Recombinant factor VIIa while on extracorporeal membrane oxygenator support: a word of caution †
01 Aug 2012-European Journal of Cardio-Thoracic Surgery (Oxford University Press)-Vol. 42, Iss: 2, pp 387-388
TL;DR: It is shown that patients receiving recombinant factor VIIa (rFVIIa) for intractable bleeding after cardiac surgery are not at an increased risk of thromboembolic events, and this effective haemostatic agent can be used with an acceptable safety profile in this patient population.
Abstract: We read with interest the article by Chapman et al. . They showed that patients receiving recombinant factor VIIa (rFVIIa) for intractable bleeding after cardiac surgery are not at an increased risk of thromboembolic events. Therefore, they concluded that this effective haemostatic agent can be used with an acceptable safety profile in this patient population. We would like to ask the authors whether, among the 236 patients receiving rFVIIa, they had patients supported by extracorporeal membrane oxygenator (ECMO). Bleeding is a major problem in postoperative ECMO implantation for post-cardiotomy cardiogenic shock . Severe haemorrhage requiring re-exploration occurs in up to 58% of cases  and carries a dismal prognosis. Among patients who returned to the operating theatre, a surgical source of bleeding is not identified in more than half of the patients . Hence, the off-label use of rFVIIa represents an attractive haemostatic agent for controlling bleeding attributed to a disseminated intravascular coagulation-like phenomenon . We entirely agree with their opinion about the effectiveness of rFVIIa as a haemostatic agent, and we would like to report an exceptional thrombotic complication that we recently encountered: a native non-calcified aortic valve thrombosis in a patient on ECMO support who received rFVIIa for massive bleeding after coronary artery bypass grafting (CABG) surgery. A 60-year old male patient was admitted on an elective basis for CABG surgery. His past medical history included hypertension and multiple sclerosis. Coronary angiogram revealed triple vessel disease. Transthoracic echocardiography disclosed a normal aortic valve and an ejection fraction at 45%. The patient had a normal hepatic and renal function and a normal coagulation profile before surgery. Cardiopulmonary bypass (CPB) was established through median sternotomy. The obtuse marginal artery was not identified during surgery due to severe adherence between the lateral aspect of the left ventricle and the pericardium while the right coronary artery and the left anterior descending artery were bypassed. Weaning from CPB was unsuccessful, and femoro-femoral ECMO was instituted. The patient was transported to the angiography laboratory where a drug eluting stent was successfully implanted in the proximal circumflex artery. Massive bleeding from the chest tube was recorded. Therefore, a 90-μg/kg of rFVIIa was infused, and bleeding decreased. Heparin infusion was commenced 18 h after the surgery. On postoperative day (POD) 1, a transoesophageal echocardiogram (TEE) revealed severely depressed contractility of the left ventricle and thrombus formation on the three cusps of the aortic valve on the aortic side. Despite full heparinization, a complete thrombosis of the aortic valve was disclosed on POD 3, and no clots were noted in the ECMO tubing. His family refused permission for further treatment and he died after the removal of the support. In view of our experience with this drug, we recommend caution when rFVIIa is used in the postoperative period after cardiac surgery in the setting of ECMO support; careful patient management by routinely performing TEE and maintaining inotropic support for ventricular contractility and cusps mobility is mandatory to prevent thrombus formation on the aortic cusps.
TL;DR: In patients with extensive mediastinal infiltration, invasive staging is not needed and patients with a peripheral clinical stage I NSCLC do not usually need invasive confirmation of mediastsinal nodes unless a PET scan finding is positive in the nodes.
