I was recently part of a fairly large discussion via email on what to do with the proliferation of transcatheter aortic valve replacement programs in the United States. One of the discussants posed the question, “With the proliferation of TAVR programs, how do we continue to have TAVR programs that are high volume and high quality?”
This is a concern a lot of us share.
History has shown that our country’s PCI programs should have been subject to more stringent oversight. While most interventional cardiologists and cath lab teams have sought to deliver the highest level of quality from day 1 and have “policed” themselves through peer review, registry participation and more recently through accreditation opportunities, we cannot deny that some programs have bad statistical outcomes or, even worse, don’t look at or report their outcomes. Nor can we refute that there are some bad operators who have not put their patients’ safety first. At this point, any physician who has received privileging from a hospital can perform caths or even interventions. Proving that someone has skill is almost impossible.
Fast-forward to TAVR or even other new advanced technologies:
- How can we keep the standard of care high without feeling like we are practicing in a “police state”?
- Should anyone who wants to perform the new technology be allowed to do so if they meet the minimal criteria?
- Will the increase in programs “water down” the experience of centers? We all know the more experience you have, the better the outcomes should be.
- What about the “Heart Team” approach? There are heart teams, and then there are heart teams.
I am fortunate to work at an institution with a truly integrated heart team. Often you cannot tell who the cardiologist is and who the surgeon is. We see all of the patients together in a valve clinic, make all of our decisions together, and meet routinely to discuss how to improve our program and to review outcomes. On top of that is the intensity of our inpatient valve service. You could say we live and breathe valves on a day-to-day basis!
Now, we have a national coverage decision from CMS and a TVT registry. A TVT accreditation module is being developed, although we don’t know yet if it will be voluntary or mandatory.
Will this be enough? Or is it time for the profession itself to regulate new technologies?
Molly Szerlip, MD, is an interventional cardiologist at The Heart Hospital Baylor Plano, Texas, and medical director of the Valve Service.