Yesterday, the FDA approved Edward Lifescience’s percutaneous transvalvular aortic valve replacement catheter for human use. Despite this, it appears unlikely that implants of these valves will progress in short order due to concerns of demand for the expensive technology in the era of increased scrutiny of device utilization by payers, especially CMS. Which constraints will be placed on cardiologists and which institutions will be approved for this technology are issues still being considered. At the current rate, it appears unlikely at this time that this technology will be deployed before the end of the year.
One new trend in cardiovascular circles (and a trend that is very politically-correct in our new "Accountable Care Organization" era of medicine that also plays well with health care marketing teams) has been the installation of new, very expensive ‘hybrid’ catheterization laboratory/operating rooms capable of transitioning from a conventional operating room to a catheterization laboratory (or back again) in larger hospitals. It is clear that patient selection for percutaneous valve procedures will likely require collaboration between cardiothoracic surgeons and cardiologists and some valvular procedures may require both specialists in complicated cases.
Here’s a time-lapse video of the conversion of a hybrid operating room from the University of California, San Diego where a patient first had a DaVinci robot-assisted single-vessel off-pump coronary bypass operation followed by placement of an intracoronary stent in another coronary artery by cardiologists. (Not sure why it was done this way, but I don’t know specifics about the case.)
While staged DaVinci robot procedures with angioplasty probably won’t be common, these fancy "hybrid" operating rooms (OR’s) are much more likely to be used for percutaneous valve implantations or even atrial fibrillation ablations using simultaneous epicardial and endocardial approaches.