JACC: CARDIOVASCULAR INTERVENTIONS VOL. 5, NO.

1, 2012

© 2012 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 1936-8798/$36.00

PUBLISHED BY ELSEVIER INC. DOI: 10.1016/j.jcin.2011.08.011

The Leipzig Prospective Vascular Ultrasound

Registry in Radial Artery Catheterization
Impact of Sheath Size on Vascular Complications

Madlen Uhlemann, MD, Sven Möbius-Winkler, MD, Meinhard Mende, PHD,

Ingo Eitel, MD, Georg Fuernau, MD, Marcus Sandri, MD, Volker Adams, PHD,
Holger Thiele, MD, Axel Linke, MD, Gerhard Schuler, MD, Stephan Gielen, MD

Leipzig, Germany

Objectives This study investigated the impact of sheath size on the rate of radial artery occlusions
(RAO) (primary objective) and other access site complications (hemorrhage, pseudoaneurysm, arte-
riovenous fistula) as secondary objectives after transradial coronary catheterization.

Background The number of vascular access complications in the published data ranges from
5% to 38% after transradial catheterization.

Methods Between November 2009 and August 2010, 455 patients 65.3 ⫾ 10.9 years of age (62.2%
male) with transradial access with 5-F (n ⫽ 153) or 6-F (n ⫽ 302) arterial sheaths were prospectively
recruited. Duplex sonography was obtained in each patient before discharge. Patients with symptomatic
RAO were treated with low-molecular-weight heparin (LMWH), and a follow-up was performed.

Results The incidence of access site complications was 14.4% with 5-F sheaths compared with
33.1% with 6-F sheaths (p ⬍ 0.001). Radial artery occlusion occurred in 13.7% with 5-F sheaths com-
pared with 30.5% with 6-F sheaths (p ⬍ 0.001). There was no difference between groups with
regard to hemorrhage, pseudoaneurysms, or arteriovenous fistulas. Female sex, larger sheath size,
peripheral arterial occlusive disease, and younger age independently predicted RAO in multivariate
analysis. In total, 42.5% of patients with RAO were immediately symptomatic; another 7% became
symptomatic within a mean of 4 days. Of patients with RAO, 59% were treated with LMWH. The
recanalization rates were significantly higher in patients receiving LMWH compared with conven-
tional therapy (55.6% vs. 13.5%, p ⬍ 0.001) after a mean of 14 days.

Conclusions The incidence of RAO by vascular ultrasound was higher than expected from previous
data, especially in patients who underwent the procedure with larger sheaths. (J Am Coll Cardiol
Intv 2012;5:36 – 43) © 2012 by the American College of Cardiology Foundation

From the Department of Internal Medicine/Cardiology, Heart Centre, and the Coordination Centre for Clinical Trials, University
of Leipzig, Leipzig, Germany. Dr. Möbius-Winkler is a proctor for Atritech Inc. Dr. Linke received honoraria and is a consultant
for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Manuscript received August 17, 2011; accepted August 31, 2011.
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 1, 2012 Uhlemann et al. 37
JANUARY 2012:36 – 43 Impact of Sheath Size on Vascular Complications

