The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters

A Kadner

Anna-Maria Belli

B Kapoor

C Kirchhof

Eli Atar

HJ Steeg van der

Jan Borggrefe

Jens Trentmann

JF Eidt

Jim A. Reekers

K Mukhopadhyay

Kamil Zeleňák

Martin Libicher

Pierre Goffette

Pieter Hooijboer

R Katzenschlager

S Looby

SS Upponi

Stefan Müller-Hülsbeck

English

PubMed

Crossref

CardioVascular and Interventional Radiology

CIRSE Vascular Closure Device Registry

Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only  5.9 cm, and two vessel occlusions. The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameter

Reekers, J.A.

Müller-Hülsbeck, S.

Libicher, M.

Atar, E.

Trentmann, J.

Goffette, P.

Borggrefe, J.

Zeleňák, K.

Hooijboer, P.

Belli, A.M.

NARCIS 

Reekers, Jim A

Müller-Hülsbeck, Stefan

Libicher, Martin

Atar, Eli

Trentmann, Jens

Goffette, Pierre

Borggrefe, Jan

Zeleňák, Kamil

Hooijboer, Pieter

Belli, Anna-Maria

DIAL UCLouvain

CIRSE vascular closure device registry.

Springer - Publisher Connector

CLINICAL INVESTIGATION
CIRSE Vascular Closure Device Registry
Jim A. Reekers • Stefan Mu¨ller-Hu¨lsbeck • Martin Libicher •
Eli Atar • Jens Trentmann • Pierre Goffette • Jan Borggrefe •
Kamil Zelenˇa´k • Pieter Hooijboer • Anna-Maria Belli
Received: 1 February 2010 / Accepted: 12 March 2010 / Published online: 28 October 2010
 The Author(s) 2010. This article is published with open access at Springerlink.com
Abstract
Purpose Vascular closure devices are routinely used after
many vascular interventional radiology procedures. How-
ever, there have been no major multicenter studies to assess
the safety and effectiveness of the routine use of closure
devices in interventional radiology.
Methods The CIRSE registry of closure devices with an
anchor and a plug started in January 2009 and ended in
August 2009. A total of 1,107 patients were included in the
registry.
Results Deployment success was 97.2%. Deployment
failure specified to access type was 8.8% [95% confidence
interval (95% CI) 5.0–14.5] for antegrade access and 1.8%
(95% CI 1.1–2.9) for retrograde access (P = 0.001). There
was no difference in deployment failure related to local
PVD at the access site. Calcification was a reason for
deployment failure in only \0.5% of patients. Postde-
ployment bleeding occurred in 6.4%, and most these
(51.5%) could be managed with light manual compression.
During follow-up, other device-related complications were
reported in 1.3%: seven false aneurysms, three hematoma
[5.9 cm, and two vessel occlusions.
Conclusion The conclusion of this registry of closure
devices with an anchor and a plug is that the use of this
device in interventional radiology procedures is safe, with a
low incidence of serious access site complications. There
seems to be no difference in complications between ante-
grade and retrograde access and other parameters.
Keywords Interventional radiology  Closure device 
Puncture site
Introduction
Currently, vascular closure devices are routinely used after
many vascular interventional radiology procedures. In
cardiology, many large studies on safety and effectiveness
have been published, where reduction in procedure time
and early ambulation and discharge were the main end-
points. However, there have been no major multicenter
J. A. Reekers (&)
Department of Radiology, Academic Medical Center,
Meibergdreef 9, NH 1105 AZ Amsterdam, The Netherlands
e-mail: j.a.reekers@amc.uva.nl
S. Mu¨ller-Hu¨lsbeck
Department of Radiology, Academic Hospitals, Flensburg,
Germany
M. Libicher
Department of Radiology, University Clinics, Colonge, Germany
E. Atar
Department of Radiology, Hasharon Hospital, Petah Tikva,
Israel
J. Trentmann  J. Borggrefe
Department of Radiology, University Clinics
Schleswig-Holstein, Kiel, Germany
P. Goffette
Department of Radiology, University Clinics St. Luc, Brussels,
Belgium
K. Zelenˇa´k
Department of Radiology, University Hospital, Martin, Slovakia
P. Hooijboer
Department of Radiology, Scheper Ziekenhuis, Emmen,
Netherlands
A.-M. Belli
Department of Radiology, St. Georges Hospital, London, UK
123
Cardiovasc Intervent Radiol (2011) 34:50–53
DOI 10.1007/s00270-010-0004-y
studies to assess the safety and effectiveness of the routine
use of closure devices in interventional radiology. Only
single-center data have been published [1–4]. This lack of
data, combined with the popularity of closure device
complications at morbidity and mortality conferences and
in case reports, might give a biased impression about
closure devices [5, 6]. If their safety is to be accurately
assessed, it is necessary to ascertain the number of all
closure devices used in a given institute in relation to the
rate of complications. To obtain these data, CIRSE con-
ducted a registry to investigate the safety of closure devi-
ces. Although the initial registry was intended to be open to
all CE-marked closure devices, only closure devices with
an anchor and plug were finally included.
Registry Design
The registry was advertised through CIRSE e-mail and on
the CIRSE Web site. It was open to all centers with more
than 50 closure devices experience. The registry was
conducted online and was hosted on an external server. The
design of the registry, data management, and final reporting
were performed by CIRSE. Device companies were not
involved in this process. The registry was designed to
collect data from up to 100 sites by members of CIRSE and
intended to recruit 1,000 patients. Collected data included
deployment success, time to hemostasis, time to mobili-
zation, and time to discharge. A record of all in-hospital
access site complications was also made. Patients returning
with late closure device problems could also be included in
this registry.
Material and Methods
The registry started in January 2009 and ended in August
2009. Twenty-eight centers from 10 European countries
participated in the registry. Only acute procedure-related
data were entered, and no direct patient identifiable infor-
mation was obtained; there were no privacy issues. The
medical ethical commission in one larger center looked at
the protocol and concluded that no informed consent was
needed. Only devices with an anchor and extravascular
plug (Angio-Seal, St. Jude Medical) were included in the
registry. A minimum experience of 50 closure devices was
required to enter patients onto the registry. The contributors
to the registry were asked to include consecutive patients.
No in-or exclusion criteria on the indication for closure
device use were given. Complications were registered
before discharge and in follow-up; only complications
in patients who returned spontaneously with a puncture
site–related problem were registered. These were not
linked to the original procedure for privacy reasons.
All v2 tests we performed for statistical analysis used
were standard tests.
Results
A total of 1,107 patients were included in the registry. The
number of included patients per country varied between
438 and 16. Lowest inclusion per center was 1 and highest
inclusion per center was 172. Of the included patients, 676
were male. Mean age distribution was between 55 and
75 years, with no difference between male and female
patients. A total of 80.4% of all patients were on some form
of antithrombotic medication. A total of 44.3% were
receiving aspirin, 57.7% unfractionated heparin, and 10.7%
clopidogrel. A total of 84.7% of all procedures were per-
formed with retrograde arterial access and 15.3% with
antegrade access. A total of 34.4% [95% confidence
interval (95% CI) 27.2–42.2] of all patients with antegrade
access had diabetes. For retrograde punctures, this was
22.5% (95% CI 19.8–25.4). This difference was highly
significant, with a P-value of 0.002. There was no differ-
ence in type of access between male and female patients.
The percentage of obese patients (body mass index of[25)
was equal in antegrade and retrograde access, with 23.9
and 25.1%, respectively.
