Ludwigshafen am Rhein, Germany
Ludwigshafen am Rhein, Germany

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Steg P.G.,Departement Hospitalo University | Steg P.G.,Royal Brompton Hospital | Van't Hof A.,Isala Klinieken | Hamm C.W.,Kerckhoff Clinic and Thoraxcenter | And 21 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown. METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients. CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis. Copyright © 2013 Massachusetts Medical Society.


Kleemann T.,Klinikum Ludwigshafen | Hochadel M.,University of Heidelberg | Strauss M.,Klinikum Ludwigshafen | Skarlos A.,Klinikum Ludwigshafen | And 2 more authors.
Journal of Cardiovascular Electrophysiology | Year: 2012

Prognostic Impact of Inappropriate Shocks. Introduction: Recent studies suggest a worse impact of inappropriate shock therapies on the outcome of patients with an implantable cardioverter-defibrillator (ICD). However, it is not known whether the worse impact is attributed to the ICD shock itself or due to the underlying heart disease. The aim of the study was to evaluate the impact of inappropriate ICD shocks on clinical outcome by comparing ICD shocks triggered by atrial fibrillation (AF) with shocks caused by lead failure. Methods and Results: A total of 1,411 consecutive patients of the prospective single-center ICD-registry Ludwigshafen who underwent an ICD implantation between 1992 and 2008 for primary or secondary prevention of sudden cardiac death were analyzed. During the median follow-up of 3 years, 297 (21%) patients experienced inappropriate ICD shocks. Sixty percent of patients had inappropriate shocks due to AF and 24% due to lead defect or T-wave oversensing. Multiple ICD shocks (‰¥2) triggered by AF were associated with a worse prognosis, whereas a single shock due to AF or 1 or multiple shocks resulting from lead failure were not. ICD shocks caused by AF occurred more often in tandem with a serious adverse event than in patients with a lead failure (15% vs 6%, P < 0.05). Conclusion: Multiple ICD shocks triggered by AF are associated with a worse prognosis in ICD patients, whereas a single shock due to AF or shocks resulting from lead failure are not. These data support that the ICD shock itself has no worse impact on the outcome of ICD patients.


Wischmann T.,University of Heidelberg | Korge K.,Klinikum Ludwigshafen | Scherg H.,University of Heidelberg | Strowitzki T.,University of Heidelberg | Verres R.,University of Heidelberg
Human Reproduction | Year: 2012

Background Little is known about the long-term course taken in life by couples who had undergone medically assisted reproduction (MAR). The aim of this study was to find out in a large sample whether, in comparison with parents, involuntarily childless couples have a different subjective perception of overall and specific quality of life over a period of >10 years. Methods Between 1994 and 1997, 564 couples participated in the initial Heidelberg Fertility Consultation Service study of psychosocial aspects of infertility. In March 2008, a follow-up questionnaire was sent to all of these couples. Both partners were asked about the current status of their desire for a child and their satisfaction with life, their self-esteem, partnership, sexuality and career, as well as their current attitude towards the MAR they had undergone and experience of the process.RESULTSThe final sample consisted of 148 couples and 60 women (response rate: 41 of the women and 31 of the men contacted). Fifty-nine percent of the women had at least one genetically related child, 11 had a foster or adopted child and 30 remained childless. Comparisons of psychological variables between parents and childless couples were done for the 148 couples only. Post-MAR parents indicated significantly higher self-esteem than childless couples (P < 0.01) and were more inclined to go through the infertility treatment again than childless couples (P < 0.001 for women, P < 0.05 for men). Positive aspects of infertility were seen more often by childless couples than by parents (P < 0.001). Childless women reported more occupational satisfaction than mothers (P < 0.01), while no such difference was identified in the male partners. Concerning overall life satisfaction, satisfaction with friendships and the partnership, and sexual satisfaction there were no statistically significant differences between childless women/men and mothers/fathers. Conclusions Overall, our 10-year follow-up survey indicated good psychological adjustment both in childless couples and in post-MAR parents. A decline of sexual satisfaction in childless couples (often reported in the literature) was not observed in this large sample. Quality of life in the long-term can safely be said to be high, both in the definitively childless couples and the post-MAR parents. These findings should be integrated into the information and counselling for would-be parents prior to infertility treatment. A major limitation of this study is that the majority of women and men from the initial study did not respond in our follow-up study. © 2012 The Author.


