Crit Care Nurse 2005 Jun; 25(3): 30-37
Clinical Article
CE Online
Predictors of Complications Associated With Closure Devices After Transfemoral Percutaneous Coronary Procedures
Jenny B. Hamner, RN, DSN, CCRN
E. Jean Dubois, RN, MSN, CRNP
Tanya P. Rice, RN, BSN
Jenny B. Hamner is an associate professor and assistant dean at Auburn University School of Nursing, Auburn, Ala.
E. Jean Dubois is an assistant professor at Auburn University School of Nursing and the clinical liaison to East Alabama Medical Center, Opelika, Ala.
Tanya P. Rice is the cardiology case manager at East Alabama Medical Center.
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Transfemoral percutaneous coronary procedures have evolved in the past several years as a mainstay in both diagnostic and interventional cardiology. However, safe management of vascular access sites after removal of percutaneous catheters remains a serious concern. Manual compression of the site, the traditional method for closure of the femoral artery, is associated with a complication rate of up to 5%, marked discomfort and immobility for patients, and prolonged hospitalization.1,2 New techniques for management of vascular access sites after diagnostic or interventional transfemoral percutaneous coronary procedures have been introduced to increase patients’ comfort and promote a safe recovery. Specifically, new vascular closure devices approved by the Food and Drug Administration have replaced manual compression and are associated with decreased length of stay and increased comfort and satisfaction for patients.3 These devices include an implantable collagen plug (VasoSeal, Datascope Corp, Montvale, NJ)4,5 and a percutaneous suture device (Perclose, Perclose, Inc, Redwood City, Calif ).6,7 Compared with traditional methods used to achieve hemostasis, these closure devices have high overall levels of safety and efficacy.2,3,8–10 Major complications such as vascular repair surgery, bleeding requiring transfusion, and infection associated with the collagen plug are 2.9%, and the incidence of minor complications, including hematoma, bleeding, and pseudoaneurysm, is 7.2% or less.11 Complications associated with the percutaneous suture device are 11% or less. Despite these remarkable statistics, identification of risk factors and predictors of complications that persist with evolving technology is needed.
The lack of research-based guidelines indicating patients’ risk factors for complications after use of closure devices was of particular interest to medical and nursing staff at East Alabama Medical Center, Opelika, Ala. As part of a quality improvement program in the cardiac catheterization laboratory, a comprehensive review of complications related to closure devices within the institution revealed a complication rate well within the ranges reported in the literature. For that reason, we did not seek to establish the incidence of complications. Instead, our objective was to determine if specific variables were predictive of the likelihood of complications related to use of the 2 closure devices. If patients’ characteristics predictive of complications after coronary procedures could be determined, screening procedures and standards of care could be modified to minimize complications.
Therefore, the purpose of our study was to identify variables predictive of complications associated with closure devices after transfemoral percutaneous coronary procedures. Specific complications examined included the following:
- hematoma formation,
- bleeding with a decrease in hematocrit level of 10% or bleeding that required transfusion,
- bleeding without a decrease in hematocrit level,
- pseudoaneurysm,
- loss of pedal pulses,
- infection at the access site, and
- culture of blood or of material from the wound positive for microorganisms.
Specific aims of the study were to determine what variables among baseline statistics, preprocedural variables, and intraprocedural variables were predictive of complications related to closure devices.
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Overview of the VasoSeal and Perclose Devices
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The VasoSeal collagen plug consists of 3 primary elements: an insertion sheath and tissue dilator assembly, a guidewire and guidewire introducer, and 2 cartridges each containing an 80- to 100-mg plug of purified bovine collagen. The device delivers collagen into the tissue track created by removal of a sheath device and onto the exterior surface of the artery. The collagen interacts with platelets, creating a hemostatic seal directly over the puncture wound in the artery.12
The Perclose suture device incorporates 2 components: a sheath holding 1 or 2 pairs of needles connected by a suture loop and a rotating barrel used to facilitate the positioning of the device before needle deployment and to guide the needles during their travel through the subcutaneous track.3 The device uses a percutaneous means to suture and close the arterial site.13 Table 1
is an overview of patients in whom safety and efficacy of use of the VasoSeal and Perclose closure devices have not been established, nursing implications related to closure devices, and discharge teaching.
