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Cardiac Treatment (at BGMC) Gives Hope To Inoperable Patients
Many patients with seriously narrowed aortic valves have faced a bleak future with no medical options, but a new procedure now offers the sickest of the sick a promising treatment.
Two patients are doing well after receiving a transcatheter aortic valve replacement, or TAVR, using the first artificial heart valve that can be implanted without major surgery, a team of Buffalo physicians says.
The physicians here are among the first nationally to use the Sapien valve, outside of doctors involved in the device's clinical studies.
"This is the most exciting thing in cardiology since stents were developed for heart disease. Patients who were written off for dead beforehand will now have a therapy," said Dr. Vijay Iyer, who led the surgical team.
Edwards Lifesciences received approval for the device in November from the Food and Drug Administration.
Lifesciences estimates that 250,000 Americans suffer from severe symptoms of aortic stenosis, a narrowing of the main artery carrying blood out of the heart that occurs in older age. The company estimates a majority of the patients go untreated because the standard therapy — open-heart surgery — is too risky.
The heart becomes weak as it works harder to pump enough blood through a smaller opening, leading to such problems as heart failure. Once symptoms of severe aortic valve disease start, more than half of the patients die within two years, according to the FDA.
The new, minimally invasive procedure will be limited for the time being to certain patients and, likely, to medical centers with sufficient staff and facilities for the complex procedure. Only about 70 patients a year in Western New York are expected to meet the criteria, said Iyer, medical director of cardiology at Kaleida Health and an assistant professor of cardiology at the University at Buffalo.
"In health care, your volume of patients is a key determinant of quality. This is a technology that needs to be disseminated carefully," he said.
The valve replacement requires a team of specialists, including heart and vascular surgeons, specialists in heart imaging and cardiologists who perform angioplasty and other minimally invasive procedures.
The new valve, which consists of cow tissue and polyester attached to a stainless steel mesh frame, in most cases is inserted through the groin and advanced to the heart through blood vessels using a tiny tube called a catheter.
Using real-time X-rays for guidance, physicians blow up a balloon on the end of the catheter to expand the valve so it stays in place in the damaged or diseased aorta.
The procedure will open up a course of treatment to elderly or frail patients who are not good candidates for open-heart surgery and who have age-related aortic disease caused by calcium deposits. It is not approved for patients who can handle surgery.
The FDA's approval of the Sapien valve was based on a study of 365 patients who could not tolerate open-heart surgery. Half the patients received the Sapien valve, and the other half received another treatment that did not require major surgery.
Patients who received the new valve experienced 2 1/2 times as many strokes and eight times as many vascular and bleeding complications, the FDA reported, but the implant patients were more likely to be alive one year after surgery. Nearly 70 percent of the Sapien patients survived after one year, compared with 50 percent of those who received an alternative treatment, according to the FDA.
Newer research results indicate valve replacement patients may experience improved quality of life, including fewer repeat hospitalizations, compared with patients who receive a different treatment.
"This opens up a treatment door to patients who are older and sick with other problems, patients who basically faced a death sentence," said Dr. Anne Curtis, chairwoman of the UB Department of Medicine and a cardiologist.
Physician groups are working with government agencies to track patients who receive the valve replacement and to determine coverage under Medicare, the federal health plan for the elderly. Meanwhile, the procedure is being reimbursed on a case-by-case basis.
Doctors will have to carefully screen patients for the valve replacement, taking into consideration the patient's age, heart condition, level of aortic stenosis and other medical problems, Curtis and Iyer cautioned.
"We don't know the long-term benefits of TAVR," Curtis said. "We don't know how long they last. We have to be careful about jumping on a bandwagon too quickly."
Some physicians have questioned the results of the clinical trial of the Sapien device, asking if the better survival rate came about because the patients who received the alternative treatment fared worse than predicted.
The FDA must closely monitor the safety of the procedure, Drs. Rita Redberg and Sankret Dhruva of the University of California, San Francisco, wrote in the September issue of the New England Journal of Medicine.
One other area of concern revolves around likely pressure to expand the minimally invasive valve replacement beyond the sickest patients, as has happened in Europe, where the Sapien valve has been in use since 2007 and a second-generation device is under study.
Doctors say use of the valve replacement on younger or less-risky patients in the United State is unlikely anytime soon because of the need for more research. So far, doctors say the complications are acceptable only for inoperable patients who have no other options.