Journal of Cardiovascular Nursing

Vol. 25, No. 3, pp 00Y00 x Copyright B 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins

Predictors of Complications Following

Sheath Removal With Percutaneous
Coronary Intervention
Linda M. Sulzbach-Hoke, PhD, RN, CCNS, ACNS-BC, CCRN; Sarah J. Ratcliffe, PhD;
Stephen E. Kimmel, MD, MSCE; Daniel M. Kolansky, MD; Rosemary Polomano, PhD, RN, FAAN

Background and Research Objectives: Complex antiplatelet and antithrombotic regimens used in conjunction with
percutaneous coronary intervention may increase the risk of vascular complications. The purpose of this study was
to examine predictors of vascular complications following sheath removal for percutaneous coronary intervention.
Subjects and Methods: This prospective cohort study enrolled 413 patients during a 7-month period. Data elements
were collected by chart abstraction. Practice variable included pharmacological agents and method and duration of
sheath removal procedure. Patient outcomes included hematoma formation, bleeding occurrence, pseudoaneurysm
prevalence, incidence of arteriovenous fistula formation, and thrombosis. Results and Conclusions: Of the 413
patients, 68 (16.5%) had a complication. Sixty-four (15.5%) developed hematomas ranging in size from 1 to 5 cm
(n = 35, 8.5%) to greater than 5 cm (n = 29, 7.0%), 6 experienced bleeding (1.5%), 4 (1%) had arteriovenous fistulas,
and 3 (0.7%) developed pseudoaneurysms. There were no significant differences for complications using manual,
C-clamp, or arterial vascular closure device. Patients with a higher systolic blood pressure (135 vs 129; df = 410,
P = .025) and of older age (66 vs 63; df = 411, P = .016) were significantly more likely to have complications. Clinically
significant major vascular complications were low. Arterial closure devices, mechanical C-clamp, and manual
compression all provide low and comparable complication risks following sheath removal in the era of antiplatelet and
antithrombotic therapies. Patients who are older and those with elevated blood pressure should have their femoral
access site closely monitored and be observed for vascular complications.
KEY WORDS: arterial closure devices, hematoma, manual compression, mechanical C-clamp, percutaneous
coronary intervention, sheath removal, vascular complications

P ercutaneous coronary intervention (PCI) is widely

used in the treatment of patients with coronary
Linda M. Sulzbach-Hoke, PhD, RN, CCNS, ACNS-BC, CCRN
Clinical Nurse Specialist, Cardiac Intermediate Care Unit, Hospital of
the University of Pennsylvania, and Adjunct Assistant Professor of
Nursing, University of Pennsylvania School of Nursing, Philadelphia.
Sarah J. Ratcliffe, PhD
Assistant Professor of Biostatistics, Department of Biostatistics and
Epidemiology, University of Pennsylvania School of Medicine,
Philadelphia.
Stephen E. Kimmel, MD, MSCE
Associate Professor of Medicine and Epidemiology, University of
Pennsylvania School of Medicine, Philadelphia.
Daniel M. Kolansky, MD
Associate Professor of Medicine, University of Pennsylvania School
of Medicine, and Hospital of the University of Pennsylvania,
Philadelphia.
Rosemary Polomano, PhD, RN, FAAN
Associate Professor of Pain Practice, University of Pennsylvania
School of Nursing, and Associate Professor of Anesthesiology and
Critical Care, University of Pennsylvania, Philadelphia.
Research was conducted at the Hospital of the University of
Pennsylvania, Philadelphia.
Correspondence
Linda M. Sulzbach-Hoke, PhD, RN, CCNS, ACNS-BC, CCRN, Cardiac
Intermediate Care Unit, Hospital of the University of Pennsylvania, 3400
Spruce St., Philadelphia, PA 19104 (linda.hoke@uphs.upenn.edu).
artery disease and acute coronary syndromes. In
2006, an estimated 1,313,000 PCI procedures were
performed.1 Increasingly complex antiplatelet and anti-
thrombotic regimens used in conjunction with PCI
may increase the risk of femoral vascular complica-
tions associated with PCI. Several methods for sheath
removal include manual compression, C-clamp, pneu-
matic devices, and arterial closure devices. Selecting
a method for sheath removal is often dependent on
clinician preference, and there is no compelling evi-
dence or widely accepted practice guidelines to favor
one approach over another.
Despite advances in technology for PCI, there is
no consensus regarding optimal method to achieve
vascular hemostasis while minimizing complication
rates. Percutaneous coronary intervention complica-
tions have been linked to increased consumption of
healthcare resources, delays in hospital discharge,
and patient dissatisfaction. It was reported that PCI
bleeding complications cost an additional US $13,092
and added 4.4 days to a patient’s hospitalization,2 and
vascular complications cost an additional US $4,830
and 2.1 hospital days.3

