P
Phyllis
New Procedure done in Michigan on Thursday:
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March 15, 2005
A Promising Recovery After a New Aortic Valve Procedure
By BARNABY J. FEDER
team of cardiologists in Michigan has implanted an artificial heart valve in a 76-year-old man by feeding the device through a vein in his left leg instead of opening his chest and stopping his heart.
The patient, Fernando Giangrande, had the three-hour procedure on Thursday, left the hospital on Sunday and was back at work yesterday customizing vintage cars at his Ford dealership. Replacement of the valve through open-heart surgery normally requires a week in the hospital and a longer total recovery time, assuming the patient was deemed strong enough to have the surgery in the first place.
The experimental implant was the first of at least 150 that federal regulators will require before considering approval of the technique for widespread use. But medical experts say the procedure could eventually extend the lives of many people who are too frail or ill to endure open-heart surgery. Failing valves are diagnosed in tens of thousands of Americans each year, and that number is expected to grow as baby boomers pass the age of 70.
"It's a miracle," Mr. Giangrande said on Sunday evening after returning home from William Beaumont Hospital in Royal Oak, a northern suburb of Detroit. He recalled that two years ago, surgeons in Port Huron, Mich., told him there was nothing they could safely do to counter the progression of his heart disease.
The procedure replaces the aortic valve, which keeps blood from flowing backward into the heart. The doctors at Beaumont, who will describe the procedure today at a news conference, encountered several snags.
Medical experts warn that even if the technique is mastered, the heart repairs may not last as long as those achieved through conventional surgery.
Mr. Giangrande's doctor, Dr. William W. O'Neill, the chief of cardiology at Beaumont, said that in its current form, the technique is a last resort. "People who are good candidates for open-heart surgery should not even look into this," he said in a brief interview immediately after the procedure.
Long-term durability has been hard to gauge so far because the only candidates for the technique in this country and abroad have been so gravely ill that some have died during the procedure. Many others survived only a few days or months, even though the new valve was functioning.
In the only previous attempt of the procedure in this country, performed in September 2003 by Dr. O'Neill, the patient died within five days. And in Europe, where cardiologists have been experimenting with the approach for three years, only 3 of the more than 40 patients have survived for more than a year.
The complexity of the procedure is also a reminder of why many innovations that improve individual health tend to drive up overall health care spending. Open-heart replacement of the aortic valve typically costs more than $50,000. Although the new technique may shorten hospital stays, it may ultimately prove more costly.
Edwards Lifesciences, the company that makes the valve and the tools to install it, says the products may cost $10,000 to $12,000 per procedure. That is roughly double what Edwards and its competitors charge for surgically implanted aortic valves and the related equipment.
And so the device, if successfully developed for the commercial market, is likely to become another topic in the simmering debate about how much society can afford to invest in extending life.
The new procedure also reflects the progress being made by minimally invasive practices in technology-driven fields like cardiac surgery. The trend toward intravenous delivery of artery-opening balloons and stents that prevent blockages from recurring has contributed to a 20 percent decline in heart bypass surgeries in the United States in recent years.
Mr. Giangrande's new aortic valve consists of tissue from the outer wall of a horse's heart sewn to the interior of a large stent, which is a cylindrical mesh of stainless steel. To deliver the device, the doctors attached it to the tip of a plastic catheter and compressed it to the width of a pencil. They inserted the catheter into the large femoral vein in Mr. Giangrande's left thigh and threaded it through the vessel toward his heart.
When the device reached the entrance to his aorta, the doctors inflated a balloon at the end of the catheter to expand the valve and embed the stent in the calcified rim of his old valve.
After receiving his grim prognosis from the doctors in Port Huron two years ago, and getting a similar second opinion, Mr. Giangrande said he had become too weak to walk. He told his wife, Kathy, "If this is old age, let's get it over with."
A 5-foot-10-inch bear of a man who has used the name Fred Grande since starting kindergarten, Mr. Giangrande received a pacemaker in 1999 and has weighed as much as 350 pounds. In late 2003, he sought the advice of Dr. O'Neill, a pioneer in numerous catheter-based therapies. Dr. O'Neill got Mr. Giangrande back on his feet by conducting extensive angioplasty, a procedure that inflates balloons inside constricted vessels to widen them, and inserting coronary stents to keep the vessels propped open.
Stents, though, could not treat Mr. Giangrande's diseased aortic valve, which was barely functioning because of hardened fat deposits, a condition called stenosis.