Abstract: Background The treatment of non-small cell lung cancer (NSCLC) is determined by accurate definition of the stage. If there are no distant metastases, the status of the mediastinal lymph nodes is critical. Although imaging studies can provide some guidance, in many situations invasive staging is necessary. Many different complementary techniques are available. Methods The current guidelines and medical literature that are applicable to this issue were identified by computerized search and were evaluated using standardized methods. Recommendations were framed using the approach described by the Health and Science Policy Committee of the American College of Chest Physicians. Results Performance characteristics of invasive staging interventions are defined. However, a direct comparison of these results is not warranted because the patients selected for these procedures have been different. It is crucial to define patient groups, and to define the need for an invasive test and selection of the best test based on this. Conclusions In patients with extensive mediastinal infiltration, invasive staging is not needed. In patients with discrete node enlargement, staging by CT or positron emission tomography (PET) scanning is not sufficiently accurate. The sensitivity of various techniques is similar in this setting, although the false-negative (FN) rate of needle techniques is higher than that for mediastinoscopy. In patients with a stage II or a central tumor, invasive staging of the mediastinal nodes is necessary. Mediastinoscopy is generally preferable because of the higher FN rates of needle techniques in the setting of normal-sized lymph nodes. Patients with a peripheral clinical stage I NSCLC do not usually need invasive confirmation of mediastinal nodes unless a PET scan finding is positive in the nodes. The staging of patients with left upper lobe tumors should include an assessment of the aortopulmonary window lymph nodes.
TL;DR: Extracorporeal membrane oxygenation support is an acceptable option for patients with postcardiotomy cardiogenic shock who otherwise would die and is justified by good long-term outcome of hospital survivors.
Abstract: Objective Adult postcardiotomy cardiogenic shock potentially requiring mechanical circulatory support occurs in 0.5% to 1.5% of cases. Risk factors influencing early or long-term outcome after extracorporeal membrane oxygenation implantation are not well described. Methods Between May 1996 and May 2008, 517 adult patients received extracorporeal membrane oxygenation support for postcardiotomy cardiogenic shock. Procedures were isolated coronary artery bypass grafting (37.4%), isolated valve surgery (14.3%), coronary artery bypass grafting plus valve surgery (16.8%), thoracic organ transplantion (6.5%), and other combinations (25.0%). Fifty-four preoperative and 42 procedural risk factors concerning in-hospital mortality were evaluated by logistic regression analyses. Results Mean age was 63.5 years, 71.5% were male, ejection fraction was 45.9% ± 17.6%, logistic EuroSCORE was 21.6% ± 20.7%. Extracorporeal membrane oxygenation was established through thoracic (60.8%) or extrathoracic (39.2%) cannulation. Extracorporeal membrane oxygenation support was 3.28 ± 2.85 days. Intra-aortic balloon pumps were implanted in 74.1%. Weaning from extracorporeal membrane oxygenation was successful for 63.3%, and 24.8% were discharged. Cerebrovascular events occurred in 17.4%, gastrointestinal complications in 18.8%, and renal replacement therapy in 65.0%. Risk factors for hospital mortality were age older than 70 years (odds ratio, 1.6), diabetes (odds ratio, 2.5), preoperative renal insufficiency (odds ratio, 2.1), obesity (odds ratio, 1.8), logistic EuroSCORE greater than 20% (odds ratio, 1.8), operative lactate greater than 4 mmol/L (odds ratio, 2.2). Isolated coronary artery bypass grafting (odds ratio, 0.44) was protective. Cumulative survivals were 17.6% after 6 months, 16.5% after 1 year, and 13.7% after 5 years. Conclusions Extracorporeal membrane oxygenation support is an acceptable option for patients with postcardiotomy cardiogenic shock who otherwise would die and is justified by good long-term outcome of hospital survivors. Because of high morbidity and mortality, extracorporeal membrane oxygenation must be decided by individual risk profile.
TL;DR: EBUS-TBNA can be used to accurately sample and stage patients with clinical stage 1 lung cancer and no evidence of mediastinal involvement on CT and PET and the negative predictive value was 98.9%.