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2 Journal of Cardiovascular Nursing x May/June 2010
The incidence of vascular complications ranges
from 5.4% to 37%.2Y9 Wide variations in reporting
these occurrences are attributed to differences among
studies for definitions and criteria for complications,
assessments of vascular complications, compression
techniques, and protocols for sheath removal. For ex-
ample, some investigations have included ecchymosis
and oozing, which do not require medical interven-
tion or affect length of stay. Others limit complications
to only the major ones such as significant bleeding that
requires transfusion. Regardless of how unfavorable
the outcomes with PCI procedures are defined and
captured, the potential for serious events has stimu-
lated interest in researching techniques for sheath
removal that are associated with the best possible
outcomes.
A meta-analysis by Jones and McCutcheon10 re-
vealed that few studies address techniques performed
to attain hemostasis after sheath removal. Furthermore,
there are significant gaps in the current state of the
science, and researchers have not been able to docu-
ment relationships, if any, between sheath removal
techniques, devices, antiplatelet medications, patient
characteristics, and complication rates in PCI patients.
A randomized study of 90 PCI patients by Benson
et al6 found an overall vascular complication rate of
14.4%, and manual sheath removal was associated
with significantly fewer complications of rebleeding
or hematoma formation compared with the C-clamp
or pneumatic device (# 2 P = .04). In contrast, no
significant differences by compression method for
vascular complications, discomfort, and distress were
detected by Chlan et al7 when 306 patients were
randomized to C-clamp, manual compression, and
pneumatic device. A follow-up study on the same 306
patients identified that patients with smaller body
surface area had an increased risk for hematoma
development, and patients with advanced age had an
increased risk for ecchymosis.8
Arterial closure devices have the potential to reduce
the time to hemostasis, facilitate patient mobilization,
decrease hospital length of stay, and improve patient
satisfaction. However, their safety with respect to
vascular complications remains unclear. Outcomes
related to access site complications with arterial
closure devices with PCI patients receiving antiplatelet
agents showed a 4.2% vascular complication rate11
and were associated with failed hemostasis.12 Another
randomized controlled trial with 167 PCI patients
found a 7% failure rate for maintaining hemostasis
with arterial closure device compared with no failures
using manual compression, but no significant differ-
ence in rates was detected between groups for the
development of hematoma.13 Findings from a meta-
analysis from 30 studies involving 37,066 PCI patients
favored mechanical compression over arterial clo-
Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
sure devices for preventing complications; however,
the synthesis of results from multiple studies did find
that arterial closure devices improved patient satisfac-
tion and time to ambulation.14
Nursing management of patients undergoing PCI
is critical to improving outcomes and reducing com-
plications. The development of protocols and proce-
dures for sheath removal must be based on scientific
evidence that indicates which practices are the most
efficient10 and effective. Acknowledging that compli-
cations exist with all methods and result in increased
length of stay and hospital costs, studies must be
designed to systematically identify care strategies that
are most beneficial as well as predictors of vascular
complications in routine clinical settings. We con-
ducted a descriptive correlational study to examine
vascular complications associated with 4 different
methods of sheath removal practices following PCI
and the influence of specific patient factors on out-
comes. A secondary outcome was to capture the vas-
cular complication rates after PCI sheath removal and
more specifically the incidence and type of vascular
complications experienced by patients during the
course of routine clinical care.
Methods
A prospective, observational case series with a study
cohort of patients requiring PCI for the treatment of
acute coronary syndrome was conducted. No inter-
ventions or study conditions were manipulated as part
of this research. Clinical nurses were trained during
orientation to the unit on sheath removal using the
clamp, manual, and pneumatic device. Each nurse was
checked off on the sheath competency after removing
6 sheaths. Clinical nurses were instructed in the im-
portance of: withdrawing about 5 to 10 mL of blood
prior to removing the catheters to ensure that there are
no clots; they were also instructed to position the hemo-
stasis option (manual or C-clamp) 1 to 2 cm above the
site where the arterial sheath enters the skin since the
arterial puncture site is superior and medial to the skin
puncture site, assess the circulation to the extremity
distal to the site of the arterial sheath removal, and
palpate the area around the arterial site, maintain bed
rest for 6 hours after arterial sheath removal when using
manual or C-clamp and 4 hours with closure devices.15
Patients were exposed to routine clinical care fol-
lowing their procedure, at the discretion of health-
care providers, and data were subsequently collected
on both practice and patient outcomes. Approval
from our institutional review board was obtained
with waiver of consent for participants because the
study involved data collection by chart abstraction,
and all participant data were deidentified. Patients
who underwent PCI were eligible for inclusion in the
 PCI Vascular Complications 3