The heart has four valves controlling the flow of blood through the heart, and the most common malfunction involves the mitral valve, the third in the pathway. The new technique has focused on stenosis of the aortic valve, the on-ramp to the body's circulatory system, because it accounts for roughly 80 percent of the more than 15,000 deaths each year attributed primarily to valve disease, according to the American Heart Association. But doctors and medical equipment analysts say that variations on the technique could someday be used instead of surgery to replace or repair any of the heart's valves.
Edwards Lifesciences, based in Irvine, Calif., hopes to complete enough tests here and overseas to gain approval to sell the devices in Europe as early as next year and in the United States by the end of 2007. The company, spun out of Baxter International four years ago, is currently the leading manufacturer of surgically installed heart valves.
In addition to the catheter-based delivery of aortic valves, Edwards is working on a similar approach to repairing damaged mitral valves.
Researchers in Europe led by Dr. Philipp Bonhoeffer, chief of cardiology at the Great Ormond Street Hospital for Children in London, have used catheters to replace pulmonary valves, which prevent blood being pumped to the lungs from flowing backward.
Because pulmonary valve defects are often congenital, many of Dr. Bonhoeffer's 75 test patients have been children. The pulmonary valve is much smaller and easier to insert, he said, and no deaths have been linked to its installation. Working with the valve's maker, Medtronic, a Minneapolis company, Dr. Bonhoeffer hopes to begin F.D.A.-approved trials in this country within a year.
Dr. O'Neill said the type of device inserted in Mr. Giangrande still needed substantial refinement to have any chance of becoming widely used. He said Edwards Lifesciences was working on an approach that would allow the valve to be inserted directly through the aorta, which would avoid threading the catheter through the heart.
In Mr. Giangrande's case, the procedure required three cardiologists and a large support team.
The first effort to deploy the valve failed when it became jammed in a passageway the team made through a wall in Mr. Giangrande's heart. When Dr. O'Neill tried to pull it back, the balloon inside the valve inflated. Unable to go forward, the team spent 30 minutes scrambling to move the valve back down the large vein that runs up the spine. They pinned it into the wall of the vessel just above his kidneys, where it is expected to have no impact on blood flow. A second artificial valve was attached to the catheter and, ultimately, successfully installed.
"We didn't catch a break anywhere," Dr. O'Neill said.
Copyright 2005 The New York Times Company | Home | Privacy Policy | Search | Corrections | RSS | Help | Back to Top
--------------------------------------------------------------------------------
March 15, 2005
A Promising Recovery After a New Aortic Valve Procedure
By BARNABY J. FEDER
team of cardiologists in Michigan has implanted an artificial heart valve in a 76-year-old man by feeding the device through a vein in his left leg instead of opening his chest and stopping his heart.
The patient, Fernando Giangrande, had the three-hour procedure on Thursday, left the hospital on Sunday and was back at work yesterday customizing vintage cars at his Ford dealership. Replacement of the valve through open-heart surgery normally requires a week in the hospital and a longer total recovery time, assuming the patient was deemed strong enough to have the surgery in the first place.
The experimental implant was the first of at least 150 that federal regulators will require before considering approval of the technique for widespread use. But medical experts say the procedure could eventually extend the lives of many people who are too frail or ill to endure open-heart surgery. Failing valves are diagnosed in tens of thousands of Americans each year, and that number is expected to grow as baby boomers pass the age of 70.
"It's a miracle," Mr. Giangrande said on Sunday evening after returning home from William Beaumont Hospital in Royal Oak, a northern suburb of Detroit. He recalled that two years ago, surgeons in Port Huron, Mich., told him there was nothing they could safely do to counter the progression of his heart disease.
The procedure replaces the aortic valve, which keeps blood from flowing backward into the heart. The doctors at Beaumont, who will describe the procedure today at a news conference, encountered several snags.
Medical experts warn that even if the technique is mastered, the heart repairs may not last as long as those achieved through conventional surgery.
Mr. Giangrande's doctor, Dr. William W. O'Neill, the chief of cardiology at Beaumont, said that in its current form, the technique is a last resort. "People who are good candidates for open-heart surgery should not even look into this," he said in a brief interview immediately after the procedure.
Long-term durability has been hard to gauge so far because the only candidates for the technique in this country and abroad have been so gravely ill that some have died during the procedure. Many others survived only a few days or months, even though the new valve was functioning.
In the only previous attempt of the procedure in this country, performed in September 2003 by Dr. O'Neill, the patient died within five days. And in Europe, where cardiologists have been experimenting with the approach for three years, only 3 of the more than 40 patients have survived for more than a year.
