Scott Morgan wrote off the pain on his left side as an old sports injury, never imagining it was a sign his heart was failing. When he finally went to the hospital last year, he was shocked to learn he needed a transplant.
With fewer than 2,500 donated hearts that become available each year in the U.S. for transplant, Morgan’s doctors offered him another option. He got a mechanical pump placed inside his chest to keep him alive.
“Before the surgery, I was at the point that I wanted to die,” said Morgan, 53, a retired tuxedo store owner who at some point contracted a virus that shut down his heart’s main pumping chamber. “I wanted to make videos for my family and my grandchildren so they could watch them after I passed. I was so tired, I just didn’t want to fight any more.”
Just five years ago, Morgan’s options would have been limited to drug therapy or cumbersome devices that wore out after a year to 18 months. Newer pumps that are made by Thoratec Corp. (THOR) and HeartWare International Inc. (HTWR) are buying more time until a donor organ is available. And though the machines don’t yet replace transplants, Thoratec has a device that is being used as a permanent solution for patients ineligible for one.
About 5.1 million patients are living with heart failure in the U.S., a number that is growing as more people survive heart attacks, high blood pressure and diabetes with irreparable damage. The statistics work relentlessly against them. About 20 percent of heart failure patients die within 12 months and half don’t make it beyond five years.
“It’s an area that’s still relatively young in its development, but it’s making big strides,” Pasquale said in a telephone interview. “It’s still a small market today, but it’s approaching critical mass where some of the big companies may begin to be interested.”
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The Thoratec and HeartWare devices are attached to the left ventricle, the heart’s main pumping chamber. A tube runs around the heart and connects to the aorta, which funnels oxygen-rich blood to the rest of the body. A small electric motor ensures the blood is continuously moving between the two.
There were 5,500 machines, known as left ventricular assist devices, implanted worldwide last year, said Doug Godshall, chief executive officer of Framingham, Massachusetts-based Heartware. The U.S. market is about $475 million, while sales worldwide may hit $700 million this year, Pasquale said.
The benefits of the pump are clear, said John Stulak, a cardiovascular surgeon at the Mayo Clinic in Rochester, Minnesota, who studies and implants the devices. Every trial comparing them with the best drug therapy, often the only treatment available, shows they lengthen and improve lives, he said.
The landmark study of the devices, published in the New England Journal of Medicine in 2001, showed the older models cut the risk of death by more than half for those who can’t get a transplant. Twenty-three percent of heart-failure patients with the devices were still alive at two years with better quality of life, compared with 8 percent on optimal medical management.
Thoratec, based in Pleasanton, California, revolutionized the market in April 2008, when its HeartMate II received U.S. Food and Drug Administration approval. The device uses a spinning rotor to provide constant blood flow, making it quiet and durable. A 2009 study found 46 percent of HeartMate II patients were alive after two years without a stroke or repairs on the device, compared with 11 percent of those getting medical management.
HeartWare won FDA approval in November for a miniature pump that sits at the base of the heart with no mechanical bearings, providing easier implants and another option for small patients including women and children. The study used to win approval found 96 percent of patients were still alive after six months.
The mechanical pumps are currently used for the sickest of the sick, those whose lifespans are measured in days or months, rather than years or decades. Picking the right patient who can cope with the challenges is critical, Stulak said.
A power cord, called a drive line, supplies the electricity for the device. It emerges from the patient’s abdomen and is connected to batteries, which last for about 12 hours, or is plugged into an electrical outlet. Patients must have backup batteries on hand at all times, as they have about 15 minutes to replace them in case of a power failure. They also carry a controller, which regulates and tracks the device’s operation.
Even for patients like Morgan, who is unrelentingly positive and tells at least two strangers every day about his LVAD, there are adjustments to be made. He said he panics every time he forgets his bag with an extra controller and batteries, fearing electrical failures or a malfunction.
“You have to be organized, change your batteries two or three times a day, make sure they are charged, check the ones you are wearing to be sure you have enough energy left,” he said. “It’s not that hard to do, you just have to be conscious and careful.”
Patients can’t swim or soak in a bathtub or undergo an MRI, and questions may be raised about driving and showering, he said. Traveling can be difficult and patients must take blood thinners for the rest of their lives.
“As we are learning more about LVADs, and we’re getting more experience and people are living longer, we are starting to see it’s not completely a walk in the park,” said Randy Starling, head of heart failure and cardiac transplant medicine at the Cleveland Clinic in Ohio. “We are starting to see some of the other potential complications,” including bleeding in the stomach, infections and erratic heart rates, he said.
The cost of the devices are also significantly higher, at more than $360,000 over five years, than the $63,000 for medically managed patients, according to a study from Duke University in Durham, North Carolina.
Improvements by the industry planned for the next several years include changes that may allow the devices to be fully implantable. Investigators are already working on wireless energy transfer to remotely charge an implanted battery.
It may be possible to eventually reach 30,000 to 50,000 patients with improvements in the equipment patients must carry, smaller drive lines, faster recovery and fewer complications, Godshall said. He envisions the improvements in the next five to eight years will result in pumps with the kind of benefit seen in transplants.
“If we can get 50 percent 10-year survival, like transplants get, that’s ultimately where we need to get,” Godshall said. “At the same time, we need to improve quality of life.”
Still, the LVADs are making more patients eligible for the transplants, said the Cleveland Clinic’s Starling. Just a few years ago, only 10 percent of transplant patients were on mechanical support. Now that number is closer to 50 percent, he said.
Morgan, the retired tuxedo store owner from California, is hoping he’s one of the rare patients whose heart fully recovers after an LVAD takes over its work load and gives it a break. Fewer than 10 percent of people fall into that category, said Starling, who has had experience where the machines were removed and had to be reimplanted. His goal is to help patients keep their original hearts in working order as long as possible.
“Every patient I see with heart failure, in my mind, my mission is to get that heart better and not take it out and send that patient for a transplant,” he said. “There are very few heart transplant recipients who make it over 25 years. Once you do a transplant, it’s fait accompli. You have to live with it, and the clock is ticking.”
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