A Retrospective Analysis of the Use of 3-Factor Prothrombin Complex Concentrates for Refractory Bleeding After Cardiopulmonary Bypass in Children Undergoing Heart Surgery: A Matched Case-Control Study

Harris, Andrea D; Hubbard, Richard; Sam, Rebecca; Xu, Zhang; Salazar, Jorge D.; Gautam, Nischal K.

doi:10.1177/1089253219899255

Cited by 9 publications

(10 citation statements)

References 12 publications

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“…This is consistent with the other publications reporting the use of PCCs in both pediatric cardiac surgery and adult cardiac surgery. [5][6][7][8][9][10] The overall incidence of postoperative thromboembolism in our cohort of 165 neonates with a rate of 7.3% and 13.3% at POD 7 and 30, respectively, is consistent with the rate reported from other neonatal studies ranging from 9% to 30%. 14,15,22 Risk for postoperative neonatal thromboembolism is multifactorial and includes cyanosis, blood product transfusion, prolonged CPB times, use of hypothermic circulatory arrest, and indwelling central venous catheter lines.…”

Section: Discussionsupporting

confidence: 90%

“…This is lower than previously reported doses from other pediatric studies, which range from 25 to 70 IU/kg. 8–10 Our exploratory analysis found no increased risk for 7- and 30-day thrombosis rate in patients who had received ≥20 IU/kg. Based on our study findings of efficacy at lower doses, we recently reduced our starting a4FPCC dose from 10 to 5 IU/kg for neonates and titrate additional 5 IU/kg doses based on clinical effect.…”

Section: Discussionmentioning

confidence: 70%

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Activated 4-Factor Prothrombin Complex Concentrate as a Hemostatic Adjunct for Neonatal Cardiac Surgery: A Propensity Score-Matched Cohort Study

Navaratnam

Mendoza

Zhang

et al. 2022

Anesthesia &Amp; Analgesia

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BACKGROUND: Prothrombin complex concentrates are an emerging "off-label" therapy to augment hemostasis after cardiopulmonary bypass (CPB), but data supporting their use for neonatal cardiac surgery are limited. METHODS: We retrospectively reviewed neonates undergoing open heart surgery with firsttime sternotomy between May 2014 and December 2018 from a hospital electronic health record database. Neonates who received activated 4-factor prothrombin complex concentrate (a4FPCC) after CPB were propensity score matched (PSM) to neonates who did not receive a4FPCC (control group). The primary efficacy outcome was total volume (mL/kg) of blood products transfused after CPB, including the first 24 hours on the cardiovascular intensive care unit (CVICU). The primary safety outcome was the incidence of 7-and 30-day postoperative thromboembolism. Secondary outcomes included 24 hours postoperative chest tube output, time to extubation, duration of CVICU stay, duration of hospital stay, 30-day mortality, and incidence of acute kidney injury on postoperative day 3. We used linear regression modeling on PSM data for the primary efficacy outcome. For the primary safety outcome, we tested for differences using McNemar test on PSM data. For secondary outcomes, we used linear regression, Fisher exact test, or survival analyses as appropriate, with false discovery rate-adjusted P values. RESULTS: A total of 165 neonates were included in the final data analysis: 86 in the control group and 79 in the a4FPCC group. After PSM, there were 43 patients in the control group and 43 in the a4FPCC group. We found a statistically significant difference in mean total blood products transfused for the a4FPCC group (47.5 mL/kg) compared with the control group (63.7 mL/kg) for PSM patients (adjusted difference, 15.3; 95% CI, 29.4-1.3; P = .032). We did not find a statistically significant difference in 7-or 30-day thromboembolic rate, postoperative chest tube output, time to extubation, incidence of postoperative acute kidney injury (AKI), or 30-day mortality between the groups. The a4FPCC group had a significantly longer length of intensive care unit stay (32.9 vs 13.3 days; adjusted P = .049) and hospital stay (44.6 vs 24.1 days; adjusted P = .049) compared with the control group. CONCLUSIONS: We found that the use of a4FPCC as a hemostatic adjunct for post-CPB bleeding in neonatal cardiac surgery was associated with a decrease in mean total blood products transfused after CPB without an increased rate of 7-or 30-day postoperative thromboembolism. Our findings suggest that a4FPCCs can be considered as part of a hemostasis pathway for refractory bleeding in neonatal cardiac surgery.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 70%

Activated 4-Factor Prothrombin Complex Concentrate as a Hemostatic Adjunct for Neonatal Cardiac Surgery: A Propensity Score-Matched Cohort Study

Navaratnam

Mendoza

Zhang

et al. 2022

Anesthesia &Amp; Analgesia

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“…Perioperative management has also undergone substantial changes related to the conduct of anesthesia and intraoperative cardiopulmonary bypass (25)(26)(27), as well as approaches to myocardial protection with improved cardioplegia (28)(29)(30). The importance of precise general anesthesia, proper mechanical ventilation, anticoagulation and blood products management, as well as cardiopulmonary bypass strategies have allowed physicians and surgeons to pursue more aggressive treatment strategies with safety and confidence.…”

Section: Review Methodsmentioning

confidence: 99%

A narrative review of modern approach and outcomes evaluation in congenital heart defects