Deployment success was 97.2%. Failures were due to
calcifications (n = 5), device problems (n = 7), and other
unspecified (n = 16). Deployment failure specified to
access type was 8.8% (95% CI 5.0–14.5) for antegrade
access and 1.8% (95% CI 1.1–2.9) for retrograde access
(P = 0.001). There was no difference in deployment fail-
ure related to sheath size or French size of the closure
device (6F or 8F). Nor was deployment success related to
local PVD at the access site. Calcification was a reason for
deployment failure in only \0.5% of patients.
Postdeployment bleeding occurred in 6.4%, and most of
these (51.5%) could be managed with light manual com-
pression. Pressure dressing was only applied in 22.1%. In
71.6% of the pressure dressing population, the pressure was
applied for \1 h.
There were 26 reported complications, of which 13
(1.2%) were reported as serious: two false aneurysms, six
hematoma [5.9 cm, 1 significant bleeding, two vessel
occlusion, and two vessel dissections. Access site compli-
cations were generally equal for antegrade and retrograde
access, at 4% (95% CI 1.6–8.8) and 2.3% (95% CI
1.4–3.6), respectively. This difference was not significant
(P = 0.342).
J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 51
123
Time to ambulation was more than 1 h in 94.8% of
patients. A total of 43.7% of all patients were discharged
between 9 and 24 h after the procedure, and 52.3% were
discharged after more than 24 h. The closure device only
shortened the anticipated discharge time in 12.2% of
patients. Discharge was delayed after closure device in
0.9%.
During follow-up, other device-related complications
were reported in 1.3% (n = 15): seven false aneurysms,
three hematoma [5.9 cm, two vessel occlusions, one par-
tial occlusion of the vessel, and two severe pain at the
access site.
We have looked at the data concerning complications
and could not find a difference between high and low
inclusion centers. However, the number of complications is
too small to draw any scientific conclusions.
Discussion
The current negative view of the use of closure devices in
peripheral vascular disease has been heavily influenced by
the anecdotal reporting of complications. These compli-
cations should be viewed in the context of the overall usage
of these devices in interventional practice to get a true
incidence of these complications. To get a better under-
standing of the safety and the possible advantages of rou-
tine use of these devices after an interventional radiology
procedure, CIRSE embarked on an independent closure
device registry, which included more than 1,100 patients
over a period of 7 months, demonstrating that these devices
are widely used in interventional radiology. Most devices
(84.7%) are still used after retrograde access, probably
including many over the bifurcation procedures. Almost all
patients in this registry ([80%) were receiving some form
of antithrombotic therapy, which implies that the devices
were used after some form of vascular intervention.
Antegrade access is more commonly used in patients with
diabetes, where below-the-knee pathology can be more
easily reached than through an over-the-bifurcation
procedure.
Deployment success was [97%. There is a significant
difference in deployment success, with more failures in the
antegrade access group: 8.8% in the antegrade and 1.8% in
the retrograde group. Other parameters such as obesity,
sheath size, and local calcifications did not seem to be
predictors for deployment failure. The latter is in contra-
diction to the instructions for use by the manufacturer of
the device. Access site complications were equal in both
antegrade and retrograde access. Minor postdeployment
bleeding was seen in 6.4% and was easily handled. This
was probably due to the mismatch between anchor and
plug, which can be seen after a puncture has been too steep.
There were 1.2% serious complications before dis-
charge, with no difference between antegrade or retrograde
access. There is one small prospective randomized trial that
compares manual compression and Angio-Seal in day-care
patients with peripheral interventional procedures [7]. In
this study, no significant differences in complications were
found between manual compression and Angio-Seal. There
were no serious complications in either group, but there
was a 12% failure rate in deployment of the closure device.
However, there was a significant difference in time to
hemostasis to the advantage of a closure device. The 1.2%
puncture site complications are low. One of the main
promotional reasons for the use of a closure device after an
arterial intervention in interventional radiology is early
ambulation with early discharge. However, even though
the closure device seems to be safe and effective, less than
50% of all patients were discharged within 24 h. This is
probably more a reflection of local reimbursement policy
than of concerns about the closure device, because the
other 50% was discharged at between 9 and 24 h. After
discharge, a 1.3% incidence of serious complications can
still be expected at the access site, and patients should be
informed of this possibility.
In general, the conclusion of this registry of closure
devices with an anchor and a plug is that the use of this
device in interventional radiology procedures is safe, with a
low incidence of serious access site complications. There
seems to be no difference in complications between ante-
grade and retrograde access and other parameters. These
results are also supported by some small and large single-
center publications [1–4, 8, 9]. There was early ambulation,
but shortening of anticipated discharge could not be pro-
ven, most likely due to external and local circumstances.
Although not part of this registry, as a result of the design
as an acute registration, patient comfort should also be an
important issue in the decision to use a closure device after
an interventional radiology procedure.
Conflict of interest The authors declare that they have no conflict
of interest.
Open Access This article is distributed under the terms of the
Creative Commons Attribution Noncommercial License which per-
mits any noncommercial use, distribution, and reproduction in any
medium, provided the original author(s) and source are credited.
References
1. Kirchhof C, Schickel S, Schmidt-Lucke C, Schmidt-Lucke JA
(2002) Local vascular complications after use of the hemostatic
puncture closure device Angio-Seal. Vasa 31:101–106
2. Kapoor B, Panu A, Berscheid B (2007) Angio-seal in antegrade
endovascular interventions: technical success and complications in
a 55-patient series. Endovasc Ther 14:382–386
52 J. A. Reekers et al.: CIRSE Vascular Closure Device Registry
123
3. Kadner A, Schmidli J, Schwegler I et al (2008) Complications
associated with the arterial puncture closure device—Angio-Seal.
Vasc Endovasc Surg 42:225–227
4. Looby S, Keeling AN, McErlean A et al (2008) Efficacy and safety
of the angioseal vascular closure device post antegrade puncture.
Cardiovasc Intervent Radiol 31:558–562
5. Eidt JF, Habibipour S, Saucedo JF et al (1999) Surgical
complications from hemostatic puncture closure devices. Am J
Surg 178:511–516
6. van der Steeg HJ, Berger P, Krasznai AG et al (2009) Acute
arterial occlusion after deployment of the Angio-Seal closure
device: is it as uncommon as we think? Eur J Vasc Endovasc Surg
38:715–717
7. Upponi SS, Ganeshan AG, Warakaulle DR et al (2007) Angioseal
versus manual compression for haemostasis following peripheral
vascular diagnostic and interventional procedures—a randomized
controlled trial. Eur J Radiol 61:332–334
8. Katzenschlager R, Tischler R, Kalchhauser G et al (2009) Angio-
Seal use in patients with peripheral arterial disease (ASPIRE).
Angiology 60:536–538
9. Mukhopadhyay K, Puckett MA, Roobottom CA (2005) Efficacy
and complications of Angioseal in antegrade puncture. Eur J
Radiol 56:409–412
J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 53
123


