New Data and Publications

Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval

USpella, presented at TCT 2009 by Brijeshwar Maini, M.D., co-chair, cardiovascular research, interventional cardiologist, Pinnacle Health; attending cardiologist, Moffitt Heart & 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% 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%
• 30-day survival rate was 97%

   AMI patient results in USpella

• Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% 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%;
• Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged

Maini concludes that, “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.”

The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.

The three-year follow-up results from MACH II were presented by Jose PS Henriques, M.D., Ph.D., Academic Medical Center, University of Amsterdam, at the Abiomed customer evening symposium at TCT 2009. The results measured the three-year follow-up of 20 large anterior STEMI patients in the MACH II trial and demonstrated significant overall improvements in cardiac function as well as quality of life in the ten patients that received Impella 2.5 within the trial.

All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes:

• Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points.
• Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient
• Impella 2.5 patients saw no effects on aortic valve at three-year follow-up

“The initial MACH II results demonstrated that Impella had sustained benefits at four months and the three-year analysis, showing a 10% increase in ejection fraction, is an even stronger indicator that this device will make a significant difference in AMI treatment,” said Henriques. “Additionally, these findings could suggest that Impella 2.5 patients who have been discharged have higher rates of recovery and lower chances of hospital re-admittance.”

Impella 2.5

Hemodynamic Preinciples to Patient Application

Tuesday, September 22, 2009

Opening Comments

Dr. William W. O'Neill

Professor and Executive Dean for Clinical Affairs

University of Miami

Miami, FL

Science of Hemodynamics

Dr. John M. Lasala

Director of Interventional Cardiology; Professor of Medicine

Washington University School of Medicine

Barnes-Jewish Hospital

St. Louis, MO

Impella and PCI

Dr. Samin K. Sharma

Director of the Interventional Cardiology Cath Lab

Professor of Medicine

Mount Siani School of Medicine

New York, NY

Impella and AMI

Dr. Jose P.S. Henriques

Cath Lab Director

Academic Medical Centre

Amsterdam, The Netherlands

Panel Discussion

Impella 2.5

Case Reviews of Real World Application

Wednesday, September 23, 2009

Opening Comments

Dr. Charanjit S. Rihal

Director - Cardiac Cath Lab; Professor of Medicine

Mayo Clinic

Rochester, MN

USPella Registry

Dr. Brijeshwar Maini

Co-chair, Cardiovascular Research

Pinnacle Health and Vascular Institute

Harrisburg, PA

Case Presentation

Dr. Rajesh Dave

Chairman of Endovascular Medicine

Director, Central PA DV Research Institute

Pinnacle Health and Vascular Institute

Harrisburg, PA

Case Presentation

Dr. Steven J. Yakubov

Cardiovascular Disease, Interventional Cardiology

Riverside Methodist Hospital

Columbus, OH

Case Presentation

Dr. Srihari Naidu

Director, Cardiac Catheterization Laboratory

Winthrop University Hospital

Minneola, NY

Case Presentation

Dr. Tyrone J. Collins

Program Director, Interventional Cardiology Fellowship

Co-director, Cardiac Cetheterization Laboratory

Ochsner Clinic Foundation

New Orleans, LA

Case Presentation

Dr. Wissam Gharib

Assistant Prof. of Medicine; Dir. of Cardiac Cath Lab

West Virginia University Cardiology

Morgantown, WV

Impella 2.5

Hemodynamic Support in High-risk PCI and Cardiogenic Shock: 

A Case -based Review

Friday, September 25, 2009

Program Chair:

Dr. Roxana Mehran

Columbia University Medical Center

New York, NY

Co-Chair:

Dr. Igor F. Palacios

Massachusetts General Hospital Heart Clinic

Boston, MA

Co-Chair:

Dr. Raj Makkar

Cedars-Sinai Medical Center

Los Angeles, CA

For a complete view of Abiomed presentations visit tctmd.com