Breakthrough In Valve Replacement Options

We talk a lot about cardiovascular disease. After all, it affects approximately 84 million Americans and causes about 2,200 deaths a day! Chances are you think we're just talking about heart attack and stroke, but there are many other forms of CVD: One is called aortic stenosis. It's the most common cardiac-valve lesion and is present in up to 9 percent of folks 65 and older.

Aortic stenosis happens when the valve between your heart and your aorta (the main artery supplying oxygenated blood to the body) narrows, preventing the valve from opening fully. This reduces blood flow from your heart and deprives your organs of needed oxygen and nutrients. Many cases (49 percent) are the result of atherosclerosis causing calcification and degeneration of the valve and valve opening.

Symptoms include chest pain or tightness with activity, feeling dizzy or faint, shortness of breath, fatigue and heart palpitations. If not treated, it could lead to heart failure, arrhythmia, blood clots and stroke.

Treatment options have been limited to open-heart surgery - cracking open your sternum so your cardiac surgeon can access your heart and replace a faulty valve with a new one. As you can imagine, such invasive surgery can lead to prolonged, expensive hospital stays and, ironically, a chance of stroke, decreased mental function and death.

That got some folks thinking about a better way to do the repair.

In 2000, two engineers, Stan Rowe and Stan Rabinowitz, and two cardiologists, Alain Cribier and Marty Leon, decided to find out if, instead of using a scalpel, they could sneak a catheter loaded with a new valve through an artery and into the heart by making only a tiny incision in the groin.

They invited Dr. Oz to join their scientific advisory board, which brought together a variety of specialists, and over the next year, the team built the device. At the time, using it was considered so risky that it was only inserted as a last resort in European patients who were already dying from other causes, such as cancer.

Over the next decade, scientists, surgeons, cardiologists and anesthesiologists worked to improve its safety and effectiveness. Dr. Mike, for instance, helped introduce an intraoperative echocardiographic monitoring technique that was essential for improving the noninvasive surgery. The results of early trials on very sick patients had excellent results. Now, in America, almost a quarter million valves have been implanted using this procedure on patients for whom the conventional surgery was high risk.

The next step was to establish that this less invasive way to replace a faulty valve was as safe and effective in people with low risk of complications from the standard surgery.

The PARTNER3 Trial of the balloon-expandable SAPIEN 3 system, published in the New England Journal of Medicine, has the answer. Beginning in March 2016, a total of 1,000 patients enrolled in the trial received either the standard valve replacement surgery or the new, non-invasive TAVR (transcatheter aortic-valve replacement). The goal was to find out if there was a difference in the rates of complications, including death from any cause, stroke or re-hospitalization at one year after the procedure.

The results revealed that 15.1 percent of the traditional surgical patients had one or more of these complications, while only 8.5 percent of the recipients of the new TAVR procedure did. They also felt better and did better afterward. Safer, faster and less expensive, with faster recovery!

True, the results reflect only one year's worth of outcomes and don't address the problem of long-term valve deterioration from wear and tear, which the researchers will continue to study. But we believe the results should change how cardiologists, surgeons and patients look at treatment for aortic stenosis. It also should prompt the federal government and insurance companies to ask if this minimally invasive valve replacement is equivalent, or even preferable to, standard surgery for many (maybe most) of the 2.5 million older Americans with aortic stenosis.

©2019 Michael Roizen, M.D. and Mehmet Oz, M.D.
Distributed by King Features Syndicate, Inc.

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