Abstract 13350: High-Dose Supplementation of Selenium in Patients Receiving an Implantation of Left Ventricular Assist Device: A Double-Blinded, Randomized, Controlled Pilot Study

• Published in: Circulation (New York, N.Y.) Vol. 138; no. Suppl_1 Suppl 1; p. A13350
• Main Authors: Stoppe, Christian, Laaf, Elena, Hill, Aileen, Zayat, Rachad, Moza, Ajay, Marx, Gernot, Goetzenich, Andreas, Schälte, Gereon, Heyland, Daren, Benstoem, Carina
• Format: Journal Article
• Language: English
• Published: by the American College of Cardiology Foundation and the American Heart Association, Inc 06.11.2018
• ISSN: 0009-7322; 1524-4539

IntroductionAn increasing number of patients require implantation of left ventricular assist device (LVAD) for the management of their end-stage heart failure. Organ dysfunctions and infectious complications belong to the most common adverse events, resulting from inflammation and oxidative stress. The essential trace element selenium is considered as cornerstone of the antioxidant defense mechanisms, which may offer therapeutic benefits.HypothesisSelenium supplementation provides beneficial effects after LVAD implantation.MethodsAdult patients scheduled to undergo LVAD implantation (destination therapy) were randomized to receive 300μg of sodium-selenite the evening before surgery, followed by high dose IV selenium supplementation (3000μg after induction, 1000μg on ICU admission, and 1000μg daily in ICU) or placebo. Patients with known severe renal dysfunction & chronic liver disease were excluded. The main outcomes of the pilot study were to determine its efficacy, feasibility (recruitment rates) and monitoring of adherence to the protocol. In an explorative approach, we evaluated major clinical endpoints, for the following confirmatory study.ResultsIn total, 20 patients met the inclusion criteria. The average recruitment rate was 1.5 patients/month (0-3). The average duration of the study intervention was 12.6 days (7-14) and there was a 97.7% compliance with dose administration. During the postoperative course, the inflammatory response, assessed by IL6 was similar between the groups. The number and duration of organ dysfunctions, requiring the need for ICU support was comparable. The placebo group showed a no significant faster recovery in this small cohort 12.5h (0.1-29.4) vs 20.5h (0.2-28.2). The intervention group presented a higher cardiac output, higher systolic and mean blood pressures, as well as lower pulmonary and central venous blood pressures on the 1. day of surgery.ConclusionsSelenium supplementation in patients receiving LVAD implantation was feasible and showed efficacy on patients` outcomes. A larger, more definitive trial is currently being planed.