Roland Prondzinsky

Carl-von-Basedow Hospital, Merseburg, Saxony-Anhalt, Germany

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Publications (75)183.4 Total impact

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    ABSTRACT: Optimal positioning of the left ventricular (LV) lead at the latest activated part of the left ventricle is one of the major challenges in implantation of cardiac resynchronization therapy (CRT) devices with respect to ascertaining an optimal resynchronization effect resulting in a high responder rate. In the present study, we evaluated the feasibility of transcoronary measurement of LV electrical activation by a coated guidewire in a porcine model.
    The Journal of invasive cardiology 10/2014; 26(10):520-6. · 1.57 Impact Factor
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    ABSTRACT: The recently published German-Austrian S3 Guideline for the treatment of infarct related cardiogenic shock (CS) revealed a lack of evidence for all recommended therapeutic measures. To determine the effects in terms of efficacy, efficiency and safety of cardiac care with inotropic agents and vasodilator strategies versus placebo or against each other for haemodynamic stabilisation following surgical treatment, interventional therapy (angioplasty, stent implantation) and conservative treatment (that is no revascularization) on mortality and morbidity in patients with acute myocardial infarction (AMI) complicated by CS or low cardiac output syndrome (LCOS). We searched CENTRAL, MEDLINE (Ovid), EMBASE (Ovid) and ISI Web of Science, registers of ongoing trials and proceedings of conferences in January 2013. Reference lists were scanned and experts in the field were contacted to obtain further information. No language restrictions were applied. Randomised controlled trials in patients with AMI complicated by CS or LCOS. Data collection and analysis were performed according to the published protocol. All trials were analysed individually. Hazard ratios (HRs) and odds ratios with 95% confidence intervals (CI) were extracted but not pooled because of high heterogeneity between the control group interventions. Four eligible, very small studies were identified from a total of 4065 references. Three trials with high overall risk of bias compared levosimendan to standard treatment (enoximone or dobutamine) or placebo. Data from a total of 63 participants were included in our comparisons, 31 were treated with levosimendan and 32 served as controls. Levosimendan showed an imprecise survival benefit in comparison with enoximone based on a very small trial with 32 participants (HR 0.33; 95% CI 0.11 to 0.97). Results from the other similarly small trials were too imprecise to provide any meaningful information about the effect of levosimendan in comparison with dobutamine or placebo. Only small differences in haemodynamics, length of hospital stay and the frequency of major adverse cardiac events or adverse events overall were found between study groups.Only one small randomised controlled trial with three participants was found for vasodilator strategies (nitric oxide gas versus placebo) in AMI complicated by CS or LCOS. This study was too small to draw any conclusions on the effects on our key outcomes. At present there are no robust and convincing data to support a distinct inotropic or vasodilator drug based therapy as a superior solution to reduce mortality in haemodynamically unstable patients with CS or low cardiac output complicating AMI.
    Cochrane database of systematic reviews (Online) 01/2014; 1:CD009669. · 5.70 Impact Factor
  • Susanne Unverzagt, Roland Prondzinsky, Frank Peinemann
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    ABSTRACT: To assess whether the reported trial characteristics are associated with treatment effects on all-cause mortality within critical care medicine. We identified all eligible randomized controlled trials (RCTs) from Cochrane Reviews on patients with sepsis, septic shock, and cardiogenic shock. Risk of bias was judged on 12 trial characteristics, including the differentiation between single-center and multicenter trials. Hierarchical random-effects models quantified the impact of the risk of bias items on the reported effect estimates of mortality. Twelve meta-analyses that involved 82 RCTs were selected and judged. Single-center trials estimated a significant larger treatment effect compared with multicenter trials (ratio of odds ratios, 0.64; 95% confidence interval: 0.47, 0.87). Treatment effect tended to be overestimated with selective reporting of preplanned end points. Biases in different trial characteristics are unlikely to operate independently and may have modified these associations. The results of this study highlight a substantial difference in treatment effect estimates between single-center and multicenter trials. Therefore, we recommend that results from single-center trials should be cautiously used for decision making.
