High Incidence of Thromboembolic Events in Left Ventricular Assist Device Patients Treated With Recombinant Activated Factor VII

Bruckner, Brian A.; DiBardino, Daniel J.; Ning, Qian; Adeboygeun, Alfred; Mahmoud, K. H.; Valdes, J. Parcero; Eze, JC; Allison, Paul M.; Cooley, Denton A.; Gregorič, Igor D.; Frazier, O.H.

doi:10.1016/j.healun.2009.04.028

Cited by 50 publications

(28 citation statements)

References 19 publications

(19 reference statements)

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“…Certainly, the risk of thrombotic complications related to rFVIIa administration during cardiac surgery(16, 17) exceeds the risk of rFVIIa use in hemophiliacs(18). Interestingly, despite concerns of increased morbidity with rFVIIa administration, the effect of rFVIIa on postoperative renal function has not been thoroughly explored(9, 17, 19, 20).…”

Section: Introductionmentioning

confidence: 99%

“…Although risk of thromboembolic complications has been investigated(9, 16, 17), studies evaluating risk of mortality after cardiac surgery are limited(6, 14, 19) because they were underpowered(9, 12, 21), lacked a control group(6, 7, 16), examined a diverse patient population(17), or used passive surveillance techniques so the true incidence of adverse outcomes was unknown(22). Further, few investigations were limited to the placement of left ventricular assist device or thoracic aortic surgery, compromising the generalizability of the results(12, 16).…”

Section: Introductionmentioning

confidence: 99%

“…Further, few investigations were limited to the placement of left ventricular assist device or thoracic aortic surgery, compromising the generalizability of the results(12, 16). Importantly, whether the patient's perioperative risk profile and severity of illness affects risk of mortality and morbidity associated with rFVIIa administration has not been examined.…”

Section: Introductionmentioning

confidence: 99%

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Recombinant Factor VII Is Associated With Worse Survival in Complex Cardiac Surgical Patients

Alfirevic

Duncan

You

et al. 2014

The Annals of Thoracic Surgery

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Background Recombinant, activated factor VII(rFVIIa) decreases requirements for allogenic blood transfusion and chest re-exploration in cardiac surgical patients. Whether rFVIIa increases risk for postoperative adverse events is unclear. We tested whether rFVIIa administration was associated with increased mortality, neurologic and renal morbidity in cardiac surgical patients. Risk of thromboembolic complications and the dose-response of rFVIIa on mortality and morbidity was also evaluated. Methods Of 27,977 patients who had complex cardiac surgery, 164 patients(0.59%) received rFVIIa perioperatively. Using propensity-matching techniques, patients were matched to a maximum of 3 controls. Patients who received rFVIIa were compared with controls on risk of mortality, neurologic and renal morbidity and thromboembolic complications, including a composite of myocardial infarction, pulmonary embolism, and deep venous thrombosis. A corresponding “dose-response” analysis using multivariable logistic regression was also performed. Results Propensity techniques successfully matched 144 patients(88%) with 359 controls. Of patients who received rFVIIa, 40% experienced in-hospital mortality compared to 18% of controls(OR 2.82(1.64, 4.87);P<0.001). Furthermore, 31% of patients treated with rFVIIa vs 17% of controls experienced renal morbidity(OR 2.07(1.19, 3.62);P=0.002), however neurologic morbidity and thromboembolic complications were not different among groups. High-dose(>60mcg/kg) did not increase risk for mortality compared to treatment with low-dose rFVIIa(<60mcg/kg). Conclusion Administration of rFVIIa is associated with increased mortality and renal morbidity in cardiac surgery patients.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Recombinant Factor VII Is Associated With Worse Survival in Complex Cardiac Surgical Patients

Alfirevic

Duncan

You

et al. 2014

The Annals of Thoracic Surgery

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“…After an intracerebral haemorrhage event, retrospective analysis indicates that aspirin can be resumed after 1 week and warfarin after 10 days without expansion of the haemorrhage or thrombotic events [3]. In patients with nonsurgical life-threatening haemorrhage unresponsive to standard measures, recombinant activated factor VIIa can be used but it may increase thromboembolic events [14,15].…”

Section: Frequent Complications In Mcs Patientsmentioning

confidence: 99%

Understanding Left Ventricular Assist Devices

et al. 2018

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Background/Aims: Long-term mechanical assist devices are now commonly used in the treatment of severe heart failure to unload the failing ventricle, maintain sufficient end-organ perfusion and improve functional capacity. Depending on the assisted ventricles, 3 categories of long-term assist devices are available: left ventricular assist device (LVAD), biventricular assist device and total artificial heart. Improvements in technology, especially the advent of smaller, durable continuous flow pumps, have led to the use of LVADs in a much broader population of patients in the last 10 years. Both the number of patients living with LVADs and the life expectancy of these patients are increasing. Regarding this growing number of patients with LVAD, intensivists need to understand the physiology of the devices, their functioning, potential complications and their management. Methods: We performed a narrative review of relevant medical literature regarding the physiology of patients with LVAD and management of common complications relevant to the critical care physicians. Results: The most frequent complications occurring in the LVAD patients after the post-operative period are bleeding, driveline infections, thrombosis, device malfunction, right ventricular failure and arrhythmias. Bleeding is the most frequent adverse event in LVAD due to a combination of anticoagulation and acquired von Willebrand disease secondary to shear stress produced within the pump. Their management includes antiplatelet therapy arrest, reduction of the anticoagulation regimen and specific therapy if feasible. Infection is the second most common cause of death after cardiac failure in LVAD patients. All infections must be aggressively treated to avoid seeding the device. Device thrombosis can develop even when patients are adequately anticoagulated and taking antiplatelet therapy because the LVAD is responsible for a chronic hypercoagulable state. Conclusion: Management of these unique patients in the ICU is best accomplished with a multidisciplinary team that includes specialists in advanced heart failure, LVAD nurse coordinators and intensivists.

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“…The safety of factor concentrates in LVAD patients has not been established. Bruckner et al have shown a high incidence of thromboembolic events (37%) with a high-dose factor VII (30e70 mg/kg) compared with a low-dose regimen (9.4% with 10e20 mg/kg) during LVAD procedures [67]. The successful use of prothrombin complex concentrate (PCC) has been reported in two patients with LVAD undergoing noncardiac surgery (NCS) without any thromboembolic sequelae [68].…”

Section: Bleeding and Transfusionsmentioning

confidence: 99%

Mechanical circulatory support

Subramaniam

2015

Best Practice & Research Clinical Anaesthesiology

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High Incidence of Thromboembolic Events in Left Ventricular Assist Device Patients Treated With Recombinant Activated Factor VII

Cited by 50 publications

References 19 publications

Recombinant Factor VII Is Associated With Worse Survival in Complex Cardiac Surgical Patients

Recombinant Factor VII Is Associated With Worse Survival in Complex Cardiac Surgical Patients

Understanding Left Ventricular Assist Devices

Mechanical circulatory support

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