[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: 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 has been only limited evidence from randomised controlled trials, the previous guidelines of the American Heart Association/American College of Cardiology (AHA/ACC) and the European Society of Cardiology (ESC) strongly recommended the use of the IABP in patients with infarction-related cardiogenic shock on the basis of pathophysiological considerations, non-randomised trials and registry data. The recent guidelines downgraded the recommendation based on a meta-analysis which could only include non-randomised trials showing conflicting results. Up to now, there have been no guideline recommendations and no actual meta-analysis including the results of the large randomised multicentre IABP-SHOCK II Trial which showed no survival benefit with IABP support. This systematic review is an update of the review published in 2011.
Full-text · Article · Mar 2015 · Cochrane database of systematic reviews (Online)
[Show abstract][Hide abstract] ABSTRACT: Background: Optimal positioning of the CS-lead at the latest activated part of the left ventricle is one of the major challenges in CRT-implantation with respect to ascertain a high responder rate. In the present study we evaluated the feasibility of transcoronary measurement of left ventricular activation by a coated guidewire in a porcine model.
Methods and results: Transcoronary measurement of ventricular activation was performed in 16 pigs under general anaesthesia. LBBB was induced by transvenous pacing in the right ventricular apex (RVA).
A specially coated guidewire (Vision Wire) – serving as the different electrode - was positioned subsequently in the proximal and distal part of each left coronary main vessel. As the indifferent electrode a cutaneus skin patch electrode was placed at the back of the thorax of the animal. Both electrodes were connected to a portable EP-Lab-System.
Mean QRS-width whilst transvenous right ventricular pacing was 83±5 ms with a typical LBBB-pattern. The time measured between the beginning of the QRS-complex in the surface-ECG and the local signal achieved by the tip of the guidewire was 32±9 ms in the distal RCX and 51±6 ms in the medial RCX yielding a mean delay of 19 ms within this vessel. In the LAD, the local signal was 23±10 ms in the distally and 40±10 ms proximally part of the vessel resulting in a mean delay of 18 ms.
Conclusions: Transcoronary measurement of left ventricular electrical asynchrony by a specially coated guidewire is feasible. As far as a coronary angiography is a mandatory part of the evaluation of patients for CRT-implant this "transcoronary mapping procedure" can be easily performed thereby evaluating the latest activated part of the left ventricle in advance of the implant procedure of a CRT-device.
Preview · Article · Oct 2014 · The Journal of invasive cardiology
[Show abstract][Hide abstract] ABSTRACT: Cardiogenic shock occurring in 5% to 10% of patients with acute myocardial infarction still remains a life-threatening complication. As regards treatment options with inotropic and vasoactive drugs for infarct related cardiogenic shock, there is only very little evidence generated by randomised controlled trials. We included four small randomised controlled trials with a total of 66 participants. Mortality rates ranged from 18% to 47% in the four studies. Only one inotropic drug and one vasodilative were studied in four different comparisons with other active drugs or placebo. Levosimendan showed a trend towards beneficial haemodynamic effects and improved survival rates, but this evidence was based on very limited data which were insufficient to draw robust conclusions. This means that there is no trial evidence for inotropic or vasodilator drugs which shows convincing benefits and confirmed superiority regarding haemodynamic management or survival rates.
Full-text · Article · Jan 2014 · Cochrane database of systematic reviews (Online)
[Show abstract][Hide abstract] 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.
No preview · Article · Aug 2013 · Journal of clinical epidemiology
[Show abstract][Hide abstract] ABSTRACT: Guidelines for evidence-based management of patients with cardiogenic shock after acute myocardial infarction focuses on early revascularisation of the occluded coronary artery as well as on support of cardiac failure and improvement of impaired organ perfusion. Also of great importance is effective treatment of shock complications, especially acute respiratory failure and other forms of multiple organ dysfunction syndrome (MODS). Cardiovascular therapy has to be accompanied by best general intensive care of these critically ill patients with high mortality. Most lives can be saved by early revascularisation, and this class I recommendation has a high level of evidence. So far, most of the other guideline recommendations are of low evidence level, in most cases based on expert opinions. Recently, the Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP SHOCK II) trial with 600 patients has shown that adjunctive IABP therapy - for long a class I recommendation - does not reduce 30-day and six-month motality.
No preview · Article · Aug 2013 · Interventional Cardiology (London)
[Show abstract][Hide abstract] 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.
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.
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.
[Show abstract][Hide abstract] 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.
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)].
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.
No preview · Article · Feb 2013 · Clinical Research in Cardiology
[Show abstract][Hide abstract] 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.
No preview · Article · Sep 2012 · The Journal of invasive cardiology
[Show abstract][Hide abstract] 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.
No preview · Article · Jul 2012 · Medizinische Klinik - Intensivmedizin und Notfallmedizin
[Show abstract][Hide abstract] 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).
No preview · Article · May 2012 · Artificial Organs
[Show abstract][Hide abstract] 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.
Full-text · Article · Jan 2012 · Shock (Augusta, Ga.)
[Show abstract][Hide abstract] 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.
No preview · Article · Jan 2012 · Clinical Research in Cardiology
[Show abstract][Hide abstract] 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.
No preview · Article · Jul 2011 · Cochrane database of systematic reviews (Online)
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] 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.
No preview · Article · May 2011 · Intensivmedizin + Notfallmedizin
[Show abstract][Hide abstract] 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. Table 23 summarizes some of the essential statements.