Presentation of Abiomed's Impella Quality Assurance Program Highlights Importance of Treatment Protocols
March 19, 2017—Abiomed announced that data from the company's Impella Quality (IQ) Assurance Program, which includes the IQ Database and cVAD Registry were presented as featured clinical research at the American College of Cardiology's (ACC) 66th annual scientific session in Washington, DC.
The data were derived from the IQ Database documenting the real-world treatment of approximately 50,000 patients in the United States, with a subset of 15,259 acute myocardial infarction cardiogenic shock (AMICS) patients. The Impella heart pump results indicate an association between the use of best practice protocols and improved survival and native heart recovery, as compared to inconsistent treatment or inexperienced hospitals.
According to the company, the Abiomed IQ Assurance Program is a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Trends in the observational IQ Database, combined with information from Abiomed's Institutional Review Board (IRB)-approved cVAD Registry have helped identify best practices and protocols that are associated with improved survival and native heart recovery in hospitals using Impella devices.
Best practice protocols include unloading the left ventricle of the with Impella before percutaneous coronary intervention in the setting of cardiogenic shock, reducing the escalation of inotrope therapy, utilizing hemodynamic monitoring for escalation and weaning during support, and experienced physicians implanting Impella heart pumps.
Results from the IQ Database demonstrate that since the Impella line of heart pumps received premarket approval from the US Food and Drug Administration (FDA) in April 2016 for use in treating AMICS, there has been an observed 14% relative improvement in survival as compared to the previous year.
In 2016, there were 89,000 AMICS cases nationwide and approximately 5,000 (6%) were treated with Impella heart pumps. This compares with approximately 35,600 (40%) treated with the intra-aortic balloon pump (IABP), even though randomized controlled trials show no hemodynamic augmentation or survival benefit for IABP patients in AMICS. Although it was 510(k) cleared in 1976 as a result of already being on the market, the IABP is not FDA approved as safe and effective for the AMICS indication, noted the company.
The data presented at the ACC meeting also included new data from the Detroit Cardiogenic Shock Initiative (DCSI), which is an unprecedented collaboration between five heart hospitals in Detroit. Principal investigator William W. O'Neill, MD, Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Michigan, presented the DCSI data. The presentation highlighted the treatment of 37 patients utilizing these best practices and protocols derived from Abiomed's IQ Assurance Program and the most experienced heart hospitals.
Applying these systematic best practices, DCSI hospitals showed an increase in cardiogenic shock survival rates from 51% baseline to 84%, with 100% of survivors discharged home with their native heart. In Abiomed's press release, Dr. O'Neill commented, "These results validate earlier studies from the cVAD Registry that early circulatory support is critical for survival and heart recovery in cardiogenic shock. We are proud of the positive results of our unprecedented collaboration. By sharing our best practice protocols, we remain committed to improving shock outcomes in Detroit and around the world."
The company stated that these new data support previously published studies with percutaneous heart pumps (such as Impella) supporting cardiogenic shock patients. Those studies represent approximately 12,000 Medicare/insurance patients and 154 cVAD Registry patients respectively.
Abiomed explained that the mission of the IQ Assurance Program is to improve real-world outcomes in protected PCI and cardiogenic shock patients through training, education, and utilization of clinical guidelines, protocols, and best practices derived from observational quality assurance data (IQ), IRB approved registry data (cVAD), and investigational device exemption-approved FDA studies. The points reflected specifically in the IQ Database, as compared to the IQ Program, which includes the cVAD Registry and FDA studies, are not statistically powered or prespecified, and no statistical conclusions can be drawn from the observational database, advised the company.