Oksana Volod, you’ve written a wonderful book on viscoelastic testing. Bring us up to speed on viscoelastic testing. It seems we’re making progress with increasing the understanding of it and getting it incorporated in ever more places.
Dr. Volod (Cedars-Sinai): That’s correct. There is growing recognition of the need for rapid, bedside assessment of a patient’s hemostatic status. When we relied on earlier platforms such as the TEG 5000 and ROTEM Delta, these systems were manual, labor-intensive, and required specialized expertise and workflow support—capabilities that not every laboratory or clinical area could consistently provide. The transition to newer, cartridge-based, and point-of-care platforms such as Quantra, ROTEM Sigma, and TEG 6s has been transformative. These systems can be deployed directly in the operating room and ICU, allowing for rapid, actionable hemostasis assessment during surgery and critical care.
Initially, I was not comfortable moving our legacy system into the OR environment. With strong collaboration from our perfusionists, we were able to do so, but it required close oversight on my part. With the newer platforms, I feel much more comfortable delegating responsibilities, as the systems are more standardized and user-friendly.
Our primary surgical teams selected the Quantra for the cardiac and liver transplant suites, where rapid identification of coagulopathy is critical. For more advanced or consultative hemostasis assessments, I continue to maintain a TEG 5000 and TEG 6s in the laboratory. Since the TEG 5000 is being phased out, I am currently evaluating options for the next laboratory-based system. One platform I am considering is the ROTEM Sigma, which retains point-of-care functionality—something my laboratory values—while offering a broader and more familiar parameter set for certain complex cases.
Each viscoelastic testing platform has distinct strengths and limitations, and device selection ultimately depends on institutional needs, patient populations, and clinical workflows. For example, our obstetrics team recently approached me regarding viscoelastic testing for postpartum hemorrhage management. We completed a formal assessment comparing the ROTEM Sigma and Quantra. Although the team was accustomed to ROTEM-type data, they ultimately felt the Quantra better met their clinical needs, and we are now completing validation.
I continue to believe there is value in maintaining a ROTEM platform within the laboratory. As a result, our institution may ultimately operate two or even three different viscoelastic testing systems, each deployed where it provides the greatest clinical value.
Chris Gillespie, can you add to what’s been said about viscoelastic testing and its applications and the directions it’s going?
Chris Gillespie (HemoSonics): The challenge with viscoelastic testing now is the tests are indications based. At HemoSonics we are focusing on expanding the indications to reduce the burden on the laboratory. If the test is used off-label or without an indication, it changes the test to high complexity, which puts additional burdens on the laboratory. For example, we recently received approval for peripartum obstetric procedures. As the first and only viscoelastic testing system with this indication, hospitals now have an on-label solution for their obstetric patients.
One of the themes in the instrument roundtables in the past two years has been IT problems, particularly with cybersecurity. Sometimes the cybersecurity clearance for instruments is a long line to get around. Andrew Goodwin, have you experienced that at your site?
Dr. Goodwin (University of Vermont): Yes. We have an involved review when we bring in new instrumentation. Part of it is we want to do the right thing, but part of it is because we had a 25-day downtime following a cyberattack [in 2020]. Making sure systems are secure and operating in the best interest of the patient is critically important.
Oksana Volod, do you have a comment to make about IT?
Dr. Volod (Cedars-Sinai): When we bring an assay in-house, we typically consider all key stakeholders, but IT is sometimes overlooked. We recently encountered a situation where we were ready to implement an assay, yet the process could not move forward because of IT-related limitations. This highlights the need for laboratories to recognize IT as a critical stakeholder from the very beginning. Early discussions should include what type of assay is being implemented, the data and connectivity requirements, and whether middleware will be needed. Taking a proactive approach to IT involvement upfront ultimately streamlines implementation and avoids delays later on.