study the day after their procedure prior to their dis-
charge. Data elements included patient demographics,
health status and comorbidities, practice variables (eg,
type of sheath removal), and patient outcomes and
complications (eg, hematoma formation). This was
a 1-time event collected prior to discharge.
Sample
Patients undergoing PCI at an academic medical center
following their procedure were enrolled in the study.
These patients were hospitalized on the cardiac inten-
sive care or cardiac intermediate care units. Those who
were hemodynamically unstable after PCI (ie, requir-
ing pulmonary artery catheter monitoring or intra-
aortic balloon pump therapy) and those having a PCI
using the radial artery were excluded from the study.
devices were deployed, this was at the discretion of
the physician performing the PCI.
h Patient outcomes: hematoma formation (before, dur-
ing, and after removal), bleeding occurrence, pseu-
doaneurysm prevalence, incidence of arteriovenous
(AV) fistula formation, and thrombosis. For the
purpose of this study, vascular complication outcome
variables were operationally defined and are shown
in Table 1. Ultrasound was not routinely performed
on all patients; only those with clinical evidence of a
bruit, large hematoma, or pain at the femoral access
site were further evaluated with ultrasound proce-
dures. Other potential complications from sheath
removal include deep vein thrombosis from pro-
longed compression time and surgery to repair
pseudoaneurysm, AV fistula, or massive bleeding.

Outcomes
A data collection tool was used to record interven-
tion events and outcome variables for all participat-
ing patients. Data elements included
h Patient demographics: body mass index, age, sex,
and race.
h Health status and comorbidities: current diagnosis
and history of diabetes, hypertension, vascular dis-
ease, myocardial infarction, and tobacco use.
h Practice variables: pharmacological agents admin-
istered in the course of clinical care, method of sheath
removal, sheath size, and duration of sheath removal
procedures. All anticoagulant medications given
during hospitalization were documented; however,
it is important to note that this therapy was given
based on physician preference and discretion. The
method for sheath removal was not controlled or
manipulated as part of this study and solely left to the
judgments and practice preference of nurses caring
for these patients. Thus, some methods were used
more frequently than others. When arterial closure
Procedures
The principal investigator provided group and one-
on-one education on the purpose of the study, data
collection process, and study outcomes to the nurses.
The importance of accurately recording all patient
events and the sequence of care was emphasized. Nurses
were instructed to document which method of sheath
removal was used: manual, C-clamp (CompressAR,
Advanced Vascular Dynamics, Portland, OR) or pneu-
matic (FemoStop, Radi Medical Systems AB, St. Jude
Medical, Inc., St. Paul, MN) compression. Some pa-
tients required 2 different methods of sheath removal.
For example, nurses may have initiated hemostasis
with a clamp but may have subsequently switched to
the manual method if complications were noted.
Therefore, only the first sheath removal method used
was included in the data analysis. When arterial
closure devices (ie, Angio-Seal, Kensey Nash Corpo-
ration, Exton, PA; or Perclose, Abbott Laboratories,
Abbott Park, IL) were used for hemostasis by physi-
cians in the catheterization laboratory, this informa-
tion was recorded.

