From the New England Society for Vascular Surgery
Routine use of ultrasound guidance in femoral arterial access for peripheral vascular intervention decreases groin hematoma rates Jeffrey Kalish, MD,a Mohammad Eslami, MD,a David Gillespie, MD,b Marc Schermerhorn, MD,c Denis Rybin, PhD,d Gheorghe Doros, PhD,d and Alik Farber, MD,a on behalf of the Vascular Study Group of New England, Boston and Fall River, Mass Background: Use of fluoroscopy and bone landmarks to guide percutaneous common femoral artery (CFA) access has decreased access site complications compared with palpation alone. However, only limited case series have examined the benefits of ultrasound to guide CFA access during peripheral vascular intervention (PVI). We evaluated the effect of routine vs selective use of ultrasound guidance (UG) on groin hematoma rates after PVI. Methods: The Vascular Study Group of New England database (2010-2014) was queried to identify the complication of postprocedural groin hematoma after 7359 PVIs performed through CFA access. Hematoma (including pseudoaneurysms) was defined as minor (requiring compression or observation), moderate (requiring transfusion or thrombin injection), and major (requiring operation). Both procedure-level and interventionalist-level analyses were performed. Multivariable Poisson regression models were used to compare hematoma rates of interventionalists based on routine ($80% of PVIs) and selective (80 years (RR, 0.47; 95% CI, 0.27-0.85; P [ .01), body mass index $30 (RR, 0.51; 95% CI, 0.29-0.90; P [ .02), and sheath size >6F (RR, 0.43; 95% CI, 0.23-0.79; P < .01). Conclusions: Routine UG may potentially protect against the complication of hematoma for both modifiable and nonmodifiable patient and procedural characteristics. Encouraging routine UG is a feasible quality improvement opportunity to decrease patient morbidity after PVI. (J Vasc Surg 2015;61:1231-8.)
Local vascular complications are the most frequent adverse outcomes of femoral artery puncture, with an incidence reported between 1% and 10%.1-3 These complications include groin hematoma, retroperitoneal hematoma, vessel thrombosis, pseudoaneurysm, and arteriovenous fistula.4,5 Known risk factors for complications include female gender,6 obesity,7 anticoagulants,7 interventional vs From the Division of Vascular and Endovascular Surgery, Boston Medical Center, Bostona; the Department of Vascular Surgery, Southcoast Health System, Fall Riverb; the Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Bostonc; and the Department of Biostatistics, Boston University School of Public Health, Boston.d Author conflict of interest: none. Presented as a Plenary presentation at the 2014 Joint Annual Meeting of New England Society for Vascular Surgery (NESVS)/Eastern Vascular Society (EVS), Boston, Mass, September 11-14, 2014. Reprint requests: Jeffrey Kalish, MD, Director of Endovascular Surgery, Boston Medical Center, 88 East Newton St, Collamore 5, D-506, Boston, MA 02118 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2014.12.003
diagnostic procedures,8 and larger sheath size.9 For both coronary and peripheral vascular procedures, the use of bone landmarks and fluoroscopy compared with palpation alone has decreased the incidence of access site complications.10 Although the use of ultrasound has been reported in case series involving central venous access,11 pediatric patients,12 and absent femoral pulses and obesity with large leg circumference,13 its routine role in common femoral artery (CFA) access is a more recent trend in the literature. The Femoral Artery Access with Ultrasound Trial (FAUST), published in 2010, is the first randomized trial of fluoroscopy-guided compared with ultrasound-guided retrograde CFA access.14 Even with the short learning curve required for successful ultrasound guidance (UG), the results of the trial showed absolute benefits for UG compared with fluoroscopy, including a decreased incidence of groin hematoma with use of ultrasound. The purpose of our study was to use the Vascular Study Group of New England (VSGNE) database to examine the peripheral vascular intervention (PVI) cohort and to identify variables associated with the complication of postprocedural groin hematoma. More specifically, we evaluated the effect of routine vs selective use of UG on the groin hematoma rates after PVI. 1231
