More Data On The SAPIEN Transcathether Valve Replacement From The European Union
September 16th, 2008I just learned from CNN.com that additional data regarding the Edwards’ SAPIEN valve was made public over the weekend. As you may recall, there has been very positive remarks and very conservative comments about the actual success of this new technology for aortic valve replacement.
Here are the key datasets:
- Interim follow-up results from the pre-commercial transapical PARTNER EU registry of 67 transapical patients were presented on Saturday and showed a 30-day survival of 82 percent and a six-month survival of 56 percent. PARTNER EU is a European registry conducted primarily in 2007 that represents Edwards’ early transapical experience.
- The 30-day results from the post-approval commercial SOURCE registry were presented today. SOURCE is designed to evaluate commercial use of the Edwards SAPIEN valve with a prescribed training and proctoring program. It is a registry of procedural and short-term clinical outcomes. The current data reflect 309 cases at hospitals in 12 European countries. Survival at 30 days was 88 percent.
- The largest single site transapical experience from Leipzig was also updated, and showed continued progress in early and late mortality on a cohort of 113 patients. Six-month survival was 74 percent and 12-month survival was 71 percent.
In review of the above numbers, it appears that six-month survival rates range from 56% to 74% with a 12-month survival rate of 71% at Leipzig. As to whether or not the data is encouraging, it is somewhat hard to determine considering we do not know the health conditions/status of the SAPIEN recipients. As you may know, transcatheter valve approaches are intended to help elderly, fragile patients achieve the benefits of aortic valve replacement without the risks/dangers of an invasive procedure.
Keep on tickin!
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| About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient's Guide To Heart Valve Surgery. This unique book integrates clinical research with the personal experiences of 135 former patients to help future patients and their caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here. |
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