Topera in the news
Atrial Fibrillation: Evidence builds that a shift in treatment paradigm may be underway. Bruce Nudell, Credit Suisse, April 8th 2013
In a very recent JACC article, a sub-group analysis from CONFIRM suggested that when conventional ablation works, it works because FIRM identified rotors / foci are coincidentally ablated…. Of note, in patients with Paroxysmal AF, about half the sources were in regions that were likely to be ablated during conventional ablation (near the pulmonary veins or left atrial roof), whereas among patients with Persistent AF, only 33.5% of these sources were in stereotypical sites"
Cryo BalloonPulmonary Vein IsolationIs it Really All So “Simple”? Sabine Ernst,MD, Editorial Comment, JACC Vol61: March 2013
“Simultaneous mapping systems are currently shining a new light on AF, improving our understanding of the role of the PVs (as trigger sites) and the atria (for both trigger sites and maintenance of AF) Although extra-PV triggers have thus far been reported to be relatively rare, the simultaneous mapping systems allow a quasi- “satellite perspective” to observe the phenomenon during ongoing AF. They demonstrate surprisingly simple patterns that resemble hurricanes on weather forecast maps, which seemed to be successfully eliminated by non–PV-isolating ablation (12). If these observations are confirmed in larger trials by multiple operators, then one could even speculate on a potential decline in the need for PV isolation for AF ablation in years to come"
Letter From The Editor In Chief, Innovations in Cardiac Rhythm Management, Feb 2013
“if this technology pans out for atrial fibrillation it could truly represent the holy grail of atrial fibrillation ablation… As we have used this technology we can certainly attest that there is something to this technology… Most of our rotor atrial fibrillation ablation cases were in patients with persistent atrial fibrillation. Rotors were identified in multiple locations within both the left and right atria. We are definitely excited about performing more of these procedures in the upcoming few months”
Focal Impulse and Rotor Modulation (FIRM) for Paroxysmal and Persistent Atrial Fibrillation, EPLabDigest, Jan 2013
“Independent laboratories now show that stable rotors and focal sources sustain paroxysmal as well as persistent AF. Elimination of all patient-specific sources by FIRM can terminate AF and render it non-inducible prior to any other ablation, and substantially increase single-procedure freedom over conventional ablation in patients with paroxysmal AF and persistent AF. Notably, rotors and focal sources do not show an electrogram ‘fingerprint,’ but are detectable only by wide-area contact mapping…"
Heart to Heart: Cardiologists collaborate … to study atrial fibrillation, Jan 2013
For many years, doctors thought atrial fibrillation was caused by many electrical circuits misfiring all over the upper atrial chambers of the heart…….Ablation has long been a traditional treatment for atrial fibrillation, but traditionally the locations are chosen because doctors believe they're generally good spots to choose – the doctor isn't targeting specific spots for each patient….With FIRM, doctors find that location by using an electrical mapping catheter and then use a radio frequency cauterization tool to ablate or desiccate the tissue in that spot.."
Top cardiovascular technology trends of 2012, The Advisory Board Company, Jan 2013
“#4 FIRM ablation on the horizon.. This procedure refers to the process of targeting physiologic factors, known as rotors or focal impulses, to uncover AF’s cause. Using the FIRM approach, multi-pole catheters send signals through a proprietary computer software which highlights areas of activation, allowing the EP performing the case, to view “areas of interest” to ablate."
Who's Got the Beat? The Tricky Choice Between Catheter Ablation or Medical Therapy for AF, Cardiosource Interventional News, Dec 2013
“Pinpointing the cause of AF could contribute to greater success with catheter ablation. Recent research has suggested for the first time that AF is caused by small electrical sources within the heart, in the form of electrical spinning tops (“rotors”).. "
A New Strategy for Managing Atrial Fibrillation, Medpage Today, Nov 2012
"New research is aimed at localizing the tissue source of the disorganized electrical impulses that generate AF. Our understanding of AF is evolving, and the source of AF is proving to be more focal than had been previously believed, lending itself to more precise physiological (as opposed to anatomical) mapping.".
"Our physician consultants have given relatively positive feedback regarding Topera and see the concept as innovative and potentially game changing."
AHA 2012 Wrap Up, Matthew J Dodds, Citigroup, November 2012
“.. the mapping concept of picking up electrical rotors and performing site specific ablation vs. broad-based tissue scarring so its RhythmView system has the potential to be more of a treatment breakthrough…. At the AHA, data was updated to show over 200 cases in total, including nearly 70 patients mapped outside of UCSD (where the technology was developed)”
Device Companies Follow New Map To Atrial Fibrillation, START-UP, Oct 2012
“Given what we don’t know about the causes and sources of atrial fibrillation, there are those who think that developing new ablation catheters is almost beside the point. Mark Josephson, MD, chief of cardiovascular medicine at the Beth Israel Deaconess Medical Center, ended a presentation called “Ablation for Atrial Fibrilla- tion: A Critical Appraisal,” by saying, “The truth is we don’t know what to ablate or how much to ablate in the various types of atrial fibrillation..”