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1232 Kalish et al
METHODS Study design. This was a retrospective observational study of the VSGNE registry to identify patients who underwent PVI. The VSGNE is a regional cooperative quality improvement initiative developed in 2002 to prospectively study outcomes in patients undergoing vascular and endovascular surgery. The details on this registry have been published previously15 and are available online at www.vsgne. org. The Institutional Review Board at Boston University School of Medicine approved the use of the de-identified data for this study, and patient informed consent was waived. Patient population. A total of 7359 PVIs performed through CFA access were recorded in the VSGNE by 159 interventionalists at 26 academic and community hospitals during the study interval from January 2010 through January 2014. Inclusion and exclusion criteria. We included all patients who underwent elective, urgent, or emergent PVI procedures for claudication, critical limb ischemia (rest pain or tissue loss), and acute ischemia. We included PVI performed through antegrade or retrograde CFA access, either unilateral or bilateral, and excluded access by other means (arm, graft, popliteal, or other). We excluded patients who had PVI with a concomitant CFA endarterectomy, if groin cutdown was used for CFA access, or if PVI was performed for aneurysm. Fifteen PVI procedures were excluded from analysis because of incomplete data recorded regarding hematoma. Outcome and variable definitions. In our analysis, we reviewed patient demographics, pre-existing medical comorbidities, and operative details. More than 100 variables were collected prospectively for each procedure and recorded in the VSGNE database. The definitions of medical comorbidities and procedure details within VSGNE have been previously described.15 The main postprocedural outcome measure of hematoma (includes pseudoaneurysm) was defined in the VSGNE database as minor (requiring compression or observation), moderate (requiring transfusion or thrombin injection), and major (requiring operation). The self-reported outcomes were captured before discharge only and not from subsequent inpatient or outpatient encounters. We also evaluated the outcomes of interventionalists based on their routine or selective use of UG. Routine UG was defined as using ultrasound for CFA access in $80% of PVI procedures, whereas selective UG was defined as using ultrasound for CFA access in 6F during 21.2% of PVIs, and closure devices (including Perclose, Angio-Seal, StarClose, Mynx, and other) were used during 42% of PVIs. The number of arteries treated during PVI was one or two in 87.2% of cases and three to six in 12.8% of cases. Heparin was used in 94.3% of cases, bivalirudin was used in 2.5% of cases, and protamine was given in 22.2% of cases. Procedure-level analysis. The overall postprocedural groin hematoma rate after PVI was 4.5%, and the rate of combined moderate and major hematoma was 0.8%. Across the VSGNE centers, hematoma complication rates
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Fig 1. Interventionalist percentage use of ultrasound guidance (UG).
ranged from 1.1% to 19.2% (Fig 2). By univariate analysis (Table II), the following factors were found to be associated with hematoma: age (7.0% among 80þ years old compared with 4.0% in those younger than 80 years), gender (5.9% in females vs 3.7% in males), bilateral femoral access (6.5% vs 4.2% for unilateral access), sheath size (6.1% in >6F vs 4.1% in #6F), and number of arteries treated (5.8% in $3 vs 4.3% in 80 years (OR, 2.45; 95% CI, 1.31-4.57; P ¼ .005), sheath size >6F (OR, 1.62; 95% CI, 1.24-2.11; P < .001), female gender (OR, 1.54; 95% CI, 1.22-1.94; P < .001), and bilateral femoral access (OR, 1.44; 95% CI, 1.08-1.93; P ¼ .013). Use of closure devices was protective against hematoma (OR, 0.47; 95% CI, 0.37-0.61; P < .001).