Since the first successful diagnostic transradial coronary consensus with regard to the optimum cutoff time for a
catheterization by Campeau in 1989 (1) and the first positive Allens test. As reported by Jarvis et al. (24), the use
transradial percutaneous coronary intervention (PCI) by of Allen test for assessment of the ulnar collateral blood
Kiemeneij in 1993 (2), the radial artery has been increas- supply of the hands is unreliable and does not satisfactorily
ingly used as an access site for coronary procedures, because perform as a discriminatory test. Currently, criteria for an
of lower rate of access site complications, shorter hospital abnormal Allen test are clinically not well defined, and
stay, improved patient comfort, and safe hemostasis (3,4) performing an Allen test is still not considered “standard
compared with transfemoral access (5–7). Nonetheless, care” (25,26).
radial access still accounts for only 10% of coronary cath- Transradial coronary catheterization. Six-French sheaths
eterizations worldwide and for ⬍2% of coronary procedures (RADIFOCUS Introducer II, Terumo, Europe N.V, Leu-
in the United States (8). Bleeding at the vascular access site ven, Belgium) (outer diameter 2.10 mm, 7-cm length) were
is an important predictor for post-interventional morbidity used in 302 patients, and 5-F sheaths (Engage TR Intro-
and mortality as demonstrated in several studies (7,9 –15). ducer, SJM TM, St. Jude Medical, Inc., St. Paul, Minne-
sota) (outer diameter 1.92 mm, 7-cm length) were em-
See page 44 ployed in 153 patients. In the absence of large prospective trials
we liberally used 6-F sheaths in patients with high risk for
The recently published multicenter RIVAL (radial versus CAD. In particular, in patients presenting with acute coronary
femoral access for coronary intervention) trial (15) was syndromes, a 6-F sheath was used more frequently because of
conducted to compare radial with femoral access in the the anticipated higher likelihood of PCI.
setting of acute coronary syndromes. The radial access was All sheaths were hydrophilic-
shown to reduce major vascular complications compared coated. After local anesthesia Abbreviations
with the femoral access. Another interesting finding was the with xylocaine 2% the right ra- and Acronyms
mortality reduction in favor of transradial access in patients dial artery was punctured in 442 CAD ⴝ coronary artery
with ST-segment elevation myocardial infarction. patients (97.1%), whereas in 13 disease
The rate of post-procedural radial artery occlusion (RAO) patients (2.9%) the arterial ac- CI ⴝ confidence interval
and the increased radiation exposure (16,17) remain the pri- cess site was the left radial artery. LMWH ⴝ
mary concern of transradial access. Although radiation expo- Unfractionated heparin of 2,500 low-molecular-weight-heparin
sure mainly depends on operator training and experience with IU was administered for a diag- OR ⴝ odds ratio
transradial coronary angiography (18), a number of factors nostic angiography, and in total PAOD ⴝ peripheral arterial
might affect RAO rate. In the published data, RAO rates are 100 IU/kg body weight was occlusive disease
surprisingly different, ranging from 5% to 38% (19 –22). The given for PCI. An intra-arterial PCI ⴝ percutaneous
large variance might be related to the fact that radial artery bolus of 0.2 mg nitroglycerin coronary intervention
patency after catheterization was assessed by clinical forearm was routinely given to prevent RAO ⴝ radial artery
inspection and pulse palpation rather than vascular ultrasound arterial spasm. Verapamil was occlusion

in the vast majority of studies (23). To quantify the true rate only administered in the occur-
and to elucidate risk factors for access site complications, we rence of spasm of the radial artery. After completion of the
conducted the present prospective registry with high- cardiac catheterization procedure, sheaths were removed
resolution vascular ultrasound after transradial diagnostic immediately and a compression device (RadiStop, St. Jude
angiography and PCI with 5-F and 6-F vascular sheaths. Medical Inc., or Terumo TR BAND, Terumo) was applied
according to the instructions of the manufacturer to achieve
Methods hemostasis. The TR BAND was applied with occlusive
compression, slow removal of air until bleeding occurred,
Patient cohort. Between November 2009 and August 2010, and then re-insufflation of 1 to 2 ml of air. RadiStop
455 consecutive patients undergoing transradial cardiac compression devices were applied with palpation of the
catheterization at our high-volume tertiary care center were pulse of the radial artery distal to the compression site, and
enrolled in this prospective registry. Informed consent for in case of an absent pulse, the device was loosened until the
transradial coronary catheterization, including the follow-up pulse was palpable again or bleeding occurred.
Doppler examination, was obtained in all patients. Vascular ultrasound. Color Doppler ultrasound studies were
Vascular risk factors (hypertension, hyperlipoproteinemia, performed by experienced sonographers in all 455 patients
diabetes, and smoking) were assessed with standard defini- within 1.0 ⫾ 1.3 days after the procedure to examine the
tions. The presence of coronary artery disease (CAD), radial, ulnar, and brachial arteries of the access forearm with
peripheral arterial occlusive disease (PAOD), and cerebro- a Vivid 7 ultrasonography system (General Electric Medical
vascular disease was recorded in all patients. An Allen test Systems, Andover, Massachusetts) featuring a 9- to 12-
was not routinely performed, because there is no clear MHz multifrequency vascular probe.
38 Uhlemann et al. JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 1, 2012

