Early experience with infectious complications of percutaneous femoral artery closure devices☆☆☆
Article Outline
Abstract
Percutaneous femoral artery closure devices are being used routinely after cardiac catheterizations. The use of these devices has been advocated to decrease length of stay, promote early ambulation, and prevent bleeding. We reviewed the use of these devices in our institution and report three cases of infectious complications (two pseudoaneurysms and one infected hematoma). Reports of infected pseudoaneurysms after cardiac catheterization before the implementation of these devices are rare. The use of these devices may be associated with an increased incidence of infected femoral pseudo-aneurysms. (J Vasc Surg 2000;32:205-8.)
Percutaneous closure of cardiac catheterization sites has been advocated to achieve earlier hemostasis, improve patient comfort, promote early ambulation, decrease the length of stay, and prevent postprocedure bleeding.1, 2, 3 We reviewed our recent experience with two products, the Perclose and the Angio-Seal femoral artery closure devices. The Perclose (Perclose Inc, Redwood, Calif) is a device that places a nonabsorbable braided polyester suture on both sides of the femoral artery defect on removal of the femoral catheter. The arteriotomy is then closed by tying the suture. The Angio-Seal (Sherwood Davis and Geck, St Louis, Mo) is a closure device that uses an absorbable intraluminal anchor and an extraluminal collagen sponge to be used as a tamponade for the arteriotomy. An absorbable braided suture draws the anchor and collagen together to form a seal.
In approximately 450 patients in whom the devices were used after a cardiac catheterization, there were three complications due to infection. Two of the patients had infected pseudoaneurysms, and the third patient had a complex groin infection requiring extensive debridement. Before this experience, there were no identified infectious complications of femoral arterial catheterization at this institution. The infections in these patients appear to be multifactorial in etiology, but clearly associated with the foreign body.
Case reports
Case 1
A 54-year-old woman with a past history of hypertension, type 2 diabetes mellitus, and peripheral vascular disease was seen with symptoms suggestive of unstable angina, and she underwent a diagnostic cardiac catheterization from a right femoral approach. The coronary angiogram revealed normal coronary arteries, and her femoral artery was closed with the Perclose device after limited femoral arteriography indicated an adequate lumen for deployment. She was discharged on the day of the catheterization and had staphylococcal sepsis 16 days later. She was febrile and had a white blood cell count of 32 ×103/mm3. A tender, pulsatile mass with surrounding erythema was present in her right groin. She was taken to the operating room for urgent exploration of her femoral artery. Proximal control of the external iliac artery was obtained in the retroperitoneum through an oblique flank incision, and a vertical incision was then made over the femoral artery in the groin. Blood and purulent material were aspirated, and control of the superficial and deep femoral arteries was obtained. There was extensive necrosis of the anterior wall of the common femoral artery. This arterial injury was repaired with patch angioplasty using the greater saphenous vein from the contralateral lower extremity. Her groin wound was closed over a suction drain, and the other wounds were closed primarily. Intraoperative cultures grew methicillin-sensitive Staphylococcus aureus , as did the preoperative blood cultures. The patient was treated with cefazolin for a total of 10 days, and she was discharged home on the ninth postoperative day.
Case 2
A 55-year-old man with a history of coronary artery disease, hypertension, and type 1 diabetes mellitus was seen with stable angina and underwent a diagnostic cardiac catheterization. He had three-vessel coronary artery disease. After limited femoral arteriography, the right femoral artery was closed with the Perclose device. He was discharged on the day of his catheterization, and he was scheduled for coronary artery bypass grafting 3 weeks later. However, 13 days after the catheterization, he went to the emergency department with complaints of bleeding and purulent drainage from his right groin. He was afebrile and had a white blood cell count of 9 ×103/mm3. Duplex scanning examination of the right groin revealed a pseudoaneurysm (Figure).