TABLE 1 Patient Outcomes and Definitions

Outcome Variables Definitions
Hematoma Any swelling or palpable mass
Small hematoma 1Y5 cm in diameter
Large hematoma 95 cm in diameter
Bleeding occurrence 92.0-g point drop from baseline hemoglobin and/or clinical complications (such as retroperitoneal bleed)
to indicate bleeding (such as a blood transfusion). Note: Patients who had oozing of blood were not
considered having a complication because oozing could not be quantified and did not change the length
of stay and did not delay discharge.
Pseudoaneurysm Forms outside the arterial wall, is contained by the surrounding tissue, continues to communicate with the
artery via the puncture site, is detected by physical examination and confirmed by ultrasound-containing
Doppler-detected flow.
Arteriovenous fistula Abnormal communication between the femoral artery and vein confirmed by ultrasound-containing
Doppler-detected flow.
Thrombosis Complete occlusion of the femoral vessel as detected by the absence of distal foot pulses and confirmed
by ultrasound-containing Doppler-detecting flow.

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4 Journal of Cardiovascular Nursing x May/June 2010

Nurses were instructed to measure all hematomas
with a tape measure. Hematomas were divided into 2
categories: 5 cm or less for small hematoma and greater
than 5 cm for large hematomas. The principal inves-
tigator collected all data through ongoing chart abstrac-
tion. During the course of the study, nurses were free to
use their clinical judgment in selecting the sheath re-
moval method that they believed to be most appropriate
and were not biased or influenced by the investigators.
Power Analysis
The sample size was calculated based on the primary
outcome variable of interest, the rate of hematomas.
The average rate of hematoma for all patients was
estimated at 16%; however, if only large hematomas
were considered, this rate would drop to approxi-
mately 8%. For the one primary independent vari-
able of interest, sheath removal method, the total
number of patients required for a medium effect size
(0.30), ! = .05 with 80% power, across the range for
complications (8%Y16%) was 176 to 322. To detect
a 1.5-fold increase in the compression times between
the 2 outcome groups, with ! = .05 and 80% power,
357 patients were needed.
mographic and pharmacological agents are shown in
Table 2. Patients ranged in age from 38 to 90 years
(mean, 63.54 [SD, 10.3] years); 316 (76.5%) were
men, and 97 (23.5%) were women. Most were white
(n = 320; 77.5%) and had a history of hypertension
(n = 312; 75.5%) and myocardial infarction (n = 254;
61.5%). There were no elevated international normal-
ized ratios due to coumadin or liver failure.
Most patients (n = 219; 53%) received a glyco-
protein IIB/IIIA inhibitor; heparin, n = 382 (92.5%);
aspirin, n = 409 (99%); and clopidogrel, n = 405
(98.1%), for baseline treatment during and after PCI
procedure. Heparin was weight-based dosed, at 50
to 70 units/kg, with an activating clotting time goal
of 200 to 250 seconds for patients receiving a
glycoprotein IIB/IIIA inhibitor and longer than 300
seconds for those not on such agents. Clopidogrel was
loaded at 300 or 600 mg, independent of glycoprotein
IIB/IIIA inhibitor use, and continued at 75 mg daily.
Most patients had a 6F arterial catheter (76%), and
sheaths were removed after the activating clotting time
was less than 180 seconds.
Of the 413 patients, 68 patients (16.5%) had a
complication such as hematoma, bleeding occurrence,
pseudoaneurysm, and/or AV fistula. Thrombosis was

