Krishna Ram, Sysmex has introduced new ventures in coagulation. Tell us how that’s going and what your reaction is to the educational challenge.
Krishna Ram, senior product marketing manager, hemostasis portfolio, IVD product marketing, Sysmex: Sysmex America began selling hemostasis instruments and reagents under the Sysmex brand in the U.S. in April 2024, but hemostasis testing is not new for Sysmex in other areas of the world. As DOAC prevalence increases, it doesn’t necessarily negate warfarin. There are still clinicians who prefer warfarin. Overdoses remain a worry; that will never disappear. But the idea of being able to manage and monitor these patients in the short term makes warfarin still a much-needed anticoagulant.
Clinical need, driven by clinicians and pharmacies, has driven the use of apixaban and rivaroxaban, less so edoxaban, specifically in the U.S. As patients are prescribed these DOACs, laboratories have to keep up. Reference laboratories are already ahead of the curve, but what about other laboratories, community hospitals—will they keep ahead? If we look at the number of publications coming out, there are numerous advocating anti-Xa assays for low-molecular-weight and unfractionated heparin but also DOACs, rather than the use of APTT.
It used to be a standard part of Mike Laposata’s lecture to talk about how with hematologist-oncologists, or hem-oncs, it was small “hem,” big “onc.” And if you go to the American Society of Hematology meeting, you see it’s a cancer meeting and it’s hard to find a coagulation analyzer there. Andrew Goodwin, are we missing a single point of getting together that would help with the education?
Dr. Goodwin (University of Vermont): Since I’ve been a physician at UVM, I’ve been fortunate because we have a dedicated group of hematologists who are part of the thrombosis and hemostasis program. They are truly the so-called classical benign hematologists. This group has a further subspecialty interest in coagulation. I thought the rest of the world worked that way until I went to meetings and realized it’s not. There is crossover, but specializing in coagulation medicine is increasingly its own subspecialty requiring expertise. When I’m on call, our clinical colleagues are relying on the laboratory or classical benign hematologists to help and guide them in their decision-making.
We must continue to educate the hematology-oncology community at large, and in the areas where dedicated hematologists are interested in this, we need to collaborate with them to educate the physician community. That’s the approach I’ve taken at UVM, and I remain fortunate to be part of the thrombosis and hemostasis program.
Claudia Escobar, how many other sites have dedicated benign hematologists?
Claudia Escobar (Diagnostica Stago): Unfortunately, not many. And I think the lack of education stands throughout the health care system, not just the clinicians or in nursing, but also laboratorians—they don’t want to deal with coagulation. They say it’s too complex.
Several years ago, we collaborated with Dot Adcock on a publication regarding anticoagulant impact on all types of coagulation assays, and we share it with our customers. Some don’t do a heparin neutralization. Ninety-nine percent don’t do a DOAC-Stop. But at least this information gives them an idea of what might be happening with their patient. Overall, coagulation education is lacking.
Madeline Wiegman, I assume the staffing shortage we see across the board in laboratories compounds the problem, particularly for senior leaders, not only pathologists but senior medical laboratory scientists.
Madeline Wiegman (Werfen): Absolutely. From a manufacturer’s standpoint, there are a few important sticking points. One is education—on basic coagulation, case studies, and what to do in situations such as appropriate testing for patients transitioning from a DOAC to unfractionated heparin therapy. The other is to create tools to help technologists during this challenging time. If you’re lucky, you have a dedicated coagulation technologist. If not, they’re a generalist, so they’re not sitting in front of one coagulation analyzer all day. Vendors need to innovate with our solutions. How can we make our instruments easier to use? How can we make our systems easier for laboratory management? How can we automate and standardize? On Werfen’s ACL Top Family, we automated preanalytical checks for coagulation, making sure it’s standardized without variability from technologist to technologist, lab to lab. On our recently cleared ACL Top Family 70 series, we’ve automated many performance verifications, such as lot-to-lot testing. You can transmit the data from the 70 series into our HemoHub middleware solution, which automates data analysis and reporting.
As manufacturers, we need to listen to our customers, laboratorians and thought leaders, and think about how we can continue to improve our products with workflow improvements, such as lab decision support within our platforms, software, and middleware, to make things easier.