Heart beats in anticipation
New domestic technical developments will soon come to the service of cardiac surgeons
The release of domestic high-tech products for Belarusian cardiac surgery is an important and promising direction in the development of the industry. This is especially evident amid the unstable flow of foreign materials into the country. However, today we are talking not only about import substitution: the production of our own products for cardiac surgery is the key to further success in the treatment of cardiovascular diseases. Deputy Director for Innovative Development and High Technology of the Republican Scientific and Practical Centre Cardiology Yuri Ostrovsky spoke about new developments.
From the time of the Soviet Union, Belarusian cardiac surgeons inherited a shortage of mechanical artificial heart valves. In 1993, domestic analogues of Western prostheses were created in the country. Now they are greatly improved.
“We entered the 5th-6th generation, there were single-leaf valves, now they are double-leaf valves. To date, more than ten thousand implantations of the standard valve, which has been used since 2009, have been performed. Everything is fine with it: the performance indicators are absolutely no different from Western counterparts, although the product is cheaper. And most importantly, we do not depend on foreign suppliers and have a huge selection of mechanical prostheses for any valve position — aortic, mitral, and so on,” Yuri Ostrovsky explains.
Yuri Ostrovsky
Over time, it became clear to specialists that due to the increased average life expectancy of the country’s population, the need for biological heart valves will increase every year. They are needed primarily by patients over the age of 65 years.
“So far, there is no industrial production of such valves, and they themselves are quite expensive — $1200-1300 apiece. But things are changing,” Yuri Petrovich specifies.
Preclinical and experimental studies of a frameless biological prosthesis (though so far only in the aortic position) have been completed at the Electronmash plant in the capital. The Republican Scientific and Practical Centre ‘Cardiology’ plans to start clinical trials this summer.
If there are no problems, the process can take two to three months. If there is a go-ahead for industrial production, then this will cover all the country’s need for these products. Another plus is that domestic products are cheaper than imported analogues.
The Deputy Director of the Republican Scientific and Practical Centre emphasises that it will be a completely Belarusian prosthesis, including the material and its processing, and cardiac surgeons need to have several types of biological prostheses, “In this direction, we are co-operating with the resident of the BNTU technopark, the Polymedtech enterprise. By the end of summer, we are planning to hand over for clinical trials scaffold bioprostheses that can be placed in any position.”
The biological heart valve is a high-precision technique. Its implementation takes a lot of time, but the result is worth it. Any valve must ‘hold’ 10 years in the human body. However, this does not mean that they will not last longer.
‘Mechanics’ can work for a very long time, because the margin of safety exceeds the resource of human life.
“In the West, recently in Russia, and now in Belarus, the so-called devitalised biomaterial for a biological heart valve is being developed. This is the pericardium of calves, from the tissue of which not only antigens, but also any cellular structure is removed, leaving a bare ‘framework’. In our country, this project is being carried out jointly with the Institute of General and Inorganic Chemistry of the National Academy of Sciences of Belarus, the Institute of Biophysics and Cell Engineering of the National Academy of Sciences of Belarus, the Polymedtech and Pharmland enterprises. We are only at the beginning of the journey, but as a result, a valve should appear, which, when working in the human body, is populated by its own cells and becomes, as it were, natural. It does not require specific medical support,” Yuri Ostrovsky goes on.
There are also advances in the work on the creation of artificial prostheses of the heart vessels, Yuri Ostrovsky notes, “Biological vascular prostheses were created from the same material — the pericardium of calves, processed according to a scheme that has been known for 20 years. They have passed preclinical trials, animal testing. True, the biomaterial is not suitable for all patients, someone needs a synthetic fabric. Polymedtech purchased a device that allows them to produce the necessary materials. But a problem arose: when implanting these prostheses, absolute tightness is needed. Specialists from Penza and the Skolkovo innovation centre are involved in co-operation, but there are coatings of a completely different type. Callogen treatment is used: Polymedtech manufactures prostheses, sends them to Penza, where they are processed. But we will go further. We will process the same prostheses at Skolkovo, and they will be used not only in vascular surgery, but for very complex operations for aortic aneurysm. After all, this is not just a vascular prosthesis — in the presence of an internal stent made of self-expanding nitinol, the technology for performing such operations is greatly simplified.”
Since 2009, more than 500 heart transplants have been performed at the Republican Scientific and Practical Centre Cardiology. There are indisputable successes, but there are also difficulties, Yuri Ostrovsky does not hide, we are talking about an increase in the duration of ischemia — the exclusion of a donor organ from the blood circulation, “In reality, we have to fit in at four hours. But it doesn’t always work out. A transport container is needed to ensure the transportation of any donor organ (heart, kidney, liver) at a standard temperature of plus 4-6 degrees Celsius. We don’t have it yet. We tried to deal with this issue on our own, we plan to co-operate with Russian developers from Novosibirsk. I think everything will work out, and we will be able to increase the safe ischemia time of the donor heart to six hours. This will allow delivering the organ from one point of the country to another, even by car. This is a big boon for patients.”
To the point
On the one hand, the violation of the usual ties with Western countries in the medical field creates additional difficulties for our specialists. On the other hand, this is a serious incentive for the development of our own high-tech industries. Moreover, Belarusian specialists have a lot of promising developments.Reference
The history of the Republican Scientific and Practical Centre Cardiology dates back to August 1977, when the Belarusian Research Institute of Cardiology was established in Minsk. For 45 years, it has gone from a research laboratory to a highly specialised scientific and practical institution, equipped with modern furnishment and medical equipment. Every year, thousands of Belarusian patients from all regions and about 500 foreign citizens receive consultative assistance at the centre. The number of annual high-tech interventions has reached 3,500, the entire range of cardiac surgeries is performed in high-risk patients, including heart transplantation, ‘heart-lung’, ‘heart-kidney’ complexes.By Aleksandr Nesterov