Heart patients recalled over possible 'unnecessary' procedure

More than 160 patients with advanced heart conditions are to be recalled by the Belfast Health Trust after a review found they may have undergone a procedure unnecessarily.

Only those patients who were fitted with a Cardiac Resynchronization Therapy (CRT) device, which is different and more complex than a standard pacemaker, between 2007 and 2023 are affected.

In a statement the trust stressed the CRT devices were safe and that patients treated by cardiologist Dr Ernest Lau do not need to take any immediate action.

A complaint made by a patient in 2023 prompted the trust to notify the Royal College of Physicians (RCP), which asked for a review of cases dating back to 2007.

The Belfast Trust said Lau remained an employee but had not seen patients in the past three years while the review was ongoing.

It added that it could not discuss any further HR issues.

In the past few weeks, letters were sent to 25 patients, however an additional 35 people have been contacted this week advising them of the development.

A spokesperson for the trust confirmed to BBC News NI that the recall could affect up to 163 patients and it was initially contacting smaller groups.

The trust said between 2023 and 2024 it had identified some concerns regarding decisions to implant very specific and specialist devices for a number of patients under the care of Lau and at that stage asked the RCP to "carry out an expert and independent review of several cases".

The RCP, according to the trust, "subsequently agreed with some of the concerns around Lau's decision making and it recommended further investigation.

While concerns about the cardiologist were raised by colleagues in 2020, action was not taken until a complaint was made by a patient some three years later.

The trust said due to patient confidentiality they could not discuss any details about the welfare of the patient who brought the complaint.

It is not clear why patients have only been recently notified.

It is understood the trust is also looking back over deceased patient records.

At this stage no link has been identified, however, that could change as the review continues.

A spokesperson emphasised that it is only those people who were fitted with a CRT device and between 2007 and 2023 who are affected by the recall.

CRT devices, also known as biventricular pacemakers, are designed for patients with specific, advanced heart conditions where the heart's lower chambers (ventricles) do not contract in a synchronised manner.

While functioning like a normal pacemaker to treat slow heart rhythms, a CRT-P device also delivers small electrical impulses to the left and right ventricles to help them contract at the same time, so your heart pumps more efficiently.

While thousands of people in Northern Ireland are fitted with standard pacemakers, CRT devices are less common.

A review of cases between 2007 and 2023 identified 684 people having been fitted with a CRT device.

In what is normal practice, the RCP set criteria for which patients should be recalled.

Of the 684 people identified, based on the criteria, 163 required review.

The trust said that number could increase.

Those cases have been further broken down to smaller groups, which the trust said was allowing cardiologists to carry out the reviews while continuing with their normal work.

Based on the case review those affected are either being invited to attend for a face-to-face consultation or advised that while a consultation is not necessary if they wish to have one appointment, it will be facilitated.

In a statement, the trust said it had begun the process of writing to each person, offering them the opportunity to meet a consultant cardiologist to go through the results of the review process.

It added it was only focusing on patients who had a CRT device inserted by Lau.

A number of patients have already been seen by a specialist consultant cardiologist involved in the review process at a dedicated clinic and more will be seen in the coming weeks.

They will be notified by letter.

A relation of one of those patients said the letter had caused a lot of distress.

Sources told BBC News NI some consultants were angry about the length of time it takes the trust to review a consultant's work.

One medic said that the review process is unnecessarily lengthy and causes distress among patients and frustration between doctors in the affected department.

Anyone with concerns is encouraged to contact the trust.