The rate of stroke - one of the complications most concerning to physicians and patients because it increases mortality and affects quality of life - is among the lowest reported. At one month, the major stroke rate was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. In addition, in more than 800 extreme risk patients enrolled in the CoreValve Continued Access Study, CoreValve patients experienced an even lower rate of major stroke (1.8 percent at one month).
"The fact that nearly three-quarters of patients were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population. Not only do the results meet the CoreValve study's safety and efficacy endpoints for patients at extreme risk for surgery, but the positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve," said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the Trial who presented the results at TCT.
The study also found significant and sustained functional and quality-of-life improvements, with the heart failure symptoms of most patients (90.0 percent) improving at least one class at one year (as measured by NYHA Class), and quality-of-life scores improving 27.4 points at one year (as measured by the KCCQ 100-point scale, in which a 20-point change is considered highly significant)
Overall hemodynamic (blood flow) performance was strong with mean gradients (resistance)
Major vascular complication rates were low: 8.3 percent at one month and 8.5 percent at one year. Consistent with previous studies on self-expanding technology, the permanent pacemaker rate was 22.2 percent at one month and, importantly, pacemaker implants were not associated with mortality for these patients.
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The National Association of Medical Sales Representative™(
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