Final Results from the National Cardiogenic Shock Initiative (NCSI) Study Demonstrate the Benefit of Early Cardiac Unloading with Impella

The final results of the physician-led National Cardiogenic Shock Initiative (NCSI) Study demonstrate a 71% survival to discharge with greater than 90% native heart recovery when best practices are used, including placement of an Impella heart pump prior to revascularization (PCI). The study evaluated the outcomes of 406 consecutive patients who presented with acute myocardial infarction cardiogenic shock (AMICS) at 80 participating sites throughout the United States. The study shows a protocol-based approach to increasing survival rates in cardiogenic shock is reproducible in both academic and community hospital settings. Results were presented today by Babar Basir, DO, director of the acute mechanical circulatory support program at Henry Ford Hospital and co-principal investigator of the study, at the 2021 Society of Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions.

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The NCSI Study is a single-arm, prospective study assessing outcomes associated with early mechanical circulatory support (MCS) in AMICS patients treated with PCI. The goal of the NCSI Study is to increase cardiogenic shock survival, which has historically been approximately 50%, by providing early unloading therapy and allowing the heart to rest prior to PCI, promoting native heart recovery. The NCSI Study prospectively validated the previously identified best practices of identifying shock early, placing Impella support pre-PCI within 90 minutes of arriving at the hospital, using a pulmonary artery catheter to guide decision-making, and reducing the use of inotropes and vasopressors.

The study investigators categorized patients according to SCAI Shock classification stages. For SCAI stages C/D, they found higher survival to discharge (79%), 30-days (77%) and 1-year (62%) compared to historical data in similar patients during the last 30 years. SCAI stage E patients, who are on the brink of cardiovascular collapse, also had improved survival to discharge (54%), 30-days (49%), and 1-year (31%) compared to recent studies of patients who were not treated with the NCSI protocol that published in Journal of American College of Cardiology (33% survival to discharge) and Catherization and Cardiovascular Interventions (22.6% survival to 30-days).