Cardiac MRI: An Impending Turf Battle?

Recently, there has been much debate about a looming deterioration in the environment offered by the United States for high-tech companies to conduct their research and development (R&D) and innovation efforts. When the Medical Device Excise Tax was enacted a couple of years ago, it was perceived by some as a major hit against the United States’ appeal as an innovation hub for MedTech companies.

Many predicted the decision to fund part of the Affordable Care Act by imposing a 2.3% lower margin on medical device makers would signify the beginning of an inescapable move offshore of United States technology and market innovations. While the long-term effect of higher tax rates remains to be seen, in medical imaging today, the innovation slowdown in the United States seems to owe much more to another factor – the delay in regulatory approvals.

Cardiac MRI and the TAVR Push
Together with echocardiography (both TTE and TEE), angiography, and multi-detector CT, cardiac MR is part of the imaging arsenal surrounding transcatheter aortic valve replacement (TAVR) procedures – arguably the most important development of this decade and a real game-changer for interventional cardiology. TAVR has been in fairly wide clinical use in Europe for several years already, with many medical device vendors providing CE-marked valves to the market. In the U.S. however, Edwards Lifesciences’ Sapien product remained the only approved product for more than three years, until earlier this year when Medtronic finally obtained approval from the Food and Drug Administration (FDA) to market its new CoreValve system.

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As TAVR procedures were gradually advancing in the European clinical field and rationalizing new product investments in cardiac MRI, both procedures in the United States were remaining largely confined to few academic and research settings. Facing a more ready and more mature market in Europe, Europe-based imaging and informatics companies have had every good reason to make significant advances in informatics solutions for Cardiac MR imaging over the last few years.

Europe the Innovation Hub for Cardiac MRI Informatics
Among the three major MRI equipment manufacturers (GE Healthcare, Siemens Healthcare, and Philips Healthcare), Siemens has developed an edge with cardiac MRI. Outside of the equipment makers, most of today’s independent vendors in the cardiac MRI informatics arena are based out of Europe. Namely, Medis Medical (the Netherlands), Pie Medical (the Netherlands), and Circle Cardiovascular (the Netherlands/Canada) are the main players in the field, with much innovation influx reportedly also coming from Israel. The fourth largest MRI vendor, Toshiba Medical, whose wholly-owned subsidiary Vital Images only provides a basic cardiac MRI package, recently inked a partnership with Medis.

As such, cardiac MRI informatics offers a good example of how regulatory delays have played in disfavor of the United States, and in this case, to the benefit of Europe which now enjoys a clear head start. Furthermore, this synopsis of cardiac MRI informatics would explain why innovation in this field was much more present on the show floor of the European Society of Cardiology (ESC) Congress in Barcelona last month, than at the American College of Cardiology’s last March.

Cardiac MRI, with its strong capabilities to perform many precise and reproducible measurements, is extremely well aligned with the push toward structured reporting and quantitative imaging – two areas where Europe is generally ahead of the United States. This helps explain the fact that two out of the three aforementioned application vendors have their background in quantification tools for the cath lab.

Cardiac MRI Procedure Volumes on the Rise
While the procedure volume of cardiac MRI in the United States was estimated to be less than half a million only a year ago – representing a minor subset of the approximately 34 million MRIs performed last year, things are starting to change quickly in the clinical field. For example, the majority of participants in the latest ECRI survey of MRI customers (September 2014), have indicated that they have begun using cardiac MRI “routinely,” compared to only three years ago when the procedure was mostly being used for experimental purposes.

Part of this rise in clinical adoption may be attributed to the recent launch into the market of MRI-safe cardiovascular devices, notably pacemakers. This and various other clinical, technological, and market drivers, suggest that the cardiac MRI procedure volume in the United States is now well on track for surpassing the one million mark in 2015. In fact, despite its slow start, compared to its European counterpart, in a few years’ time the United States will, without a doubt, represent the largest global market for cardiac MRI equipment and informatics.

Uncertain Reimbursement Model and Turf Battles Ahead
As the United States slowly climbs to claim the number one spot it holds with virtually every other medical imaging segment, the road ahead looks all but free of roadblocks. Currently, most providers wanting to perform a cardiac MRI on their patient have to go through cumbersome pre-authorization processes. Going forward, it is still unclear where, within the clinical care pathways being developed alongside new bundled payment initiatives for cardiovascular conditions, expensive cardiac MRI procedures will ultimately find their place.

As with most emerging imaging procedures, radiologists were the first to jump on the cardiac MRI bandwagon, due to the fact that they could leverage their longstanding experience with and ownership of MRI. However, as cardiologists slowly start coming along as well, it will be interesting to see the type of arrangements that radiology and cardiology groups will make regarding cardiac MRI, and how the procedure will play out across their diagnostic and interventional service lines, particularly in the era of the hybrid interventional radiology/cardiology operating room.