Two of Britain's most prestigious transplant hospitals placed patients in danger by continuing to use a heart pump associated with significantly higher mortality rates than an alternative device, an investigation has revealed.
The Device and The Data
The Freeman Hospital in Newcastle and London's Harefield Hospital persisted with the Medtronic device despite NHS concerns raised as early as 2018. Shockingly, half of all patients fitted with this particular pump died within three years of implantation.
Internal NHS data from a 2019 audit exposed the alarming disparity in outcomes. Of the 119 patients who received the Medtronic device, 54 had died within two years. Meanwhile, only 15 out of 97 patients fitted with the competing Abbott pump died during the same period.
These ventricular assist devices serve as mechanical pumps that help circulate blood throughout the body. They're typically offered to patients either awaiting heart transplants or those deemed ineligible for transplantation.
A Young Life Cut Short
The human cost of this medical controversy is tragically illustrated by the case of Greg Marshall, a fit and healthy 26-year-old with ambitions to join the Royal Marines. After suffering acute heart failure in 2019, doctors at Freeman Hospital recommended the Medtronic device.
Greg underwent surgery several months after the concerning NHS data became available. His mother, Tessa Marshall, revealed they weren't presented with the long-term risks and that the hospital even brought in an existing patient to testify about the device's benefits.
"I kick myself now, for not doing any more research," Ms Marshall confessed.
The surgery led to devastating complications. Greg suffered a stroke that impaired his speech and left him with limited movement on his left side. Then, in July 2020, the device suddenly stopped working and failed to restart - exactly the malfunction that would later prompt its withdrawal.
Despite being rushed to hospital, the device couldn't be repaired and remained inside Greg as doctors refused further surgery, fearing another stroke. He was placed on the transplant waiting list but tragically suffered a fatal cardiac arrest in September 2023.
"It was a massive shock to us all," his mother said.
Conflicts of Interest and Regulatory Failures
The situation is further complicated by revelations that leading cardiologists at both hospitals worked as paid consultants for Medtronic. The family claims Professor Stephan Schueler, the health professional responsible for Greg's care, didn't declare this financial relationship as required by General Medical Council guidelines.
Professor Schueler defended his position, stating: "There was never a financial incentive nor any salary arrangements with Medtronic for me or anybody else in our team to choose one device over the other."
Meanwhile, the Medicines and Healthcare products Regulatory Agency continued to approve the device for use, unaware that the NHS hadn't shared the damning 2019 data with them.
Freedom of Information requests later revealed that between October 2018 and June 2021, the mortality rate for the Medtronic device was two-and-a-half times higher than the Abbott alternative. During this period, 49% of Medtronic recipients died within three years compared to just 19% of those with Abbott devices.
Both hospitals defended their decisions, claiming they were based on "complex clinical decisions" and that there were "no clear grounds" at the time to believe Abbott's device was superior.
Medtronic eventually withdrew the product in 2021, citing safety concerns including the restart malfunction experienced by Greg Marshall.