Interventionalist-level analysis. Among the 114 interventionalists with $10 PVI procedures, hematoma rates ranged from 0% to 30%, with a mean of 2.9% in the routine users and 5.7% in the selective users. After adjustment for patient characteristics, the interventionalist-level analysis showed that routine UG was protective against groin hematoma (RR, 0.62; 95% CI, 0.46-0.84; P < .01). Furthermore, as the percentage usage of UG increased from 0% to 80þ%, the hematoma RRs similarly decreased from 0.97 (95% CI, 0.63-1.48) to 0.74 (95% CI, 0.57-0.95). Subgroup analysis revealed that routine UG was protective against groin hematoma under the following circumstances: age >80 years (RR, 0.47; 95% CI, 0.270.85; P ¼ .01), body mass index (BMI) $30 (RR, 0.51; 95% CI, 0.29-0.90; P ¼ .02), sheath size >6F (RR, 0.43; 95% CI, 0.23-0.79; P < .01), and unilateral femoral access (RR, 0.59; 95% CI, 0.41-0.84; P < .01). Whereas closure devices were already shown to be protective against hematoma, routine UG seemed to add to that protective effect (RR, 0.42; 95% CI, 0.22-0.79; P < .01). In the other subgroups that were identified as risk factors for hematoma on multivariable analysis, routine UG had no statistically significant effects: female (RR, 0.78; 95% CI, 0.53-1.14; P ¼ .19), bilateral femoral access (RR, 1.57; 95% CI, 0.88-2.81; P ¼ .13). DISCUSSION Summary. Groin hematoma after CFA access during PVI ranged from 1.1% to 19.2% across VSGNE centers, with an overall rate of 4.5%. Although the incidence of moderate and severe hematoma was only 0.8% across the VSGNE, this general complication led to an appreciable increase in hospital resource utilization (increased admission
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Table I. Demographics of the patient population and procedure performed Characteristic Patient procedures Demographics Age, years 18-50 50-60 60-70 70-80 80þ Gender Male Female Race White Other BMI, median (IQR) Preadmission living Home Nursing home Ambulatory status Independent Not independent Medical history Smoking Never Ever Hypertension CAD CHF COPD CABG/PCI Diabetes Dialysis Previous bypass Previous PVI Aspirin Clopidogrel Chronic anticoagulant Procedure characteristics Urgency Elective Urgent/emergent Femoral access Unilateral Bilateral Retrograde access UG Fluoroscopy time, minutes, median (IQR) Contrast volume, mL, median (IQR) Sheath size #6 >6 Closure device Heparin Bivalirudin Protamine Number of arteries treated 18,000 consecutive patients undergoing PCI in northern New England and created a scoring system to estimate individual patient risk.6 The rate of vascular groin complications (defined as access site injury requiring treatment or bleeding requiring transfusion) was 2.98%, and the two variables with the highest predictive ORs for hematoma were age $70 years (OR, 2.7) and female gender (OR, 2.4). Whereas that study identified additional patient characteristics that predicted groin complications, many of the examined variables are not evaluated within the VSGNE (bleeding disorder, myocardial infarction, shock), nor do they apply to peripheral interventions (number of PCIs, type of coronary lesion). Another coronary trial, Coronary Angioplasty vs Excisional Atherectomy Trial (CAVEAT-I), also examined risk factors for the in-hospital composite end point of peripheral vascular complications.16 Of the 1012 randomized patients, the incidence of groin complications was 6.6%, and in this group of patients, there was a twofold increase in hospital cost and sevenfold increase in long-term deaths. Greater age, female gender, postprocedural heparin, and intra-aortic balloon counterpulsation were predictive of increased risk of the groin complications. Although other studies identified obesity as an independent patient characteristic predictive of groin hematoma,7 the VSGNE did not mirror those results. However, when UG was evaluated in the presence of morbid obesity (BMI $30), routine UG was more protective against hematoma compared with selective UG. Moreover, ultrasound has been shown in other studies to aid in the successful cannulation of the CFA in patients with larger leg circumference (>60 cm) and to decrease the number of attempts needed for cannulation.13 Procedural predictors of hematoma. Certain aspects of the procedure itself lead to varying risks for groin hematoma. Interventions, as opposed to diagnostic procedures, typically require some type of antithrombotic medication, and such intraprocedural (antiplatelet or anticoagulant) or postprocedural medications (intravenous heparin) have been shown to increase the risks for groin hematoma.1 Larger sheath sizes, including the 7F and 8F sheaths more typical for interventions as opposed to diagnostic procedures, also lead to increased hematoma rates.3 Although the majority of the literature is again related to
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Fig 2. Hematoma complication rates across Vascular Study Group of New England (VSGNE) centers.