    Journal of clinical epidemiology 08/2013; · 5.48 Impact Factor
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    ABSTRACT: BACKGROUND: Scoring systems in critical care patients are essential for prediction of outcome and for evaluation of therapy. In this study we determined the value of the APACHE II, APACHE III, Elebute-Stoner, SOFA, and SAPS II scoring systems in the prediction of mortality in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). MATERIAL AND METHODS: In this prospective, observational study, patients who were admitted to the ICU with CS complicating AMI were consecutively included. Data for the APACHE II, APACHE III, Elebute-Stoner, SOFA, and SAPS II scores were recorded on admission and during the following 96 h. Receiver operating characteristic curve analyses and the area under the curve (AUC) were used to estimate the predictive ability (mortality) of the scoring systems on admission and the maximum value. RESULTS: Mortality among the 41 patients included in this study was 44 %. On admission, the mean APACHE II (p = 0.035), APACHE III (p = 0.003), SAPS II (p = 0.001), and SOFA (p = 0.042) scores were significantly higher in nonsurvivors than in survivors. At maximum score, APACHE II (p = 0.009), APACHE III (p < 0.001), and SAPS II (p < 0.001) appeared to have higher significance. On admission, the discrimination for APACHE III was 0.786, for SAPS II 0.790, and for APACHE II 0.691. The maximum-score AUC for APACHE II was 0.726, for APACHE III 0.827, and for SAPS II 0.832. Elebute-Stoner and SOFA did not yield valuable results at maximum score or, in the case of Elebute-Stoner, on admission. CONCLUSION: These results suggest that at the time of diagnosis and at maximum value, the SAPS II, APACHE III, and APACHE II scores may be useful in predicting a high probability of survival of patients with CS complicating AMI.
    Medizinische Klinik, Intensivmedizin und Notfallmedizin. 04/2013;
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    ABSTRACT: OBJECTIVE: We retrospectively assessed the incidence of hemorrhagic complications associated with pacemaker implantation in patients receiving one or more antiplatelet agents. DESIGN AND SETTING: Retrospective multicenter case-control study. Data were collected from three cardiac units in Germany from 2006 to 2010. METHODS: A total of 495 pacemaker patients were enrolled. 99 patients received dual antiplatelet therapy (aspirin and clopidogrel), 198 were given only aspirin and 198 had no antiplatelet therapy (control). Patients were matched for age and sex. Implant-related bleeding complications were defined as major bleeding, if surgical pocket exploration or blood transfusion were needed. Minor bleeding complications were defined as one or more of the following conditions: fall of hemoglobin content >1.5 g/dl not requiring blood transfusion; pocket hematoma; pocket effusion not requiring surgical revision. MEASUREMENTS AND RESULTS: Hemorrhagic complications were seen in 4/198 control patients and 6/198 aspirin-only patients [2 vs. 3 %, p = 0.5, OR = 1.52 (0.42-5.46)]. Patients undergoing dual antiplatelet therapy had significantly more bleeding complications than patients in the aspirin-only group [11/99: 11.1 vs. 3 %, p = 0.005, OR = 3.95 (1.43-11.16)]. Major complications occurred in 1/198 control patients and 2/198 aspirin-only patients [0.5 vs. 1 %, p = 0.6, OR = 2.01 (0.18-22.35)]. In contrast, 7/99 patients undergoing dual antiplatelet therapy exhibited major complications [7.1 vs. 1 %, p = 0.004, OR = 7.46 (1.52-36.50)]. CONCLUSIONS: Although in patients undergoing pacemaker implantation dual antiplatelet therapy with aspirin and clopidogrel caused a significant increase of bleeding complications, the use of aspirin alone was not associated with a significant increase in bleeding complications.
