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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., (© 2021 International Center for Artificial Organs and Transplantation and Wiley Periodicals LLC.)

There are no evidence-based guidelines for antithrombotic therapy in left ventricular assist device patients. We evaluated the efficacy of a multi-agent, test-guided protocol, which remained consistent throughout our use of the Heartware HVAD. Thrombelastography and platelet function analyzer (PFA)-100 guide antiplatelet titration. Goals are normal kaolin thrombelastography maximum amplitude and prolonged PFA-100. We analyzed incidence and rates of nonprocedural bleeding, stroke, and pump thrombosis for all 81 primary Heartware left ventricular assist devices implanted since 2011. For each event, we examined whether each test was within goal range. We also compared medication burden and dosage between patients with and without events. Pump thrombosis and hemorrhagic stroke each occurred in two patients (2.5%; 0.03 events/patient-year [EPPY]), and ischemic stroke in six (7.4%; 0.10 EPPY). Nonprocedural bleeding occurred 75 times in 34 patients (42%; 1.24 EPPY), primarily gastrointestinal (28%; 0.66 EPPY). Subtherapeutic international normalized ratio (INR) was the most common at thrombotic events; supratherapeutic partial thromboplastin time, international normalized ratio (INR), and PFA-adenosine diphosphate (ADP) were common at bleeding events. Medication burden and dosage were lower in patients with events than in stable patients. Protocol-guided antithrombotic therapy resulted in low rates of pump thrombosis and hemorrhagic stroke. Ischemic stroke and gastrointestinal bleeding rates were higher than in a comparable HVAD population. Optimization of our protocol to decrease its complexity and to reduce bleeding is underway.

Background: We previously investigated preoperative variables associated with qualitative inflow cannula malposition in the HeartMate II (Thoratec-Abbott, Abbott Park, IL) continuous-flow left ventricular assist device. In this report, we assess inflow cannula malposition quantitatively in recipients of both the HeartMate II and the HeartWare (Medtronic-HeartWare, Minneapolis, MN) and examine its association with device thrombosis., Methods: Malposition was quantified based on angular deviation from a hypothetic ideal inflow cannula position in two orthogonal computed tomography imaging planes. Ideal position lies on a line from the apex to the center of the mitral valve. Positive anterior plane angulation indicates deviation toward the superior free wall; negative, toward the inferior wall. Positive lateral plane angulation indicates deviation toward the septum; negative, toward the lateral wall. Device thrombosis was assessed based on clinical criteria., Results: Fifty-four HeartMate II patients and 68 HeartWare patients were analyzed. Inflow cannula deviation was significantly higher for HeartMate II than for HeartWare (anterior plane angle 36.7 ± 16.8 versus -18.7 ± 11.6 degrees, p < 0.001; lateral plane angle 23.7 ± 20.1 versus 0.2 ± 15.0 degrees, p < 0.001. Pump thrombosis occurred in 31% of HeartMate II patients and 2.9% of HeartWare patients (p < 0.001). In a multivariate model, HeartMate II and increasing inflow cannula deviation toward the septum were associated with higher thrombosis risk (odds ratio 1.35 per 10-degree increase)., Conclusions: We found distinct device-dependent differences in inflow cannula positioning and thrombosis, with HeartWare showing both less malposition and less thrombosis. Malposition toward the ventricular septum may contribute to pump thrombosis through a vicious cycle of suction events, low flow, and speed reduction., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Jarvik 2000, an axial flow ventricular assist device (VAD), is currently under investigation for bridge to transplant (BTT) indications. The principal advantage of the Jarvik device is intraventricular pump placement. This eliminates the inflow cannula and pump pocket and allows for uncomplicated left ventricular implantation without sternotomy. Here we describe the evolution of our surgical implantation and explantation technique. Methods: Data for all patients undergoing implantation of a left VAD (LVAD) (n = 35) at the University of Maryland between September 2002 and September 2010 were retrospectively reviewed. Preoperative patient demographics and clinical status and operative technique and outcomes were reviewed. Results: A simple technique for enclosing the pump and outflow graft greatly simplifies the explantation procedure and reduces the risk of lung adhesions and injury. Off-pump implantation reduces operative time and intraoperative red cell transfusions but carries a risk of incomplete ventricular coring, which may precipitate pump thrombosis. The benefits of the left thoracotomy approach were seen in the reduced need for intraoperative red cell transfusion and reduced total intensive care unit (ICU) stay for patients who had undergone previous sternotomy. Conclusions: The Jarvik 2000 has several distinctive features that simplify surgical management and permit flexible application in an expanded range of candidates for LVAD implantation, particularly in patients who have undergone previous sternotomy. [ABSTRACT FROM AUTHOR]