cardiac catheterization, similar results would be expected with peripheral interventions. In the VSGNE study, the use of heparin or protamine as well as alternative antithrombotic medications was not found to be associated with increased hematoma rates, but no standardized protocols could be elucidated with VSGNE data. Although the PVI data set within VSGNE evaluates only interventions and not diagnostic angiograms, sheath size >6F was found to be a risk factor of groin hematoma. Vascular closure devices. A significant amount of literature is devoted to closure devices in comparison to manual compression and their effects on both the procedures themselves and the postprocedural complications. In an early meta-analysis of available literature, Koreny et al4 contended that closure devices (including some of the devices still in use to this day) not only may be ineffective but also may increase the risk of groin hematoma and pseudoaneurysm. More recent studies have revealed the opposite results, with vascular closure devices showing promise as a means to reduce groin complications. In an evaluation of more than 1.8 million PCIs reported to the CathPCI registry from 2005 to 2009, Tavris et al5 revealed significantly lower bleeding or vascular complication rates of certain closure devices (Angio-Seal, Perclose, StarClose, and Boomerang) compared with manual compression; in addition, all types of hemostatic strategies showed reduced complication rates over time. A meta-analysis of interventional radiology procedures showed similar benefits of vascular closure devices compared with manual compression in terms of reducing groin complications.2
Although the use of closure devices may be a causative factor to decrease groin complications, other studies assert that the establishment of protocols and appropriate patient selection drive the benefits of the closure devices. In their evaluation of peripheral vascular disease patients, Goodney et al17 achieved process improvement by instituting a standardized percutaneous arterial closure protocol based on selective closure device use guided by sheath size, arterial calcification, and previous access scarring. Whereas closure devices as a group were protective against groin hematoma in this VSGNE study population, the sample size did not allow adequate differentiation between the hematoma rates depending on the exact type of closure device used, nor could the data examine whether complications after use of a closure device were more severe than those after manual compression. Access methods and hematoma. Numerous studies have confirmed the benefits of using fluoroscopy and bone landmark guidance to access the CFA compared with standard palpation alone.10 Additional small case series and trials have begun to examine the utility of UG to further decrease the complications associated with CFA access. On the basis of their prospective, randomized evaluation of 112 patients undergoing peripheral angiography/interventions after either UG or traditional palpation guidance, Dudeck et al13 recommended ultrasound for patients with weak or absent femoral pulses and those with obesity (defined as leg circumference >60 cm). Although they did not find any differences in complication rates between the two groups, they did identify a decreased
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Table II. Hematoma rates by univariate analysis of the cohort
Table II. Continued. Characteristic
Characteristic Demographics Age group, years 18-80 80þ Gender Male Female Medical history Hypertension Yes No COPD Yes No CABG/PCI Yes No Diabetes Yes No Dialysis Yes No Previous bypass Yes No Previous PVI Yes No Aspirin or clopidogrel Yes No Chronic anticoagulant Yes No Procedure Urgency Elective Urgent/emergent Femoral access Unilateral Bilateral Retrograde access Yes No Access guidance Ultrasound No ultrasound Sheath size #6 >6 Closure device Yes No Heparin Yes No Bivalirudin Yes No Protamine Yes No
Hematoma rate, %
P value
4.0 7.0
