Under full anesthesia, a small metallic clip is threaded from a patient's thigh to his or her heart through a plastic tube. The clip is then attached to a valve of the heart, and left there.
This delicate process -- a new catheterization procedure being tested at five locations in the United States, one of which is the University's Medical Center -- is hardly a picnic, but certainly preferable to open heart surgery.
And that's exactly what it seeks to prevent. The innovation may allow the approximately 4 million patients in the United States with faulty heart valves -- mitral valve regurgitation, in medical jargon -- to delay or even avoid open heart surgery.
"It allows us to avoid the morbidity associated with open heart surgery," Director of Interventional Cardiology Howard Herrmann said.
Herrmann is one of five doctors in the country who have performed the procedure. His patient underwent catheterization in late July, and is now doing "very well," Herrmann said.
However, he stressed the experimental nature of the procedure. Open heart surgery is "still the primary treatment," he said.
"This research is not yet meant to replace open heart surgery... we're still trying to understand who it best works for."
Although the procedure does not involve stopping the heart, as open heart surgery does, it still has its risks.
"Theoretically, the clip could dislodge," Herrmann said. There is also risk of stroke or heart attack.
"Part of the point of research is to look for these risks and figure them out," he added. Herrmann believes the risks of catheterization are "comparable" to those of open heart surgery at this stage in the research.
The clinical trial program is being led by Ted Feldman, director of the Cardiac Catheterization Lab at Evanston Hospital in Illinois. Other sites include Emory University, Swedish Hospital in Seattle and the Cleveland Clinic Foundation.
The procedure and the clip device were invented by Evalve, Inc., a California-based research and development company.
According to Ferolyn Powell, president and chief executive officer of the company, the procedure has been in the works since 1999. A year and a half ago, the company began approaching clinical sites for testing.
"We had quite a long list of criteria," she said of the process of choosing institutions to conduct the tests. These included both skill with catheters as well as a good track record with Food and Drug Administration-regulated clinical studies.
Although Evalve has not previously worked with the University, Powell said other medical development companies had spoken "very highly" of both Penn and Herrmann.
Clinical trials are also important to Penn. "We pride ourselves [on] being an innovative hospital at the forefront of medical knowledge," Herrmann said.
"We're always trying to get the newest and greatest thing."
According to Herrmann, his department is often involved in up to a dozen clinical trials at any one time. In 1989, Penn clinically tested stents, wire mesh tubes used to prop open arteries, which became approved for general use in 1994. Later, in 2002, the University tested a version of the instrument that is coated with drugs that prevent adverse reactions, which was approved in April.