Impact of Sheath Size on Vascular Complications JANUARY 2012:36 – 43

Endpoints and definitions. The primary objective of the

study was the incidence of post-procedural RAO as con-
firmed by absence of antegrade flow in vascular high-
resolution ultrasound. Secondary objectives were other local
access site complications (bleeding events, pseudoaneurysm,
and arteriovenous fistula), respectively. Bleeding events were
defined according to the Global Use of Strategies to Open
Occluded Arteries bleeding definitions (mild, moderate,
and severe bleeding events) (14).
Follow-up. Symptomatic patients with RAO were treated
with low-molecular-weight heparin (LMWH) in body
weight-adjusted dose for 7 to 14 days. Asymptomatic
patients did not receive a specific therapy. In patients with
Figure 1. Study Flow Chart
RAO, a follow-up was conducted after 7 to 14 days after the
A total of 455 patients were enrolled in the registry, of whom 389 patients
transradial catheterization (clinical examination and vascular
underwent diagnostic coronary catheterization with 5-F and 6-F sheaths. A
ultrasound examination). percutaneous coronary intervention was performed in 66 patients.
Statistical analysis. All data were prospectively collected and
entered into the registry. Dichotomous variables are re-
ported as numbers and proportions. Continuous parameters nary angiography, and in 66 patients (14.5%) a PCI was
are presented as mean ⫾ SD. The 2 groups (5-F vs. 6-F) performed. The rate of PCI differed significantly between
were compared by t tests for continuous variables. Nonpara- the 2 groups (1.2% with 5-F sheaths vs. 21.2% with 6-F
metric variables were compared by Fisher exact tests, and sheaths). The amount of contrast media was significantly
ordered proportions were compared by Armitage’s test for higher in the 6-F group (55 ml vs. 87 ml, p ⬍ 0.001), and
trend. Potential risk factors for post-procedural RAO were left ventriculographies were performed significantly more
investigated first by univariate logistic regression. A multi- often in the 6-F group (38 vs. 114, p ⫽ 0.006). There was,
variate logistic regression model with all significant variables however, no significant difference in fluoroscopic time between
was established to estimate odds ratios (ORs) inclusive 95% the 2 groups.
confidence bounds. All tests were performed as 2-sided at Vascular complication rates. Vascular access site complica-
significance level ␣ ⫽ 5%. tions are displayed in Tables 3 and 4.
Two separate analyses were performed to confirm that The primary objective (RAO) occurred in 92 patients of the
baseline group differences (e.g., frequency of PCI) do not 6-F group and in 21 patients of the 5-F group (30.5% vs.
confound our findings: first, we matched 2 ⫻ 153 patients 13.7%, p ⬍ 0.001). In 22 patients (19.5%) with ultrasono-
by 1:1 propensity matching before analysis. Propensity graphic signs of RAO, the radial artery pulse was still palpable.
scores were calculated by logistic regression model with The secondary objective of the overall incidence of local
variables like age and body mass index significantly associ- access site complications was 33.1% (n⫽ 100) in the 6-F
ated with 5-F and 6-F sheaths. group versus 14.4% (n ⫽ 22) in the 5-F group (p ⬍ 0.001).
Statistical analyses were performed with SPSS (version Three patients developed a pseudoaneurysm in the 6-F
19.0, SPSS. Inc., Chicago, Illinois). group (1.0%), whereas none was observed in the 5-F group
(p ⫽ NS). Two of these patients were treated successfully with
Results ultrasound-guided compression; however, 1 patient required a
surgical repair. Arteriovenous fistulas were detected in 3 pa-
Patient characteristics. A total of 455 consecutive patients tients (1.0%) of the 6-F group and in 1 patient (0.7%) of the
with a clinical indication for coronary catheterization who 5-F group (p ⫽ NS) with no need for further specific therapy.
successfully underwent the transradial coronary procedure There were no moderate or severe access site bleedings
were included in the registry (Fig. 1). according to Global Use of Strategies to Open Occluded
In 302 patients (66.4%), a 6-F arterial sheath was used, Arteries definitions requiring blood transfusions or surgical
whereas in 153 patients (33.6%), the procedure was per- repair. Hematomas with a maximal size of 5 cm at the right
formed with a 5-F arterial sheath. Baseline patient charac- forearm were noted in 6 patients (2.0%) of the 6-F group
teristics are displayed in Table 1. Both groups did not differ and in none of the 5-F group.
with regard to age, sex, cardiovascular risk factors, and oral Predictors of RAO. The univariate analysis of predictors of
medication. Patients with CAD, especially triple vessel post-procedural RAO is presented in Table 5. With 6-F
disease, are over-represented in the 6-F sheaths group. sheaths, the presence of PAOD, younger age, and female
Procedural data. Procedural data are illustrated in Table 2. sex were strong predictors of post-procedural RAO. There
In total, 389 patients (85.5%) underwent diagnostic coro- was a strong trend toward a higher occurrence of RAO in
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 1, 2012 Uhlemann et al. 39
JANUARY 2012:36 – 43 Impact of Sheath Size on Vascular Complications