Data Analysis TABLE 2 Demographics and Characteristics

Among All Patients With and Without
Study data were subjected to both descriptive and in-
Complications
ferential statistical analyses. The occurrence of statisti-
cally significant differences in outcome variable means No Complication Complication
and prevalence rates related to intervention variables Parameter (n = 345) (n = 68) P
were determined using the # 2 test, Student t test for Age, mean (SD), y 62.97 (10.2) 66.38 (10.0) .012
independent groups, or Mann-Whitney U tests as ap- Sex, no. male (%) 267 (64.6) 49 (11.9) .350
Race .874
propriate. Only meaningful significant relationships White 268 (64.9) 52 (12.6)
were targeted as part of this investigation. Nonwhitea 77 (18.6) 16 (3.9)
When appropriate, measurable practice variables and Body mass index, 29.5 (5.7) 29.42 (8.5) .824
patient outcomes were categorized into nominal level mean (SD), kg/m2
data to achieve the most detailed information. Any Systolic BP, mean 129.25 (20.3) 134.72 (21.4) .045
(SD), mm Hg
practice or patient outcome with less than 5% frequency Medical history, n (%)
was not used in further analysis or, if appropriate, was Diabetes 114 (27.6) 29 (7) .163
combined with another variable. Furthermore, the same Hypertension 260 (63.1) 52 (12.6) 1.0
rule was applied to categories within a variable. How- Vascular disease 39 (9.4) 8 (19.4) .837
ever, if a category with less than 5% frequency could not Myocardial infarction 215 (52.1) 39 (9.4) .50
Currently smoking 83 (20.1) 11 (26.6) .205
be combined with another category, the patients in this Medications during/
group were excluded from further analyses. after PCI, n (%)
Each outcome was separately compared with the tPA 1 (0.2)
outcomes using appropriate statistical methodology. IIB/IIIA inhibitor 182 (44.1) 37 (9) .894
Variable effects with P G .2 were considered for the Heparin 301 (72.9) 63 (15.1) .303
Low molecular weight 8 (2.3) 1 (0.2) 1.0
multivariate model. However, if it was not signifi- heparin
cant but there was some clinical evidence to support Aspirin 345 (83.5) 68 (16.5)
the variable in the model, it was included. Clopidogrel 338 (81.8) 67 (16.2)
Bivalirudin 20 (4.8)
Results Abbreviations: BP, blood pressure; IIB/IIIA, glycoprotein IIB/IIA inhibitor; PCI,
percutaneous coronary intervention; tPA, tissue plasminogen activator.
During the 7 months from November 2003 through a
Due to small numbers in nonwhite groups, race was recoded as white
May 2004, 413 patients were enrolled. Baseline de- versus nonwhite.

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 PCI Vascular Complications 5

TABLE 3 Sheath Removal Methods and removal (manual, C-clamp, and arterial vascular clo-
Complications sure device), no significant differences in complication
rates by removal method (Table 3) were observed.
Complication
Frequency, Frequency, The use of arterial vascular closure devices was
Type n (%) n (%) P relatively limited in this study; therefore, the 2 types
of devices used (Angio-Seal, a collagen plug, n = 62;
n = 413 n = 68 .654
Manual 105 (25.4) 17 (25) .486 and Perclose, a percutaneous suture device, n = 19)
C-clamp 223 (54.0) 38 (55.9) .544 were combined to form 1 group. The pneumatic
Arterial closure device 81 (19.6) 13 (19.1) device was used only 4 times (1%), so it was
Collagen closure devicea 62 (15.0) 8 (11.7) .464 excluded from the analyses. There were no signifi-
Percutaneous suture 19 (4.6) 5 (7.4) .218
cant differences in complications by medications
closure devicea
Pneumatic deviceb 4 (1) 0 used during or after the procedure. Most hematomas
occurred after compression (n = 25; 6.1%), followed
a
Collagen closure device (Angio-Seal) and percutaneous suture closure by during sheath removal (n = 19; 4.6%). Patients
device (Perclose) are subgroups of the arterial closure device.
b
The pneumatic device was used only 4 times (1%), so it was excluded with complications had significantly higher systolic
from analyses. blood pressures (135 vs 129; df = 410, P = .025)
and were significantly older (66 vs 63; df = 411,
not present in any patient. While a subset of patients P = .016). Height, weight, body mass index, and
had more than 1 complication, for example, a hema- body surface area did not affect the complication
toma and a pseudoaneurysm, most of the 68 patients rates (Table 2).
experienced a single complication, for example, hema- The method of sheath removal had no statistically
toma. There were a total of 64 hematomas (15.5%), significant effect on hematoma size (P = .084) (Table 4).
with 35 hematomas 1 to 5 cm (8.5%) and 29 (7.0%) However, arterial vascular closure devices did have a
greater than 5 cm; 6 bleeding occurrences (1.5%); 4 AV higher proportion of large hematomas (70%) than did
fistulas (1%); and 3 pseudoaneurysms (0.7%). manual devices (57.1%) and a higher proportion than
Other potential complications from sheath re- did C-clamp (34.4%).
moval include deep vein thrombosis from prolonged To examine the relationship of compression time
compression time and surgery to repair the pseudoa- to hemostasis, it was necessary to exclude the 68
neurysm, AV fistula, or massive bleeding. To our patients associated with complications as compres-
knowledge, from this prospective, observational case sion time was extended and 23 patients in whom the
series with a study cohort of patients, there were no pneumatic and arterial vascular closure devices were
documented deep vein thromboses. There were 3 used. For patients without complications, there was
patients who required the operating room: one to a significantly shorter compression time for those
repair a pseudoaneurysm; another, an AV fistula; and exposed to the manual sheath removal method (n = 90)
the third, the femoral artery. Two pseudoaneurysms compared with C-clamp device (n = 183) (median, 20
resolved with thrombin injections. vs 35; P G .001) (Table 5).
Using # 2 tests, there were no significant statistical
differences in complication rates by sex, race, diag-
nosis, and medical history of diabetes, hypertension,
Discussion
myocardial infarction, smoking, and vascular disease Determining sheath removal procedures and care of pa-
(Table 2). In examining the first method of sheath tients following PCI remain the primary responsibility

