22 November 2018
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As part of a nationwide recall implemented by NHS England, Spire Healthcare has contacted approximately 660 patients to notify them of the potential risk of exposure to Mycobacterium chimaera infection from certain devices used during heart valve replacement/repair surgery.
The need for a patient notification exercise has arisen following guidance from Public Health England (PHE), the Medicines and Healthcare Regulatory Authority (MHRA) and NHS England in February 2017. This guidance suggests that a device used since 1st January 2013 to heat and cool the blood during some types of heart surgery has been linked to a rare bacterial infection caused by Mycobacterium chimaera. This device was manufactured by global medical technology company, Sorin/LivaNova, and was used in four of our hospitals during the relevant period (Spire Hull and East Riding, Cardiff, Bristol and St Anthony’s hospitals).
Following this guidance, Spire Healthcare acted quickly and removed all affected Sorin devices in March 2017. The risk from this infection is very low – on average, one person in every 5,000 people who have open heart surgery for valve replacement or repair will develop it. For patients having other types of open heart surgery, the risk is even lower at 1 in 100,000.
No cases of the infection have been identified in patients who had surgery since this guidance was published, but we continue to monitor the situation closely.
Patients who are generally well and do not have any symptoms do not need to worry, or take any immediate action. Tests can only identify the bacteria when symptoms are present.
There is no need for those who have already had valve replacement or repair surgery to be concerned unless they experience symptoms of infection, which include:
Patients with these symptoms - for which there are much more common causes - should not be alarmed or seek emergency treatment, but should contact their doctor, even if their surgery was many years ago.
If you live overseas, make an appointment to see your GP if you experience any of these symptoms and take your letter with you to your appointment.
If you are due to undergo heart treatment at a Spire Healthcare hospital, please be advised there is no need to delay or cancel your surgery. Your doctor should talk to you before surgery about the risks involved, including Mycobacterium chimaera infection. The risk of infection from these bacteria is very low and much lower than the risk of not having appropriate treatment, so delaying surgery won’t usually be recommended.
Anyone who has had open heart surgery since 1 January 2013 is at risk, including people who had their operation outside the UK.
The risk of infection has been linked to a device used to heat and cool the blood during some types of open heart surgery.
About one person in every 5,000 who have had valve replacement/valve repair will develop the infection. For patients who have had other types of open heart surgery, for example, Coronary Artery Bypass Graft, the risk is even lower at 1 in 100,000.
The infection could be present even if no symptoms have been experienced to date, as in some cases it has taken up to five years for symptoms to develop.
This is a very rare but potentially serious infection and people can die if they’re not treated, so it’s important to know the symptoms and contact NHS 111 or NHS Direct Wales if you feel unwell.
If you live overseas, you should contact your GP if you feel unwell.
If you’re feeling well, you don’t need to do anything straight away.
The symptoms can, if they develop, take up to five years to appear and regrettably you can’t be tested to see if you will develop symptoms in the future.
When you next visit your GP, make sure they know you’ve had open heart surgery since 2013 and ask them to check that your medical record includes this information.
Also make sure you’re aware of the symptoms of a Mycobacterium chimaera infection and contact NHS 111 or NHS Direct Wales if you develop any of these.
If you live overseas, you should contact your GP if you feel unwell.
Treatments for Mycobacterium chimaera are available but the outcomes, even if identified early, are variable and not without side effects. It may involve further surgery and the long term use of certain antibiotics.
If you’re diagnosed with the infection, you’ll require further investigations and infectious disease teams will determine the most appropriate treatment option following discussion with microbiology and cardiology teams.
No. Infections with Mycobacterium chimaera cannot be spread from person to person.
Extra measures have been put in place to reduce the chances of a Mycobacterium infection during open heart surgery, but there is still a very small risk of developing the infection: about one person in every 5,000 who has had valve replacement/valve repair will still develop the infection.
If you’re about to have open heart surgery, your doctor should talk to you about the risks involved, including Mycobacterium chimaera infection.
The risk of infection from these bacteria is very low and much lower than the risk of not having appropriate treatment, so delaying surgery won’t usually be recommended.
The Mycobacterium chimaera infection has been linked with a specific device used to heat and cool the blood during some types of open heart surgery.
PHE advised us, along with other providers, in November 2015 about what hospitals need to do to reduce the risk of infection to patients. It also notified doctors to ask them to inform their patients of the associated risks. No new cases have been diagnosed so far in patients who have had heart surgery since these procedures were put in place in 2015.
PHE continued to monitor the infection rates and notified all healthcare providers in February 2017 of the increased risk when using Sorin Heater Cooler Units. NHS England advised that all patients who have undergone certain procedures needed to be notified, along with their GP. Following this guidance, Spire Healthcare removed all affected Sorin devices in March 2017.
Hospitals who used this device are writing to everyone who has had heart valve surgery since 2013 to make them aware of the risk of this infection. About one person in every 5,000 who has had valve replacement /valve repair will develop the infection.
For patients who have had other types of open heart surgery, for example, Coronary Artery Bypass Graft, the risk is even lower at 1 in 100,000. For these patients, NHS England has asked us to inform them at their next consultant appointment.
A stringent set of safety and monitoring measures have been put in place to mitigate against any future similar event. These measures include: the replacement of the original machines with those of a different design; the use of filtered/sterile water to fill tanks, the frequent cleaning of tanks and water channels with disinfectant solutions and the regular sampling of water from the machines. Finally, the machines are being re-sited to minimise the risk of any aerosols generated (even if these no longer contain bacteria) from reaching the patient in theatre.
Spire is contacting approximately 660 patients who had heart valve repair/replacement surgery since January 2013 at four of our hospitals to inform them that they are at risk of infection.
These hospitals are Spire Bristol, Hull & East Riding, Cardiff and St Anthony’s hospitals.
NHS England estimates that approximately 48,000 patients have had heart valve surgery since January 2013 and will be receiving a letter notifying them of the risk.
(Note: This is based on an analysis of Hospital Episode Statistics (HES) to identify patients undergoing procedures likely to necessitate cardiopulmonary bypass suggests 48,472 heart/valve patients and 1,132 heart/lung transplant patients would be included in a notification exercise (surgery between 1 Jan 2013 to 31 Sept 2016)
You can contact Spire Healthcare’s cardiac patient helpline on 0800 085 7470 between 8.30am and 8pm, Monday to Friday, and Saturday 9am to 5pm. If you call outside these hours you can leave your contact details and a member of the clinical team will call you back within 72 hours. Alternatively, you can arrange a call back at a convenient time by emailing with your preferred contact details.Arrange a call back
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