Table 1. Baseline Patient Characteristics Table 3. Vascular Access Site Complications

5-F Sheath 6-F Sheath 5-F Sheath 6-F Sheath

(n ⴝ 153) (n ⴝ 302) p Value (n ⴝ 152) (n ⴝ 303) p Value

Age (yrs) 65.1 ⫾ 10.8 64.9 ⫾ 11.0 0.27 Total number of access site complications 22 (14.5%) 104 (34.3%) ⬍0.001
Male 97 (63.4%) 186 (61.6%) 0.76 Radial artery occlusion 21 (13.7%) 92 (30.5%) ⬍0.001
Body mass index (kg/m2) 30.8 ⫾ 5.8 29.2 ⫾ 5.8 0.005 Pseudoaneurysm 0 (0%) 3 (1.0%) 0.56
Hypertension 145 (95.4%) 290 (96.0%) 0.81 Arteriovenous fistula 1 (0.7%) 3 (1.0%) 1.00
Diabetes mellitus 53 (34.9%) 101 (33.4%) 0.83 Moderate/severe bleeding 0 (0%) 0 (0%) —
Dyslipidemia 100 (65.8%) 214 (70.9%) 0.28 Mild bleeding 0 (0%) 6 (2.0%) 0.19
Current smoking 22 (14.5%) 52 (17.2%) 0.50 Values are n (%).
History of smoking 31 (20.4%) 78 (25.8%) 0.24
Coronary artery disease 61 (39.9%) 177 (58.6%) ⬍0.001
1-vessel disease 30 (19.6%) 76 (25.2%)
Subgroup analyses were performed, including 389 pa-
2-vessel disease 21 (13.7%) 50 (16.6%) tients who underwent diagnostic angiography only (151
3-vessel disease 10 (6.5%) 51 (16.9%) 0.03 patients with 5-F, 238 patients with 6-F). The univariate
Acute coronary syndrome 6 (3.9%) 26 (8.6%) 0.08 analysis of predictors of RAO in patients undergoing
Cerebrovascular disease 14 (9.2%) 26 (8.6%) 0.86 diagnostic catheterization only is presented in Table 6.
Peripheral arterial occlusive disease 10 (6.6%) 35 (11.6%) 0.10 With 6-F sheaths, the presence of PAOD, younger age, and
Aspirin 93 (60.8%) 183 (60.6%) 1.00 female sex were again strong predictors of post-procedural
Statins 81 (52.9%) 167 (55.7%) 0.62 RAO. Cerebrovascular disease was not associated with
Beta-blockers 99 (64.7%) 213 (71.0%) 0.20 a higher occurrence of RAO in patients with diagnostic
ACE inhibitors 88 (57.5%) 169 (56.3%) 0.84 catheterization only (Tables 4 and 6).
Angiotensin II receptor blockers 37 (24.2%) 83 (27.7%) 0.50 In multivariate regression analysis all of our results
Calcium-channel blocker 40 (26.1%) 70 (23.3%) 0.56 remained unchanged in patients who underwent diagnostic
LV ejection fraction (%) 57 ⫾ 10 56 ⫾ 11 0.58 catheterization only (Table 7).
Serum creatinine (mg/dl) 1.0 ⫾ 0.3 1.0 ⫾ 0.6 0.28 PCI did not increase vascular access site complications in
Platelets (⫻103/␮l) 221 ⫾ 64 230 ⫾ 78 0.20
the present registry.
13.8 ⫾ 1.4 13.7 ⫾ 1.7
Hemoglobin (mg/dl) 0.46
In propensity score analysis of 2 ⫻ 153 patients (5-F and
Values are mean ⫾ SD or n (%). 6-F), again, all main results remained unchanged. Only the
ACE ⫽ angiotensin-converting enzyme; LV ⫽ left ventricular.
presence of PAOD did not show a significant association
with the occurrence of RAO in these 306 patients.
patients with known cerebrovascular disease in univariate Body mass index was not associated with a higher
analysis. occurrence of RAO (p ⫽ 0.335).
In multivariate regression analysis, the use of 6-F Clinical course of patients with RAO. Of all patients with
sheaths (OR: 2.68, 95% confidence interval [CI]: 1.56 to RAO, 42.5% (n ⫽ 48) were symptomatic within 24 h after
4.59, p ⬍ 0.001), female sex (OR: 2.36, 95% CI: 1.50 to the transradial coronary procedure. Another 8 patients
3.73, p ⬍ 0.001), age (OR: per-year 0.96, 95% CI: 0.94 (7.1%) became symptomatic within a mean of 4.1 ⫾ 2.1
to 0.98, p ⫽ 0.001), and the presence of PAOD (OR: days (2 to 8 days) after the coronary catheterization, when
2.04, 95% CI: 1.02 to 4.22, p ⫽ 0.04) were significantly resuming physical activity at home. The most frequent
symptoms were a painful forearm and thenar. Other symp-
associated with post-procedural RAO in all patients.
toms were a loss of handgrip force and paresthesia. How-
Independent predictors for post-procedural RAO are
displayed in Figure 2.
Table 4. Vascular Access Site Complications in Patients With
Diagnostic Catheterization Only (N ⴝ 389)
Table 2. Procedural Data
5-F Sheath 6-F Sheath
(n ⴝ 151) (n ⴝ 238) p Value
5-F Sheath 6-F Sheath
(n ⴝ 153) (n ⴝ 302) p Value
Total number of access site complications 22 (14.6%) 82 (34.5%) ⬍0.001
Percutaneous coronary intervention 2 (1.2%) 64 (21.2%) ⬍0.001 Radial artery occlusion 21 (13.9%) 76 (31.9%) ⬍0.001
Fluoroscopy duration (min) 3.6 ⫾ 3.3 4.1 ⫾ 4.1 0.19 Pseudoaneurysm 0 (0%) 2 (0.8%) 0.524
Amount of contrast media (ml) 55 ⫾ 26 87 ⫾ 56 ⬍0.001 Arteriovenous fistula 1 (0.7%) 3 (1.3%) 1.000
Left ventriculography 38 (24.8%) 114 (37.7%) 0.006 Moderate/severe bleeding 0 (0%) 0 (0%) —
Right radial artery 151 (98.7%) 291 (96.4%) 0.24 Mild bleeding 0 (0%) 5 (2.1%) 0.161

