Impact of Sheath Size on Radial Access Site
Complications:
The Leipzig Prospective Vascular Ultrasound Registry
in Radial Artery Catheterization.
Results of 574 consecutive Patients
M.Uhlemann, S.Gielen, S. Möbius-Winkler, A.Linke, S. Erbs, G.C. Schuler
Department of Internal Medicine/Cardiology
University of Leipzig, Heart Center
Disclosure Statement of Financial Interest
We DO NOT have a financial interest/arrangement or affiliation with one or
more organizations that could be perceived as a real or apparent conflict of
interest in the context of the subject of this presentation.
Reduced Major Bleeding Rates in Radial vs. Femoral Access
Metaanalysis of 23 Randomized Trials
Jolly SS et al., Am Heart J 2009;157:132-40
Radial versus Femoral Access in Acute Coronary Syndroms (RIVAL Trial)
• Incidence of the
primary outcome
was 3.7% in the radial
and 4.0% in the femoral
group
• Benefit for radial access
in STEMI patients
(p=0.03)
• Reduction of local
bleeding complications
(p<0.001)
Sanjit S Jolly et al., Lancet 2011; 377:1409-20
Aim of Study
1.
To quantify the objective rate of vascular access site
complications
(bleeding, radial artery occlusion, pseudoaneurysm, av-fistula)
by using routine postinterventional Doppler ultrasound
2.
To assess the impact of sheath size on access site complication
(5 French and 6 French)
Methods and Material
• Prospective registry between 11/2009-01/2011 using standard protocol:
5 F- and 6 F arterial sheaths with hydrophilic coating
2500 IU unfractionated heparin for diagnostic angiography,
100 IU/kg bodyweight i.v. for PCI
0.2 mg Nitroglycerin i.a. routinely,
2.5 mg Verapamil only in occurrence of vascular spasm
Application of a compression device (RadiStop/Terumo) for 3 hours
according to the manufacturer`s instruction
High resolution vascular ultrasound of the radial, ulnar and
brachial artery (9-14 MHz probe)
Patient Population (574 consecutive patients)
Age (y)
5 F Sheath
6 F Sheath
n=259
n=315
64.9±10.9
0.41
167 (64.5%)
196 (62.2%)
0.60
Body mass index (kg/m²)
30.3±6.0
29.3±5.8
0.05
Coronary artery disease
107 (41.3%)
186 (59.0%)
Single-vessel disease
54 (20.8%)
79 (25.1%)
Two-vessel disease
30 (11.6%)
54 (17.1%)
Three-vessel disease
24 (9.3%)
53 (16.8%)
Acute coronary syndrome
8 (3.1%)
28 (8.9%)
0.03
Cerebrovascular disease
32 (12.4%)
27 (8.6%)
0.17
Peripheral arterial occlusive
22 (8.5%)
37 (11.7%)
0.22
Male gender
disease
65.7±10.5
P-value
<0.001
Incidence of Post-procedural Access Site Complications
*
Number of Patients
120
32.4 %
Composite endpoint of
access site complications:
80
40
• radial artery occlusion
• pseudoaneurysm
• av-fistula
• moderate/severe
bleeding (GUSTO)
19.3 %
50
102
5 French
6 French
0
Sheath size
*P<0.001
Incidence of Radial Artery Occlusion (RAO)
*
Number of patients
120
29.8%
80
40
18.5%
48
94
5F sheath
6F sheath
0
Sheath size
*P<0.001
Incidence of Bleeding, Pseudoaneurysm and AV-Fistulas
5 F Sheath
n=259
6 F Sheath
n= 315
P-value
Pseudoaneurysm
1 (0.4%)
3 (1.0%)
N.S.
Arterio-venous fistula
1 (0.4%)
3 (1.0%)
N.S.
Severe bleeding
0
0
N.S.
Frequency of Acute Symptoms in Patients with RAO
Number of patients
120
59.2%
80
40
40.8%
58
84
0
symptoms
no symptoms
Most frequent symptom:
painful forarm and thenar
(loss of handgrip force,
paraesthesia)
No critical limb ischemia
Additionally 8 patients (5.6 %) became symptomatic within
a mean of 4 days after the procedure when resuming physical activity
at home
Predictors of RAO in Univariate Analysis
PValue
Odds
Ratio
95% C.I
for
Odds
Ratio
Lower
Upper
Female gender
<0.001
2.008
1.364
2.950
Age*
<0.001
0.966
0.949
0.984
0.002
1.870
1.259
2.777
0.009
2.126
1.212
3.729
0.020
1.957
1.111
3.446
6 F sheath
Peripheral
disease
occlusive
Cerebrovascular
disease
* Age increase of 1y is associated with a little lower risk.
However, this results in an odds ratio of 1.67 for a 10y younger patient, for instance!
Risk Factors for RAO in a Multivariate Model
lower
higher
risk of RAO
Study Limitations
• No randomized study design
• Single center experience
• Limited number of patients
• Real world clinical setting (unselected patients and experienced
yet unselected interventional cardiologists)
Summary
• Even though radial access for catheterization did not show severe
bleeding complications, the rate of radial artery occlusions detected
by vascular ultrasound examination was higher than expected and
previously reported.
• Use of 5F-sheaths significantly decreased the rate of radial artery
occlusions compared to 6 F-sheaths.
• Younger age, female gender and peripheral occlusive disease are
strong predictors for radial artery occlusion.
• The true rate of symptomatic RAO may be underestimated at
discharge by clinical assessment alone (pulse palpation).
Conclusion
To optimize the
post-procedural management of patients
with transradial coronary procedures,
vascular ultrasound of the access
site before discharge may be a
valuable, objective and
non-invasive tool to detect even clinically
inapparent access site complications.
Thank you for your kind attention
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Correspondence
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