Routine use of ultrasound guidance in femoral arterial access for peripheral vascular intervention decreases groin hematoma rates Jeffrey Kalish, MD,a Mohammad Eslami, MD,a David Gillespie, MD,b Marc Schermerhorn, MD,c Denis Rybin, PhD,d Gheorghe Doros, PhD,d and Alik Farber, MD,a on behalf of the Vascular Study Group of New England, Boston and Fall River, Mass Background: Use of fluoroscopy and bone landmarks to guide percutaneous common femoral artery (CFA) access has decreased access site complications compared with palpation alone. However, only limited case series have examined the benefits of ultrasound to guide CFA access during peripheral vascular intervention (PVI). We evaluated the effect of routine vs selective use of ultrasound guidance (UG) on groin hematoma rates after PVI. Methods: The Vascular Study Group of New England database (2010-2014) was queried to identify the complication of postprocedural groin hematoma after 7359 PVIs performed through CFA access. Hematoma (including pseudoaneurysms) was defined as minor (requiring compression or observation), moderate (requiring transfusion or thrombin injection), and major (requiring operation). Both procedure-level and interventionalist-level analyses were performed. Multivariable Poisson regression models were used to compare hematoma rates of interventionalists based on routine ($80% of PVIs) and selective (80 years (RR, 0.47; 95% CI, 0.27-0.85; P [ .01), body mass index $30 (RR, 0.51; 95% CI, 0.29-0.90; P [ .02), and sheath size >6F (RR, 0.43; 95% CI, 0.23-0.79; P < .01). Conclusions: Routine UG may potentially protect against the complication of hematoma for both modifiable and nonmodifiable patient and procedural characteristics. Encouraging routine UG is a feasible quality improvement opportunity to decrease patient morbidity after PVI. (J Vasc Surg 2015;61:1231-8.)
Local vascular complications are the most frequent adverse outcomes of femoral artery puncture, with an incidence reported between 1% and 10%.1-3 These complications include groin hematoma, retroperitoneal hematoma, vessel thrombosis, pseudoaneurysm, and arteriovenous fistula.4,5 Known risk factors for complications include female gender,6 obesity,7 anticoagulants,7 interventional vs From the Division of Vascular and Endovascular Surgery, Boston Medical Center, Bostona; the Department of Vascular Surgery, Southcoast Health System, Fall Riverb; the Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Bostonc; and the Department of Biostatistics, Boston University School of Public Health, Boston.d Author conflict of interest: none. Presented as a Plenary presentation at the 2014 Joint Annual Meeting of New England Society for Vascular Surgery (NESVS)/Eastern Vascular Society (EVS), Boston, Mass, September 11-14, 2014. Reprint requests: Jeffrey Kalish, MD, Director of Endovascular Surgery, Boston Medical Center, 88 East Newton St, Collamore 5, D-506, Boston, MA 02118 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2014.12.003
diagnostic procedures,8 and larger sheath size.9 For both coronary and peripheral vascular procedures, the use of bone landmarks and fluoroscopy compared with palpation alone has decreased the incidence of access site complications.10 Although the use of ultrasound has been reported in case series involving central venous access,11 pediatric patients,12 and absent femoral pulses and obesity with large leg circumference,13 its routine role in common femoral artery (CFA) access is a more recent trend in the literature. The Femoral Artery Access with Ultrasound Trial (FAUST), published in 2010, is the first randomized trial of fluoroscopy-guided compared with ultrasound-guided retrograde CFA access.14 Even with the short learning curve required for successful ultrasound guidance (UG), the results of the trial showed absolute benefits for UG compared with fluoroscopy, including a decreased incidence of groin hematoma with use of ultrasound. The purpose of our study was to use the Vascular Study Group of New England (VSGNE) database to examine the peripheral vascular intervention (PVI) cohort and to identify variables associated with the complication of postprocedural groin hematoma. More specifically, we evaluated the effect of routine vs selective use of UG on the groin hematoma rates after PVI. 1231