Reekers, Jim A.

Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only &lt; 0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma &gt; 5.9 cm, and two vessel occlusions. The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameter

UvA-DARE

Search4Dev

UvA-DARE is a service provided by the library of the University of Amsterdam (http://dare.uva.nl)
UvA-DARE (Digital Academic Repository)
CIRSE Vascular Closure Device Registry
Reekers, J.A.; Müller-Hülsbeck, S.; Libicher, M.; Atar, E.; Trentmann, J.; Goffette, P.;
Borggrefe, J.; Zeleňák, K.; Hooijboer, P.; Belli, A.M.
Published in:
Cardiovascular and interventional radiology
DOI:
10.1007/s00270-010-0004-y
Link to publication
Citation for published version (APA):
Reekers, J. A., Müller-Hülsbeck, S., Libicher, M., Atar, E., Trentmann, J., Goffette, P., Borggrefe, J., Zeleňák, K.,
Hooijboer, P., & Belli, A. M. (2011). CIRSE Vascular Closure Device Registry. Cardiovascular and interventional
radiology, 34(1), 50-53. https://doi.org/10.1007/s00270-010-0004-y
General rights
It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s),
other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons).
Disclaimer/Complaints regulations
If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating
your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask
the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam,
The Netherlands. You will be contacted as soon as possible.
Download date: 04 Feb 2021
CLINICAL INVESTIGATION
CIRSE Vascular Closure Device Registry
Jim A. Reekers • Stefan Müller-Hülsbeck • Martin Libicher •
Eli Atar • Jens Trentmann • Pierre Goffette • Jan Borggrefe •
Kamil Zeleňák • Pieter Hooijboer • Anna-Maria Belli
Received: 1 February 2010 / Accepted: 12 March 2010 / Published online: 28 October 2010
 The Author(s) 2010. This article is published with open access at Springerlink.com
Abstract
Purpose Vascular closure devices are routinely used after
many vascular interventional radiology procedures. How-
ever, there have been no major multicenter studies to assess
the safety and effectiveness of the routine use of closure
devices in interventional radiology.
Methods The CIRSE registry of closure devices with an
anchor and a plug started in January 2009 and ended in
August 2009. A total of 1,107 patients were included in the
registry.
Results Deployment success was 97.2%. Deployment
failure specified to access type was 8.8% [95% confidence
interval (95% CI) 5.0–14.5] for antegrade access and 1.8%
(95% CI 1.1–2.9) for retrograde access (P = 0.001). There
was no difference in deployment failure related to local
PVD at the access site. Calcification was a reason for
deployment failure in only \0.5% of patients. Postde-
ployment bleeding occurred in 6.4%, and most these
(51.5%) could be managed with light manual compression.
During follow-up, other device-related complications were
reported in 1.3%: seven false aneurysms, three hematoma
[5.9 cm, and two vessel occlusions.
Conclusion The conclusion of this registry of closure
devices with an anchor and a plug is that the use of this
device in interventional radiology procedures is safe, with a
low incidence of serious access site complications. There
seems to be no difference in complications between ante-
grade and retrograde access and other parameters.
Keywords Interventional radiology  Closure device 
Puncture site
Introduction
Currently, vascular closure devices are routinely used after
many vascular interventional radiology procedures. In
cardiology, many large studies on safety and effectiveness
have been published, where reduction in procedure time
and early ambulation and discharge were the main end-
points. However, there have been no major multicenter
J. A. Reekers (&)
Department of Radiology, Academic Medical Center,
Meibergdreef 9, NH 1105 AZ Amsterdam, The Netherlands
e-mail: j.a.reekers@amc.uva.nl
S. Müller-Hülsbeck
Department of Radiology, Academic Hospitals, Flensburg,
Germany
M. Libicher
Department of Radiology, University Clinics, Colonge, Germany
E. Atar
Department of Radiology, Hasharon Hospital, Petah Tikva,
Israel
J. Trentmann  J. Borggrefe
Department of Radiology, University Clinics
Schleswig-Holstein, Kiel, Germany
P. Goffette
Department of Radiology, University Clinics St. Luc, Brussels,
Belgium
K. Zeleňák
Department of Radiology, University Hospital, Martin, Slovakia
P. Hooijboer
Department of Radiology, Scheper Ziekenhuis, Emmen,
Netherlands
A.-M. Belli
Department of Radiology, St. Georges Hospital, London, UK
123
Cardiovasc Intervent Radiol (2011) 34:50–53
DOI 10.1007/s00270-010-0004-y
studies to assess the safety and effectiveness of the routine
use of closure devices in interventional radiology. Only
single-center data have been published [1–4]. This lack of
data, combined with the popularity of closure device
complications at morbidity and mortality conferences and
in case reports, might give a biased impression about
closure devices [5, 6]. If their safety is to be accurately
assessed, it is necessary to ascertain the number of all
closure devices used in a given institute in relation to the
rate of complications. To obtain these data, CIRSE con-
ducted a registry to investigate the safety of closure devi-
ces. Although the initial registry was intended to be open to
all CE-marked closure devices, only closure devices with
an anchor and plug were finally included.
Registry Design
The registry was advertised through CIRSE e-mail and on