    Clinical Research in Cardiology 02/2013; · 3.67 Impact Factor
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    ABSTRACT: Transcoronary pacing for the treatment of bradycardias during percutaneous coronary intervention (PCI) is a useful technique in interventional cardiology. The standard technique is unipolar pacing with the guidewire in the coronary artery against a cutaneous patch electrode. We developed a novel approach for transcoronary pacing by using intravascular electrodes in different positions in the aorta in a porcine model. Unipolar transcoronary pacing was applied in 8 pigs under general anesthesia using a standard floppy guidewire in a coronary artery as the cathode with additional insulation of the guidewire by a monorail angioplasty balloon. Intravascular electrodes positioned in the aorta thoracalis and the aorta abdominalis served as indifferent anodes. The efficacy of transcoronary pacing with intravascular anodal electrodes was assessed by measurement of threshold and impedance data and the magnitude of the epicardial electrogram in comparison to unipolar transvenous pacing using the same indifferent anodal electrodes. Transcoronary pacing with the guidewire-balloon combination using indifferent intravascular electrodes was effective in all cases. Transcoronary pacing thresholds obtained against the indifferent coil electrodes in the aorta thoracalis (0.8 ± 0.5 V) and in the aorta abdominalis (0.8 ± 0.5 V) were similar to those obtained with unipolar transvenous pacing (0.7 ± 0.3 V and 0.6 ± 0.2 V, respectively), whereas the tip-electrode in the aorta thoracalis serving as indifferent anode produced significantly higher pacing thresholds (guidewire, 2.8 ± 2.6 V; transvenous lead, 1.5 ± 0.8 V). The lower pacing threshold of the coil-electrodes was associated with significantly lower impedance values (aorta thoracalis, 285 ± 63 ohm; aorta abdominalis, 294 ± 61 ohm) as compared to the tip-electrode in the aorta thoracalis (718 ± 254 ohm). The amplitude of the epicardial electrogram acquired by the intracoronary guidewire was without significant differences between the indifferent electrodes. Transcoronary pacing in the animal model using a standard guidewire with balloon insulation and intravascular indifferent electrodes is depending on the optimal configuration of the anodal electrode. The use of intravascular coil electrodes with a sufficient surface area can produce 100% capture at thresholds comparable to transvenous pacing. Therefore, technical integration of these coil electrodes into the access sheath or the guiding catheter with respect to handling these tools in daily clinical practice in the catheterization laboratory could further facilitate the transcoronary pacing approach.
    The Journal of invasive cardiology 09/2012; 24(9):451-5. · 1.57 Impact Factor
  • Susanne Unverzagt, Roland Prondzinsky, Frank Peinemann
    G-I-N 2012 Conference, 22-25 August 2012, Berlin, Germany; 08/2012
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    ABSTRACT: BACKGROUND: The IABP SHOCK trial was designed as a morbidity-based randomized controlled trial to determine the effect of intraaortic balloon pulsation (IABP) in patients with infarct-related cardiogenic shock (CS). The primary endpoint was the change in the APACHE II score over a 4-day period. The prospective hypothesis was that adding IABP therapy to "standard care" would reduce CS-triggered multiorgan dysfunction syndrome (MODS). The primary endpoint showed no difference between conventionally managed cardiogenic shock patients and those with additional IABP support. In an inflammatory marker substudy, we analyzed the prognostic value of the cytokines interferon-γ (INF-γ), tumor necrosis factor-α (TNF-α), macrophage inflammatory protein-1β (MIP-1β), granulocyte-colony stimulating factor (G-CSF), and monocyte chemoattractant protein-1β (MCP-1β). We also investigated the influence of IABP support, age, and gender on cytokine levels. DESIGN: The inflammatory marker substudy of the prospective, randomized, controlled, open label IABP SHOCK Trial (ClinicalTrials.gov ID NCT00469248). MATERIALS AND METHODS: A prospective, randomized, single-center study in a 12-bed intensive care unit at a university hospital was performed. A total of 40 consecutive patients were enrolled. The observational period was 96 h. RESULTS: The investigated cytokines showed a significant contribution in the prediction of mortality. Initial (on admission) and maximal cytokine levels during the observational period showed a similar predictive power. Patients with elevated levels of pro- and antiinflammatory cytokines had a higher risk of dying. The maximal level measured over the observation period in the hospital was also suited to identify the survivors. Close correlations between maximal cytokine levels resulted in the choice of only one independent marker (MIP-1β) into the multivariate model (OR 1.024, 95% CI 1.005-1.043). Initial cytokine levels were also suitable to predict the survivors; the risk of death significantly increases with increasing IFN-γ level (OR 1.119, 95% CI 1.005-1.246). Cytokine levels were not affected by the presence of IABP support. Age (< 75 or > 75 years) and gender did not have a clinically relevant effect on INF-γ, TNF-α, MIP-1β, G-CSF, and MCP-1 in CS patients. CONCLUSION: The inflammatory response in patients with myocardial infarction complicated by CS, as reflected by the inflammatory markers INF-γ, TNF-α, MIP-1β, G-CSF, and MCP-1β, have been shown to be of prognostic value in estimating clinical outcome.
    Medizinische Klinik, Intensivmedizin und Notfallmedizin. 07/2012; 107(6):476-484.
