Abstract 4460: Supported High-Risk Percutaneous Coronary Intervention Using The Impella LP2.5 Device. The Europella Registry

Sjauw, Krischan D.; Hassager, Christian; Danna, Paolo; Konorza, Thomas; Engström, Annemarie E.; Minden, H; Machado, Francisco Pereira; Pedrazzini, Giovanni; Wagner, Daniel R.; Kerber, Sebastian; Schamberger, Rainer; Schofer, Joachim; Mathey, D; Erbel, Raimund; Viecca, Maurizio; Engstrøm, Thomas; Henriques, José P.S.

doi:10.1161/circ.118.suppl_18.s_893

Cited by 5 publications

(6 citation statements)

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“…Several studies are performed using an intraaortic balloon pump (IABP) and coaxial left cardiac support device (Impella device (Abiomed, Danvers, USA)) without showing any clear benefits for IABP. e Impella with its larger hemodynamic support showed some advantages although the official primary endpoint was not reached [4][5][6][7][8][9]. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is an alternative option for mechanical support options providing more extensive hemodynamic support in patients with the potential or ongoing failure of circulation.…”

Section: Introductionmentioning

confidence: 99%

Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry

Griffioen

Oord

Wely

et al. 2022

Journal of Interventional Cardiology

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Background. If surgical revascularization is not feasible, high-risk PCI is a viable option for patients with complex coronary artery disease. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides hemodynamic support in patients with a high risk for periprocedural cardiogenic shock. Objective. is study aims to provide data about short-term outcomes of elective highrisk PCI with ECMO support. Methods. A retrospective single-center registry was performed on patients with high-risk PCI receiving VA-ECMO support. e short-term outcome was defined as the incidence of major adverse cardiac events (MACE) during the hospital stay and within 60 days after discharge. Results. Between January 2020 and December 2021, 14 patients underwent high-risk PCI with ECMO support. e mean age was 66.5 (±2.5) and the majority was male (71.4%) with a mean left ventricular ejection fraction of 33% (±3.0). Complexity indexes were high (STS-PROM risk score: 2.9 (IQR 1.5-5.8), SYNTAX score I: 35.5 (±2.0), SYNTAX score II (PCI): 49.8 (±3.2)). Femoral artery ECMO cannulation was performed in 13 patients (92.9%) requiring additional antegrade femoral artery cannula in one patient because of periprocedural limb ischemia. e mean duration of the ECMO run was 151 (±32) minutes. One patient required prolonged ECMO support and was weaned after 2 days. Successful revascularization was achieved in 13 patients (92.8%). Procedural success was achieved in 12 patients (85.7%) due to one unsuccessful revascularization and one procedural death. MACE during hospital stay occurred in 4 patients (28.6%) and within 60 days after discharge in 2 patients (16.7%). Conclusion. High-risk PCI with hemodynamic support using VA-ECMO is a feasible treatment option, if surgical revascularization is considered very high risk. Larger and prospective studies are awaited to confirm the benefits of ECMO support in elective high-risk PCI comparing ECMO with other mechanical circulatory support devices, including coaxial left cardiac support devices and IABP. Trial Registration. is trial is registered with NCT05387902.

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Section: Introductionmentioning

confidence: 99%

Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry

Griffioen

Oord

Wely

et al. 2022

Journal of Interventional Cardiology

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“…Data from two retrospective registries, including interventional cardiac support with an Impella 2.5 (Abiomed Inc, Danvers, MA, USA ) device, found comparable survival rates of 94.5% (Europella) and 93.1% (USpella). 15,16 As shown by the baseline characteristics, the patients included in the CS group were in profound cardiogenic shock with a remarkable need for inotropes, vasopressors and mechanical ventilation. Additionally, cardiopulmonary resuscitation prior to VA-ECMO was performed in 30% of the patients and the calculated median SAVE-Score was 1 (Risk Class II, predicted survival rate 58%).…”

Section: Discussionmentioning

confidence: 99%

“…We observed a slightly higher survival rate of 94.1% in our study population. Data from two retrospective registries, including interventional cardiac support with an Impella 2.5 (Abiomed Inc, Danvers, MA, USA ) device, found comparable survival rates of 94.5% (Europella) and 93.1% (USpella) 15,16 …”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of ECG‐synchronized pulsatile extracorporeal membrane oxygenation in the clinical setting: The SynCor Trial

