Main article: Human heart
Technologies
CoreValve - aortic valve replacement system
Main article: CoreValve (aortic valve replacement system)
Masters - artificial heart valve
Main article: Masters (artificial heart valve)
Medtronic Avalus - pericardial aortic valve
Main article: Avalus
2024
Breakthrough in artificial heart valves made
In mid-September 2024, it became known that Canadian researchers from the University of British Columbia presented a breakthrough technology for creating artificial heart valves, combining the best achievements of mechanical and biological technologies.
Tissue valves, as a rule, act better than mechanical valves, but last an average of 15-20 years, after which the patient needs another replacement. Mechanical valves can last a lifetime, but do not work as well as tissue valves, and patients have to take anticoagulants daily, risking bleeding. The new iValve technology combines the advantages of both techniques: the efficiency of fabric valves and the durability of mechanical valves.
In addition, the inventors note that iValve valves have been specifically designed for use in high heart rate environments, for example in children, and thereby can solve the long-standing problem of infant surgery.
A prototype valve of the new type performed well in laboratory tests, and researchers are now preparing to conduct animal trials and clinical studies involving humans. If all goes well, the researchers hope to bring iValve to market in two years. So far, the developers have presented only an artificial aortic valve, but also intend to create a mitral valve.
 | We have shown that iValve can provide the structural benefits of a mechanical heart valve and last a patient a lifetime. However, unlike mechanical valves, it does not impair hemodynamic characteristics and does not increase the risk of thrombosis, so patients do not require constant intake of anticoagulants, associated with a risk of bleeding and a deterioration in quality of life.[1] |  |
The world's first aortic valve made of donor tissues has been developed in Russia
On February 28, 2024, Russian researchers from the I. M. Sechenov First Moscow State Medical University announced the development of the world's first aortic valve from donor tissues. Its basis is a homologous pericardium - a pericardial bag.
According to scientists, the product has a number of unique features. A special method of processing biological material and solution for its storage has been applied, thanks to which the components of the valve are not calcined. In other words, calcium deposition does not occur, which is one of the major problems with the use of biological implants. In addition, it is estimated that the life of such a product will be 40% longer than that of traditional aortic valve prostheses. And this means that the valve from the homologous (donor) pericardium will most likely be installed for life: thus, the patient will not need repeated surgery.
It is assumed that the new type of aortic valve will be used in the therapy of a wide range of cardiovascular diseases. Among them are called congenital defects, stenosis, insufficiency and infectious endocarditis. After treatment with the new method, the valve flaps are potentially resistant to infectious pathogens, which expands the scope of the product.
The work was carried out under the leadership of Roman Komarov, director of the Clinic for Cardiovascular Surgery at Sechenov University. As of the end of February 2024, the new type of valve samples are being tested in a pulse duplicator, after which they will be implanted in laboratory animals.
| | Optimal results of preclinical studies will give the green light to the start of clinical testing, a new prosthesis will be implanted in middle-aged patients, the university said in a statement.[2] | |
2023
In Novosibirsk, they developed a mitral valve for the heart and are preparing to launch its production
On December 1, 2023, it became known about plans to launch the production of mitral heart valves in Russia. The authors of the development were scientists from the E.N. Meshalkin National Medical Research Center in Novosibirsk. Read more here.
A valve for a children's heart has been developed in Russia, which grows with a child
In November 2023, it became known about the development in Russia of a unique bionic heart valve. The idea belongs to Shamil Gaysin, a student at Samara State Medical University. The valve he created was called TrueValve. It is assumed that this product will be able to reduce the dependence of Russian cardiovascular surgery on imports. Read more here.
In Russia, created a neural network for the manufacture of artificial heart valves
Specialists of the Research Institute of Complex Problems of Cardiovascular Diseases have developed a neural network for the manufacture of artificial heart valves. The press service of the Russian Science Foundation (RNF) spoke about this development in October 2023.
