Dagmar M. Ouweneel

Percutaneous cardiac support devices for cardiogenic shock: current indications and recommendations

Cardiogenic shock (CS) is a physiological state in which inadequate tissue perfusion results from cardiac dysfunction, most commonly following acute myocardial infarction. Non-ischaemic causes include myocarditis, end-stage cardiomyopathy or sustained arrhythmias. The use of reperfusion therapy has substantially reduced 30-day mortality in acute ST-segment elevation myocardial infarction (STEMI) patients.w1–w3 Currently, the optimal reperfusion therapy is timely primary percutaneous coronary intervention (PCI). The improvement in clinical outcome has been mostly observed in STEMI patients without cardiogenic shock. Despite reperfusion therapy, approximately 6–10% of STEMI patients develop cardiogenic shock during initial hospitalisation.1 ,2 w4 The large multicentre Should we Emergently Revascularise Occluded Coronaries for Cardiogenic Shock? (SHOCK) trial and registry demonstrated that early revascularisation, including PCI or coronary artery bypass grafting, in cardiogenic shock patients improves clinical outcome, but the overall 6-month mortality of cardiogenic shock patients remained 50%3 in accordance with other reports.1 w4 Despite reperfusion by primary PCI, cardiogenic shock remains the leading cause of death for hospitalised STEMI patients.1 w5 Cardiogenic shock after STEMI is mostly a consequence of decreased myocardial contractility due to the infarction, resulting in a cascade of decreased cardiac output, hypotension and decreased coronary blood flow (CBF), which will further reduce contractility and cardiac output. This vicious circle may not only lead to further myocardial ischaemia, but also to diminished organ perfusion and may ultimately result in multiple organ failure and death. Additional aggravation of the downward spiral is caused by a systemic inflammatory response and excess nitric oxide synthesis induced by the myocardial infarction, which further induces vasodilatation.2 Clinically, cardiogenic shock is characterised by hypotension and defined by a systolic blood pressure of less …

The ICM research agenda on extracorporeal life support

PurposeThis study aimed to concisely describe the current standards of care, major recent advances, common beliefs that have been contradicted by recent trials, areas of uncertainty, and clinical studies that need to be performed over the next decade and their expected outcomes with regard to extracorporeal membrane oxygenation (ECMO).MethodsNarrative review based on a systematic analysis of the medical literature, national and international guidelines, and expert opinion.ResultsThe use of venovenous ECMO (VV-ECMO) is increasing in the most severe forms of acute lung injury. In patients with cardiogenic shock, short-term veno-arterial ECMO (VA-ECMO) provides both pulmonary and circulatory support. Technological improvements and recently published studies suggest that ECMO is able to improve patients’ outcomes. There are, however, many uncertainties regarding the real benefits of this technique both in hemodynamic and respiratory failure, the territorial organization to deliver ECMO, the indications and the use of concomitant treatments.ConclusionsAlthough there have been considerable advances regarding the use of ECMO in critically ill patients, the risk/benefit ratio remains underinvestigated. ECMO indications, organization of ECMO delivery, and use of adjuvant therapeutics need also to be explored. Ongoing and future studies may be able to resolve these issues.

Prognostic value of access site and nonaccess site bleeding after percutaneous coronary intervention: a cohort study in ST-segment elevation myocardial infarction and comprehensive meta-analysis

