Why the study?
Does 4-factor prothrombin complex concentrate (4F-PCC) improve the safety and efficacy of vitamin K antagonist reversal compared to traditional agents in LVAD patients with intracranial hemorrhage?
Does 4-factor prothrombin complex concentrate (4F-PCC) improve the safety and efficacy of vitamin K antagonist reversal compared to traditional agents in LVAD patients with intracranial hemorrhage?
4F-PCC-assisted VKA reversal in LVAD patients with ICH is safe and more efficient than traditional agents, while carefully selected patients with small ICH may be managed without active reversal.
Supports 4F-PCC for faster VKA reversal in LVAD-ICH; leaves open randomized confirmation before practice change.
The safety of alternative vitamin K antagonist (VKA) reversal strategies in patients with left ventricular assist devices (LVAD's) who present with intracranial hemorrhage (ICH) are not well known. A review of LVAD patients with ICH from May 2008 to 2015 was conducted, comparing the safety and efficacy of 4-factor prothrombin complex concentrate-assisted VKA reversal (4F-PCC group, n = 10) to reversal with traditional agents alone (no-PCC group, n = 10). An analysis of a no-reversal strategy in selected patients (n = 11) with ICH was additionally performed. Thirty-one cases of ICH on LVAD support were reviewed. The rate of post reversal thromboembolic events was not significantly different between 4F-PCC and no-PCC patients (0% vs. 10%, p = 1.0); however, the time to VKA reversal was shorter (474 vs. 945 minutes, p = 0.02) and fresh frozen plasma (FFP) requirements lower (1.9 vs. 3.6 units, p = 0.05) in 4F-PCC patients, with no difference in mortality between groups (p = 1.0). Eleven patients (mean ICH volume: 0.4 cm) were successfully managed without active VKA reversal, with no increased hemorrhage noted on neuroimaging. These results suggest that 4F-PCC-assisted reversal in LVAD patients is safe and may improve the efficacy of VKA reversal. Our findings also indicate that carefully selected patients with small ICH volumes may be safely managed by discontinuing anticoagulation and allowing the international normalized ratio (INR) to normalize physiologically.
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Wong et al. (2016) studied this question.
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