Intraoperative prothrombin complex concentrate administration and outcomes in patients undergoing left ventricular assist device implantation

Abstract

Prothrombin complex concentrate (PCC) administration has increased among cardiac surgery patients in recent years; however, use in LVAD implantation/exchange is not widespread due to the fear of thrombotic complications. The purpose of this study was to compare the clinical outcomes of patients undergoing LVAD implantation/exchange with intraoperative PCC administration versus traditional transfusion practices alone. Adult LVAD implants/exchanges at our institution between 2015 and 2018 were included. Patients were categorized as receiving intraoperative PCC or no-PCC (traditional). The primary outcome was the need for allogenic transfusion and transfusion volume at 48 hours after initial intensive care unit (ICU) admission.Secondary outcomes included metrics of morbidity and mortality. A total of 160 patients (39 PCC, 121 traditional) were analyzed. In unadjusted analysis, patients in the PCC group received lower intraoperative transfusion volumes compared to the traditional group although not statistically significant (1464 mL [IQR 796, 4876] vs.2568 mL [IQR 1292, 3606]; P value .37). In the fully adjusted analysis, patients in the PCC group had increased odds of transfusion within 48 hours of ICU admission (OR 4.06, 95% CI: 1.35-12.20; P < .01); however, there was no significant difference in transfusion volumes (P = .09). Patients receiving PCCs had higher incidence of deep vein thrombosis (10.3% vs. 0%; P < .01) and 30-day mortality (17.9% vs. 4.1%; P < .01). LVAD pump thrombosis occurred in 2.6% versus 0.8% in the PCC and traditional groups, respectively; P = .98. Patients undergoing LVAD implantation and exchange represent a complex surgical cohort. The results of this study suggest that the intraoperative PCC use during LVAD implant/exchange was associated with reduced intraoperative transfusions. Intraoperative PCC use was, however, associated with higher odds of postoperative transfusion, although transfusion volumes were not significantly different. While the deep vein thrombosis and 30-day mortality rates were higher in the PCC group, these results are likely related to the degree of surgical and patient complexity rather than PCC use itself. Further studies are needed to assess PCC use in this surgical cohort.

Use of plasma late on cardiopulmonary bypass in patients undergoing left ventricular assist device implantation

“…Bleeding and right ventricular dysfunction are associated with morbidity and mortality in patients undergoing LVAD implantation 9,10,14 . Management strategies designed to limit volume overload and reduce right ventricular dysfunction, such as the use of prothrombin complex concentrates, have been described, though concerns regarding safety have limited widespread adoption 15 . An alternative transfusion technique unique to cardiac surgery is the administration of plasma late on CPB, which theoretically allows for the augmentation of factor levels while preserving the ability to remove excess volume via ultrafiltration.…”

“…been described, though concerns regarding safety have limited widespread adoption. 15 An alternative transfusion technique unique to cardiac surgery is the administration of plasma late on CPB, which theoretically allows for the augmentation of factor levels while preserving the ability to remove excess volume via ultrafiltration. The purpose of this study was to compare perioperative outcomes for patients undergoing LVAD implantation receiving plasma late on CPB to similar patients who did not receive plasma on bypass.…”

Coagulation and Transfusion Updates From 2021

“…Similarly, there was a nonsignificant trend toward higher LVAD pump thrombosis with PCC (2.6% v 0.8%, p = 0.98). 33 In another retrospective investigation of activated PCC (factor VIII inhibitor bypassing activity [FEIBA]) for post-LVAD coagulopathy, FEIBA use was associated with no increase in 14-day thrombotic outcomes (11.0% v 7.6%, p = 0.343) or mortality rate (3.7% v 1.3%, p = 0.179). 34 Although the authors suggested a favorable risk-benefit profile for FEIBA use in LVAD surgery, they acknowledged that future studies still are required to fully assess the safety profile.…”

Prothrombin Complex Concentrate vs Plasma for Post–Cardiopulmonary Bypass Coagulopathy and Bleeding

“…Distinct advantages to PCC administration include higher factor concentration with significantly less infusate volume, ambient storage (ie, at room temperature) with rapid reconstitution, not having to worry about ABO blood group compatibility, and lower risk of transfusion-related complications . To our knowledge, data evaluating the use of PCCs in this population are limited to retrospective studies and 2 prospective pilot studies, which have demonstrated faster return of the international normalized ratio (INR) to the target range, reduced blood loss and transfusion requirements, more effective hemostasis, and an adverse event rate similar to that of plasma transfusion …”

“…5 To our knowledge, data evaluating the use of PCCs in this population are limited to retrospective studies and 2 prospective pilot studies, which have demonstrated faster return of the international normalized ratio (INR) to the target range, reduced blood loss and transfusion requirements, more effective hemostasis, and an adverse event rate similar to that of plasma transfusion. 3,[6][7][8][9][10][11][12][13][14][15] The purpose of this study was to analyze perioperative outcomes in patients undergoing CPB surgery, with particular fo-cus on bleeding, transfusion, and thrombotic complications. We hypothesized that PCC use would reduce bleeding and transfusion requirements in cardiac surgical patients without increasing thrombotic complications.…”