Summary

Advice

The technology described in this briefing is the Impella 2.5 left ventricular assist device. It is used to temporarily support a patient's circulatory system during elective and urgent high-risk percutaneous coronary interventions (PCI).
The innovative aspects are that it directly unloads the left ventricle, providing continuous forward flow in the ascending aorta, independent of the patient having any intrinsic cardiac output or rhythm. This is different to intra‑aortic balloon pumps (IABPs), which provide pulsed therapy. This has the potential to increase overall cardiac output and improve oxygenation while protecting the heart muscle.
The intended place in therapy would be as part of a comprehensive mechanical assist solution for people needing elective or urgent high-risk PCI.
The key points from the evidence summarised in this briefing are from 1 meta‑analysis, 1 large randomised controlled trial, 2 single-arm registry studies and 1 retrospective comparative single-arm study (involving a total of 1,586 patients). There were no statistically significant differences in 30‑day major adverse events when using Impella 2.5 compared with IABP. Fewer major adverse events were reported at 90‑day follow‑up when using Impella 2.5. This was statistically significant using the per protocol analysis but not for the intention-to-treat analysis.
Key uncertainties around the evidence are that a randomised controlled trial was terminated early because interim analysis showed that the primary clinical outcome was unlikely to be achieved. There are also currently no data from other studies directly comparing Impella 2.5 with IABP.
The cost of a single-use Impella 2.5 catheter is approximately £15,000, although volume discounts are available. The reusable Automated Impella Controller, which is needed to use the device, costs approximately £35,000 for 2 units, excluding VAT. The unit cost of an IABP is estimated to be £600. Adopting Impella 2.5 is likely to pose an additional cost to the NHS.