Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery

BackgroundMost recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate.Materials and MethodsThere were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa.ResultsPostoperative blood loss was significantly lower in group N treated with rFVII (P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, (P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C (P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C (P < .0001).ConclusionOur findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients

Renal protection during the operation of infrarenal aorta

INTRODUCTION Despite the progress in surgical and anesthetic management decreased renal function is still observed after abdominal infrarenal aortic surgery and remains an important problem in postoperative period. Although data regarding the efficacy of perioperative renal protection are conflicting, it is widely believed that renal protection before aortic cross-clamping is beneficial and therefore is commonly used. The aim of this study was to evaluate the impact of renal protection in patients undergoing elective infrarenal aortic surgery (1 ARS). PATIENTS AND METHODS We have prospectively studied 80 patients undergoing elective infrarenal aortic surgery from October 1996 to May 1998 in the Clinical Center of Serbia because of aorto-occlusive disease or aortic aneurysm. Patients were excluded from the study for three reasons: prior renal dysfunction suprarenal aortic cross-clamping and ruptured aortic aneurysm. We have randomized the patients in two groups: without renal protection- group A (n = 40) and with renal protection- group V (n = 40). Preanaesthetic medication consisted of midazolam (5 mg i.m).Anesthesia was induced with etomidat 0.3 mg/kg, fentanyl 0.05-0.1 mg and succinil-holin Img/kg. Ventilation was controlled using 50% of nitrous oxide and oxygen. Supplemental anesthesia consisted of isofluran and fentanyl, in order to maintain the mean arterial pressure and heart rate ± 20% regarding preoperative values. In all patients two peripheral vein and radial artery catheters were cannulated before anesthesia. Central venous catheter and Foley urinary bladder catheter were inserted after the induction of anesthesia. Two-lead electrocardiograms were recorded. All patients in group V were given intravenously mannitol (0.3 g/kg) before aortic cross-clamping (ACC). After aortic cross-clamping, these patients received furosemide (20-40 mg) or dopamine (1-3 pg/kg/min) to the end of surgery (Table 1). In 8 time points (preoperatively, after induction during ACC, 2 and 8 hours after ACC, on day 1, 2 and 3 postoperatively) haemodynamic parameters (mean arterial and central venous pressure), volume load, urinary output, creatinine and free-water clearance, serum electrolytes, BUN, creatinine, plasma and urine osmolality and ACC time were analyzed in each patient. Renal complications were classified as transient or persistent. Transient renal dysfunction was defined as a greater rise Belgrade than 20% rise in peak serum creatinine level over baseline serum creatinine level, with a peak of at least 168 pmol/L. Persistent renal insufficiency was defined as a greater rise than 20% rise in discharge serum creatinine level over baseline serum creatinine level, with a peak of at least 168 umol/L. Moreover, renal insufficiency was defined as a free-water clearance greater than -15 ml/h. Aortic cross-clamping time was defined as a period in which the proximal inflow was occluded. The results were expressed as means ± SD. Statistical difference detected with Student's t-test, with p &lt; 0.05 being considered significant. RESULTS Patients in groups A and V were similar regarding the age (64.32 vs. 62.00), sex (males 35, females vs. males 34, females 6) and preoperative diseases. (Tab. 2) No difference was found between groups regarding any of the parameters (BUN, serum creatinine electrolytes, volum load, creatinine and free-water clearance, haemodynamic parameters, plasma and urine osmolality). Urinary output was higher in group V during and 2 hours after ACC. (Graph 1) ACC time was similar in two groups (24.1 min vs 24.5 min). (Graph. 2) Only one patient in group V revealed transitory renal insufficiency, not requiring special treatment. These data indicate that renal protection did not influence renal function. Short ACC time may have impact on the obtained results. Our results suggest that renal protection should not be considered as mandatory for elective infrarenal aortic surgery. Because of the short ACC time observed in this study (in comparision to other studies), further studies of renal protection in patients with longer ACC time are needed

Hybrid procedure in the treatment of thoracoabdominal aortic aneurysms: Case report

Introduction. Treatment of thoracoabdominal aortic aneurysms is a major problem in vascular surgery. Conventional open repair is associated with significant rates of mortality and morbidity and therefore, there is a need for better solutions. One of them is a hybrid procedure that includes visceral debranching. This paper presents the first such case performed in Serbia, with a brief overview on all published procedures worldwide. Case Outline. A 57-year-old woman was admitted to the hospital because of thoracoabdominal aneurysms type V by Crawford-Safi classifications. Because of the significant comorbidities it was concluded that conventional treatment would bear unacceptably high perioperative risk, and that the possible alternative could be the hybrid procedure in two stages. In the first stage aortobiliacal reconstruction with bifurcated Dacron graft (16×8 mm) and visceral debranching with hand made tailored branched graft was done. In the second act, the thoracoabdominal aneurysm was excluded with implantation of the endovascular Valiant stent graft, 34×150 mm (Medtronic, Santa Rosa, CA). Control MSCT angiography showed a proper visceral branch patency and positioning of the stent graft without endoleaks. Nine months after the procedure the patient was symptom-free, with no aneurysm, diameter change and no graft-related complication. All visceral branches were patent. Conclusion. So far about 500 cases of visceral debranching have been published with the aim of treating thoracoabdominal aneurysms, and still we have no valid guidelines concerning this method. However, in carefully selected high-risk patients this is an excellent alternative to open surgery of thoracoabdominal aneurysms

