Abbott System of the transkateterny implantation of the aortal valve (TIAV)

The system of transkateterny implantation of the aortal valve (TIAK – engl. Transcatheter Aortic Valve Implantation, TAVI) is intended for low-invasive replacement of the aortal valve of heart because of the limited blood-groove caused by an aortal stenosis.

2021: Obtaining the registration certificate in Russia

On February 8, 2021 the Abbott company announced obtaining the registration certificate of Federal Service for Surveillance in Healthcare of the Russian Federation on the system of transkateterny implantation of the aortal valve (TIAK – engl. Transcatheter Aortic Valve Implantation, TAVI) for low-invasive replacement of the aortal valve of heart because of the limited blood-groove caused by an aortal stenosis.

The Aortal Stenosis (AS) – one of the most frequent pathologies of the valve device holding upper places in the list of the reasons of an invalidization and death rate of the population in the Russian Federation, the USA and Europe. Conservative methods of therapy of an aortal stenosis do not exist, the only effective method – prosthetics of the aortal valve. In numerous researches it is shown that classical transaction of prosthetics using artificial blood circulation at patients of the senior age group with the different accompanying pathology is integrated to the high level of hospital lethality which, according to different authors, reaches 11-15%. According to the research Euro Heart Survey, in the European population of 33% of the patients suffering from critical AS are not considered by general practitioners as candidates for surgical treatment.

The valve of Abbott company is intended for implantation in own aortal valve of the patient and does not require open transaction. Under local anesthesia or the general anesthesia through a small puncture of a femoral artery in inguinal area the new valve in a compressed status is started and reveals in heart, destroying badly functioning natural aortal valve. The procedure takes 30-120 minutes and, on average, the patient can leave home next day.

According to data of Abbott company, the innovation valve is already used more than in 55 countries, and the number of the implanted devices exceeded  30,000. The published world researches show significant results on decline in mortality indicators from all reasons and frequency of development of a stroke.

"We began to execute transactions of transkateterny prosthetics of the aortal valve in 2010. For February, 2021 our experience contains more than 2000 such transactions, and it became possible thanks to implementation of a new type of VMP in 2014", - Timur Emvyarovich Imayev, MD, the chief researcher of laboratory of hybrid techniques of treatment of department of cardiovascular surgery of Federal State Budgetary Institution NMITs Kardiologii of MZ Russian Federation noted. - We welcome entry into the market of new devices because there has to be a choice both at the doctor, and at the patient".

"When developing the innovation valve our purpose was to provide to doctors new solutions which would improve a possibility of delivery, the location accuracy and performance when replacing the patient or the injured aortal heart valve using minimum invasive therapy, - Michael Dale, the senior vice president of division of structural pathologies of heart of Abbott company told. - Results of a research of real clinical practice confirm results of our previous clinical trials which showed that it is the valve saving lives, improving quality of life and helping patients to resume their daily activity".

According to the data provided by Timur Emvyarovich Imayev, MD, the chief researcher of laboratory of hybrid techniques of treatment of department of cardiovascular surgery of "NMITs of Cardiology", the volume of operation of transkateterny implantation of the aortal valve in Russia does not reach due level and is only 6% of requirement.

"If to rely on calculations of the European society of cardiologists, we need to execute 24.9 thousand transactions a year. We fall short also 2,000 transactions a year", – Timur Imayev specified.