The complexity of the procedure is also a reminder of why many innovations that improve individual health tend to drive up overall health care spending. Open-heart replacement of the aortic valve typically costs more than $50,000. Although the new technique may shorten hospital stays, it may ultimately prove more costly.
Edwards Lifesciences, the company that makes the valve and the tools to install it, says the products may cost $10,000 to $12,000 per procedure. That is roughly double what Edwards and its competitors charge for surgically implanted aortic valves and the related equipment.
And so the device, if successfully developed for the commercial market, is likely to become another topic in the simmering debate about how much society can afford to invest in extending life.
The new procedure also reflects the progress being made by minimally invasive practices in technology-driven fields like cardiac surgery. The trend toward intravenous delivery of artery-opening balloons and stents that prevent blockages from recurring has contributed to a 20 percent decline in heart bypass surgeries in the United States in recent years.
Mr. Giangrande's new aortic valve consists of tissue from the outer wall of a horse's heart sewn to the interior of a large stent, which is a cylindrical mesh of stainless steel. To deliver the device, the doctors attached it to the tip of a plastic catheter and compressed it to the width of a pencil. They inserted the catheter into the large femoral vein in Mr. Giangrande's left thigh and threaded it through the vessel toward his heart.
When the device reached the entrance to his aorta, the doctors inflated a balloon at the end of the catheter to expand the valve and embed the stent in the calcified rim of his old valve.
After receiving his grim prognosis from the doctors in Port Huron two years ago, and getting a similar second opinion, Mr. Giangrande said he had become too weak to walk. He told his wife, Kathy, "If this is old age, let's get it over with."
A 5-foot-10-inch bear of a man who has used the name Fred Grande since starting kindergarten, Mr. Giangrande received a pacemaker in 1999 and has weighed as much as 350 pounds. In late 2003, he sought the advice of Dr. O'Neill, a pioneer in numerous catheter-based therapies. Dr. O'Neill got Mr. Giangrande back on his feet by conducting extensive angioplasty, a procedure that inflates balloons inside constricted vessels to widen them, and inserting coronary stents to keep the vessels propped open.
Stents, though, could not treat Mr. Giangrande's diseased aortic valve, which was barely functioning because of hardened fat deposits, a condition called stenosis.
The heart has four valves controlling the flow of blood through the heart, and the most common malfunction involves the mitral valve, the third in the pathway. The new technique has focused on stenosis of the aortic valve, the on-ramp to the body's circulatory system, because it accounts for roughly 80 percent of the more than 15,000 deaths each year attributed primarily to valve disease, according to the American Heart Association. But doctors and medical equipment analysts say that variations on the technique could someday be used instead of surgery to replace or repair any of the heart's valves.
Edwards Lifesciences, based in Irvine, Calif., hopes to complete enough tests here and overseas to gain approval to sell the devices in Europe as early as next year and in the United States by the end of 2007. The company, spun out of Baxter International four years ago, is currently the leading manufacturer of surgically installed heart valves.
In addition to the catheter-based delivery of aortic valves, Edwards is working on a similar approach to repairing damaged mitral valves.
Researchers in Europe led by Dr. Philipp Bonhoeffer, chief of cardiology at the Great Ormond Street Hospital for Children in London, have used catheters to replace pulmonary valves, which prevent blood being pumped to the lungs from flowing backward.
Because pulmonary valve defects are often congenital, many of Dr. Bonhoeffer's 75 test patients have been children. The pulmonary valve is much smaller and easier to insert, he said, and no deaths have been linked to its installation. Working with the valve's maker, Medtronic, a Minneapolis company, Dr. Bonhoeffer hopes to begin F.D.A.-approved trials in this country within a year.
Dr. O'Neill said the type of device inserted in Mr. Giangrande still needed substantial refinement to have any chance of becoming widely used. He said Edwards Lifesciences was working on an approach that would allow the valve to be inserted directly through the aorta, which would avoid threading the catheter through the heart.
In Mr. Giangrande's case, the procedure required three cardiologists and a large support team.
The first effort to deploy the valve failed when it became jammed in a passageway the team made through a wall in Mr. Giangrande's heart. When Dr. O'Neill tried to pull it back, the balloon inside the valve inflated. Unable to go forward, the team spent 30 minutes scrambling to move the valve back down the large vein that runs up the spine. They pinned it into the wall of the vessel just above his kidneys, where it is expected to have no impact on blood flow. A second artificial valve was attached to the catheter and, ultimately, successfully installed.
"We didn't catch a break anywhere," Dr. O'Neill said.
Copyright 2005 The New York Times Company | Home | Privacy Policy | Search | Corrections | RSS | Help | Back to Top
