Transcathether aortic valve replacement (TAVR), an increasingly common procedure that favors insertion of a new valve via a catheter, has the potential to revolutionize cardiac care, Michelle Fay Cortez reports for Bloomberg Businessweek.
Approximately 70,000 U.S. residents undergo aortic valve procedures to alleviate symptoms like chest pain and shortness of breath so severe it can interfere with everyday activities, according to the Society of Thoracic Surgeons. Historically, the condition was treated with open-heart surgery, which involves cracking open the chest cavity, removing the damaged valve, and replacing the tissue with a prosthesis.
While the older and more invasive approach requires eight weeks of recovery, patients can recover in as little as one week with TAVR, which requires just a tiny incision between the ribs or through the femoral artery in the groin. Doctors say the difference in recovery times could make aortic valves created by Edwards Lifesciences and Medtronic part of standard cardiac care.
In a study of Edwards' Sapien valve, 24.3% of patients who underwent the minimally invasive procedure died, compared with 26.8% of patients who had open heart surgery. The Sapien patients also spent on average eight days in the hospital, compared with 12 days for open-heart surgery patients. Though the Sapien valves cost $30,000, compared to $6,000 for older valves, patients save by spending less time in the OR and the hospital, the company argues.
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Glenn Novarro, an analyst with RBC Capital Markets, predicts the market for the valves could climb to $2.5 billion as other manufacturers produce similar products. To date, the U.S. market for the valves has fallen below analysts' expectations, in part because few hospitals are trained in the procedure.
Minneapolis-based Medtronic is hoping to expand the use of its CoreValve device, which currently is approved only for patients who cannot undergo open-heart surgery. A second company with Medtronic's "ability to go out and educate the general cardiologists, should expand the marketplace," Novarro says, adding, "If the patients are there, we just aren't doing a good enough job getting to them. It's about educating the cardiologists, who are the gatekeepers, and educating the consumer to let them know there is an alternative to open surgery."
High hopes for new devices
Regulators, investors, and physicians at the American College of Cardiology (ACC) meeting over the weekend paid special attention to possible side effects of the minimally invasive valve replacement. If the side effects prove comparable to open-heart surgery, the convenience of the new procedure will likely present an attractive option for patients with damaged aortic valves, says Prediman Shah, a cardiologist at Cedars Sinai Heart Institute in Los Angeles.
"Cardiovascular surgeons should watch out," Shah, who chairs the ACC meeting, told Bloomberg Businessweek. "In the next few years, it's very likely it will be a relatively rare patient who will have a surgical valve replacement" (Cortez, Bloomberg Businessweek, 3/28).
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