Use of recalled heart device at Newcastle Hospitals: What patients need to know

Use of recalled heart device at Newcastle Hospitals: What patients need to know

Nina Kennett, Clinical Negligence

What is the HeartWare HVAD?

The HeartWare HVAD is a type of mechanical heart pump known as a Left Ventricular Assist Device (LVAD). It’s made by a company called Medtronic, an American manufacturer of medical devices. LVADs are used to support people with severe heart failure by helping the heart pump blood around the body.

In many cases, the device is fitted while a patient is waiting for a heart transplant. It may also be offered to patients who are not suitable candidates for transplants. The device is surgically implanted into the heart and connected to an external controller and battery system, which the patient relies on to stay alive.

What concerns have been raised?

Concerns about the safety of the HeartWare HVAD are not new. As early as 2018, a preliminary audit carried out by NHS Blood and Transplant raised alarm about patient outcomes.

The audit showed that outcomes for patients fitted with the Medtronic device were significantly worse. Of the 119 patients who received it, around 45% had died within three years. By comparison, only around 15% of patients fitted with a similar device, the HeartMate III manufactured by another company, Abbott, died over the same period.

Despite these findings, the Medtronic device continued to be used and recommended at the Freeman Hospital in Newcastle and Harefield Hospital in London. Other UK transplant centres, including Royal Papworth Hospital stopped using the device altogether after reviewing the data.

Why was the device still being used?

It later emerged that senior cardiologists at both the Freeman and Harefield hospitals were acting as paid consultants for the Medtronic. This has raised concerns about potential conflicts of interest and whether treatment decisions were influenced by factors beyond patient safety.

Newcastle upon Tyne Hospitals NHS Foundation Trust has stated that it continued to use the Medtronic device because it believed the audit data was not reliable, citing differences in patient selection and other variables.

Regulatory action and withdrawal of the device

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medical devices used in the UK are safe and effective. At the time of the 2018 audit, the MHRA was not aware of the NHS Blood and Transplant data.

A subsequent Freedom of Information request revealed that between October 2018 and June 2021, the mortality rate associated with the Medtronic device was around two and a half times higher than that of the Abbott alternative.

In June 2021, Medtronic withdrew the HeartWare HVAD from production and sale on safety grounds. Data showed that the device increased the risk of stroke and death. There were also concerns about a specific malfunction, which caused delays, and in some cases failure, when the device attempted to restart after stopping.

What does this mean for patients?

Since the device was withdrawn, patients and families have been coming forward expressing concern that they were not fully informed about the risks associated with the HeartWare HVAD or that safer alternatives were available at the time of surgery.

This raises questions about informed consent as for consent to be valid, patients must be given clear information about material risks and reasonable alternative treatments, so that they can make an informed decision about their care.

How we can help

If you or a loved one was fitted with a HeartWare HVAD and are now concerned about how that decision was made, our Clinical Negligence Team can help.

We offer clear, compassionate advice and can talk you through whether there are grounds to investigate what happened, including whether you were given all the information you should have been at the time.

If you would like to speak to a member of our team, please contact usto arrange an initial conversation.