Gene Therapy for UK Heart Failure Patients
Patients with severe heart failure are to be treated with gene therapy for the first time in Britain.Earlier clinical trials have suggested the treatment could reverse damaging changes inside cardiac cells that weaken the muscle and reduce the ability of the heart to pump blood.
The condition affects up to 1,000,000 people in the UK.
Doctors backed by the British Heart Foundation will give 100 patients an infusion of a harmless virus that has been genetically engineered to carry an extra gene, called SERCA2a.
The virus infects cardiac cells. Once inside, the gene becomes activated and makes a protein crucial to normal beating of the heart.
Dr Alexander Lyon, consultant cardiologist at The Royal Brompton Hospital, is leading the Cupid 2 trial. He said: “When the heart muscle is injured it activates a series of compensatory changes, but over time fatigue sets in which results in the natural version of this gene switching off. ”When the gene is repaired it produces more of the functional protein and the problem is reversed.”
The first patients will be given the treatment in the next three to six weeks at hospitals in London and Glasgow.
They will be tracked and compared to another group of study volunteers who will receive a dummy treatment.
A previous pilot study in the United States found the treatment dramatically reduced emergency hospitalisations and deaths.
The 39 patients given the gene are still in a stable condition after three years.
Professor Sian Harding, head of the British Heart Foundation’s Centre for Regenerative Medicine at Imperial College London, whose team developed the therapy, said: “It’s been a painstaking, 20-year process to find the right gene and make a treatment that works. ”But we’re thrilled to be working with cardiologists to set up human trials that could help people living with heart failure.”
Questions about Digoxin
We think it would be prudent to get a balanced report on the latest on Digoxin and it’s links to Deaths with people with Atrial Fibrillation which is a heart rhythm condition as these reports tend to have a habit of spreading like a wild fire and by the time you hear of it the message has been put on the grapevine and the real messages have fallen off the cliff!
The study, which was published online in the European Heart Journal on Nov. 27, 2012, showed that patients who took digoxin who had atrial fibrillation (AF) died in significant numbers whilst on the medication.
Digoxin is made from an extract from the foxglove plant used on patients who have AF and heart failure. Theoretically, it makes the heart beat stronger and more regularly. It is notoriously hard to use because there is a narrow dose range between where it is helpful and when it can cause harm. High doses have been seen to increase death in patients.
For the study, researchers looked at data from 4,060 AF patients who took digoxin before or during the 3.5 year study. The subjects had all enrolled in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) to determine any affects digoxin had on increased death rates.
Digoxin was associated with a 41% increase in deaths from any cause, after controlling for other factors. Patients who took digoxin also had a 35 percent increase in deaths from cardiovascular causes, and a 61 percent increase in deaths from arrhythmias, or problems with heart rate.
“These results mean that among AF patients taking digoxin compared to those not on digoxin in the AFFIRM trial, within five years one additional patient out of six will die from any cause, one additional patient out of eight will die from cardiovascular causes, and one additional patient out of 16 will die from arrhythmias,” Samy Claude Elayi, associate professor of medicine at the Gill Heart Institute, University of Kentucky, in Lexington said in a press release.
Elayi added that the results show that widespread use of dioxin may be detrimental to patients who are suffering from AF. However, the findings do not show that the medication is bad for everyone he pointed out to Reuters.
“But in patients that have no heart failure and (have) atrial fibrillation, I think there is no reason to use this drug as a first line,” Elayi said.
Dr. Ali Ahmed, who has studied digoxin at the University of Alabama at Birmingham, told Reuters in a later statement that the study was flawed because it was looking for problems caused by digoxin and did not assign people blindly to the study. He said other “…other patient diseases may have caused the deaths.
“This should be taken with extreme caution, because of the potential for confounding and bias from a variety of sources,” Ahmed, who wasn’t involved in the new research, said.
Natasha Stewart, senior cardiac nurse at the British Heart Foundation (BHF), added to the BBC that while digoxin isn’t the first medication of choice in the U.K., some patients are taking it — and there are plenty of benefits for AF and heart failure patients.
“Before we jump to any conclusions about the dangers of the drug, we’d need to see further research into what might be causing these increased risks,” she said. “Patients who are prescribed digoxin should not stop taking their meds without discussing their concerns with their doctor.”
I think the last statement says it all really and it is important that if you are concerned that you should discuss your concerns with your Doctor or Heart Failure Nurse and not change your medication in anyway unless directed to do so.
