December 18, 2009 – Results from the Europella registry, evaluating the safety and feasibility of the Abiomed Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures, was published in the Dec. 15 issue of the Journal of the American College of Cardiology (JACC).
The paper, “Supported High-Risk Percutaneous Coronary Intervention Using the Impella 2.5 Device: The Europella Registry,” supports the safety, feasibility and potential usefulness of hemodynamic support with Impella in high-risk PCI.
“As high-risk PCI increasingly becomes the alternative for patients turned down for surgery, the Europella registry demonstrates that Impella 2.5 proves a safe and effective method of support for these high-risk procedures,” said Jose P. S. Henriques, M.D., Ph.D., Academic Medical Center, University of Amsterdam. “These results are very encouraging in indicating Impella’s ability to maintain hemodynamic support by safely unloading the left ventricle and decreasing oxygen demand in high-risk PCI patients.”
The Europella registry is the largest multicenter study ever reported for high-risk PCI conducted with Impella. It including 144 consecutive high-risk PCI patients with complex coronary lesions, such as last remaining vessel or left main lesions. Patients were treated at 10 European centers.
Patients in the study were older, with a mean age of 72 years. About 54 percent had an LV ejection fraction of 30 percent or less. The prevalence of comorbidities was high and the Mean European System for Cardiac Operative Risk Evaluation score was 8.2± 3.4, About 43 percent of the patients were refused for coronary artery bypass graft surgery. Left main coronary artery PCI, last patent vessel PCI, and complex multivessel disease comprised 52 percent, 17 percent and 82 percent of the cases.
Successful passage through the femoral artery and implantation of the Impella 2.5 into the left ventricle was achieved in all 144 patients. The study showed a low rate of major adverse cardiac and cerebrovascular, no device malfunction, and low rate of complications confirming the safety, ease of use of the technology. The primary endpoint included successful deployment, operation and explantation of the Impella 2.5.
For more information: www.abiomed.com, content.onlinejacc.org