According to the developers, scientists have generated 11 thousand models of various valves to train artificial intelligence. Moreover, this is done in such a way that the valve can last the patient as long as possible.
| | The application of new methods in the design of medical devices will help improve the quality of devices, speed up the development process and reduce the cost of their production. As a result, such an innovation can provide greater access for patients to high-quality medical care and stimulate innovation in other areas of medical science, "said Evgeny Ovcharenko, project manager, candidate of technical sciences, head of the laboratory of new biomaterials at the KPSSZ Research Institute. | |
As explained in the RPF, the need to develop such a technology is due to the fact that the heart valves wear out as a result of loads. Their average service life is ten to 15 years. For them to function correctly, they need to be updated - for this the patient will need to undergo another heart operation.
To extend the life of prostheses, scientists are trying to optimize their shape and design. However, this process takes weeks if it is done manually. Thanks to artificial intelligence, the selection of the necessary characteristics will be faster.
At the next stage of work, scientists intend to make a real prototype of a heart valve based on parameters selected using a neural network. The product will undergo laboratory tests and be compared with models already used in cardiac surgery.[3]
After a heart valve prosthetics operation, the first woman in Russia was able to give birth to a child
On July 31, 2023, it became known about the first case in Russia when, after an operation to prostrate a heart valve, a woman was able to give birth to a child. This was told in the Ministry of Health of the Russian Federation.
In 2021, at the Clinic of Cardiovascular Surgery of the First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of Russia, the patient underwent Ozaki's operation to prosthetic the aortic valve with a treated pericardium, after some time she was able to give birth to a healthy child.
The 30-year-old entered the Cardiovascular Surgery Clinic with a heart valve defect requiring replacement. According to statistics, without treatment, the life expectancy of such patients is from two to five years, the five-year survival rate is less than 45%, the press service of the Ministry of Health notes.
Earlier, in another medical institution, she was recommended to install a mechanical prosthesis, which, after installation, requires lifelong intake of anticoagulants. The patient planned to have a baby, which is almost impossible with the mechanical valve installed. Therefore, it was decided to install a valve from the treated autopericard.
| | The patient came for a routine examination a year after the birth of the child, - said the director of the Clinic of Cardiovascular Surgery of the First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor Roman Komarov. - Ultrasound of the heart shows the heart of a healthy person, the patient is not taking any drugs at the moment. | |
Sechenovka says that they have begun to integrate this technique into the clinical practice of regional medical institutions in Russia and Belarus. So, under the guidance of Professor Komarov, master classes were held in Kemerovo, Astrakhan, Smolensk, Minsk, Belgorod and Syktyvkar.[4]
Synthetic heart valve that grows with human body developed
On June 7, 2023, American scientists from Harvard University announced the development of a heart valve that, after implantation, can grow with the patient. Read more here.
For the first time in the world, a prosthetic valve was installed in a beating heart
In mid-March 2023, it became known that Italian surgeons from the Molinette hospital in Turin for the first time in the world performed a successful operation to implant a transcatheter prosthetic mitral valve in a beating heart.
Transcatheter implantation is already used for the aortic valve: this is the optimal treatment for age-related patients with aortic stenosis and a high risk of death with traditional surgery. However, in the case of the mitral valve of the heart, there are a number of difficulties associated with the complex anatomy of the organ. In addition, such a procedure requires the most coordinated interaction of members of the cardiac team in hyperspecialized centers.
The world's first transcatheter implantation of a mitral valve was performed on a 62-year-old patient suffering from severe mitral insufficiency. She was found unfit to perform traditional cardiac surgery due to a variety of risk factors. The installation of a prosthetic valve in the beating heart was successful, and after five days of hospitalization the patient was transferred to the Veruno rehabilitation center.
Thus, doctors did not have to use extracorporeal circulation, that is, perform open heart surgery using an artificial circulation apparatus. The patient has an Epygon prosthesis - a unique artificial valve with two flaps, perfectly simulating a natural heart valve. This prosthesis is designed by Italian specialists and made in France by Affluent Medical. The valve was implanted in the cardio-thoracic vascular department of Molinette Hospital in Citta della Salute under the guidance of Professor Mauro Rinaldi[5]
2022
A domestic transcatheter valve was implanted through the femoral artery at the National Medical Research Center of Cardiology
On June 20, 2022, it became known that the first Russian transcatheter prosthesis of the aortic valve through the femoral artery was implanted at the Chazov National Medical Research Center of Cardiology. Read more here.
