July 14, 2021
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
Let’s begin by talking about the effectiveness of the device. Although the primary effectiveness endpoint of Early Liver Allograft Dysfunction (EAD) showed superiority of the OCS device over cold static storage, FDA scientists note that EAD is intended as a predictor of clinical outcomes, such as recipient and graft survival, but it is less important than those actual clinical outcomes. The data do not indicate any superiority of the OCS over cold static storage with respect to graft survival or recipient survival at 30 days, 6 months, and 12 months post-transplant.
Although the OCS is potentially equally as effective as the usual cold static storage, there are additional risks compared to cold static storage. For example, there were 3 cases of device malfunction in the study. Although the risks of device malfunction can be partially mitigated by transferring the organ to cold static storage, the device malfunction could cause organ damage. This risk is greater than the risk of organ damage from using cold static storage.
There were also 3 cases of organs being deemed unsuitable for transplant following storage in the OCS system. FDA scientists question whether the livers were damaged by the OCS system, and they believe it is likely that inadequate perfusion and oxygenation led to rising lactate levels in the perfusate. Because it is common practice to start recipient surgery before the donor liver arrives, high-risk patients may unnecessarily be put under anesthesia and receive unnecessary surgery in cases where, upon arrival at the transplant center, an OCS preserved liver is deemed unsuitable for transplant. We therefore share the FDA’s concerns about the potential harm to high-risk patients.
Cold static storage does not have these same risks that I described for the OCS system. For that reason, we conclude that the OCS system has additional risks compared with traditional standard of care, without any benefits for survival.
The Advisory Committee voted 12 Yes, 5 No, and with 1 Abstention that the benefits of the device outweigh the risks.