Search

Left ventricular assist device outflow graft stenosis is a rare but life-threatening complication of mechanical cirulatory support therapy. Current treatment modalities (pump exchange or systemic thrombolytic therapy) are associated with significant mortality and morbidity. Implantation of bare metal stents within the stenosed outflow graft is an alternative. Herein, we describe a series of three cases with successful stent placement. This seems to be safe and successful; however, correct and early diagnosis of outflow stenosis can be challenging. Information provided by the HeartWare ventricular assist device (HVAD) logfiles is extremely helpful for diagnosis.

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.