We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two stories about medical devices that either emerged or resurfaced in the merry month of May, each of which involves a cardiologist and what some of us now think of as not-so-social media.
Cabana and the case for catheter ablation
We’ve all heard at least a little of the noise about catheter ablation for atrial fibrillation over the years, including assertions that the technique needed to perform the procedure takes a long time to master. Some of the recent noise has to do with p scores and clinical trial failures, but there has been a lot of pushback on that score, much of it coming from cardiologists.
We reported on the so-called Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial at the 2018 edition of the Heart Rhythm Society annual meeting, and this study came up statistically short of superiority for disabling stroke and total mortality against medical management. This was a hefty study, though, matching more than a dozen ablation catheters made by multiple device makers against several pharmaceuticals. The study enrolled more than 2,200 at more than 125 multinational sites, so it was no minor undertaking.
The failure to hit the primary endpoint was the subject of a lot of derision and scorn when the results were announced last year, but the clinical reaction has been short of entirely dismissive. One good example of this is the reaction of Brad Knight, a professor of cardiology at Northwestern Medical School, who pointed out recently that any incident of paroxysmal afib of 30 seconds or longer would count as a failure in many clinical trials. However, Knight also pointed to another study, one that pitted three catheters against each other, with the net result that paroxysmal afib was reduced by 99% across the board. That kind of reduction in symptoms is no mean feat, Knight said, pointing out that there are very few treatments for any condition that can knock 99% off the burden of the disease.
Still, John Mandrola, a cardiac electrophysiologist in private practice in Kentucky, took a shot at some of the optimism about ablation in a May 29 tweet describing ablation as “a damn big deal.” Mandrola (@drjohnm) said he had suffered from afib and feared ablation, and noted that the procedure may require two hours of general anesthesia.
The problem of course is still that antiarrhythmic drugs carry a ton of side effects nobody wants. Amiodarone is associated with vomiting, constipation and heart failure, and patients don’t want to have to deal with these issues indefinitely. The obvious implication is that patient choice is still paramount so long as payers continue to pay, something cardiologists are going to have to grapple with, no matter how they feel about the procedure. The net result for device makers is clearly a win, but anything they can do to cut down on procedure time certainly wouldn’t hurt.
Califf jumps into debate over device safety
One might have thought Scott Gottlieb was the only recent FDA commissioner with a lot of social media bandwidth, but his predecessor, Bob Califf, has his own following on Twitter, and he took a shot at some of the media coverage regarding FDA’s regulation of medical technology.
In a May 6 tweet, Califf (@califf001) cited an editorial in the New York Times that claimed 80,000 deaths and two million injuries were due to purportedly defective medical devices, an opinion piece based on coverage provided by the International Consortium of Investigative Journalists. The NYT editorial repeats the now-shopworn argument that the 510(k) is a regulatory loophole, a strange assertion given that the term “510(k)” is drawn directly from the statute.
Hard to see something as a loophole if it’s right there where Congress described it precisely as it is used, isn’t it? Apparently not.
In any event, Califf, a cardiologist by training, tweeted that he was entirely on board with the need for unique device identifiers and with “quality outcome trials on important medical devices,” but he said also he was disappointed that the editorial board decided “to stoop so low in its rhetoric.” One might think this is a predictable reaction for a former FDA commissioner, but let’s not forget that Califf was brought on board during the presidential administration of a Democrat, not that of a Republican. So it’s not plausible to say Califf was hired as hard-nosed, free-market guy as might have reasonably been assumed regarding Gottlieb.
While device makers are no doubt encouraged by Califf’s willingness to go on the record about all this, it’s a bit optimistic to imagine anyone at the NYT editorial board undertaking a little soul-searching as a result. The headline for the editorial, “80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices,” is pure clickbait…and let’s face it, we in the media are in a bad way without our clicks. So it goes.