TABLE 4 Sheath Removal Method by All Complicationsa

Arterial Closure Devicesb
Method Manual C-Clamp (Collagen/Percutaneous) All Complicationsc
Hematoma diameter 1Y5 cm 8 (1.9) 24 (5.8) 0/3 (0.7) 35 (8.5)
Hematoma diameter 95 cm 9 (2.2) 13 (3.1) 6 (1.5)/1 (0.2) 29 (7)
Bleeding occurrence 2 (0.5) 3 (0.7) 1 (0.2)/0 6 (1.5)
Pseudoaneurysm 2 (0.5) 1 (0.2) 0/0 3 (0.7)
AV fistula 1 (0.2) 2 (0.5) 1 (0.2)/0 4 (1.0)
P .486 .544 .464/.218

Abbreviation: AV, arteriovenous.

a
Values are presented as n (%). There were a total of 64 hematomas (15.5%), with 35 hematomas 1 to 5 cm (8.5%) and 29 hematomas greater than
5 cm (7.0%); 6 bleeding occurrences (1.5%); 4 AV fistulas (1%); and 3 pseudoaneurysms (0.7%).
b
Collagen closure device/percutaneous suture closure device.
c
All complications, per patient; however, some patients had several complications listed such as a hematoma and a pseudoaneurysm, while most had
a single complication such as a hematoma.

