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Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.

Publication ,  Journal Article
Macaluso, GP; Pagani, FD; Slaughter, MS; Milano, CA; Feller, ED; Tatooles, AJ; Rogers, JG; Wieselthaler, GM
Published in: ASAIO J
January 1, 2022

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.

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Published In

ASAIO J

DOI

EISSN

1538-943X

Publication Date

January 1, 2022

Volume

68

Issue

1

Start / End Page

14 / 20

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • International Normalized Ratio
  • Humans
  • Hemorrhage
  • Biomedical Engineering
  • Atrial Fibrillation
  • Anticoagulants
  • 4003 Biomedical engineering
  • 0903 Biomedical Engineering
 

Citation

APA
Chicago
ICMJE
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Macaluso, G. P., Pagani, F. D., Slaughter, M. S., Milano, C. A., Feller, E. D., Tatooles, A. J., … Wieselthaler, G. M. (2022). Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients. ASAIO J, 68(1), 14–20. https://doi.org/10.1097/MAT.0000000000001572
Macaluso, Gregory P., Francis D. Pagani, Mark S. Slaughter, Carmelo A. Milano, Erika D. Feller, Antone J. Tatooles, Joseph G. Rogers, and Georg M. Wieselthaler. “Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.ASAIO J 68, no. 1 (January 1, 2022): 14–20. https://doi.org/10.1097/MAT.0000000000001572.
Macaluso GP, Pagani FD, Slaughter MS, Milano CA, Feller ED, Tatooles AJ, et al. Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients. ASAIO J. 2022 Jan 1;68(1):14–20.
Macaluso, Gregory P., et al. “Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.ASAIO J, vol. 68, no. 1, Jan. 2022, pp. 14–20. Pubmed, doi:10.1097/MAT.0000000000001572.
Macaluso GP, Pagani FD, Slaughter MS, Milano CA, Feller ED, Tatooles AJ, Rogers JG, Wieselthaler GM. Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients. ASAIO J. 2022 Jan 1;68(1):14–20.

Published In

ASAIO J

DOI

EISSN

1538-943X

Publication Date

January 1, 2022

Volume

68

Issue

1

Start / End Page

14 / 20

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • International Normalized Ratio
  • Humans
  • Hemorrhage
  • Biomedical Engineering
  • Atrial Fibrillation
  • Anticoagulants
  • 4003 Biomedical engineering
  • 0903 Biomedical Engineering