The pump could benefit some of the roughly 8,000 people on waiting lists for the 2,000 donor hearts that become available each year. About 30% of those on the waiting lists die before a donor heart becomes available for transplant.
"This is the first artificial replacement organ that has achieved FDA approval," said Marvin Slepian, chief executive of Tucson-based SynCardia Systems, which makes the CardioWest mechanical heart.
"It will be popular in end-stage heart disease centers, where they see sick patients who have no other options," said Jack Copeland, a professor at the University of Arizona and a SynCardia founder. He said the company hopes to train doctors to implant the heart at four to six centers in the next year.
The CardioWest is a direct descendant of the Jarvik-7, implanted into dentist Barney Clark in 1982. That experiment and others that followed made worldwide headlines, but not for their success. Volunteers suffered strokes, bleeding, infections, clots and other catastrophic side effects, prompting the FDA to temporarily shut down the artificial heart program.
Two decades and countless prototypes later, doctors reported in August that the retooled heart had sustained 79% of 81 patients until they could obtain a transplant, compared with 46% of 35 patients who did not get the heart. The device was redesigned to reduce the risk of side effects.
"It's a laudable achievement," said Bud Frazier, chief of heart transplantation at Houston's Texas Heart Institute.
About 5 million people in the USA have hearts too weak to satisfy the body's demand for blood. Doctors diagnose 550,000 cases a year; about 300,000 people die each year. Roughly 50,000 of the most severe cases could benefit from a transplant.
To implant the CardioWest, surgeons remove the bottom half of the heart and stitch the device in its place. Patients remain in the hospital, tethered by hoses to a large, noisy pump.
Slepian says SynCardia is working on more portable hearts to serve as permanent replacements someday. Other companies are working on models, as well.
Slepian says the heart will cost $80,000 to $100,000. Medicare and insurance plans now reimburse a portion of the cost of lesser heart pumps, called ventricular assist devices. Medicare does not cover artificial hearts. Now that the CardioWest has been approved, Slepian says, that may change.
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