Study Shows Abiomed's Impella Used With Best Practices Increases Survival of Cardiogenic Shock

September 24, 2018—Abiomed, Inc. announced that a new analysis of data from the company's Impella Quality (IQ) database shows a relative increase of 24% in mean survival in acute myocardial infarction (AMI) cardiogenic shock patients after FDA's postmarket approval of the Impella for cardiogenic shock. William O’Neill, MD, presented the findings at the TCT 2018, the 30th Transcatheter Cardiovascular Therapeutics annual scientific symposium held September 21–25 in San Diego, California. Dr. O'Neill is Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Michigan.

According to the company, part of the reason for the increase was a near doubling in the number of hospital centers achieving a > 80% survival to explant. Dr. O'Neill commented in Abiomed's announcement, “This real-world evidence shows an unprecedented increase in survival outcomes for AMI cardiogenic shock patients and is a result of the increased adoption of best practices for treating cardiogenic shock.”

The analysis is based on 11,566 AMI cardiogenic shock patients treated with Impella between April 2015 and June 2018 from Abiomed's IQ Database. The IQ Database is a collection of observational, quality assurance data on more than 95% of Impella patients since the Impella heart pump’s introduction to the United States.

From the IQ Database, three best practices were identified and adopted into treatment protocols at a growing number of hospitals through the physician-led National Cardiogenic Shock Initiative (NCSI). The best practices include placing Impella before percutaneous coronary intervention (PCI), reducing the use of inotropes, and the use of hemodynamic monitoring.

Dr. O’Neill added, “We are seeing this improvement only a year and a half after these best practices were identified and championed. In my career, I haven’t before seen this kind of rapid change of outcomes in interventional cardiology. Historically, survival rates for AMI cardiogenic shock have stagnated around 50%. The adoption of these best practices and the improvement in cardiogenic shock outcomes for so many patients is incredibly gratifying.”

Separately at TCT, Dr. O’Neill also presented initial data from the first 104 patients treated with the NCSI protocol. The data showed a 77% survival to discharge with 99% native heart recovery.