A 10,000 volt 3D electric sprayer, which fires out a stream of heart cells. It can create thin sheets of beating cells that researchers hope they can use to patch-up pieces of damaged heart.As more people survive Heart attacks then it means more are living with a damaged heart. When heart muscle cells dies it is replaced by scarring, just as it does after you cut your leg. But scar tissue does not beat, so it can leave the heart struggling to pump blood. In some cases it can make even the simplest of tasks as exhausting as running a marathon.The British Heart Foundation researchers are trying to develop the patches. The thin sheets of heart cells could be layered onto the heart to help it beat or maybe even sprayed directly onto scar tissue inside the heart.
Dr Suwan Jayasinghe a medical engineer has assembled the pieces of the bio-electric sprayer. First a syringe is filled with heart cells. In the future it is thought these cells could be taken from a patient’s heart and grown or a patient’s stem cells could be converted into heart cells. These are then passed through a needle. However, unlike a graffiti artist’s spray can, this is not enough to get the thin accurate spray of cells needed to build the heart tissue.
Instead 10,000 volts going through the needle create an electric field to control the cells. “You get the formation of a fine jet which then breaks up into a myriad of droplets and those droplets are what form the sheet,” said Dr Jayasinghe. “The beautiful thing is that we can add various other cell types into this cell suspension and create three dimensional cardiac tissues that are fully functional.” Under a microscope it is then possible to see the cells beating in the patch. The next test is to see if the patches can actually help a damaged heart to beat, by testing them in animals”
Researcher Dr Anastasis Stephanou said: “Hopefully we can show that these engineered cardiac sheets improve the function of a damaged heart.”
“A heart is made up of different cell types, so we would be able to design the technology where we would be able to place the right number of cell types to develop the actual cardiac tissue.” “So we feel the technology we have is quite superior in terms of the other cardiac tissue engineering technologies that are available.”
Professor Peter Weissberg, medical director at the British Heart Foundation which funds the research, said: “Creating heart muscle is a huge challenge and involves a mix of different cells and blood vessels that need to line-up perfectly with one another.
“This groundbreaking research is trying to find a way to build ‘pieces of the heart’ outside the body. We hope that one day these pieces can be grafted onto damaged hearts to help them pump more strongly.”
Heart Failure Rehab rears its ugly head again
We presume this article rings bells with people?
More heart patients should benefit from cardiac rehabilitation, health campaigners have said. They made the plea after new figures showed just 3% of eligible patients with heart failure were offered this, compared to about two-thirds of those who have had either a heart attack or cardiac bypass surgery.
Across Scotland, a total of 65.2% of heart attack patients were referred for cardiac rehabilitation, as were 68.5% of people who had bypass surgery. But just 3.1% of those with heart failure were referred for rehabilitation, along with only 7.4% of those with unstable angina. Pumping Marvellous find this digraceful and this indicates the attitude towards Heart Failure and how to deal with the ever growing problem by the NHS.
While 7,845 heart attack patients were referred for rehabilitation between April 2010 and March 2011, only 144 people with heart failure and 340 with unstable angina were put forward.
The British Heart Foundation (BHF) Scotland and Chest, Heart and Stroke Scotland are now calling for more of these patents to benefit from the treatment. The two charities argued that rehabilitation only costed about £600 per patient, and could help save lives, with heart patients 30% less likely to die over a 10-year period if they have taken part in a cardiac rehab programme.
Ben McKendrick, senior policy and public affairs manager at BHF Scotland, said: “Cardiac rehab saves lives but there is an unacceptable gulf between the levels of support offered to patients with different heart conditions.
“When someone suffers a heart problem – be it angina, a heart attack or heart failure – they not only suffer a damaged heart but often a damaged spirit as well. Heart patients tell us that cardiac rehab helps mend that spirit and puts them on the road to living a full life again.”
Scottish Health Secretary Nicola Sturgeon said “excellent” progress had been made in offering rehabilitation. She said: “In 2007 around 45% of people in the clinical priority groups had access to cardiac rehabilitation, this figure has now risen to 65%. While this substantial increase is a great achievement, we recognise that there is still much more to do to help improve the quality of care for people living with heart failure.
“Our National Advisory Committee on heart disease will continue to work closely with cardiac services and the voluntary sector to take this forward. Our focus is not just on providing the best possible care in the acute setting, but also on helping people’s longer-term recovery in their own communities.”
