The heart relies on four valves that act as one-way gates, controlling blood flow out of each of the heart's four chambers. The mitral valve between the two left chambers of the heart has two leaflets, or cusps; the tricuspid, pulmonary and aortic valves each have three. The leaflets swing open and shut like saloon doors with every beat, maintaining a steady blood supply. (A person's heart generally beats 80 million times a year and five to six billion times over the course of a normal lifetime, according to Irvine, Calif.–based valve producer Edwards Lifesciences.)
Slide Show: Artificial heart valve improvements over the past 50 years
As comedian and actor Robin Williams, 57, and 83-year-old former first lady Barbara Bush found out recently, in many cases, the valves don't last a lifetime; some become leaky. Called a regurgitating valve, this allows pumped blood to wash back into the heart. Others pick up calcium from the blood, eventually becoming hardened, restricting blood flow (a condition known as stenosis). When the body does not receive enough blood, a person can experience symptoms such as shortness of breath. Aortic and mitral valves most commonly require treatment. Once symptoms such as lightheadedness and blackouts arise, a person with an untreated faulty aortic valve has a 50 percent chance of dying within six months, says Eugene Grossi, a professor of cardiothoracic surgery at New York University School of Medicine and director of cardiac surgery research.
That means that for thousands of Americans, an artificial heart valve fashioned from tissue-thin flaps is all that stands between health and heart failure. About 140,000 Americans go under the knife for valve replacement or repair every year, according to Toronto-based Millennium Research Group, a firm that tracks the medical device, pharmaceutical and biotechnology industries.
Doctors have developed several stand-ins for the natural tissue that can regulate blood flow without missing a beat. "Heart valves are the one device that when you get it in and it's successful, you add 10 or 15 years to their life," says Donald Bobo, vice president for heart valve therapy at Edwards Lifesciences. Edwards—along with Saint Jude Medical in Saint Paul, Minn., and Minneapolis-based Medtronic, Inc.—is a top provider of artificial valves worldwide, Bobo says. Sorin Group in Milan, Italy, also has a share in the global heart valve therapy market, estimated to be worth $1.6 billion in 2008, according to Edwards market estimates.
Valve technology took off in 1958 when engineer and Edwards founder Miles "Lowell" Edwards applied his experience designing hydraulic debarking methods for the lumber industry and a fuel-injection system for World War II aircraft to the medical arena. Working with cardiothoracic surgeon Albert Starr, the two developed a valve that Starr could use in his ailing patients. Surgeons implanted the Starr-Edwards artificial valve, designed in Edward's backyard workshop, for the first time in 1960. Although that first patient died shortly after receiving the device, the second survived for 10 more years before dying from a fall off a ladder.
People tried dozens of different designs in the ensuing decades, says Ajit Yoganathan, a biomedical engineer who studies valves at the Georgia Institute of Technology in Atlanta. "Most of them were developed in someone's garage or someone's basement." The technology has evolved from a caged-ball design into valves with artificial flaps, pig valves processed for human use, and hand-sewn biologic valves made from cow tissue.
"All of these valves have analogues in hydraulics, pipelines, aviation, automobiles," Bobo says. But the human body presents special challenges. "Blood ends up being a pretty different environment compared to oil or gas," he adds. The lipids in blood can destroy synthetic materials; tissue valves are subject to the same wear and tear and calcification that natural valves are.
"There is still room for improvement," such as better materials, Yoganathan says. He would also like to see small valves available to children with congenital heart defects. The next development likely to hit the U.S. market is valves that can be implanted without open heart surgery.