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A new technique that uses the body’s natural building materials to seal a hole in the heart has been developed and approved for use in Britain, avoiding the need for open-heart surgery or metal implants.
Doctors will be able to deploy an umbrella-like device made of proteins to mend the common defect, which is thought to increase greatly the chance of having a stroke. The implant is eventually absorbed by the body and replaced by the patient’s own tissue.
Up to one in four people are thought to be born with a hole between the right and left atrium of the heart, a condition that is also known as patent foramen ovale (PFO). The hole can allow unfiltered blood and fat particles to pass into the arteries and cause blockages.
Most people with PFO do not suffer any symptoms, but over time the hole can affect blood supply to the brain, causing debilitating migraines and possibly strokes. Of the 150,000 Britons who have a stroke each year, up to 40 per cent will have PFO.
Surgeons close up to 1,000 PFOs a year but they believe that by making the operation quicker and less invasive they can help more people.
Trials of the new bioabsorbable implant, known as BioSTAR, found that it effectively sealed holes in more than 50 patients, with no adverse effects reported. Most of the holes were closed within 30 days.
During the procedure, the implant is fed through a catheter in the leg and up to the heart to cover the hole. It is supported by a scaffold of highly purified and very strong collagen, which unfolds either side of the septum like a pair of small umbrellas.
Collagen, which can be derived from pigs, is the main protein used in connective tissue in mammals. It binds quickly to the heart and is easily can be absorbed over time.
Previous devices to treat PFO have been made of metal and polyester, which remain in the heart indefinitely and potentially cause severe health complications. Doctors are using more and more biological materials in surgical procedures. Michael Mullen, a heart consultant at the Royal Brompton Hospital in London, said that patients undergoing the procedure would suffer less pain, have a shorter stay in hospital and recover more quickly than if they had traditional surgery.
“The BioSTAR device allows us to close PFO quickly, effectively and safely,” he said. “Crucially, the responses that it triggers mean that patients heal naturally and that minimal foreign material is left behind in the heart.
“Collagen is 25 per cent of our total body protein. It is contained in skin, bones and teeth. Therefore, using collagen to repair and support parts of the human body makes perfect sense.”
Janet Savage, 61, one of the test patients, said that the operation had rid her of migraines. “I was initially shocked to find out that I had a hole in my heart. It sounds so dramatic but I was only tested for it when I had a mini-stroke and blacked out while driving. I had previously assumed that my migraines were unrelated and just something I had to put up with from time to time, but since having the operation I’ve never felt better.”
David Hildick-Smith, consultant cardiologist at the Royal Sussex County Hospital in Brighton, who also participated in the research, said: “PFO appears to allow blod clots and other debris to clog up arteries in patients, which not only causes strokes but other problems. Using the bioabsorbable device is a radical rethink of a treatment option for migraine but it seems to have shown some very positive results. For a proportion of sufferers, this could end up as a cure for them.”
The foramen ovale is a small hole located in septum between the upper chambers of the heart. It occurs naturally in a foetus as it develops in the womb, to speed up the travel of blood through the heart. As a developing baby does not use its own lungs to supply oxygen-rich blood, deriving it instead from its mother through the umbilical cord. The foramen ovale allows blood to flow from the right side of the baby’s heart to the left side, without having to go via the lungs.
Normally, the foramen ovale closes at birth when increased blood pressure on the left of the heart forces the opening to close. But in some people, with PFO, the septum does not close properly. The defect generally manifests itself as a flap valve, only opening during certain conditions when there is more pressure inside the chest.
— A “living laboratory” in the shape of a mouse with human liver cells could soon be helping drug companies to develop new products. The mouse is able to live normally with 90 per cent of its liver repopulated by human cells. The cells function as if they were inside a human patient, producing all the same blood-clotting factors and proteins. They can be used to study the way compounds are biologically processed in the body and tolerated - essential for any form of drug development. Scientists hope that the mouse, produced at Oregon Health and Science University, will soon become the “gold standard” for both investigating drug metabolism and new ways of tackling liver infections such as hepatitis and malaria.
How it works
Device is inserted by catheter through artery in the groin