Values are mean ⫾ SD or n (%). Values are n (%).

40 Uhlemann et al. JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 1, 2012

Impact of Sheath Size on Vascular Complications JANUARY 2012:36 – 43

Table 5. Univariate Association of Different Risk Factors With Table 6. Univariate Association of Different Risk Factors With
Radial Artery Occlusion Radial Artery Occlusion in Patients With Diagnostic Catheterization Only
(N ⴝ 389)
95% CI for Odds Ratio
p Value Odds Ratio Lower Upper 95% CI for Odds Ratio
p Value Odds Ratio Lower Upper
Female 0.001 2.110 1.370 3.247
Age* 0.005 0.973 0.954 0.992 Female ⬍0.001 2.348 1.471 3.748

6-F sheath ⬍0.001 2.754 1.635 4.639 Age* 0.005 0.970 0.949 0.990

Peripheral arterial disease 0.037 1.986 1.042 3.783 6-F sheath ⬍0.001 2.904 1.700 4.961

Cerebrovascular disease 0.056 1.941 0.984 3.827 Peripheral arterial disease 0.018 2.424 1.165 5.043
Cerebrovascular disease 0.247 1.570 0.732 3.368
*Age increase of 1 year is associated with a little lower risk. However, this results in an odds ratio of
1.67 for a 10-years-younger patient. *Age increase of 1 year is associated with only a small relative decrease in risk of RAO. However,
CI ⫽ confidence interval. this difference results in an odds ratio of 1.67 for a 10-years-younger patient.
CI ⫽ confidence interval.

