Safety and Efficacy of Recombinant Factor VIIa (NovoSeven) Use during ECMO Support in Patients after Cardiac Surgery

2021 ◽  
Vol 5 (4) ◽  
Author(s):  
Natanov R ◽  
◽  
Madrahimov N ◽  
Fleissner F ◽  
Mogaldea A ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Postoperative Bleeding ◽  
Ecmo Support ◽  
Surgical Patients ◽  
Safety And Efficacy ◽  
Rfviia Administration ◽  
Significant Difference ◽  
Ecmo Therapy

Background: Acute postoperative bleeding in cardiac surgical patients is a major cause of morbidity and mortality. Substitution of coagulatory factors may not always provide optimal hemostasis and off label, use of recombinant FVIIa has been proposed. When on ECMO, extra care must be taken during coagulatory substitution as clotting of the system may cause cardiovascular complications and possible ECMO failure, leading to death. In this paper, we examined the safety and efficacy of rFVIIa during ECMO support in postoperative cardio-surgical patients. Methods: We retrospectively examined all patients receiving rFVIIa postoperatively from December 2005 and January 2020. Clinical characteristics, demographics, bleeding, thrombotic complications, mortality, and rFVIIa administration were analyzed. Results: A total of 74 patients received rFVIIa postoperatively due to uncontrollable bleeding after cardiac surgery on our ICU. Of these patients, 23 patients were on ECMO treatment. Twelve patients received rFVIIa during, but not prior to the initiation of ECMO therapy. Six patients (50%) were male; mean age was 46 years (30-72 years). Eleven patients (91.7%) were on venoarterial ECMO, one patient was on central ECMO (8.3%). Dose of administered rFVIIa was corrected for body weight; mean dosage was 82μg/kg. We saw a significant reduction in need for red packed cells, fresh frozen plasma and thrombocyte transfusion after rFVIIa administration. There was no impact on the functionality of the ECMO system, especially regarding the oxygenator after rFVIIa administration. One patient suffered a stroke due thromboembolism (8.3%). One patient developed late thromboembolism in the leg (8.3%), and two cases of pulmonary embolism (16.7%) were recorded. Overall survival was 25% and there was no significant difference in survival between ECMO and non-ECMO patients. Weaning from ECMO could be achieved successfully in 41.7% of our patients. Conclusion: Recombinant Factor VIIa is an effective agent in reducing blood loss during ongoing ECMO therapy in patients with refractory bleeding. Although no direct relation between rFVIIa application and thromboembolic events could be established, its use should be done with the utmost care and in selected patients. However, rFVIIa therapy did not impact ECMO function in our cohort.

scholarly journals Quality of Life Following Urgent LVAD Implantation for ECMO Therapy in Cardiogenic Shock: A Long-Term Follow-Up

Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 747
Author(s):  
Rafal Berger ◽  
Hasan Hamdoun ◽  
Rodrigo Sandoval Boburg ◽  
Medhat Radwan ◽  
Metesh Acharya ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cardiogenic Shock ◽  
Left Ventricular ◽  
Ecmo Support ◽  
Circulatory Support ◽  
Significant Difference ◽  
Va Ecmo ◽  
Ecmo Therapy

Background and Objectives: Over the past decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has developed into a mainstream treatment for refractory cardiogenic shock (CS) to maximal conservative management. Successful weaning of VA-ECMO may not be possible, and bridging with further mechanical circulatory support (MCS), such as urgent implantation of a left ventricular assist device (LVAD), may represent the only means to sustain the patient haemodynamically. In the recovery phase, many survivors are not suitably prepared physically or psychologically for the novel issues encountered during daily life with an LVAD. Materials and Methods: A retrospective analysis of our institutional database between 2012 and 2019 was performed to identify patients treated with VA-ECMO for CS who underwent urgent LVAD implantation whilst on MCS. Post-cardiotomy cases were excluded. QoL was assessed prospectively during a routine follow-up visit using the EuroQol-5 dimensions-5 level (EQ-5D-5L) and the Patient Health Questionnaire (PHQ-9) surveys. Results: Among 126 in-hospital survivors of VA-ECMO therapy due to cardiogenic shock without prior cardiac surgery, 31 (24.6%) urgent LVAD recipients were identified. In 11 (36.7%) cases, cardiopulmonary resuscitation (CPR) was performed (median 10, range 1–60 min) before initiation of VA-ECMO, and in 5 (16.7%) cases, MCS was established under CPR. Mean age at LVAD implantation was 51.7 (+/−14) years and surgery was performed after a mean 12.1 (+/−8) days of VA-ECMO support. During follow-up of 46.9 (+/−25.5) months, there were 10 deaths after 20.4 (+/−12.1) months of LVAD support. Analysis of QoL questionnaires returned a mean EQ-5D-5L score of 66% (+/−21) of societal valuation for Germany and a mean PHQ-9 score of 5.7 (+/−5) corresponding to mild depression severity. When compared with 49 elective LVAD recipients without prior VA-ECMO therapy, there was no significant difference in QoL results. Conclusions: Patients requiring urgent LVAD implantation under VA-ECMO support due to CS are associated with comparable quality of life without a significant difference from elective LVAD recipients. Close follow-up is required to oversee patient rehabilitation after successful initial treatment.

Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease

2005 ◽  
Vol 11 (8) ◽  
pp. 895-900 ◽  
Author(s):  
Raymond M. Planinsic ◽  
Jan van der Meer ◽  
Giuliano Testa ◽  
Luis Grande ◽  
Angel Candela ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Liver Disease ◽  
Chronic Liver Disease ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Chronic Liver ◽  
Bolus Administration ◽  
Safety And Efficacy ◽  
Single Bolus

Recombinant Factor VIIa Is Associated With Increased Thrombotic Complications in Pediatric Cardiac Surgery Patients

2017 ◽  
Vol 124 (5) ◽  
pp. 1431-1436 ◽  
Author(s):  
Laura Downey ◽  
Morgan L. Brown ◽  
David Faraoni ◽  
David Zurakowski ◽  
James A. DiNardo
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Pediatric Cardiac Surgery ◽  
Thrombotic Complications

scholarly journals Clinical agreement and interchangeability of TEG5000 and TEG6s during cardiac surgery

2020 ◽  
Vol 48 (1) ◽  
pp. 43-52
Author(s):  
Qi Wong ◽  
Kelly P Byrne ◽  
Scott C Robinson
Keyword(s):  
Cardiac Surgery ◽  
Reaction Time ◽  
Alpha Angle ◽  
Maximum Amplitude ◽  
Surgical Patients ◽  
Treatment Recommendation ◽  
New Device ◽  
Management Algorithm ◽  
Arterial Blood ◽  
Significant Difference

TEG6s® is a new device introduced by the Haemonetics Corporation and designed to provide the same information as TEG® 5000 (Haemonetics Corporation, Braintree, MA, USA) but with much greater ease of use. We tested whether using citrated TEG6s gave reaction time, maximum amplitude and percentage of clot that had lysed at 30 minutes values similar to a non-citrated TEG5000, to allow clinical interchangeability using our current thrombelastography management algorithm for cardiac surgery. We also examined the agreement between the alpha-angle and functional fibrinogen maximum amplitude in our cardiac surgical patients.  In total, 243 paired arterial blood samples in 99 patients were tested, using TEG5000 (non-citrated) and TEG6s (citrated) after induction of anaesthesia (prior to heparin administration), following protamine administration at the end of the cardiac bypass and whenever a TEG5000 was requested after this by the attending anaesthetist. Bland–Altman plots and Lin’s concordance coefficient were used to compare agreement whereas modified Bland–Altman plots and McNemar’s test were used to illustrate the differences in management recommendations between the two thrombelastography devices.  All 243 samples were compared for reaction time and alpha-angle; 239 samples were compared for maximum amplitude; 136 samples were compared for the percentage of clot that had lysed at 30 minutes; 16 samples were compared for functional fibrinogen maximum amplitude. Lin’s concordance coefficient for these parameters was: reaction time 0.63, alpha-angle 0.39, maximum amplitude 0.5, percentage of clot that had lysed at 30 minutes 0.09 and functional fibrinogen maximum amplitude 0.31. Differences between the two devices became more marked at more abnormal values. Significant differences in median values, suggesting a fixed bias, were found for maximum amplitude and functional fibrinogen maximum amplitude. Differences in treatment recommendation could only be calculated for reaction time and maximum amplitude. Maximum amplitude was found to have a significant difference in treatment recommendation between the two devices using our current thrombelastography management algorithm for cardiac surgery with TEG6s recommending treatment in 11.5% more patients than TEG5000.  Using the TEG6s with our current TEG5000–based thrombelastography management algorithm for cardiac surgery would result in a change in treatment recommendation in at least 10% of our cardiac surgical patients. Agreement between the two thrombelastography devices appears to decrease with increasing patient coagulopathy. New algorithms will need to be developed and tested to validate TEG6s for cardiac surgical patients in our institution.

