As cardiologists, we understand that the FDA is tasked with the safety of medical devices, and they saw a statistical safety signal, so I think they are well within their purview to recommend against using paclitaxel-coated devices in most patients with PAD until we learn more. I do think it’s a bit hyperbolic, however, to suggest that insurance agencies will stop reimbursing for use of these devices and that medicolegal issues should drive the issue as to whether physicians chose to use these devices in the best interest of their patients.
Now, the die is cast, and we have to work together to best evaluate the cause of the mortality link. VIVA Physicians is aligning itself with all major industry stakeholders, have engaged an independent statistician expert in meta-analyses and have a statistical plan in the works. The FDA will review it and comment on this plan, but not necessarily endorse it, and then we will move forward very quickly with our patient-level data meta-analysis.
The bottom line is that we need to define a signal with causation. We need to find the smoking gun, if there is one. And we need to do it very quickly.
In the interim, doctors should follow data-driven guidelines and follow their ethical obligations to the best care of their patients. Personally, I would suggest we defer the interventional care of claudicants with these devices until the causation of the safety signal is defined. For patients with critical limb ischemia, however, we have to balance the potential, yet-to-be-defined risk for mortality with the best care of these high-risk patients. We have to move together quickly with the FDA and industry to define the potential safety signal with causation as soon as possible.
Krishna Rocha-Singh, MD, FACC, FAHA
Chief Scientific Officer
Prairie Heart Institute of Illinois at St. John’s Hospital, Springfield, Illinois
Board Member, VIVA Physicians
Disclosures: Rocha-Singh reports he is a consultant for Medtronic.