KERRYN Foale was looking forward to the happiest day of her life. Just 22, she was engaged to be married to her long-term boyfriend Ricky Lyons.
But tragedy struck on June 5, 2011, when a device implanted in Ms Foale’s body to help with a congenital heart condition catastrophically failed. According to the coroner’s report, an electric shock produced by her implantable cardioverter defibrillator (ICD), designed to restore her heart’s stable rhythm if it unexpectedly beat far faster than usual, never reached the vital organ. At the very moment Ms Foale needed it most, her device was effectively useless.
The case has raised questions about exactly how many people are fitted with similar devices in Australia, the extent to which they are being tested and how far medical professionals can go in ensuring their patient’s safety.
“Kerryn was a lovely, kind-hearted, intelligent young lady who was always full of life, and a pleasure to look after as her cardiologist,” said Professor Chris Semsarian, who recalled her wedding day preparations.
“She’ll always be remembered for her enchanting smile and sincere kindness to those around her.”
Late last month, an inquest concluded that Ms Foale, from Colo Vale in the NSW Southern Highlands, suffered from an enlarged heart and likely died after experiencing a fast cardiac ventricular event — essentially a greatly increased heart rate.
Ms Foale’s ICD and high voltage lead had been sourced from US cardiac devices provider St Jude.
The chair of the Cardiac Society of Australia and New Zealand’s electrophysiology and pacing council, Professor Andrew McGavigan, told news.com.au that young people were more likely to have heart muscle damage than heart attacks and ICDs were commonly used in these conditions.
“ICDs are put in people who have an impaired heart function with a dangerously fast heart rhythm and unless electricity is passed to the heart to defibrillate it, it’s invariably fatal.”
The ICD provides this electric shock and are “almost like an insurance policy just in case.”
“Undoubtedly,” he said, “ICDs save lives.”
According to the coroner’s report, Ms Foale was first implanted with an ICD and Riata brand 1570 lead in 2003. In 2006, the ICD was replaced but, as was standard if it wasn’t faulty, the lead was left in place.
Ms Foale’s device was last checked on December 15, 2010 and, again, was found to be functioning normally. The very same day as her check-up, however St Jude issued an advisory in the US stating a number of the 227,000 Riata silicone leads in circulation had exhibited signs of abrasion, some in a little more than two years. The company advised that doctors pay close attention to patients with the lead and test every three to six months. Removal of the lead was not recommended, the product was discontinued and the company said its newer leads were less likely to suffer from abrasion.
Earlier this year, St Jude agreed to set aside $14.25 million to settle around 950 US claims relating to the leads. St Jude’s US head office did not respond to repeated requests from news.com.au for comment.
Just shy of six months after her final test Mr Foale’s device failed due to abrasion in the lead, the inquest concluded. When her beat became abnormal, the electric shock from the device missed the heart completely.
The Therapeutic Goods Administration (TGA) has said of the 3962 leads in Australia there have been some 128 reports of abrasions.
During the inquest, the coroner, Hugh Dillon, recommended that consideration be given to setting up a national register of all cardiac devices and the details of the patients they were implanted in; that all device failures be reported to authorities and guidelines for the testing of older devices be revamped.
One of the “unfortunate and sad” features of the case, said Mr Dillon, was that Ms Foale was due to be fitted with a more modern ICD that would have likely alerted her doctors to any faults far earlier.
“Like all technology they improve and there is no doubt the older devices don’t have all the self-diagnostic features of the modern devices,” said Prof McGavigan.
There are various tests for older ICDs including electric shocks, however this could be painful to the patient “and there’s not a recommendation to do so on a regular basis because the incidence (of failure) is low”, he said. Performing a surgery to test a device can also cause its own problems.
“Everything we do in medicine is a balance between potential benefit and potential risk ... if the things we to do improve outcomes have a danger in themselves.”
Prof McGavigan said a registry of cardiac devices had been set up but, as it wasn’t retrospective and didn’t currently cover every hospital, the exact number or identity of patients with the older leads wasn’t known. However, he said, there were probably few still implanted and “the vast majority of devices are safe and effective.”
Expanding the registry was dependent on more funding, he said.
A spokesman for Assistant Minister for Health, Fiona Nash, said the Government had invested $12.2 million in the cardiac devices registry, among other initiatives, and that suppliers of ICDs were already required to monitor their effectiveness and report all serious issues to the TGA.
“TGA legislation does not provide for health care professionals to report all failures in the way the coroner asked. However, the TGA advises there is no evidence anywhere in the world that additional compulsory reporting by healthcare professionals — as well as sponsors — would improve patient outcomes.”
A spokeswoman for the Cardiac Society said they were currently reviewing the coroner’s recommendations while Prof McGavigan said if any patients had concerns about their ICDs they should see their cardiologist.
Ms Foale was “full of life,” Mr Dillon said in the coroner’s report. “She loved her family and was very close to them. Their profound sense of loss must have been heightened not only by her death but the fact that it took place shortly before the wedding towards she and her family had been looking forward with such happy anticipation.”
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