- Adam’s Heart Valve Surgery Blog - http://www.heart-valve-surgery.com/heart-surgery-blog -

More Data On The SAPIEN Transcathether Valve Replacement From The European Union

Posted By Adam Pick On September 16, 2008 @ 7:08 am In Studies, Heart Surgery Options | No Comments

I 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 [1] new technology for aortic valve replacement.

SAPIEN Aortic Valve By Edwards Lifesciences - Transcatheter 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 [2] aortic valve replacement without the risks/dangers of an invasive procedure.

Keep on tickin!


[3] To learn more about Adam and his heart valve surgery book, click here.


Article printed from Adam’s Heart Valve Surgery Blog: http://www.heart-valve-surgery.com/heart-surgery-blog

URL to article: http://www.heart-valve-surgery.com/heart-surgery-blog/2008/09/16/sapien-transcathether-valve-replacement-edwards/

URLs in this post:
[1] new technology for aortic valve replacement: http://www.heart-valve-surgery.com/heart-surgery-blog/2008/09/02/latest-technology-in-aortic-valve-s
urgery/

[2] aortic valve replacement: http://www.heart-valve-surgery.com/aortic-valve-replacement-surgery.php
[3] To learn more about Adam and his heart valve surgery book, click here: http://www.heart-valve-surgery.com/heart-valve-surgery-book-download-guide.php

Click here to print.