Rhein | Hocini M.,Hpital Cardiologique du HautLevque | Lehrmann H.,Herz Zentrum Bad Krozingen | And 10 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: We compared the safety of different devices by screening for subclinical intracranial embolic events after pulmonary vein isolation with either conventional irrigated radiofrequency (RF) or cryoballoon or multielectrode phased RF pulmonary vein ablation catheter (PVAC). Background: New devices specifically designed to facilitate pulmonary vein isolation procedures have recently been introduced. Methods: This prospective, observational, multicenter study included patients with symptomatic atrial fibrillation referred for pulmonary vein isolation. Ablation was performed using 1 of the 3 catheters. Strict periprocedural anticoagulation, with intravenous heparin during ablation to achieve an activated clotting time >300 s, was ensured in all patients. Cerebral magnetic resonance imaging was performed before and after ablation. Results: Seventy-four patients were included in the study: 27 in the irrigated RF group, 23 in the cryoballoon group, and 24 in the PVAC group. Total procedure times were 198 ± 50 min, 174 ± 35 min, and 124 ± 32 min, respectively (p < 0.001 for PVAC vs. irrigated RF and cryoballoon). Findings on neurological examination were normal in all patients before and after ablation. Post-procedure magnetic resonance imaging detected a single new embolic lesion in 2 of 27 patients in the irrigated RF group (7.4%) and in 1 of 23 in the cryoballoon group (4.3%). However, in the PVAC group 9 of 24 patients (37.5%) demonstrated 2.7 ± 1.3 new lesions each (p = 0.003 for the presence of new embolic events among the 3 groups). Conclusions: The PVAC is associated with a significantly higher incidence of subclinical intracranial embolic events. Further study of the causes and significance of these emboli is required to determine the safety of the PVAC. © 2011 American College of Cardiology Foundation.


Hochholzer W.,Herz Zentrum Bad Krozingen | Hochholzer W.,Brigham and Women's Hospital | Trenk D.,Herz Zentrum Bad Krozingen | Fromm M.F.,Friedrich - Alexander - University, Erlangen - Nuremberg | And 5 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: The aim of this study was to evaluate the relative impact of demographic and clinical variables versus the cytochrome P450 2C19 (CYP2C19) polymorphism on antiplatelet effects of clopidogrel. Background: Platelet responses to clopidogrel show a marked interindividual variability with substantial impact on clinical outcome. Several demographic and clinical characteristics as well as a polymorphism of CYP2C19 have been described as predictors for a low response to clopidogrel. Methods: This analysis enrolled 760 patients undergoing elective coronary stent implantation after loading with 600 mg of clopidogrel. Residual platelet aggregation was determined by optical aggregometry (adenosine diphosphate 5 μmol/l) before discharge. We analyzed the predictive value of the CYP2C19*2 polymorphism and baseline variables for an insufficient antiplatelet response by multivariable regression analysis and classification and regression trees analysis and determined the proportion responsible for the antiplatelet response of these predictors by multivariable linear regression analysis. Results: Major independent predictors for an insufficient antiplatelet response to clopidogrel were CYP2C19*2 carrier status (odds ratio [OR]: 2.74; 95% confidence interval [CI]: 1.93 to 3.90) together with age (OR: 1.03; 95% CI: 1.01 to 1.05), diabetes mellitus (OR: 1.75; 95% CI: 1.19 to 2.56), and body mass index (OR: 1.06; 95% CI: 1.02 to 1.11). The classification and regression trees analysis demonstrated that CYP2C19*2 carrier status followed by diabetes mellitus was the best discriminator between a sufficient and an insufficient antiplatelet response to clopidogrel. The full linear regression model including all these parameters could only explain 11.5% of the antiplatelet response (5.2% by CYP2C19*2 carrier status alone). Conclusions: Thus, our study does not suggest that, in patients critically dependent on adequate platelet inhibition, genotyping alone or in combination with clinical factors can replace phenotyping of platelet function. (Effect of Clopidogrel Loading and Risk of PCI [EXCELSIOR]; NCT00457236). © 2010 American College of Cardiology Foundation.


Zeller T.,Herz Zentrum Bad Krozingen | Macharzina R.,Herz Zentrum Bad Krozingen
Vasa - Journal of Vascular Diseases | Year: 2011

Chronic mesenteric ischemia (CMI) is most likely caused by atherosclerosis and less frequently by external compression, fi bromuscular dysplasia and vasculitis. Symptomatic CMI is an uncommon, potentially under-diagnosed condition caused by fi xed stenoses or occlusion of in most conditions at least two visceral arteries. If only one of the three major bowel providing arteries - the celiac trunk, the superior and inferior mesenteric arteries - is affected, the patient is usually asymptomatic due to a tight collateral network. Symptoms and clinical signs of CMI may vary from the classical triad of postprandial pain, weight loss and upper abdominal bruit to nonspecifi c symptoms thus frequently resulting in delayed diagnosis. Established non-invasive diagnostic means are duplex ultrasound or CTand MR-angiography offering excellent three dimensional reconstruction of the vessel pathology facilitating the decision for the appropriate revascularisation strategy. During the last decade, despite higher restenosis rates endovascular revascularization has replaced surgical revascularization as therapy of choice in most centers. If untreated CMI of atherosclerotic origin is associated with a high morbidity and mortality. This manuscript reviews the most relevant clinical aspects of the disease and the current practice of diagnosis and treatment of CMI.


