Krischan D. Sjauw

A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction : should we change the guidelines?

Aims Intra-aortic balloon counterpulsation (IABP) in ST-segment elevation myocardial infarction (STEMI) with cardiogenic shock is strongly recommended (class IB) in the current guidelines. We performed meta-analyses to evaluate the evidence for IABP in STEMI with and without cardiogenic shock. Methods and results Medical literature databases were scrutinized to identify randomized trials comparing IABP with no IABP in STEMI. In absence of randomized trials, cohort studies of IABP in STEMI with cardiogenic shock were identified. Two separate meta-analyses were performed respectively. The first meta-analysis included seven randomized trials (n = 1009) of STEMI. IABP showed neither a 30-day survival benefit nor improved left ventricular ejection fraction, while being associated with significantly higher stroke and bleeding rates. The second meta-analysis included nine cohorts of STEMI patients with cardiogenic shock (n = 10529). In patients treated with thrombolysis, IABP was associated with an 18% [95% confidence interval (CI), 16-20%; P < 0.0001] decrease in 30 day mortality, albeit with significantly higher revascularization rates compared to patients without support. Contrariwise, in patients treated with primary percutaneous coronary intervention, IABP was associated with a 6% (95% CI, 3-10%; P < 0.0008) increase in 30 day mortality. Conclusion The pooled randomized data do not support IABP in patients with high-risk STEMI. The meta-analysis of cohort studies in the setting of STEMI complicated by cardiogenic shock supported IABP therapy adjunctive to thrombolysis. In contrast, the observational data did not support IABP therapy adjunctive to primary PCI. All available observational data concerning IABP therapy in the setting of cardiogenic shock is importantly hampered by bias and confounding. There is insufficient evidence endorsing the current guideline recommendation for the use of IABP therapy in the setting of STEMI complicated by cardiogenic shock. Our meta-analyses challenge the current guideline recommendations.

A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience

OBJECTIVES We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI). BACKGROUND The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation. METHODS In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction <or=35%) and underwent PCI on an unprotected left main coronary artery or last patent coronary conduit. Patients with recent ST-segment elevation myocardial infarction or cardiogenic shock were excluded. The primary safety end point was the incidence of major adverse cardiac events at 30 days. The primary efficacy end point was freedom from hemodynamic compromise during PCI (defined as a decrease in mean arterial pressure below 60 mm Hg for >10 min). RESULTS The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 +/- 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 +/- 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI. CONCLUSIONS The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859).

Supported High-Risk Percutaneous Coronary Intervention With the Impella 2.5 Device: The Europella Registry

OBJECTIVES This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI). BACKGROUND Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump. METHODS The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function. RESULTS Patients were older (62% >70 years of age), 54% had an LV ejection fraction < or = 30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively. CONCLUSIONS This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.

Effects of left ventricular unloading by Impella Recover LP2.5 on coronary hemodynamics

We studied the effects of LV unloading by the Impella on coronary hemodynamics by simultaneously measuring intracoronary pressure and flow and the derived parameters fractional flow reserve (FFR), coronary flow velocity reserve (CFVR), and coronary microvascular resistance (MR).

Left ventricular unloading in acute ST-segment elevation myocardial infarction patients is safe and feasible and provides acute and sustained left ventricular recovery

To the Editor: Unloading the left ventricle (LV) after ST-segment elevation myocardial infarction (STEMI) in addition to reperfusion therapy may reduce infarct size and may give the myocardium time to recuperate from ischemic stunning ([1][1]). This may be particularly true in STEMI patients with

The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients presenting with severe and profound cardiogenic shock: The Academic Medical Center intensive care unit experience*

Objective:Cardiogenic shock remains an important therapeutic challenge, with high in-hospital mortality rates. Mechanical circulatory support may be beneficial in these patients. Since the efficacy of the intra-aortic balloon pump seems limited, new percutaneously placed mechanical left ventricular support devices, such as the Impella system, have been developed for this purpose. Our current purpose was to describe our experience with the Impella system in patients with ST-elevation myocardial infarction presenting in profound cardiogenic shock, who were admitted to our intensive care unit for mechanical ventilation. Methods:From January 2004 through August 2010, a total of 34 ST-elevation myocardial infarction patients with profound cardiogenic shock were admitted to our intensive care unit and treated with either the Impella 2.5 or the Impella 5.0 device. Baseline and follow-up characteristics were collected retrospectively. Measurements and Main Results:Within the study cohort, 25 patients initially received treatment with the Impella 2.5, whereas nine patients received immediate Impella 5.0 support. Eight out of 25 patients in the Impella 2.5 group were upgraded to 5.0 support. After 48 hrs, 14 of 25 patients in the 2.5 group were alive, five of whom had been upgraded. In the 5.0 group, eight out of nine patients were alive. After 30 days, six of 25 patients in the 2.5 group were alive, three of whom had been upgraded. In the 5.0 group, three of nine patients were alive at 30 days. Conclusions:In ST-elevation myocardial infarction patients with severe and profound cardiogenic shock, our initial experience suggests improved survival in patients who received immediate Impella 5.0 treatment, as well as in patients who were upgraded from 2.5 to 5.0 support, when compared to patients who received only Impella 2.5 support.

