Two of the UK’s leading transplant centres continued fitting a heart device that they knew was deadlier than its rival product. Medtronic’s HeartWare HVAD was a pump surgically implanted for end-stage heart failure – and it was well documented that its mortality rate was significantly higher than other options. But top cardiologists at both hospitals were found to be paid consultants for Medtronic, the hospitals were aware of their involvement, and the NHS had already raised concerns. Were leading doctors deliberately implanting deadly devices?
The Staggering HVAD Mortality Rate
Patients with a weakened heart can be offered a Left Ventricular Assist Device (LVAD) if they are deemed unsuitable for a transplant, or stuck waiting for one. For many people, the LVAD helping to pump blood around the body is their only chance of survival outside of a transplant.
LVADs have saved lives for decades and the two top competitors were Medtronic, who produced the HVAD device, and Abbott, who made the Heartmate III. In 2018, an audit was conducted by NHS Blood and Transplant (NHSBT) to compare the pumps’ performance, and shocking results were published in 2019:
- Medtronic: 54 of 119 patients (45%) died within two years
- Abbott: 15 of 97 patients (15%) died within the same period
- The number of strokes and instances of people requiring a new pump was also significantly higher for Medtronic
They Knew – and Kept Implanting
The Freeman Hospital in Newcastle and Harefield in London continued using the pump for years, deciding to question the data rather than prioritise patient safety. Other hospitals, such as the Royal Papworth Hospital in Cambridge, made the call before the NHS analysis was even shared – they had picked up on the pattern themselves and stopped using the Medtronic device in February 2018, considering the Heartmate III to be superior.
The Newcastle and London hospitals, however, continued to solely use the Medtronic device until 2021 when the manufacturer withdrew it from sale “in the interest of patient safety”. In the three years between the 2018 audit and 2021 withdrawal, 50% of patients with the Medtronic device died, compared to 19% of recipients of the Abbott device.
Were They Paid to Implant It?
Until recently, the head of Freeman’s cardiothoracic department was Prof Stephan Schueler, also known as “king of the castle” by former colleagues. Public records later revealed that he had a decade-long relationship with the Medtronic manufacturer. Patients were not made aware of his financial relationship with the company, despite disclosure being a requirement of the General Medical Council (GMC) – the doctor’s regulator.
The Freeman Hospital stated publicly that it was “aware” of the NHS data published in 2019, but felt its scientific reliability was lacking.
At Harefield Hospital, André Simon was the director of heart and lung transplantation and ventricular assist devices. He had a similarly long-standing relationship with Medtronic, dating back to 2014. The hospital said it was “aware” of his work for Medtronic, and that it had been declared in multiple papers. They also confirmed that he was one of a number of senior people “involved” in deciding which devices are used and that there was “collective support” for the continued use of the Medtronic device until 2021.
Dr John Dunning, who replaced André Simon at Harefield, said they continued to use the Medtronic device as “it was the preference” of his predecessor.
It Wasn’t Just the UK
Investigations in the US show that regulators also relied on voluntary remediation, just like in the UK, before sales were stopped in June 2021. They had access to the same data – higher mortality and neurological events, and pumps that failed to restart. By the time the device was officially pulled, more than 19,000 people received it.
In June 2021, the FDA finally disclosed that Medtronic would stop distribution and sale of HVAD because of the links to increased mortality, adverse neurological events, heart complications, and a known defect which led to the device stopping and not restarting. Congress later opened an inquiry into the FDA’s handling of the device.
“It Was Entirely Preventable”
Robbie Burns, a patient representative at NHSBT, retrieved many of the documents relating to hospitals’ continued use of the Medtronic device. “If I had been in the position of receiving the Medtronic device, and looked back at the data, I would be going, ‘Why on earth did you do this?’”
“It was entirely preventable” Burns said.
In separate public statements, both Freeman and Harefield hospitals said they made “complex clinical decisions” before continuing to use the Medtronic device, and reiterated there were “no clear grounds” at the time to believe that the Abbott device was significantly superior to the Medtronic one.
Medtronic say they notified physicians in June 2021 about their decision to cease distribution of the device, citing patient safety being its top priority. The company says it continues providing support to the 1,200 living patients currently implanted with the device.
Final Thought
The HVAD story is about more than a defective device, also highlighting the risks of a health system that prioritises profits over patient wellbeing. Regulators deferred their decision, instead waiting for the manufacturer to make the call despite damning statistics. Families suffered avoidable loss. Why was this allowed to happen?
Join the Conversation
Did you know about the defects? How can the decision makers be held accountable for the unnecessary deaths from potentially profit-driven choices? Share your thoughts below.
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Did patients receive informed consent? i.e. were they told that there was a safer alternative, and that people making decisions had an undeclared financial interest in the less safe one being fitted? At first sight, without knowing the other side of the story, this seems like serial murders may have been committed and worthy of the severest penalty.