There are more people in need of new hearts than there are hearts available — that's a big reason companies like Abbott Laboratories and Medtronic sell advanced implantable pumps called left-ventricular assist devices (LVADs) to circulate a person's blood when their heart can't do the job alone. Now the devices are capable of doing the job for the long term.
On Friday, Illinois-based Abbott Labs announced that the Food and Drug Administration has approved a new use for its HeartMate 3 LVAD that allows the device to be prescribed for long-term "destination" therapy in patients with advanced heart failure who aren't likely to get the new heart they need. The approval made good on predictions by Abbott Labs CEO Miles White, who told investors this week that such an approval was imminent.
The HeartMate 3 "does represent an innovative leap in the support of patients that require long-term therapy with mechanical circulatory support," said Dr. Philip Adamson, medical director of Abbott's Heart Failure business. "The survival [rate] of 83 percent at two years, which rivals transplant if you can believe that, it changes the whole game, it changes the way we look at patients who are suffering for end-stage heart failure."
The HeartMate 3 has a novel design that incorporates a fully magnetically levitated propeller to move blood, eliminating friction and heat thought to contribute to clotting problems in older versions of the device. A New England Journal of Medicine report earlier this year examined two-year outcomes in 366 patients and found superior survival and adverse event rates in the HeartMate 3 vs. the HeartMate II, at 83 percent vs. 76 percent.
Medtronic's competing device, the HeartWare HVAD system, has had FDA approvals for both destination and bridge-to-transplant therapy for more than a year. Thursday's approval now closes that product gap, though Medtronic still touts its smaller HeartWare system as the only one approved for the less-invasive thoracotomy implant method. A Medtronic spokeswoman said a recent study documented an 87 percent survival rate for thoracotomy patients after two years. A different LVAD study documented a 76 percent survival rate at one year for the device.
HeartWare also tends to be cheaper than the HeartMate 3. Hospitals pay a range of prices around $80,000 for a HeartWare device, while the HeartMate 3 runs closer to $95,000, according to research by med-tech market analyst Fernando Amador of Decision Resources Group.
The HeartMate 3's predecessor, the HeartMate II, was priced similarly to the HeartWare. But design enhancements in the HeartMate 3 have led to lower rates of post-surgical complications. "What we think is going to happen is, this device is going to completely replace the HeartMate II device. We see that in the data," Amador said. "From what we've heard, physicians are saying there is no reason to use HeartMate II ... which is probably why they are able to charge that premium."
Heart failure is a progressive condition in which the heart becomes less able to pump blood because of a variety of underlying factors. About 6 million Americans have it, of whom 10 percent have what's considered advanced heart failure, according to the American Heart Association.
"When heart failure (HF) progresses to an advanced stage, difficult decisions must be made," the AHA says on its website. "Do I want to receive aggressive treatment? Is quality of life more important than living as long as possible? How do I feel about resuscitation?"
LVADs can take over the pumping function of a failing heart, but they also present some of the most expensive implantable-device surgeries. An article in the peer-reviewed journal JACC: Heart Failure reported last year that the average total cost to implant an LVAD in Medicare beneficiaries was $175,000, more than double the cost of a heart transplant.
Amador said between 5,000 and 5,500 Americans will have LVAD implants this year. That compares with 2,200 adult heart transplants that happen annually in the U.S., according to the JACC article.
"Although LVADs do not appear to provide high value by current benchmarks, there are currently few other effective treatments for the 250,000 patients with advanced HF," the study authors wrote last year, based on their analysis of 2009-2010 Medicare data.
"Providing access to therapies that prolong survival in this population may be an important consideration for coverage and reimbursement policies."