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II Trial to evaluate transcatheter aortic valve implantation (TAVI) using the Edwards SAPIEN XT balloon expandable valve in aortic stenosis patients who are refused conventional surgery. "In the PARTNER I Trial, the patients were very sick," explains Dr. Pedersen. "For those patients randomized to medi- cal therapy without the device, there was 50% mortality at one year. Even in the group receiving the device, there was a 30% mortality at one year. These mortal- ity statistics are worse than most cancers. Nevertheless, with the device, there was a profound 20% absolute decrease in mortality. The PARTNER I study data also demonstrated dramatic improvement in quality of life by almost all measures, an extremely important point in very elderly patients. "It's been a long time since we've seen randomized data that made such a huge difference," notes Dr. Pedersen. "For every five patients treated, one life was saved. This is remarkable when you consider that, typically, we treat 30 to 100 people to save one life. On average, the transcatheter valve increased lifespan by 1.9 years. If you give a 90-year-old patient another two years of life with significantly enhanced quality, I think that's pretty good. But more importantly, the patient does." The Edwards SAPIEN XT valve has received panel approval. Presuming the U.S. Food and Drug Administration (FDA) follows suit and rules in favor of approval in October, this transforma- tional therapy will be on the market and available for use. It is anticipated, however, that its use will be restricted to nonsurgical candidates. The MHI Valve Center is currently evaluating patients for participation in PARTNER II. The trial requires patients have an estimated combined perioperative mortality and major morbidity of greater than 50%. The center also has extensive expe- rience in performing transcatheter balloon aortic valvuloplasty (BAV), which provides significant symptom palliation for aortic stenosis patients who are poor surgical candidates and do not qualify Drs. Lesser, Hauser, Pedersen and Kshettry review coronary CT scans to determine if a patient is best treated through a transcatheter approach. for participation in the PARTNER Trial. Although restenosis is reported in 42% to 83% of these patients at six to 12 months, they can safely be redilated to extend the durability of quality of life enhancement. "This is not a definitive procedure, but it fairly safely takes most patients from NYHA [New York Heart Association] functional class 4 to functional class 1 to 2," notes Dr. Pedersen. "It works well, and the risk is low — a 1% to 2% risk of mortality and a 1.5% risk of stroke. We do 80 to 100 of these procedures a year. Patients are generally out of the hospital in one to three days, and they feel much better. BAV also improves the probability that these patients will continue to func- tion independently." The MHI Valve Center participated in the EVEREST II Trial, evaluating the use of the MitraClip, a percutaneous valve repair technique, to address mitral insufficiency. Unlike the PARTNER studies, this research was not restricted to high-risk patients. Any patient with a qualifying mitral valve abnormality who was willing to be randomized to the mitral clip or surgical repair was able to participate. "Of all patients with severe mitral insufficiency, mitral clip therapy may be appropriate for 25%," explains Dr. Pedersen. "The dominant jet of mitral sufficiency must originate from the P2 facet, or central portion, of the posterior valve leaflet. Although surgical repair is excellent and the preferred therapy for degenerative mitral regurgitation (MR), we are starting to realize that surgical repair may not be the gold standard for patients with functional mitral regurgita- tion. Functional MR is a ventricular disease resulting from left ventricular dysfunction. Although it hasn't been proven yet, the clip may be the better option for some patients in this group, especially those at high surgical risk." Seventy-two percent of patients repaired with the mitral clip had a successful out- come at one year compared with 88% of the surgically treated group in the randomized EVEREST II Trial. "This is very positive, MDNEWS.COM MD NEWS Twin Cities | 9 PHOTOS © DAVID GINSBERG

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