Role Of Recombinant Factor Viia In The Management Of Severe Perioperative Bleeding In Cardiac Surgery, Qatari Experience

2014 ◽  
Author(s):  
Hesham Ahmed Ewila ◽  
Mahmoud Abdallah ◽  
Alejandro Kohn Tuli ◽  
Abdul Rasheed Pattath ◽  
Shaban Mohammed
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Perioperative Bleeding

Off-Label Use of Recombinant Factor VIIa in United States Hospitals: 2000-2008.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 67-67
Author(s):  
Aaron C. Logan ◽  
Veronica Yank ◽  
Randall S. Stafford
Keyword(s):  
United States ◽  
Cardiac Surgery ◽  
Hospital Mortality ◽  
Intracranial Hemorrhage ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Off Label Use ◽  
Off Label ◽  
Academic Hospitals ◽  
Label Use

Abstract Abstract 67 Background: Recombinant factor VIIa (rFVIIa) is FDA-approved for treatment of bleeding due to factor VIII or factor IX inhibitors in the setting of congenital or acquired hemophilia or due to congenital factor VII deficiency. When first introduced into clinical practice in 1999, rFVIIa was used predominantly for these labeled indications. Over the years since it became widely available, rFVIIa has been employed extensively for off-label indications. The data to support these uses are sparse or, in some cases, contradictory. Objective: To estimate patterns of off-label rFVIIa use in United States hospitals. Data source: We evaluated data from the Premier Perspectives database of United States hospitals. This representative sample was used to extrapolate national usage patterns of rFVIIa. For each hospitalization at member institutions, the database includes information on patient demographics, primary and secondary diagnoses, medications dispensed, service items used, and disposition at discharge. We examined data encompassing hospitalizations between January 1, 2000 and December 31, 2008. Results: Use of rFVIIa was reported in 235 of 615 hospitals (38%) in the Premier database. 12,644 hospitalizations involving administration of rFVIIa during the study period were identified. Based on statistical weights for each member hospital, this translates to an estimated 73,747 hospitalizations nationwide during which rFVIIa was employed, 18,311 (25%) of which occurred during 2008. Between 2000 and 2008, off-label use of rFVIIa increased more than 140-fold, such that in 2008, 97% of in-hospital indications were off-label. In contrast, in-hospital use for the hemophilias has increased 3.7-fold since 2000 and appears to have plateaued, such that on-label use accounted for only 4.2% of use overall and 2.7% of use in 2008. We found cardiac surgery (29% of use in 2008), trauma (28%), and intracranial hemorrhage (11%) to be the most common off-label indications for rFVIIa use. Consistent with the growth of these and other off-label indications, there has been a significant increase in the mean age of patients receiving rFVIIa from 3 years in 2000 to 59 years in 2008. Conditions with a prominent proportion of use in the elderly (>65 years) included aortic aneurysm (82%), prostatectomy (66%), brain trauma (64%), intracranial hemorrhage (58%), cardiac surgery (57%), and gastrointestinal bleeding (57%). Across all indications, in-hospital mortality has increased substantially over time from 5% in 2000 to 27% in 2008. The highest in-hospital mortality rates were associated with aortic aneurysm (57%), neonatal use (54%), variceal bleeding (51%), other liver disease (49%), liver biopsy (45%), vascular procedures (43%), intracranial hemorrhage (43%), brain trauma (40%), body trauma (36%), and gastrointestinal bleeding (35%). The population receiving rFVIIa for the most common indication, adult cardiac surgery, experienced 24% in-hospital mortality. Amongst all patients treated with rFVIIa in 2008, 43% were discharged to home. Most of the remaining patients were transferred to other facilities, including nursing homes, rehabilitation hospitals, and other acute care facilities. In contrast, hemophilia patients receiving rFVIIa experienced a 3.8% in-hospital mortality rate, while 85% were discharged directly home. Finally, we identified a significant shift in rFVIIa use from academic hospitals (89% in 2000) to non-academic hospitals (67% in 2008). Conclusions: In hospitalized patients, off-label use of rFVIIa far exceeds use for the small number of licensed indications. Cardiac surgery, trauma, and non-traumatic intracranial hemorrhage represent the top indications for in-hospital rFVIIa use in the United States, together accounting for an estimated 12,448 of 18,311 (68%) uses during 2008. Across all off-label indications, in-hospital mortality is high, suggesting a substantial proportion of 'end-stage' use of rFVIIa. Use in such circumstances raises concerns about efficacy, associated adverse events, and allocation of resources. The marked shift in off-label use from academic to non-academic hospitals suggests wide acceptance despite these concerns. These patterns of expanding use are concerning given the absence of strong and consistent evidence to support the off-label application of rFVIIa. Disclosures: Off Label Use: This work characterizes patterns of off-label use of recombinant factor VIIa in United States hospitals..

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