1. Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients
- Author
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Georg Wieselthaler, Joseph G. Rogers, Antone Tatooles, Gregory Macaluso, Carmelo A. Milano, Erika D. Feller, Mark S. Slaughter, and Francis D. Pagani
- Subjects
endocrine system ,medicine.medical_specialty ,Biomedical Engineering ,Biophysics ,Time in therapeutic range ,Hemorrhage ,Bioengineering ,Gastroenterology ,HVAD ,Biomaterials ,Therapeutic index ,Internal medicine ,Atrial Fibrillation ,left ventricular assist device ,medicine ,Humans ,International Normalized Ratio ,Thrombus ,Adverse effect ,Stroke ,biology ,business.industry ,Anticoagulants ,General Medicine ,medicine.disease ,Transthyretin ,Treatment Outcome ,time in therapeutic range ,Adult Circulatory Support ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,biology.protein ,destination therapy ,business ,Major bleeding ,Destination therapy - Abstract
Supplemental Digital Content is available in the text., 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.
- Published
- 2021