Abiomed says cardiogenic shock survival rates improve since Impella approval
Three years ago this week, Abiomed's Impella heart pump received its FDA PMA approval for AMI cardiogenic shock. At the time of Impella's FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance Database was 51% in the United States. Impella heart pumps, combined with the adoption of best practices, which include the use of Impella pre-PCI, have contributed to a significant increase in cardiogenic shock survival and native heart recovery. New data from the IQ Database on nearly 5,000 patients treated between April 2018 and March 2019 show an increase in survival from 51% to 67%2, a relative increase of 34% in survival. Since FDA PMA approval, Abiomed has collected data on nearly 100% of U.S. Impella patients in the observational IQ Database. This clinical data, combined with the FDA post-approval 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, including use of Impella pre-PCI, reduction of inotropes, early identification of shock, and hemodynamic monitoring with pulmonary artery catheters, have now been validated in multiple publications. The most recent results that further validate best practices published online this week in the Journal of the American College of Cardiology. After Inova Heart and Vascular Institute instituted a best practice protocol that includes early use of percutaneous mechanical circulatory support, AMI cardiogenic shock survival at 30 days rose from 44% to 82%.