Key result
A revised antithrombotic protocol decreased the gastrointestinal bleeding rate compared to the original protocol (0.30 vs 0.66 EPPY, P=.003), but increased the incidence of pump thrombosis.
Why the study?
An original antithrombosis protocol in HeartWare recipients yielded low pump thrombosis and hemorrhagic stroke but increased bleeding, prompting implementation of a revised protocol to reduce complexity and bleeding.
Does a revised antithrombotic protocol with decreased antiplatelet use and anticoagulation intensity reduce bleeding and thrombotic events in HeartWare HVAD recipients?
Cohort (n=123)
Does a revised antithrombotic protocol with decreased antiplatelet use and anticoagulation intensity reduce bleeding and thrombotic events in HeartWare HVAD recipients?
A revised, lower-intensity antithrombotic protocol successfully reduced bleeding rates but significantly increased the risk of pump thrombosis in HeartWare HVAD recipients.
Answers are grounded in this paper and cite their sources.
Revised protocol may reduce GIB and bleeding in HVAD recipients; leaves open whether TEG/PFA guidance improves net outcomes.
We previously reported low rates of pump thrombosis and hemorrhagic stroke, but increased bleeding, under our original antithrombosis protocol (P1) in HeartWare recipients. We designed and implemented a revised protocol (P2) to reduce complexity and bleeding. Thrombelastography and PFA-100 guide antiplatelet titration. Goals for P2 were altered to decrease antiplatelet use and anticoagulation intensity. We compared the incidence and rates of gastrointestinal bleeding (GIB), embolic (eCVA) and hemorrhagic (hCVA) stroke, pump thrombosis (PT), and total bleeding (GIB+hCVA), total thrombosis (eCVA+PT), and total events between P1 and P2. Laboratory and medication data were assessed. Patients with and without hemocompatibility-related adverse events (HRAEs) were compared. The study included 123 patients (P1: 65; P2: 58). GIB rate decreased (P1: 0.66; P2 0.30 EPPY, P = .003). CVA rates and incidence were statistically similar, although hCVA incidence increased (P1: 3%; P2: 12%, P = .06). Incidence (P1: 3%; P2: 16%, P = .02) and rate (P1: 0.03; P2: 0.12 EPPY, P = .08) of PT increased. Incidence and rate of overall HRAEs and thrombotic events were similar, while bleeding rate decreased (P1: 0.69; P2: 0.40 EPPY, P = .02). Twelve-month medication burden decreased. Compared to non-HRAE patients, patients with bleeding HRAEs had more antiplatelet and pentoxifylline use, but less statin use; and lower PFAs. Patients with thrombotic HRAEs had less dual antiplatelet use, lower INRs, R-times, and PFA-ADP values. A revised antithrombotic protocol decreased GIB and overall hemorrhagic HRAE rate and medication burden. Unfortunately, PT increased. Non-HRAE and HRAE patients differed in anticoagulation and antiplatelet intensity. These differences will guide the revision of P2.
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Sorensen et al. (2021) conducted a cohort in HeartWare HVAD recipients (n=123). Revised antithrombotic protocol (P2) vs. Original antithrombotic protocol (P1) was evaluated on Gastrointestinal bleeding (GIB) rate (p=.003). A revised antithrombotic protocol decreased the gastrointestinal bleeding rate compared to the original protocol (0.30 vs 0.66 EPPY, P=.003), but increased the incidence of pump thrombosis.
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