Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.
Journal
ASAIO journal (American Society for Artificial Internal Organs : 1992)
ISSN: 1538-943X
Titre abrégé: ASAIO J
Pays: United States
ID NLM: 9204109
Informations de publication
Date de publication:
01 01 2022
01 01 2022
Historique:
pubmed:
16
9
2021
medline:
2
2
2022
entrez:
15
9
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34524147
doi: 10.1097/MAT.0000000000001572
pii: 00002480-202201000-00003
pmc: PMC8700308
doi:
Substances chimiques
Anticoagulants
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
14-20Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.
Déclaration de conflit d'intérêts
Disclosure: Dr. Macaluso is a Medtronic consultant and Advisory Board, Abbott consultant, Novartis Speaker, Astra Zeneca Speaker, United Therapeutics Speaker, Pfizer Speaker. Dr. Slaughter is in Medtronic steering committee, and received research grant funding Medtronic. Dr. Wieselthaler is a Medtronic Consultant. Dr. Feller is in Medtronic Advisory Board. Dr. Pagani is a member of the Scientific Advisory Board for FineHeart, Inc., member of the data safety monitoring board for Carmat, Inc., member of the data safety monitoring board for the National Heart, Lung, and Blood Institute PumpKIN clinical trial, and Chair, The Society of Thoracic Surgeons Intermacs Task Force. The other authors have no conflicts of interest to report.
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