A Comparison of Arterial Closure Devices to Manual Compression in Liver Transplantation Candidates Undergoing Coronary Angiograp

Coronary artery disease is common in adult patients with end-stage liver disease who are candidates for orthotopic liver transplantation.1 Patients with end-stage liver disease are predisposed to spontaneous bleeding complications due to thrombocytopenia, reduced synthesis of coagulation factors and increased fibrinolytic activity.2–4 The impaired immunity has been shown to lead to a higher frequency of bacteremia and subsequent increased mortality.5,6 Vascular access site hematomas and infections are well known complications of cardiac catheterization.7 Several trials have reported similar complication rates with arterial closure devices when compared to manual compression.8–11 However, in two more recent studies, the use of arterial closure devices during cardiac catheterization has been associated with an increased complication rate at the access site.12,13 The purpose of this study was to evaluate the frequency of complications with arterial closure devices when compared to manual compression in candidates for orthotopic liver transplantation who underwent cardiac catheterization. Methods Patients. A prospective cohort study was performed at Northwestern Memorial Hospital from December 1999 to August 2001 to evaluate the major complication rate of arterial closure devices. During this period, all adult patients with end-stage liver disease who were candidates for orthotopic liver transplantation underwent a complete cardiovascular evaluation, including cardiac catheterization. At cardiac catheterization, ilio-femoral angiography was performed to determine suitability for the use of an arterial closure device. Arterial hemostasis was achieved using either a 6 French (Fr) Angio-Seal (Daig Corporation, St. Jude Medical Company, St. Paul, Minnesota) or Perclose device (Perclose Inc., Redwood City, California), or manual compression. The choice of access closure device was at operator discretion. Definitions. Vascular complications were defined as minor oozing (bleeding which extended the patients bedrest), small hematoma 3 cm, pseudoaneurysm, arteriovenous fistula or femoral occlusion. Hematoma size was determined by manual palpation and measurement. The development of infection was also monitored. Complete blood count and coagulation profile were measured the day of cardiac catheterization. Time to ambulation was measured from the time cardiac catheterization was completed to the time the patient was able to ambulate. Statistical analysis. A Fisher’s exact test was used to compare categorical variables. An unpaired student’s t-test was used to compare continuous variables. A level of p Patient characteristics. Eighty patients with end-stage liver disease who were candidates for orthotopic liver transplantation underwent 81 cardiac catheterization procedures. Table 1 lists the etiology of liver failure, with 6 patients having two etiologic factors. Those listed under “other” include autoimmune, hepatic malignancy, isoniazid toxicity, amyloidosis, hemochromatosis and a1-antitrypsin deficiency. Procedural characteristics. Thirty-one patients received an arterial closure device (39%), whereas 49 patients (50 procedures) received manual compression (61%). One patient had 2 procedures and received manual compression after both. Table 2 lists patient characteristics with baseline platelet and INR values. Of the 31 patients who received an arterial closure device, twenty-five received Angio-Seal (81%) and 6 received Perclose (19%). Clinical endpoints. The rate of all vascular complications of patients receiving an arterial closure device tended to be lower when compared to patients who received manual compression (6% versus 20%; p = 0.12) (Table 3). One patient who received manual compression developed an acute femoral artery occlusion after sheath removal. This patient went emergently for vascular surgery for embolectomy and received 2 units of packed red blood cells. No other major vascular complications occurred in either group. There were no systemic or access site infections in either group. The time to ambulation was significantly less in the group receiving arterial closure devices versus manual compression (4.2 ± 1.8 hours versus 6.6 ± 3.7 hours; p = 0.0003). Two patients who received manual compression were not included. One developed a femoral artery occlusion and the other died the day after cardiac catheterization due to acute liver failure. Patients with platelet counts = 1.5 have been recognized to be at high risk for bleeding complications following percutaneous liver biopsy.2 Therefore, an analysis of this high-risk subgroup was performed. There were 23/50 procedures (46%) in the manual compression group and 13/31 procedures (42%) in the arterial closure device group that met these criteria (Table 4). There was no significant difference in the utilization of arterial closure devices compared to manual compression (p = 1.0) or in the rate of complications between the two groups (p = 0.22). Discussion This prospective, non-randomized study demonstrated that in a coagulopathic population of patients undergoing evaluation for liver transplantation, there was no increase in vascular complications with arterial closure devices compared to manual compression. Minimal data exist regarding the use of arterial closure devices in high-risk cohorts. Recently, Wong et al. evaluated the complication rate in a separate high-risk subset, namely obese patients, and demonstrated no significant difference in complications in the arterial closure device group compared to the manual compression group.14 The risk of infection, device dysfunction, operator error, operator learning curve and lack of data with these devices have made their use in high-risk patients infrequent. The current trial, along with the trial by Wong et al., demonstrates the potential for more widespread application of arterial closure devices in high-risk patients. Patients with end-stage liver disease are at increased risk for bleeding complications given the diminished synthetic function of the liver leading to coagulopathy, as well as congestive thrombocytopenia secondary to hepatosplenomegaly. Chronic liver disease is also associated with immunosuppression secondary to reticuloendothelial system dysfunction and a decrease in production of complement proteins. This combination places these patients at high risk for infections or bleeding complications when undergoing vascular procedures. Modalities that can minimize these risks are important in the preoperative evaluation for liver transplant, not only given the complications that may arise, but also given the serious consequences that would affect the patient’s transplant status. In this group of patients referred to a tertiary care center for liver transplantation, no significant differences were noted in complications following cardiac catheterization when arterial closure devices were compared to manual compression. The trend toward a decrease in minor complications in the arterial closure device group warrants further investigation. The immediate mechanical formation of hemostasis associated with arterial closure devices may be superior in patients at higher risk for bleeding complications. Infection associated with the use of arterial closure devices has made the safety of these devices a concern in immunocompromized patients. The absence of infections in our study population is of particular importance, given the potential serious ramifications of even minor infections. Study limitations. Although prospective, the study was not randomized. Furthermore, operators were given the choice of using arterial closure device or manual compression after ilio-femoral angiography. Therefore, operators could have selected patients at higher risk (i.e., those with thrombocytopenia, severe coagulopathies, severe anemia or peripheral vascular disease) and recommended manual compression. However, when a high-risk cohort was analyzed, there was no significant difference in either the use of arterial closure devices or in the observed complication rates. Conclusion. Arterial closure devices can be safely used in candidates for orthotopic liver transplantation, despite the patients’ coagulopathic predisposition toward bleeding and infection. This can be accomplished with a significant decrease in the time to ambulation when compared to manual compression.

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