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Tens of thousands of cardiac patients may not need open heart surgery



Operation is courageous: in order to replace the heart failure valve, cardiologists insert a replacement for the patient's inguinal space and lay it to the heart, maneuvering it to the place of the old valve.

A procedure called transtheter replacement aortic valve (TAVR) has been reserved mainly for patients, such as the elderly and patients, that they may not experience an open heart operation. Now, two major clinical trials have shown that TAVR is equally useful in young, healthy patients.

This may be even better by offering a lower risk of stroke and death being discontinued, as opposed to open heart surgery. Cardiologists say it is likely to change the standard of care for most patients with inadequate aortic valves

"Is it important? So, "said Dr. Robert Lederman, who runs the interventional cardiology research program at the National Institute of Heart, Lungs, and Blood.

Research should be published in the New England Journal of Medicine and presented on Sunday at the American College of Cardiology, Annual Meeting

. Annually, about 20,000 patients will be eligible for TAVR, in addition to nearly 60,000 middle and high-risk patients undergoing surgery now.

"This is a clear victory for TAVR," said Dr. Michael J. Mac, a heart surgeon at Baylor Scott and the White Heart Hospital Plano in Texas. From now on, "we will be very selective" about who gets an open heart surgery, said Dr. Mac, the chief researcher in one of the studies.

Some healthier patients will still need traditional surgery – for example, they are born with two flaps to the aortic valve instead of the usual three. The presence of two valves can lead to an early failure of the aortic valve. TAVR has not been tested in these patients, and the condition is more common in younger patients with low surgical risk. Violation of the aortic valve arises due to the stiffness of the valve, which controls the flow of a large blood vessel in the heart, which supplies blood to the rest of the body. Patients are often tired and suffocated.

There is no way to prevent a condition, but a cure, except for replacing the valve. The main risk factor is progressive age

Although more than 1 000 patients took part in both studies, the tests differed somewhat from the design, making direct comparisons difficult. A study led by Dr. McAcqua and Dr. Martin Leon, an interventional cardiologist at the Columbia University in New York, tracked mortality by turning off stroke and hospitalization for one year after procedures. Levels were 15% surgical compared to 8.5% of TAVR. The levels of mortality and stroke-disabling – the most important factors for patients – were 2.9% in surgical operations versus 1% of TAVR

. operations against 5.3% of TAVR.

Tests sponsored by TAVR, Edwards Lifesciences from Irvine, Calif., And Medtronic, headquartered in Dublin. The two companies do some other valves. The Edwards valve is compressed to a balloon catheter that pushes through the blood vessel from the groin to the aorta. After reaching the aorta, the cardiologist inflates the balloon and expands the valve, which pushes the defective valve out. The Medtronic valve is made of nicotinol, a metal that is compressed when it is cold and expanding when heated. The valve is cooled and applied to the catheter. When he reaches the aorta, the cardiologist pushes the vagina, releasing the new valve. Insulated by the body, it expands to fill the narrowed hole and stays there.

With traditional surgery, on the contrary, the doctor carves out an old valve and sews a new one, removing the old valve instead of leaving it in the heart

Doctor. Jeffrey J. Popma, interventional cardiologist at Beth Israel Deaconess in Boston, led the second study and is a consultant to both manufacturers. He uses both devices in surgery, and said that the important conclusion is that both were better for surgery.

The research involved leading surgeons and cardiologists in academic medical centers, many of whom were enlisted as consultants. Independent data and safety monitoring committees monitored the test, and independent statistics confirmed the results

Aortic valve replacement was carried out over decades, and surgeons know that the valves placed during the operation last at least 10-15 years. It remains to see if the TAVR valves will also run. This question is especially important for young patients. The average age of subjects in current studies was low until the mid 70's, younger than a decade or more than in most patients receiving TAVR now.

Dr. Herman said. The TAVR valves cost much more than the valves placed surgically, but insurers usually pay the same for any procedure. Dr. Herman said.

More than half a dozen companies are manufacturing surgical valves, but only two market-based TAVR valves. Perhaps with more competition, Dr Herrmann said, prices for TAVR valves will decrease.

At the moment, to the patient, which procedure they choose, Dr. Popma said – TAVR or surgery. Robert Pettinato 79-year-old pensioner in Scranton, Pennsylvania, there was no question. He felt a slight chest pain and it was difficult for him to finish golf.

But last year, when his cardiologist told Mr. Pettinato that he needed a new valve, he could get TAVR the only way. enter a clinical trial. He joined Edwards at the University of Pennsylvania.

In November, he had TAVR, stayed in the hospital for 24 hours and left home. A few days later, he went to a football match at the University of Lehigh against his archivist Lafayette. (He is a Lehigh graduate and never misses this game.)

Shortly thereafter, his younger brother Jim, who lives in Florida, was supposed to have a replacement for the aortic valve. He wanted TAVR, but clinical trials were closed. He made an operation in his place.

Brother took four months to recover to play golf, said Pettinato . Pettinato returned to the golf course. "I'm the most daring guy in the world," he said.


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