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Table 1 Overview of devices used to close the common femoral access site of patients who have undergone diagnostic or interventional percutaneous coronary procedures
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Methods
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Study Design and Sample
A descriptive correlational design with comparative procedures for subgroups was used to examine relationships between variables of patients who experienced complications related to use of the 2 closure devices and patients who did not during the months of October 2000 through March 2002 at East Alabama Medical Center. The center is a 350-bed acute care regional referral center with a staff of 5 invasive cardiologists, who perform more than 3500 transfemoral percutaneous coronary procedures annually, including left- and/ or right-sided heart catheterizations, angioplasties, atherectomy procedures, and stent placements.
The data were obtained from existing hospital records of 141 patients admitted for a transfemoral percutaneous coronary procedure during the 18-month period. Through data collected by the cardiovascular case manager, we knew that 47 patients experienced complications during the study time frame. Data on a group of 94 patients were randomly selected from medical records of patients who had closure devices placed with no complications during the study period.
The total sample size of 141 subjects, with roughly one third of the total sample representing the dependent variable (complications), was considered acceptable for the multiple regression and correlational statistical techniques applied in this study.14 A total of 10 to 15 subjects per independent variable was required for model testing.14 The models examined in this study ranged from 3 to 9 predictors (independent variables); therefore, a sample size of 141 was judged to be adequate for model testing14 (see Sidebar).
Study Variables
The study variables were 3 subsets of factors thought to influence complications related to placement of a closure device. The first subset consisted of baseline variables and included age, sex, height, weight, and hematocrit level at the time of admission. The second subset was preprocedural variables and included coexisting conditions of diabetes, peripheral vascular disease, hypertension, and bleeding disorders. Bleeding disorders were defined as preexisting thrombocytopenia, anemia, or von Willebrand disease. Systolic and diastolic blood pressure at the time of admission and use of a closure device within the preceding 6 weeks were also included in this subset. The third subset of variables was intraprocedural variables and included the type of closure device (VasoSeal or Perclose), procedure type (cardiac catheterization, angioplasty, angioplasty with stent, or atherectomy), number of attempts required to cannulate the artery, length of procedure in minutes, staged procedure (1 procedure after another within 48 hours), venous cannulation, units of heparin used, and highest systolic and diastolic blood pressure.
Instruments and Procedures
After approval was granted by the appropriate internal review boards, we collected all data through a review of patients’ medical records and recorded the relevant information on a data collection form. This form was developed by us; reviewed by 2 cardiovascular nurses, 1 senior nurse researcher, and 1 statistician; and pretested with 3 chart reviews. Minor revisions were made. The form facilitated collection of data related to complications as well as the 3 subsets of independent variables.
After data collection was complete, data were entered into an SPSS statistical analysis program (SPSS Inc, Chicago, Ill) directly from the code sheets and summarized for the 2 groups of patients. Preliminary univariate analysis with 
2 tests and t tests was performed to determine which variables related individually to complications. Logistic regression was performed by using the 3 subsets of independent variables to predict the probability that the dependent variable (complications) would occur after placement of a closure device.
The results from logistic regression were used to predict the likelihood that complications would occur given specific results of the independent variable(s). In other words, logistic regression was used to calculate the probability that a patient with a specific set of independent variables would have complications. A forward selection procedure was used; that is, a variable was selected only if it improved prediction of complications (see Sidebar for further clarification).
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Results
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Baseline variables are summarized in Table 2 for the 2 groups in the study: patients with and without complications. Of these variables, the only one that differed significantly between the 2 groups was hematocrit level at the time of admission. Patients who had complications had a lower hematocrit level (t = 2.055; P = .04). The 2 groups did not differ in age, sex, and size. Table 3 summarizes the complications experienced by the 47 patients who had complications. The most frequent complication was bleeding without a decrease in hematocrit level. Major complications, such as pseudo-aneurysm, loss of distal pulse, and infection, were rare. Some patients had more than 1 complication.
