Transcatheter aortic valve replacement, or TAVR, is a little over 10 years old, and although it was approved in the United States only last year, there have been more than 50,000 implants in 40 countries, according to a recent review published in the Journal of American College of Cardiology (J Am Coll Cardiol, doi:10.1016/j.jacc.2012.01.071).
The Canadian authors, Dr. John G. Webb and Dr. David A. Wood, provide a meticulous and comprehensive review of the procedure, covering the current and up-and-coming valves, patient selection and evaluation, routes of implantation, and the risks of the procedure.
Throughout the article, the authors point out that increased level of experience, use of lower profile delivery systems, and thorough screening and imaging can reduce the risk of complications.
The SAPIEN transcatheter heart valve, made by Edwards Lifesciences, is the only valve currently approved in the United States for inoperable, high-risk patients.
More recently, an advisory panel to the Food and Drug Administration recommended the approval of the valve for high-risk patients who are operable, but it’s yet to be seen whether the agency will approve the valve for that indication.
Meanwhile, some reports show that TAVR will be the main driving force behind the U.S. heart valve market, projected to reach $1.5 billion by 2016.
"It is possible that, with time, TAVR will become a preferred option for a much broader group of patients," the authors conclude. However, a major concern remains: "When are patients too ill, frail, or old to gain significant benefit in terms of duration or quality of life?"
See the Storify below of the arrival and approval of the SAPIEN valve in the United States:
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