Melissa Walton-Shirley


November 19, 2014

I'll make this short.

All three of us were there for a reason. This was no moment to divide and conquer as some could argue. Marlene Busko, heartwire journalist; John Mandrola, EP extraordinaire–fellow blogger; and I stormed the MagnaSafe registry talk this morning.[1] We were there for good reason. One of the world's leading authorities on scanning what we all know as non–MRI-conditional devices would be presenting his data. Dr Robert J Russo (Scripps Clinic, La Jolla, CA) did not disappoint, and afterward, he was kind enough to sit down with all three of us for a long discussion.

This isn't a game.

There are lots of angles to this story, but the most important angle is that more patients with devices should be propelled past the regulatory hype and fear tactics to get the scan they need. Now is not the time to stall. This is real life, and it's even more real life, threateningly real, if you are the one with a question of MS, a brain tumor, an aneurysm, acute stroke, or a spinal-cord injury. It's a quality-of-life issue for patients with bad hips or sore knees. Quality-of-life issues count too. Bad hips and bad knees equal sedentary lifestyle and increased cardiac-event rates.

1000 pacemaker patients and 500 ICD patients didn't lie.

They lived. There was a 0% incidence of death with MRIs performed (although thoracic MRIs were excluded but coming soon) in the MagnaSafe registry. In addition, some of them got upward of 10 scans without adverse outcomes! There was one generator change required because the gadget wasn't programmed correctly, confirming what we've known all along: device patients need monitoring, resetting, and an exit reinterrogation. Data—I said data!!!—demonstrate it can be a doctor, nurse, registered nurse practitioner, physician's assistant—someone, almost anyone, with adequate device knowledge and MRI preparation training. There is no mystery here. Patients with devices need to be evaluated going in and coming out of the scanner. They need a continuous-pulse oximetry during the exam so we can monitor pulse rates. It's not rocket science.

Don't say it doesn't matter.

You can say that in a few years we won't even need to consider it because everyone will have an MRI-compatible device. But everyone knows that leads outlive generators. Don't forget about those patients.

Patients with traditional "non–MRI-compatible" leads are people too. And by the way, we can now stop calling them non–MRI-compatible. They aren't.

We just need a license to drive.

So, there isn't one good reason patients cannot have an MRI with appropriate monitoring at this hour except: we don't have the regulatory papers in place for payment; and the guidelines aren't up to par. It's much like needing a driver's license. You may be able to win the Indy 500, but if you don't have a driver's license, you won't be puttin' the pedal to the metal anytime soon.

The science is there.

But this story is less about science and more about the shortcomings of real healthcare reform.

Part of "real" healthcare reform means that our government, our medical associations, and our thought leaders should already have in place a rotating tribunal of seasoned, bold, and knowledgeable researchers and clinicians who travel to the major three cardiology meetings and stay behind for another week crunching through the data and delivering edicts on change. They won't be able to address everything, but for findings like these that affect so many patients with such an acute need for imaging, the lack of immediate response is shameful. It's really nobody's fault, though. Dr Russo was very careful to compliment the FDA and other regulatory agencies for assisting with the written protocol. The holdup isn't intentional, but like an apology, intention doesn't change anything.

Don't tell me we can't push through the barriers faster.

If we found today that three bottles of aspirin sold by a corporation at several different sites contained poison, you'd see a public-health warning this afternoon. The machinery is there for a black-and-white issue such as a pill recall or warning. It's that machinery we should tap into that could encourage radiologists to do a scan today (okay, let's start tomorrow) with the help of device-knowledgeable personnel.

And a word to nervous device companies that have lots of money invested in MRI-compatible generators and leads.

You will still get yours. We're happy to have those MRI- compatible leads and devices around. I'll help you. Your talking points will be personnel and cost. Your devices will save time and money. You'll win in the long run with that argument. But please, please, do not be obstructionist and short-sighted on this issue. Be human. Be compassionate. Be helpful, even. Jump out there. Push the scanning movement, and you'll be respected for it. You might even sell more devices because it screams compassion. Thanks, Dr Russo, for your compassion.

So that's it. That's my appeal, my plea, my one shot. I have no disclosures. I don't implant devices. I provide care to patients who have devices. I refer patients for devices. I have friends and family with devices. Perhaps the salient point to this discussion is the fact that so do you.


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