First in Men Multicenter Experience with the Impella 5.5

Abstract

The Abiomed Impella 5.5 (Danvers, MA), is a newly developed axial flow trans-aortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula. The Impella 5.5 is intended for longer use and received in 2018 CE mark for 30 days. This study evaluates the first-in-man series from six high volume mechanical circulatory support centers in Germany after CE approval. The worldwide first 37 consecutive patients have been implanted in six German centers between March 2018 and September 2019 for post CE mark evaluation. Mean age was 59.1±11.5yearsand 35 (94.6%) were male. Main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (43%). Mean support time was 15.9± 26 days (up to 161) with a total of more than 587 patient-days on support. Average flow rate was 3.7 ± 0.7 l/min. 30 day survival was 72.9%. Survival to next therapy was 75.7%. 13 (35.1%) have been weaned from the device for native heart recovery and 14 (37.8%) have been bridged to a durable device. 13 patients (35.1%) have been mobilized to chair and 11 (29.7%) were able to walk around. There were no strokes or thrombembolic complications. 5 patients (13.5 %) had hemolysis. 9 patients (24.3%) had pump dislocations. The Impella 5.5 provides promising early outcomes for patients with acute heart failure and expends the spectrum of available devices. More implantations are needed to further evaluate performance of the device.