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Journal ArticleDOI

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. [1]. 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 [2]. Severe haemorrhage requiring re-exploration occurs in up to 58% of cases [3] 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 [1]. Hence, the off-label use of rFVIIa represents an attractive haemostatic agent for controlling bleeding attributed to a disseminated intravascular coagulation-like phenomenon [4]. 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.

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Journal ArticleDOI
TL;DR: French off-label use of rFVIIa rescue therapy was followed by control of bleeding in a substantial number of the patients with seemingly acceptable safety; however, thrombotic risk remains a matter of concern.
Abstract: Objectives The study aimed to describe French off-label use of rFVIIa for intractable bleeding in major cardiovascular surgery. Methods Retrospective observational analysis of data from 2005 to October 2007 (no formal guidelines were available) was employed. The collect request form was elaborated by a multidisciplinary committee. Results Data on 109 patients--37 mechanical cardiac assist devices--were collected, with repeated injection for 24%. Bleeding stopped, decreased or continued in 43%, 37% and 20% of the cases, respectively. For patients treated in the intensive care unit (ICU), hourly bleeding decreased from 365 ± 212 to 115 ± 106 ml h(-1) (p 1g.l(-1)) and platelets (>50 G.l(-1)) before rFVIIa. The bleeding outcome (cessation, decrease or no change) was associated with the infused dose (81 ± 31, 71 ± 24, 64 ± 23 μg.kg(-1); p = 0.044) and did not differ whether rFVIIa was administered in the operating room (49%) or ICU (51%). Thrombotic events occurred in 13% of patients without assist devices and in 27% of those with them (but without obvious intra-device clotting). The overall 28-day survival rate was 60% and associated with bleeding outcome (p = 0.002). Conclusions rFVIIa rescue therapy was followed by control of bleeding in a substantial number of the patients with seemingly acceptable safety; however, thrombotic risk remains a matter of concern. Our observational study suggests that the dose to be tested prospectively is at least 80 μg.kg(-1).

29 citations

BookDOI
01 Jan 2007
TL;DR: Difficult decisions in thoracic surgery are made about whether to operate on the outside or the inside with a minimally invasive procedure.
Abstract: Difficult decisions in thoracic surgery : , Difficult decisions in thoracic surgery : , کتابخانه دیجیتال جندی شاپور اهواز

28 citations

Journal ArticleDOI
TL;DR: SND during VMPR is safe and should be routinely performed even when nodal metastases is considered unlikely, and VATS-SND is more accurate than PET in staging the mediastinum for NSCLC.
Abstract: OBJECTIVES The aim of this study is to investigate the role of routine systematic mediastinal nodal dissection (SND) performed during video-assisted thoracic surgery (VATS) major pulmonary resections (VMPRs) as a staging strategy for non-small-cell lung cancer (NSCLC), compared with preoperative staging by conventional positron emission tomography (PET) and computed tomography (CT) imaging. METHODS All patients suspected of having early lung cancer (T1-2, N0-1 and M0) were staged preoperatively by CT/PET. During VMPR, all lymph nodes on the right side at stations 2-4, 7, 8, 9, 10 and 11 and on the left stations 4-6, 7, 8, 9, 10, 11 and 3 when indicated were dissected en bloc. Histology was provided on the paraffin-embedded nodes, and patients staged accordingly. Preoperative and postoperative stagings were compared. Stage migration and impact on clinical pathway were noted. Stage IIa and higher were referred for adjuvant chemotherapy. RESULTS Between April 2007 and January 2011, 106 consecutive patients with suspected primary NSCLC proceeded to VMPR+SND. Histology confirmed NSCLC in 96 patients. Forty-five were men and 51 women. Median age was 68.6 (range 42.8-84.7) years. As many as 91 (94.8%) patients underwent lobectomy, three (3.1%) bilobectomy and two (2.1%) pneumonectomy. PET accurately correlated with SND histological diagnosis in 42 (43.8%) patients. The unexpected N2 disease in cN0-1 was 9/86 (10.5%). SND resulted in 25 stage migrations, upstaged 16 (16.6%) and down-staged nine (9.4%) patients. All upstagings were adenocarcinoma. Four (4.2%) PET-negative patients had multi-station N2 disease. SND resulted in changing the clinical pathway for 19 (20%) patients. Fourteen (14.6%) patients upstaged to qualify for chemotherapy, and 5/9 (5.2%) down-staged patients were saved the chemotherapy. There was no morbidity or mortality attributable to this added procedure. CONCLUSIONS SND during VMPR is safe and should be routinely performed even when nodal metastases is considered unlikely. VATS-SND is more accurate than PET in staging the mediastinum for NSCLC. PET sensitivity is significantly reduced in adenocarcinoma and might result in stage migration. Adjuvant multidisciplinary treatment should be based on SND staging.