A collagen device is advanced to midway through the hole

Umbrella-like structure is then released, making first seal of hole

A second umbrella seals hole. Catheter is removed

- One in four people has a hole in the heart, which usually closes over at birth
- 90-95 per cent of an implant to seal the hole can be absorbed and replaced by a patient’s own tissue
- This closes the hole permanently, reducing the risk of stroke
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I am 36 years old and suffered a stroke 2 years ago. I completely recovered and it was found after a battery of tests that I had a small hole in my heart. The initial cardiography test didnt even pick it up, a camera was stuck down my throat and then the hole was found. It has been recommended to me to close my PFO, in Brussels. I would like to know what are the side effects of the proceedure? Will I have to continue taking asprine every day and if so why do the proceedure at all?
caroline, Brussels, belgium
I am 42 years old and had a stroke last year. I had various tests and it showed I had a PFO. I am writing this as last week 18 March 08 the PFO was closed. Of course I was frightened but more scared of what could happen if I left it. Well I am pleased to say a week after surgery I am completely back to normal and going back to work and getting on with my life.
Thanks to the pioneering research which enables heart surgery to be key hole.
Clare T . Brighton England
clare tatham, brighton,
I am now 34 years old, when I was 33 Years old I had a stroke after 4 months I was diagonsed to having a hole in the heart, the consultant was really helpful and told me in detail what would happen and I was put forward to have the pfo done after 1 day I was out of hospital and apart from the bruising you wouldnt be able to guess I have been in to have it done. I am worried that my 3 children who are 10,12,14 years will have inherited this from me as my sister has been told she has a heart murmer so it could be down our family line.
Nikki Downes, Wolverhampton, West Midlands
I am 33 yrs old, and after having a stroke 3 yrs ago I was finally diagnosed last year as having a hole in my heart and told I would need an op to close it. I have just had a letter saying I can have my consultation in December. I am scared because no-one has explained my condition to me, what would happen if I don't have the op etc. I am a mum of of a lovely 2yr old boy and would love to try for a sibling for him. Can anyone offer me any advice, or has anyone had the op and can tell me about it ?
louise johns, Hayle, Cornwall, England
i was just operated with the bio star. only 2 days hospital, no pain, i just feel as well as the day before and I will be able to go back diving in a couple of monthes. that may be an industry driven idea as someone say, but I can tell you I ll be so happy to go back to my diver work without the fears that I had before!
stephane, lausanne, switzerland
Incidentally, I didn't correct the ridiculous assertion that surgeons "close 100 PFOs each year". Since devices have been available (about 10 years) no PFO is referred for surgery!
If anyone reading this nonsense is alarmed that they have a PFO - don't be. It's as normal as having 2 eyes.
David E Ward, London,
This article is very misleading. First of all everyone has a Foramen Ovale in the uterus and in 75% of us it closes at birth. In the huge majority of patients with a persistently open (patent) foramen (PFO) no harm results. Indeed it is normal. In a tiny number who develop strokes it is assumed that if there is a PFO it is responsible in the absence of other causes. The most convincing evidence for harm caused by a PFO is in scuba diving where a type of "bends" can affect the brain (and other organs such as the eyes, skin). There is NO convincing evidence to link PFO causally with migraine. Device closure trials are ongoing. Finally the bioabsorbable device is only the most recent development in PFO closure. A metallic spring device has been around for nearly 10 years with very good results. There is no evidence that the bio device is superior. This is an industry driven idea. For the record we at St Georges have put in over 450 of these metallic devices (for PFO and abnormal holes.
David E Ward, London, UK
I had the starflex implant last year and it has changed my life. I have suffered severe migraines for over 15yrs and since the pfo closure I haven't had any.
Jayne, Liverpool,
I had the starflex implant last year to close my PFO, since then I haven't suffered a migraine.... it has changed my life completly. before the closure I had 2-3 severe migraines a month which affected my life and work enormously.
Jayne, Liverpool,