Trenk D.,Herz Zentrum Bad Krozingen | Hochholzer W.,Herz Zentrum Bad Krozingen | Fromm M.F.,Friedrich - Alexander - University, Erlangen - Nuremberg | Zolk O.,Friedrich - Alexander - University, Erlangen - Nuremberg | And 3 more authors.
Circulation: Cardiovascular Genetics | Year: 2011

Background - Recently published data indicate that the paraoxonase-1 (PON1) Q192R genotype - and not as previously shown activity of cytochrome P450 (CYP) 2C19 - is the major determinant of metabolic bioactivation of clopidogrel and thereby variability of antiplatelet effect of clopidogrel. We sought to investigate whether the PON1 Q192R gene polymorphism affects platelet reactivity in patients undergoing elective coronary stent placement. Methods and Results - The study included 760 consecutive patients undergoing elective coronary stent placement after loading with clopidogrel 600 mg. Platelet function was assessed by adenosine diphosphate-induced (ADP 5 and 20 μmol/L) platelet aggregation and by flow-cytometric analysis of platelet surface protein expression before clopidogrel, at the time of coronary stent placement, and before discharge after coronary stent placement. PON1 Q192R genotype [NM-000446.5:c.575A≥G single nucleotide polymorphism (rs662)] was analyzed by TaqMan polymerase chain reaction. Residual platelet aggregation (ADP 5 μmol/L) at predischarge was 8.0% (3.0% to 17.0%) [median (interquartile range)] in PON1 QQ192 patients (n=384), 8.0% (3.0% to 15.0%) in PON1 QR192 (n=304), and 11.0% (3.0% to 18.0%) in PON1 RR192 (n=72; P=0.603). By multivariable linear regression, residual platelet aggregation was not associated with PON1 QQ192/QR192 (partial η 2<0.001, P=0.728) but with CYP2C19*2 loss-of-function allele (partial η 2=0.045, P<0.001) as well as any CYP2C19*17 gain-of-function allele (partial η 2=0.012, P=0.004). All other platelet assays also showed no significant association between PON1 Q192R genotype and antiplatelet effect of clopidogrel. The 1-year incidence of death and myocardial infarction did not differ between PON1 Q192R genotypes. Conclusions - On-treatment platelet reactivity in patients undergoing coronary stent placement after loading with clopidogrel 600 mg was not associated with PON1 Q192R genotype. © 2011 American Heart Association, Inc.


Minners J.,Herz Zentrum Bad Krozingen | Allgeier M.,Herz Zentrum Bad Krozingen | Gohlke-Baerwolf C.,Herz Zentrum Bad Krozingen | Kienzle R.-P.,Herz Zentrum Bad Krozingen | And 2 more authors.
Heart | Year: 2010

Background: On echocardiography approximately onethird of patients with severe aortic valve stenosis based on aortic valve area (AVA<1.0 cm 2) demonstrate a nonsevere mean pressure gradient (ΔPm; ≤40 mm Hg) despite apparently normal left ventricular function. It has been suggested that inconsistent echocardiographic grading may be due to 'paradoxical' low stroke volume. However, the correct echocardiographic assessment of stroke volume hinges on the often problematic measurement of the left ventricular outflow tract (LVOT) diameter. Objective: To investigate whether inconsistent grading and reduced stroke volume persist when the quantification of aortic valve stenosis is based on cardiac catheterisation which is independent of LVOT measurements. Methods and results: 333 consecutive patients underwent cardiac catheterisation within 30 days after their index echocardiography showing an AVA ≤2 cm2 and shortening fraction ≥30%. On invasive testing 85 patients (26%) demonstrated inconsistent (AVA<1 cm2 and ΔPm≤40 mm Hg) and 153 (46%) consistent grading (AVA<1 cm2 and ΔPm>40 mm Hg) with the remainder (28%) presenting with a calculated AVA≥1 cm2. Inconsistently graded patients were older (71 vs 67 years, p<0.006) with no differences in sex or body surface area between groups. Stroke volume and stroke volume index were significantly lower in inconsistently graded patients (63±14 vs 73±18 ml and 35±7 vs 39±7 ml/m2, respectively, both p<0.001). However, 41/85 (48%) of inconsistently graded patients had a normal stroke volume index >35 ml/m2. Conclusion: In the framework of current guidelines inconsistent grading of aortic valve stenosis is common, extends to cardiac catheterisation and is only partially explained by low stroke volume despite apparently normal left ventricular systolic function.

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