Artificial Heart Developed
Before the end of this year, Ottawa heart surgeon Dr. Wilbert Keon hopes to open the chest of a patient whose heart has reached a state of "terminal failure" and install a shiny plastic-encased object a little larger than a man's fist. If all goes well, the implanted device will not only save the recipient's life but allow that person to resume most normal activities. Like similar devices currently under development in the United States, the Canadian-developed HeartSaver is designed to be fully implantable and permanent - a one-pound, high-tech package that will perform some of the vital blood-pumping functions for a natural heart that is too badly damaged to keep on beating by itself.
The product of two decades of research and more than $30 million invested by the Ottawa-based World Heart Corp., the technology could prolong the lives of millions. Currently, only two possibilities face most patients in the final stages of heart failure - a heart transplant, or death. But transplants depend on an uncertain supply of organs. And in Canada - whose citizens are notoriously reluctant to donate organs - doctors performed only 166 heart transplants in 1997. More than 45,000 Canadians die of heart failure each year; the annual global death toll is about five million. "The worldwide demand for this product," predicts Tofy Mussivand, the medical engineer who spearheaded development of the device, "will be huge." Michael Lorimer, an analyst at Toronto-based Scotia Capital Markets, estimates that global sales of a successful device like HeartSaver could total as much as $5 billion annually.
The HeartSaver is basically a pump that can take over the job of forcing oxygen-rich blood from a damaged organ's left ventricle - the quadrant of the heart with the heaviest workload and the one that most frequently wears out - to the rest of the body. Four U.S.-made machines already on the market can provide short-term help to damaged hearts, either by keeping them pumping while their owners wait for transplants, or by giving short-term support while an organ recovers from a disease or heart attack. Several of those firms are developing fully implantable versions similar to HeartSaver, and one is currently undergoing clinical trials.
HeartSaver - officially the HeartSaver VAD (for ventricular assist device) - has several advantages over its competitors. One is that, unlike its rivals, HeartSaver does not have power and communications lines penetrating the user's skin, posing a constant infection risk. HeartSaver's power, from a battery worn on a belt or shoulder strap, flows magnetically from a disk on the patient's chest to a matching disk inside the chest. The disks also transmit data communications through the skin. A HeartSaver user who wants to shower, bathe or swim can remove the external battery - an internal battery with a one-hour power supply takes over. "People will be able to go back to work, play tennis and have a nearly normal life expectancy," says Ottawa entrepreneur Rod Bryden, the corporation's chairman and CEO.
The HeartSaver system includes a matchbox-sized transmitter that can relay a steady stream of data on the patient's condition. In November, World Heart officials at a medical conference in Düsseldorf, Germany, showed how they could monitor and adjust a HeartSaver worn by a dummy named Dave 4,800 km away in Ottawa.
If the device works in humans, it will fulfil a dream the 63-year-old Keon has pursued since his student days in the early 1960s at Montreal's McGill University. As director of the University of Ottawa Heart Institute, Keon set up a team in 1989 to develop a permanent, fully implantable VAD, and named Mussivand as its leader. To put the project on a commercial footing, Keon enlisted Bryden, who set up the World Heart Corp. in April, 1996, and began raising badly needed financing. (World Heart shares trade on the Toronto Stock Exchange and the U.S.-based Nasdaq network.) HeartSaver is expected to sell for about $60,000, compared with the $65,000 cost of a heart transplant.
So far, HeartSaver has been successfully tested for short periods only in calves. Currently, Mussivand's team is carrying out a new series of animal trials that will run until October, and if Health Canada gives the go-ahead, the first test on a human could take place in December. If that is a success, company officials expect the device could proceed rapidly to a full-scale clinical trial, with several hundred HeartSavers installed in Canadian and European recipients by the end of 2000. Keon, meanwhile, is looking ahead to another stage in his vision, in which the HeartSaver technology would become the basis for an artificial heart to completely replace failed human hearts. But that, cautions Keon, will depend on how well HeartSaver performs during the first crucial tests of its ability to prolong the lives of people for whom time has almost run out.
Maclean's January 25, 1999