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Practices and Complications of Vascular Closure Devices and Manual Compression in Patients Undergoing Elective Transfemoral Coronary Procedures
Practices and Complications of Vascular Closure Devices and Manual Compression in Patients Undergoing Elective Transfemoral Coronary Procedures Nathaniel R. Smilowitz, MD, Ajay J. Kirtane, MD, Michael Guiry, RPA-C, MBA, William A. Gray, MD, Pilar Dolcimascolo, RPA-C, Michael Querijero, RPA-C, Claudia Echeverry, RCIS, Nellie Kalcheva, MD, Braulio Flores, MD, Varinder P. Singh, MD, LeRoy Rabbani, MD, Susheel Kodali, MD, Michael B. Collins, MD, Martin B. Leon, MD, Jeffrey W. Moses, MD, and Giora Weisz, MD* Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case– control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators’ discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease >3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p ⴝ 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case– control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates. © 2012 Published by Elsevier Inc. (Am J Cardiol 2012;xx:xxx)
Femoral arterial puncture is the most commonly used arterial access method for diagnostic and interventional coronary procedures. Manual compression (MC) with prolonged bedrest to achieve hemostasis has been increasingly replaced by the use of vascular closure devices (VCDs). The use of VCDs enables rapid postprocedure hemostasis, a shorter duration of bedrest with sooner ambulation, and earlier discharge.1 Different of VCDs have been approved for use in the United States including suture-based, sealant-
Center for Interventional Vascular Therapy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York. Manuscript received January 25, 2012; revised manuscript received and accepted February 28, 2012. Dr. Gray is a consultant to and has received research support from Abbott Vascular, Redwood City, California and has minor equity in AccessClosure, Mountain View, California. Dr. Moses is a consultant to Abbott Vascular. *Corresponding author: Tel: 212-305-7060; fax: 212-342-3680. E-mail address: [email protected] (G. Weisz). 0002-9149/12/$ – see front matter © 2012 Published by Elsevier Inc. doi:10.1016/j.amjcard.2012.02.065
based, and collagen-plug based devices. With improved operator experience and the development of newer generations of closure devices, complication rates have decreased.2,3 Even with these improvements, complications of vascular access continue to affect procedure-related morbidity and mortality, hospital length of stay, and health care costs. Despite the potential benefits and improvements with VCDs, there is still no consensus on whether they are superior to MC.4 – 6 Few large studies have compared vascular access strategies in patients undergoing elective coronary procedures.7,8 We performed a retrospective review of consecutive patients who underwent elective coronary angiography or intervention with femoral arterial access to evaluate patterns of use and outcomes associated with various vascular closure strategies in the modern era of elective angiography. Methods This is a retrospective evaluation of consecutive patients undergoing ambulatory elective transfemoral coronary anwww.ajconline.org
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Table 1 Baseline characteristics of patients with vascular access complications compared to controls without complications
Table 2 Coronary procedure characteristics in patients with vascular access complications compared to controls without complications
Variable
Variable
Age (years) Men Previous myocardial infarction Previous percutaneous coronary intervention Previous coronary bypass Mean ejection fraction (%) Documented hypertension Documented dyslipidemia Diabetes mellitus Chronic kidney disease (glomerular filtration rate ⬍60 ml/min) End-stage renal disease Weak/absent distal pulses Peripheral arterial disease Smoking history Platelet count ⬍100/ mm3 Mean international normalized ratio Body mass index (kg/m2) Number of coronary arteries narrowed 0 1 2 3
Vascular Complication
p Value
Yes (n ⫽ 74)
No (n ⫽ 74)
70.5 ⫾ 13.0 39 (53%) 20 (27%)
64.4 ⫾ 12.3 50 (68%) 13 (18%)
33 (45%)
28 (38%)
0.4
13 (18%)
10 (14%)
0.5
51 ⫾ 10.8
0.23
55 (74%)
53 (72%)
0.71
52 (70%)
44 (60%)
0.17
22 (30%) 29 (39%)
25 (34%) 18 (24%)
0.6 0.05
53.2 ⫾ 9.3
0.004 0.06 0.17
1 (1%) 17 (23%)
5 (7%) 17 (23%)
0.1 1
14 (19%)
16 (22%)
0.68
21 (28%) 4 (5%)
22 (30%) 1 (1%)
0.86 0.17
1.2 ⫾ 1.2
1.0 ⫾ 0.2
0.23
28 ⫾ 5.1
28.9 ⫾ 5.3
0.34 0.82*
21 (28%) 14 (19%) 18 (24%) 21 (28%)
21 (28%) 18 (24%) 18 (24%) 17 (23%)
* Chi-square distribution.
giography at the New York-Presbyterian/Columbia University Medical Center from January 1, 2008 to December 31, 2010. Emergency and inpatient coronary procedures were excluded from analysis. In patients who presented for an elective coronary procedure and required hospital admission, all subsequent in-hospital interventions were excluded from analysis. In total 8,580 patients underwent 9,861 elective coronary angiographic procedures and percutaneous coronary interventions (PCIs) during the study period. Of these, 736 were accessed through the radial artery and 9 through the brachial artery. Femoral arterial access was used in 9,116 procedures (92.4%); 8 procedures were excluded because of incomplete data. The remaining 9,108 procedures in 7,994 patients were the basis for study analysis. For femoral arterial access, operators identified bony anatomic landmarks by fluoroscopy and attempted a single anterior common femoral puncture. As an institutional pro-
Percutaneous coronary intervention Femoral access site Right femoral access Left femoral access Right and left femoral access Repeat femoral access* Anticoagulation/antiplatelet None Aspirin Clopidogrel Ticlopidine Bivalirudin Heparin Eptifibatide Sheath size 5–6Fr 7–8Fr Closure strategy Manual compression Vascular closure device Mean contrast volume (ml) Mean procedure duration (min)
Vascular Complication
p Value
Yes (n ⫽ 74)
No (n ⫽ 74)
32 (43%)
30 (41%)
0.73
54 (73%) 11 (15%) 9 (12%)
64 (87%) 7 (10%) 3 (4%)
0.04 0.31 0.07
18 (24%)
22 (30%)
0.46
14 (19%) 68 (92%) 59 (80%) 1 (1%) 38 (51%) 11 (15%) 4 (5%)
20 (27%) 62 (84%) 51 (69%) 0 (0%) 31 (42%) 6 (8%) 1 (1%)
0.24 0.13 0.13 0.32 0.25 0.2 0.17
40 (54%) 34 (46%)
55 (74%) 19 (26%)
0.01
32 (43%) 42 (57%) 214.8 ⫾ 133.6 99 ⫾ 92
19 (26%) 55 (74%) 184.6 ⫾ 130.7 66 ⫾ 48
0.025 0.17 0.008
* Number of patients with documentation of an ipsilateral femoral arterial puncture before the index coronary procedure. Table 3 Vascular complications by femoral closure strategy Variable
VCD (n ⫽ 6,527)
MC (n ⫽ 2,581)
p Value
Significant groin bleeding Bleeding by Thrombolysis In Myocardial Infarction criteria Hematoma ⱖ5 cm Retroperitoneal bleed Femoral arterial perforation Pseudoaneurysm Vascular occlusion Venous thrombosis Arterial occlusion Arteriovenous fistula Access-site infection
19 (0.29%) 3 (0.05%)
21 (0.81%) 5 (0.19%)
⬍0.001 0.03
13 (0.20%) 2 (0.03%) 1 (0.02%)
12 (0.46%) 2 (0.08%) 2 (0.08%)
0.03 0.33 0.85
11 (0.17%) 7 (0.11%) 3 (0.05%) 4 (0.06%) 4 (0.06%) 1 (0.02%)
9 (0.35%) 1 (0.04%) 0 (0%) 1 (0.04%) 1 (0.04%) 0 (0%)
0.1 0.32 0.27 0.67 0.67 0.53
tocol, all patients (even patients undergoing diagnostic angiography) received aspirin (loading dose 325 mg, maintenance 81 mg/day) and clopidogrel (loading dose 600 mg ⱖ2 hours before the procedure, maintenance 75 mg/day) when PCI was planned or optional unless contraindications existed. Anticoagulation with heparin or bivalirudin was administrated for interventional cases. Use of IIb/IIIa inhibitors was at the discretion of each operator.