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    ABSTRACT: The European ST-elevated myocardial infarction (STEMI) guideline suggested the intra-aortic balloon pump (IABP) with a recommendation level I and a level of evidence C as an effective measure in combination with balloon angioplasty in patients with cardiogenic shock (CS), stent implantation, and inotropic and vasopressor support. Similarly, upon mechanical complication due to myocardial infarction (MI), the guideline suggests that in patients with a ventricular septal defect or in most patients with acute mitral regurgitation, preoperative IABP implantation is indicated for circulatory support. The American College of Cardiology/American Heart Association STEMI guideline recommends the use of the IABP with a recommendation level I and a level of evidence B if CS does not respond rapidly to pharmacological treatment. The guideline notes that the IABP is a stabilizing measure for angiography and early revascularization. Even in MI complications, the use of preoperative IABP is recommended before surgery. Within this overview, we summarize the current evidence on IABP use in patients with CS complicated by MI. From our Cochrane data analysis, we conclude that in CS due to acute MI (AMI) treated with adjuvant systemic fibrinolysis, the IABP should be implanted. In patients with CS following AMI, treated with primary percutaneous coronary intervention (PCI), the IABP can be implanted, although data are not distinctive (i.e., indicating positive and negative effects). In the future, randomized controlled trials are needed to determine the use of IABP in CS patients treated with PCI. When patients with CS are transferred to a PCI center with or without thrombolysis, patients should receive mechanical support with an IABP. To treat mechanical MI complications-in particular ventricular septal defect-patients should be treated with an IABP to stabilize their hemodynamic situation prior to cardiac surgery. Similar recommendations are given in the German Austrian guidelines on treatment of infarction-related CS patients (http://www.awmf.org/leitlinien/detail/ll/019-013.html).
    Artificial Organs 05/2012; 36(6):505-11. · 1.96 Impact Factor
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    ABSTRACT: We conducted the IABP Cardiogenic Shock Trial (ClinicalTrials.gov ID NCT00469248) as a prospective, randomized, monocentric clinical trial to determine the hemodynamic effects of additional intra-aortic balloon pump (IABP) treatment and its effects on severity of disease in patients with acute myocardial infarction complicated by cardiogenic shock (CS). Intra-aortic balloon pump counterpulsation is recommended in patients with CS complicating myocardial infarction. However, there are only limited randomized controlled trial data available supporting the efficacy of IABP following percutaneous coronary intervention (PCI) and its impact on hemodynamic parameters in patients with CS. Percutaneous coronary intervention of infarct-related artery was performed in 40 patients with acute myocardial infarction complicated by CS, within 12 h of onset of hemodynamic instability. Serial hemodynamic parameters were determined over the next 4 days and compared in patients receiving medical treatment alone with those treated with additional intra-aortic balloon counterpulsation. There were no significant differences among severity of disease (i.e., Acute Physiology and Chronic Health Evaluation II score) initially and no differences among both groups for disease improvement. We observed significant temporal improvements of cardiac output (4.8 ± 0.5 to 6.0 ± 0.5 L/min), systemic vascular resistance (926 ± 73 to 769 ± 101 dyn · s(-1) · cm(-5)), and the prognosis-validated cardiac power output (0.78 ± 0.06 to 1.01 ± 0.2 W) within the IABP group. However, there were no significant differences between the IABP group and the medical-alone group. Additional IABP treatment did not result in a significant hemodynamic improvement compared with medical therapy alone in a randomized prospective trial in patients with CS following PCI. Therefore, the use and recommendation for IABP treatment in CS remain unclear.
    Shock (Augusta, Ga.) 01/2012; 37(4):378-84. · 2.87 Impact Factor
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    ABSTRACT: The IABP-SHOCK-trial was a morbidity-based randomized controlled trial in patients with infarction-related cardiogenic shock (CS), which used the change of the quantified degree of multiorgan failure as determined by APACHE II score over a 4-day period as primary outcome measure. The prospective hypothesis was that adding IABP therapy to "standard care" would improve CS-triggered multi organ dysfunction syndrome (MODS). The primary endpoint showed no difference between conventionally managed cardiogenic shock patients and those with IABP support. In an inflammatory marker substudy, we analysed the prognostic value of interleukin (IL)-1β, -6, -7, -8, and -10 in patients with acute myocardial infarction complicated by cardiogenic shock. Inflammatory marker substudy of the prospective, randomized, controlled, open label IABP-SHOCK-trial (Clinical-Trials-gov-ID-NCT00469248). A single-center study was performed in a 12-bed Intensive-Care-Unit in an university hospital in which 40 consecutive patients were enrolled with an observational period of 96 h. The pro- and anti-inflammatory markers IL-6, -7, -8 and -10 showed a predictive power for mortality of infarct-related CS patients, while IL-1β did not discriminate. The maximal values during the observational period, in case of IL-7 the minimal value, showed the best power to predict mortality. Both, ROC and multivariate analyses confirmed these suggestions (area under the curve: IL-8, 0.80 ± 0.08; IL-6, 0.79 ± 0.08; IL-10, 0.76 ± 0.08; IL-7, 0.69 ± 0.08). Inflammatory markers were not affected by the presence of IABP support. The inflammatory response in patients with myocardial infarction complicated by cardiogenic shock, as reflected by the inflammatory markers IL-6, IL-7, IL-8 and IL-10, demonstrates a clinically relevant prognostic contribution to clinical outcome.