Preprocedural and intraprocedural variables are listed in Tables 4 and 5. The 2 groups of patients differed significantly in 5 of the variables in these 2 subsets. Specifically, the groups differed in complications among patients who (1) had placement of a closure device in the preceding 6 weeks (2=9.99, P=.002); (2) had a staged procedure (1 procedure after another within 48 hours) (2= 7.42, P=.006); (3) required a higher dose of heparin during their procedure (t=3.195, 2=.002); (4) had a cardiac catheterization procedure (2=5.76, P=.02); and (5) had an atherectomy procedure (2=10.37, P=.001).
A total of 3 models were developed and tested to predict complications. Model 1 tested 5 baseline variables (age, height, weight, sex, and hematocrit level) known to be predictive of complications. The model was restricted to those variables that made a significant contribution to the prediction of complications. Only 1 variable, hematocrit level, was an accurate predictor of complications at a statistically significant level.
Model 2 tested a set of 7 preprocedural variables, including the presence of diabetes, peripheral vascular disease, hypertension, and bleeding disorders. Bleeding disorders were defined as preexisting thrombocytopenia, anemia, and von Willebrand disease. Baseline systolic and diastolic blood pressure and use of a closure device (VasoSeal or Perclose) within the preceding 6 weeks were variables included in this model. The prediction accuracy of this model was 1.5% greater than that of the null model, and the difference was statistically significant. This model was then restricted to include only those variables that made a significant contribution to the prediction of complications. Two variables from this model, bleeding disorder and previous use of a closure device, were predictive of complications.
Model 3 tested a set of 9 intraprocedural variables known to be predictive of complications. These variables were the type of closure device (VasoSeal or Perclose), procedure type (cardiac catheterization, angioplasty, angioplasty with stent, or atherectomy), number of attempts required to cannulate the artery, length of procedure in minutes, staged procedure (1 procedure after another within 48 hours), venous cannulation, units of heparin used, and highest systolic and diastolic blood pressure. This model did not reach statistical significance; that is, none of these variables were predictive of complications. An attempt to further restrict this model to those variables that made a significant contribution did not reveal any significant predictors.
Logistic regression was used to estimate a final predictive model, using variables identified in models 1 and 2 as significant predictors of complications (hematocrit level, presence of bleeding disorder, and previous use of a closure device). The Wald statistic (a statistical test of significance that suggests that the dependent variable, in this instance complications, is explained by the predictor variables rather than by chance14) verified the statistical significance of each of these variables. With the final model, prediction accuracy was improved by 5.6%, achieving statistical significance. This model was further restricted to those variables that made a significant contribution to the prediction of complications. The resulting model consisted of just a single predictor variable: previous use of a closure device. Table 6 summarizes these findings.
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Discussion
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This study was designed to compare patients who had complications after placement of a closure device with patients who did not. The intent was to determine if specific variables were predictive of whether complications developed after placement of a closure device. Of the baseline variables examined in model 1, only lower hematocrit levels were predictive of complications. These findings suggest that patients undergoing transfemoral procedures who have low hematocrit levels before the procedure should be monitored carefully for complications, especially because formation of a hematoma or bleeding at the access site after the procedure could cause an even further decrease in hematocrit level.
The preprocedural variables predictive of complications were previous use of a closure device and preexisting bleeding disorders, suggesting that patients who have had placement of a closure device before the current procedure or who have a preexisting bleeding disorder may be at risk for complications. Of note, only 1 subject in this study had a preexisting bleeding disorder; therefore, findings should be applied cautiously. None of the intraprocedural variables were predictive of complications in the model testing.
The final model combined hematocrit level, previous use of a closure device, and presence of bleeding disorder in its analysis and indicated that these variables in combination may be predictive of complications. Patients with a low hematocrit level, a bleeding disorder, and previous use of a closure device should be monitored carefully for complications. Previous use of a closure device was the strongest predictor variable.