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6 Journal of Cardiovascular Nursing x May/June 2010
TABLE 5 Compression Times (in Minutes) for Patients Without Complications
Typea n Mean SD
Manual 90 20.29 6.32
C-clamp 183 37.30 17.01
Total 273 31.69 16.45
a
Patients with a manual sheath removal had a significant 15-minute lower compression time, on average, than subjects with a C-clamp (median, 20
vs 35; P G .001).
of nurses. Assessment and management of vascular
complications are essential because the use of anti-
coagulant therapy often administered to patients having
PCI affects clotting times. Importantly, independent
nursing judgments regarding the methods for sheath
removal and frequency of monitoring should be
based on current evidence and knowledge of the
risks for complications, given the patient character-
istics and circumstances surrounding the PCI pro-
cedure. Our study identified that patient variables such
as age, health status and comorbidities, and nursing
practices can have important implications for deter-
mining the predictors of vascular complications.
Vascular complications in this study (16.5%)
were similar to the rates reported in the literature.
Variations in the incidence of vascular complications
documented by other investigators can be attributed
to differences in how complications are defined and
measured. For example, there are striking distinc-
tions in the ways that vascular complications are
characterized including the presence of ecchymosis
and oozing and size of hematomas or magnitude of
bleeding events. If one excludes small hematomas,
which are usually clinically insignificant, then of the
413 patients, only 42 patients (10.2%) had a compli-
cation defined as large hematoma (95 cm), bleeding
occurrence, pseudoaneurysm, and/or AV fistula. In
addition, if we restrict the analysis to those patients
who sustained a clinically significant major vascular
complication, defined as AV fistula, those who had a
pseudoaneurysm, or patients with a bleeding compli-
cation requiring transfusion for drop in hemoglobin of
greater than 2 g, then major vascular complications
occurred in only 13 patients (3.2%).
We were unable to detect major differences in
vascular complication rates with manual, C-clamp,
and arterial closure device for sheath removal (Table 3).
Chlan et al7 also demonstrated no significant dif-
ferences in vascular complications using pneumatic,
C-clamp, or manual compression. However, study pro-
cedures were implemented by 30 highly trained nurses
who had an average of 12 years of experience. Despite
vascular complications (16%) including oozing, ecchy-
mosis, and hematoma, the inability to find differences
among sheath removal techniques may have been
attributed to nurses being more experienced in the care
of patients after PCI. Our investigation was conducted
Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Median Minimum Maximum P
20 10 45 .001
35 10 110
30 10 110
with clinical nurses who had varied experiences and
time in practice, and we believe that this is more
representative of a naturalistic environment with nurses
having various levels of knowledge and expertise.
The C-clamp was used most frequently for sheath
removal (54%) by the nurses. The C-clamp provides
the application of constant pressure while maintain-
ing limb perfusion and allows for hands-free line re-
moval so nurses can monitor patients while providing
appropriate care. While manual compression was used
25.4% of the time, nurses who used this method felt
that they had more control than with the C-clamp. If
the clamp is not positioned correctly, it may result in
failure to achieve hemostasis. Although not statistically
significant, investigators observed that if there was a
hematoma, the C-clamp produced smaller hematomas,
whereas the manual method and arterial closure de-
vices were more likely to have larger hematomas
(Table 4).
Manual compression for some practitioners is not
an option based on strength and ability to hold a
good compression for 15 to 20 minutes. If hand and
arm fatigue develops during the procedure, the
amount of pressure to the femoral artery may vary,
causing vascular complications. When a hematoma
developed, compression time increased, making it
difficult to assess the effect of compression time.
However, patients without complications had a
significant difference in compression times. Patients
with sheath removal using manual compression had
a 15-minute lower compression time, on average,
compared with patients with a C-clamp (median, 20
vs 35; P G .001). Similar results were confirmed by
Bogart16; mean length of time to hemostasis was 22
minutes in the manual compression group and 31 min-
utes in the mechanical compression group (P G .001).
When providing manual compression to the femoral
artery, it is easier to release pressure to examine and
assess if hemostasis is achieved. This is not possible
with the C-clamp or pneumatic device; nurses may
leave it on longer as it is convenient and without op-
portunities to assess hemostasis.
Arterial closure devices were used in 19.6% of the
patients. This technique was at the discretion of the
physician performing the procedure. Appropriate
patient selection is important and should be placed
only after confirmation of the vascular anatomy and

