Heart Healing Looks Promising

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Virus engineering to heal hearts...

Gene therapy: 'Heart-healing virus' trial starts
30 April 2013 - Patients in the UK have been enrolled into a trial to see if an engineered virus can be used to heal their damaged and struggling hearts.

The trial will use a virus to introduce genetic material into heart muscle to reverse the organ's decline. The British Heart Foundation said the idea had "great potential" but needed to be proven in clinical trials. Heart failure affects more than 750,000 people in the UK and can leave some people too weak to climb the stairs. It occurs when the organ is damaged, for example after being starved of oxygen in a heart attack, and becomes too weak to effectively pump blood around the body. There have been huge medical leaps in keeping patients alive after a heart attack, but the consequence is a rapidly growing number of people living with heart failure.

Researchers at Imperial College London found levels of the protein SERCA2a were lower in heart-failure patients. So they devised a genetically modified virus, with the instructions for producing more of the protein, that can infect the heart. The virus will be released into the damaged heart muscle of the 200 patients involved in the trial via a tube inserted into the leg and pushed up through the blood vessels. Prof Sian Harding, from Imperial College London, said: "It's bringing [the heart] back to the point where patients were pretty well, just after the initial damage occurred. "We think this is a treatment that can improve quality of life for quite a lot of people."

Heart failure is increasingly common

Dr Alexander Lyon, a cardiologist at Royal Brompton Hospital, where some patients will take part in the trial, said: "This is the first ever gene therapy trial for heart failure. "Our goal is to fight back against heart failure by targeting and reversing some of the critical molecular changes arising in the heart when it fails." The Golden Jubilee National Hospital in Clydebank is also taking part in the trial. Dr Mark Petrie said: "As a national service treating Scottish patients with the most serious heart failure, it is vital that we are at the forefront of new research and developments."

Prof Peter Weissberg, the medical director of the British Heart Foundation, said: "Whilst drugs can offer some relief, there is currently no way of restoring function to the heart for those suffering with heart failure. "Gene therapy aims to improve the function of weak heart muscle cells, whereas our Mending Broken Hearts Appeal is aimed at finding ways to replace dead heart muscle cells after a heart attack. "Both approaches are novel and both offer great potential for the future."

BBC News - Gene therapy: 'Heart-healing virus' trial starts

 

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New Tiny, Wireless Pacemaker...

Study: Tiny, Wireless Pacemaker Could Be Surgery-Free Option
August 30, 2015 — A tiny, wireless pacemaker could offer some heart patients a surgery-free alternative to the traditional devices, a new study found, yet some doctors said there are lingering safety questions and warned patients not to rush to get the new technology.

Unlike traditional pacemakers – which need a generator and wires and are implanted via surgery – the new pacemaker is a wireless tiny tube that can be attached to the right side of the heart using a catheter inserted through the leg. "This is another landmark in the development of pacemakers," said Dr. Christopher Granger of the American Heart Association, who was not part of the new study. Still, he said doctors need time to learn how to use any new technology to avoid potential problems. "I would tell patients to be careful of being one of the first to get this unless there's a compelling reason," Granger said.

Minipacemaker

In the new research, doctors in Australia, Canada and the U.S. implanted the minipacemaker into more than 500 people. After six months, nearly 7 percent of patients reported side effects including the device poking holes in their heart. In comparison, about 10 percent of patients who get regular pacemakers suffer complications. The study was published online Sunday in the New England Journal of Medicine and is being presented at a meeting of the European Society of Cardiology in London. The research was paid for by the pacemaker's manufacturer, St. Jude Medical. The miniature pacemaker is already approved in Europe and the new study will likely be submitted to the U.S. Food and Drug Administration.

Study of device

A study of the device in Europe, however, was twice stopped last year and in May when a worrying number of complications were reported, including one case where the device got dislodged and stuck in the artery leading to the patient's lungs. A similar pacemaker made by Medtronic is also licensed in Europe. While most pacemakers have wires connecting the device to the right and left sides of the heart, the new device sits in the right ventricle and doesn't coordinate the two sides. Experts estimated the tiny new pacemaker might work for up to 30 percent of patients.

New pacemaker is wireless tiny tube that can be attached to right side of heart using catheter inserted through leg

Many doctors in Europe are still wary of the new device, which is at least double the price of a regular one. Dr. Jose Ramon, president of the Spanish Society of Cardiology, said his hospital only implanted the new pacemaker in about a dozen patients last year, compared to approximately 500 patients who got a traditional device. The tiny pacemaker also lacks some functions that are standard for normal devices, like tracking irregular heart rhythms.

No remote monitoring

"It can't monitor patients remotely, so they have to go to the hospital for checks," said Dr. Jagmeet Singh, a spokesman for the American College of Cardiology. Still, Dr. Vivek Reddy of Mount Sinai Hospital in New York, who led the new research, said he expected the device to be approved by the FDA. "Patients are going to want this new pacemaker," he predicted. "It's up to doctors to talk to their patients about this, but patients will want [the smaller pacemaker] once they know about it."

Study: Tiny, Wireless Pacemaker Could Be Surgery-Free Option

 

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Replace it - don't repair it...

Study Shows Advantages of Mitral Valve Replacement Over Repair
November 10, 2015 - Paients with severe leakage from the mitral valve of the heart who had the valve replaced had significantly lower rates of recurrence and heart failure two years after the procedure than those who underwent surgical repair, according to data presented on Monday.

Mitral valve regurgitation, in which blood leaks backward through the valve into the heart, increases the risk of serious heart problems and death. It affects more than 2 million Americans. There was no difference in survival between the two approaches, or in improvement in heart function, measured by amount of blood in the left ventricle following a heartbeat, after two years. But results of the 251-patient study showed clear advantages of replacement.

Post surgery results

A doctor checks a screen showing a graphical representation of a human heart. Several companies, including Medtronic, Abbott Laboratories, Edwards and Boston Scientific have been investing in mitral valve technology.​

Two years after undergoing surgery, 59 percent of patients in the repair group had experienced moderate or severe recurrence of the condition versus 3.8 percent in the replacement group, researchers found. There was also a higher rate of reported heart failure events, 48 versus 29, and readmissions to hospital, 93 versus 59, in the repair group, data presented at the American Heart Association scientific meeting in Orlando showed. "At two years this is affecting clinical outcomes," said Annetine Gelijns, one of the study's lead investigators. "What is extraordinarily interesting is if you look at these results, they really point at replacement as probably being the preferred option for this group of patients," she said. "There was a lot of controversy about what was the best way to surgically approach the mitral valve," Gelijns, from Mount Sinai Hospital in New York, explained. The field had gravitated toward repair, but reports of high rates of recurrence led researchers to undertake this study, in which surgeons chose valves at their discretion, including those from St. Jude Medical, Edwards Lifesciences and Medtronic.

Trend noticed

There was a trend toward improved quality of life reported by patients in the replacement group, researchers said. Procedures were performed via open heart surgery, but companies are looking at ways to replace the mitral valve through less invasive methods. Companies, including Medtronic, Abbott Laboratories, Edwards and Boston Scientific have been investing in mitral valve technology, which they see as a potentially lucrative future growth driver. Edwards and Medtronic lead the field of minimally invasive aortic valve replacement. Some patients who had successful repair saw their left ventricle return to normal size, but doctors are not yet able to identify who is most likely to see that benefit, researchers said.

Study Shows Advantages of Mitral Valve Replacement Over Repair