Coronary Artery Disease/Vascular Closure Devices in Elective Coronary Procedures
Sheath removal after PCI was performed according to local hospital protocol. Operators selected VCD or MC as the primary method of hemostasis. When a VCD was selected, it was deployed immediately after completion of the procedure. Sheath removal and MC were performed immediately if no antithrombin was administered, when activated clotting time was ⬍170 seconds in patients treated with heparin, or 2 hours after discontinuation of bivalirudin. The VCDs that were used included Angioseal (St. Jude Medical, St. Paul, Minnesota), Perclose-Proglide and Starclose (Abbott Vascular, Redwood City, California), and Mynx (AccessClosure, Mountain View, California). Certified experienced operators deployed all closure devices according to the manufacturers’ instructions for use. Ambulation was initiated 2 hours after hemostasis after diagnostic angiography without administration of anticoagulation. After PCI with administration of anticoagulation, ambulation was initiated 2 hours after deployment of a VCD and 6 hours after hemostasis with MC. Postprocedure access-site evaluation and documentation were systematically performed by experienced catheterization laboratory staff. All documented access-site vascular complications were reviewed. Major vascular complications were defined as significant groin bleeding (resulting in blood transfusion, hemoglobin decrease ⱖ3 g/dl, hematoma ⱖ5 cm, retroperitoneal bleeding, femoral artery perforation, or bleeding leading to increased length of hospitalization ⱖ2 nights), pseudoaneurysm (documented by ultrasonography), arteriovenous fistula formation, vascular obstruction, or access-site infection.9 VCD failure was defined by unsuccessful deployment or failure to achieve hemostasis. Patients with postprocedure access complications were compared 1:1 to randomly selected controls without evidence of vascular complication in a nested case– control method. Hospital charts were reviewed to identify clinical, procedural, and laboratory data. Statistical analyses were conducted by unpaired Student’s t test for normally distributed continuous data and by chi-square and Fisher’s exact tests for categorical variables. Conditional logistic regression was used to identify independent predictors of vascular complications in the nested case– control subset. Statistical models were generated based on clinically relevant covariates and those identified during univariate analysis (age, gender, body mass index, chronic kidney disease, history of repeat femoral access, sheath size, closure strategy), followed by stepwise selection and backward elimination of nonsignificant variables. After establishing baseline significant predictors, a second model was developed to assess the additive predictive influence of closure strategy. Binomial logistic regression was used for the unmatched study population, with a model generated through backward elimination to include significant covariates and independent variables with strong trends toward predictive significance. Twotailed p values ⬍0.05 were considered statistically significant for all tests. All statistical analyses were conducted using SPSS 19 (IBM, Armonk, New York). The study was approved by the local institutional review board.
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Table 4 Multivariable predictors of vascular complications Model Variables Model 1: case–control analysis 7–8Fr sheath size Age Model 2: case–control analysis 7–8Fr sheath size Age Vascular closure device Model 3: full study population Vascular closure device Male gender
Adjusted OR (95% CI)
p Value
2.46 (1.09–5.55) 1.04 (1.01–1.08)
0.03 0.01
2.25 (0.97–5.19) 1.04 (1.01–1.07) 0.60 (0.26–1.37)
0.06 0.02 0.22
0.52 (0.33–0.83) 0.66 (0.42–1.04)
⬍0.01 0.07
Congenital logistic regression was employed for matched case– control analysis (models 1 and 2). Binomial logistic regression was used to model the unmatched study population (model 3).
