FDA and TAVI


Here’s the latest news on TAVI in the United States – and the status of the procedure, which is currently undergoing further evaluation by the FDA.

Here are some highlights from the article:

“In July, the FDA’s  Circulatory System Device Panel favored TAVI approval in the U.S. The  panel voted on three items, including: safety, effectiveness and whether  the benefits outweigh the risks. If the FDA accepts panel  recommendations, TAVI procedures would be available to U.S. patients.

However, CMS noted that it is aware of the high stroke and death rates associated with TAVI, and said that it remains concerned about adverse events that may occur, particularly when the procedure is performed by less experienced operators. Rates of stroke and death at 30 days were 6.7 percent and 5 percent, respectively, for those who received TAVI. At one year, these rates were 10.6 percent and 30.7 percent, CMS reported.”

As readers know; here at Cartagena Surgery – we’ve advised caution for the time being – until we have more long-term outcome data on transcatheter aortic valves.

However, after much consideration, and discussion with other people both in and outside the field of cardiac surgery – I have decided that I will begin interviewing and bringing more information about the procedure and providers performing this procedure in the USA.  Ultimately, while I may personally, (and professionally) feel that the TAVI procedure has not undergoing sufficient rigorous testing for my patients – I do not want to withhold information from them.

So, I have started writing and contacting providers to obtain more information about the physicians and medical centers performing this procedure. I will discuss these providers further in future posts.

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