ever, critical limb ischemia did not occur in any patient. Of

the 113 patients with RAO, 22 patients were lost to follow Discussion
up. In 91 patients the first follow-up ultrasound examina-
tion was performed after a mean time interval of 9.3 ⫾ 5 The present large prospective registry demonstrates that
days (range 2 to 37 days). Fifty-four symptomatic patients clinical assessment alone might miss clinically relevant RAO
were treated with LMWH in body weight-adjusted dose and might therefore underestimate the true risk of RAO. In
(n ⫽ 17) or in half-therapeutic dose in case of additional addition, the present registry is, to the best of our knowl-
dual antiplatelet therapy (n ⫽ 37) over a mean time period of 6 ⫾ edge, the first to compare radial access site complications
7 days. Asymptomatic patients (n ⫽ 37) were not treated between 5-F and 6-F sheaths. It confirms that 5-F sheaths
with LMWH. At time of first follow-up, the recanalization reduce the rate of RAO by as much as 55%—a finding with
rate of the radial artery was 31.5% (17 of 54) after treatment significant implications for the routine use of transradial
with LMWH, compared with 5.4% (2 of 37) in patients coronary catheterization.
without an anticoagulatory therapy (p ⫽ 0.003). Routine radial artery ultrasound and the true rate of RAO. The
In patients with persistent RAO at first follow-up, a second rate of vascular access site complications after transradial
follow-up ultrasound study was conducted after a mean time coronary catheterization as monitored by vascular high-
interval of 14 days after catheterization. At this time, the final resolution ultrasound examination was significantly higher
recanalization rate was 55.6% (30 of 54) in patients after in the present registry than expected from previous studies
treatment with LMWH compared with 13.5% (5 of 37) in (27–30). This finding implies that routine clinical radial
patients without anticoagulation (p ⬍ 0.001). pulse checks might be inaccurate and insensitive in detect-

Figure 2. Odds Ratios for Potential Risk Factors for RAO in a Multivariate Model

In a multivariate model, the use of 6-F sheaths, female sex, younger age, and the presence of peripheral arterial occlusive disease were significantly associated
with the occurrence of post-procedural radial artery occlusion (RAO).
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 1, 2012 Uhlemann et al. 41
JANUARY 2012:36 – 43 Impact of Sheath Size on Vascular Complications

