Large Clinical Study Supports Abiomed’s Impella 5.5 With SmartAssist

January 29, 2021—Abiomed announced findings from a large study of 356 patients treated with the company’s Impella 5.5 with SmartAssist at 16 centers in the United States and Germany. The study demonstrated a 79% survival rate at explant. Additionally, a majority of surviving patients recovered their native heart function without needing further mechanical support or a heart transplant.

According to the company, the large multicenter study was presented by Edward Soltesz, MD, at STS 2021, the Society of Thoracic Surgeons annual meeting held as a virtual event January 29-31. Dr. Soltesz is a cardiovascular and heart transplant surgeon at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute in Cleveland, Ohio. The data were obtained from the Impella Quality database and examined centers with 10 or more patients treated with Impella 5.5 with SmartAssist.

Abiomed summarized the study’s findings, noting that the Impella 5.5 with SmartAssist demonstrated successful clinical and device outcomes with the following results:

• 79% overall patient survival rate (n = 301)
• 86% survival for cardiomyopathy cardiogenic shock patients (n = 141)
• 67% survival for acute myocardial infarction cardiogenic shock patients (n = 88)
• 68% survival for postcardiotomy cardiogenic shock patients (n = 34)

“We were able to achieve a 79% overall survival rate by taking a novel approach in supporting these critically ill patients,” commented Dr. Soltesz in the announcement. “I am looking forward to seeing more prospective studies around this minimally invasive, high-flow temporary device.”

Co-Investigator Scott Silvestry, MD, added, “This report demonstrates the benefit of the significant unloading with Impella 5.5 use in cardiogenic shock patients. We are impressed with the improved survival rates seen with Impella 5.5 use compared to traditional therapies. The use of best practices, techniques, and this innovative new technology allows us to provide a better outlook to our patients.” Dr. Silvestry is Surgical Director of Thoracic Transplant, Thoracic, and Cardiovascular surgery at AdventHealth in Orlando, Florida.

The STS study presentation provides additional evidence of improved outcomes with use of Impella 5.5 with SmartAssist. In July 2020, Abiomed announced the publication of findings from the initial United States commercial experience with the device. Dr. Soltesz; Danny Ramzy, MD; and Mark Anderson, MD, published the study in the American Society for Artificial Internal Organs’ ASAIO Journal (2020;66:746-752). The study examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health, and Cedars-Sinai Medical Center.

The ASAIO study found 84% survival to explant for Impella 5.5 with SmartAssist patients in cardiogenic shock and other challenging cardiac conditions. Native heart recovery was achieved in 76% of those patients.

In 2019, Impella 5.5 with SmartAssist, which delivers peak flows of > 6 liters per minute, received FDA approval as therapy of cardiogenic shock for up to 14 days.

In August 2020, the FDA granted all left-sided Impella heart pumps, including Impella 5.5 with SmartAssist, emergency use authorization to treat certain patients with COVID-19–related complications who are undergoing extracorporeal membrane oxygenation treatment in the United States, noted the company.