    Clinical Research in Cardiology 01/2012; 101(5):375-84. · 3.67 Impact Factor
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    ABSTRACT: Background. The present guideline (http://leitlinien.net/) focuses exclusively on cardiogenic shock due to myocardial infarction (infarction-related cardiogenic shock, ICS). The cardiological as well as the intensive care medicine strategies dealt with in this guideline are essential to the successful treatment of patients with ICS. However, both European and American guidelines on myocardial infarction focus on cardiological aspects. Methods. Evidence on diagnosis, monitoring and therapy of ICS was collected and recommendations compiled in a nominal group process by members of the German and Austrian Societies for Cardiology, Medical and Interdisciplinary Intensive Care Medicine, Cardiac Surgery, Anaesthesiology, and Cardiac Preventive Medicine under the auspices of the German Working Group of Medical Scientific Societies (AWMF). Results. A total of 111 recommendations and seven algorithms were compiled. Appendix 1 summarizes some of the essential statements.
    Der Kardiologe 06/2011; 5(3):166-224.
  • Der Kardiologe 06/2011; Volume 5(Issue3):166-224.
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    ABSTRACT: Hintergrund. Diese Leitlinie (http://leitlinien. net/) fokussiert ausschließlich auf den infarktbedingten kardiogenen Schock (IkS). Beide Strategien, sowohl die kardiologische als auch die intensivmedizinische, sind zur erfolgreichen Behandlung der Patienten mit IkS essenziell. Dennoch beschäftigen sich sowohl die europäische als auch die amerikanische Herzinfarkt-Leitlinie nahezu ausschließlich mit den kardiologischen Aspekten. Methoden. In einem nominalen Gruppenprozess der Delegierten der Deutschen und österreichischen Gesellschaften für Kardiologie, Internistische und Interdisziplinäre Intensivmedizin, Herz- und Thoraxchirurgie, Anästhesiologie sowie Prävention und Rehabilitation wurde unter Leitung der Arbeitsgemeinschaft der medizinisch-wissenschaftlichen Fachgesellschaften (AWMF) die Evidenz zur Diagnose, zum Monitoring und zur Therapie des IkS systematisch gesammelt und – darauf aufbauend – Empfehlungen ausgearbeitet. Ergebnisse. Es wurden 111 Empfehlungen erarbeitet und – darauf basierend – 7 Algorithmen mit konkreten Anweisungen zum Handlungsablauf. Anhang 1 fasst einige wesentliche Empfehlungen zusammen.
    Intensivmedizin + Notfallmedizin 05/2011; 48(4):291-344.
