Comparison of Arterial Puncture Closure Devices with Standard Manual Compression after Cardiac Catheterization at Robinson Memor

This article prompted the cardiac catheterization lab staff to review and evaluate practices and outcomes at Robinson Memorial Hospital (RMH). Robinson Memorial Hospital is a 250-bed, community hospital in Ravenna, Ohio. The diagnostic cardiac catheterization laboratory has been in operation for 20 years. Coronary interventions are not performed, so this analysis strictly involves diagnostic heart catheterization. Method A retrospective analysis of all diagnostic heart catheterization procedures utilizing a femoral approach performed in 2003 was performed. This analysis involved a review of all patients who experienced a vascular complication following heart catheterization. The analysis included review of the procedural record as well as the hospital record for this procedural stay. Parameters evaluated for each patient included: number of punctures required for the procedure, number of previous procedures, physician/staff involved, device involved or manual compression, laboratory data including Protime/INR, and concurrent medications. Objectives 1. To assess the safety and efficacy of APCDs compared to standard manual compression following diagnostic heart catheterization at RMH. 2. To evaluate any relationship between vascular complications and the use of APCDs. Study Selection All patients undergoing diagnostic heart catheterization at RMH via the femoral approach in 2003 were included in this analysis. All procedures were performed utilizing either 4F or 6F systems. The choice of catheters (4F vs. 6F) was based on patient size and physician preference. No effort to analyze the merits of either system was undertaken in this review. Manual compression was performed for a minimum of ten minutes in procedures utilizing 4F catheters and a minimum of twenty minutes when 6F systems were employed. APCDs were only employed following 6F procedures. APCD deployment and/or manual compression was performed by cath lab staff consisting of registered nurses and scrub techs. Following hemostasis, the sites were dressed with a 4x4 gauze pad under a bio-occlusive dressing. Sandbags or pressure dressings were not utilized. Ambulation was attempted after 2 hours of bed rest following manual compression (4F) or APCD closure (6F). In the anticoagulated patient, ambulation was attempted after 4 hours of bed rest regardless of closure method. A small number of patients had manual compression after a 6F procedure, and in these patients, ambulation was attempted after 6 hours. APCDs utilized at RMH were either Perclose A-T (Abbott Vascular) or VasoSeal ES (Datascope, Inc.). Diagnostic catheters were both 4F and 6F Daig Spyglass catheters (St. Jude Medical) and Daig Ultimum ACT sheaths (St. Jude Medical). In some patients, topical patches (SyvekPatch [Marine Polymer Technologies, Inc.] and Chito-Seal [Abbott Vascular Devices]) were used along with manual compression. Patients receiving topical patches were not placed in a separate category, because these were used solely at physician discretion, rather than as the result of any specific criteria. All flush solutions used during diagnostic heart catheterizations have a 10:1 ratio of heparin added (5000 units of heparin in 500ml normal saline). No patients received additional heparin dosing during diagnostic heart catheterization, and ACT or PTT were not routinely measured. Vascular complications included pseudoaneurysm, bleeding/ hematoma requiring additional compression (minor bleed) and intravascular thrombus. No patient undergoing catheterization in 2003 had a major bleed requiring transfusion. Results In 2003, 740 diagnostic heart catheterizations were performed via the femoral approach at RMH (Table 1). Three hundred seventy-one patients (50%) underwent manual compression as the method of closure following catheterization, while a closure device was utilized in 369 (50%) patients. The VasoSeal device was used in 186 patients (25%) and the Perclose was used in 183 (25%) of patients. Thirteen (13) patients (1.8%) experienced a vascular complication following the catheterization procedure. Six patients (0.8%) had a pseudoaneurysm. Five resolved by ultrasound-guided manual compression, and one resolved spontaneously, requiring no treatment. Four patients (0.5%) had a minor bleed/hematoma requiring additional manual compression, but not requiring surgery or transfusion. Three patients (0.4%) demonstrated an intravascular thrombus; two required surgical removal and one received heparin therapy (Table 2). The thirteen complications occurred in procedures performed by 3 physicians: Dr. A (7), Dr. B (3) and Dr. C (3). A breakdown of procedures revealed that Dr. A performed 343 heart caths (46%) while Dr. B performed 209 (28%) and Dr. C performed 105 (14%) accounting for 657 of the total procedures. No relationship between performing physician and complications was noted. All complications involved the right common femoral artery as the puncture site. Twelve patients had single punctures for access while one patient had multiple arterial punctures before access could be achieved. Three patients had zero previous procedures, while 8 patients had 1-2 