JOURNAL OF VASCULAR SURGERY May 2015
1232 Kalish et al
METHODS Study design. This was a retrospective observational study of the VSGNE registry to identify patients who underwent PVI. The VSGNE is a regional cooperative quality improvement initiative developed in 2002 to prospectively study outcomes in patients undergoing vascular and endovascular surgery. The details on this registry have been published previously15 and are available online at www.vsgne. org. The Institutional Review Board at Boston University School of Medicine approved the use of the de-identified data for this study, and patient informed consent was waived. Patient population. A total of 7359 PVIs performed through CFA access were recorded in the VSGNE by 159 interventionalists at 26 academic and community hospitals during the study interval from January 2010 through January 2014. Inclusion and exclusion criteria. We included all patients who underwent elective, urgent, or emergent PVI procedures for claudication, critical limb ischemia (rest pain or tissue loss), and acute ischemia. We included PVI performed through antegrade or retrograde CFA access, either unilateral or bilateral, and excluded access by other means (arm, graft, popliteal, or other). We excluded patients who had PVI with a concomitant CFA endarterectomy, if groin cutdown was used for CFA access, or if PVI was performed for aneurysm. Fifteen PVI procedures were excluded from analysis because of incomplete data recorded regarding hematoma. Outcome and variable definitions. In our analysis, we reviewed patient demographics, pre-existing medical comorbidities, and operative details. More than 100 variables were collected prospectively for each procedure and recorded in the VSGNE database. The definitions of medical comorbidities and procedure details within VSGNE have been previously described.15 The main postprocedural outcome measure of hematoma (includes pseudoaneurysm) was defined in the VSGNE database as minor (requiring compression or observation), moderate (requiring transfusion or thrombin injection), and major (requiring operation). The self-reported outcomes were captured before discharge only and not from subsequent inpatient or outpatient encounters. We also evaluated the outcomes of interventionalists based on their routine or selective use of UG. Routine UG was defined as using ultrasound for CFA access in $80% of PVI procedures, whereas selective UG was defined as using ultrasound for CFA access in 6F during 21.2% of PVIs, and closure devices (including Perclose, Angio-Seal, StarClose, Mynx, and other) were used during 42% of PVIs. The number of arteries treated during PVI was one or two in 87.2% of cases and three to six in 12.8% of cases. Heparin was used in 94.3% of cases, bivalirudin was used in 2.5% of cases, and protamine was given in 22.2% of cases. Procedure-level analysis. The overall postprocedural groin hematoma rate after PVI was 4.5%, and the rate of combined moderate and major hematoma was 0.8%. Across the VSGNE centers, hematoma complication rates
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Fig 1. Interventionalist percentage use of ultrasound guidance (UG).
ranged from 1.1% to 19.2% (Fig 2). By univariate analysis (Table II), the following factors were found to be associated with hematoma: age (7.0% among 80þ years old compared with 4.0% in those younger than 80 years), gender (5.9% in females vs 3.7% in males), bilateral femoral access (6.5% vs 4.2% for unilateral access), sheath size (6.1% in >6F vs 4.1% in #6F), and number of arteries treated (5.8% in $3 vs 4.3% in 80 years (OR, 2.45; 95% CI, 1.31-4.57; P ¼ .005), sheath size >6F (OR, 1.62; 95% CI, 1.24-2.11; P < .001), female gender (OR, 1.54; 95% CI, 1.22-1.94; P < .001), and bilateral femoral access (OR, 1.44; 95% CI, 1.08-1.93; P ¼ .013). Use of closure devices was protective against hematoma (OR, 0.47; 95% CI, 0.37-0.61; P < .001).
