Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients. Issue 1 (January 2022)

• Record Type: Journal Article
• Authors: Macaluso, Gregory P.; Pagani, Francis D.; Slaughter, Mark S.; Milano, Carmelo A.; Feller, Erika D.; Tatooles, Antone J.; Rogers, Joseph G.; Wieselthaler, Georg M.
• Is Part Of: ASAIO journal. Volume 68:Issue 1(2022)
• Publication Date: 2022-01
• Subjects: left ventricular assist device -- time in therapeutic range -- destination therapy -- HVAD; Artificial organs -- Periodicals; 617
• DOI: 10.1097/MAT.0000000000001572
• Languages: English
• ISSNs: 1058-2916

Abstract

Abstract : The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0–3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1–24 months postimplant and were categorized as: low TTR (10–39%), moderate TTR (40–69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs . 0.54 events per patient year [EPPY]; p < 0.001), GI bleeding (1.22 vs. 0.38 EPPY; p < 0.001), stroke (0.47 vs. 0.17 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.02), infection (1.44 vs. 0.69 EPPY; p < 0.001), and renal dysfunction (0.23 vs. 0.05 EPPY; p < 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs . 0.54 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.007), cardiac arrhythmia (0.32 vs. 0.24 EPPY; p = 0.04), and infection (0.90 vs. 0.69 EPPY; p = 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p = 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management. Abstract : Supplemental Digital Content is available in the text.