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Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Original Article 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 S. 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 N Engl J Med 2010; 363:1597-1607 DOI: 10.1056/NEJMoa1008232. Results A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P. Aortic stenosis is an insidious disease with a long latency period followed by rapid progression after the appearance of symptoms, resulting in a high rate of death (approximately 50% in the first 2 years after symptoms appear) among untreated patients.
Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with aortic stenosis, and in the absence of serious coexisting conditions, the procedure is associated with low operative mortality. Dualshock 3 Pc Drivers Download. 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. For these patients, who are at high surgical risk, 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, 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.
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%. Dell Optiplex 745 Audio Driver Windows Xp Free Download. Thus far, all the studies of TAVI have been observational registry studies, without standardization of end-point definitions (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. Patient Selection We enrolled in the PARTNER trial patients with severe aortic stenosis and cardiac symptoms for whom conventional surgery to replace the aortic valve was associated with high risk. Severe aortic stenosis was defined as an aortic-valve area of less than 0.8 cm 2, a mean aortic-valve gradient of 40 mm Hg or more, or a peak aortic-jet velocity of 4.0 m per second or more. All the patients had New York Heart Association (NYHA) class II, III, or IV symptoms. Study Device and Procedure The Edwards SAPIEN heart-valve system (Edwards Lifesciences) consists of a trileaflet bovine pericardial valve and a balloon-expandable, stainless-steel support frame.