DANVERS, Mass.– Abiomed (NASDAQ: ABMD), a leader in breakthrough heart, lung and kidney support technologies, will feature the most recent Impella research and technological advances aimed at improving outcomes for acute myocardial infarction cardiogenic shock (AMICS) patients during the Society for Cardiovascular Angiography and Interventions (SCAI) 2022 Scientific Sessions, May 19 – 22, in Atlanta.
Researchers identified 13 studies in the PubMed and Cochrane databases, representing 6,810 AMICS patients. The patients were divided into two groups – those who received Impella support pre-PCI (n=2,970) and those who received Impella support during or post-PCI (n=3,840). The data showed significantly reduced short-term mortality rates in AMICS patients who received Impella support pre-PCI, compared to those who received Impella support during or post-PCI (37.2% vs 53.6%, p=0.002). Midterm mortality was also lower in AMICS patients who received Impella support pre-PCI compared to those who received it during or post-PCI (47.9% vs 73%, p=0.022).
This meta-analysis published online on May 6 in the International Journal of Cardiology. Lead author Mario Iannaccone, MD, an interventional cardiologist at San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy, will present the study results at SCAI on Friday, May 20, starting at 12:00 pm EDT.
“These results add to a plurality of evidence that the timing of Impella placement for AMICS may impact mortality rates, and that placing AMICS patients on Impella support prior to PCI can improve their survival in both the short and midterm,” said Dr. Iannaccone.
SCAI will mark the full market launch of Impella RP with SmartAssist, the only right heart pump equipped with dual-sensor technology to assist with pump management. Impella RP with SmartAssist pumps blood from the inferior vena cava to the pulmonary artery and enables biventricular support when the left side is supported with a left-side Impella. The FDA has granted its highest level of approval to Impella RP with SmartAssist to provide circulatory support for up to 14 days in certain patients.
Data from the SHOCK Trial and Registry has shown that 37% of AMICS patients exhibit right ventricular dysfunction, which leads to a three times increased risk of mortality. A FDA post-market approval study showed the use of Impella RP within 48 hours of cardiogenic shock onset leads to 73% survival, compared to 14% survival when implanted after 48 hours of cardiogenic shock when heart failure is present.
SCAI also provides Abiomed an opportunity to highlight its latest FDA approval, which simplifies Impella management with the goal of improving patient outcomes. On April 19, the US Food and Drug Administration granted pre-market approval for the use of sodium bicarbonate purge solution as an alternative to heparin. This sodium bicarbonate option is for patients who are intolerant to heparin or for whom heparin is contraindicated due to heparin-induced thrombocytopenia or bleeding.
