some of the PARTNER trial results (Sapien valve TAVI)

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Lynlw

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Results from one of the legs of the PARTNER trial so far were released. Here are a couple links

http://www.theheart.org/article/1124645.do is a short article about it
Transcatheter valves slash deaths, hospitalizations vs standard care: PARTNER

http://www.nejm.org/doi/full/10.1056/NEJMoa1008232#t=articleMethods

Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
Martin B. Leon, M.D., Craig R. Smith, M.D., Michael Mack, M.D., D. Craig Miller, M.D., Jeffrey W. Moses, M.D., Lars G. Svensson, M.D., Ph.D., E. Murat Tuzcu, M.D., John G. Webb, M.D., Gregory P. Fontana, M.D., Raj R. Makkar, M.D., David L. Brown, M.D., Peter C. Block, M.D., Robert A. Guyton, M.D., Augusto D. Pichard, M.D., Joseph E. Bavaria, M.D., Howard C. Herrmann, M.D., Pamela C. Douglas, M.D., John L. Petersen, M.D., Jodi J. Akin, M.S., William N. Anderson, Ph.D., Duolao Wang, Ph.D., and Stuart Pocock, Ph.D. for the PARTNER Trial Investigators

September 22, 2010 (10.1056/NEJMoa1008232)

Aortic stenosis is an insidious disease with a long latency period1 followed by rapid progression after the appearance of symptoms,2-5 resulting in a high rate of death (approximately 50% in the first 2 years after symptoms appear) among untreated patients.1,6-8 Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with aortic stenosis,9-11 and in the absence of serious coexisting conditions, the procedure is associated with low operative mortality.12,13 However, in clinical practice, at least 30% of patients with severe symptomatic aortic stenosis do not undergo surgery for replacement of the aortic valve, owing to advanced age, left ventricular dysfunction, or the presence of multiple coexisting conditions.14-17 For these patients, who are at high surgical risk,18,19 a less invasive treatment may be a worthwhile alternative.

Transcatheter aortic-valve implantation (TAVI) is a new procedure, in which a bioprosthetic valve is inserted through a catheter and implanted within the diseased native aortic valve. Since 2002, when the procedure was first performed,20,21 there has been rapid growth in its use throughout the world for the treatment of severe aortic stenosis in patients who are at high surgical risk.22-32 The most recent clinical studies showed that the rate of death from any cause at 1 year among patients treated with TAVI was approximately 25%.27-29,31 Thus far, all the studies of TAVI have been observational registry studies, without standardization of end-point definitions33,34 (and unpublished data) and without control populations. There is a paucity of rigorous, evidence-based clinical data to substantiate the incremental benefits of TAVI as compared with current standard therapies.

The Placement of Aortic Transcatheter Valves (PARTNER) trial was a multicenter, randomized clinical trial comparing TAVI with standard therapy in high-risk patients with severe aortic stenosis, including a prespecified cohort of patients who were not considered to be suitable candidates for surgery. In this article, we report the outcomes with TAVI as compared with standard therapy among the patients in the PARTNER trial who were not suitable candidates for surgery.

This is just a short part of the article more at http://www.nejm.org/doi/full/10.1056/NEJMoa1008232#t=articleMethods
 
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