The operation is a bold one: To replace a failing heart valve, the cardiologists place a replacement through the patient's groin and trace it to the heart, maneuvering it instead of the old valve.
The procedure, called transcortical aortic valve replacement (TAVR), has been reserved primarily for patients so old and sick that they may not survive open heart surgery. Two major clinical studies now show that TAVR is equally useful in younger and healthier patients.
It may even be better and it offers lower risk of disabling strokes and deaths compared to open heart surgery. Cardiologists say it will probably change the standard of care for most patients with failing aortic valves.
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Dr. Lederman was not involved in the studies and did not consult for the two units that sponsored them.
In open heart surgery, a patient's ribs are cracked apart and the heart is stopped to insert the new aortic valve.
With TAVR, the only incision is a small hole in the groin where the catheter is inserted. Most patients are sedated, but alert throughout the procedure, and recovery only takes days, not months, as is often the case after regular surgery.
The results "shift our thinking from asking who will get TAVR to why should a few surgery," said Dr. Howard Herrmann, head of intervention cardiology at the University of Pennsylvania.
"If I were a patient, I would choose TAVR," said Dr. Gilbert Tang, heart surgeon at the Icahn School of Medicine on Mount Sinai in New York, who was not involved in the new study.
The studies will be published in the New England Journal of Medicine and presented on Sunday at the American College of Cardiology Annual Meeting.
The Food and Drug Administration is expected to approve the procedure for low-risk patients. As many as 20,000 patients a year will be eligible for TAVR, in addition to the nearly 60,000 middle and high risk patients who are receiving the surgery now.
"This is a definite victory for TAVR," said Dr. Michael J Mack, heart surgeon at Baylor Scott and White Heart Hospital-Plano, in Texas. From now on, we will be very selective about who gets open heart surgery, said Dr. Mack, a lead researcher in one of the trials.
Some healthier patients will still need the traditional surgery – for example, those born with two flaps to the aortic valve instead of the regular ones. Having two flaps can lead to early aortic valve failure.
TAVR was not tested in these patients, and the condition occurs more often in younger patients who have low surgical risk.
Aortic valve failure is due to a stiffening of the valve control flow from the large vessel in the heart that provides blood to the rest of the body. Patients are often tired and short of breath.
There is no way to prevent the condition and no other treatment than to replace the valve. The most important risk factor is increasing age.
Although both studies were registered over 1000 patients, the samples were different in design, making direct comparisons difficult.
The study led by Dr. Mack and Dr. Martin Leon, an interventional cardiologist at Columbia University in New York, tracked deaths, disable strokes and hospitalizations one year after the procedures. The prices were 15 per cent with surgery against 8.5 per cent with TAVR.
The deaths and deactivation keys – the most important factors for the patients – were 2.9 percent with surgery against 1 percent with TAVR.
The second study estimated deaths or disabling strokes in two years and found rates of 6.7 percent with surgery versus 5.3 percent with TAVR.
The sample was sponsored by manufacturers of TAVR valves, Edwards Life Sciences of Irvine, California, and Medtronic, headquartered in Dublin. The two companies make slightly different valves. The Edwards Valve is compressed on a balloon catheter which is pushed through a blood vessel from the groin to the aorta. When it reaches the aorta, a cardiologist blows the balloon and expands the valve, which pushes away the failing valve.
The Medtronic valve is made of nitinol, a metal that shrinks when it is cold and expands when it is hot. The valve is cooled and placed on a catheter. When it reaches the aorta, the cardiologist pulls back a vagina, releasing the new valve. Heated by the body, it expands to fill the narrowed opening and remains there.
With a traditional surgery, a doctor breaks the old valve and sews in a new one, removing the old valve instead of leaving it in the heart.
Dr. Jeffrey J. Popma, an intervention cardiologist at Beth Israel Deaconess in Boston, led the second trial and is a consultant to both manufacturers. He uses both devices in surgery and said the important finding is that both were preferable to surgery.
The studies involved leading surgeons and cardiologists at academic medical centers, many as consultants. Independent data and security monitoring committees monitored the samples, and independent statisticians confirmed the results.
Aortic valve settlements have been performed for decades, and surgeons know valves placed during the operation for the last 10 to 15 years. It remains to be seen whether TAVR valves will also go.
The question is particularly important for younger patients. The average age of subjects in the current studies was low to mid-70s, younger by decades or more than most patients who received TAVR now.
Hospitals offering TAVR will take a financial hit when low-risk patients begin to choose what Dr. Herrmann said. The TAVR valves cost far more than surgical valves, but insurance companies usually pay equally for both procedures.
"Open-heart surgery, especially in low-risk patients, is very profitable" Dr. Herrmann said.
More than half a dozen companies make surgical valves, but only two TAVR valves on the market. Perhaps with more competition, says Dr. Herrmann, the prices of TAVR valves come down.
Currently, it will be up to most patients which procedure they choose, Dr. Popma sa – TAVR or surgery.
For Robert Pettinato 79 year old pensioner in Scranton, Pa., There was no question. He had felt mild chest pain, and he had a hard time completing a round of golf.
But last year, when the cardiologist told Mr. Pettinato that he needed a new valve, the only way he could get TAVR into a clinical trial was. He attended the Edwards study at the University of Pennsylvania.
He had TAVR in November, lived in the hospital for 24 hours and went home. A few days later, he went to the football match at Lehigh University against his archrival, Lafayette. (He is a Lehigh alumnus and never misses the game.) Shortly afterwards, his younger brother Jim, who lives in Florida, had to replace aortic capsules. He wanted TAVR, but the clinical trials were closed. He had surgery instead.
It took his brother four months to get enough to play a round of golf, Mr. Pettinato said.
Herr. Pettinato is back to playing golf himself. "I'm the luckiest guy in the world," he said.