Effects of mechanical left ventricular unloading by Impella on left ventricular dynamics in high-risk and primary percutaneous coronary intervention patients

Objectives: We studied online left ventricular (LV) dynamic effects of mechanical LV unloading directly after percutaneous coronary intervention (PCI). Background: Limited clinical information is available on the direct LV dynamic consequences of LV unloading in patients undergoing high‐risk PCI and primary PCI for acute ST‐elevation myocardial infarction. Methods: The effects of the Impella LP2.5 device on LV dynamics were studied in 11 patients (elective high‐risk PCI, n = 6; primary PCI, n = 5). LV pressure and volume were continuously assessed by a pressure‐conductance catheter at 4 different support levels of the Impella, from 0 L/min at baseline to 2.5 L/min at maximal support. Results: The response to increased LV unloading was not different between both groups of patients. The pooled data showed no change on global and systolic LV function during increased LV unloading, while diastolic function showed improvement as indicated by an increased LV compliance in all patients. There was a decrease in end‐diastolic pressure from 22 ± 12 to 13 ± 9 mm Hg (P = 0.0001), in end‐diastolic elastance from 0.134 ± 0.060 to 0.091 ± 0.064 mm Hg/mL (P = 0.009), and in end‐diastolic wall stress from 84 ± 50 to 47 ± 39 mm Hg (P = 0.004). Conclusions: LV unloading decreases end‐diastolic wall stress and improves diastolic compliance dose‐dependently. Our results indicate beneficial LV unloading effects of Impella during high‐risk and primary PCI.

Right ventricular dysfunction is an independent predictor for mortality in ST‐elevation myocardial infarction patients presenting with cardiogenic shock on admission

Despite improvement in prognosis for ST‐elevation myocardial infarction (STEMI) patients, mortality remains high in STEMI patients presenting with cardiogenic shock (CS). Right ventricular (RV) dysfunction is an established independent predictor for adverse prognosis in STEMI patients without CS. The purpose of our study was to determine the prognostic value of RV dysfunction on admission in STEMI patients presenting in CS.

The influence of gender on short- and long-term outcome after primary PCI and delivered medical care for ST-segment elevation myocardial infarction

AIMS Despite the advances in treatment for acute ST-elevation myocardial infarction (STEMI) during the past decades for both men and women, most previous studies reported on significantly higher unadjusted in-hospital and long-term mortality rates among women compared with men. Most of these studies have been performed in the (pre-)thrombolytic and early post-thrombolytic era. Many studies reported on myocardial infarction or acute coronary syndromes and did not specifically address STEMI. Moreover, the association of gender, quality of care and mortality has not been systematically assessed. METHODS AND RESULTS Early as well as long-term clinical outcome and delivered quality care was evaluated in an unselected cohort of 3,277 (2,367 men and 910 women) consecutive STEMI patients treated by primary PCI in a tertiary referral institution between January 1995 and 2006. Mean follow-up was 3.2+/-2.2 years. The unadjusted early and late hazards of mortality were not significantly different between men and women (30-days HR 0.87; 95%CI 0.67-1.12; 3-year HR 0.87; 95%CI 0.71-1.10), despite more adverse clinical characteristics in women. Gender was not an independent predictor for mortality and adjustment for covariates did not alter these results. Quality of care was similar between both sexes. CONCLUSIONS Despite higher age and more disadvantageous clinical characteristics, unadjusted early as well as long-term mortality in women with STEMI treated by primary PCI was equal compared with men. Women have longer ischaemic times compared with men but not due to a difference in delivered care. Quality of care before, during and after reperfusion was equal for men and women.

Percutaneous mechanical cardiac assist in myocardial infarction. Where are we now, where are we going?

Since its first clinical application in patients with cardiogenic shock (CS) in 1968, the intra aortic balloon pump (IABP) increasingly has been used for several clinical conditions requiring mechanical cardiac assistance. In current practice, IABP therapy is still the most accessible and most frequently used method of mechanical cardiac assistance. It is primarily being used as a therapeutic instrument for hemodynamic stabilization in left ventricular failure and cardiogenic shock, mainly in patients with myocardial infarction. Although IABP therapy showed to be effective for stabilization of hemodynamically compromised patients, it has failed to show any long‐term survival benefit in any setting of acute myocardial infarction. The rapid developments in ventricular assist device technology have led to the availability of several percutaneous implantable left ventricular assist devices (LVADs). These more potent percutaneous LVADs herald a promising alternative therapeutic approach for mechanical cardiac assistance other than IABP therapy. This article reviews the current status, capabilities, limitations, and future perspectives of currently available percutaneous treatment options for mechanical cardiac assistance in acute myocardial infarction.