Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry.
OBJECTIVE
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.
Sjauw
Krischan D
KD
Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Konorza
Thomas
T
Erbel
Raimund
R
Danna
Paolo L
PL
Viecca
Maurizio
M
Minden
Hans-Heinrich
HH
Butter
Christian
C
Engstrøm
Thomas
T
Hassager
Christian
C
Machado
Francisco P
FP
Pedrazzini
Giovanni
G
Wagner
Daniel R
DR
Schamberger
Rainer
R
Kerber
Sebastian
S
Mathey
Detlef G
DG
Schofer
Joachim
J
Engström
Annemarie E
AE
Henriques
Jose P S
JP
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001803:Blood Transfusion / Q000706:statistics & numerical data; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D005060:Europe / Q000453:epidemiology; D005240:Feasibility Studies; D005260:Female; D006353:Heart-Assist Devices; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D020521:Stroke / Q000453:epidemiology; D013318:Stroke Volume; D018487:Ventricular Dysfunction, Left / Q000401:mortality / Q000628:therapy*