the CIRSE Web site. It was open to all centers with more
than 50 closure devices experience. The registry was
conducted online and was hosted on an external server. The
design of the registry, data management, and final reporting
were performed by CIRSE. Device companies were not
involved in this process. The registry was designed to
collect data from up to 100 sites by members of CIRSE and
intended to recruit 1,000 patients. Collected data included
deployment success, time to hemostasis, time to mobili-
zation, and time to discharge. A record of all in-hospital
access site complications was also made. Patients returning
with late closure device problems could also be included in
this registry.
Material and Methods
The registry started in January 2009 and ended in August
2009. Twenty-eight centers from 10 European countries
participated in the registry. Only acute procedure-related
data were entered, and no direct patient identifiable infor-
mation was obtained; there were no privacy issues. The
medical ethical commission in one larger center looked at
the protocol and concluded that no informed consent was
needed. Only devices with an anchor and extravascular
plug (Angio-Seal, St. Jude Medical) were included in the
registry. A minimum experience of 50 closure devices was
required to enter patients onto the registry. The contributors
to the registry were asked to include consecutive patients.
No in-or exclusion criteria on the indication for closure
device use were given. Complications were registered
before discharge and in follow-up; only complications
in patients who returned spontaneously with a puncture
site–related problem were registered. These were not
linked to the original procedure for privacy reasons.
All v2 tests we performed for statistical analysis used
were standard tests.
Results
A total of 1,107 patients were included in the registry. The
number of included patients per country varied between
438 and 16. Lowest inclusion per center was 1 and highest
inclusion per center was 172. Of the included patients, 676
were male. Mean age distribution was between 55 and
75 years, with no difference between male and female
patients. A total of 80.4% of all patients were on some form
of antithrombotic medication. A total of 44.3% were
receiving aspirin, 57.7% unfractionated heparin, and 10.7%
clopidogrel. A total of 84.7% of all procedures were per-
formed with retrograde arterial access and 15.3% with
antegrade access. A total of 34.4% [95% confidence
interval (95% CI) 27.2–42.2] of all patients with antegrade
access had diabetes. For retrograde punctures, this was
22.5% (95% CI 19.8–25.4). This difference was highly
significant, with a P-value of 0.002. There was no differ-
ence in type of access between male and female patients.
The percentage of obese patients (body mass index of[25)
was equal in antegrade and retrograde access, with 23.9
and 25.1%, respectively.
Deployment success was 97.2%. Failures were due to
calcifications (n = 5), device problems (n = 7), and other
unspecified (n = 16). Deployment failure specified to
access type was 8.8% (95% CI 5.0–14.5) for antegrade
access and 1.8% (95% CI 1.1–2.9) for retrograde access
(P = 0.001). There was no difference in deployment fail-
ure related to sheath size or French size of the closure
device (6F or 8F). Nor was deployment success related to
local PVD at the access site. Calcification was a reason for
deployment failure in only \0.5% of patients.
Postdeployment bleeding occurred in 6.4%, and most of
these (51.5%) could be managed with light manual com-
pression. Pressure dressing was only applied in 22.1%. In
71.6% of the pressure dressing population, the pressure was
applied for \1 h.
There were 26 reported complications, of which 13
(1.2%) were reported as serious: two false aneurysms, six
hematoma [5.9 cm, 1 significant bleeding, two vessel
occlusion, and two vessel dissections. Access site compli-
cations were generally equal for antegrade and retrograde
access, at 4% (95% CI 1.6–8.8) and 2.3% (95% CI
1.4–3.6), respectively. This difference was not significant
(P = 0.342).
J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 51
123
Time to ambulation was more than 1 h in 94.8% of
patients. A total of 43.7% of all patients were discharged
between 9 and 24 h after the procedure, and 52.3% were
discharged after more than 24 h. The closure device only
shortened the anticipated discharge time in 12.2% of
patients. Discharge was delayed after closure device in
0.9%.
During follow-up, other device-related complications
were reported in 1.3% (n = 15): seven false aneurysms,
three hematoma [5.9 cm, two vessel occlusions, one par-
tial occlusion of the vessel, and two severe pain at the
access site.
We have looked at the data concerning complications
and could not find a difference between high and low
inclusion centers. However, the number of complications is
too small to draw any scientific conclusions.
Discussion
The current negative view of the use of closure devices in
peripheral vascular disease has been heavily influenced by
the anecdotal reporting of complications. These compli-
cations should be viewed in the context of the overall usage
of these devices in interventional practice to get a true
incidence of these complications. To get a better under-
standing of the safety and the possible advantages of rou-
tine use of these devices after an interventional radiology
