TAVI Device Prompts FDA Notice
A finding published on October 5th in The New England Journal of Medicine entails that the TAVI and SAVI (replacement heart valve devices) both showed a significant decrease of leaflet motion in the patients that were tested, as well as the Portico TAVI devices.
Investigators for the Food and Drug Administration (FDA) have begun warning doctors and other healthcare providers about the risks of blood clots with the devices.
Replacement Heart Valves Explained
According to the U.S. Department of Health and Human Service’s affiliate, the U.S. National Library of Medicine, replacement heart valves are used surgically to repair or replace diseased heart valves.
There are four valves in the human heart: aortic, mitral, tricuspid, and pulmonic; these valves all made to control blood flow to and from the heart. Of the four valves, the mitral valve is most commonly repaired; and due to its inability to be repaired, the aortic valve is most commonly replaced.
Details of FDA Issued Warning
- The findings that prompted the FDA notice involve transcatheter aortic heart implants and surgical aortic valve implants that have been used for over two decades, as stated by a reporter for MassDevice.
- Reduced leaflet mobility was found in 22 of 55 (40%) patients in the Portico trial.
- Reduced leaflet mobility was also found in 17 of 132 patients (13%) in the registries trial.
- In the final trial, Portico IDE trial, according to the New England Journal of Medicine, the entire group of 11 patients treated with the anti-coagulation drug warfarin showed restored leaflet motion.
- The FDA says that it may have to execute follow-up CT scans or transesophageal echocardiographies.
- FDA watchdog’s also say they feel that the valves, “remain reasonably safe and effective when used according to their approved indications.”