Abiomed is touting promising study results for its Impella 5.5 with SmartAssist device. 

A large clinical study of 356 patients treated with Impella 5.5 with SmartAssist at 16 U.S. and German centers found a 79 percent survival rate at explant. A majority of surviving patients recovered their native heart function without needing further mechanical support or a heart transplant.

“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,” said Scott Silvestry, M.D., co-author of the study and surgical director of thoracic transplant, thoracic and cardiovascular surgery at AdventHealth in Orlando, Fla. “The use of best practices, techniques and this innovative new technology allows us to provide a better outlook to our patients.”

The study is the first large, multicenter experience examining survival rates with Impella 5.5 with SmartAssist support. It was presented late last month at The Society of Thoracic Surgeons (STS) 2021 Annual Meeting by lead author Edward Soltesz, M.D., MPH, a cardiovascular and heart transplant surgeon at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute. The data was obtained from the Impella Quality (IQ) database and examined centers with 10 or more patients treated with Impella 5.5 with SmartAssist.
 
The authors conclude Impella 5.5 with SmartAssist demonstrates successful clinical and device outcomes, including:

• A 79 percent overall patient survival rate (n=301)
• An 86 percent survival for cardiomyopathy cardiogenic shock patients (n=141)
• A 67 percent survival for AMI cardiogenic shock patients (n=88)
• A 68 percent survival for postcardiotomy cardiogenic shock patients (n=34)

“We were able to achieve a 79 percent overall survival rate by taking a novel approach in supporting these critically ill patients,” said Dr. Soltesz. “I am looking forward to seeing more prospective studies around this minimally invasive, high-flow temporary device.”
 
The STS study presentation provides additional evidence of improved outcomes with use of Impella 5.5 with SmartAssist. A study published in July in the American Society for Artificial Internal Organs (ASAIO) Journal found 84 percent survival to explant for Impella 5.5 with SmartAssist patients in cardiogenic shock and other challenging cardiac conditions. Seventy-six percent of those patients achieved native heart recovery. 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.
 
In 2019, Impella 5.5 with SmartAssist received the U.S. Food and Drug Administration’s (FDA) highest level of approval for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist delivers peak flows of greater than 6 liters per minute. Benefits of the Impella 5.5 with SmartAssist include:

• Impella Connect, providing cloud-based remote monitoring
• Ease of insertion, via the axillary artery or ascending aorta
• Designed for long-duration support, with patient ambulation, ceramic bearings and no pigtail
• Forward flow with maximum unloading, to provide end organ and coronary perfusion and allow the heart to rest
• Enables heart recovery, as a minimally invasive, weanable VAD
• Ease of patient management, can be intelligently positioned, weaned and managed with SmartAssist

 
In August, 2020, the FDA granted all left-sided Impella heart pumps, including Impella 5.5 with SmartAssist, an emergency use authorization (EUA) to treat certain patients with COVID-19-related complications who are undergoing extracorporeal membrane oxygenation (ECMO) treatment in the United States.
 
The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are U.S. FDA-approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
 
Impella Left Ventricular (LV) Support Systems are also authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ four days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support.