Evaluation of adjusted international normalized ratio goal in patients with HeartMate 3 left ventricular assist devices.
advanced heart failure
anticoagulation
left ventricular assist device
warfarin
Journal
Artificial organs
ISSN: 1525-1594
Titre abrégé: Artif Organs
Pays: United States
ID NLM: 7802778
Informations de publication
Date de publication:
Oct 2023
Oct 2023
Historique:
revised:
08
04
2023
received:
30
12
2022
accepted:
28
04
2023
medline:
30
10
2023
pubmed:
15
5
2023
entrez:
15
5
2023
Statut:
ppublish
Résumé
The HeartMate3 left ventricular assist device (HM3 LVAD) has shown a low incidence of thrombosis, but bleeding risk is as high as 43%. We aim to describe the impact of lower international normalization ratio (INR) goal on clinical outcomes. In February 2019, our tertiary care institution lowered INR goal in HM3 patients from manufacturer recommendations to 1.8-2.2 and retrospectively analyzed the data. Two cohorts were compared: patients with lower INR goal upon implant (De novo) and those with subsequently lowered INR goal (Adjusted). The Adjusted group also served as its own historical control. Both groups continued aspirin 81 milligrams daily per manufacturer recommendations. The primary outcomes were incidences of bleed and thrombosis events within 12 months. Secondary outcomes included survival free of disabling stroke or reoperation to remove or replace the device and Rosendaal time in therapeutic range (TTR) over 12 months. Thirty-one patients were evaluated for inclusion with 26 meeting criteria. Within 12 months, incidence of bleeding events was 25% and 28.6% in the De novo and Adjusted groups, respectively. Incidence of thrombotic events within 12 months was 0% in the De novo group and 7.1% in the Adjusted group. Twelve-month survival free of disabling stroke or reoperation to remove or replace the device was higher over 12 months for patients in the De novo group (91.7% vs. 78.6%). Median 12-month TTR was 36%, which was primarily attributable to subtherapeutic deviations. A lower INR goal may be safe when initiated De novo following implantation of the HM3. This study informs the need for larger prospective studies.
Sections du résumé
BACKGROUND
BACKGROUND
The HeartMate3 left ventricular assist device (HM3 LVAD) has shown a low incidence of thrombosis, but bleeding risk is as high as 43%. We aim to describe the impact of lower international normalization ratio (INR) goal on clinical outcomes.
METHODS
METHODS
In February 2019, our tertiary care institution lowered INR goal in HM3 patients from manufacturer recommendations to 1.8-2.2 and retrospectively analyzed the data. Two cohorts were compared: patients with lower INR goal upon implant (De novo) and those with subsequently lowered INR goal (Adjusted). The Adjusted group also served as its own historical control. Both groups continued aspirin 81 milligrams daily per manufacturer recommendations. The primary outcomes were incidences of bleed and thrombosis events within 12 months. Secondary outcomes included survival free of disabling stroke or reoperation to remove or replace the device and Rosendaal time in therapeutic range (TTR) over 12 months.
RESULTS
RESULTS
Thirty-one patients were evaluated for inclusion with 26 meeting criteria. Within 12 months, incidence of bleeding events was 25% and 28.6% in the De novo and Adjusted groups, respectively. Incidence of thrombotic events within 12 months was 0% in the De novo group and 7.1% in the Adjusted group. Twelve-month survival free of disabling stroke or reoperation to remove or replace the device was higher over 12 months for patients in the De novo group (91.7% vs. 78.6%). Median 12-month TTR was 36%, which was primarily attributable to subtherapeutic deviations.
CONCLUSIONS
CONCLUSIONS
A lower INR goal may be safe when initiated De novo following implantation of the HM3. This study informs the need for larger prospective studies.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1613-1621Informations de copyright
© 2023 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.
Références
Mehra M, Uriel N, Naka Y, Cleveland JC Jr, Yuzefpolskaya M, Salerno CT, et al. A fully magnetically levitated left ventricular assist device-final report. N Engl J Med. 2019;380(17):1618-27.
Mehra M, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, et al. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2017;376(5):440-50.
Netuka I, Ivák P, Tučanová Z, Gregor S, Szárszoi O, Sood P, et al. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018;37(5):579-86.
Mehra M. The burden of haemocompatibility with left ventricular assist systems: a complex weave. Eur Heart J. 2019;40(8):673-7.
Marshall D, Sanchez J, Yuzefpolskaya M, Sayer GT, Takeda K, Naka Y, et al. Safety of reduced anti-thrombotic strategy in patients with HeartMate 3 left ventricular assist device. J Heart Lung Transplant. 2021;40:237-40.