AB5000 VADs can restore normal hemodynamics in AMI cardiogenic shock patients: Report

Results from the U.S. registry of Abiomed, Inc. (NASDAQ: ABMD), AB5000 patients were recently published in the September 2010 issue of The Annals of Thoracic Surgery. The paper, "Use of the AB5000^TM Ventricular Assist Device in Cardiogenic Shock After Acute Myocardial Infarction (AMI)," concludes that the "results from this nationwide registry suggest that VADs can restore normal hemodynamics and support recovery of native cardiac function in the majority of survivors when conventional therapies fail."

“This is the largest reported paper on AMI cardiogenic shock patients on VAD support. It demonstrates that aggressive and early implantation of bridge to recovery VADs, such as the AB5000, can potentially improve recovery and survival outcomes of cardiogenic shock patients”

"This is the largest reported paper on AMI cardiogenic shock patients on VAD support. It demonstrates that aggressive and early implantation of bridge to recovery VADs, such as the AB5000, can potentially improve recovery and survival outcomes of cardiogenic shock patients," said Mark Anderson, MD, Robert Wood Johnson Medical School. "Recovery should be the first option. Though VAD support for AMI cardiogenic shock patients is not yet in the clinical guidelines, this paper shows that temporary heart recovery devices have the ability to recover heart muscle and avoid heart transplantation in these critically ill patients."

This study reports on the results of the first 100 patients with AMI cardiogenic shock and implanted with the AB5000 VAD. The paper reported the following:

Results

• Fifty two percent of the 100 cardiogenic shock patients were in shock for more than 24 hours before VAD implant, the median time from shock to VAD implant was 26.5 hours and 44% of the patients underwent CPR for a mean average of 20 minutes before VAD implant. All 100 patients received high-dose inotropic support and 91% received an intra-aortic balloon before receiving VAD support.
• The estimated survival rate for AMI cardiogenic shock patients, calculated for this patient population using the Logistic EuroSCORE, is less than 15%. The actual survival rate for the same patient population in the AB5000 registry was 40%.
• Two thirds or 63% of the survivors experienced recovery of their native hearts. Recovery was defined as patients demonstrating stable unassisted cardiac function 30 days after VAD explant or at discharge.
• The survival for recovery patients at two years after VAD explant was 78% (Kaplan-Meier estimated).
• Of the survivors who stayed on AB5000 support and were not able to recover their native hearts, 80% were successfully transplanted and discharged.

"The AB5000 is the only VAD that is designed and FDA-approved for all indications of heart muscle recovery. This paper demonstrates that heart muscle recovery is the most likely outcome for AMI cardiogenic shock survivors who have received support from a recovery VAD," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "Additionally, the paper discusses that the use of today's percutaneous VADs can help lower the threshold for VAD support in AMI cardiogenic shock patients."