Duplex scanning examination of an infected femoral pseudoaneurysm. Color photograph (top) shows the femoral artery (FA) with a pseudoaneurysm extending anteriorly. The pseudoaneurysm cavity is obliterated with purulent debris. The neck (N) of the pseudoaneurysm is seen extending from the common femoral artery. The arrow in the lower photograph indicates the pseudoaneurysm capsule.
Case 3
A 63-year-old man with a history of hypertension, coronary artery disease and type 2 diabetes mellitus underwent a diagnostic cardiac catheterization for stable angina. His femoral artery was closed with the Angio-Seal device after limited femoral arteriography demonstrated an adequate lumen. He was discharged later on the day of the catheterization, and 12 days later he complained of pain in the groin through which the catheterization was performed. He was afebrile and had a white blood cell count of 13 ×103/mm3. He had erythema and swelling at the catheterization site. A duplex scanning examination of the groin revealed a 3-cm fluid collection anterior to the femoral artery, but there was no obvious pseudoaneurysm. He was taken to the operating room for exploration of the right groin. A large amount of clotted blood and purulent debris surrounded the common femoral artery; however, the artery itself was intact. The suture from the closure device was contained within the infected hematoma. After extensive soft tissue debridement and pulsatile lavage, the wound was packed open to heal secondarily. Intraoperative cultures grew methicillin-sensitive S aureus . The patient remained hospitalized on the cardiology service, and he was treated with intravenous vancomycin and local wound care. He was discharged on the ninth postoperative day to continue local wound care at home.
Discussion
Percutaneous femoral artery closure devices have been developed to allow for early ambulation, to decrease the length of stay, and to prevent bleeding after femoral cannulation procedures. They are proposed to improve both patient comfort and catheterization laboratory productivity when compared with traditional manual or mechanical pressure to achieve hemostasis after sheath removal.2, 4 In our institution, the Angio-Seal and the Perclose devices have been used in approximately 450 patients undergoing diagnostic and therapeutic cardiac catheterization. The three cases reported here represent our initial experience with infectious complications after femoral artery instrumentation. These complications have each necessitated urgent surgical intervention, prolonged hospitalizations, and extended recovery periods. Two patients had large open wounds that required frequent dressing changes to achieve closure by secondary intention. In one case, coronary artery bypass surgery was delayed for 2 months until the wounds healed.
Several similarities among these cases deserve mention. Each patient underwent a diagnostic study using a 6-French catheter. Although all of the patients were taking aspirin, none received periprocedural anticoagulation. As a consequence of underlying diabetes, all three of these patients were immunocompromised to some degree. The pathogen identified in all three patients was a common skin organism, S aureus; however, according to the standard practice, none of these patients received antibiotics before the catheterization procedure. In addition to these similarities in patient characteristics, both of these closure devices leave a suture that extends from the femoral artery to the skin, and this suture was recovered at surgery in all cases. Because the suture was amputated at skin level at the time of placement, several centimeters of foreign material remained in each wound. From the analysis of these cases, we postulated that the long sutures provided an access tract for skin flora to reach the deep tissues, and the combination of diabetes and foreign body contributed to the virulence of the local infection.