OBJECTIVES This study sought to investigate the prognostic value of access site bleeding (ASB) and non-ASB for recurrent ischemic outcomes and mortality in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND The prognostic value of ASB-related complications after STEMI is subject to debate. METHODS The prognostic value of ASB and non-ASB for 1-year mortality, recurrent myocardial infarction (MI), stent thrombosis, and stroke was investigated in 2,002 STEMI patients undergoing primary percutaneous coronary intervention. In addition, we performed a meta-analysis of studies investigating the prognostic value of ASB and non-ASB in patients undergoing percutaneous coronary intervention. RESULTS Seventy-four patients (3.7%) were treated by radial access. ASB developed in 124 patients (6.3%) and non-ASB developed in 102 (5.2%). By multivariable analysis, ASB was not associated with a higher risk of 1-year mortality (hazard ratio [HR]: 1.03; p = 0.89), recurrent MI (HR: 1.16; p = 0.64), stent thrombosis (HR: 0.55; p = 0.42), or stroke (HR: 0.47; p = 0.31). Non-ASB was independently associated with 1-year mortality (HR: 2.77; p < 0.001) and stent thrombosis (HR: 3.10; p = 0.021), but not with recurrent MI and stroke. In a meta-analysis including 495,630 patients, non-ASB was associated with a greater adjusted risk of subsequent 1-year mortality than ASB (HR: 1.66; 95% CI: 1.56 to 1.76 and HR: 1.21; 95% CI: 1.11 to 1.31). CONCLUSIONS In STEMI, ASB was not significantly associated with 1-year clinical outcomes, whereas non-ASB was significantly associated with 1-year mortality and stent thrombosis. These results taken together with those of previous studies indicate a greater risk of subsequent mortality in patients with non-ASB.

Evaluating the learning curve in the prospective Randomized Clinical Trial of hemodynamic support with Impella 2.5 versus Intra-Aortic Balloon Pump in patients undergoing high-risk percutaneous coronary intervention: a prespecified subanalysis of the PROTECT II study

BACKGROUND The introduction of new medical devices may be accompanied by a learning curve. METHODS To evaluate the impact of the device learning curve on the outcomes of PROTECT II trial, comparing Impella 2.5 versus the intra-aortic balloon pump (IABP) during high-risk percutaneous coronary intervention, we report on a prespecified analysis, excluding the first Impella 2.5 and IABP patients at each site. RESULTS A total of 448 patients were enrolled at 74 sites. Among these, 58 patients were the first to receive Impella 2.5 at their site, 62 were the first to receive IABP. A trend toward higher major adverse events (MAEs) at 30 days was observed for the subgroup of first versus remaining Impella 2.5 patients: 44.8% versus 31.7%, P = .072. MAE rates for the first and remaining IABP patients were similar at 30 days. After exclusion of the first patient in each group, MAE rates for Impella 2.5 and IABP were 31.7% versus 40.0% (P = .119) at 30 days and 38.0% versus 50.0% (P = .029) at 90 days. CONCLUSIONS Significantly lower 90-day MAE rates were observed with the use of Impella 2.5 compared to the use of IABP after excluding the first patient per group at each site. This prespecified analysis suggests a learning curve associated with initial introduction of the Impella 2.5. Clinical trials should better address the training aspect of new devices, especially when compared with more established devices.

Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump for Treating Cardiogenic Shock: Meta-Analysis

In patients with cardiogenic shock after acute myocardial infarction (AMI), mortality remains high despite advances in treatment. Short-term percutaneous circulatory support devices provide superior hemodynamic support compared with the intra-aortic balloon pump (IABP). American guidelines have

Percutaneous short-term active mechanical support devices in cardiogenic shock: a systematic review and collaborative meta-analysis of randomized trials

Aims Evidence on the impact on clinical outcome of active mechanical circulatory support (MCS) devices in cardiogenic shock (CS) is scarce. This collaborative meta-analysis of randomized trials thus aims to investigate the efficacy and safety of percutanzeous active MCS vs. control in CS. Methods and results Randomized trials comparing percutaneous active MCS to control in patients with CS were identified through searches of medical literature databases. Risk ratios (RR) and 95% confidence intervals (95% CI) were calculated to analyse the primary endpoint of 30-day mortality and device-related complications including bleeding and leg ischaemia. Mean differences (MD) were calculated for mean arterial pressure (MAP), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), and arterial lactate. Four trials randomizing 148 patients to either TandemHeart™ or Impella® MCS (n = 77) vs. control (n = 71) were identified. In all four trials intra-aortic balloon pumping (IABP) served as control. There was no difference in 30-day mortality (RR 1.01, 95% CI 0.70 to 1.44, P = 0.98, I2 = 0%) for active MCS compared with control. Active MCS significantly increased MAP (MD 11.85 mmHg, 95% CI 3.39 to 20.31, P = 0.02, I2 = 32.7%) and decreased arterial lactate (MD - 1.36 mmol/L, 95% CI - 2.52 to - 0.19, I2 = 0%, P = 0.02) at comparable CI (MD 0.32, 95% CI - 0.24 to 0.87, P = 0.14, I2 = 44.1%) and PCWP (MD - 5.59, 95% -15.59 to 4.40, P = 0.14, I2 = 81.1%). No significant difference was observed in the incidence of leg ischaemia (RR 2.64, 95% CI 0.83 to 8.39, P = 0.10, I2 = 0%), whereas the rate of bleeding was significantly increased in MCS compared to IABP (RR 2.50, 95% CI 1.55 to 4.04, P < 0.001, I2 = 0%). Conclusion Results of this collaborative meta-analysis do not support the unselected use of active MCS in patients with CS complicating AMI.

