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FINALIST: Advancements in Health Care
Christopher T. Salerno, MD, FACS
Surgical Director, Heart Transplant and Mechanical Assist Device Program, St. Vincent Heart Center
More than 5 million people in the United States have congestive heart failure. About 250,000 of those are patients with advanced cases who face an 80-percent chance of dying within a year. But a device being tested at the St. Vincent Heart Center could drastically improve those grim odds.
Dr. Christopher Salerno was the second cardiothoracic surgeon in the country to implant the Heartmate III Left Ventricular Assist System, a tennis-ball-size disc that is attached to the heart’s left ventricle to help the weakened heart circulate blood throughout the body.
Since clinical trials began last summer, Salerno has implanted six of the 15 to 20 devices installed in U.S. patients. Only about 50 have been installed worldwide in the trial that the developer of the device, Pleasanton, California-based Thoratec, hopes will lead to widespread approval.
(IBJ photo/Eric Learned)It’s no surprise Salerno, 49, is involved, considering Thoratec reached out to him almost a decade ago to get his input as the Heartmate III was being developed. Salerno, then working at the University of Washington in Seattle, has a degree in biomedical engineering. He did his medical training at Stanford University, not far from Pleasanton, and had some familiarity with Thoratec.
So far, he’s happy with the company’s work. The sample size is still small, but Salerno is pleased with the results he’s seen.
“We’ve had phenomenally good success. In terms of restoring normal physiology, I haven’t seen anything that is superior,” he said.
The exciting prospect, Salerno said, is that the Heartmate III could be approved for use in almost any patient with heart failure. Trials for similar devices have been confined to specific groups of patients. The Heartmate III can be implanted in a wide range of patients. There is no upper age limit.
The youngest patient to get the device from Salerno was a 19-year-old from North Vernon who is waiting for a heart transplant. Other surgeons have installed the device in patients in their 80s who could live with the device as long as it continues to work, which should be about 20 years. The only patients likely to be excluded, Salerno said, are those who are on dialysis or have other serious conditions, such as cancer or emphysema.
Those who receive the device during the approximately four-hour surgery to install it wake up with an external power pack run by batteries that must be changed every 12 to 24 hours. Salerno said that’s a long battery life for devices in the same category, and changing the batteries is a small price for an outcome that so far has resulted in 85 percent of patients showing no signs of heart failure.
Salerno doesn’t expect the device to be widely available for another three to four years. The trial involves 400 patients, some of whom will receive the Heartmate III. Others will receive a device already on the market. After all the patients have their devices, they’ll be followed for a year to assess and compare the results.
Although the formal trial is capped at 400 patients, Salerno said it’s not uncommon for regulators to allow continued access, so it’s possible he’ll be able to continue implanting the Heartmate III before final approval is granted.•
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