News: Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases Cardiogenic Shock Survival

A new analysis of data from Abiomed’s Impella Quality (IQ) Database shows a relative increase of 24% in mean survival in acute myocardial infarction (AMI) cardiogenic shock patients since Impella’s cardiogenic shock FDA post-market approval. Part of the reason for the increase was a near doubling in the number of hospital centers achieving a greater than 80% survival to explant. This data was presented at the 30th Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, California, by William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.

“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,” said Dr. O’Neill.

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 use of inotropes, and use of hemodynamic monitoring.

“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,” said Dr. O’Neill. “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. The NCSI protocol includes placing Impella pre-PCI, reducing the use of inotropes, and right heart hemodynamic monitoring.

The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.