Zeymer U.,Institute For Herzinfarktforschung Ludwighafen | Mochmann H.-C.,Charite Campus Benjamin Franklin | Mark B.,Klinikum Ludwigshafen | Arntz H.-R.,Charite Campus Benjamin Franklin | And 4 more authors.
JACC: Cardiovascular Interventions | Year: 2015

OBJECTIVES: This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST-segment elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (PPCI). BACKGROUND: Little is known about the timing of onset of antiplatelet action after a pre-percutaneous coronary intervention (PCI) loading dose of clopidogrel or prasugrel in patients with STEMI. METHODS: This double-blind, prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel (n = 31) or 600 mg clopidogrel (n = 31). The primary endpoint was the platelet reactivity index (PRI) measured with the vasodilator-stimulated phosphoprotein assay 2 h after intake of the study medication. Secondary endpoints were PRI after 4 h, TIMI (Thrombolysis In Myocardial Infarction) patency of the infarct-related artery before and after PCI, and clinical events until day 30. RESULTS: The PRI after 2 h (50.4 ± 32.7% vs. 66.3 ± 22.2%; p = 0.035) and after 4 h (39.1 ± 27.5% vs. 54.5 ± 49.3%; p = 0.038) were significantly lower with prasugrel compared with clopidogrel. In addition, the rate of patients with a PRI <50% tended to be higher with prasugrel compared with clopidogrel after 2 h (46.7% vs. 28.6%; p = 0.15) and after 4 h (63.0% vs. 38.9%; p = 0.06). There were no significant differences in TIMI 2/3 patency before PCI (39.2% vs. 31.0%; p = 0.43) and TIMI 3 patency after PCI (88.5% vs. 89.3%; p = 0.92). CONCLUSIONS: The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared with clopidogrel. Therefore, prasugrel should be preferred to clopidogrel in this setting. (ETAMI-Study: Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute Myocardial Infarction; NCT01327534) © 2015 by the American College of Cardiology Foundation.


Clemmensen P.,Nykoebing F Hospital | Wiberg S.,Copenhagen University | Van'T Hof A.,Isala Klinieken | Deliargyris E.N.,The Medicines Company | And 14 more authors.
JACC: Cardiovascular Interventions | Year: 2015

OBJECTIVES: This study sought to determine clinical, procedural, and treatment factors associated with acute stent thrombosis (AST) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. BACKGROUND: Bivalirudin started during transport for primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction significantly reduced major bleeding compared with heparin with or without glycoprotein IIb/IIIa inhibitors (GPI), but it was associated with an increase in AST. METHODS: We compared patients with (n = 12) or without AST (n = 2,184) regarding baseline, clinical, and procedural characteristics and antithrombotic treatment strategies (choice of P2Y12 inhibitor, post-primary PCI bivalirudin infusion dose [0.25 mg/kg/h, or BIV-LOW] vs. [1.75 mg/kg/h, or BIV-PCI] vs. heparin ± GPI). Logistic regression was performed to identify independent correlates of AST. RESULTS: The overall AST rate was 0.6% and was higher with bivalirudin than with heparin ± GPI (1.1% vs. 0.2%; p = 0.007). Median time to AST was 2.3 h (interquartile range: 1.9 to 2.8 h). Patients with AST had less hypertension (2 of 14 [14.0%] vs. 961 of 2,182 [44.0%]; p = 0.03), and more frequently received GPI (11 of 14 [78.6%] vs. 880 of 2,183 [40.3%]; p = 0.004). Multivariate analysis using Firth penalized maximum likelihood estimation found hypertension (odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.07 to 0.92; p = 0.037) and BIV-LOW (OR: 5.8, 95% CI: 1.5 to 22.2; p = 0.010) predictive of AST. Choice of P2Y12 inhibitor had no impact on AST. Compared with heparin ± GPI, AST rates were higher for BIV-LOW (11 of 670 [1.6%] vs. 2 of 947 [0.2%]; p = 0.008), but not different for BIV-PCI (1 of 244 [0.4%]; p = 0.588). CONCLUSIONS: In this post-hoc analysis from EUROMAX, AST occurred very early and was not mitigated by the novel P2Y12 inhibitors. Prolonging the bivalirudin infusion at the PCI dose (but not at a lower dose) appeared to mitigate the risk of AST. © 2015 by the American College of Cardiology Foundation.


In the present day, coronary angiography and percutaneous coronary intervention are considered to be safe procedures with low complication rates in general. Nevertheless due to their widespread use and their application in a continually aging population known to carry a higher risk for complications, periprocedural stroke affects thousands of patients undergoing coronary angiography and percutaneous coronary intervention worldwide every year. Stroke is reported to occur in 0.05-0.1% of diagnostic cardiac catheterizations and in 0.18-0.44% of patients treated with percutaneous coronary intervention in clinical routine today. Despite all improvements in pharmacological and technical issues, the rate of stroke after cardiac catheterization has remained almost constant over the last 20 years of invasive cardiology of invasive and interventional cardiology, which is most probably due to the immutability of the majority of risk factors before cardiac procedures. An advanced age, arterial hypertension, diabetes mellitus, coronary angiography performed under emergency conditions, history of stroke, renal failure, the use of an intra-aortic balloon pump, congestive heart failure and interventions at bypass grafts have been identified as risk factors for periprocedural stroke in large registries. Due to exceedingly high rates of mortality and disability stroke after coronary angiography still has an enormous impact on the patient's prognosis and on quality of life. If patients survive this devastating complication, most of them suffer from persistent neurological deficits such as motor or speech disorders. For its low incidence and consecutively missing data from randomized clinical trials, an evidence-based treatment could not yet be established, and treatment options are generally based on case series and small studies only. Nevertheless, intra-arterial thrombolysis and mechanical embolectomy seem to be promising and relatively safe approaches in the treatment of periprocedural ischemic stroke. Further research by randomized trials and large registries are needed to validate its efficacy and safety.


