Abiomed Presents Results From USpella, First U.S. Registery Evaluation Impella 2.5 VAD
September 23, 2009 – Abiomed Inc. announced new clinical data from USpella, the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).
USpella, presented at TCT 2009 by Brijeshwar Maini, M.D., cochair, cardiovascular research, interventional cardiologist, Pinnacle Health; attending cardiologist, Moffitt Heart and Vascular Group, evaluated data from 16 Impella 2.5 centers with IRB approval and over 181 patients from the more than 1,000 reported commercial Impella 2.5 cases. The registry examined both high-risk PCI and AMI patients, reporting the following results:
High-Risk PCI patient results in USpella
In 64 percent of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5 The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5 Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support Reported overall MACE was low at 6 percent 30-day survival rate was 97 percent
AMI patient results in USpella
Impella was used after conventional therapies failed, (88 percent after emergent revascularization; 88 percent after high-dose inotropes; 68 percent after IABP therapy) Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR). After Impella 2.5 support, overall ejection fraction in AMI patients
improved from 29 to 37 percent. Impella successfully supported AMI refractory shock patients with 69 percent survival to the next therapy or onto recovery. Also, 58 percent of AMI shock patients and 89 percent of AMI patients with no shock were discharged.
“USpella is the largest IRB registry reported so far for Impella 2.5 that confirms prior positive study results. Impella is safe and easy to use, provides excellent support to stabilize the patients during high risk PCI and restores the hemodynamics in unstable conditions refractory to conventional therapies,” Maini said.
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