Heart valve prosthesis delivery system transfemoral

Main article: Heart surgery

History

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.

According to the press service of the Ministry of Health of the Russian Federation, this system allows implanting an aortic valve in patients of high surgical risk through the femoral artery, without artificial circulation and median sternotomy. After the received permission from Roszdravnadzor and the implantation of the domestic aortic valve "MedLab-CT" by the transfemoral method performed at the National Medical Research Center of Cardiology, it is planned to introduce this device into wide clinical practice.

A domestic transcatheter valve was implanted through the femoral artery at the National Medical Research Center of Cardiology

The Ministry of Health emphasized that the fundamental difference between the new transcatheter valve delivery system is the possibility of implanting a domestic transcatheter prosthesis of the MedLab-CT aortic valve through the femoral artery (transfemoral access). This technical solution creates the possibility of installing a prosthetic heart valve without cardiac arrest, which significantly facilitates the implantation procedure and reduces the risks of complications for the patient, and also significantly reduces the period of rehabilitation of patients with high surgical risk, patients with concomitant severe pathology, the department added.

"MedLab-CT" has two modifications:

• aortic petal biological heart valve prosthesis (ALB);
• cardiac valve prosthesis aortic petal mechanical (ALM).

It is noted that this development became possible thanks to the joint work of the team of employees of the National Medical Research Center of Cardiology named after E.I. Chazov, headed by Academician RANRenat Akchurin, specialists of the Federal Center for Cardiovascular Surgery of the Ministry of Health of Russia (Penza), headed by Professor [[|Vladlen Bazylev]], as well as specialists of the scientific and production enterprise "MedInzh."^[1]

Product Registration

At the end of March 2022, Roszdravnadzor registered the first domestic delivery system for an aortic valve prosthesis. This product was developed by NPP "MedInzh."

The delivery system of the prosthetic heart valve transfemoral according to the MLTsK.942511.020 TS is designed to replace the affected human heart valve with a new medical device through a special catheter. Tests of the product, which proved its quality, were carried out at the Penza Center for Cardiovascular Surgery.

Heart valve prosthesis delivery system transfemoral

Dmitry Pavlyukov, deputy head of Roszdravnadzor, whose words are quoted in the agency's message, noted that previously such products were produced only by foreign enterprises. Now Russian medicine is fully equipped with products for endoprosthetics of the aortic valve of domestic production, Pavlyukov added.

According to the deputy chief physician of the hospital for X-ray vascular diagnosis and treatment of N.I. Pirogov Mikhail Maslennikov, by April 2022, half of all aortic valve operations in the United States and Western Europe are performed using the transcatheter aortic valve replacement technique, therefore, the news about the registration of a domestic valve is optimistic, especially given the positive reviews of Penza colleagues who already had the opportunity to test the system. The technology of manufacturing a valve and delivery systems is in no way inferior to a foreign one, Maslennikov said.

Director of the Clinic of Aortic and Cardiovascular Surgery, Head. Department of Cardiovascular Surgery and Invasive Cardiology of the First Moscow State Medical University named after I.M. Sechenov Professor Roman Komarov cited data according to which 10-15 thousand heart valve prosthetics are performed annually in Russian clinics, but only 3-5% of them by minimally invasive methods due to the high cost of imported^[2]

Notes