Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry

Krischan D Sjauw; Thomas Konorza; Raimund Erbel; Paolo L Danna; Maurizio Viecca; Hans-Heinrich Minden; Christian Butter; Thomas Engstrøm; Christian Hassager; Francisco P Machado; Giovanni Pedrazzini; Daniel R Wagner; Rainer Schamberger; Sebastian Kerber; Detlef G Mathey; Joachim Schofer; Annemarie E Engström; Jose P S Henriques

doi:10.1016/j.jacc.2009.09.018

Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry

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

Department of Clinical Medicine

165 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Journal of the American College of Cardiology
Volume	54
Issue number	25
Pages (from-to)	2430-4
Number of pages	4
ISSN	0735-1097
DOIs	https://doi.org/10.1016/j.jacc.2009.09.018
Publication status	Published - 2009

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Sjauw, K. D., Konorza, T., Erbel, R., Danna, P. L., Viecca, M., Minden, H-H., Butter, C., Engstrøm, T., Hassager, C., Machado, F. P., Pedrazzini, G., Wagner, D. R., Schamberger, R., Kerber, S., Mathey, D. G., Schofer, J., Engström, A. E., & Henriques, J. P. S. (2009). Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. Journal of the American College of Cardiology, 54(25), 2430-4. https://doi.org/10.1016/j.jacc.2009.09.018

Sjauw, KD, Konorza, T, Erbel, R, Danna, PL, Viecca, M, Minden, H-H, Butter, C, Engstrøm, T , Hassager, C, Machado, FP, Pedrazzini, G, Wagner, DR, Schamberger, R, Kerber, S, Mathey, DG, Schofer, J, Engström, AE & Henriques, JPS 2009, 'Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry', Journal of the American College of Cardiology, vol. 54, no. 25, pp. 2430-4. https://doi.org/10.1016/j.jacc.2009.09.018

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title = "Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry",

abstract = "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.",

author = "Sjauw, {Krischan D} and Thomas Konorza and Raimund Erbel and Danna, {Paolo L} and Maurizio Viecca and Hans-Heinrich Minden and Christian Butter and Thomas Engstr{\o}m and Christian Hassager and Machado, {Francisco P} and Giovanni Pedrazzini and Wagner, {Daniel R} and Rainer Schamberger and Sebastian Kerber and Mathey, {Detlef G} and Joachim Schofer and Engstr{\"o}m, {Annemarie E} and Henriques, {Jose P S}",

note = "Keywords: Aged; Angioplasty, Transluminal, Percutaneous Coronary; Blood Transfusion; Comorbidity; Coronary Artery Disease; Europe; Feasibility Studies; Female; Heart-Assist Devices; Hemorrhage; Humans; Male; Myocardial Infarction; Registries; Retrospective Studies; Risk Assessment; Severity of Illness Index; Stroke; Stroke Volume; Ventricular Dysfunction, Left",

year = "2009",

doi = "10.1016/j.jacc.2009.09.018",

language = "English",

volume = "54",

pages = "2430--4",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

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number = "25",

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TY - JOUR

T1 - Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry

AU - Sjauw, Krischan D

AU - Konorza, Thomas

AU - Erbel, Raimund

AU - Danna, Paolo L

AU - Viecca, Maurizio

AU - Minden, Hans-Heinrich

AU - Butter, Christian

AU - Engstrøm, Thomas

AU - Hassager, Christian

AU - Machado, Francisco P

AU - Pedrazzini, Giovanni

AU - Wagner, Daniel R

AU - Schamberger, Rainer

AU - Kerber, Sebastian

AU - Mathey, Detlef G

AU - Schofer, Joachim

AU - Engström, Annemarie E

AU - Henriques, Jose P S

N1 - Keywords: Aged; Angioplasty, Transluminal, Percutaneous Coronary; Blood Transfusion; Comorbidity; Coronary Artery Disease; Europe; Feasibility Studies; Female; Heart-Assist Devices; Hemorrhage; Humans; Male; Myocardial Infarction; Registries; Retrospective Studies; Risk Assessment; Severity of Illness Index; Stroke; Stroke Volume; Ventricular Dysfunction, Left

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

U2 - 10.1016/j.jacc.2009.09.018

DO - 10.1016/j.jacc.2009.09.018

M3 - Journal article

C2 - 20082934

SN - 0735-1097

VL - 54

SP - 2430

EP - 2434

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 25

ER -

Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry

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