Background—: Left ventricular assist device–supported patients are usually anticoagulated with a combination of aspirin and vitamin K antagonists. Long-term vitamin K antagonist therapy can be complicated by unstable international normalized ratio values and patient-related compliance problems. Therefore, direct thrombin inhibitors may represent an alternative to vitamin K antagonists. Methods and Results—: Thirty HeartWare ventricular assist device patients with stable renal function were planned for this prospective, randomized, open-label, single-center study. Patients were randomized to receive either phenprocoumon or dabigatran in addition to aspirin for long-term anticoagulation. Treatment duration was scheduled for 1 year and stopped after observation of a primary end point. Dabigatran dose was 110 and 75 mg BID in patients with normal or impaired renal function (glomerular filtration rate >80 mL/min or between 80 and 30 mL/min, respectively). The study was stopped prematurely for safety reasons after 16 patients (61±8 years, 1 female) were randomized. Thromboembolic events occurred in 4 subjects receiving dabigatran (50%) and in 1 receiving phenprocoumon (13%; P =0.28). No major bleeding was recorded, and no patient died during the study. Median time to treatment termination was significantly shorter in dabigatran patients (8.5 versus 12.0 months; P =0.015). Conclusions—: Thromboembolic events on dabigatran led to early termination of a randomized controlled trial of dabigatran versus phenprocoumon in left ventricular assist device patients. Clinical Trial Registration—: https://www.clinicaltrials.gov . Unique identifier: NCT02872649.

Mechanical circulatory support (MCS) using left ventricular assist devices (LVAD) have considerably improved the quality of life and survival rate of patients with end-stage heart failure. Despite substantial technological progress, major challenges with regard to VAD-specific and VAD-related infections have hitherto hindered the broader application of this promising therapy approach. Driveline infections (DLI) range among the main adverse events experienced in LVAD patients. However, many centers still apply their own protocol for driveline exit site (DLES) care and an international standard on prevention, reduction and early treatment of DLI after the perioperative period has not yet been defined. In March 2019, VAD coordinators and cardiac surgeons from Germany and Austria met to develop a standard of care procedure (SOP) as well as a new staging approach with recommended actions for treatment of VAD carriers. In this Driveline Expert STagINg and carE (DESTINE) study group we developed a 10-step SOP for DLES care with emphasis on essentials such as clean and save preparation, sterile dressing change and secure driveline immobilization. An advanced wound staging approach was defined with recommended actions for prevention, early detection and stage-related management of DLI. Broad consensus was reached on the fact that an interdisciplinary approach both in DLES care and DLES healing disorder awareness is required to prolong infect-free survival times on MCS as well as to ensure high patient compliance and quality of life. In conclusion, a new detailed SOP for appropriate DLES care and an advanced wound staging approach for prevention and management of DLI were defined on an expert level applicable for VAD clinicians, practitioners and care givers in Central Europe.