3D printer printed biosimilar heart valves that do not require replacement
On June 2, 2022, it became known about the creation of 3D-printed artificial heart valves, which are designed to form new tissue with the patient's own cells.
In the human body, four heart valves provide the correct direction of blood movement. It is very important that the heart valves open and close correctly. To perform this function, the heart valve tissue is heterogeneous, i.e., the heart valves exhibit different biomechanical properties within the same tissue.
A team of researchers working with Petra Mela, professor in the Department of Medical Materials and Implants at the Technical University of Munich (TUM), and Professor Elena De-Juan Pardo at the University of Western Australia, mimicked this heterogeneous structure for the first time through a 3D printing process called melt electrography. To do this, they developed a platform to print precise individual patterns and their combinations, allowing them to fine-tune different mechanical properties within the same pattern.
Melt electroforming is a relatively new additive manufacturing technology that uses high voltage to create precise patterns from very thin polymer fibers. The polymer is heated, melted and ejected from the printhead as a liquid jet to form fibers.
During this process, a high-voltage electrical voltage is applied, which significantly narrows the diameter of the polymer jet, accelerating it and attracting it to the collector. The result is a thin fiber with a diameter ranging from five to fifty micrometers. In addition, the electrical voltage stabilizes the polymer jet, which is important for creating certain, accurate patterns.
The team used medical-grade polycaprolactone (PCL), which is compatible with cells and biodegradable, for 3D printing. The idea is that once heart valves from PCL are implanted, the patient's own cells will begin to grow on the porous scaffold, as was the case in the first cell culture studies. The cells could then potentially form new tissue before the PCL scaffold decomposes.
The PCL scaffold is embedded in an elastin-like material that mimics the properties of natural elastin present in natural heart valves and has micropores smaller than the pores of the PCL structure. The goal is to leave enough space for the cells but still seal the valves for blood flow.
The designed valves were tested using simulated circulatory system simulating physiological pressure and blood flow. The heart valves opened and closed correctly under study conditions.
{{quote 'Our goal is to create bioinspired heart valves that will support the formation of new functional tissues in patients. Children will particularly benefit from such a decision, as the current heart valves do not grow with the patient and therefore have to be replaced for many years through numerous surgeries. Our heart valves, by contrast, mimic the complexity of natural heart valves and are designed to allow the patient's own cells to penetrate the scaffold, says Petra Mela. }} The next step towards clinical practice will be preclinical studies in animal samples. The team is also working to further improve the technology and develop new biomaterials.[6]
2021: In the Kirov region launch the production of heart valves for ₽150 million
On December 8, 2021, it became known about the launch by the Special Design Bureau of Medical Topics (SKB MT) of a project for the production of high-tech products for cardiovascular surgery in Kirovo-Chepetsk, Kirov Region. We are talking about the manufacture of prostheses of the aortic valve heart, conducting twisted blood flows without destruction, as well as silicone medical drainage with a radiopaque stripe. Read more here.
2020: Boston Scientific recalls defective heart valves and halts Lotus program
In mid-November 2020, Boston Scientific began recalling defective Lotus Edge aortic valves for transcatheter implantation and stopped the Lotus program. The company said it was recalling unused products solely because of problems with the delivery system, although the artificial valve implantation itself allows for clinically meaningful favorable results. Patients who have already had a Lotus Edge valve implanted are not being feared, the company said. Read more here.
Notes
- ↑ Breakthrough is a game changer in heart valve technology
- ↑ Russian heart surgeons have developed the world's first aortic valve from donor tissues
- ↑ "Improve the quality of devices": scientists have developed a neural network for the manufacture of artificial heart valves
- ↑ Ozaki's surgery allowed the patient to become a mother
- ↑ Implanted for the first time in the world a prosthesis in a beating heart, the goal of the Molinette hospital
- ↑ 3D printed, bioinspired heart valves
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