Interventionalist-level analysis. Among the 114 interventionalists with $10 PVI procedures, hematoma rates ranged from 0% to 30%, with a mean of 2.9% in the routine users and 5.7% in the selective users. After adjustment for patient characteristics, the interventionalist-level analysis showed that routine UG was protective against groin hematoma (RR, 0.62; 95% CI, 0.46-0.84; P < .01). Furthermore, as the percentage usage of UG increased from 0% to 80þ%, the hematoma RRs similarly decreased from 0.97 (95% CI, 0.63-1.48) to 0.74 (95% CI, 0.57-0.95). Subgroup analysis revealed that routine UG was protective against groin hematoma under the following circumstances: age >80 years (RR, 0.47; 95% CI, 0.270.85; P ¼ .01), body mass index (BMI) $30 (RR, 0.51; 95% CI, 0.29-0.90; P ¼ .02), sheath size >6F (RR, 0.43; 95% CI, 0.23-0.79; P < .01), and unilateral femoral access (RR, 0.59; 95% CI, 0.41-0.84; P < .01). Whereas closure devices were already shown to be protective against hematoma, routine UG seemed to add to that protective effect (RR, 0.42; 95% CI, 0.22-0.79; P < .01). In the other subgroups that were identified as risk factors for hematoma on multivariable analysis, routine UG had no statistically significant effects: female (RR, 0.78; 95% CI, 0.53-1.14; P ¼ .19), bilateral femoral access (RR, 1.57; 95% CI, 0.88-2.81; P ¼ .13). DISCUSSION Summary. Groin hematoma after CFA access during PVI ranged from 1.1% to 19.2% across VSGNE centers, with an overall rate of 4.5%. Although the incidence of moderate and severe hematoma was only 0.8% across the VSGNE, this general complication led to an appreciable increase in hospital resource utilization (increased admission
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Table I. Demographics of the patient population and procedure performed Characteristic Patient procedures Demographics Age, years 18-50 50-60 60-70 70-80 80þ Gender Male Female Race White Other BMI, median (IQR) Preadmission living Home Nursing home Ambulatory status Independent Not independent Medical history Smoking Never Ever Hypertension CAD CHF COPD CABG/PCI Diabetes Dialysis Previous bypass Previous PVI Aspirin Clopidogrel Chronic anticoagulant Procedure characteristics Urgency Elective Urgent/emergent Femoral access Unilateral Bilateral Retrograde access UG Fluoroscopy time, minutes, median (IQR) Contrast volume, mL, median (IQR) Sheath size #6 >6 Closure device Heparin Bivalirudin Protamine Number of arteries treated 18,000 consecutive patients undergoing PCI in northern New England and created a scoring system to estimate individual patient risk.6 The rate of vascular groin complications (defined as access site injury requiring treatment or bleeding requiring transfusion) was 2.98%, and the two variables with the highest predictive ORs for hematoma were age $70 years (OR, 2.7) and female gender (OR, 2.4). Whereas that study identified additional patient characteristics that predicted groin complications, many of the examined variables are not evaluated within the VSGNE (bleeding disorder, myocardial infarction, shock), nor do they apply to peripheral interventions (number of PCIs, type of coronary lesion). Another coronary trial, Coronary Angioplasty vs Excisional Atherectomy Trial (CAVEAT-I), also examined risk factors for the in-hospital composite end point of peripheral vascular complications.16 Of the 1012 randomized patients, the incidence of groin complications was 6.6%, and in this group of patients, there was a twofold increase in hospital cost and sevenfold increase in long-term deaths. Greater age, female gender, postprocedural heparin, and intra-aortic balloon counterpulsation were predictive of increased risk of the groin complications. Although other studies identified obesity as an independent patient characteristic predictive of groin hematoma,7 the VSGNE did not mirror those results. However, when UG was evaluated in the presence of morbid obesity (BMI $30), routine UG was more protective against hematoma compared with selective UG. Moreover, ultrasound has been shown in other studies to aid in the successful cannulation of the CFA in patients with larger leg circumference (>60 cm) and to decrease the number of attempts needed for cannulation.13 Procedural predictors of hematoma. Certain aspects of the procedure itself lead to varying risks for groin hematoma. Interventions, as opposed to diagnostic procedures, typically require some type of antithrombotic medication, and such intraprocedural (antiplatelet or anticoagulant) or postprocedural medications (intravenous heparin) have been shown to increase the risks for groin hematoma.1 Larger sheath sizes, including the 7F and 8F sheaths more typical for interventions as opposed to diagnostic procedures, also lead to increased hematoma rates.3 Although the majority of the literature is again related to
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Kalish et al 1235
Fig 2. Hematoma complication rates across Vascular Study Group of New England (VSGNE) centers.