The Vasoseal instructions for use11 recommend that the contralateral artery be used should repeat femoral artery puncture be required within 6 weeks. The Perclose instructions for use16 state that there are no reaccess restrictions if previous arteriotomy repairs were achieved with Abbott Vascular suturemediated closure devices. Previous placement of a closure device may be important to include during an admission/intake assessment. In addition, it may be appropriate to design a screening tool that would assist with the identification of patients with these 3 risk factors before a transfemoral percutaneous coronary procedure. Although we did not examine factors related to bed rest, mobility, and restraining of the affected extremity, it may be appropriate to consider more aggressive use of these nursing interventions in patients with these 3 risk factors.3,4
Confining the study to a single institution limits the generalizability of these findings beyond a sample of patients with similar medical conditions treated with similar medical protocols. Although the study of existing data also limits the investigation to a retrospective approach, the identification of risk factors could provide the basis for future prospective studies.
Evidence of the potential risk posed by previous therapeutic intravascular procedures and low hematocrit levels suggests variables of potential interest in prospective descriptive and intervention studies. These data also provide some basis for cost-benefit studies to determine the economic advantages of predicting and managing device-related complications. Armed with an awareness of predictors of complications, nurses and physicians are in a pivotal position to prevent complications or to detect and manage complications earlier. If an assessment indicates that a patient is at high risk for complications, then cautious management strategies can be implemented, including more frequent evaluation for complications.
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References
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- Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complication after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol. 1992;69:63–58.[Medline]
- Popma JJ, Satler LI, Pichard AD, et al. Vascular complications after balloon and new device angioplasty. Circulation. 1993;88:1569–1578.[Abstract/Free Full Text]
- Duffin DC, Muhlestein JB, Allison 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 closure devices. J Invasive Cardiol. 2001;13:354–362.[Medline]
- Brachmann J, Ansah M, Kosinski EJ, Schuler GC. Improved clinical effectiveness with a collagen vascular hemostasis device for shortened immobilization time following diagnostic angiography and percutaneous transluminal coronary angioplasty. Am J Cardiol. 1998;81:1502–1505.[Medline]
- Schrake KI, Zuck VP. Developing effective physician partnerships: the VasoSeal experience. J Cardiovasc Manag. March-April 1998;9:26–30.
- Rogers EW Jr, Doty WD, Stewart J. Significant improvements in patient care and cost savings resulting from percutaneous vascular surgery (PVS). J Cardiovasc Manag. March-April 1999;10:13–17.
- 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.[Medline]
- Amin FR, Yousufuddin M, Shamin W, et al. A prospective randomized study of Angioseal versus Femostop for femoral hemostasis after transcatheter coronary intervention. Cath Lab Digest. 2001;9(suppl):14.
- Gonze MD, Sternbergh WC III, Salartash K, Money SR. Complications associated with percutaneous closure devices. Am J Surg. 1999;178:209–211.[Medline]
- 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 angioplasty. Am J Cardiol. 1998;81:569–572.[Medline]
- Datascope Corp. VasoSeal ES: Instructions for Use. Montvale, NJ: Datascope Corp.
- Datascope Corp. A Guide for VasoSeal Patients. Montvale, NJ: Datascope Corp. P/N 002-08-0604.
- Carey D, Martin JR, Moore CA, Valentine MC, Nygaurd TW. Complications of femoral artery closure devices. Cath Lab Digest. 2001;9(suppl):8–10.
- Pedhazur EJ. Multiple Regression in Behavioral Research: Explanation and Prediction. 3rd ed. Forth Worth, Tex: Harcourt Brace College Publishers; 1997.
- Polit DF, Beck CT. Nursing Research: Principles and Methods. 7th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2004.
- Abbott Vascular Devices. Perclose Instructions for Use. Redwood City, Calif: Abbott, Inc; 1999.
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Overview of the VasoSeal...
Methods