Hattenbach L.-O.,Klinikum Ludwigshafen | Puchta J.,Goethe University Frankfurt | Hilgenberg I.,Hilgenberg GmbH
Investigative Ophthalmology and Visual Science | Year: 2012

PURPOSE. Recent studies suggest that the cannulation of retinal vessels may provide a potential access route for the administration of thrombolytic agents in retinal vessel occlusion. However, the major problem with available techniques is the limited visualization of retinal vessels with conventional surgical microscopes, making it difficult to effectively control the targeted injection of drugs. METHODS. The authors developed a novel single-piece catheter system for the endoscopically guided puncture of microvessels. Experimental punctures of retinal vessels with injection of fluid were performed in porcine cadaver eyes using a standard high-resolution gradient index microendoscope introduced through the pars plana. RESULTS. Endoscopically guided punctures were successfully performed in porcine branch retinal veins at various distances from the optic disc. Injection of recombinant tissue plasminogen activator (rt-PA), hypertonic solution (hyper HES), or normal saline solution into the vessel lumen was accomplished under direct endoscopic view in a safe and reliable manner. CONCLUSIONS. Endoscopically guided puncture of retinal microvessels is feasible and can be performed through a pars plana entry without additional micromanipulation devices. This novel technique may be a safe and effective approach to catheter-directed endovascular thrombolysis in retinal vascular occlusive diseases. © 2012 The Association for Research in Vision and Ophthalmology, Inc.


Kiessling A.H.,Goethe University Frankfurt | Lehmann A.,Anaesthesiology and Operative Intensive Care | Isgro F.,Klinikum Ludwigshafen | Moritz A.,Goethe University Frankfurt
Journal of Cardiothoracic Surgery | Year: 2011

Vacuum-assisted closure (VAC) of complex infected wounds has recently gained popularity among various surgical specialties. The system is based on the application of negative pressure by controlled suction to the wound surface. The effectiveness of the VAC System on microcirculation and the promotion of granulation tissue proliferation are proved. No contraindications for the use in deep sternal wounds in cardiac surgery are described. In our case report we illustrate a scenario were a patient developed severe bleeding from the ascending aorta by penetration of wire fragments in the vessel. We conclude that all free particles in the sternum have to be removed completely before negative pressure is used. © 2011 Kiessling et al; licensee BioMed Central Ltd.


Zeymer U.,Klinikum Ludwigshafen | Scheller B.,Saarland University
EuroIntervention | Year: 2011

A "DEB only" strategy might be a reasonable and attractive approach in small vessels of <25 mm lesion length. It avoids further reducing the lumen of the already small vessel with the stent struts. This strategy includes the use of BMS spot stenting in the case of dissections type C or higher (Figure 5). The upcoming DEB-only SVD worldwide registry will evaluate the efficacy and safety of a DEB only strategy according to the treatment recommendations in patients with small vessel disease. © Europa Edition 2011. All rights reserved.


Mayer J.,Klinikum Ludwigshafen | Boldt J.,Klinikum Ludwigshafen | Mengistu A.M.,Klinikum Ludwigshafen | Rohm K.D.,Klinikum Ludwigshafen | Suttner S.,Klinikum Ludwigshafen
Critical Care | Year: 2010

Introduction: Several studies have shown that goal-directed hemodynamic and fluid optimization may result in improved outcome. However, the methods used were either invasive or had other limitations. The aim of this study was to perform intraoperative goal-directed therapy with a minimally invasive, easy to use device (FloTrac/Vigileo), and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a standard management protocol.Methods: In this randomized, controlled trial 60 high-risk patients scheduled for major abdominal surgery were included. Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol (FloTrac/Vigileo device, GDT-group, n = 30) or a standard management group (Control-group, n = 30), based on standard monitoring data.Results: The median duration of hospital stay was significantly reduced in the GDT-group with 15 (12 - 17.75) days versus 19 (14 - 23.5) days (P = 0.006) and fewer patients developed complications than in the Control-group [6 patients (20%) versus 15 patients (50%), P = 0.03]. The total number of complications was reduced in the GDT-group (17 versus 49 complications, P = 0.001).Conclusions: In high-risk patients undergoing major abdominal surgery, implementation of an intraoperative goal-directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a standard management protocol. Trial Registration: Clinical trial registration information: Unique identifier: NCT00549419. © 2010 Mayer et al.; licensee BioMed Central Ltd.

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