The Windy City really lived up to its name during the course of ACC 2016, didn't it? It was also interesting to hear the recording on the subway stating that gambling is not allowed on the trains. Who knew?

ACC 2016 provided a lot of gist for the scribbling class, including some noise about operator volume requirements for TAVR devices. There was also pressure from physicians on FDA to approve the latest generation of devices based on data from other than the classic randomized trial, which in the past may or may not have had any effect. In both cases, the question may be who is and who should be driving these decisions.

When enough is not enough

As those in the interventional cardiology business are aware, hospitals that want to practice TAVR must have an interventional cardiologist and a cardiovascular surgeon with 20 such procedures under their belts in any 12-month period if they want Medicare payment. There was some question about whether this level suffices, given that some data emerged during ACC 2016 indicating that the device performs better even after the operators have done 100 cases.

As interesting as that discussion is, I am inclined to think that CMS did not just pluck that number out of its hat. The agency had a fair amount of clinical trial data on which to base that set point, so one has to imagine there was a reason to pick 20.

On the other hand, physicians working at any institution doing a substantial amount of surgical valve replacement will probably handle a lot more than 20 such procedures annually. For a lot of centers practicing this device type, the question probably seems a bit absurd.

There are undoubtedly exceptions, however. It is probably safe to say that many hospitals that barely make it to 20 a year are located in areas where there are few hospitals to choose from. If that's the case, raising the minimum number of procedures might force some very sick people to travel a lot farther for a procedure they need just to survive to next month.

In the case of those who are at high risk from surgeries or who simply are not candidates for surgery, is it really humane to force them to drive several hundred miles farther just so everyone can feel good about raising the minimum volume to higher than 20 procedures?

I think we all know the answer, don't we?

Regulating the regulator?

During last year's ACC gathering, Jeff Popma needled FDA about approving the Sapien 3 device by Edwards Lifesciences for inoperable and high-risk patients without putting the company through a full-blown randomized, controlled trial slog. This year, the same argument was made in reference to this valve in an intermediate-risk population.

FDA approved the Sapien 3 in June, 2015, about three months after last year's ACC meeting, but that doesn't mean the agency was responding to the pressure it was feeling from doctors. Still, it will be interesting to see how the agency handles this latest predicament. After all, much of the data in support of this notion is derived from a study that used propensity matching to compare a single-arm study of the Sapien 3 to surgical valve patients who were enrolled in the Partner 2A study.

This can't sit well with a lot of people at FDA, but we all know that doctors have a lot of pull with government agencies. Still, it's tough to gamble any serious money on the outcome here. After all, someone at FDA might not like the perception that doctors are driving the FDA train.