procedure, CIRSE embarked on an independent closure
device registry, which included more than 1,100 patients
over a period of 7 months, demonstrating that these devices
are widely used in interventional radiology. Most devices
(84.7%) are still used after retrograde access, probably
including many over the bifurcation procedures. Almost all
patients in this registry ([80%) were receiving some form
of antithrombotic therapy, which implies that the devices
were used after some form of vascular intervention.
Antegrade access is more commonly used in patients with
diabetes, where below-the-knee pathology can be more
easily reached than through an over-the-bifurcation
procedure.
Deployment success was [97%. There is a significant
difference in deployment success, with more failures in the
antegrade access group: 8.8% in the antegrade and 1.8% in
the retrograde group. Other parameters such as obesity,
sheath size, and local calcifications did not seem to be
predictors for deployment failure. The latter is in contra-
diction to the instructions for use by the manufacturer of
the device. Access site complications were equal in both
antegrade and retrograde access. Minor postdeployment
bleeding was seen in 6.4% and was easily handled. This
was probably due to the mismatch between anchor and
plug, which can be seen after a puncture has been too steep.
There were 1.2% serious complications before dis-
charge, with no difference between antegrade or retrograde
access. There is one small prospective randomized trial that
compares manual compression and Angio-Seal in day-care
patients with peripheral interventional procedures [7]. In
this study, no significant differences in complications were
found between manual compression and Angio-Seal. There
were no serious complications in either group, but there
was a 12% failure rate in deployment of the closure device.
However, there was a significant difference in time to
hemostasis to the advantage of a closure device. The 1.2%
puncture site complications are low. One of the main
promotional reasons for the use of a closure device after an
arterial intervention in interventional radiology is early
ambulation with early discharge. However, even though
the closure device seems to be safe and effective, less than
50% of all patients were discharged within 24 h. This is
probably more a reflection of local reimbursement policy
than of concerns about the closure device, because the
other 50% was discharged at between 9 and 24 h. After
discharge, a 1.3% incidence of serious complications can
still be expected at the access site, and patients should be
informed of this possibility.
In general, the conclusion of this registry of closure
devices with an anchor and a plug is that the use of this
device in interventional radiology procedures is safe, with a
low incidence of serious access site complications. There
seems to be no difference in complications between ante-
grade and retrograde access and other parameters. These
results are also supported by some small and large single-
center publications [1–4, 8, 9]. There was early ambulation,
but shortening of anticipated discharge could not be pro-
ven, most likely due to external and local circumstances.
Although not part of this registry, as a result of the design
as an acute registration, patient comfort should also be an
important issue in the decision to use a closure device after
an interventional radiology procedure.
Conflict of interest The authors declare that they have no conflict
of interest.
Open Access This article is distributed under the terms of the
Creative Commons Attribution Noncommercial License which per-
mits any noncommercial use, distribution, and reproduction in any
medium, provided the original author(s) and source are credited.
References
1. Kirchhof C, Schickel S, Schmidt-Lucke C, Schmidt-Lucke JA
(2002) Local vascular complications after use of the hemostatic
puncture closure device Angio-Seal. Vasa 31:101–106
2. Kapoor B, Panu A, Berscheid B (2007) Angio-seal in antegrade
endovascular interventions: technical success and complications in
a 55-patient series. Endovasc Ther 14:382–386
52 J. A. Reekers et al.: CIRSE Vascular Closure Device Registry
123
3. Kadner A, Schmidli J, Schwegler I et al (2008) Complications
associated with the arterial puncture closure device—Angio-Seal.
Vasc Endovasc Surg 42:225–227
4. Looby S, Keeling AN, McErlean A et al (2008) Efficacy and safety
of the angioseal vascular closure device post antegrade puncture.
Cardiovasc Intervent Radiol 31:558–562
5. Eidt JF, Habibipour S, Saucedo JF et al (1999) Surgical
complications from hemostatic puncture closure devices. Am J
Surg 178:511–516
6. van der Steeg HJ, Berger P, Krasznai AG et al (2009) Acute
arterial occlusion after deployment of the Angio-Seal closure
device: is it as uncommon as we think? Eur J Vasc Endovasc Surg
38:715–717
7. Upponi SS, Ganeshan AG, Warakaulle DR et al (2007) Angioseal
versus manual compression for haemostasis following peripheral
vascular diagnostic and interventional procedures—a randomized
controlled trial. Eur J Radiol 61:332–334
8. Katzenschlager R, Tischler R, Kalchhauser G et al (2009) Angio-
Seal use in patients with peripheral arterial disease (ASPIRE).
Angiology 60:536–538
9. Mukhopadhyay K, Puckett MA, Roobottom CA (2005) Efficacy
and complications of Angioseal in antegrade puncture. Eur J
Radiol 56:409–412
J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 53
123