Experience from a randomized controlled trial with Impella 2.5 versus IABP in STEMI patients with cardiogenic pre-shock. Lessons learned from the IMPRESS in STEMI trial.

Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.

The impact of the location of a chronic total occlusion in a non-infarct-related artery on long-term mortality in ST-elevation myocardial infarction patients

AIMS Several studies have evaluated the impact of a CTO on short- and long-term mortality in STEMI patients. It has been speculated that the adverse effect on prognosis could differ per coronary location. The purpose of this study was to evaluate whether the long-term prognosis of STEMI patients differs according to the coronary location of the CTO. METHODS AND RESULTS Between 2000 and 2012, a total of 480 STEMI patients with a CTO in a non-infarct-related artery were included. The primary outcome for the present analysis was three-year all-cause mortality, evaluating the impact of the coronary CTO and infarct location. Four hundred and thirteen patients had a single CTO in a non-infarct-related artery, whereas 67 patients had more than one CTO and in this group mortality was higher. In patients with a single CTO, the highest risk of mortality was observed when the culprit lesion was located in the LAD or proximal LCX or when the CTO lesion was located in the proximal LAD. CONCLUSIONS We previously reported that STEMI patients with a CTO have a worse prognosis than STEMI patients without a CTO. We now show that, in these patients, LAD or proximal LCX location for the culprit lesion, or proximal LAD location for the CTO lesion, is associated with the highest risk. As a result, almost all CTO patients are at increased risk for mortality due to the combination of the culprit and CTO artery location.

Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump for Treating Cardiogenic Shock

In patients with cardiogenic shock after acute myocardial infarction (AMI), mortality remains high despite advances in treatment. Short-term percutaneous circulatory support devices provide superior hemodynamic support compared with the intra-aortic balloon pump (IABP). American guidelines have

Epinephrine and short-term survival in cardiogenic shock: an individual data meta-analysis of 2583 patients

AbstractObjectiveCatecholamines have been the mainstay of pharmacological treatment of cardiogenic shock (CS). Recently, use of epinephrine has been associated with detrimental outcomes. In the present study we aimed to evaluate the association between epinephrine use and short-term mortality in all-cause CS patients. DesignWe performed a meta-analysis of individual data with prespecified inclusion criteria: (1) patients in non-surgical CS treated with inotropes and/or vasopressors and (2) at least 15% of patients treated with epinephrine administrated alone or in association with other inotropes/vasopressors. The primary outcome was short-term mortality.Measurements and resultsFourteen published cohorts and two unpublished data sets were included. We studied 2583 patients. Across all cohorts of patients, the incidence of epinephrine use was 37% (17–76%) and short-term mortality rate was 49% (21–69%). A positive correlation was found between percentages of epinephrine use and short-term mortality in the CS cohort. The risk of death was higher in epinephrine-treated CS patients (OR [CI] = 3.3 [2.8–3.9]) compared to patients treated with other drug regimens. Adjusted mortality risk remained striking in epinephrine-treated patients (n = 1227) (adjusted OR = 4.7 [3.4–6.4]). After propensity score matching, two sets of 338 matched patients were identified and epinephrine use remained associated with a strong detrimental impact on short-term mortality (OR = 4.2 [3.0–6.0]).ConclusionsIn this very large cohort, epinephrine use for hemodynamic management of CS patients is associated with a threefold increase of risk of death.