Results In total 7,994 patients underwent 9,108 consecutive elective coronary procedures by femoral arterial access, with full documentation available for this study. Diagnostic angiography only was performed in 5,936 procedures (65.2%); PCI was performed in 3,172 procedures (34.8%). Device-based closure was the primary method of hemostasis in 6,527 procedures (71.7%), with MC applied in the remaining 2,581 (28.3%). VCDs were selected for hemostasis in 2,205 PCI procedures and 4,322 diagnostic angiographic procedures (69.5% vs 72.7%, p ⬍0.001). Vascular access-site complications occurred in 74 procedures (0.81%). No patient in the study had ⬎1 vascular complication. Baseline characteristics of patients with complications are listed in Table 1; procedural variables are listed in Table 2. Complication rates were similar between PCIs and diagnostic angiographic procedures (32 [1.0%] complications with PCI vs 42 [0.71%] after diagnostic angiography, p ⫽ 0.13). Primary vascular-access complications included significant groin and retroperitoneal bleeding (n ⫽ 40), pseudoaneurysm (n ⫽ 20), vascular occlusion (n ⫽ 8), arteriovenous fistula (n ⫽ 5), and infection (n ⫽ 1). Large hematoma of ⬎5 cm (n ⫽ 25) was the most common complication after device closure and MC (Table 3). Bleeding by Thrombolysis In Myocardial Infarction criteria was observed in 25 cases (16 cases with overt groin bleeding or hematoma, 4 with pseudoaneurysm, 4 with retroperitoneal bleed, and 1 with perforation). One patient with a large access-site hematoma also developed lower-extremity ischemia from an arterial thrombus. None of the complications was associated with mortality. Patients with an access-site complication were compared in case– control fashion to randomly selected patients without complications. In univariable analyses, patients with complications were older, had a higher frequency of chronic kidney disease, more frequent use of 7Fr to 8Fr femoral sheaths, longer procedures, and a higher rate of manual closure than controls. There were no significant differences between patients with vascular complications and controls in other baseline characteristics (Table 1) and procedural variables (Table 2). Vascular complications were associated with a longer hospital stay. Patients with access-site com-
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plications spent an average of 2 additional nights in hospital compared to controls (2.5 ⫾ 2.7 vs 0.4 ⫾ 0.8 days, p ⬍0.001). In multivariate conditional logistic regression of nested case– control subsets, sheath size (odds ratio [OR] 2.46, 95% confidence interval [CI] 1.09 to 5.55) and age (OR 1.04, 95% CI 1.01 to 1.08) were predictors of postprocedure access-site complications (Table 4). A secondary regression model incorporating closure strategy identified a nonsignificant trend toward decreased complications associated with VCD use. Among all elective coronary procedures, VCDs were associated with a lower rate of complication compared to MC in univariate analysis (42 cases [0.64%] vs 32 cases [1.24%], p ⫽ 0.004). In multivariate binomial logistic regression analysis of the unmatched study population, VCD use was a predictor of decreased complications (OR 0.52, 95% CI 0.33 to 0.83; Table 4). A sensitivity analysis excluding repeat procedures in patients who underwent ⬎1 diagnostic angiographic or coronary intervention during the study period also confirmed this finding (OR 0.50, 95% CI 0.32 to 0.81). Device deployment failure, defined as unsuccessful device deployment or failure to achieve hemostasis, was documented in 80 of 6,527 procedures (1.23%) in which a VCD was selected for primary hemostasis. Of these, 39 of 4,322 occurred after diagnostic angiography and 41 of 2,205 after PCI (0.90% vs 1.86%, p ⬍0.001). Of patients with failed VCD deployment, 8 (10%) developed vascular complications including arterial occlusion (n ⫽ 4), significant groin bleeding (n ⫽ 3), and arteriovenous fistula (n ⫽ 1). Of the 3 patients with bleeding complications, 2 developed hematomas that met Thrombolysis In Myocardial Infarction bleeding criteria9; the other patient had groin bleeding requiring an extended hospital stay for observation, without any additional specific treatment. Of the 74 patients with vascular complications, blood transfusion was required in 13 (17.6%), vascular surgical repair was performed in 5 (6.8%), a percutaneous procedure (balloon angioplasty, aspiration, or femoral stent placement) was required in 3 (4.1%), and ultrasound-guided compression was performed in 2 (2.7%). Of the 40 patients with significant groin bleeding, 12 required transfusion of packed red blood cells, 1 patient underwent percutaneous balloon tamponade for retroperitoneal bleed, and 1 required a surgical intervention. The 20 patients with femoral arterial pseudoaneurysms were managed with ultrasound-guided thrombin injection (n ⫽ 8), ultrasound guided compression (n ⫽ 2), and surgical repair (n ⫽ 1). No specific therapy was required in the other 9 patients. The 8 patients with primary vascular occlusions underwent surgical thrombectomy (n ⫽ 3), percutaneous balloon dilatation (n ⫽ 1), thrombus aspiration (n ⫽ 1), or anticoagulation alone (n ⫽ 3). Within 30 days of the index procedure, 14 patients were readmitted to the hospital with a diagnosis of femoral access complication. Seven patients were admitted for diagnosis and management of a groin pseudoaneurysm, 3 patients were found to have a deep vein thrombosis distal to the access site, 2 patients had hematoma formation and rebleeding requiring transfusion, 1 patient developed a small arteriovenous fistula and was admitted for observation, and 1
patient had an infection at the access site requiring intravenous antibiotics. On average, readmission occurred 10 days after the coronary procedure, with 9 of the 14 patients (64.3%) presenting within 2 weeks. Complications after MC were significantly more likely to require transfusion of packed red blood cells than complications after device closure (10 cases [31.3%] vs 3 cases [7.1%] for VCD, p ⫽ 0.0069). Vascular surgery, percutaneous management, ultrasound-guided thrombin injection, and transfusion were required to manage complications in 15 cases (0.58%) after MC and 13 cases (0.20%) with VCD deployment (p ⫽ 0.003). Discussion Access-site complications after diagnostic angiography and PCI significantly affect morbidity, prolong hospital stay, and increase costs. Many vascular complications, especially postprocedure bleeding requiring transfusion, are associated with increased in-hospital and long-term morbidity and mortality.10 –12 Despite the promised benefits of VCDs to achieve rapid hemostasis, early ambulation, improved patient comfort, and early discharge, there is no consensus on whether VCD safety is superior to MC. Significant decreases in complication rates associated with femoral VCD use have been reported,6,13–15 and although some complications are specific for the VCD used,16,17 most studies have reported no difference between VCDs and the gold standard of MC.5,8,18 –21 Furthermore, several studies and meta-analyses have associated VCD deployment with increased rates of access-site infection, hematoma, pseudoaneurysm, limb ischemia, and vascular-site repair.4,22,23 Interpretation of the published data are further complicated by underpowered studies, differences in patient selection, closure devices used, heterogeneity in anticoagulation and antiplatelet strategies, and definitions of access-site vascular complications that vary throughout the literature. In this retrospective study we examined rates of vascular complications in a low-risk group of patients with elective procedures. Patients with acute coronary syndromes and hospitalized patients were not included, thus eliminating high-risk patients treated with anticoagulation before diagnostic angiography. In our series of consecutive patients undergoing elective coronary angiography and PCI, vascular access complications occurred in 0.81% of patients (0.71% in those with diagnostic angiography and 1.0% in those with PCI). These complication rates occurred in the lower range of those previously reported, with complications in 0.5% to 1.8% of cases after diagnostic catheterizations and 0.6% to 9% after PCI.6,24 Results from the nested case– control analysis suggest that complications are associated with large sheath size and older age. Our study did not support other reported risk factors, such as female gender, renal failure, peripheral vascular disease, smaller body surface area, and glycoprotein IIb/IIIa inhibitor use.2,10,25–27 This suggests that these latter patient characteristics and procedural variables may be greater risk factors for hospitalized patients or emergency cases but not for stable outpatients undergoing elective procedures.
Coronary Artery Disease/Vascular Closure Devices in Elective Coronary Procedures
Closure devices were associated with significantly lower rates of vascular complication compared to primary hemostasis with MC. Several VCDs with different mechanisms of action were used to achieve hemostasis in our group. The Angioseal closure device, used most frequently in our cohort, relies on an intravascular bioabsorbable anchor and a collagen sponge to achieve hemostasis. The Perclose-Proglide is a nonabsorbable polyester suture-based closure system. The Mynx VCD relies on the delivery of a polyethylene glycol-based extravascular sealant, and the Starclose SE Closure System deploys a nickel and titanium alloy clip for extravascular closure. Failure of device deployment, which occurred in 1.23% of all cases, required MC to achieve hemostasis and was associated with a high vascular complication rate (10%). Despite VCD failures and heterogeneity in mechanisms of action, there was a significant association between VCD use and a decreased incidence of vascular complications. Of the 74 cases with complications, type of access-site complication appeared to vary by method of hemostasis. MC was associated with larger numbers of hematomas and bleeds requiring transfusion, suggesting ineffective hemostasis. Conversely, most arterial vascular occlusions were observed after device closure, suggesting a mechanical problem including possible intravascular collagen, suture, or distal device migration and obstruction of flow. Vascular obstruction associated with VCD deployment has been previously reported.16,22 Pseudoaneurysm formation did not vary by femoral closure strategy and needed active intervention with thrombin injection or surgery in 45% of cases. The severity of these complications and the availability of resources necessary for repair or resolution should be considered during selection of hemostasis method and device type. Extrinsic factors including appropriate patient selection and operator experience may also affect VCD outcomes. Radial arterial access has recently risen to prominence as an alternative to femoral access. Radial access is associated with earlier ambulation, lower costs, lower rates of major vascular complications, bleeding, and need for blood transfusions, with comparable rates of major adverse cardiac events and 4% to 8% crossover to femoral access, particularly at high-volume radial centers.28 –30 In light of the low rates of femoral access complications observed after elective coronary procedures, it is unclear whether radial access can confer an incremental improvement in safety in low-risk patients. Additional studies are necessary to compare radial to femoral access complications in stable low-risk outpatients undergoing coronary angiography and PCI. Data collection was retrospective and complications were determined through chart review. Because the study was not randomized, selection of hemostasis method, case complexity, choice of antiplatelet and anticoagulant therapies, and operator skill represent unavoidable confounders. We do not have information about the success and quality of the access procedure and its effect on the development of complications. There is no documentation on the indication for and selection of VCDs. Patients perceived to be at a lower risk of access complications because of favorable vessel characteristics might have been more frequently assigned to VCD hemostasis. It is reasonable to assume that
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patients with an intraprocedural groin complication did not receive a closure device, thus deviating the results of this study. Independent of this acknowledged selection bias, this study nevertheless reports the current status and outcomes of femoral access hemostasis strategies, complications, and management in a large group of consecutive low-risk patients with elective procedures. Patients presenting to other health care facilities with late postprocedure vascular complications may not have been reliably captured in the analysis, but all patients were contacted by telephone 30 days after the procedure. All major complications should have been captured by this routine quality assessment protocol. Complication rates after closure device deployment may be skewed by operator and institutional experience with each device. Data from single tertiary centers may not accurately reflect national complication rates but provide a view of the potential management of femoral vascular access and the performance of VCDs. Careful selection of hemostasis strategy and closure device may further improve outcomes. 1. Ward SR, Casale P, Raymond R, Kussmaul WG III, Simpfendorfer C. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Angio-Seal investigators. Am J Cardiol 1998;81:569 –572. 2. Applegate RJ, Sacrinty MT, Kutcher MA, Kahl FR, Gandhi SK, Santos RM, Little WC. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 –2007. JACC Cardiovasc Interv 2008;1: 317–326. 3. Ahmed B, Piper WD, Malenka D, VerLee P, Robb J, Ryan T, Herne M, Phillips W, Dauerman HL. Significantly improved vascular complications among women undergoing percutaneous coronary intervention: a report from the Northern New England Percutaneous Coronary Intervention Registry. Circ Cardiovasc Interv 2009;2:423– 429. 4. Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and metaanalysis. JAMA 2004;291:350 –357. 5. Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 2004;44:1200 – 1209. 6. Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J 2007;153: 606 – 611. 7. Stegemann E, Hoffmann R, Marso S, Stegemann B, Marx N, Lauer T. The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization. Clin Res Cardiol 2011;100:789 –795. 8. Deuling JH, Vermeulen RP, Anthonio RA, van den Heuvel AF, Jaarsma T, Jessurun G, de Smet BJ, Tan ES, Zijlstra F. Closure of the femoral artery after cardiac catheterization: a comparison of AngioSeal, StarClose, and manual compression. Catheter Cardiovasc Interv 2008;71:518 –523. 9. Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) trial—phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol 1988;11:1–11. 10. Yatskar L, Selzer F, Feit F, Cohen HA, Jacobs AK, Williams DO, Slater J. Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: data from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv 2007;69:961–966.
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11. Omoigui NA, Califf RM, Pieper K, Keeler G, O’Hanesian MA, Berdan LG, Mark DB, Talley JD, Topol EJ. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I). J Am Coll Cardiol 1995;26:922–930. 12. Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schömig A, Kastrati A. Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point. J Am Coll Cardiol 2008;51:690 – 697. 13. Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C. Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 2001;88:493– 496. 14. Tavris DR, Gallauresi BA, Lin B, Rich SE, Shaw RE, Weintraub WS, Brindis RG, Hewitt K. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004;16:459 – 464. 15. Marso SP, Amin AP, House JA, Kennedy KF, Spertus JA, Rao SV, Cohen DJ, Messenger JC, Rumsfeld JS; National Cardiovascular Data Registry. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA 2010;303:2156 –2164. 16. Brueck M, Bandorski D, Rauber K, Boening A. Percutaneous transluminal dilatation of inadvertent partial or complete occlusion of the femoral artery caused by Angio-Seal deployment for puncture site closure after cardiac catheterization. J Invasive Cardiol 2010;22:353– 357. 17. Applegate RJ. Unintended consequences of femoral artery closure devices. J Invasive Cardiol 2010;22:358 –359. 18. Applegate RJ, Sacrinty MT, Kutcher MA, Baki TT, Gandhi SK, Santos RM, Little WC. Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998 –2003. Catheter Cardiovasc Interv 2006;67: 556 –562. 19. Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J 2004;147:31–34. 20. Tron C, Koning R, Eltchaninoff H, Douillet R, Chassaing S, SanchezGiron C, Cribier A. A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA. J Interv Cardiol 2003;16:217–221. 21. Cura FA, Kapadia SR, L’Allier PL, Schneider JP, Kreindel MS, Silver MJ, Yadav JS, Simpfendorfer CC, Raymond RR, Tuzcu EM, Franco I, Whitlow PL, Topol EJ, Ellis SG. Safety of femoral closure devices
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27. 28.
29.
30.
after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol 2000;86:780 –782, A9. Biancari F, D’Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J 2010;159:518 –531. Dangas G, Mehran R, Kokolis S, Feldman D, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638 – 641. Eggebrecht H, Haude M, Woertgen U, Schmermund A, von Birgelen C, Naber C, Baumgart D, Kaiser C, Oldenburg O, Bartel T, Kroeger K, Erbel R. Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients. Catheter Cardiovasc Interv 2002;57:486 – 495. Piper WD, Malenka DJ, Ryan TJ Jr, Shubrooks SJ Jr, O’Connor GT, Robb JF, Farrell KL, Corliss MS, Hearne MJ, Kellett MA Jr, Watkins MW, Bradley WA, Hettleman BD, Silver TM, McGrath PD, O’Mears JR, Wennberg DE; Northern New England Cardiovascular Disease Study Group. Predicting vascular complications in percutaneous coronary interventions. Am Heart J 2003;145:1022–1029. Farouque HM, Tremmel JA, Raissi Shabari F, Aggarwal M, Fearon WF, Ng MK, Rezaee M, Yeung AC, Lee DP. Risk factors for the development of retroperitoneal hematoma after percutaneous coronary intervention in the era of glycoprotein IIb/IIIa inhibitors and vascular closure devices. J Am Coll Cardiol 2005;45:363–368. Bangalore S, Arora N, Resnic FS. Vascular closure device failure: frequency and implications: a propensity-matched analysis. Circ Cardiovasc Interv 2009;2:549 –556. Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, Fox JT, Chen JP, Saito S. Transradial cardiac catheterization: a review of access site complications. Catheter Cardiovasc Interv 2011;78:840 – 846. Chase AJ, Fretz EB, Warburton WP, Klinke WP, Carere RG, Pi D, Berry B, Hilton JD. Association of the arterial access site at angioplasty with transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg). Heart 2008;94:1019 –1025. Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL Trial Group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011;377:1409 – 1420.
Femoral arterial puncture is the most commonly used arterial access method for diagnostic and interventional coronary procedures. Manual compression (MC) with prolonged bedrest to achieve hemostasis has been increasingly replaced by the use of vascular closure devices (VCDs). The use of VCDs enables rapid postprocedure hemostasis, a shorter duration of bedrest with sooner ambulation, and earlier discharge.1 Different of VCDs have been approved for use in the United States including suture-based, sealant-
Center for Interventional Vascular Therapy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York. Manuscript received January 25, 2012; revised manuscript received and accepted February 28, 2012. Dr. Gray is a consultant to and has received research support from Abbott Vascular, Redwood City, California and has minor equity in AccessClosure, Mountain View, California. Dr. Moses is a consultant to Abbott Vascular. *Corresponding author: Tel: 212-305-7060; fax: 212-342-3680. E-mail address: [email protected] (G. Weisz). 0002-9149/12/$ – see front matter © 2012 Published by Elsevier Inc. doi:10.1016/j.amjcard.2012.02.065
based, and collagen-plug based devices. With improved operator experience and the development of newer generations of closure devices, complication rates have decreased.2,3 Even with these improvements, complications of vascular access continue to affect procedure-related morbidity and mortality, hospital length of stay, and health care costs. Despite the potential benefits and improvements with VCDs, there is still no consensus on whether they are superior to MC.4 – 6 Few large studies have compared vascular access strategies in patients undergoing elective coronary procedures.7,8 We performed a retrospective review of consecutive patients who underwent elective coronary angiography or intervention with femoral arterial access to evaluate patterns of use and outcomes associated with various vascular closure strategies in the modern era of elective angiography. Methods This is a retrospective evaluation of consecutive patients undergoing ambulatory elective transfemoral coronary anwww.ajconline.org
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Table 1 Baseline characteristics of patients with vascular access complications compared to controls without complications
Table 2 Coronary procedure characteristics in patients with vascular access complications compared to controls without complications
Variable
Variable
Age (years) Men Previous myocardial infarction Previous percutaneous coronary intervention Previous coronary bypass Mean ejection fraction (%) Documented hypertension Documented dyslipidemia Diabetes mellitus Chronic kidney disease (glomerular filtration rate ⬍60 ml/min) End-stage renal disease Weak/absent distal pulses Peripheral arterial disease Smoking history Platelet count ⬍100/ mm3 Mean international normalized ratio Body mass index (kg/m2) Number of coronary arteries narrowed 0 1 2 3
Vascular Complication
p Value
Yes (n ⫽ 74)
No (n ⫽ 74)
70.5 ⫾ 13.0 39 (53%) 20 (27%)
64.4 ⫾ 12.3 50 (68%) 13 (18%)
33 (45%)
28 (38%)
0.4
13 (18%)
10 (14%)
0.5
51 ⫾ 10.8
0.23
55 (74%)
53 (72%)
0.71
52 (70%)
44 (60%)
0.17
22 (30%) 29 (39%)
25 (34%) 18 (24%)
0.6 0.05
53.2 ⫾ 9.3
0.004 0.06 0.17
1 (1%) 17 (23%)
5 (7%) 17 (23%)
0.1 1
14 (19%)
16 (22%)
0.68
21 (28%) 4 (5%)
22 (30%) 1 (1%)
0.86 0.17
1.2 ⫾ 1.2
1.0 ⫾ 0.2
0.23
28 ⫾ 5.1
28.9 ⫾ 5.3
0.34 0.82*
21 (28%) 14 (19%) 18 (24%) 21 (28%)
21 (28%) 18 (24%) 18 (24%) 17 (23%)
* Chi-square distribution.
giography at the New York-Presbyterian/Columbia University Medical Center from January 1, 2008 to December 31, 2010. Emergency and inpatient coronary procedures were excluded from analysis. In patients who presented for an elective coronary procedure and required hospital admission, all subsequent in-hospital interventions were excluded from analysis. In total 8,580 patients underwent 9,861 elective coronary angiographic procedures and percutaneous coronary interventions (PCIs) during the study period. Of these, 736 were accessed through the radial artery and 9 through the brachial artery. Femoral arterial access was used in 9,116 procedures (92.4%); 8 procedures were excluded because of incomplete data. The remaining 9,108 procedures in 7,994 patients were the basis for study analysis. For femoral arterial access, operators identified bony anatomic landmarks by fluoroscopy and attempted a single anterior common femoral puncture. As an institutional pro-
Percutaneous coronary intervention Femoral access site Right femoral access Left femoral access Right and left femoral access Repeat femoral access* Anticoagulation/antiplatelet None Aspirin Clopidogrel Ticlopidine Bivalirudin Heparin Eptifibatide Sheath size 5–6Fr 7–8Fr Closure strategy Manual compression Vascular closure device Mean contrast volume (ml) Mean procedure duration (min)
Vascular Complication
p Value
Yes (n ⫽ 74)
No (n ⫽ 74)
32 (43%)
30 (41%)
0.73
54 (73%) 11 (15%) 9 (12%)
64 (87%) 7 (10%) 3 (4%)
0.04 0.31 0.07
18 (24%)
22 (30%)
0.46
14 (19%) 68 (92%) 59 (80%) 1 (1%) 38 (51%) 11 (15%) 4 (5%)
20 (27%) 62 (84%) 51 (69%) 0 (0%) 31 (42%) 6 (8%) 1 (1%)
0.24 0.13 0.13 0.32 0.25 0.2 0.17
40 (54%) 34 (46%)
55 (74%) 19 (26%)
0.01
32 (43%) 42 (57%) 214.8 ⫾ 133.6 99 ⫾ 92
19 (26%) 55 (74%) 184.6 ⫾ 130.7 66 ⫾ 48
0.025 0.17 0.008
* Number of patients with documentation of an ipsilateral femoral arterial puncture before the index coronary procedure. Table 3 Vascular complications by femoral closure strategy Variable
VCD (n ⫽ 6,527)
MC (n ⫽ 2,581)
p Value
Significant groin bleeding Bleeding by Thrombolysis In Myocardial Infarction criteria Hematoma ⱖ5 cm Retroperitoneal bleed Femoral arterial perforation Pseudoaneurysm Vascular occlusion Venous thrombosis Arterial occlusion Arteriovenous fistula Access-site infection
19 (0.29%) 3 (0.05%)
21 (0.81%) 5 (0.19%)
⬍0.001 0.03
13 (0.20%) 2 (0.03%) 1 (0.02%)
12 (0.46%) 2 (0.08%) 2 (0.08%)
0.03 0.33 0.85
11 (0.17%) 7 (0.11%) 3 (0.05%) 4 (0.06%) 4 (0.06%) 1 (0.02%)
9 (0.35%) 1 (0.04%) 0 (0%) 1 (0.04%) 1 (0.04%) 0 (0%)
0.1 0.32 0.27 0.67 0.67 0.53
tocol, all patients (even patients undergoing diagnostic angiography) received aspirin (loading dose 325 mg, maintenance 81 mg/day) and clopidogrel (loading dose 600 mg ⱖ2 hours before the procedure, maintenance 75 mg/day) when PCI was planned or optional unless contraindications existed. Anticoagulation with heparin or bivalirudin was administrated for interventional cases. Use of IIb/IIIa inhibitors was at the discretion of each operator.
Coronary Artery Disease/Vascular Closure Devices in Elective Coronary Procedures
Sheath removal after PCI was performed according to local hospital protocol. Operators selected VCD or MC as the primary method of hemostasis. When a VCD was selected, it was deployed immediately after completion of the procedure. Sheath removal and MC were performed immediately if no antithrombin was administered, when activated clotting time was ⬍170 seconds in patients treated with heparin, or 2 hours after discontinuation of bivalirudin. The VCDs that were used included Angioseal (St. Jude Medical, St. Paul, Minnesota), Perclose-Proglide and Starclose (Abbott Vascular, Redwood City, California), and Mynx (AccessClosure, Mountain View, California). Certified experienced operators deployed all closure devices according to the manufacturers’ instructions for use. Ambulation was initiated 2 hours after hemostasis after diagnostic angiography without administration of anticoagulation. After PCI with administration of anticoagulation, ambulation was initiated 2 hours after deployment of a VCD and 6 hours after hemostasis with MC. Postprocedure access-site evaluation and documentation were systematically performed by experienced catheterization laboratory staff. All documented access-site vascular complications were reviewed. Major vascular complications were defined as significant groin bleeding (resulting in blood transfusion, hemoglobin decrease ⱖ3 g/dl, hematoma ⱖ5 cm, retroperitoneal bleeding, femoral artery perforation, or bleeding leading to increased length of hospitalization ⱖ2 nights), pseudoaneurysm (documented by ultrasonography), arteriovenous fistula formation, vascular obstruction, or access-site infection.9 VCD failure was defined by unsuccessful deployment or failure to achieve hemostasis. Patients with postprocedure access complications were compared 1:1 to randomly selected controls without evidence of vascular complication in a nested case– control method. Hospital charts were reviewed to identify clinical, procedural, and laboratory data. Statistical analyses were conducted by unpaired Student’s t test for normally distributed continuous data and by chi-square and Fisher’s exact tests for categorical variables. Conditional logistic regression was used to identify independent predictors of vascular complications in the nested case– control subset. Statistical models were generated based on clinically relevant covariates and those identified during univariate analysis (age, gender, body mass index, chronic kidney disease, history of repeat femoral access, sheath size, closure strategy), followed by stepwise selection and backward elimination of nonsignificant variables. After establishing baseline significant predictors, a second model was developed to assess the additive predictive influence of closure strategy. Binomial logistic regression was used for the unmatched study population, with a model generated through backward elimination to include significant covariates and independent variables with strong trends toward predictive significance. Twotailed p values ⬍0.05 were considered statistically significant for all tests. All statistical analyses were conducted using SPSS 19 (IBM, Armonk, New York). The study was approved by the local institutional review board.
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Table 4 Multivariable predictors of vascular complications Model Variables Model 1: case–control analysis 7–8Fr sheath size Age Model 2: case–control analysis 7–8Fr sheath size Age Vascular closure device Model 3: full study population Vascular closure device Male gender
Adjusted OR (95% CI)
p Value
2.46 (1.09–5.55) 1.04 (1.01–1.08)
0.03 0.01
2.25 (0.97–5.19) 1.04 (1.01–1.07) 0.60 (0.26–1.37)
0.06 0.02 0.22
0.52 (0.33–0.83) 0.66 (0.42–1.04)
⬍0.01 0.07
Congenital logistic regression was employed for matched case– control analysis (models 1 and 2). Binomial logistic regression was used to model the unmatched study population (model 3).
Results In total 7,994 patients underwent 9,108 consecutive elective coronary procedures by femoral arterial access, with full documentation available for this study. Diagnostic angiography only was performed in 5,936 procedures (65.2%); PCI was performed in 3,172 procedures (34.8%). Device-based closure was the primary method of hemostasis in 6,527 procedures (71.7%), with MC applied in the remaining 2,581 (28.3%). VCDs were selected for hemostasis in 2,205 PCI procedures and 4,322 diagnostic angiographic procedures (69.5% vs 72.7%, p ⬍0.001). Vascular access-site complications occurred in 74 procedures (0.81%). No patient in the study had ⬎1 vascular complication. Baseline characteristics of patients with complications are listed in Table 1; procedural variables are listed in Table 2. Complication rates were similar between PCIs and diagnostic angiographic procedures (32 [1.0%] complications with PCI vs 42 [0.71%] after diagnostic angiography, p ⫽ 0.13). Primary vascular-access complications included significant groin and retroperitoneal bleeding (n ⫽ 40), pseudoaneurysm (n ⫽ 20), vascular occlusion (n ⫽ 8), arteriovenous fistula (n ⫽ 5), and infection (n ⫽ 1). Large hematoma of ⬎5 cm (n ⫽ 25) was the most common complication after device closure and MC (Table 3). Bleeding by Thrombolysis In Myocardial Infarction criteria was observed in 25 cases (16 cases with overt groin bleeding or hematoma, 4 with pseudoaneurysm, 4 with retroperitoneal bleed, and 1 with perforation). One patient with a large access-site hematoma also developed lower-extremity ischemia from an arterial thrombus. None of the complications was associated with mortality. Patients with an access-site complication were compared in case– control fashion to randomly selected patients without complications. In univariable analyses, patients with complications were older, had a higher frequency of chronic kidney disease, more frequent use of 7Fr to 8Fr femoral sheaths, longer procedures, and a higher rate of manual closure than controls. There were no significant differences between patients with vascular complications and controls in other baseline characteristics (Table 1) and procedural variables (Table 2). Vascular complications were associated with a longer hospital stay. Patients with access-site com-
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plications spent an average of 2 additional nights in hospital compared to controls (2.5 ⫾ 2.7 vs 0.4 ⫾ 0.8 days, p ⬍0.001). In multivariate conditional logistic regression of nested case– control subsets, sheath size (odds ratio [OR] 2.46, 95% confidence interval [CI] 1.09 to 5.55) and age (OR 1.04, 95% CI 1.01 to 1.08) were predictors of postprocedure access-site complications (Table 4). A secondary regression model incorporating closure strategy identified a nonsignificant trend toward decreased complications associated with VCD use. Among all elective coronary procedures, VCDs were associated with a lower rate of complication compared to MC in univariate analysis (42 cases [0.64%] vs 32 cases [1.24%], p ⫽ 0.004). In multivariate binomial logistic regression analysis of the unmatched study population, VCD use was a predictor of decreased complications (OR 0.52, 95% CI 0.33 to 0.83; Table 4). A sensitivity analysis excluding repeat procedures in patients who underwent ⬎1 diagnostic angiographic or coronary intervention during the study period also confirmed this finding (OR 0.50, 95% CI 0.32 to 0.81). Device deployment failure, defined as unsuccessful device deployment or failure to achieve hemostasis, was documented in 80 of 6,527 procedures (1.23%) in which a VCD was selected for primary hemostasis. Of these, 39 of 4,322 occurred after diagnostic angiography and 41 of 2,205 after PCI (0.90% vs 1.86%, p ⬍0.001). Of patients with failed VCD deployment, 8 (10%) developed vascular complications including arterial occlusion (n ⫽ 4), significant groin bleeding (n ⫽ 3), and arteriovenous fistula (n ⫽ 1). Of the 3 patients with bleeding complications, 2 developed hematomas that met Thrombolysis In Myocardial Infarction bleeding criteria9; the other patient had groin bleeding requiring an extended hospital stay for observation, without any additional specific treatment. Of the 74 patients with vascular complications, blood transfusion was required in 13 (17.6%), vascular surgical repair was performed in 5 (6.8%), a percutaneous procedure (balloon angioplasty, aspiration, or femoral stent placement) was required in 3 (4.1%), and ultrasound-guided compression was performed in 2 (2.7%). Of the 40 patients with significant groin bleeding, 12 required transfusion of packed red blood cells, 1 patient underwent percutaneous balloon tamponade for retroperitoneal bleed, and 1 required a surgical intervention. The 20 patients with femoral arterial pseudoaneurysms were managed with ultrasound-guided thrombin injection (n ⫽ 8), ultrasound guided compression (n ⫽ 2), and surgical repair (n ⫽ 1). No specific therapy was required in the other 9 patients. The 8 patients with primary vascular occlusions underwent surgical thrombectomy (n ⫽ 3), percutaneous balloon dilatation (n ⫽ 1), thrombus aspiration (n ⫽ 1), or anticoagulation alone (n ⫽ 3). Within 30 days of the index procedure, 14 patients were readmitted to the hospital with a diagnosis of femoral access complication. Seven patients were admitted for diagnosis and management of a groin pseudoaneurysm, 3 patients were found to have a deep vein thrombosis distal to the access site, 2 patients had hematoma formation and rebleeding requiring transfusion, 1 patient developed a small arteriovenous fistula and was admitted for observation, and 1
patient had an infection at the access site requiring intravenous antibiotics. On average, readmission occurred 10 days after the coronary procedure, with 9 of the 14 patients (64.3%) presenting within 2 weeks. Complications after MC were significantly more likely to require transfusion of packed red blood cells than complications after device closure (10 cases [31.3%] vs 3 cases [7.1%] for VCD, p ⫽ 0.0069). Vascular surgery, percutaneous management, ultrasound-guided thrombin injection, and transfusion were required to manage complications in 15 cases (0.58%) after MC and 13 cases (0.20%) with VCD deployment (p ⫽ 0.003). Discussion Access-site complications after diagnostic angiography and PCI significantly affect morbidity, prolong hospital stay, and increase costs. Many vascular complications, especially postprocedure bleeding requiring transfusion, are associated with increased in-hospital and long-term morbidity and mortality.10 –12 Despite the promised benefits of VCDs to achieve rapid hemostasis, early ambulation, improved patient comfort, and early discharge, there is no consensus on whether VCD safety is superior to MC. Significant decreases in complication rates associated with femoral VCD use have been reported,6,13–15 and although some complications are specific for the VCD used,16,17 most studies have reported no difference between VCDs and the gold standard of MC.5,8,18 –21 Furthermore, several studies and meta-analyses have associated VCD deployment with increased rates of access-site infection, hematoma, pseudoaneurysm, limb ischemia, and vascular-site repair.4,22,23 Interpretation of the published data are further complicated by underpowered studies, differences in patient selection, closure devices used, heterogeneity in anticoagulation and antiplatelet strategies, and definitions of access-site vascular complications that vary throughout the literature. In this retrospective study we examined rates of vascular complications in a low-risk group of patients with elective procedures. Patients with acute coronary syndromes and hospitalized patients were not included, thus eliminating high-risk patients treated with anticoagulation before diagnostic angiography. In our series of consecutive patients undergoing elective coronary angiography and PCI, vascular access complications occurred in 0.81% of patients (0.71% in those with diagnostic angiography and 1.0% in those with PCI). These complication rates occurred in the lower range of those previously reported, with complications in 0.5% to 1.8% of cases after diagnostic catheterizations and 0.6% to 9% after PCI.6,24 Results from the nested case– control analysis suggest that complications are associated with large sheath size and older age. Our study did not support other reported risk factors, such as female gender, renal failure, peripheral vascular disease, smaller body surface area, and glycoprotein IIb/IIIa inhibitor use.2,10,25–27 This suggests that these latter patient characteristics and procedural variables may be greater risk factors for hospitalized patients or emergency cases but not for stable outpatients undergoing elective procedures.