International Migration, Integration and Social Cohesion online publications

UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl)UvA-DARE (Digital Academic Repository)CIRSE Vascular Closure Device RegistryReekers, J.A.; Müller-Hülsbeck, S.; Libicher, M.; Atar, E.; Trentmann, J.; Goffette, P.;Borggrefe, J.; Zeleňák, K.; Hooijboer, P.; Belli, A.M.DOI10.1007/s00270-010-0004-yPublication date2011Document VersionFinal published versionPublished inCardiovascular and interventional radiologyLink to publicationCitation for published version (APA):Reekers, J. A., Müller-Hülsbeck, S., Libicher, M., Atar, E., Trentmann, J., Goffette, P.,Borggrefe, J., Zeleňák, K., Hooijboer, P., & Belli, A. M. (2011). CIRSE Vascular ClosureDevice Registry. Cardiovascular and interventional radiology, 34(1), 50-53.https://doi.org/10.1007/s00270-010-0004-yGeneral rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s)and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an opencontent license (like Creative Commons).Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, pleaselet the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the materialinaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letterto: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. Youwill be contacted as soon as possible.Download date:09 Mar 2023CLINICAL INVESTIGATIONCIRSE Vascular Closure Device RegistryJim A. Reekers • Stefan Müller-Hülsbeck • Martin Libicher •Eli Atar • Jens Trentmann • Pierre Goffette • Jan Borggrefe •Kamil Zeleňák • Pieter Hooijboer • Anna-Maria BelliReceived: 1 February 2010 / Accepted: 12 March 2010 / Published online: 28 October 2010 The Author(s) 2010. This article is published with open access at Springerlink.comAbstractPurpose Vascular closure devices are routinely used aftermany vascular interventional radiology procedures. How-ever, there have been no major multicenter studies to assessthe safety and effectiveness of the routine use of closuredevices in interventional radiology.Methods The CIRSE registry of closure devices with ananchor and a plug started in January 2009 and ended inAugust 2009. A total of 1,107 patients were included in theregistry.Results Deployment success was 97.2%. Deploymentfailure specified to access type was 8.8% [95% confidenceinterval (95% CI) 5.0–14.5] for antegrade access and 1.8%(95% CI 1.1–2.9) for retrograde access (P = 0.001). Therewas no difference in deployment failure related to localPVD at the access site. Calcification was a reason fordeployment failure in only \0.5% of patients. Postde-ployment bleeding occurred in 6.4%, and most these(51.5%) could be managed with light manual compression.During follow-up, other device-related complications werereported in 1.3%: seven false aneurysms, three hematoma[5.9 cm, and two vessel occlusions.Conclusion The conclusion of this registry of closuredevices with an anchor and a plug is that the use of thisdevice in interventional radiology procedures is safe, with alow incidence of serious access site complications. Thereseems to be no difference in complications between ante-grade and retrograde access and other parameters.Keywords Interventional radiology  Closure device Puncture siteIntroductionCurrently, vascular closure devices are routinely used aftermany vascular interventional radiology procedures. Incardiology, many large studies on safety and effectivenesshave been published, where reduction in procedure timeand early ambulation and discharge were the main end-points. However, there have been no major multicenterJ. A. Reekers (&)Department of Radiology, Academic Medical Center,Meibergdreef 9, NH 1105 AZ Amsterdam, The Netherlandse-mail: j.a.reekers@amc.uva.nlS. Müller-HülsbeckDepartment of Radiology, Academic Hospitals, Flensburg,GermanyM. LibicherDepartment of Radiology, University Clinics, Colonge, GermanyE. AtarDepartment of Radiology, Hasharon Hospital, Petah Tikva,IsraelJ. Trentmann  J. BorggrefeDepartment of Radiology, University ClinicsSchleswig-Holstein, Kiel, GermanyP. GoffetteDepartment of Radiology, University Clinics St. Luc, Brussels,BelgiumK. ZeleňákDepartment of Radiology, University Hospital, Martin, SlovakiaP. HooijboerDepartment of Radiology, Scheper Ziekenhuis, Emmen,NetherlandsA.-M. BelliDepartment of Radiology, St. Georges Hospital, London, UK123Cardiovasc Intervent Radiol (2011) 34:50–53DOI 10.1007/s00270-010-0004-ystudies to assess the safety and effectiveness of the routineuse of closure devices in interventional radiology. Onlysingle-center data have been published [1–4]. This lack ofdata, combined with the popularity of closure devicecomplications at morbidity and mortality conferences andin case reports, might give a biased impression aboutclosure devices [5, 6]. If their safety is to be accuratelyassessed, it is necessary to ascertain the number of allclosure devices used in a given institute in relation to therate of complications. To obtain these data, CIRSE con-ducted a registry to investigate the safety of closure devi-ces. Although the initial registry was intended to be open toall CE-marked closure devices, only closure devices withan anchor and plug were finally included.Registry DesignThe registry was advertised through CIRSE e-mail and onthe CIRSE Web site. It was open to all centers with morethan 50 closure devices experience. The registry wasconducted online and was hosted on an external server. Thedesign of the registry, data management, and final reportingwere performed by CIRSE. Device companies were notinvolved in this process. The registry was designed tocollect data from up to 100 sites by members of CIRSE andintended to recruit 1,000 patients. Collected data includeddeployment success, time to hemostasis, time to mobili-zation, and time to discharge. A record of all in-hospitalaccess site complications was also made. Patients returningwith late closure device problems could also be included inthis registry.Material and MethodsThe registry started in January 2009 and ended in August2009. Twenty-eight centers from 10 European countriesparticipated in the registry. Only acute procedure-relateddata were entered, and no direct patient identifiable infor-mation was obtained; there were no privacy issues. Themedical ethical commission in one larger center looked atthe protocol and concluded that no informed consent wasneeded. Only devices with an anchor and extravascularplug (Angio-Seal, St. Jude Medical) were included in theregistry. A minimum experience of 50 closure devices wasrequired to enter patients onto the registry. The contributorsto the registry were asked to include consecutive patients.No in-or exclusion criteria on the indication for closuredevice use were given. Complications were registeredbefore discharge and in follow-up; only complicationsin patients who returned spontaneously with a puncturesite–related problem were registered. These were notlinked to the original procedure for privacy reasons.All v2 tests we performed for statistical analysis usedwere standard tests.ResultsA total of 1,107 patients were included in the registry. Thenumber of included patients per country varied between438 and 16. Lowest inclusion per center was 1 and highestinclusion per center was 172. Of the included patients, 676were male. Mean age distribution was between 55 and75 years, with no difference between male and femalepatients. A total of 80.4% of all patients were on some formof antithrombotic medication. A total of 44.3% werereceiving aspirin, 57.7% unfractionated heparin, and 10.7%clopidogrel. A total of 84.7% of all procedures were per-formed with retrograde arterial access and 15.3% withantegrade access. A total of 34.4% [95% confidenceinterval (95% CI) 27.2–42.2] of all patients with antegradeaccess had diabetes. For retrograde punctures, this was22.5% (95% CI 19.8–25.4). This difference was highlysignificant, with a P-value of 0.002. There was no differ-ence in type of access between male and female patients.The