K
Karlynn
Anyone know of this? Since I don't pay a lot of attention to tissue valve advancements, this could very well have been discussed here and I didn't read it. It sounds promising, but the big gap that wasn't discussed in regards to longevity performance was in the large age group between "child" and 80 year-olds.
New heart valve option
Still undergoing U.S. trials, device approved in Europe
By Terri Yablonsky Stat
Special to the Tribune
Published April 25, 2006
For people facing the breakdown of an aortic valve, the choice hasn't been pleasant: Replace it with an animal-tissue valve that itself may need replacing or with a manmade version that condemns the patient to a life of blood thinners and dietary restrictions. But a new heart valve still in clinical studies shows promise of being more biocompatible and mechanically durable than any tissue valve.
The SuperStentless Plus valve, manufactured by Shelhigh Inc., Millburn, N.J., is in Food and Drug Administration clinical trials at Central DuPage Hospital in Winfield. Made of cow pericardium and pig leaflets, the valve has been approved for use in Europe, where it has been used for nine years, and has been in U.S. trials for five years.
Patients who need a valve replacement have had to choose between a tissue valve or a mechanical version. Because mechanical valves make the blood clot, patients with these valves must take Coumadin, a blood thinner, the rest of their lives. That's why many patients prefer tissue, or biologic, valves from cows or pigs.
Tissue valves eventually wear out, however, and require replacement. "The younger you are, the faster it wears out," said Dr. Marc Gerdisch, director of cardiac surgery at Central DuPage Hospital. Typical tissue valves historically have failed because the body recognizes the valve as foreign matter, and the valve slowly deteriorates.
Though all other tissue valves deteriorate and calcify within a few years, no child or adult over age 80 has demonstrated tissue failure or calcification with the Shelhigh valve, according to Gerdisch. Babies usually have an accelerated calcification process, but those with the Shelhigh valve show no calcification, he said, adding, "The evidence is very strong that in an older person, the likelihood of valve deterioration is very low."
When Shelhigh valves have been removed, such as in a child who has outgrown one, the valves have been covered with a normal layer of endothelium, the material that lines the inside of blood vessels. That means the valve is being incorporated by the body, Gerdisch said. "No other valve grows normal endothelium, or normal cellular lining," he said.
Too, other valves commonly start failing within five years, Gerdisch explained. "I don't think there's ever been a tissue valve with the mechanical durability to withstand the continuous opening and closing of a valve," he said. Based on the science thus far, he expects the Shelhigh valve will outlast previous tissue valves.
The valve is implanted in a minimally invasive procedure using a very small incision. The breast bone is not divided, so the patient can return to normal activities sooner than with conventional valve replacement.
Gerdisch has implanted the valve in 35 patients so far with excellent results, he said. Because the valve is part of an FDA trial, he is limited to using it in people age 55 and over, but "I anticipate that age will lower."
The Shelhigh valve can be available for children up to 10 years of age in the U.S. through an FDA humanitarian device exemption, so the valve in small sizes can be implanted in the pediatric population.
Gerdisch recently implanted the valve in James Stade, 65, of Wheaton, who suffered congestive heart failure. "My aortic valve was calcified and wasn't opening properly," Stade said. "Three days after surgery, I came home from the hospital. I feel fine."
Stade's energy level has seen a boost since the surgery.
"I can now stay up late working on my patent drawings," said Stade, who owns a patent-illustration business in Chicago. "I'm not getting mentally fatigued like before."
If all continues to go well in trials, Gerdisch predicts FDA approval of the valve in about a year.
New heart valve option
Still undergoing U.S. trials, device approved in Europe
By Terri Yablonsky Stat
Special to the Tribune
Published April 25, 2006
For people facing the breakdown of an aortic valve, the choice hasn't been pleasant: Replace it with an animal-tissue valve that itself may need replacing or with a manmade version that condemns the patient to a life of blood thinners and dietary restrictions. But a new heart valve still in clinical studies shows promise of being more biocompatible and mechanically durable than any tissue valve.
The SuperStentless Plus valve, manufactured by Shelhigh Inc., Millburn, N.J., is in Food and Drug Administration clinical trials at Central DuPage Hospital in Winfield. Made of cow pericardium and pig leaflets, the valve has been approved for use in Europe, where it has been used for nine years, and has been in U.S. trials for five years.
Patients who need a valve replacement have had to choose between a tissue valve or a mechanical version. Because mechanical valves make the blood clot, patients with these valves must take Coumadin, a blood thinner, the rest of their lives. That's why many patients prefer tissue, or biologic, valves from cows or pigs.
Tissue valves eventually wear out, however, and require replacement. "The younger you are, the faster it wears out," said Dr. Marc Gerdisch, director of cardiac surgery at Central DuPage Hospital. Typical tissue valves historically have failed because the body recognizes the valve as foreign matter, and the valve slowly deteriorates.
Though all other tissue valves deteriorate and calcify within a few years, no child or adult over age 80 has demonstrated tissue failure or calcification with the Shelhigh valve, according to Gerdisch. Babies usually have an accelerated calcification process, but those with the Shelhigh valve show no calcification, he said, adding, "The evidence is very strong that in an older person, the likelihood of valve deterioration is very low."
When Shelhigh valves have been removed, such as in a child who has outgrown one, the valves have been covered with a normal layer of endothelium, the material that lines the inside of blood vessels. That means the valve is being incorporated by the body, Gerdisch said. "No other valve grows normal endothelium, or normal cellular lining," he said.
Too, other valves commonly start failing within five years, Gerdisch explained. "I don't think there's ever been a tissue valve with the mechanical durability to withstand the continuous opening and closing of a valve," he said. Based on the science thus far, he expects the Shelhigh valve will outlast previous tissue valves.
The valve is implanted in a minimally invasive procedure using a very small incision. The breast bone is not divided, so the patient can return to normal activities sooner than with conventional valve replacement.
Gerdisch has implanted the valve in 35 patients so far with excellent results, he said. Because the valve is part of an FDA trial, he is limited to using it in people age 55 and over, but "I anticipate that age will lower."
The Shelhigh valve can be available for children up to 10 years of age in the U.S. through an FDA humanitarian device exemption, so the valve in small sizes can be implanted in the pediatric population.
Gerdisch recently implanted the valve in James Stade, 65, of Wheaton, who suffered congestive heart failure. "My aortic valve was calcified and wasn't opening properly," Stade said. "Three days after surgery, I came home from the hospital. I feel fine."
Stade's energy level has seen a boost since the surgery.
"I can now stay up late working on my patent drawings," said Stade, who owns a patent-illustration business in Chicago. "I'm not getting mentally fatigued like before."
If all continues to go well in trials, Gerdisch predicts FDA approval of the valve in about a year.
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