High Survival Rate Linked to New Impella 5.5 With SmartAssist

The first published United States experience of patients who received Abiomed’s newest heart pump, Impella 5.5 with SmartAssist, found that 84 percent of the patients survived to explant with 76 percent native heart recovery. The study was published in the American Society for Artificial Internal Organs (ASAIO) Journal.
 
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 (Hackensack, N.J.) and Cedars-Sinai Medical Center. Study authors and cardiac surgeons Ed Soltesz, M.D., Mark Anderson, M.D., and Danny Ramzy, M.D., concluded that Impella 5.5 with SmartAssist is safe and effective for a number of challenging clinical scenarios, including AMI cardiogenic shock.
 
“This report demonstrates the benefit of unloading cardiogenic shock patients and it is encouraging to see real-world data demonstrate improved survival rates with use of Impella 5.5 with SmartAssist,” said Ramzy, assistant professor, surgical director of the lung transplant program, and director, robotic and minimally invasive cardiac surgery at Cedars-Sinai Medical Center. “The continued use of best practices, techniques and innovative technology like Impella allows us to provide better patient care that improves outcomes and quality of life.”
 
In September 2019, Impella 5.5 with SmartAssist received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. It is a micro-axial, surgically implanted, temporary heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow native heart recovery and early assessment of residual myocardial function. Its benefits include:
 

• Ease of insertion through the axillary artery or the anterior aorta
• Designed for long-duration support with durable ceramic bearings, no pigtail to minimize adhesions, and ability for patient ambulation
• Forward flow with maximum unloading, to provide end organ and coronary perfusion, while allowing the heart to rest
• Better patient management with intelligent device positioning, management, and weaning with SmartAssist technology
• Equipped with Impella Connect, a cloud-based monitoring and collaborative patient management platform that allows for remote monitoring of the Impella console. During the COVID-19 crisis, this online, HIPAA-compliant monitoring service is being provided at no cost to help medical providers manage patients 24/7.

 
The 55 patients in the study were implanted with Impella 5.5 with SmartAssist between Oct. 16, 2019, and March 4, 2020. Specifically, the study authors determined:

• Thirty-five patients (63.6 percent) were successfully weaned off the technology.
• Eleven patients (20 percent) went on to receive another therapy, two patients (3.6 percent) expired while on support, and seven patients (12.7 percent) had care withdrawn.
• More than three-quarters, or 76.1 percent of survivors, recovered native heart function.
• There were no device-related strokes, hemolysis, or limb ischemia observed.

 
The results demonstrate Impella provides dependable acute mechanical circulatory support for patients who need it by stabilizing their hemodynamics during treatment.
 
The Impella 2.5 and Impella CP devices are FDA-approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP is FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery. The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP has been authorized for the above emergency use by FDA under an Emergency Use Authorization and has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
 
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to five days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with SmartAssist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia.