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Infectious Complications of Percutaneous Vascular Closure Devices
ORIGINAL ARTICLE
VASCULAR CLOSURE DEVICES AND INFECTION
Infectious Complications of Percutaneous Vascular Closure Devices MUHAMMAD R. SOHAIL, MD; AKBAR H. KHAN, MD; DAVID R. HOLMES, JR, MD; WALTER R. WILSON, MD; JAMES M. STECKELBERG, MD; AND LARRY M. BADDOUR, MD OBJECTIVE: To describe the infectious complications of percutaneous vascular closure devices (PVCDs) on the basis of our institutional experience with PVCDs and the published medical literature. PATIENTS AND METHODS: We retrospectively reviewed all cases of PVCD-related infection seen at the Mayo Clinic in Rochester, Minn, between January 1, 2000, and December 31, 2003, and searched the English language medical literature for all previously published reports. RESULTS: We identified 46 cases in the medical literature and 6 cases from our institutional database. The median age of patients was 63 years (range, 40-79 years). Diabetes mellitus and obesity were the most common comorbidities. The median incubation period from device insertion to presentation with access-site infection was 8 days (range, 2-29 days). The most common presenting symptoms were pain, erythema, fever, swelling, and purulent drainage at the access site. Mycotic pseudoaneurysm (22 cases) was the most common complication. Staphylococcus aureus was responsible for most (75%) of the infections. All patients underwent surgical débridement, and 54% required reconstructive procedures. The median duration of antibiotic treatment was 28 days (range, 7-42 days). The mortality rate was 6% (3 patients). CONCLUSIONS: Infection associated with PVCD placement is uncommon but is an extremely serious complication. Morbidity is high, and aggressive medical and surgical interventions are required to achieve cure.
Mayo Clin Proc. 2005;80(8):1011-1015 MPA = mycotic pseudoaneurysm; OSSA = oxacillin-sensitive Staphylococcus aureus; PVCD = percutaneous vascular closure device
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n the past, hemostasis of an arteriotomy site was achieved by manual compression of the access site for 15 minutes, followed by up to 8 hours of bed rest. The ability to achieve earlier hemostasis with percutaneous vascular closure devices (PVCDs) and the resultant increases in patient comfort, shorter time to ambulation, and less demand on personnel for applying manual compression have contributed to the increasing use of these devices.1-3 Currently, 5 PVCDs have been approved by the US Food and Drug Administration. The Vasoseal vascular hemostatic device (Datascope, Montvale, NJ), the AngioSeal hemostatic puncture closing device (St. Jude Medical, Minnetonka, Minn), and the Duett system (Gershony vascular sealing device, Vascular Solutions, Minneapolis, Minn) use various mechanisms of collagen or other substance deposition to achieve hemostatic control. The Perclose system (Perclose Inc, Redwood City, Calif) and SuperStitch (Sutura, Inc, Fountain Valley, Calif) deploy a suture to close the arteriotomy site.4,5 Mayo Clin Proc.
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Placement of PVCDs can be complicated by various noninfectious and infectious events including hemorrhage, hematoma, pseudoaneurysm formation, arteriovenous fistula, limb ischemia, access-site infection, femoral endarteritis, and septic emboli.6 Overall, a complication rate of up to 2% has been reported.2,7 Infectious complication rates range from 0.0% to 5.1%.1,3,8-12 In this article, we review both our institutional experience with PVCD-related infections and the published medical literature that describes additional cases of PVCDrelated infection. PATIENTS AND METHODS We retrospectively reviewed all cases of PVCD-related infections seen at the Mayo Clinic in Rochester, Minn, between January 1, 2000, and December 31, 2003. During this time, 26,790 patients underwent cardiac catheterization, PVCDs were deployed in 1662 patients, and 215 devices were used by interventional radiologists for vascular puncture site hemostasis. Cases of PVCD-related infection were identified by searching the Mayo central diagnostic index, surgical procedures index, cardiac catheterization laboratory database and interventional radiology records. All patients with PVCD-related access-site infection underwent surgery and had intraoperative confirmation of infection. Patients who presented initially with noninfectious complications such as hematoma or pseudoaneurysm that were managed surgically and who subsequently developed infection were excluded from this review. These patients were considered to have surgical complications and not infectious complications of the initial catheterization and PVCD placement. All patients had given written authorization for use of their medical records for research, and the study was approved by the Mayo Foundation Institutional Review Board. From the Division of Infectious Diseases (M.R.S., W.R.W., J.M.S., L.M.B.), Department of Internal Medicine (A.H.K.), and Division of Cardiovascular Diseases (D.R.H.), Mayo Clinic College of Medicine, Rochester, Minn. Presented as an abstract (No. 169) at the 42nd Annual Meeting of Infectious Diseases Society of America, Boston, Mass, September 30-October 3, 2004. Individual reprints of this article are not available. Address correspondence to Muhammad R. Sohail, MD, Division of Infectious Diseases, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: sohail [email protected]). © 2005 Mayo Foundation for Medical Education and Research
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TABLE 1. Summary of 6 Patients With PVCD-Related Infection Treated at the Mayo Clinic* Patient No./ age (y)/sex
Comorbid condition
Device
1/75/M
DM, COPD
Angio-Seal
OSSA
8
2/79/M
DM, obesity
Angio-Seal
OSSA
6
3/41/F
SLE
Perclose
ORSA
6
Erythema, tenderness, purulent drainage, abscess Pain, swelling, erythema, abscess Pain, MPA, abscess
4/76/F
Obesity
Perclose
4
MPA, abscess
5/75/M
None
Perclose
Enterococcus species, Morganella morganii, Escherichia coli OSSA
2
6/77/M
Malignancy, COPD
Perclose
OSSA
Fever, swelling, MPA, abscess Pain, swelling, MPA, abscess
Organism
Postoperative day
17
Presentation
Antibiotic (duration)
Outcome (follow-up duration)
Cefazolin (4 wk)
Resolved (6 mo)
Vancomycin (4 wk) Vancomycin (4 wk) Cefepime (1 wk) Ciprofloxacin (2 wk)
Resolved (4 mo) NA
Nafcillin (5 wk) Cefazolin (4 wk)
Resolved (4 mo)
Resolved (48 mo) Resolved (36 mo)
*COPD = chronic obstructive pulmonary disease; DM = diabetes mellitus; MPA = mycotic pseudoaneurysm; NA = not available; ORSA = oxacillin-resistant Staphylococcus aureus; OSSA = oxacillin-sensitive S aureus; PVCD = percutaneous vascular closure device; SLE = systemic lupus erythematosus.
We reviewed all previously published case reports of infections associated with use of PVCDs and searched the English language medical literature by using the online bibliographic databases of the National Library of Medicine (MEDLINE and PubMed). Search terms included closure device, vascular, infection, sepsis, abscess, wound, and complication. Also, we performed an extensive bibliography search of the articles identified through MEDLINE and PubMed. RESULTS Ninety cases of PVCD-related infection were identified by searching the medical literature and our institutional database.1-3,5-9,12-27 Fifty-two cases (including 6 from the Mayo Clinic’s institutional database) listed access-site infection as a primary complication of PVCD deployment.1,5,8,9,13-20,23,25,27 All patients underwent surgery and had intraoperative confirmation of infection. Among our patients, 5 had closure devices placed at our institution, and the sixth had a PVCD deployed in an outside hospital and subsequently presented to the Mayo Clinic with access-site infection. The demographics, microbiology, and outcome of the 6 patients with PVCDrelated infection treated at the Mayo Clinic are summarized in Table 1. Cumulative incidence for device-related infection in our cardiology practice was 0.24% (4/1662; 95% confidence interval, 0.07%-0.62%). We were unable to estimate the cumulative incidence of PVCD-related infection in the vascular radiology group because of limited follow-up data. Demographic characteristics of the 52 study patients are summarized in Table 2. 1012
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Among the 52 patients, 48 underwent cardiac catheterization, 2 underwent cerebral arteriography, 1 underwent renal angiography, and the remaining patient underwent intra-arterial chemotherapy as the initial procedures followed by use of PVCDs for puncture-site hemostasis. Devices used to achieve hemostasis of the access sites included the Perclose device (38 patients) and the Angio-Seal device (9 patients). The type of device was not specified in 5 patients. The median patient age was 63 years (range, 4079 years); 74% of patients were men. Comorbidities were not uniformly reported (only 20 patients). Diabetes mellitus (80%) and obesity (20%) were the 2 most commonly reported comorbid conditions. Other comorbidities included systemic lupus erythematosus, splenectomy, chronic obstructive pulmonary disease, end-stage renal disease, and malignancy (Table 2). The median incubation period from device insertion to presentation of PVCD-related infection was 8 days (mean, 10 days; range, 2-29 days). Symptoms including pain (52%), erythema (42%), swelling (30%), and drainage (24%) from the access site, as well as fever (38%), were the most common at presentation (Table 3). Blood cultures were positive in 86% of reported cases. Mycotic pseudoaneurysm at the access site was the most common complication (22 of 52 patients, 42%), which required extensive débridement and reconstruction. S aureus was the single most common (43 isolates, 75%) infecting organism (Figure 1). Of the 43 isolates, 82% were OSSA, and 18% were oxacillin-resistant S aureus. Coagulase-negative Staphylococcus was the second most common pathogen, isolated in 5% of patients. Other organisms included Peptostreptococcus, Enterococcus species, Corynebacterium species, Haemophilus
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VASCULAR CLOSURE DEVICES AND INFECTION
influenzae, Streptococcus species, Enterobacter, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas species. Fourteen percent of infections were polymicrobial. All patients underwent surgical débridement, and 54% required reconstructive procedures for treatment of PVCDrelated infection. Four patients required multiple, complex surgical interventions. A venous patch was surgically placed in 12 patients; femoral artery reconstruction was needed in 1, arterial bypass in 5, and primary artery closure in 7, and 2 patients underwent the BEST (bolstered, everted, saphenous vein patch technique) procedure.14 The median duration of antibiotic treatment was 28 days (mean, 24 days; range, 7-42 days). Routes of antibiotic administration were specified in 26 patients: 22 (85%) received intravenous antibiotics (mean, 26 days), 3 received combined intravenous and oral antibiotics, and 1 was treated with oral antibiotics alone. Cefazolin and vancomycin were the most commonly used antibiotics. Outcome variables were reported in 49 patients. Complete resolution of PVCD-related infection was achieved in 44 patients (90%) with combined medical and surgical treatment. Two patients (4%) had permanent disability including 1 below-knee amputation.18 The mortality rate was 6% (3 patients).5,9 All deaths were in patients with S aureus infection and were due to severe sepsis complicated by multisystem organ failure. ILLUSTRATIVE CASE A 75-year-old man (No. 5; Table 1) underwent catheterization of the left side of the heart for severe coronary artery disease. The access site was closed with use of a Perclose device. The patient presented with fever, leuk ocytosis, and fullness in the right groi n on the second stoperative po day. Blood cultures revealed oxacillin-sensitive Staphylococcus aureus (OSSA) within 12 hours of blood draw. Transesophageal echocardiography revealed no evidence of infective endocarditis. Ultrasonography of the right groin showed a 6-cm infected mycotic pseudoaneurysm (MPA). Operative tissue culture revealed OSSA. Intravenous nafcillin was initiated. The patient underwent débridement, resection of the PVCD, and repair of the MPA 4 days later after blood cultures were confirmed negative. The patient continued taking nafcillin for an additional 4 weeks. He experienced complete resolution of infection and had no evidence of infection relapse over the next 4 years of follow-up.
TABLE 2. Demographic Characteristics of 52 Patients* No. of patients† Median age (range) (y) Sex, No. (%) Male Female Device Perclose Angio-Seal Unspecified Primary procedure Cardiac catheterization Cerebral arteriography Renal angiography Intra-arterial chemotherapy Comorbidities Diabetes mellitus Obesity Systemic lupus erythematosus Splenectomy Chronic obstructive pulmonary disease End-stage renal disease Malignancy
38 9 5 48 2 1 1 16 4 1 1 1 1 1
though relatively safe, this procedure causes patient discomfort and prolonged immobility. In recent years, with the increasing use of smaller catheters at many institutions, including our own, duration of bed rest after cardiac catheterization has been shortened to 1 to 3 hours, depending on the catheter size used. Complications associated with catheterization and manual compression include formation of hematoma, arteriovenous fistula, and pseudoaneurysm.28 Rates of these noninfectious complications have ranged from 0.0% to 1.1% for diagnostic catheterization and from 5.9% to 17% for percutaneous coronary intervention TABLE 3. Clinical Presentation of 52 Patients* Percentage of patients† Incubation period (d) Median Range Systemic signs Fever Localized signs/symptoms at catheterization site Pain Erythema Swelling Drainage Complications Mycotic pseudoaneurysm Arteriotomy-site abscess Septic emboli Bacteremia
Manual compression for 15 minutes, followed by up to 8 hours of bed rest, has been used traditionally to achieve hemostasis of the cardiac catheterization access site. Al•
38 (74) 14 (26)
*From the Mayo Clinic series and a review of the literature. †Unless indicated otherwise.
DISCUSSION
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8 (mean, 10) 2-29 38 52 42 30 24 42 22 7 86
*From the Mayo Clinic series and a review of the literature. †Unless indicated otherwise. •
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80 70
(18% Oxacillin-resistant Staphylococcus aureus)
Percentage
60 50 40
(82% Oxacillin-sensitive S aureus)
30 20 10 0
S aureus (75%)
Gram-negative Coagulaserods negative (13%) Staphylococcus (5%)
Others (7%)
FIGURE 1. Microbiology (57 isolates in 52 patients).
when stents were deployed.4 In contrast, infection has been reported rarely.5,25,29,30 Early ambulation and increased patient comfort have led to increased use of PVCDs. Although bleeding and vascular complication rates with use of these devices are similar to those that characterize manual compression,10,11 infection has emerged as a more common complication with use of PVCDs, with a reported incidence of 0.0% to 5.1%.1,3,8-12 Hematoma formation at the puncture site and the presence of foreign material in the intravascular space and arterial wall likely serve as a nidus for subsequent infection. Infection associated with the PVCD results in localized endarteritis at the insertion site, which is a risk factor for subsequent development of MPA.1,14,15 The median incubation period from PVCD insertion to clinical presentation with access-site infection was 8 days; this relatively short period is likely due to the presence of S aureus, a highly virulent organism, in most patients (75%). Diagnosis of device-related infection should be considered in patients who present with local signs of inflammaTABLE 4. Treatment Recommendations for PVCD-Related Infection* Detailed history and physical examination to evaluate for metastatic foci of infection (eg, septic arthritis) Two sets of blood cultures Doppler ultrasonography to evaluate for mycotic pseudoaneurysm Empirical broad-spectrum antibiotics that should include coverage for oxacillin-resistant Staphylococcus aureus (ie, vancomycin) Intravenous antibiotics for 2 to 4 weeks against identified organism Duration of antibiotics may be extended up to 6 weeks for complicated cases (ie, septic arthritis, endocarditis) Surgical débridement should be considered for all patients *Refer to text for further information and references. PVCD = percutaneous vascular closure device.
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tion, fever, and/or leukocytosis within 1 to 2 weeks after device placement. A detailed medical history and physical examination should be performed for each patient, and attention should be paid to any metastatic focus of infection such as septic arthritis or distal septic emboli (patient 3 in the current series). Positive blood cultures are extremely high in patients with PVCD-related infection (86% in the current review). For all patients with suspected PVCDrelated infection, at least 2 sets of blood cultures should be obtained on admission and before initiation of antibiotics. Empirical antibiotic choice should include coverage for oxacillin-resistant S aureus with vancomycin. Once microbiological results are available, patients should receive 2 to 4 weeks of systemic antibiotics directed against the in vitro antibiotic susceptibility test results of pathogens isolated from blood and tissue cultures. Antibiotic duration may be prolonged, up to 6 weeks in complicated cases with complex MPA, septic arthritis, osteomyelitis, and infective endocarditis. Treatment recommendations for patients with PVCD-related infection are summarized in Table 4. Mycotic pseudoaneurysm is the most common complication (42% in the current review) of PVCD-associated accesssite infection. If suspected, patients should undergo ultrasonography of the groin to evaluate for abscess or MPA. All patients require surgical intervention for débridement or reconstructive procedures. Most patients can be cured with combined medical and surgical treatment. There are no reported cases of success with medical therapy alone. Perclose and Angio-Seal were the 2 most commonly used closure devices in the current series of PVCD-related infections. This finding reflects the overall high usage rate of these 2 devices. There are no data to suggest that a particular device is associated with a higher risk of infection. Despite extensive use of PVCDs in our cardiology practice, the cumulative incidence of infectious complications remains low (0.24%; 95% confidence interval, 0.07%0.62%). This relatively low risk of infection may in part be due to experienced operators at our institution and meticulous attention to aseptic techniques including change of gloves and repeated sterilization of the access site between removal of the catheterization procedure sheath and deployment of the PVCD. These strategies were incorporated into standard clinical practice soon after initial cases of PVCD-related infection developed. Similar strategies have been adopted at other institutions once infection was recognized as a serious complication of PVCD deployment.8,31 Currently, there are limited guidelines for the prevention of access-site infections. Some experts have recommended prophylactic use of antibiotics before PVCD placement in high-risk patients, especially for those with diabetes mellitus1,8,9,17,32; however, no prospective clinical trial data are available to assess the effectiveness of this
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VASCULAR CLOSURE DEVICES AND INFECTION
TABLE 5. Prophylaxis for PVCD-Related Infection* Use strict aseptic technique Change gloves and repeat sterilization of the site between removal of the catheterization sheath and deployment of the PVCD There are no good data to support routine use of primary (at time of placement) or secondary (eg, dental procedure) prophylaxis with antibiotics Consider primary antibiotic prophylaxis for patients with diabetes mellitus or for patients in whom prosthetic vascular graft is entered for arterial access *Refer to text for further information and references. PVCD = percutaneous vascular closure device.
strategy. We do not routinely give prophylactic antibiotics to all patients undergoing PVCD placement at the Mayo Clinic. Prophylaxis is given to patients who undergo puncture of a prosthetic vascular graft in the groin for catheterization access with subsequent closure device placement (Table 5). Interestingly, use of a 2% aqueous chlorhexidine antiseptic for preparation of the insertion site before central venous catheter placement has been associated with a significant reduction in insertion-site infection compared with use of a 10% povidone-iodine solution.33 However, no such data are available with PVCD insertion-site preparation, and 10% povidone-iodine continues to be used routinely for skin preparation in our cardiology practice. CONCLUSIONS Infection associated with the use of PVCDs is uncommon but is associated with severe morbidity (requiring multiple surgical débridement, prolonged hospitalization, and antibiotics) and mortality. Lack of awareness of this rare but emerging infectious complication of PVCD placement can delay diagnosis and appropriate treatment of this potentially life-threatening illness. We thank Dr Haraldur Bjarnason (Chair, Division of Interventional Radiology) for providing data regarding use of PVCD in vascular radiology practice. REFERENCES 1. Johanning JM, Franklin DP, Elmore JR, Han DC. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg. 2001;34:983-985. 2. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials. Am J Cardiol. 2000;85:864-869. 3. Gerckens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol. 1999;83:1658-1663. 4. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003;14:865-885. 5. Smith TP, Cruz CP, Moursi MM, Eidt JF. Infectious complications resulting from use of hemostatic puncture closure devices. Am J Surg. 2001;182:658-662. 6. Carey D, Martin JR, Moore CA, Valentine MC, Nygaard TW. Complications of femoral artery closure devices. Catheter Cardiovasc Interv. 2001;52:3-7. 7. Eidt JF, Habibipour S, Saucedo JF, et al. Surgical complications from hemostatic puncture closure devices. Am J Surg. 1999;178:511-516.
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8. Cooper CL, Miller A. Infectious complications related to the use of the angio-seal hemostatic puncture closure device. Catheter Cardiovasc Interv. 1999;48:301-303. 9. Cherr GS, Travis JA, Ligush J Jr, et al. Infection is an unusual but serious complication of a femoral artery catheterization site closure device. Ann Vasc Surg. 2001;15:567-570. 10. Ward SR, Casale P, Raymond R, Kussmaul WG III, Simpfendorfer C, Angio-Seal Investigators. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998; 81:569-572. 11. Cura FA, Kapadia SR, L’Allier PL, et al. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol. 2000;86:780-782, A789. 12. von Hoch F, Neumann FJ, Theiss W, Kastrati A, Schomig A. Efficacy and safety of collagen implants for haemostasis of the vascular access site after coronary balloon angioplasty and coronary stent implantation: a randomized study. Eur Heart J. 1995;16:640-646. 13. Pipkin W, Brophy C, Nesbit R, Mondy JS III. Early experience with infectious complications of percutaneous femoral artery closure devices. J Vasc Surg. 2000;32:205-208. 14. Whitton Hollis H Jr, Rehring TF. Femoral endarteritis associated with percutaneous suture closure: new technology, challenging complications. J Vasc Surg. 2003;38:83-87. 15. Yamamoto N, Koyano K, Azuma M, Ochiai H, Kashiwabara T. Groin infection caused by a percutaneous femoral artery closure device: report of a case. Surg Today. 2003;33:801-804. 16. Geary K, Landers JT, Fiore W, Riggs P. Management of infected femoral closure devices. Cardiovasc Surg. 2002;10:161-163. 17. Heck DV, Muldowney S, McPherson SH. Infectious complications of perclose for closure of femoral artery punctures [letter]. J Vasc Interv Radiol. 2002;13:430-431. 18. Toursarkissian B, Mejia A, Smilanich RP, Shireman PK, Sykes MT. Changing patterns of access site complications with the use of percutaneous closure devices. Vasc Surg. 2001;35:203-206. 19. Sprouse LR II, Botta DM Jr, Hamilton IN Jr. The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices. J Vasc Surg. 2001;33:688-693. 20. Wilson JS, Johnson BL, Parker JL, Back MR, Bandyk DF. Management of vascular complications following femoral artery catheterization with and without percutaneous arterial closure devices. Ann Vasc Surg. 2002;16:597-600. 21. Noguchi T, Miyazaki S, Yasuda S, et al. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000;19:451-455. 22. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary interventions. Catheter Cardiovasc Interv. 2001;54:146-151. 23. Tolerico PH, McKendall GR. Femoral endarteritis as a complication of percutaneous coronary intervention. J Invasive Cardiol. 2000;12:155-157. 24. Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001;13:354-362. 25. Tan SL. Explantation of infected hemostatic puncture closure devices: a case report. Vasc Surg. 1999;33:507-510. 26. Sanborn TA, Gibbs HH, Brinker JA, Knopf WD, Kosinski EJ, Roubin GS. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol. 1993;22:1273-1279. 27. Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg. 2003;17:66-71. 28. Pracyk JB, Wall TC, Longabaugh JP, et al. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol. 1998;81:970-976. 29. Cowley MJ, Mullin SM, Kelsey SF, et al. Sex differences in early and long-term results of coronary angioplasty in the NHLBI PTCA Registry. Circulation. 1985;71:90-97. 30. Cleveland KO, Gelfand MS. Invasive staphylococcal infections complicating percutaneous transluminal coronary angioplasty: three cases and review. Clin Infect Dis. 1995;21:93-96. 31. Eggebrecht H, Haude M, Baumgart D, Erbel R. Infectious complications related to the use of the angio-seal hemostatic puncture closure device [letter]. Catheter Cardiovasc Interv. 2000;49:352-353. 32. Baddour LM, Bettmann MA, Bolger AF, et al, American Heart Association. Nonvalvular cardiovascular device-related infections. Circulation. 2003; 108:2015-2031. 33. Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991;338:339-343.
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Infectious Complications of Percutaneous Vascular Closure Devices MUHAMMAD R. SOHAIL, MD; AKBAR H. KHAN, MD; DAVID R. HOLMES, JR, MD; WALTER R. WILSON, MD; JAMES M. STECKELBERG, MD; AND LARRY M. BADDOUR, MD OBJECTIVE: To describe the infectious complications of percutaneous vascular closure devices (PVCDs) on the basis of our institutional experience with PVCDs and the published medical literature. PATIENTS AND METHODS: We retrospectively reviewed all cases of PVCD-related infection seen at the Mayo Clinic in Rochester, Minn, between January 1, 2000, and December 31, 2003, and searched the English language medical literature for all previously published reports. RESULTS: We identified 46 cases in the medical literature and 6 cases from our institutional database. The median age of patients was 63 years (range, 40-79 years). Diabetes mellitus and obesity were the most common comorbidities. The median incubation period from device insertion to presentation with access-site infection was 8 days (range, 2-29 days). The most common presenting symptoms were pain, erythema, fever, swelling, and purulent drainage at the access site. Mycotic pseudoaneurysm (22 cases) was the most common complication. Staphylococcus aureus was responsible for most (75%) of the infections. All patients underwent surgical débridement, and 54% required reconstructive procedures. The median duration of antibiotic treatment was 28 days (range, 7-42 days). The mortality rate was 6% (3 patients). CONCLUSIONS: Infection associated with PVCD placement is uncommon but is an extremely serious complication. Morbidity is high, and aggressive medical and surgical interventions are required to achieve cure.
Mayo Clin Proc. 2005;80(8):1011-1015 MPA = mycotic pseudoaneurysm; OSSA = oxacillin-sensitive Staphylococcus aureus; PVCD = percutaneous vascular closure device
I
n the past, hemostasis of an arteriotomy site was achieved by manual compression of the access site for 15 minutes, followed by up to 8 hours of bed rest. The ability to achieve earlier hemostasis with percutaneous vascular closure devices (PVCDs) and the resultant increases in patient comfort, shorter time to ambulation, and less demand on personnel for applying manual compression have contributed to the increasing use of these devices.1-3 Currently, 5 PVCDs have been approved by the US Food and Drug Administration. The Vasoseal vascular hemostatic device (Datascope, Montvale, NJ), the AngioSeal hemostatic puncture closing device (St. Jude Medical, Minnetonka, Minn), and the Duett system (Gershony vascular sealing device, Vascular Solutions, Minneapolis, Minn) use various mechanisms of collagen or other substance deposition to achieve hemostatic control. The Perclose system (Perclose Inc, Redwood City, Calif) and SuperStitch (Sutura, Inc, Fountain Valley, Calif) deploy a suture to close the arteriotomy site.4,5 Mayo Clin Proc.
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Placement of PVCDs can be complicated by various noninfectious and infectious events including hemorrhage, hematoma, pseudoaneurysm formation, arteriovenous fistula, limb ischemia, access-site infection, femoral endarteritis, and septic emboli.6 Overall, a complication rate of up to 2% has been reported.2,7 Infectious complication rates range from 0.0% to 5.1%.1,3,8-12 In this article, we review both our institutional experience with PVCD-related infections and the published medical literature that describes additional cases of PVCDrelated infection. PATIENTS AND METHODS We retrospectively reviewed all cases of PVCD-related infections seen at the Mayo Clinic in Rochester, Minn, between January 1, 2000, and December 31, 2003. During this time, 26,790 patients underwent cardiac catheterization, PVCDs were deployed in 1662 patients, and 215 devices were used by interventional radiologists for vascular puncture site hemostasis. Cases of PVCD-related infection were identified by searching the Mayo central diagnostic index, surgical procedures index, cardiac catheterization laboratory database and interventional radiology records. All patients with PVCD-related access-site infection underwent surgery and had intraoperative confirmation of infection. Patients who presented initially with noninfectious complications such as hematoma or pseudoaneurysm that were managed surgically and who subsequently developed infection were excluded from this review. These patients were considered to have surgical complications and not infectious complications of the initial catheterization and PVCD placement. All patients had given written authorization for use of their medical records for research, and the study was approved by the Mayo Foundation Institutional Review Board. From the Division of Infectious Diseases (M.R.S., W.R.W., J.M.S., L.M.B.), Department of Internal Medicine (A.H.K.), and Division of Cardiovascular Diseases (D.R.H.), Mayo Clinic College of Medicine, Rochester, Minn. Presented as an abstract (No. 169) at the 42nd Annual Meeting of Infectious Diseases Society of America, Boston, Mass, September 30-October 3, 2004. Individual reprints of this article are not available. Address correspondence to Muhammad R. Sohail, MD, Division of Infectious Diseases, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: sohail [email protected]). © 2005 Mayo Foundation for Medical Education and Research
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VASCULAR CLOSURE DEVICES AND INFECTION
TABLE 1. Summary of 6 Patients With PVCD-Related Infection Treated at the Mayo Clinic* Patient No./ age (y)/sex
Comorbid condition
Device
1/75/M
DM, COPD
Angio-Seal
OSSA
8
2/79/M
DM, obesity
Angio-Seal
OSSA
6
3/41/F
SLE
Perclose
ORSA
6
Erythema, tenderness, purulent drainage, abscess Pain, swelling, erythema, abscess Pain, MPA, abscess
4/76/F
Obesity
Perclose
4
MPA, abscess
5/75/M
None
Perclose
Enterococcus species, Morganella morganii, Escherichia coli OSSA
2
6/77/M
Malignancy, COPD
Perclose
OSSA
Fever, swelling, MPA, abscess Pain, swelling, MPA, abscess
Organism
Postoperative day
17
Presentation
Antibiotic (duration)
Outcome (follow-up duration)
Cefazolin (4 wk)
Resolved (6 mo)
Vancomycin (4 wk) Vancomycin (4 wk) Cefepime (1 wk) Ciprofloxacin (2 wk)
Resolved (4 mo) NA
Nafcillin (5 wk) Cefazolin (4 wk)
Resolved (4 mo)
Resolved (48 mo) Resolved (36 mo)
*COPD = chronic obstructive pulmonary disease; DM = diabetes mellitus; MPA = mycotic pseudoaneurysm; NA = not available; ORSA = oxacillin-resistant Staphylococcus aureus; OSSA = oxacillin-sensitive S aureus; PVCD = percutaneous vascular closure device; SLE = systemic lupus erythematosus.
We reviewed all previously published case reports of infections associated with use of PVCDs and searched the English language medical literature by using the online bibliographic databases of the National Library of Medicine (MEDLINE and PubMed). Search terms included closure device, vascular, infection, sepsis, abscess, wound, and complication. Also, we performed an extensive bibliography search of the articles identified through MEDLINE and PubMed. RESULTS Ninety cases of PVCD-related infection were identified by searching the medical literature and our institutional database.1-3,5-9,12-27 Fifty-two cases (including 6 from the Mayo Clinic’s institutional database) listed access-site infection as a primary complication of PVCD deployment.1,5,8,9,13-20,23,25,27 All patients underwent surgery and had intraoperative confirmation of infection. Among our patients, 5 had closure devices placed at our institution, and the sixth had a PVCD deployed in an outside hospital and subsequently presented to the Mayo Clinic with access-site infection. The demographics, microbiology, and outcome of the 6 patients with PVCDrelated infection treated at the Mayo Clinic are summarized in Table 1. Cumulative incidence for device-related infection in our cardiology practice was 0.24% (4/1662; 95% confidence interval, 0.07%-0.62%). We were unable to estimate the cumulative incidence of PVCD-related infection in the vascular radiology group because of limited follow-up data. Demographic characteristics of the 52 study patients are summarized in Table 2. 1012
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Among the 52 patients, 48 underwent cardiac catheterization, 2 underwent cerebral arteriography, 1 underwent renal angiography, and the remaining patient underwent intra-arterial chemotherapy as the initial procedures followed by use of PVCDs for puncture-site hemostasis. Devices used to achieve hemostasis of the access sites included the Perclose device (38 patients) and the Angio-Seal device (9 patients). The type of device was not specified in 5 patients. The median patient age was 63 years (range, 4079 years); 74% of patients were men. Comorbidities were not uniformly reported (only 20 patients). Diabetes mellitus (80%) and obesity (20%) were the 2 most commonly reported comorbid conditions. Other comorbidities included systemic lupus erythematosus, splenectomy, chronic obstructive pulmonary disease, end-stage renal disease, and malignancy (Table 2). The median incubation period from device insertion to presentation of PVCD-related infection was 8 days (mean, 10 days; range, 2-29 days). Symptoms including pain (52%), erythema (42%), swelling (30%), and drainage (24%) from the access site, as well as fever (38%), were the most common at presentation (Table 3). Blood cultures were positive in 86% of reported cases. Mycotic pseudoaneurysm at the access site was the most common complication (22 of 52 patients, 42%), which required extensive débridement and reconstruction. S aureus was the single most common (43 isolates, 75%) infecting organism (Figure 1). Of the 43 isolates, 82% were OSSA, and 18% were oxacillin-resistant S aureus. Coagulase-negative Staphylococcus was the second most common pathogen, isolated in 5% of patients. Other organisms included Peptostreptococcus, Enterococcus species, Corynebacterium species, Haemophilus
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VASCULAR CLOSURE DEVICES AND INFECTION
influenzae, Streptococcus species, Enterobacter, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas species. Fourteen percent of infections were polymicrobial. All patients underwent surgical débridement, and 54% required reconstructive procedures for treatment of PVCDrelated infection. Four patients required multiple, complex surgical interventions. A venous patch was surgically placed in 12 patients; femoral artery reconstruction was needed in 1, arterial bypass in 5, and primary artery closure in 7, and 2 patients underwent the BEST (bolstered, everted, saphenous vein patch technique) procedure.14 The median duration of antibiotic treatment was 28 days (mean, 24 days; range, 7-42 days). Routes of antibiotic administration were specified in 26 patients: 22 (85%) received intravenous antibiotics (mean, 26 days), 3 received combined intravenous and oral antibiotics, and 1 was treated with oral antibiotics alone. Cefazolin and vancomycin were the most commonly used antibiotics. Outcome variables were reported in 49 patients. Complete resolution of PVCD-related infection was achieved in 44 patients (90%) with combined medical and surgical treatment. Two patients (4%) had permanent disability including 1 below-knee amputation.18 The mortality rate was 6% (3 patients).5,9 All deaths were in patients with S aureus infection and were due to severe sepsis complicated by multisystem organ failure. ILLUSTRATIVE CASE A 75-year-old man (No. 5; Table 1) underwent catheterization of the left side of the heart for severe coronary artery disease. The access site was closed with use of a Perclose device. The patient presented with fever, leuk ocytosis, and fullness in the right groi n on the second stoperative po day. Blood cultures revealed oxacillin-sensitive Staphylococcus aureus (OSSA) within 12 hours of blood draw. Transesophageal echocardiography revealed no evidence of infective endocarditis. Ultrasonography of the right groin showed a 6-cm infected mycotic pseudoaneurysm (MPA). Operative tissue culture revealed OSSA. Intravenous nafcillin was initiated. The patient underwent débridement, resection of the PVCD, and repair of the MPA 4 days later after blood cultures were confirmed negative. The patient continued taking nafcillin for an additional 4 weeks. He experienced complete resolution of infection and had no evidence of infection relapse over the next 4 years of follow-up.
TABLE 2. Demographic Characteristics of 52 Patients* No. of patients† Median age (range) (y) Sex, No. (%) Male Female Device Perclose Angio-Seal Unspecified Primary procedure Cardiac catheterization Cerebral arteriography Renal angiography Intra-arterial chemotherapy Comorbidities Diabetes mellitus Obesity Systemic lupus erythematosus Splenectomy Chronic obstructive pulmonary disease End-stage renal disease Malignancy
38 9 5 48 2 1 1 16 4 1 1 1 1 1
though relatively safe, this procedure causes patient discomfort and prolonged immobility. In recent years, with the increasing use of smaller catheters at many institutions, including our own, duration of bed rest after cardiac catheterization has been shortened to 1 to 3 hours, depending on the catheter size used. Complications associated with catheterization and manual compression include formation of hematoma, arteriovenous fistula, and pseudoaneurysm.28 Rates of these noninfectious complications have ranged from 0.0% to 1.1% for diagnostic catheterization and from 5.9% to 17% for percutaneous coronary intervention TABLE 3. Clinical Presentation of 52 Patients* Percentage of patients† Incubation period (d) Median Range Systemic signs Fever Localized signs/symptoms at catheterization site Pain Erythema Swelling Drainage Complications Mycotic pseudoaneurysm Arteriotomy-site abscess Septic emboli Bacteremia
Manual compression for 15 minutes, followed by up to 8 hours of bed rest, has been used traditionally to achieve hemostasis of the cardiac catheterization access site. Al•
38 (74) 14 (26)
*From the Mayo Clinic series and a review of the literature. †Unless indicated otherwise.
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8 (mean, 10) 2-29 38 52 42 30 24 42 22 7 86
*From the Mayo Clinic series and a review of the literature. †Unless indicated otherwise. •
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VASCULAR CLOSURE DEVICES AND INFECTION
80 70
(18% Oxacillin-resistant Staphylococcus aureus)
Percentage
60 50 40
(82% Oxacillin-sensitive S aureus)
30 20 10 0
S aureus (75%)
Gram-negative Coagulaserods negative (13%) Staphylococcus (5%)
Others (7%)
FIGURE 1. Microbiology (57 isolates in 52 patients).
when stents were deployed.4 In contrast, infection has been reported rarely.5,25,29,30 Early ambulation and increased patient comfort have led to increased use of PVCDs. Although bleeding and vascular complication rates with use of these devices are similar to those that characterize manual compression,10,11 infection has emerged as a more common complication with use of PVCDs, with a reported incidence of 0.0% to 5.1%.1,3,8-12 Hematoma formation at the puncture site and the presence of foreign material in the intravascular space and arterial wall likely serve as a nidus for subsequent infection. Infection associated with the PVCD results in localized endarteritis at the insertion site, which is a risk factor for subsequent development of MPA.1,14,15 The median incubation period from PVCD insertion to clinical presentation with access-site infection was 8 days; this relatively short period is likely due to the presence of S aureus, a highly virulent organism, in most patients (75%). Diagnosis of device-related infection should be considered in patients who present with local signs of inflammaTABLE 4. Treatment Recommendations for PVCD-Related Infection* Detailed history and physical examination to evaluate for metastatic foci of infection (eg, septic arthritis) Two sets of blood cultures Doppler ultrasonography to evaluate for mycotic pseudoaneurysm Empirical broad-spectrum antibiotics that should include coverage for oxacillin-resistant Staphylococcus aureus (ie, vancomycin) Intravenous antibiotics for 2 to 4 weeks against identified organism Duration of antibiotics may be extended up to 6 weeks for complicated cases (ie, septic arthritis, endocarditis) Surgical débridement should be considered for all patients *Refer to text for further information and references. PVCD = percutaneous vascular closure device.
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tion, fever, and/or leukocytosis within 1 to 2 weeks after device placement. A detailed medical history and physical examination should be performed for each patient, and attention should be paid to any metastatic focus of infection such as septic arthritis or distal septic emboli (patient 3 in the current series). Positive blood cultures are extremely high in patients with PVCD-related infection (86% in the current review). For all patients with suspected PVCDrelated infection, at least 2 sets of blood cultures should be obtained on admission and before initiation of antibiotics. Empirical antibiotic choice should include coverage for oxacillin-resistant S aureus with vancomycin. Once microbiological results are available, patients should receive 2 to 4 weeks of systemic antibiotics directed against the in vitro antibiotic susceptibility test results of pathogens isolated from blood and tissue cultures. Antibiotic duration may be prolonged, up to 6 weeks in complicated cases with complex MPA, septic arthritis, osteomyelitis, and infective endocarditis. Treatment recommendations for patients with PVCD-related infection are summarized in Table 4. Mycotic pseudoaneurysm is the most common complication (42% in the current review) of PVCD-associated accesssite infection. If suspected, patients should undergo ultrasonography of the groin to evaluate for abscess or MPA. All patients require surgical intervention for débridement or reconstructive procedures. Most patients can be cured with combined medical and surgical treatment. There are no reported cases of success with medical therapy alone. Perclose and Angio-Seal were the 2 most commonly used closure devices in the current series of PVCD-related infections. This finding reflects the overall high usage rate of these 2 devices. There are no data to suggest that a particular device is associated with a higher risk of infection. Despite extensive use of PVCDs in our cardiology practice, the cumulative incidence of infectious complications remains low (0.24%; 95% confidence interval, 0.07%0.62%). This relatively low risk of infection may in part be due to experienced operators at our institution and meticulous attention to aseptic techniques including change of gloves and repeated sterilization of the access site between removal of the catheterization procedure sheath and deployment of the PVCD. These strategies were incorporated into standard clinical practice soon after initial cases of PVCD-related infection developed. Similar strategies have been adopted at other institutions once infection was recognized as a serious complication of PVCD deployment.8,31 Currently, there are limited guidelines for the prevention of access-site infections. Some experts have recommended prophylactic use of antibiotics before PVCD placement in high-risk patients, especially for those with diabetes mellitus1,8,9,17,32; however, no prospective clinical trial data are available to assess the effectiveness of this
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VASCULAR CLOSURE DEVICES AND INFECTION
TABLE 5. Prophylaxis for PVCD-Related Infection* Use strict aseptic technique Change gloves and repeat sterilization of the site between removal of the catheterization sheath and deployment of the PVCD There are no good data to support routine use of primary (at time of placement) or secondary (eg, dental procedure) prophylaxis with antibiotics Consider primary antibiotic prophylaxis for patients with diabetes mellitus or for patients in whom prosthetic vascular graft is entered for arterial access *Refer to text for further information and references. PVCD = percutaneous vascular closure device.
strategy. We do not routinely give prophylactic antibiotics to all patients undergoing PVCD placement at the Mayo Clinic. Prophylaxis is given to patients who undergo puncture of a prosthetic vascular graft in the groin for catheterization access with subsequent closure device placement (Table 5). Interestingly, use of a 2% aqueous chlorhexidine antiseptic for preparation of the insertion site before central venous catheter placement has been associated with a significant reduction in insertion-site infection compared with use of a 10% povidone-iodine solution.33 However, no such data are available with PVCD insertion-site preparation, and 10% povidone-iodine continues to be used routinely for skin preparation in our cardiology practice. CONCLUSIONS Infection associated with the use of PVCDs is uncommon but is associated with severe morbidity (requiring multiple surgical débridement, prolonged hospitalization, and antibiotics) and mortality. Lack of awareness of this rare but emerging infectious complication of PVCD placement can delay diagnosis and appropriate treatment of this potentially life-threatening illness. We thank Dr Haraldur Bjarnason (Chair, Division of Interventional Radiology) for providing data regarding use of PVCD in vascular radiology practice. REFERENCES 1. Johanning JM, Franklin DP, Elmore JR, Han DC. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg. 2001;34:983-985. 2. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials. Am J Cardiol. 2000;85:864-869. 3. Gerckens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol. 1999;83:1658-1663. 4. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003;14:865-885. 5. Smith TP, Cruz CP, Moursi MM, Eidt JF. Infectious complications resulting from use of hemostatic puncture closure devices. Am J Surg. 2001;182:658-662. 6. Carey D, Martin JR, Moore CA, Valentine MC, Nygaard TW. Complications of femoral artery closure devices. Catheter Cardiovasc Interv. 2001;52:3-7. 7. Eidt JF, Habibipour S, Saucedo JF, et al. Surgical complications from hemostatic puncture closure devices. Am J Surg. 1999;178:511-516.
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8. Cooper CL, Miller A. Infectious complications related to the use of the angio-seal hemostatic puncture closure device. Catheter Cardiovasc Interv. 1999;48:301-303. 9. Cherr GS, Travis JA, Ligush J Jr, et al. Infection is an unusual but serious complication of a femoral artery catheterization site closure device. Ann Vasc Surg. 2001;15:567-570. 10. Ward SR, Casale P, Raymond R, Kussmaul WG III, Simpfendorfer C, Angio-Seal Investigators. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998; 81:569-572. 11. Cura FA, Kapadia SR, L’Allier PL, et al. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol. 2000;86:780-782, A789. 12. von Hoch F, Neumann FJ, Theiss W, Kastrati A, Schomig A. Efficacy and safety of collagen implants for haemostasis of the vascular access site after coronary balloon angioplasty and coronary stent implantation: a randomized study. Eur Heart J. 1995;16:640-646. 13. Pipkin W, Brophy C, Nesbit R, Mondy JS III. Early experience with infectious complications of percutaneous femoral artery closure devices. J Vasc Surg. 2000;32:205-208. 14. Whitton Hollis H Jr, Rehring TF. Femoral endarteritis associated with percutaneous suture closure: new technology, challenging complications. J Vasc Surg. 2003;38:83-87. 15. Yamamoto N, Koyano K, Azuma M, Ochiai H, Kashiwabara T. Groin infection caused by a percutaneous femoral artery closure device: report of a case. Surg Today. 2003;33:801-804. 16. Geary K, Landers JT, Fiore W, Riggs P. Management of infected femoral closure devices. Cardiovasc Surg. 2002;10:161-163. 17. Heck DV, Muldowney S, McPherson SH. Infectious complications of perclose for closure of femoral artery punctures [letter]. J Vasc Interv Radiol. 2002;13:430-431. 18. Toursarkissian B, Mejia A, Smilanich RP, Shireman PK, Sykes MT. Changing patterns of access site complications with the use of percutaneous closure devices. Vasc Surg. 2001;35:203-206. 19. Sprouse LR II, Botta DM Jr, Hamilton IN Jr. The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices. J Vasc Surg. 2001;33:688-693. 20. Wilson JS, Johnson BL, Parker JL, Back MR, Bandyk DF. Management of vascular complications following femoral artery catheterization with and without percutaneous arterial closure devices. Ann Vasc Surg. 2002;16:597-600. 21. Noguchi T, Miyazaki S, Yasuda S, et al. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000;19:451-455. 22. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary interventions. Catheter Cardiovasc Interv. 2001;54:146-151. 23. Tolerico PH, McKendall GR. Femoral endarteritis as a complication of percutaneous coronary intervention. J Invasive Cardiol. 2000;12:155-157. 24. Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001;13:354-362. 25. Tan SL. Explantation of infected hemostatic puncture closure devices: a case report. Vasc Surg. 1999;33:507-510. 26. Sanborn TA, Gibbs HH, Brinker JA, Knopf WD, Kosinski EJ, Roubin GS. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol. 1993;22:1273-1279. 27. Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg. 2003;17:66-71. 28. Pracyk JB, Wall TC, Longabaugh JP, et al. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol. 1998;81:970-976. 29. Cowley MJ, Mullin SM, Kelsey SF, et al. Sex differences in early and long-term results of coronary angioplasty in the NHLBI PTCA Registry. Circulation. 1985;71:90-97. 30. Cleveland KO, Gelfand MS. Invasive staphylococcal infections complicating percutaneous transluminal coronary angioplasty: three cases and review. Clin Infect Dis. 1995;21:93-96. 31. Eggebrecht H, Haude M, Baumgart D, Erbel R. Infectious complications related to the use of the angio-seal hemostatic puncture closure device [letter]. Catheter Cardiovasc Interv. 2000;49:352-353. 32. Baddour LM, Bettmann MA, Bolger AF, et al, American Heart Association. Nonvalvular cardiovascular device-related infections. Circulation. 2003; 108:2015-2031. 33. Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991;338:339-343.
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