Coronary Artery Disease/Vascular Closure Devices in Elective Coronary Procedures
Closure devices were associated with significantly lower rates of vascular complication compared to primary hemostasis with MC. Several VCDs with different mechanisms of action were used to achieve hemostasis in our group. The Angioseal closure device, used most frequently in our cohort, relies on an intravascular bioabsorbable anchor and a collagen sponge to achieve hemostasis. The Perclose-Proglide is a nonabsorbable polyester suture-based closure system. The Mynx VCD relies on the delivery of a polyethylene glycol-based extravascular sealant, and the Starclose SE Closure System deploys a nickel and titanium alloy clip for extravascular closure. Failure of device deployment, which occurred in 1.23% of all cases, required MC to achieve hemostasis and was associated with a high vascular complication rate (10%). Despite VCD failures and heterogeneity in mechanisms of action, there was a significant association between VCD use and a decreased incidence of vascular complications. Of the 74 cases with complications, type of access-site complication appeared to vary by method of hemostasis. MC was associated with larger numbers of hematomas and bleeds requiring transfusion, suggesting ineffective hemostasis. Conversely, most arterial vascular occlusions were observed after device closure, suggesting a mechanical problem including possible intravascular collagen, suture, or distal device migration and obstruction of flow. Vascular obstruction associated with VCD deployment has been previously reported.16,22 Pseudoaneurysm formation did not vary by femoral closure strategy and needed active intervention with thrombin injection or surgery in 45% of cases. The severity of these complications and the availability of resources necessary for repair or resolution should be considered during selection of hemostasis method and device type. Extrinsic factors including appropriate patient selection and operator experience may also affect VCD outcomes. Radial arterial access has recently risen to prominence as an alternative to femoral access. Radial access is associated with earlier ambulation, lower costs, lower rates of major vascular complications, bleeding, and need for blood transfusions, with comparable rates of major adverse cardiac events and 4% to 8% crossover to femoral access, particularly at high-volume radial centers.28 –30 In light of the low rates of femoral access complications observed after elective coronary procedures, it is unclear whether radial access can confer an incremental improvement in safety in low-risk patients. Additional studies are necessary to compare radial to femoral access complications in stable low-risk outpatients undergoing coronary angiography and PCI. Data collection was retrospective and complications were determined through chart review. Because the study was not randomized, selection of hemostasis method, case complexity, choice of antiplatelet and anticoagulant therapies, and operator skill represent unavoidable confounders. We do not have information about the success and quality of the access procedure and its effect on the development of complications. There is no documentation on the indication for and selection of VCDs. Patients perceived to be at a lower risk of access complications because of favorable vessel characteristics might have been more frequently assigned to VCD hemostasis. It is reasonable to assume that
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patients with an intraprocedural groin complication did not receive a closure device, thus deviating the results of this study. Independent of this acknowledged selection bias, this study nevertheless reports the current status and outcomes of femoral access hemostasis strategies, complications, and management in a large group of consecutive low-risk patients with elective procedures. Patients presenting to other health care facilities with late postprocedure vascular complications may not have been reliably captured in the analysis, but all patients were contacted by telephone 30 days after the procedure. All major complications should have been captured by this routine quality assessment protocol. Complication rates after closure device deployment may be skewed by operator and institutional experience with each device. Data from single tertiary centers may not accurately reflect national complication rates but provide a view of the potential management of femoral vascular access and the performance of VCDs. Careful selection of hemostasis strategy and closure device may further improve outcomes. 1. Ward SR, Casale P, Raymond R, Kussmaul WG III, Simpfendorfer C. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Angio-Seal investigators. Am J Cardiol 1998;81:569 –572. 2. Applegate RJ, Sacrinty MT, Kutcher MA, Kahl FR, Gandhi SK, Santos RM, Little WC. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 –2007. JACC Cardiovasc Interv 2008;1: 317–326. 3. Ahmed B, Piper WD, Malenka D, VerLee P, Robb J, Ryan T, Herne M, Phillips W, Dauerman HL. Significantly improved vascular complications among women undergoing percutaneous coronary intervention: a report from the Northern New England Percutaneous Coronary Intervention Registry. Circ Cardiovasc Interv 2009;2:423– 429. 4. Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and metaanalysis. JAMA 2004;291:350 –357. 5. Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 2004;44:1200 – 1209. 6. Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J 2007;153: 606 – 611. 7. Stegemann E, Hoffmann R, Marso S, Stegemann B, Marx N, Lauer T. The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization. Clin Res Cardiol 2011;100:789 –795. 8. Deuling JH, Vermeulen RP, Anthonio RA, van den Heuvel AF, Jaarsma T, Jessurun G, de Smet BJ, Tan ES, Zijlstra F. Closure of the femoral artery after cardiac catheterization: a comparison of AngioSeal, StarClose, and manual compression. Catheter Cardiovasc Interv 2008;71:518 –523. 9. Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) trial—phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol 1988;11:1–11. 10. Yatskar L, Selzer F, Feit F, Cohen HA, Jacobs AK, Williams DO, Slater J. Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: data from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv 2007;69:961–966.
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11. Omoigui NA, Califf RM, Pieper K, Keeler G, O’Hanesian MA, Berdan LG, Mark DB, Talley JD, Topol EJ. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I). J Am Coll Cardiol 1995;26:922–930. 12. Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schömig A, Kastrati A. Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point. J Am Coll Cardiol 2008;51:690 – 697. 13. Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C. Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 2001;88:493– 496. 14. Tavris DR, Gallauresi BA, Lin B, Rich SE, Shaw RE, Weintraub WS, Brindis RG, Hewitt K. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004;16:459 – 464. 15. Marso SP, Amin AP, House JA, Kennedy KF, Spertus JA, Rao SV, Cohen DJ, Messenger JC, Rumsfeld JS; National Cardiovascular Data Registry. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA 2010;303:2156 –2164. 16. Brueck M, Bandorski D, Rauber K, Boening A. Percutaneous transluminal dilatation of inadvertent partial or complete occlusion of the femoral artery caused by Angio-Seal deployment for puncture site closure after cardiac catheterization. J Invasive Cardiol 2010;22:353– 357. 17. Applegate RJ. Unintended consequences of femoral artery closure devices. J Invasive Cardiol 2010;22:358 –359. 18. Applegate RJ, Sacrinty MT, Kutcher MA, Baki TT, Gandhi SK, Santos RM, Little WC. Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998 –2003. Catheter Cardiovasc Interv 2006;67: 556 –562. 19. Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J 2004;147:31–34. 20. Tron C, Koning R, Eltchaninoff H, Douillet R, Chassaing S, SanchezGiron C, Cribier A. A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA. J Interv Cardiol 2003;16:217–221. 21. Cura FA, Kapadia SR, L’Allier PL, Schneider JP, Kreindel MS, Silver MJ, Yadav JS, Simpfendorfer CC, Raymond RR, Tuzcu EM, Franco I, Whitlow PL, Topol EJ, Ellis SG. Safety of femoral closure devices
22.
23.
24.
25.
26.
27. 28.
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