First-in-Man Implantations of a Newly Developed Transaortic Axial Flow Ventricular Assist Device (Impella 5.5)

Abstract

Purpose The transaortic axial flow device Impella 5.0 (Abiomed, Danvers, Massachusetts, USA) is an established and approved short-term device for patients with left ventricular failure in need of mechanical circulatory support, especially in those patients who are in need of full left ventricular circulatory support. However, it is approved for up to 6 (10 in CE countries) days only. In certain situations, longer duration of support is needed. Therefore, the Impella 5.5 was developed and has currently a CE-approval for 30 days of support. Methods Recently, the Impella 5.5 received CE mark approval. The newly developed pump has new motor bearings, new optical flo and pressure sensing and measurement, a shorter and stiffer housing and cannula and is lacking a pig-tail extension at the tip of the pump. Compared to the former Impella 5.0 the only access site for implantation of the Impella 5.5 is the axillary artery. Results We present the experience of the first-in-man implantations of the Impella 5.5 in a single center. To date, the first four out of six implantations have been performed in our institution in patients in cardiogenic shock. In all patients end-organ function recovered. 30 day survival was 50%. One patient was bridged to a permanent device and in another the cardiac function recovered. Conclusion The newly designed Impella 5.5 provides full support with a flow up to 5.5 l/min and is CE approved for up to 30 days. Implantation and placement of the device is feasible and safe. During support, no pump related adverse events occurred. More implantations are planned in Europe to evaluate the encouraging first experiences.