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    ABSTRACT: Bradycardia complicating percutaneous coronary intervention (PCI) can require temporary pacing. A transcoronary approach using the guidewire in the coronary artery may be a useful alternative to transvenous pacing. The purpose of the present study was to compare the efficacy of two different coronary guidewires in transcoronary pacing: a novel guidewire (VisionWire®, Biotronik, Germany) which has a coating to electrically insulate the shaft, thereby maximizing current delivery through the intracoronary section compared to a standard guidewire (without insulation) and a standard guidewire/balloon combination. Unipolar transcoronary pacing was performed in 15 pigs under general anesthesia. In each animal, the new VisionWire was compared to a standard floppy guidewire and to a standard floppy guidewire loaded with a standard angioplasty balloon (which provides additional shaft insulation). The coronary guidewire was the cathode and a skin patch electrode (on the anterior or posterior chest wall) was the anode. We examined the effect of different electrode combinations on transcoronary pacing as assessed by threshold and impedance data and the magnitude of the epicardial electrocardiogram. Transcoronary pacing with the bare standard guidewire was effective in 77% of cases using an anterior skin patch electrode and in 87% with a posterior patch at pacing thresholds of 6.7 ± 2.9 V and 4.1 ± 3.0 V, respectively. Loading the same guidewire with an angioplasty balloon increased the pacing efficacy to 100% with significantly lower pacing thresholds of 2.4 ± 1.6 V with an anterior patch and 1.6 ± 1.3 V with a posterior patch (p < 0.001). The bare VisionWire yielded 100% pacing efficacy, with the lowest pacing thresholds of 1.6 ± 0.7 V and 1.0 ± 0.6 V anterior and posterior patch positions, respectively (p < 0.001). In all studies the pacing efficacy was higher and thresholds lower with the skin patch electrode on the posterior chest wall than on the anterior chest wall. Transcoronary pacing in the animal model is an effective technique. The VisionWire, (even without the additional insulation of a balloon in place) performed better than a standard guidewire (with or without balloon use), and enabled 100% pacing efficacy at acceptable thresholds. Thus, transcoronary pacing, particularly with specific coronary guidewires may be a useful alternative to transvenous pacing during PCI, particularly in the emergency situation when unexpected bradycardias arise during transradial angioplasty when no central venous access is immediately available for transvenous pacing.
    The Journal of invasive cardiology 03/2011; 23(3):108-14. · 1.57 Impact Factor
  • Journal of The American College of Cardiology - J AMER COLL CARDIOL. 01/2011; 57(14).
  • Journal of The American College of Cardiology - J AMER COLL CARDIOL. 01/2011; 57(14).
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    ABSTRACT: Intra-aortic balloon pump counterpulsation (IABP) is currently the most commonly used mechanical assist device for patients with cardiogenic shock due to acute myocardial infarction.Although there is only limited evidence by randomised controlled trials, the current guidelines of the American Heart Association/American College of Cardiology and the European Society of Cardiology strongly recommend the use of the intra-aortic balloon counterpulsation in patients with infarction-related cardiogenic shock on the basis of pathophysiological considerations as also non-randomised trials and registry data. To determine the effect of IABP versus non-IABP or other assist devices guideline compliant standard therapy, in terms of efficacy and safety, on mortality and morbidity in patients with acute myocardial infarction complicated by cardiogenic shock. Searches of CENTRAL, MEDLINE and EMBASE, LILACS, IndMed and KoreaMed, registers of ongoing trials and proceedings of conferences were conducted in January 2010, unrestricted by date. Reference lists were scanned and experts in the field contacted to obtain further information. No language restrictions were applied. Randomised controlled trials on patients with myocardial infarction complicated by cardiogenic shock. Data collection and analysis were performed according to a published protocol. Individual patient data were provided for five trials and merged with aggregate data. Summary statistics for the primary endpoints were hazard ratios (HR's) and odds ratios with 95% confidence intervals (CI). Six eligible and two ongoing studies were identified from a total of 1410 references. Three compared IABP to standard treatment and three to percutaneous left assist devices (LVAD). Data from a total of 190 patients with acute myocardial infarction and cardiogenic shock were included in the meta-analysis: 105 patients were treated with IABP and 85 patients served as controls. 40 patients were treated without assisting devices and 45 patients with LVAD. HR's for all-cause 30-day mortality of 1.04 (95% CI 0.62 to 1.73) provides no evidence for a survival benefit. While differences in survival were comparable in patients treated with IABP, with and without LVAD, haemodynamics and incidences of device related complications show heterogeneous results. Available evidence suggests that IABP may have a beneficial effect on the haemodynamics, however there is no convincing randomised data to support the use of IABP in infarct related cardiogenic shock.
    Cochrane database of systematic reviews (Online) 01/2011; · 5.70 Impact Factor
  • Critical care medicine 05/2010; 38(5):1390-1. · 6.37 Impact Factor
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    ABSTRACT: Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI. The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding. The AIDA STEMI study addresses important questions regarding the efficacy and safety of intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.
    American heart journal 04/2010; 159(4):547-54. · 4.65 Impact Factor

Publication Stats

533 Citations
183.40 Total Impact Points

Institutions

  • 2008–2013
    • Carl-von-Basedow Hospital
      Merseburg, Saxony-Anhalt, Germany
  • 1997–2013
    • Martin Luther University of Halle-Wittenberg
      • • Clinic for Internal Medicine III
      • • Institute of Medical Epidemiology, Biostatistics, and Computer Science
      Halle-on-the-Saale, Saxony-Anhalt, Germany