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According to the Company, results showed that patients implanted with 3f Enable displayed no structural valve deterioration at five years, and demonstrated 93% freedom from valve mortality at five years post-implant.
Starting at 10 years, however, structural valve deterioration and reoperations became significantly more frequent in patients with biological valves.
The morphologic features associated with structural valve deterioration (SVD) included collagen degeneration, calcification, prolapse, increased cusp stiffness/cusp immobilization, fluid insudation, fibrosis and cusp tears (Figures 2 through 4).
The data in the CryoValve Human Heart Valve Clinical Experience 2004 report, collected and analyzed on a yearly basis, includes patient survival and freedom from endocarditis, thromboembolism, and structural valve deterioration.
According to the study, over the 20-year follow-up period, the Biocor valve was found to perform well on key measures of long-term performance including freedom from reoperation due to structural valve deterioration (the rate at which patients remain free from another operation related to degeneration that could affect the valve's proper functioning).
The data in the CryoValve Human Heart Valve Clinical Experience 2003 report, collected and analyzed on a yearly basis, includes patient survival and freedom from endocarditis, thromboembolism, and structural valve deterioration.
With tissue valves typically experiencing structural valve deterioration at 10 to 15 years, it is a very serious decision to implant a valve knowing that a reoperation is likely.
The report concluded that patients 60 years and older who received the valve had a nearly 90 percent chance of not needing a new valve, due to structural valve deterioration, for 16 years.