previous procedures and 2 patients had > 3 previous procedures. There is no clear relationship between number of previous procedures or number of arterial punctures and complications in this review; however, the following should be noted. Ten of thirteen patients experiencing a vascular complication had a previous procedure at the same site. Of the six patients who had pseudoaneurysm, 5 had multiple procedures in the same vessel. Three of 4 patients with bleeding/hematoma had multiple procedures and 2 of 3 patients with thrombus had multiple procedures. This is of interest, but the clinical significance of these numbers is not clear. Six patients with vascular complications had APCDs used to close the arterial puncture site (2 Perclose and 4 VasoSeal). Seven patients had manual compression (2 with patches) as the method of closure. Of the three patients who had intravascular thrombus present, 2 patients had closure utilizing Perclose and the other had manual compression. Six patients had pseudoaneurysm of the right common femoral artery. Three of these patients had been closed using a VasoSeal and three had manual holds. Of the 4 patients who had bleeding/hematoma, three had been manual holds while one was a VasoSeal closure (Table 3). This suggests that there may be a higher incidence of bleeding/ hematoma with manual compression versus APCDs and opposes the conclusion of the meta-analysis. Evaluation of medications and laboratory data revealed that 7 patients had been on coumadin (warfarin) prior to procedure. Coumadin was held prior to procedures but INRs ranged between 0.8 and 1.7 on the day of procedure (Table 4). Seven patients had INRs of 1.2 or greater at the time of catheterization. In addition, 5 patients were receiving subcutaneous Lovenox (enoxaparin) at a dosage of 1mg/kg every 12 hours. Doses were held the morning of procedure, but all patients had received dosing at 10 pm the night before and the night of the procedure. One patient was receiving subcutaneous heparin at a dose of 5000 units every 12 hours; he also received dosing the night before and the night of the catheterization. In all, 10 of the 13 patients who had a vascular complication following heart catheterization had been anticoagulated with coumadin or Lovenox/heparin. No patient with a vascular complication had received a GP IIb/IIIa platelet antagonist (Integrilin [eptifibatide], Aggrastat [tirofiban hydrochloride] or ReoPro [abciximab]). Conclusions In 2003, 740 patients had diagnostic heart catheterization at Robinson Memorial Hospital with 13 (1.8%) experiencing a vascular complication post procedure. This falls within the range, 1.5%-9%, reported in the meta-analysis printed in JAMA.^6-7 Manual compression was the closure method in 371 patients (50%) and arterial puncture closure devices were used in 369 patients (50%). VasoSeal was the closure device used for 186 patients (25% of total) and Perclose was the closure device for 183 patients (25% of total). The fact that these numbers are so balanced is purely coincidental and not the result of any randomization. Seven patients who experienced vascular complications had manual compression and 6 patients were closed using a closure device. The review of heart catheterization procedures performed at RMH in 2003 provides no evidence to support the suggestion that the use of vascular closure devices increases the risk of vascular complication following cardiac catheterization. However, it is important to note that this was not a randomized trial but, rather, a retrospective analysis of the previous year’s procedures. The ability to draw conclusions from 13 patients experiencing complication is limited by the small size of this group. However, this review suggests that the biggest single factor relating to risk for complication appears to be anticoagulation with coumadin, Lovenox or heparin prior to and following cardiac catheterization. Longer hold times or prolonged bed rest in these patients may reduce the incidence of complication, but that conclusion cannot be drawn from this review. In addition, the number of procedures a patient has may also impact risk of complication. Both of these conclusions would seem logical and are, in fact, supported by the findings in this review. The clinical experience at the cardiac catheterization laboratory at Robinson Memorial Hospital strongly suggests that the use of closure devices can improve patient comfort and speed the time to ambulation and discharge for patients. This review strongly disputes the suggestion that use of arterial puncture closure devices increases the risk of hematoma or pseudoaneurysm following diagnostic heart catheterization. Our analysis indicates that these devices can be used both safely and effectively in comparison to standard manual compression. The author would like to thank Jan Bahle RN, MSN Clinical Nurse Specialist, Cardiovascular Department, Robinson Memorial Hospital and Barbara Dieckman RN, MSN, Critical Care Instructor, Kent State University School of Nursing for their editorial assistance with this article. Marc Streem can be contacted at mstreem@neo.rr.com

This article prompted the cardiac catheterization lab staff to review and evaluate practices and outcomes at Robinson Memorial Hospital (RMH).