Topera Medical Inc.’s RhythmView technology, which is a GPS of the heart’s electrical activity, is steadily gaining attention among U.S. physicians who diagnose and treat atrial fibrillation, the most common disorder of heart rhythm.
Even though the technology will not be on the market until early 2013, doctors who specialize in diagnosing and treating irregular heartbeats are contacting Topera to learn “how and when one can purchase the RhythmView system,” said Dr. Ruchir Sehra, Topera’s chief medical officer and co-founder.
RhythmView, which was cleared by the Food and Drug Administration, creates 3-D maps of the electrical activity of patients’ hearts, and like GPS, guides physicians to the sites in the heart tissue that trigger irregular heart rhythms, which can cause strokes and weaken heart muscle over time, leading to heart failure.
UC San Diego cardiologist Dr. Sanjiv Narayan, who conducted the research behind the technology, referred to these sites as electrical spinning tops and hotspots. Narayan said that knowing the hotspots’ locations in the heart tissue enables him and other physicians who specialize in cardiac electrophysiology to therapeutically neutralize the sources of the abnormal rhythms by disconnecting them from the rest of the heart.
To eliminate the hotspots, cardiac electrophysiologists typically use cardiac ablation, in which the doctor inserts a thin wire through a leg vein and up into the heart through the blood vessels to target the tissue responsible for atrial fibrillation.
Atrial Fibrillation Is on the Rise
The standard procedure for detecting the sources of abnormal rhythms for catheter cauterization, however, is imprecise. It is a “‘one size fits all’ estimate of where to target,” Narayan said. As a result, many patients have to undergo multiple procedures to eliminate or lessen their irregular heartbeats.
“Accordingly, the success rate of that approach is 50 percent for one procedure,” Narayan said. In clinical studies at UCSD and eight other medical centers in the nation, he said that RhythmView “greatly improved that success to over 82 percent for one procedure.”
Because the clinical studies, which are named CONFIRM, indicate that RhythmView should reduce the number of medical procedures needed; it should lower the cost of treating atrial fibrillation.
And, just in time, according to Dr. John Miller, professor of medicine and head of the clinical cardiac electrophysiology group at Indiana University School of Medicine in Indianapolis. “Atrial fibrillation is on the rise. Reasons for this are many, but the implication is that an increasing number of people will be bothered by the palpitations, racing, shortness of breath, fatigue or lightheadedness associated with sudden, unpredictable occurrences of AF.”
Miller added that the initial results of the CONFIRM clinical studies indicate that less heart tissue damage results from RhythmView than the current method.
“This very promising technology will soon be tested in a larger number of patients. If successful, it could revolutionize the way AF is treated in the future,” Miller said.
‘Dawn of a New Phase’
“This is the dawn of a new phase of managing this common arrhythmia that is mechanism-based,” said Dr. Kalyanam Shivkumar, director of the UCLA Cardiac Arrhythmia Center and professor of medicine and radiological sciences at UCLA.
As part of the CONFIRM clinical trial, both Miller and Shivkumar evaluated HeartRhythm in their patients with atrial fibrillation.
RhythmView is based on 10 years of research, which was funded by the National Institutes of Health, at UCSD where Narayan is professor of medicine at Sulpizio Cardiovascular Center and director of electrophysiology at the San Diego Veterans Affairs Medical Center.
Narayan said he wanted to “find the basic mechanisms underlying AF. By marrying bioengineering approaches with detailed recordings in patients and computer software that we developed in my lab, we were able to find these 'spinning tops' and target them for ablation.”
UC San Diego licensed the patents for the technology to Topera, which Narayan co-founded in 2008. He is an adviser and not an officer of Topera.
In addition to providing a novel approach to treating atrial fibrillation, Narayan’s research showed for the first time that irregular heart rhythm is triggered by small electrical sources within the heart in the form of electrical spinning tops.
Narayan and his colleagues reported the discovery as well as the results of the CONFIRM in the July issue of the Journal of the American College of Cardiology.
The name Topera represents topographic opera, Narayan said, because the company’s technology “creates a map of a symphony from originally chaotic signals.”
Cathy Yarbrough is a freelance writer for the San Diego Business Journal.