Australia should be regarded as a ‘hot bed’ when it comes to research involving new atrial fibrillation models of care, said Professor Simon Stewart director of the Mary MacKillop Institute for Health Research in Melbourne, speaking to delegates attending a session on heart failure.
But he also said there are challenges translating that research on the world stage.
According to Professor Stewart the SAFETY trial reported in The Lancet was the first study to examine the benefits of AF- specific care on AF hospital re-admission and survival.
While the intervention didn’t stop patients from having an event requiring hospitalisation, it did prolong a second, and arguably more important, primary endpoint – days alive out of hospital, he said.
According to Professor Stewart, for every 100 patients with AF exposed to the SAFETY management program there were seven fewer deaths, 900 fewer days of costly hospital stay, and 1000 more days alive and out-of-hospital compared to standard care.
But in 2016 when the European Cardiac Society updated its guidelines on AF management Professor Stewart said it dismissed the trial describing the intervention as only having a ‘marginal effect’ on unplanned admissions and death.
“In terms of survival SAFETY showed a six percent absolute difference between the intervention and control groups in favour of the intervention. That’s quite a profound impact. Coming back to the ESC guidelines, that’s not a marginal effect,” he told delegates.
“When you examine what we found in SAFETY I think we’ve got a fair case for disagreeing with their statement,” he added.
“But there’s the battle we face presenting Australian data and it being interpreted in places like Europe and the US, it’s difficult for us to get some breakthrough.”
Professor Stewart also argued the point that guideline committees should be more transparent about affiliations not just to industry but also to their own research into models of care.
“Disease management programs now are just as therapeutic as devices and pharmacology. We declare our conflicts in terms of pharma and devices; we should also declare our conflicts in terms of whether we’ve been involved in developing disease management programs. My concern is I think authors now tend cite their own evidence and I don’t think they should be the people to write those recommendations,” he said referring to the ESC updated AF guidelines.
Also discussing the type of patients who should be selected for specific AF and Heart Failure care, Professor Stewart said that not all patients would benefit – particularly those older and sicker patients.
“At one end of the spectrum you’ve got younger patients who are emerging either with a syndrome of heart failure or AF and who are less complex – keep them away from outreach models, they get better outcomes being managed by specialised clinics.”
In the middle he said are more complex patients who are not quite at the end of the disease spectrum and it is these patients who do better with home based-interventions, he argued.
“Right at the end there’s that really sick population that we need to let go, that we need to apply palliation. We have emerging data from our trials that show if we try to apply heart failure management and even AF management to these patients who require palliation then they get worse outcomes than management with standard care.”
“So standard models of care for heart failure are not benign. We need to be smarter about how we apply our models of care. Doing trials like SAFETY are important; they help us identify the subsets of patients who have worse outcomes than good. Management itself can be a bad thing and we need to sort the good from the bad.”