27 citations

Journal ArticleDOI
TL;DR: Genomic analysis of lymph nodes, which may be used to improve the detection of micrometastases and to improve risk stratification, is currently being studied and has the potential to guide therapeutic decision making as well.

6 citations

Journal ArticleDOI
TL;DR: In conclusion, the Amer et al. underline the effectiveness of video-assisted thoracic surgery in the systematic mediastinal nodal dissection and suggest that preoperative behaviour is shareable and in good equilibrium between idealism and pragmatism.
Abstract: A recent study by Amer et al. [1] investigated the role of systematic mediastinal nodal dissection performed during videoassisted major pulmonary resection as a staging approach for non-small-cell lung cancer versus preoperative staging by computed tomography (CT) and positron emission tomography (PET). Precise staging is essential to provide accurate knowledge of disease progression in patients with non-small-cell lung cancer; in effect, the valuable editorial comment on the mentioned trial remarked that the authors ‘ignored the data that support the use of mediastinoscopy prior to VATS lobectomy, even in clinical stage I disease’ [2]. In reality, the American College of Chest Physicians clinical practice guidelines are open to the possibility that invasive staging is probably not needed in patients with peripheral tumours with no nodal involvement on CT and PET scans [3]. The coeval European Society of Thoracic Surgeons guidelines indicated that invasive staging can be omitted for patients with stage I lung cancer and negative mediastinal PET imaging on the condition that the tumour is peripheral [4]. From a formal point of view, the colleagues from Southampton could not be blamed for their preoperative protocol. Moreover, standard cervical mediastinoscopy usually only biopsies the paratracheal and subcarinal stations [4]; but, in order to reach every mediastinal station, transcervical extended mediastinal lymphadenectomy (TEMLA) [5] should be carried out. In addition, when positive lynphnodes are found, TEMLA should be redone for restaging after chemotherapy even if such a procedure seems excessive in a patient with a peripheral pulmonary nodule of a few millimetres plus negative mediastinal imaging. As an alternative, the endoscopic ultrasonography transbronchial needle aspiration (EBUS-TBNA) provides accurate mediastinal staging; such a technique is accepted by the American College of Chest Physicians and European Society of Thoracic Surgeons guidelines for clinical N2–3 lung cancer, but EBUS-TBNA has been proposed in the staging of CTand PET-negative mediastinum [6] our 6-year-long experience in EBUS-TBNA suggests that the biopsy of a few millimetre lymph-node is a hard duty especially in paratracheal stations. In conclusion, we consider that the Amer et al. preoperative behaviour is shareable and in good equilibrium between idealism and pragmatism [1]. Amer et al. underline the effectiveness of video-assisted thoracic surgery in the systematic mediastinal nodal dissection [1]. A number of studies had validated the video-assisted mediastinal dissection, but more explanatory is the simple photograph included in the article: during video-assisted thoracic surgery, the vision on mediastinal structures is so close and clear that surgeons can work in the best conditions. We conclude ‘nullus est liber tam malus, ut non aliqua parte prosit’ (There is no book so bad that it is not profitable in some part, Pliny); the article from Southampton highlights an up-to-date clinical practice based on good common sense and, moreover, restates the feasibility of a complete mediastinal dissection during video-assisted thoracic surgery.

4 citations