et al. 2021

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Introduction Mechanical circulatory support (MCS) devices are increasingly used as a treatment option in resuscitation or in patients with cardiogenic shock (CS). Prophylactic implantation in high‐risk percutaneous coronary interventions (HRPCI) is another upcoming indication. The i‐cor ECG‐synchronized cardiac assist device combines the hemodynamic support of a veno‐arterial extracorporeal membrane oxygenation (VA‐ECMO) with the ability to generate a pulsatile flow and thus decreasing adverse effects of VA‐ECMO on myocardial function. Aim of this study was to obtain data concerning feasibility, safety and outcomes in both indications. Methods A total of 47 patients (34 HRPCI, 13 CS) were included in nine German centers and participated in this study. Demographic and clinical parameters, procedural as well as follow‐up data were prospectively recorded and analyzed. Results Device implantation and initiation of ECG‐synchronized cardiac assist was technical successful in all cases and no failures of the consoles or disposable parts were observed. Furthermore, intended percutaneous coronary interventions and successful weaning from cardiac assist was achieved in 97.1% of HRPCI patients. We observed a 30d‐survival of 94.1% in the HRPCI group and 69.2% in the CS group. Main complications in both groups were bleeding events (14.7% HRPCI, 23.1% CS) and critical limb ischemia (2.9% HRPCI, 38.5% CS). Conclusion The i‐cor ECG‐synchronized cardiac assist device appears safe and feasible showing clinical outcomes comparable to existing data in the setting of high‐risk percutaneous coronary interventions and acute cardiogenic shock. Further prospective trials are warranted to identify optimal patient and interventional characteristics that will benefit most of this novel kind of mechanical circulatory support.

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“…First, the Europella registry showed 30-day mortality of 5.5%. 52 Second, Cohen et al compared patients from the USpella registry who would have met the inclusion criteria for PROTECT-II with patients treated in the Impella arm of PROTECT-II without detecting a significant mortality difference (although registry patients were older and had more frequent relevant preexisting comorbidities). 47 These results are consistent with other analyses of the USpella registry.…”

Section: Impella-facilitated Nonemergent High Risk Percutaneous Coron...mentioning

confidence: 99%

“…The most common complications of Impella support in elective clinical scenarios were access site bleeding and hemolysis. 44,47,50,52 To prevent the latter, frequent echocardiographic control of the Impella position is advisable—the teardrop should be about 3.5 cm from the aortic valve annulus to ensure that the inflow is in the midventricular cavity according to the manufacturer’s recommendation. Acute renal failure and pericardial effusion were reported in patients with Impella support during VT ablation, whereas the reported incidence of cardiac tamponade ranged up to 11%, occurring mostly in patients undergoing epicardial mapping and catheter ablation.…”

Section: Complications Associated With Impella Supportmentioning

confidence: 99%

Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology

Lüsebrink¹,

Kellnar²,

Krieg³

et al. 2022

Circulation

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The Impella device (Impella, Abiomed, Danvers, MA) is a percutaneous transvalvular microaxial flow pump that is currently used for (1) cardiogenic shock, (2) left ventricular unloading (combination of venoarterial extracorporeal membrane oxygenation and Impella concept), (3) high-risk percutaneous coronary interventions, (4) ablation of ventricular tachycardia, and (5) treatment of right ventricular failure. Impella-assisted forward blood flow increased mean arterial pressure and cardiac output, peripheral tissue perfusion, and coronary blood flow in observational studies and some randomized trials. However, because of the need for large-bore femoral access (14 F for the commonly used Impella CP device) and anticoagulation, the incidences of bleeding and ischemic complications are as much as 44% and 18%, respectively. Hemolysis is reported in as many as 32% of patients and stroke in as many as 13%. Despite the rapidly growing use of the Impella device, there are still insufficient data on its effect on outcome and complications on the basis of large, adequately powered randomized controlled trials. The only 2 small and also underpowered randomized controlled trials in cardiogenic shock comparing Impella versus intra-aortic balloon pump did not show improved mortality. Several larger randomized controlled trials are currently recruiting patients or are in preparation in cardiogenic shock (DanGer Shock [Danish-German Cardiogenic Shock Trial; NCT01633502]), left ventricular unloading (DTU-STEMI [Door-To-Unload in ST-Segment–Elevation Myocardial Infarction; NCT03947619], UNLOAD ECMO [Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO], and REVERSE [A Prospective Randomised Trial of Early LV Venting Using Impella CP for Recovery in Patients With Cardiogenic Shock Managed With VA ECMO; NCT03431467]) and high-risk percutaneous coronary intervention (PROTECT IV [Impella-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function; NCT04763200]).

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Abstract 4460: Supported High-Risk Percutaneous Coronary Intervention Using The Impella LP2.5 Device. The Europella Registry

Cited by 5 publications

References 0 publications

Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry

Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry

Efficacy and safety of ECG‐synchronized pulsatile extracorporeal membrane oxygenation in the clinical setting: The SynCor Trial

Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology

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