Statement and contextual information from ÃÛÌÒAPP Hospitals provided to the BBC

ÃÛÌÒAPP Hospitals has provided high quality care for patients with advanced heart disease for many decades.

The cumulative knowledge and expertise of our specialists who care for this group of critically ill patients has been built over many years, leading to significant improvements in patient outcomes.  The team at the Freeman Hospital work at the forefront of developing transplant and other techniques which have saved, or prolonged, the lives of hundreds of critically ill patients with advanced heart disease.

Patients with very advanced heart failure may need a device called a left ventricular assist device (LVAD). This mechanical pump helps the heart do its job when it’s too weak to work on its own.

These patients are among the most clinically complex and it is a procedure of last resort. It comes with significant lifelong risks which are always explained to patients and their families, including device failure, infection, bleeding and stroke. 

Each patient is carefully assessed, using information available at the time, to agree the safest and most effective treatment options with them and their families.

As would be expected, we contacted patients and families affected when issues with the functioning of the Heartware device became clear. 

We remain available to them should they have any ongoing concerns or questions.

Clinical research and innovation with manufacturers now mean that this technology can help patients to have a good quality of life outside hospital for some years.

Use of devices at the Freeman Hospital

Clinicians at the Freeman Hospital were aware of a draft paper by NHS Blood and Transplant in April 2019, looking at the Heartware HVAD and the Heartmate 3 device.

The scientific value of this data was regarded as not comparable or reliable, due to too many variables of patient selection and other significant factors (including the small number of implants in the UK).

Significantly, the paper was never accepted in any national or international scientific publication.

The March 2019 Momentum III study in the New England Journal of Medicine did not directly compare the Heartmate 3 with the HeartWare HVAD devices, which would be the standard level of evidence needed to show superiority of one device over the other.

Continued use of the HVAD at the Freeman Hospital in 2019/2020 was based on complex clinical decisions and available, verified evidence. We had considered using HeartMate 3 earlier than this date but this was deferred due to an issue with the device.

It’s important to add that switching from one device to a different one is complicated, has significant training requirements and is not without risk.

At that time, there were no clear grounds for our teams to believe that the HVAD was significantly inferior to the HeartMate 3.

Until early 2021, both devices were licenced for use. We withdrew our use of the HeartWare HVAD device when we received an alert from the Medicines and Healthcare products Regulatory Agency (MHRA)

Research

There were several other international publications around the same time which showed excellent outcomes with the HeartWare device, similar to that for the HeartMate 3 device.

As above, these studies, listed below, were sponsored by Medtronic.

• Long-term survival of patients with advanced heart failure receiving a left ventricular assist device intended as a bridge to transplantation: The registry to evaluate the HeartWare Left Ventricular Assist System. Circulation: Heart Failure, volume 13, number 3, published March 2020

This long-term registry report demonstrated excellent long-term survival. The survival rate at 2 years was 78% (c.f. 82 % for HeartMate 3 quoted in the NHSBT audit) and survival extended to 51% at 7 years.

• Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. Circulation: Journal of Heart and Lung Transplantation, published April 2019

This paper reported a 24-month survival following implantation of HeartWare of 87% in 144 patients from a USA and Canadian registry.

Taken together, these trials provide good data and assurance regarding international experience of HeartWare.

• ÃÛÌÒAPP Hospitals and ÃÛÌÒAPP University published our own data (MacGowan et al, International Journal of Cardiology, ) showing improving outcomes with the HeartWare device over two eras of use (2009 – 2015 and 2016 – 2020). One year survival improved from 70% to 80% between the two eras studied. The main reason results improved was through better patient selection.

Some patients whom we had implanted in earlier eras were simply too sick to be helped by this (or any other) device. This also means that the excess deaths that have been suggested would not have been any better with the HeartMate 3 device either.

We know now that implanting any long-term device (HeartWare or HeartMate 3) in patients who are too sick, results in adverse outcomes. Patient selection, particularly in relation to right ventricular function, is key to the success of any programme, regardless of the device used.