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INTERVENTIONAL CARDIOLOGY

Supported High-Risk Percutaneous Coronary Intervention With the Impella 2.5 Device

The Europella Registry

Krischan D. Sjauw, MD^_*, Thomas Konorza, MD, Raimund Erbel, MD, PhD, Paolo L. Danna, MD, PhD, Maurizio Viecca, MD, PhD, Hans-Heinrich Minden, MD, PhD, Christian Butter, MD, Thomas Engstrøm, MD, PhD^||, Christian Hassager, MD, PhD^||, Francisco P. Machado, MD, PhD^¶, Giovanni Pedrazzini, MD, PhD^#, Daniel R. Wagner, MD, PhD^_**, Rainer Schamberger, MD, PhD, Sebastian Kerber, MD, PhD, Detlef G. Mathey, MD, PhD, Joachim Schofer, MD, PhD, Annemarie E. Engström, MD^_* and Jose P.S. Henriques, MD, PhD^_*,_*

^_* Academic Medical Center–University of Amsterdam, Amsterdam, the Netherlands
Universitäts Klinikum, Essen, Germany
Sacco Hospital, Milano, Italy
Heart Center Brandenburg in Bernau, Berlin, Germany
^|| University Hospital of Copenhagen, Copenhagen, Denmark
^¶ Hospital de Santa Cruz, Carnaxide, Portugal
^# Cardiocentro Ticino, Lugano, Switzerland
^_** Centre Hospitalier, Luxembourg, Luxembourg
Herz-und Gefäß-Klinik, Bad Neustadt, Germany
Center for Cardiology and Vascular Intervention, Hamburg, Germany

Manuscript received May 25, 2009; revised manuscript received September 3, 2009, accepted September 14, 2009.

^_* Reprint requests and correspondence: Dr. Jose P. S. Henriques, Department of Cardiology, Academic Medical Center–University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands (Email: j.p.henriques{at}amc.uva.nl).

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 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.

Key Words: high-risk percutaneous coronary intervention • Impella 2.5 • percutaneous left ventricular assist device • safety and feasibility

Abbreviations and Acronyms   CABG = coronary artery bypass grafting   CAD = coronary artery disease   EuroSCORE = European System for Cardiac Operative Risk Evaluation   IABP = intra-aortic balloon pump   LMCA = left main coronary artery   LV = left ventricle/ventricular   LVAD = left ventricular assist device   LVEF = left ventricular ejection fraction   MI = myocardial infarction   MVD = multivessel disease   PCI = percutaneous coronary intervention

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