Abstract: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) can reliably sample enlarged mediastinal lymph nodes in patients with non-small cell lung cancer (NSCLC), and in practice is mostly used to sample nodes visible on CT or positron emission tomography (PET). Few data are available on the use of endoscopic procedures to stage the mediastinum in clinical stage 1 lung cancer. The aim of the present study was to determine the results of EBUS-TBNA in sampling mediastinal lymph nodes in patients with lung cancer and a radiographically normal mediastinum and no PET activity. From January 2004 to May 2007, patients highly suspicious for NSCLC with CT scans showing no enlarged lymph nodes (no node > 1 cm) and a negative PET finding of the mediastinum underwent EBUS-TBNA. Identifiable lymph nodes at locations 2r, 2L, 4r, 4L, 7, 10r, 10L, 11r, and 11L were aspirated. All patients underwent subsequent surgical staging. Diagnoses based on aspiration results were compared with those based on surgical results. One hundred patients (mean age, 52.4 years; 59 men) were included. After surgery, 97 patients (mean age, 52.9 years; 57 men) had NSCLC confirmed and were included in the analysis. In this group, 156 lymph nodes ranging 5 to 10 mm in size were detected and sampled. Malignancy was detected in nine patients but missed in one patient. Mean diameter of the punctured lymph nodes was 7.9 mm. The sensitivity of EBUS-TBNA for detecting malignancy was 89%, specificity was 100%, and the negative predictive value was 98.9%. No complications occurred. In conclusion, EBUS-TBNA can be used to accurately sample and stage patients with clinical stage 1 lung cancer and no evidence of mediastinal involvement on CT and PET. Potentially operable patients with no signs of mediastinal involvement may benefit from presurgical staging with EBUS-TBNA.
TL;DR: ECMO provides good cardiopulmonary and end-organ support; survival rates are similar to or higher than those seen with centrifugal pump support in comparable patient populations.
Abstract: Background . A mix of cardiac assist options is necessary to meet the diverse indications for cardiac support in a comprehensive heart failure program. At our institution, an adult extracorporeal membrane oxygenation (ECMO) system comprising a centrifugal pump and hollow fiber membrane oxygenator is used for short-term and temporary cardiac assist. Methods . Between December 1991 and August 1997, 82 adult cardiac patients were supported on ECMO. Indications for cardiac assist included postcardiotomy cardiogenic shock (PCCS, 55 patients), high-risk cardiology intervention (27 patients), perioperative cardiac graft failure (4 patients), and emergency cardiac resuscitation (6 patients). Data for analysis were collected by prospective completion of standardized ECMO report forms and retrospective review of hospital charts. Results . The ECMO system was inexpensive to operate, uncomplicated to implant, and adaptable for diverse indications. Survival in PCCS was 20 of 55 patients (36%), with an increased survival rate of 56% (18 of 32 patients) in patients with PCCS after isolated coronary bypass. Catheter-based revascularizations were successfully performed in 26 of 27 (96%) high-acuity patients temporarily supported by ECMO, and 23 of 27 patients (85%) survived to discharge. Survival in the cardiac graft failure group was 2 of 4 (50%). No patient supported on ECMO for cardiac resuscitation survived. Conclusions . ECMO provides good cardiopulmonary and end-organ support; survival rates are similar to or higher than those seen with centrifugal pump support in comparable patient populations.
TL;DR: The use of recombinant factor VIIa (rFVIIa) (NovoSeven RT W ) to establish hemostasis during massive perioperative bleeding in cardiac surgery has been explored in several retrospective studies.
Abstract: Objective: The use of recombinant factor VIIa (rFVIIa) (NovoSeven RT W ) to establish hemostasis during massive perioperative bleeding in cardiac surgery has been explored in several retrospective studies While early results are promising, a paucity of data leaves many questions about its safety profile We sought to further define its use and associated outcomes in a large cohort study at a single institution Methods: A retrospective cohort study design was used, in which 236 patients received rFVIIa for bleeding after cardiac surgery These patients were matched with a cohort of 213 subjects, who had similar operations during the same period of time Primary end points included thrombo-embolic events, mortality, incidence of re-operation, use of blood products, and patient disposition at 30 days Statistical significance was assessed at p < 005 Results: There was no statistically significant difference in the incidence of stroke (34%, 19%; p = 032), renal failure (85%, 70%; p = 057), or 30-day mortality (77%, 43%; p = 014) between the rFVIIa and the control groups, respectively The rFVIIa group did experience a higher rate of re-operation for bleeding (110%, 19%; p = 00001) and had a two-fold increase in the use of each of the following: cryoprecipitate, fresh-frozen plasma, platelets, and packed red blood cells, relative to the control group ( p < 000001) Conclusions: rFVIIa is an effective hemostatic agent for intractable bleeding in high-risk cardiac surgery with an acceptable safety profile rFVIIa does not appear to be associated with increased postoperative complications, including thrombo-embolic events and death # 2011 European Association for Cardio-Thoracic Surgery Published by Elsevier BV All rights reserved