{"id":8652,"date":"2012-06-16T08:17:21","date_gmt":"2012-06-16T13:17:21","guid":{"rendered":"http:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/?p=8652"},"modified":"2019-03-01T22:40:51","modified_gmt":"2019-03-02T03:40:51","slug":"sapien-valve-high-risk-stenosis","status":"publish","type":"post","link":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2012\/06\/16\/sapien-valve-high-risk-stenosis\/","title":{"rendered":"Tech Update: SAPIEN Valve Replacement Recommended For “High Risk” Aortic Stenosis Patients"},"content":{"rendered":"

The possibility of aortic valve replacement<\/a> without an incision to the sternum or ribs of the patient has become a reality for select patient categories. Together, our community has followed the evolution of catheter-based technologies including the SAPIEN heart valve replacement by Edwards Lifesciences which received FDA approval<\/a> for “inoperable” patients last year. Needless to say, patient interest specific to this and other transcatheter devices, including the CoreValve and the MitraClip, is significant.<\/p>\n

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\"SAPIEN
\nSAPIEN Heart Valve Replacement (Edwards Lifesciences)<\/p>\n

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For that reason, I wanted to make sure you were aware of a recent announcement in which an FDA panel recommended the SAPIEN heart valve replacement for wider use among “high-risk” aortic stenosis patients<\/a>. So you know, a “high risk” patient is healthy enough to have surgery but faces serious health risks because of age (often greater than 80 years old) or illnesses (like diabetes).<\/p>\n

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The 12 person committee, which met for 8 hours, voted 10-2 that the SAPIEN was safe, 12-0 that it is effective, and 11-0 that the benefits outweigh its risks. According to reports, the FDA panel is not required to follow this panel’s recommendation. However, it often does. A formal decision by the FDA is expected later in the year for this “high risk” indication.<\/p>\n

According to the Los Angeles Times<\/em>, an interesting data point recently provided from the study was that 24 percent of patients implanted with the SAPIEN heart valve were still alive after one year — compared to 27 percent who had undergone traditional, open heart surgery.<\/p>\n

While encouraging, the panel addressed complications specific to the SAPIEN:<\/p>\n