Time for Better Accountability
By
A few weeks ago, I was contacted by a journalist from Heartwire doing a story on device-related cardiac erosion in patent foramen ovale (PFO) patients. This inquiry posed an interesting question and one medical professionals should be embarrassed not to have a true answer to. The story the journalist was investigating was a single case report regarding the Amplatzer atrial septal defect (ASD) device, which had been used off-label to close a PFO. An unfortunate patient presented at an emergency room with cardiac tamponade due to erosion and underwent emergency open heart surgery to remove the Amplatzer device and repair the damage. Fortunately, the patient survived.
This raised the question, “should PFO patients who’ve undergone off-label device closure be concerned about this situation or not?” Well, I don’t know. And why is it that I don’t know? The answer is no data regarding off-label use of ASD devices for PFO closure is currently being collected as device manufacturers are under no obligation to maintain a registry, which is imperative if patients are to undergo a thorough informed consent process to understand the true risks and benefits of the PFO closure procedure. There has also been around the water cooler speculation the FDA hasn’t pushed for off-label usage registries because the agency is afraid information collected will be used in attempts to circumvent or weaken the current approval process. Regardless, patients lose. Because there is no registry, I couldn’t tell you if the unfortunate patient is 1 in a 1,000 or 1 in 100,000. I can confidently say we suspect the risk of erosion is small (less than 1%) based on anecdotal information and meta-analysis of observational studies, but it sure would be nice to know the true procedural risks before having a device permanently implanted in one’s heart.
Moreover, the fact that this information isn’t currently being collected strikes me as absurd. I recently received a letter from PetSmart informing me a fish tank heater I bought for approximately $20 some seven months earlier posed a risk to my fish. Seriously? PetSmart is committed to protecting the lives of fish after a customer spends $20, but patients can have off-label devices permanently implanted in their hearts with no information making it into a database? It seems to me that we would want to collect information on off-label use even more than labeled uses, which were rigorously studied during tightly controlled randomized clinical trials, if we are truly to protect and care for patients in the best manner possible.
The time for better accountability is now. Patients deserve answers to basic questions about their care and should be notified when issues with a device emerge. No patient should have any device implanted in his or her body without having outcomes collected in a registry. If PetSmart can do it, industry can do it.
Bray Patrick-Lake,
President and CEO of the PFO Research Foundation
