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Evaluation of adjusted international normalized ratio goal in patients with HeartMate 3 left ventricular assist
Amanda Sowder1, Ayesha Ather1,2, Emma Birks1,3
1Department of Cardiology, University of Kentucky Healthcare, Lexington, Kentucky, USA.
Insights
Lowering the international normalization ratio (INR) goal for HeartMate3 left ventricular assist device (HM3 LVAD) patients may reduce bleeding events. A de novo approach showed promising safety and efficacy outcomes in this study.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Clinical Outcomes Research
Background:
- The HeartMate3 left ventricular assist device (HM3 LVAD) is associated with a high bleeding risk (up to 43%).
- Optimizing anticoagulation management is crucial for improving patient outcomes with HM3 LVADs.
Purpose of the Study:
- To evaluate the impact of a lowered international normalization ratio (INR) goal on clinical outcomes in patients with HM3 LVADs.
- To compare outcomes between patients receiving a lower INR goal at implantation (De novo) versus those with a subsequently adjusted INR goal.
Main Methods:
- Retrospective analysis of 26 HM3 LVAD patients after implementing a lower INR goal (1.8-2.2) in February 2019.
- Comparison of two cohorts: De novo (lower INR goal at implant) and Adjusted (subsequently lowered INR goal).
- Primary outcomes: incidence of bleeding and thrombosis within 12 months; Secondary outcomes: survival free of disabling stroke or reoperation, and time in therapeutic range (TTR).
Main Results:
- Bleeding event incidence was 25% (De novo) and 28.6% (Adjusted) within 12 months.
- Thrombotic event incidence was 0% (De novo) and 7.1% (Adjusted) within 12 months.
- Twelve-month survival free of disabling stroke or reoperation was higher in the De novo group (91.7% vs. 78.6%).
Conclusions:
- Initiating a lower INR goal (1.8-2.2) at the time of HeartMate3 LVAD implantation (De novo) appears safe and potentially reduces thrombotic events.
- Further investigation in larger, prospective studies is warranted to confirm these findings.
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:
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:
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:
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.
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