Abiomed's USpella Results Presented at EuroPCR

May 25, 2010—Abiomed, Inc. (Danvers, MA) announced that William O'Neill, MD, presented updated clinical data from USpella at the EuroPCR 2010 meeting in Paris. USpella is a multicenter, observational registry of patients treated with the company's Impella 2.5 cardiac assist device in the United States. The presentation updates information originally announced at the TCT 2009 meeting on September 22 in San Francisco.

In the presentation at EuroPCR, Dr. O'Neill announced that a total of 62 centers in the United States and Canada have been invited to participate in the registry. Of these, 45 centers have accepted the invitation and have begun the institutional review board approval process. Eighteen of these centers have completed the process, are open for enrollment, and have contributed data on a total of 301 patients. Since the original presentation at TCT 2009, an independent Clinical Executive Committee has been established to adjudicate adverse event reporting. As of March 31, 2010, a total of 251 of the 301 patient data reports have completed the adjudication process and are presented in this update. 
 


Regarding prophylactic Impella support, the updated registry reported that 52% of patients had an improved New York Heart Association classification by one or more categories after Impella-supported complex percutaneous coronary intervention: before treatment, 63% of patients were in class three or four; after treatment, 70% were in class one or two. The target population for implantable cardioverter defibrillator implantation (according to American Heart Association/American College of Cardiology practice guidelines) was reduced 29% by reducing the number of patients with left ventricle ejection fraction ≤ 30% (62% of patients had left ventricle ejection fraction ≤ 30% before treatment, which was reduced to 44% of patients after treatment). Mean ejection fraction in this patient group increased from 31% to 37% after Impella 2.5 support. Dr. O'Neill noted that 56% of patients supported with Impella for complex percutaneous coronary intervention had been declined for a surgical bypass procedure due to their morbidity. Finally, the overall major adverse cardiovascular events rate was low at 8%, and the 30-day survival rate was 96%.

Regarding emergent Impella support, the device was used in acute myocardial shock patients after conventional therapies failed: 79% after emergent revascularization, 81% after high-dose inotropes, and 85% after intra-aortic balloon pump therapy. Patients that were failing intra-aortic balloon pump therapy before switching to Impella experienced a 44% gain in systolic blood pressure (before, 80 ± 15; after, 115 ± 32), a 49% gain in diastolic blood pressure (before, 45 ± 14; after, 67 ± 16), and a 46% gain in mean arterial pressure (before, 57 ± 13; after, 83 ± 17) once they were switched over. Overall hemodynamics improved with Impella support in this patient group, with cardiac index increasing from 1.8 to 2.5 L/min/m², mean arterial pressure increasing from 61 to 87 mm Hg, and wedge pressure decreasing from 29 to 19 mm Hg. After Impella 2.5 support, mean ejection fraction in the acute myocardial infarction shock patients improved from 30% to 34%. The 30-day survival rate of these patients after failing other options was 58%, reported Dr. O'Neill.