DNAplays a part in immune system reaction to Heart Failure
DNA from a person’s own heart can play a significant part in heart failure by wrongly activating the immune response. A study co-funded by the British Heart Foundation and carried out by researchers in the UK and Japan found that in some people with this DNA the immune response is triggered during heart failure. This causes inflammation which makes the heart muscles less effective and reduces the ability to pump blood around the body.
The study, published by the journal Nature, found that the immune system is triggered by the release of DNA from the energy-generating structures in heart cells called mitochondria. Mitochondria evolved billions of years from bacteria and now share a similar DNA footprint, often causing a mistaken response from the immune system which recognises it as bacteria. “This intriguing discovery is an important breakthrough in our understanding of why, during heart failure, the immune system becomes activated without the presence of any obvious external threat,” Dr Shannon Amoils, research advisor at the BHF said.
We have been saying for a long time that our patients are feeding back to us that their short term memory has been affected since being diagnosed with Heart Failure. We are pleased to see that research has proved their assumptions to be correct.
Heart failure is associated with a decline in mental processes and a loss of grey matter in the brain, new research has found. Scientists at the University of Western Australia say the changes could make it harder for people with heart failure to remember their medication and follow the instructions correctly.
The researchers performed cognitive tests and MRI scans on 35 patients with heart failure, 56 patients with ischaemic heart disease and 64 healthy volunteers. They found that people with heart failure tended to have worse immediate and long-term memory and reaction speeds than healthy people.Heart failure patients also showed changes in areas of the brain that play a role in cognitive and emotional processing.
Professor Osvaldo Almeida said: ‘What we found in this study is that both ischaemic heart disease and heart failure are associated with a loss of cells in certain brain regions that are important for the modulation of emotions and mental activity. ‘Such a loss is more pronounced in people with heart failure, but can also be seen in people with ischaemic heart disease without heart failure.’
The findings are published in the European Heart Journal and could have important implications, as figures from the British Heart Foundation suggest there are more than 27,000 new cases of heart failure each year in the UK.
Stem cells taken from a patient’s own heart have, for the first time, been used to repair damaged heart tissue, researchers claim. The study, published in the Lancet, was designed to test the procedure’s safety, but also reported improvements in the heart’s ability to pump blood.
The authors said the findings were “very encouraging”
Other experts said techniques with bone marrow stem cells were more advanced and that bigger trials were needed. The scientists say this is the first reported case of cardiac stem cells being used as a treatment in people after earlier studies had shown benefits in animals.
The preliminary trial was on patients with heart failure who were having heart bypass surgery. During the operation, a piece of heart tissue, from the right atrial appendage, was taken. While the patient was being sown up, researchers isolated cardiac stem cells from the sample and cultured them until they had about two million stem cells for each patient. The cells were injected about 100 days later. Doctors measured how efficiently the heart was pumping using the left ventricle ejection fraction – what percentage of blood was leaving one of the heart’s main chamber with every beat. Dr Roberto Bolli University of Louisville said “We believe these finding are very significant”
In the 14 patients given the treatment, the percentage increased from 30.3% at the beginning of the trial, to 38.5% after four months.
There was no change in the ejection fraction in the seven patients who were not injected with stem cells.
“Our results indicate that cardiac stem cells can markedly improve the contractile function of the heart.”
However the heart is not the only source of potentially useful stem cells. Trials have already taken place using stems cells from bone marrow.
Prof Anthony Mathur, from Barts and the London School of Medicine and Dentistry, and Prof John Martin, from University College London, are already conducting large randomised clinical trials. Prof Peter Weissberg British Heart Foundation “This is positive, but the crucial next steps are to see whether this improvement is confirmed in the final completed trial”
Prof Mathur said of the cardiac stem cell study: “Caveats very much apply. It’s a phase one trial so while the early results are great and promising, they need to design a big study to see if the results translate.”
He also cautioned that improvements in ejection fraction were not the same as increasing survival or quality of life.
Prof Martin said he was “concerned” that the seven patients in the control group showed no improvement in ejection fraction, which would normally be expected, and that they were not given a sham treatment to account for the placebo effect.
He said that was acceptable when just testing a procedure’s safety, but not when looking at effectiveness, which relies on the difference between the treated and control groups. Prof Peter Weissberg, medical director at the British Heart Foundation, argued that the improvement in heart function was similar to those in other studies.
“This is positive, but the crucial next steps are to see whether this improvement is confirmed in the final completed trial, and to understand whether the cells are actually replacing damaged heart cells or are secreting molecules that are helping to heal the heart,” he added.
