Leading heart valve manufacturers Edwards Lifesciences and Medtronic are racing each other to perfect new heart valves that could revolutionize heart valve replacement surgery. The new heart valves would result in a less-invasive surgery because they can be inserted via catheters without the requirement for an open heart procedure. And because the procedure is less invasive, more people would be candidates to receive valve replacements. Currently there is a significant population of critically ill or elderly patients who are considered too frail to undergo open heart surgery and therefore are not able to receive new heart valves.
The new heart valves have been available in Europe for 18 months and have thus far yielded positive results. Medical trials of the valves are being conducted in the U.S. amongst older, critically ill patients who are not candidates for open heart surgery. Medical experts predict that if the devices live up to their makers’ claims they could revolutionize heart valve replacement, a common heart operation, and extend the lives of thousands of frail patients who are not now considered candidates for the open heart surgery.
An estimated 20,000 people die annually from heart valve-related diseases, including those too sick to withstand the open-heart surgery. The new valves would be meant to enable more such patients to have life-saving valve replacements. Furthermore, a less risky surgery lessens the possibility of transplant errors from occurring.
In one test sample a 97 year-old man was too old and frail for open-heart surgery. Given his bleak outlook the doctors elected to try the Edwards trial. According to family members, the patient felt completely recovered just one day after the implant of the artificial valve.
The race to develop this process between Edwards and Medtronic involves one of the heart’s four valves, the aortic valve, which controls blood flow into the aorta from the heart. Aortic valves were involved in the vast majority of the estimated 95,000 open-heart surgeries in the country last year to replace a diseased valve with a new one.
The new units, known as percutaneous heart valves are implanted through catheters, in much the same way that arteries-opening stents are inserted. A catheter holding a compressed replacement valve is inserted through a small incision in the groin or, if blood vessels are blocked, through an opening near the ribs. The catheter is then snaked through a vessel into the heart and the new valve is released, compressing the diseased tissue and moving into its place.
The new technology would be expensive. The current cost of a heart valve replacement surgery is about $50,000 which includes surgical fees, hospital costs and the price of a replacement valve. The new valves currently sell for about $30,000. However, the higher prices for the valves would be offset by lower costs from anticipated shorter hospital stays.
A debate ensues whether or not this new method should replace the traditional open-heart surgery. It is pointed out that the success rate of conventional open-heart surgery is extremely high and that the replacement valves that are now in use are highly durable, lasting 10-15 years.
Also, hospitals are currently pursuing less-invasive options to the traditional open heart surgery. For example, physicians at the University of Chicago Medical Center have been utilizing the less invasive open heart surgery by gaining access to the heart through the side of the chest. These minimally invasive valve surgeries performed include aortic valve repair or replacement, mitral valve replacement and tricuspid valve repair or replacement.
If the device remains successful after testing approximately 1,000 patients, it would subsequently be approved by the Food and Drug Administration (FDA) and could be on the market in the United States in two years.
Kreisman Law Offices has been handling Cook County medical malpractice and Illinois transplant error cases for over 30 years, serving areas in and around Chicago, including Maywood, Park Ridge, Naperville, and Cicero.