Corno¹,

LaPar²,

Wen³

et al. 2021

Transl Pediatr

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Objective: The purpose of this review is to highlight critical advances and innovative approaches to the most challenging clinical situations in congenital heart surgery, to establish a new perspective from which to evaluate current clinical practice patterns and contemporary United States program ranking systems. Background:The past decades have witnessed substantial advances in the treatment of congenital heart defects. New strategies are deeply rooted in calculated risk-taking innovations. Pioneer surgeons developed, improved and refined critical operative skills and techniques to optimize cardiovascular physiology, decrease operative mortality and improve clinical outcomes.Methods: Unfortunately, in the modern surgical era, supportive environments to allow surgeons to make similar gains and innovative contributions remain scarce. In the current practice, overall procedure volume is prioritized to safeguard quality metrics, including hospital survival and length of stay, surgical complications, and neurocognitive outcomes. As a result, exceptional surgical results have become translated and defined by public ranking systems such as the US News and World Report Best Children's Hospital National Ranking (USNWR) and the Congenital Heart Surgery Database of the Society for Thoracic Surgeons (CHSD-STS), primary based upon early post-operative mortality. This reality places surgeons in a vulnerable position where pressure to achieve a high clinical ranking contrasts with a surgeon definition of "acceptable" surgical risk. Currently, the most frequently used risk stratification tools do not factor in important differences in strategies, such as staged palliation versus complete repair, or bi-ventricular versus uni-ventricular physiology. This favors hospitals pursuing multistage surgical approaches, even if the result is worse long-term morbidity, mortality and increased resource utilization. This economy of ranking-based decision-making causes surgeons either avoid operating altogether or accept less advantageous multi-staged treatment strategies for patients with elevated expected mortality. Such an environment also might present much farther-reaching negative impacts on the growth and development of junior surgeons and trainees, as well as on the pursuit of new surgical innovations to aid future generations of patients.Conclusions: Risk aversive surgical behavior is creating an environment not favorable for the children born with truly complex congenital heart defects.

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“…12 Studies evaluating prothrombin complex concentrate (PCC) found that use of PCC was associated with significantly decreased 24-h postoperative blood loss when compared with fresh frozen plasma [13][14][15] without increasing the risk of thromboembolic complications or mortality. 16,17 Another recent study by Navaratnam et al found that the use of four-factor PCC as a hemostatic adjunct for post-CPB bleeding in neonatal cardiac surgery was associated with a decrease in mean total blood products transfused after CPB without an increased rate of 7-or 30-day postoperative thromboembolism. 18 A study in adult patients, which compared outcomes following rFVIIa administration with PCC administration after CPB, showed that PCC led to significantly less chest tube output, fresh frozen plasma transfusion requirements, and platelet transfusion requirements compared with rFVIIa.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Prothrombin Complex Concentrate with Activated Factor VII Use for Bleeding Following Cardiopulmonary Bypass in Children

Benson

Hraška

Scott

et al. 2023

World J Pediatr Congenit Heart Surg

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Objective This study aims to compare the efficacy and safety of activated recombinant factor VII (rFVIIa) and prothrombin complex concentrate (PCC) in the treatment of bleeding complications following surgery requiring cardiopulmonary bypass (CPB) in children. Design/Methods This is a retrospective chart review of a single institution comprising patients aged 0 to 18 years old with congenital heart disease. Patients must have received either PCC or rFVIIa after coming off CPB. Our primary efficacy endpoint is time in the operating room from off-CPB to pediatric intensive care unit admission. Our primary safety endpoint is thrombosis through 30 days. Results Our primary efficacy outcome was significantly shorter in the PCC group compared with the rFVIIa group ( P < .0001). Similarly, secondary efficacy outcomes of packed red blood cell administration, chest tube output, and transfusion exposures all significantly favored PCC administration. However, CPB time was significantly longer, and body temperatures were significantly lower, in the rFVIIa group. Safety outcomes, including our primary safety outcome of thrombosis through 30 days, were similar between the two groups. Conclusion This study questions whether PCC could be favored over rFVIIa for hemostasis in children with congenital heart disease following CPB surgery. In addition, this study has found no difference when comparing PCC and rFVIIa in terms of safety outcomes, particularly thrombosis events. There are several limitations to this study due to the retrospective nature of the design and the differences between the two study groups. Despite the limitations, this study suggests that relatively early administration of PCC could be favored over delayed administration of rFVIIa to control recalcitrant post-CPB bleeding in the operating room.

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A Retrospective Analysis of the Use of 3-Factor Prothrombin Complex Concentrates for Refractory Bleeding After Cardiopulmonary Bypass in Children Undergoing Heart Surgery: A Matched Case-Control Study

Cited by 9 publications

References 12 publications

Activated 4-Factor Prothrombin Complex Concentrate as a Hemostatic Adjunct for Neonatal Cardiac Surgery: A Propensity Score-Matched Cohort Study

Activated 4-Factor Prothrombin Complex Concentrate as a Hemostatic Adjunct for Neonatal Cardiac Surgery: A Propensity Score-Matched Cohort Study

A narrative review of modern approach and outcomes evaluation in congenital heart defects

Comparison of Prothrombin Complex Concentrate with Activated Factor VII Use for Bleeding Following Cardiopulmonary Bypass in Children

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