Recombinant activated factor VII in the treatment of intractable non-surgical bleeding following major vascular procedures

INTRODUCTION A recombinant form of activated factor VII (rFVIIa) is a haemostatic drug that is approved for use in haemophiliacs with antibodies to factor VIII or factor IX. Most recent studies and clinical experience have shown that rFVIIa (NovoSeven ®, Novo Nordisk A/S, Denmark) gives extreme haemostatic effect in patients with severe "non-haemophilic" bleeding produced after trauma and major surgery. OBJECTIVE We present our preliminary experience of the use of rFVIIa in vascular surgery when conventional haemostatic measures are inadequate. METHOD There were 32 patients divided into five groups: Group I - 14 patients with ruptured abdominal aortic aneurysms; Group II - 10 patients with thoracoabdominal aortic aneurysms; Group III - 5 patients with retroperitoneal tumors involving great abdominal vessels; Group IV - 2 patients with portal hypertension and Group V - one patient with iatrogenic injury of brachial artery and vein during fibrinolytic treatment, because of myocardial infarction. RESULTS Clinical improvement was detected following treatment in 29 patients. Bleeding was successfully controlled as evidenced by improved haemodynamic parameters and decreased inotropic and transfusion requirements. CONCLUSION In vascular patients more liberal use of rFVIIa is limited, because no randomized controlled trial has proved its efficacy and safety in such patients; while also keeping in mind that the price of a 4.8 mg of rFVIIa is $4,080. We recommend the use of rFVIIa in vascular surgery only during and after operative treatment of thoracoabdominal aortic aneurysms, ruptured abdominal aortic aneurysms, retroperitoneal tumors involving the aorta and/or inferior vena cava, as well as portal hypertension, when non-surgical massive uncontrolled bleeding are present

Influence of preoperative parametres on survival of patients with ruptured abdominal aortic aneurysm

Between 1991-2001 total number of 1058 patients was operated at the Institute of Cardiovascular Diseases of Serbian Clinical Centre due to abdominal aortic aneurysm. Of this number, 288 patients underwent urgent surgical treatment because of ruptured abdominal aortic aneurysm. The aim of this retrospective study was to show results of the early outcome of the surgical treatment of patients with ruptured abdominal aortic aneurysm, and to define relevant preopera-tive factors that influenced their survival. There were 83% male and 17% female patients in the study, mean aged 67 years. Intrahospital mortality that included intraoperative and postoperative deaths was 53.7%. Therefore, 46.3% patients survived surgical treatment and were released from hospital. Intraoperative mortality was 13.5%. Statistics showed that the gender and the age did not have any influence on mortality of our patients, as well as their co morbid conditions (p&gt;0.05). Clinical parameters at admission in hospital such as state of consciousness systolic blood pressure, cardiac arrest and diuresis significantly influenced the outcome of treatment, as well as laboratory findings such as levels of hematocrit, hemoglobin, white blood cells, urea and creatinin (p&lt;0.05; p&lt;0.01). Ruptured abdominal aortic aneurysm still remains one of the most dramatic surgical states with very high mortality reported. We assume that importrant preoperative factors that influence the outcome of surgical treatment can be defined, but there is no single parameter which can certainly predict the lethal outcome after surgery. Also, the presence of co morbid conditions does not significantly influence the outcome of treatment in these patients. Therefore, urgent operation should not be withheld in most of the patients with ruptured abdominal aortic aneurysm

Surgical treatment of abdominal tumors closely related to major blood vessels

INTRODUCTION Radical operative treatment of abdominal tumors closely related to major blood vessels often demands complex vascular procedures. OBJECTIVE The aim of this paper was to present elementary principles and results of the complex procedures, based on 46 patients operated on at the Institute for Cardiovascular Diseases, Clinical Centre of Serbia, Belgrade, from January 1999 to July 2006. METHOD Primary localization of the tumor was the kidney in 14 patients, the suprarenal gland in 2, the retroperitoneum in 23 and the testis in 7 patients. Histologically, the most frequent were the following: renal carcinoma in 14 patients, teratoma in 7, liposarcoma in 5, fibrosarcoma and lymphoma in 3 patients. The tumor compressed abdominal aorta occurred in 3 cases, vena cava inferior in 5 and both the abdominal aorta and vena cava inferior in 11 cases. In 4 cases the tumor infiltrated the abdominal aorta, in 11 the vena cava inferior and in 8 both of them. In two patients, the tumor compressed the vena cava inferior and infiltrated the aorta; in two patients the aorta was compressed and the vena cava was infiltrated. In three cases only the exploration was performed due to multiple abdominal organ infiltration. The ex tempore biopsy showed the type of tumor in which the radical surgical treatment did not improve the prognosis. In 20 cases of tumor compression, subadventitional excision was performed. In 23 cases of infiltration, the tumor excision and vascular reconstruction had to be performed. Intraoperative blood cell saving and autotransfusion were applied in 27 patients. RESULTS The lethal outcome happened in 3 (6.5%) patients during hospitalization. In other patients all reconstructed blood vessels were patent during the postoperative hospitalization period. CONCLUSION Treatment of the abdominal tumors closely related to major blood vessels must be interdisciplinary, considering diagnostics, operability estimation and additional measures. Tumor reduction cannot improve long term prognosis, and has no major impact on life quality. There have been not many papers that analyze the long term results after such complex operations proving their appropriateness