By Jake Rossen
By Jesse Marx
By Michelle LeBow
By Alleen Brown
By Maggie LaMaack
By CP Staff
By Jesse Marx
If there were a problem with a life-saving medical device implanted in your heart, someone would tell you, right? Tom Hatch thought so. He was wrong.
The Heart of the Matter
by Beth Hawkins
Photos by Raoul Benavides
The normal adult human heart weighs about 11 ounces and resembles a fist in size. As every schoolchild learns at some point, blood enters the right side of the heart carrying carbon dioxide, travels to the lungs to be re-oxygenated, and exits out the left side. A body at rest propels some six quarts of blood per minute through the circulatory system in this fashion. Under exertion, the volume may reach 36 quarts. The electrical impulses that spur each heartbeat cause one muscle after another to contract, raising the pressure within successive compartments of the blood-filled heart. As the pressure in each chamber rises, the blood pushes open a valve that lets it rush into the next chamber. The leaves of tissue then shut, preventing the blood from flowing backward. These flaps are thin and delicate, but deceptively tough: They must open and close 60 to 90 times a minute, more than 100,000 times a day.
Tom Hatch's heart had logged nearly two billion beats before anyone suspected there might be something wrong. He was 54, a married father of six and a carpenter who took good care of himself. His blood carried enough oxygen to his muscles and organs to allow him to Rollerblade and to ski cross-country competitively. For most of his adult life he hadn't had health insurance; he'd never needed it.
But Hatch had come down with rheumatic fever as a child, and when he reached his 50s, his wife started pestering him to have his heart checked. A complication arising from untreated strep infections that was more common before penicillin, the illness causes calcium deposits on the heart valves of half of all sufferers.
Eventually Hatch gave in. The doctor he saw thought his heart sounded good, but sent him for an echocardiogram anyhow. He went home expecting to hear that his wife was a worrywart. But when the doctor called, it was to say that Hatch's heart wasn't beating correctly. She wanted him to report to the ICU for drugs and tests. Hatch tried to dismiss her, speculating that he was probably just upset. He'd relax with a couple of glasses of wine and everything would be fine. But somehow he knew better. Inside, he panicked.
The cardiologist insisted that the situation was critical. His mitral valve, the one that ushered blood into the left ventricle, was caked with calcium. The narrowed passageway prevented enough blood from getting through. Doctors tried several treatments, but over the next year Hatch's condition worsened rapidly.
On October 20, 1998, a surgeon at the University of Minnesota replaced Hatch's mitral valve. In his office before the surgery, he showed Hatch a model of the prosthetic replacement. A circle of pyrolytic carbon spanned by two flaps of the same tough material, it was surrounded on the outside by a polyester cuff called a sewing ring. The surgeon would sew through this ring to stitch the artificial valve to the heart muscle. The operation had been performed successfully for decades.
There was one small but ultimately devastating variation between the valve the surgeon showed him and the updated version he actually implanted in Hatch's heart. On the new one, the sewing cuff was covered with silver, a design change that the manufacturer hoped would help ward off infection. Hatch doesn't recall hearing this detail, but says it wouldn't have registered if he did. "It looked all right to me," recalls Hatch. "This is what they were recommending, and he was the expert."
Most people in Hatch's situation feel the same way, thankful they live in a time when their doctors have a vast array of options for repairing and replacing parts of the body. Some 25 million Americans have some form of prosthetic implant, and the devices are growing in sophistication. Some pacemakers can now phone doctors to report a heart's beats and receive adjustments, if needed. Much of the technology is nothing short of miraculous.
But, as Hatch was to learn, the U.S. system for identifying bad medical devices and protecting patients hasn't kept pace with the science. On the heels of a number of high-profile failures in the last couple of years, the industry and the Food and Drug Administration are in the throes of a crisis. Most notoriously, Guidant has come under investigation for reportedly first failing to report a potentially deadly flaw in 11 of its implantable defibrillators, and then continuing to sell existing stocks of the faulty model even after it had changed its manufacturing process to eliminate the defect. (While these troubles were unfolding, Guidant was also the object of a pending $25 billion takeover.)
The FDA, meanwhile, is increasingly under fire for making questionable concessions to the industry. Last year, for example, the agency approved an application for an implantable electrical nerve stimulator to treat depression despite staff reviewers' objections that there was no evidence the device worked. Understaffed and overwhelmed, the agency has been criticized repeatedly by congressional investigators and consumer advocates for allowing the industry to police itself.