We received a number of comments related to the Impella device.  The comments can be generally summarized as requesting 1/ a broader set of indications beyond cardiogenic shock; 2/ inclusion of a primary use option; and 3/ that the LCD is not finalized until after presentation of the PROTECT II trial at the American College of Cardiology 2011 Scientific Session 4/4/11.

Given the importance of the study and the proximity of the date, waiting for PROTECT II results seemed reasonable. Given the superior results of Impella relative to IABP in the study, indications for Impella have been liberalized to be at parity with IABP.  Also, the requirement for Impella to be used only secondary to IABP has been removed, leaving this to clinical judgment.

We received one comment regarding TandemHeart, and that from its manufacturer.  Here the request was that the indication for use as a secondary device be broadened from just cardiogenic shock to include those “at risk” for cardiogenic shock. The final LCD includes identical indications for both Impella and TandemHeart, but retains the requirement for the TandemHeart to be held in reserve for life-threatening situations either refractory to Impella or in which Impella is contraindicated. 

Official comments were submitted from the following:

Dr. William O’Neill- Leonard M. Miller School of Medicine at the University of Miami

Dr. John Lasala- Barnes Jewish Hospital-Missouri

Dr. Igor Palacios – Partners-MGH

Dr. Bonnie Weiner - Society of Cardiac Angiography and Intervention

Dr. Faisal Kahn - Caritas Christi

Dr. John Robb- Dartmouth Hitchcock

Dr. Karim Banali- Chief Medical Officer –Abiomed

Dr. Daniel Fisher-UMass Memorial Healthcare

Dawn Hopkins- Society of Cardiovascular Angiography and Interventions (SCAI)

Kraig McEwen, CEO and President of Cardiac Assist, Inc.