Findings Presented From National Cardiogenic Shock Initiative With Abiomed's Impella Best Practices
May 28, 2019—Abiomed announced that new data from the National Cardiogenic Shock Initiative (NCSI) study on 171 consecutive patients with acute myocardial infarction cardiogenic shock (AMICS) from 35 sites demonstrated 72% survival with 98% native heart recovery at discharge.
The results were presented at SCAI 2019, the Society for Cardiovascular Angiography & Interventions scientific sessions held May 19–22 in Las Vegas, Nevada and were simultaneously published online by Mir B. Basir, DO, et al in Catheterization and Cardiovascular Interventions.
According to the company, these results improve on the historical survival rate of 50% for patients with AMICS. The patients were treated with the NCSI protocol, which includes placing the Impella heart pump (Abiomed) before revascularization. The study demonstrated that the protocol-based approach to increasing survival rates in cardiogenic shock is reproducible in academic and community hospitals across the United States.
The investigators of the physician-led NCSI represent the largest working group studying the effects of mechanical circulatory support in patients with AMICS. Their goals are to increase cardiogenic shock survival, which has stagnated for the last 20 years at around 50%, and provide unloading therapy to achieve native heart recovery. The NCSI protocol includes best practices for placing Impella before percutaneous coronary interventions, identifying shock early, minimizing the use of inotropes, and hemodynamic monitoring with pulmonary artery catheters.
These best practices were retrospectively identified through Abiomed’s Impella Quality (IQ) database and the United States Impella registry, now called the cVAD study. The practices were tested and validated prospectively in the original Detroit CSI study, which demonstrated improved survival and native heart recovery.
The NCSI used patient selection criteria that mimicked previous cardiogenic shock studies. Patients included in the study were treated between July 2016 and February 2019.
Characteristics of the patients (n = 171) in the study included average age (63 years), sex (77% male), presence of AMICS on admission (68%), those on inotropes or vasopressors before or during index procedure (83%), witnessed out-of-hospital cardiac arrest (20%), in-hospital cardiac arrest (29%), and cardiopulmonary resuscitation at the time of Impella insertion (10%).
Abiomed noted that the company has collected data on approximately 100% of Impella patients in the United States in the observational IQ database from the time of the device's FDA approval. This clinical data, combined with the FDA postapproval studies embedded in Abiomed’s prospective cVAD study, helped identify and validate best practices for Impella use associated with improved survival and native heart recovery. These best practices have now been validated in multiple publications.
Principal Investigator William O’Neill, MD, commented in Abiomed's announcement, “By adopting the NCSI protocol, physicians around the country have standardized the treatment of cardiogenic shock and are improving patient outcomes by using best practices, which include early placement of the Impella heart pump. Similar to door-to-balloon time, the adoption of these best practices is an evolution in clinical practice that will benefit our sickest patients. Tracking, collecting, and applying real-world evidence will allow physicians to continue to increase survival and heart recovery for these patients.”
Dr. O'Neill is Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Michigan, where the National Cardiogenic Shock Initiative study is based. Multimedia illustrations of the data are available online here.