Dr Bolli argues that stem cells from the heart might be more useful as “their natural function is to replace the cells that continuously die in the heart due to wear and tear”. He hopes to start the next phase of clinical trials in 2012
Pumping Marvellous opinion on Palliative Care
Palliative care in England is not delivered consistently or fairly, according to an independent review. The inquiry into care for end of life patients was commissioned by the government last year, and has pointed to “stunning inequities” in the present system. Figures from the Department of Health show that one primary care trust spent £186 per death whilst another spent £6,213 which indicates the real difference in attitude to end of life care.
The report proposes that a set of guidelines should be put in place to ensure a basic standard is guaranteed by the state and a new payment system is developed to help people die at home rather than in hospital. Simon Chapman, from the National Council for Palliative Care, expressed his support for the review’s recommendations and urged the government to act. He said:”Although the majority of us would prefer to be cared for and die at home, in a care home or in a hospice, more than half of us die in hospital. “We only get one chance to get it right for dying people, which is why it must be a priority to ensure everyone who needs it can access palliative care round the clock.”
Around 470,000 people die in England each year and the report estimates that of these 355,000 need palliative care, but only 171,000 receive it.
Ciarán Devane, chief executive of Macmillan Cancer Support, welcomed the review and said: “We need to see a massive improvement on the 56% of PCTs who currently provide 24-hour community nursing to all end of life patients. “It is now up to the government to ensure that these services are standard across the country,” he added.
The report says that the system is under increasing pressure from people living longer and having more complex needs in the later stages of their lives. It suggests that a new set of tariffs should be put in place to incentivise high quality end of life care. A tariff system would be similar to a successful system which operates in Australia and would cover all clinically assessed needs of the patient. Each patient would also be provided with a coordinator who would help them use the different services which are available.
Dr Mike Knapton, associate medical director at the British Heart Foundation, has argued for a more equal system of palliative care which doesn’t disadvantage patients with heart failure. He said: “There are 750,000 people living with heart failure in the UK and they often have a poorer quality of life, more limited access to palliative care services and a worse life expectancy than many cancer patients. “This review is an important first step to readdressing the balance so heart patients get the care they deserve based on need, not diagnosis.”
The Dilnot Commission is due to report on Monday and is expected to call for individuals and the government to pay more to help rebuild the UK’s care system.
If there was a consistent approach to palliative care through the NHS mechanisms eg palliative specialist nurses run within the specialist heart failure nursing teams directed through the clinical leads then money wouldn’t be spent assessing the need as the facility would be there. The number of heart failure patients that need palliative care compared to the total of number of patients in the group are significant therefore it doesn’t require too much analysis. Or does this just keep more people in jobs managing the treacle of NHS decision making.
A sticking plaster to heal damaged hearts has been created by scientists. Packed full of healthy heart cells, it could be used to shore up areas damaged by heart attacks, cutting the odds of further ill health.
To create the inch-long patch – which is as thin as a human hair and resembles a black sticking plaster – the U.S. researchers first built a scaffold of extra-thin carbon fibres.
In experiments in a dish, healthy heart muscle, nerve and other cells ‘crawled’ on to the framework, repairing damage to the heart. In other words, it was able to bring regions of the heart left ‘dead’ by heart attack back to life, the journal Acta Biomaterialia reports.
David Stout, the study’s lead author, said: ‘This whole idea is to put something where dead tissue is to help regenerate it, so that eventually you have a healthy heart.’
Other materials were not as successful. The researchers believe the carbon fibres worked because they conduct electricity well. The first animal tests will take place this year but it is likely to be ten to 15 years before the plasters are routinely used to patch human hearts. Researcher Thomas Webster of Brown University, Rhode Islamd said ‘When someone has a heart attack, part of the heart dies. The heart compensates for that, placing it under more strain. ‘What we wanted to do was develop a material that could be inserted wherever the damage is, maybe through a catheter or small tube, so that new, healthy tissue can grow on top of it.’
While it would be best to insert the device soon after a heart attack, it may still help if it is put in up to several years later, Dr Webster added.
The approach is one of several being explored around the world.
The charity is pursuing the idea of heart patches as well as pills to trick the organ into healing itself, and injections of stem cells. Launching the appeal earlier this year, Professor Peter Weissberg, the BHF’s medical director, said: ‘The biggest issue that still eludes us is how to help people once their heart has been damaged by a heart attack.
‘Scientifically, mending human hearts is an achievable goal and we really could make recovering from a heart attack as simple as getting over a broken leg.’