Revolutionary Heart Failure Treatment

The scientific idea of ​​implanting a device to reduce pressure in the heart is based on the research and inventions of 2001 by Professor Gadi Keren, former director of the cardiology department at Ichilov Hospital and former president of the Israeli Cardiology Association. This is the development of a tiny device that is inserted through catheterization between the atria of the heart and helps reduce excess pressure in the atria and left ventricle in patients with heart failure.

In 2013, the first human implantation was performed in Israel. The product has long been approved for use in Europe, and the company hopes that after receiving approval from the American Food and Drug Administration (FDA), the product will also be used in the United States.

Ichilov Hospital is the central location for the evaluation and study of the technology from the early stages to the final months of the international clinical trial, which was submitted for approval to the FDA. The Heart Failure Unit, led by Professor Michal Lauper Perl, Director of the Heart Failure Service and Director of the Cardiology Clinic in Ichilov, participated in the experiment.

Professor Gadi Keren stated that “the technology developed by the company allows for the treatment of patients with heart failure by reducing the pressure in the left atrium, preventing and improving clinical symptoms such as shortness of breath, which patients suffer from.” According to him, “I wrote the patent in 2000, and it was registered in 2001. The ideas that emerged for this patent essentially reflected my entire professional history up to that time, including work with catheters, heart failure, and echocardiography, which I had seen performed in diagnosing patients with holes between the atria and blood flow from the left atrium to the right.

Professor Kern suggests that together all that circumstances led to the solution when the pressure in the left atrium was elevated in patients with heart failure, you could create holes in the septum to force blood to flow to the right side and reduce the pressure, since the right side is normally able to absorb large volumes without increasing the pressure.

At that time, valves had not been implanted in the heart and there was no technological solution to this problem. People thought I was completely crazy. It was very difficult to convince the high-tech medical industry of the time to raise the money to develop such a device. It was a long-term step of faith for me and other people who mobilized for this cause and believed in this idea.”

The opinion of Professor Michal Lauper Perl explained why this  device is so important. Since than 60 million patients worldwide suffer from with heart failure, and it’s about 170,000 in Israel, so this patients have to get it. Breath shortness and exercise intolerance can be the most pronounced disease manifestations. They they cause long-term and frequent hospitalization, which leads to a significant deterioration in quality of life

“There are drugs for heart failure, and this area is definitely developing, but there is still much to improve. Therefore, in recent years, there has been a trend, in addition to drug treatment, to develop all sorts of devices and invasive surgeries that can improve the situation. Heart increase pressure is one of the reasons that cause shortness of breath. Increased pressure inside the left side of the heart causes congestion in the lungs, which leads to shortness of breath, difficulty breathing and pulmonary edema, and this is one of the most common reasons for hospitalizations.”

Professor Lauper Perl said that “there are various treatments for congestion, but they are not enough, so the idea was that by placing a device between the left and right ventricles of the heart, the pressure on the left side of the heart would be increased.” In other words, when pressure is created on the left side, the blood has somewhere to go, oriented in the direction of right ascension, then the pressure is reduced.

“Such procedure as  transplantation can be without complications when specialist use a catheter. The company has done a large and comprehensive study in about 100 centers around the world, and we here in Ichilov are one of the most active centers. This is definitely a new area that will change the way we treat patients with heart failure, opening up new opportunities that will improve patients’ quality of life and hopefully reduce mortality as well.”