| Developers: | Abbott Laboratories |
| Branches: | Pharmaceuticals, medicine, healthcare |
Content |
HeartMate is a device that supports the operation of the left ventricle of the heart in patients with severe heart failure. The device is implanted directly to the heart and adopts the function of pumping blood. HeartMate and such decisions are called artificial hearts. Initially, this device was used to maintain blood circulation before a heart transplant, and then it began to be implanted on an ongoing basis in patients who contraindicated heart transplantation due to age or other factors.
2021: Carrying out the first implantation of the HeartMate III system in Russia to a child
In April 2021, the first Russia implantation of the system (auxiliary blood circulation artificial left ventricle) hearts to a child was carried out. It was performed by a team of doctors of the Sverdlovsk Regional Clinical Hospital No. 1 under the guidance of Konstantin Kazantsev, head of the department of pediatric cardiac surgery. Russian doctors were advised by specialists of the Institute of Clinical and Experimental Medicine (,): Prague Czech Republic Director of the Cardiology Center, Professor Jan Pirk and Doctor of the Department of Anesthesiology and Resuscitation Thomas Kotulyak.
In September 2020, a nine-year-old patient entered the hospital. At the end of summer, he suffered an infection, this caused a complication on the heart - infectious endomyocarditis. The boy entered with acute heart failure. The first operation was performed on the same day - doctors replaced the mitral valve destroyed by infection with a mechanical prosthesis.
The child was transferred to artificial circulation for several days to restore the left ventricle of the heart. After this operation, the patient's rehabilitation began and there was even a positive dynamics, but after a month the ability to pump blood from the heart decreased again.
As a result, the HeartMate III system was successfully implanted. This technology is based on a motor with a rotor levitating in the magnetic field, which pumps blood from the left ventricle to the aorta, without contacting other parts of the device. This practically eliminates all complications associated with damage to blood components, noted in the Ministry of Health of the Russian Federation. The only thing the child will need to get used to is a small bag with a pair of removable batteries connected to the device using a cable brought out. For the uninterrupted operation of the system, they need to be recharged once a day, the department added.[1]
2019: Withdrawal of defective devices
In early December 2019, Abbott sent a warning to customers regarding the left-ventricular apparatus of auxiliary circulation HeartMate 3. Due to the failure of the mobile power supply, these systems can suddenly shut down during operation. Defective equipment is withdrawn.
It turned out that the mobile power supply, connected to the left-ventricular apparatus of the auxiliary circulation HeartMate 3, can be irreversibly damaged due to the impact of static electricity. Severe power loss and damage to the power supply can threaten the patient's life: Abbott has already received two reports of serious undesirable events as a result of a system failure. No fatalities related to defective systems have yet been reported.
Abbott personnel plan to conduct tests at all facilities to reduce excess static electricity. In cases where the patient is not asleep, battery power is recommended instead of a mobile power supply. If the machine issues an alarm, patients are also advised to switch to the battery of the HeartMate 3 system.
In addition, Abbott provided customers with recommendations that prevent excessive static electricity from accumulating on the device housing. Experts advise switching the system to battery power before folding or changing sheets, removing laundry from the dryer, moving your legs to the carpet, touching the screens of a TV or computer. The company strongly recommends the use of moisturizers, laundry dryers, fabric softeners and skin moisturizers to reduce the accumulation of static electricity.
The security notification applies only to the mobile power supply HeartMate 3. Devices HeartMate 2 are not subject to these warnings.[2]
2017: Deaths of patients
In May 2017, Abbott Laboratories announced a massive recall of controllers for artificial hearts HeartMate II, the use of which led to the death of patients.
In total, the manufacturer received 70 reports of "incidents related to controller malfunction after replacement." In 19 cases, patients suffered various injuries. In addition, 26 deaths were recorded when people tried to replace the controller on their own, the Food and Drug Administration (FDA) said.
 | "Such changes need to be made quickly and done in hospitals, as otherwise there may be a serious problem for older or inexperienced patients. For them, a slow or incorrect replacement can lead to serious injury or death, "the department said, referring to Abbott's message. |  |
The company recalls 28,882 controllers for HeartMate II. They need to install new software and an alert system. This equipment has numbers 105109, 106015, 106762 and 107801, it was sold between July 2012 and December 2016. The production of defective controllers ceased in March 2017.
In 2014, the FDA reported four deaths and five injured people due to controller issues for HeartMate II.[3]
Notes
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