COMMENTARY

Fear, Marketing, and Corporate Influence: Lessons of the MagnaSafe Registry

John Mandrola

Disclosures

November 19, 2014

The story of MRI scanning in patients with cardiac devices exposes a lot that is wrong with the practice of medicine in 2014. If you value sound clinical decisions, those grounded in science and evidence, not fear and ignorance, this story will be a source of severe inflammation.

Entangled in the "MRI-safe" story is the power that fear, marketing, and corporate influence have in undermining medical decision making. There's a lot of talk about doing what's right for our patients. Yet, if we really cared about patient care, this problem would be fixed. And if we can't fix it by the time all medical-device companies release MRI-safe devices, the least we can do—for our patients—is to study and learn from this dark chapter.

Please. If you don't read any further, I urge you to look at the final results of the MagnaSafe registry study,[1] presented this week at the American Heart Association (AHA) 2014 Scientific Sessions. I ask you to suspend what you know now, and just consider the data on their merits.

Dr Robert Russo (Scripps Institute, La Jolla, CA) presented the final results of the MagnaSafe registry. It's important to note the registry first reported interim data in 2012. In the session today, I sat next to an established leader in academic electrophysiology. The professor asked whether I was here to write about MagnaSafe. "Maybe," I replied. "John, you should write about it. It's an important topic, one that bothers me greatly." (Notice that I am not telling you the name of the professor, which is a relevant fact in this story.)

The short story on MagnaSafe is that 1500 MRI scans were done in patients with cardiac devices without any deaths. Maybe it's worth reading that sentence again.

The 1500 cases included 1000 scans in patients with pacemakers (PMs) and 500 scans in patients with implantable cardioverter defibrillators (ICDs). In the pacemaker group, but not ICD group, researchers included PM-dependent patients. Trained personnel monitored patients during the nonthoracic MRI scans. (Dr Russo told me they now have a large series of thoracic MRI scans—no complications.) In addition, the MagnaSafe protocol required simple programming of the device before the scans.

One ICD patient had acute generator failure during an MRI. This was due to human error—the device had not been programmed to the inactive mode. Five patients had atrial fibrillation during the scan, and six patients had an electrical reset—neither led to significant clinical sequelae. No ICD patient had a shock. If you like statistics, that's 1499 of 1500 MRI scans that went without problems.

A rule of science is that data should be verified. Here I point you to this series of 438 device patients who underwent 555 MRI scans without significant complications.[2]

Now to the lessons.

Fear

I'm not sure there is a bigger impediment to helping, not harming, patients than fear. How many MRI scans do we need to do in device patients before we say it's safe enough? Books have been written and Nobel Prizes won on the matter of how fear avoidance disrupts our quest for common sense. My colleague Dr Melissa Walton-Shirley said it well: "Don't tell me we can't do this." She is right.

It is true that scanning patients with devices is not free of risk. And it requires a protocol, attention to detail, and human resources. In cardiology, we like to talk relative risks. So let's do that. Let's consider the one-in-1500 risk of scanning patients with cardiac devices relative to some of the other things we do in the name of patient care: we inject nuclear tracers (big radiation doses) to evaluate chest pain; we implant shocking devices that are of no use to the majority of patients who get them; and we burn or freeze the left atrium for a disease that is often unnecessary. Don't tell me about fear when we so easily look past the risks of routine practice.

Marketing

During his presentation, Dr Russo referred to the "arms race" between device companies. I understand marketing is part of the deal in American medicine. That doesn't mean I have to like it. What really inflamed me about the MRI-safe marketing blitz was that I, the electrophysiologist, got bypassed. The message to my colleagues in general cardiology and primary care was that their patients should get the MRI-safe pacemaker because they may need an MRI in the future. I've even had patients request the MRI-safe device.

It's normal for marketing to emphasize upsides. The problem is that they leave out the trade-offs of the MRI-safe device—lower battery life, clunky leads, and fewer diagnostics. You can be sure they also left out the Annals study and the MagnaSafe registry data. (Don't beat me about the leads. I know there are now tried-and-trued pacing leads decreed to be MRI-safe. That hasn't been the case until recently.)

Corporate Influence

The fact remains that MRI scans done in device patients are not covered by the Centers for Medicare & Medicaid Services. Another fact is that all cardiac devices, except the MRI-safe ones, come with labeling that prohibits MRI scans. These are major impediments. Yet it is also where leadership and corporate influence must be considered.

I spoke with numerous leaders in the field about this topic. One had this quote:

"Considering the millions of dollars of industry support, it would be career suicide for a key opinion leader in electrophysiology to take a strong stand in this debate."

Again, I can't tell you who said this. And therein lies the problem. You see it, right? It's all connected.

I don't aim to solve the problem of corporate influence in an editorial. And I'm surely not advocating for eliminating industry collaboration. Cardiologists must continue to work together with industry. How else would we innovate?

What I want to point out is that things, dollars especially, come with trade-offs. When we study the effects of financial support for professional societies, the inability to accept the overwhelming evidence that MRIs are safe for nearly all patients with cardiac devices will be an important chapter.

JMM

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