FIRM-guided ablation: The next big thing for AF? The Advisory Board Company, August 2012
FIRM ablation refers to the process of targeting physiologic factors (namely, rotors and focal impulses) to uncover the root cause of AF, whereas traditional approaches to AF ablation have been anatomical, focusing on the amount of power needed to ablate a particular area in a given patient… thousands of signals are channeled into a computer system, which projects images of this activation, enabling the electrophysiologist performing the procedure to see specific areas of interest in either atrium in nearly 100% of AF cases."
Technology Creates 3-D Maps of Heart’s Electrical Activity, San Diego Business Journal, July 2012
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.”.. “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...”
New targeting technology improves outcomes for patients with atrial fibrillation, Science Codex, July 2012
“..fundamental source of the arrhythmia: the tiny electrical disturbances in the heart called focal beats or 'rotors' that look like mini-tornadoes or spinning tops. Rotors can be likened to an "eye of a storm"
New AF mapping technology data may finally silence the skeptics, Larry Haimovitch< medical Device Daily, Vol 16, No, 92, May 2012
the AF mapping and ablation technology being developed by privately-owned Topera Medical was one of the shining lights of this year’sannual scientific sessions of the Heart Rhythm Society. Topera debuted at last year’s HRS with virtually no advance fanfare and reported very promising results Last year’s “too good to be true” reaction from EPs who are the undisputed experts in diagnosing and treating AF, was understandable The trial began in late 2005, the small amount of data were derived from just one clinical site and were generated by a relatively unknown EP physician, Sanjiv Narayan, MD, from the University of California San Diego . Dr. Narayan spent about a decade working in relative obscurity on this technology with grants from the National Institutes of Health (Bethesda, Maryland) and the Doris Duke Charitable Foundation (New York).
After Narayan’s highly-anticipated presentation, Warren (Sonny) Jackman, MD, gushed “amazing . . . this is about to turn the AF ablation world upside down.” Jackman, the director of clinical electrophysiology at the University of Oklahoma Health Sciences Center (Oklahoma City, Oklahoma), is widely regarded as one of the world’s “gurus” of AF catheter ablation.
Research Shows Brief Ablation of Rotor Center May Cure AFib Without Long Procedures, Diagnostic & Interventional Cardiology Magazine, May 2012
A new electromapping technique can better visualize the rotor (similar to the eye of a hurricane) around which electrical activity called initiating spirals rotate. Using this map, the electrophysiologist (EP) can position an ablation catheter on the rotor center and see immediately the results of the treatment"
HRS 2012 Wrap UP, , Matthew J Dodds, Citigroup, May 2012
“Privately-held Topera’s electrical rotor mapping technology garners EP commentary a bit like the reaction to the concept of Tesla cars of a few years ago – an almost too good to be true change in technology”
HRS Wrap-Up: Physician Perspectives on Leads, New Technology and Procedures. Rick Wise, Leerink Swann, May 14, 2012
"Privately held Topera again caused quite a stir at HRS with its theory of rotors perpetuating AF, the "FIRM" procedure, and encouraging early experiences. Every physician we spoke with was noticeably excited about Topera”
Ablating Rotors and Focal Beat Sources of Atrial Fibrillation to Improve Outcome: The CONFIRM Trial, EPLabDigest, March 2012
"On the atrial-fibrillation ablation front, the most striking news comes from Southern California. Dr Sanjiv Narayan has made himself famous with his paradigm-shifting work in the approach to AF ablation. To call his work "novel" understates it greatly. After his presentation yesterday, the father of catheter ablation, Dr Sonny Jackman, came to the microphone and said, "Amazing, this is about to turn the AF ablation world upside down."
Ablating AF At Its Source: Novel Diagnostic Mapping Tool Linked To Long-Term Benefit. Gray Sheet. May 9, 2011. David Filmore
In the CONFIRM trial, localized electrical rotors and focal impulse sources were highly prevalent during human AF, revealed using a novel computational mapping system. FIRM-Guided ablation of patient-specific AF mechanisms acutely terminated or slowed AF, and significantly augmented freedom from AF (84% at 2 years) compared with conventional ablation alone (50%). Thus, these results provide an approach to rise above the previous ceiling for success of AF ablation. Of note, two-thirds of patients in the CONFIRM trial had more difficult to treat persistent AF.
By detecting the actual sustaining mechanisms for AF in each patient, these results offer a novel treatment paradigm for AF that may increase the efficacy of ablation".