UpFront — An editorial that leaves evidence-based best practice behind and addresses medicine from the human experience.
My case for the MRI compatible pacemaker goes something like this…Last year I admitted a patient to South 6 with a syncopal episode occurring while driving and resulting in a motor vehicle accident. The patient was 63 years old and working as a contractor, and so the accident and its circumstances were quite devastating—not because of any injury, but because of the consequences of the incident.
He had pulled into his driveway in his pickup truck after a day on the job when he suddenly lost consciousness and crashed the vehicle at low speed into his other vehicle in the driveway. He was able to get out of the truck but collapsed in the yard. By the time EMS arrived, he was lucid and thankful that no one was hurt. On the telemetry unit, he was in sinus rhythm with right bundle branch block but without other conduction abnormalities. An echo revealed normal findings.
That afternoon he suffered another “syncope,” this time on the monitor. He had a 28-second asystolic sinus arrest. Under any other circumstances, I would not have hesitated to implant a permanent pacemaker the same afternoon and let him get back to his life. Seems like a “no-brainer” right?
But things were a bit more complex than usual. My patient had a slow-growing tumor in the basilar skull that had been followed annually by MRI. Implanting the device would preclude optimal imaging of his brain tumor and make an already difficult neurosurgical problem even more complex. It was the summer of 2009, and there was an option…
I contacted the regional vice president of a device company that had an MRI compatible pacemaker in the process of FDA approval. He helped me apply for compassionate use for the device so as to allow for implantation of a potentially lifesaving pacemaker that would allow for continued monitoring of the brain tumor by MRI. Seems like a “no-brainer,” right? After an extended exchange between the company and the government, the answer from the FDA came back: not “no-brainer,” just “No.”
I regretfully implanted a non-compatible device that afternoon, and the patient has done very well from the cardiac rhythm standpoint. No more syncope. No more crashing the truck in the driveway. But no more MRI…
In February 2011, the FDA finally approved the device for implantation. I have a new problem. I am trying to sort out who should not receive an MRI compatible pacemaker should they have a need for device therapy. Younger patients have the longest window of potential need for MRI, and older patients have the most acute risk for problems requiring MRI scans. In fact, the cohort of patients age 65 or greater who require pacemakers has double the risk of an indication for MRI over the remainder of their lives than even those who don’t require pacing.
Unless a person has another contraindication to MRI scans, I plan to offer all patients requiring new pacemaker implants the MRI compatible device. At similar cost to other pacemakers, it seems like a “no-brainer…”