A cardiac catheterization is one of the most common medical procedures performed in the United States, with approximately 1 million procedures performed annually.5 In the current era of aggressive periprocedural anticoagulation, femoral artery closure devices are especially attractive for potentially decreasing the time to achieve hemostasis and ambulation and for increasing the productivity of catheterization laboratories.2, 6 Early studies of these and other closure devices have demonstrated their clinical efficacy in achieving hemostasis and decreasing the incidence of minor bleeding complications.7, 8, 9 In a study of 1030 consecutive patients who had cardiac catheterization in whom the Perclose was deployed, successful closure was reported in approximately 90% of cases.10 This has been demonstrated even in patients receiving heparin anticoagulation and antiplatelet therapy with abciximab (ReoPro; Eli Lilly, Indianapolis, Ind).6 In addition, a recent study in which the Angio-Seal device was used has shown that patients can safely ambulate within an hour after femoral sheath removal.2 Despite such favorable data, none of the studied closure devices have been shown to decrease the rate of major vascular complications associated with femoral catheterization including pseudoaneurysm, arteriovenous fistula, dissection, or acute thrombosis.7 Although in some cases the time to achieve hemostasis appears to be shortened by the use of these devices, the success rates of achieving hemostasis have been slightly less than that demonstrated by the use of mechanical pressure devices alone.6
The widespread implementation of any new technology must proceed only after careful cost-benefit analysis. In the case of femoral artery closure devices, the additional femoral arteriography must be included with the unit cost of the device itself. The bleeding, mechanical, and the added infectious risks of deploying the device must then be compared with the expected benefit of earlier discharge from the outpatient unit and increased patient turnover. These logistical benefits may be abrogated by the arterial damage and wound complications associated with infections even if only a few patients are affected. In angioplasty and atherectomy cases, especially those in which aggressive antiplatelet therapy is used, the potential benefits of closure devices are even less tangible because early sheath removal and ambulation are not of practical concern in these patients.
These are the first reported cases of infected pseudoaneurysm after percutaneous femoral artery closure following cardiac catheterization. A single case report of sepsis and wound infection associated with one of the closure devices has recently been published.11 Although infectious complications represent a small fraction of our overall experience with these devices, they must be added to the list of potential adverse events associated with their use. We have treated only one other complication, a femoral occlusion caused by the Angio-Seal; however, the true incidence of complications in our series is unknown because minor infections or mechanical complications may not have prompted surgical consultation. Because the use of these devices remains in its relative infancy, it is uncertain what the infectious complication rate will ultimately be. Infectious complications after femoral artery cannulation can lead to significant morbidity, necessitating expensive inpatient treatment and prolonged outpatient therapy.
As a result of this experience, patients in whom the use of these devices is considered now receive prophylactic antibiotics, as would any patient undergoing implantation of a vascular device. Prophylactic antibiotics have been advocated by the manufacturers of both devices in immunocompromised patients; however, it is not known if the use of periprocedural antibiotics will decrease the incidence of infectious complications. Further prospective studies will be needed to evaluate whether this will be of benefit. In addition, as new data come to light concerning the complications associated with percutaneous femoral artery closure devices, careful consideration is warranted before these devices are advocated for routine use after cardiac catheterization.
References
- Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995;25:1685–1692
- . Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998;81:569–572
- Prompt and safe femoral hemostasis with a collagen device after intracoronary implantation of Palmaz-Schatz stents. Am Heart J. 1995;130:26–32
- . Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial. Cathet Cardiovasc Diagn. 1992;27:298–302
- . Textbook of cardiovascular medicine. Ch. 70 In: Philadelphia: Lippincott-Raven; 1998;p. 1936
- Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual compression (Femostop) in transcatheter coronary interventions requiring abciximab (ReoPro). Cathet Cardiovasc Intervent. 1999;47:143–147
- . Hemostasis success rates and local complications with collagen after femoral access for cardiac catheterization: analysis of 6007 published patients. Am Heart J. 1998;135:152–156
- . Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization. Clin Cardiol. 1997;20:981–992
- . A novel vascular sealing device for closure of percutaneous arterial access sites. Am J Cardiol. 1999;83:1248–1252
- . Percutaneous suture closure of the femoral artery access after diagnostic heart catheter examination or coronary intervention. Dtsch Med Wochenschr. 1996;121:1487–1491
- . Explantation of infected hemostatic puncture closure devices: a case report. Vascular Surgery. 1999;33:507–510
☆ Competition of interest: nil.
☆☆ Reprint requests: J. Sheppard Mondy III, MD, Department of Surgery, Medical College of Georgia, 1120 15th Street, Augusta, GA 30912.
PII: S0741-5214(00)66288-2
doi:10.1067/mva.2000.105678
© 2000 Society for Vascular Surgery and International Society of Cardiovascular Surgery, North American Chapter. Published by Elsevier Inc. All rights reserved.