Table 7. Odds Ratios for Potential Risk Factors for

ever, the number of interventional patients in the current
Radial Artery Occlusion in a Multivariate Model in Patients With registry might be too limited to draw definitive conclusions,
Diagnostic Catheterization Only and this will require larger sample sizes.
95% CI for Odds Ratio Younger patients and women are at a higher risk for
p Value Odds Ratio Lower Upper RAO. These findings might be related to the smaller
6-F sheath ⬍0.001 2.742 1.574 4.776 average radial artery diameter in women and the complex
Age (10 yrs) 0.001 0.663 0.523 0.842 sympathetic autonomic innervations of the radial artery,
Female ⬍0.001 2.591 1.575 4.264 which might increase the risk of vascular spasms. The exact
Peripheral arterial disease 0.010 2.936 1.300 6.632 mechanisms of post-procedural RAO remain unknown.
Cerebrovascular disease 0.336 1.524 0.646 3.598 Deftereos et al. (35) reported a significant univariate asso-
CI ⫽ confidence interval. ciation between flow-mediated dilation of the radial artery
and the occurrence of vascular spasm. In their study, female
sex tended to be more prone to radial artery spasm.
ing all RAO. As demonstrated by Bertrand et al. (31), the Moreover, our study demonstrates that patients with
incidence of RAO before hospital discharge is not assessed
known PAOD are at significantly higher risk of RAO. One
in more than 50% of coronary procedures.
potential explanation is the relationship between atheroscle-
Interestingly, in the present study 22 patients showed
rosis and structural vascular changes (luminal narrowing,
RAO in ultrasound while the radial pulse was still palpable.
intimal hyperplasia) (36).
This finding might be explained by the collateral circulation
Procedure-related risk factors. The relatively high rate of
from the palmar arches (19,32). In the study by Kerawala
RAO in the current study needs to be interpreted in the
et al. (32), the comparative blood pressure from the
context of the unselected patients from routine coronary
opposite artery ranged from 58 to 85 mm Hg (mean 70.4
procedures. In contrast to a recently published study (37)
mm Hg). This again underlines the necessity of perform-
reporting an incidence of RAO after transradial cardiac
ing vascular ultrasound examinations in each patient
catheterization of only 10.5%, our registry represents a real
before discharge even if clinical assessment does not show
world scenario with a pool of interventionalists having
abnormalities.
In addition, the unreliability of clinical pulse control different degrees of experience with the transradial ap-
might partly explain the large variation in the observed proach. The study by Zankl et al. (37) differs with regard to
incidence of RAO reported in the published data (20). the sheath sizes used (4-F, 5-F, 6-F) and the exclusive
Effect of sheath size on the RAO rate. In the present selection of senior interventionalists (⬎10,000 interven-
prospective registry the use of 6-F sheaths was indepen- tions). Furthermore, the study was not designed to primarily
dently associated with an increased rate of post-procedural investigate the potential relation between sheath size and
RAO. As reported by Bertrand et al. (31), 5-F sheaths RAO.
remain less frequently used, whereas 6-F is the standard The optimal anticoagulatory therapy is regarded to play
sheath size in general practice. Although it might be an important role for prevention of RAO, but data are still
obvious that larger sheath diameters lead to increased lacking about the optimal heparin dose. The influence of
vascular trauma, the exact pathomechanism explaining this unfractionated heparin or LMWH on the incidence of
finding remains incompletely understood. There is an in- RAO remains unclear with aspirin and clopidogrel pre-
fluence of the inner diameter of the radial artery and the treatment. A randomized study comparing a low dose
outer diameter of the sheath on the rate of RAO (33). (2,000 IU) versus a standard dose of unfractionated heparin
Because we did not measure pre-procedural radial artery (5,000 IU) in transradial diagnostic angiography did not
diameter, we are unable to comment on the role of artery show a difference in the rate of RAO between the 2 groups.
diameter-to-sheath diameter mismatch as a reason of RAO. Low-dose unfractionated heparin was reported to be safe
Acute injuries of the radial artery after transradial coronary and not inferior to standard dose (38). A study by Spaulding
intervention might also be assessed by optical coherence et al. (39) showed a rate of RAO of 24% in patients who
tomography (34). The stretching effect of the sheath and the received 2,000 to 3,000 IU of unfractionated heparin com-
passage of the sheath as well as spasms of the radial artery pared with 4.3% in patients who received 5,000 IU. As
might cause intimal flaps. Consequently, the mechanisms of reported by Bertrand et al. (31), most interventional cardi-
RAO in relation to sheath size should be further studied in ologists use unfractionated heparin in a dose between 2,000
imaging studies with optical coherence tomography (arterial and 5,000 IU, whereas approximately 5% do not use heparin
dissection vs. thrombotic occlusion). for diagnostic coronary angiography. In the present study,
Other patient-related risk factors for RAO. Transradial PCI all patients with diagnostic angiography received 2,500 IU
did not increase the incidence of vascular access site com- of unfractionated heparin and in total 100 IU/kg body
plications compared with diagnostic angiographies. How- weight when PCI was performed, resulting in a rate of
42 Uhlemann et al. JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 1, 2012

Impact of Sheath Size on Vascular Complications JANUARY 2012:36 – 43

RAO of 13.7% with 5-F sheaths compared with 30.5% with trasound of the access site before discharge might be a
6-F sheaths. valuable, objective, and noninvasive tool.
Another important factor is the concept of achieving
radial artery hemostasis. The patent hemostasis has been Reprint requests and correspondence: Dr. Stephan Gielen,
found to be highly effective in reducing RAO without Department of Internal Medicine/Cardiology, University of
compromising hemostatic efficacy (19). The optimal com- Leipzig, Heart Centre, Strümpellstrasse 39, 04289 Leipzig, Ger-
pression management is to aim just enough pressure to many. E-mail: stephan.gielen@medizin.uni-leipzig.de or sgielen@
aol.com.
avoid bleeding while maintaining antegrade flow of the
radial artery (40).
Clinical relevance of RAO. RAO might not be as harmless as
previously thought (41). In the present registry 42.5% of REFERENCES
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