cardiac catheterization, similar results would be expected with peripheral interventions. In the VSGNE study, the use of heparin or protamine as well as alternative antithrombotic medications was not found to be associated with increased hematoma rates, but no standardized protocols could be elucidated with VSGNE data. Although the PVI data set within VSGNE evaluates only interventions and not diagnostic angiograms, sheath size >6F was found to be a risk factor of groin hematoma. Vascular closure devices. A significant amount of literature is devoted to closure devices in comparison to manual compression and their effects on both the procedures themselves and the postprocedural complications. In an early meta-analysis of available literature, Koreny et al4 contended that closure devices (including some of the devices still in use to this day) not only may be ineffective but also may increase the risk of groin hematoma and pseudoaneurysm. More recent studies have revealed the opposite results, with vascular closure devices showing promise as a means to reduce groin complications. In an evaluation of more than 1.8 million PCIs reported to the CathPCI registry from 2005 to 2009, Tavris et al5 revealed significantly lower bleeding or vascular complication rates of certain closure devices (Angio-Seal, Perclose, StarClose, and Boomerang) compared with manual compression; in addition, all types of hemostatic strategies showed reduced complication rates over time. A meta-analysis of interventional radiology procedures showed similar benefits of vascular closure devices compared with manual compression in terms of reducing groin complications.2
Although the use of closure devices may be a causative factor to decrease groin complications, other studies assert that the establishment of protocols and appropriate patient selection drive the benefits of the closure devices. In their evaluation of peripheral vascular disease patients, Goodney et al17 achieved process improvement by instituting a standardized percutaneous arterial closure protocol based on selective closure device use guided by sheath size, arterial calcification, and previous access scarring. Whereas closure devices as a group were protective against groin hematoma in this VSGNE study population, the sample size did not allow adequate differentiation between the hematoma rates depending on the exact type of closure device used, nor could the data examine whether complications after use of a closure device were more severe than those after manual compression. Access methods and hematoma. Numerous studies have confirmed the benefits of using fluoroscopy and bone landmark guidance to access the CFA compared with standard palpation alone.10 Additional small case series and trials have begun to examine the utility of UG to further decrease the complications associated with CFA access. On the basis of their prospective, randomized evaluation of 112 patients undergoing peripheral angiography/interventions after either UG or traditional palpation guidance, Dudeck et al13 recommended ultrasound for patients with weak or absent femoral pulses and those with obesity (defined as leg circumference >60 cm). Although they did not find any differences in complication rates between the two groups, they did identify a decreased
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1236 Kalish et al
Table II. Hematoma rates by univariate analysis of the cohort
Table II. Continued. Characteristic
Characteristic Demographics Age group, years 18-80 80þ Gender Male Female Medical history Hypertension Yes No COPD Yes No CABG/PCI Yes No Diabetes Yes No Dialysis Yes No Previous bypass Yes No Previous PVI Yes No Aspirin or clopidogrel Yes No Chronic anticoagulant Yes No Procedure Urgency Elective Urgent/emergent Femoral access Unilateral Bilateral Retrograde access Yes No Access guidance Ultrasound No ultrasound Sheath size #6 >6 Closure device Yes No Heparin Yes No Bivalirudin Yes No Protamine Yes No
Hematoma rate, %
P value
4.0 7.0
