Clinical Research & Data, Impella Education, Surgical Applications
Impella 5.5® with SmartAssist® Experience Presented at STS 2021
Edward Soltesz, MD, MPH, describes worldwide experience with the Impella 5.5 with SmartAssist heart pump in this presentation from the 2021 Society of Thoracic Surgeons (STS) annual virtual meeting. Dr. Soltesz is the Donna and Ken Lewis endowed chair in cardiothoracic surgery and surgical director of the Kaufman Center for Heart Failure and Recovery at the Cleveland Clinic.
Dr. Soltesz explains that acute mechanical circulatory support (MCS) is increasingly being used to treat cardiogenic shock and bridge patients to a decision, native heart recovery, or next therapy (e.g., durable LVAD or heart transplant). MCS may also be used in high-risk heart surgery due to the low rates of survival following post-cardiotomy cardiogenic shock (PCCS).
Dr. Soltesz introduces and describes the Impella 5.5 with SmartAssist, which received FDA approval in September 2019 for treatment of cardiogenic shock following AMI or open-heart surgery or in the setting of cardiomyopathy or myocarditis. He states that it can provide up to 6.2 liters per minute of left ventricular support and provide support for up to 14 days. He compares the Impella 5.5 with SmartAssist to the Impella 5.0® in terms of deliverability, durability, and patient management. He also notes the benefits of SmartAssist for repositioning, patient management, and weaning.
Dr. Soltesz then presents demographic, procedural, and hemodynamic data on the outcomes of the first 356 consecutive patients receiving Impella 5.5 with SmartAssist in the United States and Germany. The data is from a retrospective study of prospectively collected data from the Impella® Quality (IQ) Database.
Among the outcomes he discusses, Dr. Soltesz explains that patients with cardiomyopathy had the highest survival (86%), although the lowest rate of heart recovery (34%). Survival in AMI cardiogenic shock (AMICS) and PCCS were 67% and 68% respectively, with 83% heart recovery among PCCS survivors. In addition, whenever the device was used to assist a high-risk procedure (off-label), 100% of patient survived, as did 100% of patients receiving Impella-assisted coronary artery bypass graft (CABG) surgery. Only 4 device-related adverse events were reported: 2 access side hematomas, 1 case of hemolysis, and 1 ingested thrombus.
Dr. Soltesz concludes that Impella 5.5 with SmartAssist is useful in various clinical scenarios and demonstrates successful clinical and device outcomes in early worldwide experience with overall survival to explant of 79% and very acceptable safety outcomes.