Few Players Dominate
As in previous years, the expo floor was dominated by the four top manufacturers—Philips, Medtronic, Biosense Webster (Johnson & Johnson), and Abbott. This year, however, focus was less on consoles and other capital equipment and more on launching catheters and devices that complete their portfolio of devices. Ultimately, these companies increasingly all provide the same types of devices—those used in cardiac arrhythmia procedures. Most notable among them is AF ablation, which is expected to double in procedural volume between 2016 and 2024.
The other half of the expo floor was populated by a wide range of start-up companies with new innovations that promised to improve the safety or efficacy of cardiac arrhythmia procedures. Their biggest opportunity for commercial success is to be acquired by one of the aforementioned four big players.
In the electrophysiology space, the “peloton” is increasingly absent; the mid-sized companies out of which a few will have the strength to challenge the industry leadership with novel approaches and technologies. This is a shame, since this is often where paradigmatic innovation originates.
Technology innovation is, to a very large extent, responsible for the emergence, growth, and continuous improvements in the electrophysiology space. The four large industry players and the companies they have acquired have assisted progressive physicians in what amounts to a revolution in cardiac arrhythmia treatment. Today, this revolution is reflected in A-Fib patients being presented with curative alternatives to a lifelong dependence on drugs. Although the much-anticipated results of the CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation) study—presented at the conference—failed to show significant differences in mortality from early AF ablation compared to drug treatment, the treatment methodology—enabled by strong technology innovation—represented massive clinical improvement.
Therefore, it was interesting to see what new innovations were presented by the big industry players. They showcased a series of new devices that took most of the stage in their oversized expo spaces, primarily devices that completed their portfolio of AF ablation devices or represented incremental improvements in efficacy. Biosense Webster presented their newest introducer sheath—the Vizigo. Meanwhile, Baylis presented a new steerable sheath to go with their transseptal needle. Abbott introduced the Advisor HD, an advanced mapping catheter. In addition, several patient monitoring and safety solutions were represented by the smaller companies.
Cost Reduction Strategies
Given device costs next to treatment complexity and success rates is the likely tallest barrier to further penetration of AF ablation and a thorough technology victory for the big four, the absence of solutions to reduce procedure costs was surprising. An exception to this was single-use device reprocessing, where recent wins in FDA clearances (including the widely used, fairly complex ViewFlex catheter) show potential for significantly reducing the cost of AF ablation and other cardiac arrhythmia procedures. The reprocessing industry has taken a turn into more complex device technologies with lumens and valves.
In the past, it was common for us to see groups of nurses from the same lab learning more about their lab practices as it relates to new devices. This year, there were fewer nurses, techs, and “hands on” folks in attendance compared to previous events. Also, there were fewer supply chain professionals in attendance. Instead, it appears the show is becoming more and more dominated by clinicians.
While financial considerations may be the simple reason hospitals don’t send their nursing and purchasing staff to Heart Rhythm Society, a shift in the discussion we had at our expo space may add a different dimension. Electrophysiologists are highly trained clinicians, but while their focus is on the clinical aspects of the cardiac arrhythmia procedures, many of them are leading the discussion regarding economic aspects as well. This is due to the fact that, in electrophysiology today, healthcare economics and clinical issues are intertwined:
Electrophysiologists are passionate about the promises of AF ablation as a curative alternative to pharmaceutical treatment. As technologies become more sophisticated, AF ablation could become a means to provide advanced heart disease solutions to millions of Americans. Since AF ablation is also one of the fastest growing areas of healthcare today, the progress of AF ablation is closely monitored, from both clinical and economic perspectives.
For the electrophysiologist, the success of AF ablation depends on his or her clinical skills, as well as on the availability of appropriate technology. The challenge today is that while highly skilled electrophysiologists are successful with AF ablation in procedures they perform, the success of AF ablation is being hampered by the complexity of technologies, the cost of devices, and the relatively low success rates. Technologies in AF ablation are too expensive, too complicated, and simply not advanced enough. As a result, penetration rates are slow to increase.
As a result, the electrophysiologist’s passion for AF ablation is restrained in terms of impact by device costs and the incremental nature of technology development. To the savvy electrophysiologist, clinical and economic factors overlap, and it was very clear in our discussions at Heart Rhythm Society that this has put the clinician in a leadership position in the economic as well as the technology discussions.
Lars Thording, Ph.D., has a background in academia, consulting, and industry leadership. He has been responsible for the launch of numerous market-disrupting solutions across healthcare, insurance and technology. Originally from Denmark, Thording has taught at universities in Denmark, Ireland, and the United States. He currently serves as the VP, marketing and public affairs, for Innovative Health, a medical device reprocessing company specializing in electrophysiology and cardiology technology. Thording currently serves on the board of the Association of Medical Device Reprocessors.