A study of 356 patients treated with Impella 5.5 with SmartAssist (Abiomed) at 16 US and German centres found a 79% survival rate at explant. The findings were presented at the Society of Thoracic Surgeons (STS) 2021 annual meeting (29–31 January, virtual) by lead author Edward Soltesz, a cardiovascular and heart transplant surgeon at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute, Cleveland, USA.
Soltesz reported that a majority of surviving patients recovered their native heart function without needing further mechanical support or a heart transplant.
The study is the first large, multicentre experience examining survival rates with Impella 5.5 with SmartAssist support. Data were obtained from the Impella Quality (IQ) database and examined centres with ten 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: 79% overall patient survival rate (n=301), 86% survival for cardiomyopathy cardiogenic shock patients (n=141), 67% survival for AMI cardiogenic shock patients (n=88), and 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,” said Soltesz. “I am looking forward to seeing more prospective studies around this minimally invasive, high-flow temporary device.”
“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, co-author of the study and surgical director of thoracic transplant, thoracic and cardiovascular surgery at AdventHealth, Orlando, USA. “The use of best practices, techniques and this innovative new technology allows us to provide a better outlook to our patients.”
In August, 2020, the US Food and Drug Administration (FDA) granted all left-sided Impella heart pumps, including Impella 5.5 with SmartAssist, an emergency use authorisation (EUA) to treat certain patients with COVID-19-related complications who are undergoing extracorporeal membrane oxygenation (ECMO) treatment in the USA.