Efficacy and Safety of Enoxaparin as Bridging Anticoagulant Therapy After Ventricular Assist Device Implantation
The implantation of a ventricular assist device has become an increasingly common method in the treatment of end-stage heart failure in recent years. The implantation of the device necessitates anticoagulant therapy. In the long term, warfarin is most often used according to guidelines, but there are no clear recommendations for early postoperative anticoagulant therapy. The aim of a clinical study published last year was to evaluate the efficacy and safety of enoxaparin as bridging anticoagulant therapy after device implantation within a 3-month postoperative period.
Introduction
Ventricular assist devices are intended as a bridge to heart transplantation for patients whose lives are at risk due to refractory end-stage heart failure. In some cases, they are also used as a final mode of therapy. The number of ventricular assist device implantations has been increasing in recent decades, which, along with undeniable benefits, also brings complications such as thrombosis or bleeding due to anticoagulant therapy. To reduce the risk of thromboembolic complications, early initiation of chronic anticoagulant therapy, most commonly in the form of the vitamin K antagonist warfarin, is recommended.
Specialist societies recommend parenteral administration of anticoagulant therapy in the form of unfractionated heparin before achieving effective INR levels. Low molecular weight heparins, such as enoxaparin, also appear to be a promising alternative method. However, sufficient evidence regarding the safety and efficacy of this method of early anticoagulant therapy was lacking. To elucidate this topic further, a clinical study was conducted to evaluate the efficacy and safety of anticoagulant therapy with enoxaparin during the 3-month period following ventricular assist device implantation.
Methodology, Course, and Study Goals
In a retrospective clinical study conducted at two centers, 250 patients who underwent ventricular assist device implantation between January 2017 and December 2018 were included. In the postoperative period, they were assigned to therapy with enoxaparin or unfractionated heparin.
The primary goal was to assess the incidence of cerebrovascular ischemic and hemorrhagic complications and clinically significant bleeding events. The secondary goal was to evaluate the length of hospitalization.
Findings
During hospitalization, data from 250 patients were evaluated, and after discharge, data from 246 patients (4 died during hospitalization) were assessed.
No significant difference was observed between the therapeutic groups in the incidence of cerebrovascular events (odds ratio [OR] 0.67; 95% confidence interval [CI] 0.07–6.39; p = 0.73) or severe bleeding events (OR 0.91; 95% CI 0.27–3.04; p = 0.88) during the index hospitalization. There was also no statistically significant difference in both parameters after the 3-month follow-up period (OR 0.85; 95% CI 0.31–2.34; p = 0.76). No fatal events occurred during the follow-up period.
The median length of hospitalization was 4 days shorter in the enoxaparin therapy group (p = 0.04).
Conclusion
The study results indicate that the use of enoxaparin represents an effective and safe method of anticoagulant therapy in the early postoperative period for patients after ventricular assist device implantation.
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Source: Shah Z., Mastoris I., Acharya P. et al. The use of enoxaparin as bridge to therapeutic INR after LVAD implantation. J Cardiothorac Surg 2020 Nov 14; 15 (1): 329, doi: 10.1186/s13019-020-01373-y.
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