Ron Burgundy: “What cologne you gonna go with? London Gentleman? Or wait…No, no, no. Hold on. Blackbeard's Delight!”
Brian Fantana: “No... It's called Sex Panther by Odeon…They've done studies, you know. Sixty percent of the time, it works every time."
Ron Burgundy: "That doesn't make sense..."
— From Anchorman: The Legend of Ron Burgundy
Atrial fibrillation (AF) is a difficult disease for patients and an expensive problem for our healthcare system. It is the most common heart rhythm disorder, characterized by a rapid and irregular heartbeat, causing heart palpitations, chronic fatigue, and debilitating pain as well as a 4-5 times increased risk of stroke. While anti-arrhythmic drugs may successfully control the disease and reduce risk factors of stroke in some patients, these drugs are often poorly tolerated and are frequently incapable of controlling disease symptoms. As an alternative treatment strategy, minimally invasive catheter ablation has been steadily gaining increased support. But despite the over 6 million patients affected by AF in the U.S., there were still only 130,000 ablations performed in the U.S. in 2012.
With such a large and growing unmet medical need, why so few cardiac ablations? For starters, ablation is hard. The current strategy for curing AF with catheter ablation relies on a procedure called pulmonary vein isolation (PVI) to block triggers that initiate AF. Electrophysiologists who can do this well are true artists—PVI requires a painstaking process of linking together a series of point to point lesions inside the heart using a catheter in a procedure that can take anywhere from two to ten hours. Frequently patients must undergo a second procedure within months of their first because their AF was not improved or has subsequently recurred. When a patient’s AF is successfully terminated, it’s a remarkable cure. But unlike Sex Panther by Odeon, data from large clinical trials evaluating AF ablation outcomes indicate that less than 60% of the time, it works every time. In several large studies, nearly half of patients treated with a single PVI procedure see their AF recur within one year. This is frustrating for both patients and clinicians—many of whom, as a result, decline to incorporate ablation as part of their practice.
Over the last decade, dozens of medical device companies have attempted to make these “one size fits all” PVI procedures easier and more reliable with innovations around different catheter designs, energy sources, robotic catheter steering and large installations of sophisticated anatomic imaging systems. Large medical device companies like Johnson & Johnson, Medtronic and St. Jude have built huge franchises with these products. These innovations to improve PVI are valuable, but focusing only on isolating triggers as an AF ablation treatment strategy has overlooked another key component to these arrhythmias. Enter Topera Medical and the ability to identify and ablate previously unseen electric rotors and focal impulses that sustain the arrhythmias.
Topera’s next generation 3-D electrophysiological mapping system is a breakthrough technology that is uniquely capable of mapping and visualizing electric rotors and focal impulses that sustain the irregular rhythms of AF, enabling electrophysiologists to provide more precise and appropriate therapy for their patients. Using this technology to identify the locations of rotors and focal impulses, which is often then followed by catheter ablation to eliminate them, clinicians across multiple labs have demonstrated the ability to achieve freedom from AF for significant numbers of their patients without recurrence of their symptoms.
Topera announced a $25 million round of financing today, and NEA is delighted to lead the round and partner with this pioneering company as it prepares to launch its RhythmView™ Workstation and FIRMap™ Catheter in the U.S. and Europe. While the company’s technology and outcomes seem almost revolutionary, it is important to note that their approach to the mapping of complex arrhythmias like AF is closely and elegantly linked to the way clinicians have historically approached cardiac ablation for simple arrhythmias. The key to successful treatment is to gain an understanding of the precise electrophysiology underlying each arrhythmia with an emphasis on identifying the critical circuits in the heart that sustain an arrhythmia. Simple arrhythmias have characteristic electrical patterns that have been easily resolved using traditional diagnostic mapping systems, and when their reentrant circuits are pinpointed and ablated, procedure success rates exceed 80-85%. For the chaotic electrical patterns of complex arrhythmias like AF, clinicians are now able to use Topera’s RhythmView™ System to pinpoint the focal impulse or electric rotor sustaining the arrhythmia. This identification allows them to more precisely target therapies such as catheter ablations and achieve success rates on par with those of simple arrhythmias.
To me, what’s equally impressive about Topera is the origin of its proprietary technology. This is in large part a credit to co-founder Sanjiv Narayan, M.D., Ph.D., Professor of Medicine at UCSD. (Stay classy, San Diego!) Dr. Narayan is a practicing cardiovascular electrophysiologist who also has a doctorate in neuroscience and a master’s degree in software engineering. He is that uniquely situated individual who, out of intellectual curiosity and compassion for his patients, committed to apply his years of postdoctoral study and insight into resolving the complex electrical signaling associated with EEGs of the brain to the complex and chaotic electrical patterns associated with atrial fibrillation in the heart.
Over the course of several years of collecting electrograms from his patients, he wrote and tested and rewrote and retested his own software code that analyzes complex rhythms of the heart and resolves them into 3-D representation of the dynamic, localized electrical activity of cardiac tissue. In addition, he undertook the process of demonstrating through rigorous clinical study that by performing conventional PVI plus targeting and ablating the rotors and focal impulses in the heart, single procedure AF ablation success rates could be dramatically to north of 80% as much as two years after the procedure compared to PVI alone, or double the success rate of the current standard of care today.
Since the first presentation of Dr. Narayan’s technology and seminal clinical results at the Heart Rhythm Society meeting in 2011, he has partnered with over a dozen other clinical investigators around the world to replicate his results and further refine Topera’s product. We have followed the team’s progress closely over that time, and recognize their commitment to leading the way in building the clinical and scientific evidence supporting a potential fundamental shift in how AF is diagnosed and treated. We’re thrilled to partner with Dr. Narayan and Topera’s management team—along with a new strategic corporate investor—to bring Topera’s technology to the market. As an investment, it is a rare occasion when we find an opportunity to apply a diagnostic technology—where its use in a procedure imparts very little incremental risk to the patient—that can have such a profound impact on improving the overall efficacy of a treatment in a growing market with a significant unmet clinical need. More important, we’re proud to support Topera in its effort to dramatically improve the standard of care for diagnosing and treating complex arrhythmias for the benefit of clinicians, their patients and the healthcare system.