in the absence of significant local peripheral arterial dis-
ease. Arterial closure devices improve patient satisfac-
tion by reducing the duration of bed rest.14 However,
Tron et al13 reported that manual compression was
significantly (P G .04) better than percutaneous suture
devices for hemostasis success, as did Koreny et al17
based on their meta-analysis of 30 randomized trials.
Older patients were more likely to have complica-
tions than were younger patients. This finding was
similar to other studies18Y21 that reported older age
was a significant variable associated with vascular
complications. Feit et al,21 in a study of 6,001 pa-
tients, identified baseline predictors of major hemor-
rhage following PCI to be advanced age (P G .0001)
and female sex (P G .0001). However, Sabo et al8 were
able to show that age was linked to the development
of ecchymosis (P G .01), but not hematoma (P = .21).
In our investigation, we did not monitor ecchymosis
because it does not delay discharge and is not clini-
cally significant if it occurs. It is important to note
that advanced age was not a predictor for vascular
complications in all studies, but despite inconclusive
findings about age, nurses should still be cautious
and extra diligent when removing sheaths in older
patients.
Results showed that patients with higher systolic
blood pressures were more likely to have a compli-
cation than were patients with lower systolic blood
pressures, which is also supported by Waksman et al,18
who reported that one of the correlates of vascular
complications was higher systolic blood pressure
(140 [SD, 25] vs 135 [SD, 20] mm Hg; P G .001).
However, our study did not find female sex or height
and weight to be significant predictors of complica-
tions as documented in other studies.8,18,19
It was evident from our results that all sheath
removal methods provide adequate hemostasis. The
occurrence of vascular complications may be, in
part, due to differences among studies in definitions
and clinical protocols that are used to direct practice
and less a consequence of the type of sheath removal
or compression technique. Thus, it may be safe to
say that without compelling evidence in favor of one
hemostasis intervention over another, nurses should
continue to use the method of sheath removal with
which they are experienced and comfortable.
Study Limitations
Since the study was conducted, there has been an
increase in the use of a 600-mg loading dose of
clopidogrel in place of the 300-mg dose. This is
expected to result in an earlier onset of action of
clopidogrel and could theoretically increase the bleed-
ing risk at the time of sheath removal; however,
because most sheath removal occurs at about 4 to
Copyright @ 2010 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
PCI Vascular Complications 7
6 hours after the procedure, the effects of either loading
dose of clopidogrel would likely be similar. In addition,
with the widespread use of early clopidogrel loading,
there has been a trend toward less use of glycoprotein
IIB/IIIA inhibitor. It is possible that one benefit would
be less access site bleeding, but this is speculative.
Catheter size and use have not changed substantially
since the study was conducted.
Because this was a descriptive study using a
convenience sample, it was anticipated that there
may be some degree of type II statistical error related
to limitations from a heterogeneous sample and lack
of control over sheath removal interventions. How-
ever, our sample size appeared to be adequate for
being able to detect statistically significant differences
if present. The study, while conducted in a naturalist
environment where nurses determine the method of
sheath removal, makes our findings more applicable
and meaningful to practice. Some may argue that the
inability to exert control over the intervention influen-
ces our results, yet our analysis was able to account for
specific patient characteristics that can affect compli-
cations. Furthermore, practice variations do exist in
routine clinical care, and it is important to assess out-
comes in the context of usual care. Patients in our study
did not have an ultrasound of their groin to confirm
clinical indicator for hematoma and other vascular
complications, so it is possible that asymptomatic pa-
tients with a pseudoaneurysm or AV fistula may have
gone undetected. To a degree, differences in medication
therapies found across institutions may limit the
generalizability of study findings.
Implications for Nursing Practice
This study provides nurses with research findings to
support independent decisions to implement inter-
ventions during sheath removal. Despite advances
in technology, vascular complications continue to be
a problem no matter which method of removing
sheaths is used. Vigilance in preventing problems as-
sociated with sheath removal can reduce vascular
events, which have been known to increase hospital
costs and cause discomfort to patients. Our findings
contribute important information to the existing
body of knowledge and evidence about sheath re-
moval practices following PCI. Importantly, nurses
need to be aware that advanced age or hypertension
seems to negatively influence patient outcomes, and
therefore, these patients require extra vigilance with
assessment and management practices. Until universally
accepted evidence-based guidelines are developed, in-
stitutions should promote practice policies and pro-
cedures that are aligned with specific standards of
practice regardless of which method is used. Future
efforts around the care of these patients should focus
8 Journal of Cardiovascular Nursing x May/June 2010
What’s New and Important
h Vascular complications should be clearly defined and
measured so the incidence of various vascular
complications can be compared from study to study.
h Nurses should continue to use their clinical
judgment in selecting the sheath removal method
that they believed to be most appropriate.
h In the era of antiplatelet and antithrombotic
therapies, arterial closure devices, mechanical
C-clamp, and manual compression all provide
low and comparable complication risks following
sheath removal.
on forming consistent definitions for parameters de-
fining what constitutes complications such as bleeding,
hemorrhage, and hematoma, so that these can be sys-
temically applied in research studies.
Conclusion
This study concludes that manual compression,
C-clamp, and arterial vascular closure devices all pro-
vide low complications for sheath removal in con-
junction with complex antiplatelet and antithrombotic
regimens. These devices can achieve hemostasis; how-
ever, manual methods appear to require less time to
hemostasis. Older patients and those with elevated
blood pressure may be at greater risk for hematoma
and thus subsequently require closer monitoring of the
femoral access site area and for signs of pending he-
matoma or bleeding during and after sheath removal.
Acknowledgments
This study was funded by a grant from Southeastern
Pennsylvania Chapter of American Association of
Critical Care Nurses and Sigma Theta Tau Xi Chapter
University of Pennsylvania School of Nursing.
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