Abstract

Background Patients with complex or high risk coronary lesions, due to extensive and diffuse multivessel, left main or last remaining coronary artery disease are increasingly being treated with percutaneous coronary intervention (PCI). As peri-procedural hemodynamic compromise and complications may occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor left ventricular (LV) function. The Impella LP2.5, a novel percutaneous implantable LVAD able to provide flow up to 2.5 L/min, may be a superior alternative to the traditionally used IABP. Methods We studied safety and feasibility of LV support with the Impella LP2.5 in 144 high-risk PCI patients. All patients were enrolled in the Europella registry, a prospective multicenter registry comprising 10 high volume tertiary PCI centers in Europe. Results Patients were old (62% >70 years), 53% had previous myocardial infarction, 54% had a LV ejection fraction ≤30% and the prevalence of co-morbid conditions was high. Mean EuroSCORE was 8.2 (SD 3.4) and 43% of the patients were refused for CABG. PCI was considered high risk due to left main, last remaining and multivessel coronary artery disease, and low LV function respectively in 53%, 17%, 81% and 35% of the cases. The mean assist time was 1 hour and 28 minutes (SD 51min). There were no intra-procedural major adverse cardiac and cerebral events. In-hospital and 30-day mortality were 4.7% and 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery and vascular complications at 30 days were respectively 0%, 0.7%, 1.4% and 4.0% Conclusions The safety and feasibility findings of Impella LP2.5 are encouraging. Our study, supports the potential usefulness of hemodynamic support with Impella LP2.5 to prevent intra-procedural major adverse events and hemodynamic compromise in high-risk PCI.

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