Dozens of patients were put at risk after two of the UK's leading transplant centres continued fitting a heart device - despite knowing of concerns it had a higher mortality rate than its rival product.
Concerns were raised by the NHS about the device in 2018. Of the patients who were subsequently fitted with the mechanical pump, half went on to die within three years.
LVADs have been life-savers for decades and, for a number of years, hospitals had a choice of two devices - the HeartWare HVAD, sold by the Irish-American company Medtronic, and the Heartmate III, sold by US manufacturer Abbott.
In October 2018, NHS Blood and Transplant (NHSBT), which oversees transplants in the UK, conducted a preliminary audit comparing how the two pumps had performed. A more detailed analysis followed in April 2019.
The results were stark. Of the 119 patients who had received the Medtronic device, 45% - or 54 patients - had died within two years. In contrast, just 15% - 15 out of 97 patients - who were given the Abbott pump had died over the same period. Similarly, the number of complications - such as strokes or needing a new pump - were significantly higher for the Medtronic device. The audit said there were "no significant differences" between the types of patients who received each device.
One of the UK's six transplant centres, the Royal Papworth Hospital in Cambridge, did not wait for the NHS analysis. It had picked up on the growing international concerns and had stopped using the Medtronic device in February 2018 "after considering the results of two randomised controlled trials", as their clinicians "considered the Heartmate III as superior".
However, Harefield Hospital continued to solely use the Medtronic device until early 2021, shortly after the manufacturer had issued a safety notice. The Freeman Hospital continued until June 2021, when the manufacturer withdrew it from sale "in the interest of patient safety".
The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), continued to approve the device for use after the 2019 analysis, though it had not been informed by the NHS of the data's existence.
Read full article.
Source: BBC News, 12 November 2025