percentage of obese patients (body mass index of[25)was equal in antegrade and retrograde access, with 23.9and 25.1%, respectively.Deployment success was 97.2%. Failures were due tocalcifications (n = 5), device problems (n = 7), and otherunspecified (n = 16). Deployment failure specified toaccess type was 8.8% (95% CI 5.0–14.5) for antegradeaccess and 1.8% (95% CI 1.1–2.9) for retrograde access(P = 0.001). There was no difference in deployment fail-ure related to sheath size or French size of the closuredevice (6F or 8F). Nor was deployment success related tolocal PVD at the access site. Calcification was a reason fordeployment failure in only \0.5% of patients.Postdeployment bleeding occurred in 6.4%, and most ofthese (51.5%) could be managed with light manual com-pression. Pressure dressing was only applied in 22.1%. In71.6% of the pressure dressing population, the pressure wasapplied for \1 h.There were 26 reported complications, of which 13(1.2%) were reported as serious: two false aneurysms, sixhematoma [5.9 cm, 1 significant bleeding, two vesselocclusion, and two vessel dissections. Access site compli-cations were generally equal for antegrade and retrogradeaccess, at 4% (95% CI 1.6–8.8) and 2.3% (95% CI1.4–3.6), respectively. This difference was not significant(P = 0.342).J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 51123Time to ambulation was more than 1 h in 94.8% ofpatients. A total of 43.7% of all patients were dischargedbetween 9 and 24 h after the procedure, and 52.3% weredischarged after more than 24 h. The closure device onlyshortened the anticipated discharge time in 12.2% ofpatients. Discharge was delayed after closure device in0.9%.During follow-up, other device-related complicationswere reported in 1.3% (n = 15): seven false aneurysms,three hematoma [5.9 cm, two vessel occlusions, one par-tial occlusion of the vessel, and two severe pain at theaccess site.We have looked at the data concerning complicationsand could not find a difference between high and lowinclusion centers. However, the number of complications istoo small to draw any scientific conclusions.DiscussionThe current negative view of the use of closure devices inperipheral vascular disease has been heavily influenced bythe anecdotal reporting of complications. These compli-cations should be viewed in the context of the overall usageof these devices in interventional practice to get a trueincidence of these complications. To get a better under-standing of the safety and the possible advantages of rou-tine use of these devices after an interventional radiologyprocedure, CIRSE embarked on an independent closuredevice registry, which included more than 1,100 patientsover a period of 7 months, demonstrating that these devicesare widely used in interventional radiology. Most devices(84.7%) are still used after retrograde access, probablyincluding many over the bifurcation procedures. Almost allpatients in this registry ([80%) were receiving some formof antithrombotic therapy, which implies that the deviceswere used after some form of vascular intervention.Antegrade access is more commonly used in patients withdiabetes, where below-the-knee pathology can be moreeasily reached than through an over-the-bifurcationprocedure.Deployment success was [97%. There is a significantdifference in deployment success, with more failures in theantegrade access group: 8.8% in the antegrade and 1.8% inthe retrograde group. Other parameters such as obesity,sheath size, and local calcifications did not seem to bepredictors for deployment failure. The latter is in contra-diction to the instructions for use by the manufacturer ofthe device. Access site complications were equal in bothantegrade and retrograde access. Minor postdeploymentbleeding was seen in 6.4% and was easily handled. Thiswas probably due to the mismatch between anchor andplug, which can be seen after a puncture has been too steep.There were 1.2% serious complications before dis-charge, with no difference between antegrade or retrogradeaccess. There is one small prospective randomized trial thatcompares manual compression and Angio-Seal in day-carepatients with peripheral interventional procedures [7]. Inthis study, no significant differences in complications werefound between manual compression and Angio-Seal. Therewere no serious complications in either group, but therewas a 12% failure rate in deployment of the closure device.However, there was a significant difference in time tohemostasis to the advantage of a closure device. The 1.2%puncture site complications are low. One of the mainpromotional reasons for the use of a closure device after anarterial intervention in interventional radiology is earlyambulation with early discharge. However, even thoughthe closure device seems to be safe and effective, less than50% of all patients were discharged within 24 h. This isprobably more a reflection of local reimbursement policythan of concerns about the closure device, because theother 50% was discharged at between 9 and 24 h. Afterdischarge, a 1.3% incidence of serious complications canstill be expected at the access site, and patients should beinformed of this possibility.In general, the conclusion of this registry of closuredevices with an anchor and a plug is that the use of thisdevice in interventional radiology procedures is safe, with alow incidence of serious access site complications. Thereseems to be no difference in complications between ante-grade and retrograde access and other parameters. Theseresults are also supported by some small and large single-center publications [1–4, 8, 9]. There was early ambulation,but shortening of anticipated discharge could not be pro-ven, most likely due to external and local circumstances.Although not part of this registry, as a result of the designas an acute registration, patient comfort should also be animportant issue in the decision to use a closure device afteran interventional radiology procedure.Conflict of interest The authors declare that they have no conflictof interest.Open Access This article is distributed under the terms of theCreative Commons Attribution Noncommercial License which per-mits any noncommercial use, distribution, and reproduction in anymedium, provided the original author(s) and source are credited.References1. Kirchhof C, Schickel S, Schmidt-Lucke C, Schmidt-Lucke JA(2002) Local vascular complications after use of the hemostaticpuncture closure device Angio-Seal. Vasa 31:101–1062. Kapoor B, Panu A, Berscheid B (2007) Angio-seal in antegradeendovascular interventions: technical success and complications ina 55-patient series. Endovasc Ther 14:382–38652 J. A. Reekers et al.: CIRSE Vascular Closure Device Registry1233. Kadner A, Schmidli J, Schwegler I et al (2008) Complicationsassociated with the arterial puncture closure device—Angio-Seal.Vasc Endovasc Surg 42:225–2274. Looby S, Keeling AN, McErlean A et al (2008) Efficacy and safetyof the angioseal vascular closure device post antegrade puncture.Cardiovasc Intervent Radiol 31:558–5625. Eidt JF, Habibipour S, Saucedo JF et al (1999) Surgicalcomplications from hemostatic puncture closure devices. Am JSurg 178:511–5166. van der Steeg HJ, Berger P, Krasznai AG et al (2009) Acutearterial occlusion after deployment of the Angio-Seal closuredevice: is it as uncommon as we think? Eur J Vasc Endovasc Surg38:715–7177. Upponi SS, Ganeshan AG, Warakaulle DR et al (2007) Angiosealversus manual compression for haemostasis following peripheralvascular diagnostic and interventional procedures—a randomizedcontrolled trial. Eur J Radiol 61:332–3348. Katzenschlager R, Tischler R, Kalchhauser G et al (2009) Angio-Seal use in patients with peripheral arterial disease (ASPIRE).Angiology 60:536–5389. Mukhopadhyay K, Puckett MA, Roobottom CA (2005) Efficacyand complications of Angioseal in antegrade puncture. Eur JRadiol 56:409–412J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 53123

UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl)UvA-DARE (Digital Academic Repository)CIRSE Vascular Closure Device RegistryReekers, J.A.; Müller-Hülsbeck, S.; Libicher, M.; Atar, E.; Trentmann, J.; Goffette, P.;Borggrefe, J.; Zeleňák, K.; Hooijboer, P.; Belli, A.M.DOI10.1007/s00270-010-0004-yPublication date2011Document VersionFinal published versionPublished inCardiovascular and interventional radiologyLink to publicationCitation for published version (APA):Reekers, J. A., Müller-Hülsbeck, S., Libicher, M., Atar, E., Trentmann, J., Goffette, P.,Borggrefe, J., Zeleňák, K., Hooijboer, P., & Belli, A. M. (2011). CIRSE Vascular ClosureDevice Registry. Cardiovascular and interventional radiology, 34(1), 50-53.https://doi.org/10.1007/s00270-010-0004-yGeneral rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s)and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an opencontent license (like Creative Commons).Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, pleaselet the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the materialinaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letterto: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. Youwill be contacted as soon as possible.Download date:10 Nov 2022CLINICAL INVESTIGATIONCIRSE Vascular Closure Device RegistryJim A. Reekers • Stefan Müller-Hülsbeck • Martin Libicher •Eli Atar • Jens Trentmann • Pierre Goffette • Jan Borggrefe •Kamil Zeleňák • Pieter Hooijboer • Anna-Maria BelliReceived: 1 February 2010 / Accepted: 12 March 2010 / Published online: 28 October 2010 The Author(s) 2010. This article is published with open access at Springerlink.comAbstractPurpose Vascular closure devices are routinely used aftermany vascular interventional radiology procedures. How-ever, there have been no major multicenter studies to assessthe safety and effectiveness of the routine use of closuredevices in interventional radiology.Methods The CIRSE registry of closure devices with ananchor and a plug started in January 2009 and ended inAugust 2009. A total of 1,107 patients were included in theregistry.Results Deployment success was 97.2%. Deploymentfailure specified to access type was 8.8% [95% confidenceinterval (95% CI) 5.0–14.5] for antegrade access and 1.8%(95% CI 1.1–2.9) for retrograde access (P = 0.001). Therewas no difference in deployment failure related to localPVD at the access site. Calcification was a reason fordeployment failure in only \0.5% of patients. Postde-ployment bleeding occurred in 6.4%, and most these(51.5%) could be managed with light manual compression.During follow-up, other device-related complications werereported in 1.3%: seven false aneurysms, three hematoma[5.9 cm, and two vessel occlusions.Conclusion The conclusion of this registry of closuredevices with an anchor and a plug is that the use of thisdevice in interventional radiology procedures is safe, with alow incidence of serious access site complications. Thereseems to be no difference in complications between ante-grade and retrograde access and other parameters.Keywords Interventional radiology  Closure device Puncture siteIntroductionCurrently, vascular closure devices are routinely used aftermany vascular interventional radiology procedures. Incardiology, many large studies on safety and effectivenesshave been published, where reduction in procedure timeand early ambulation and discharge were the main end-points. However, there have been no major multicenterJ. A. Reekers (&)Department of Radiology, Academic Medical Center,Meibergdreef 9, NH 1105 AZ Amsterdam, The Netherlandse-mail: j.a.reekers@amc.uva.nlS. Müller-HülsbeckDepartment of Radiology, Academic Hospitals, Flensburg,GermanyM. LibicherDepartment of Radiology, University Clinics, Colonge, GermanyE. AtarDepartment of Radiology, Hasharon Hospital, Petah Tikva,IsraelJ. Trentmann  J. BorggrefeDepartment of Radiology, University ClinicsSchleswig-Holstein, Kiel, GermanyP. GoffetteDepartment of Radiology, University Clinics St. Luc, Brussels,BelgiumK. ZeleňákDepartment of Radiology, University Hospital, Martin, SlovakiaP. HooijboerDepartment of Radiology, Scheper Ziekenhuis, Emmen,NetherlandsA.-M. BelliDepartment of Radiology, St. Georges Hospital, London, UK123Cardiovasc Intervent Radiol (2011) 34:50–53DOI 10.1007/s00270-010-0004-ystudies to assess the safety and effectiveness of the routineuse of closure devices in interventional radiology. Onlysingle-center data have been published [1–4]. This lack ofdata, combined with the popularity of closure devicecomplications at morbidity and mortality conferences andin case reports, might give a biased impression aboutclosure devices [5, 6]. If their safety is to be accuratelyassessed, it is necessary to ascertain the number of allclosure devices used in a given institute in relation to therate of complications. To obtain these data, CIRSE con-ducted a registry to investigate the safety of closure devi-ces. Although the initial registry was intended to be open toall CE-marked closure devices, only closure devices withan anchor and plug were finally included.Registry DesignThe registry was advertised through CIRSE e-mail and onthe CIRSE Web site. It was open to all centers with morethan 50 closure devices experience. The registry wasconducted online and was hosted on an external server. Thedesign of the registry, data management, and final reportingwere performed by CIRSE. Device companies were notinvolved in this process. The registry was designed tocollect data from up to 100 sites by members of CIRSE andintended to recruit 1,000 patients. Collected data includeddeployment success, time to hemostasis, time to mobili-zation, and time to discharge. A record of all in-hospitalaccess site complications was also made. Patients returningwith late closure device problems could also be included inthis registry.Material and MethodsThe registry started in January 2009 and ended in August2009. Twenty-eight centers from 10 European countriesparticipated in the registry. Only acute procedure-relateddata were entered, and no direct patient identifiable infor-mation was obtained; there were no privacy issues. Themedical ethical commission in one larger center looked atthe protocol and concluded that no informed consent wasneeded. Only devices with an anchor and extravascularplug (Angio-Seal, St. Jude Medical) were included in theregistry. A minimum experience of 50 closure devices wasrequired to enter patients onto the registry. The contributorsto the registry were asked to include consecutive patients.No in-or exclusion criteria on the indication for closuredevice use were given. Complications were registeredbefore discharge and in follow-up; only complicationsin patients who returned spontaneously with a puncturesite–related problem were registered. These were notlinked to the original procedure for privacy reasons.All v2 tests we performed for statistical analysis usedwere standard tests.ResultsA total of 1,107 patients were included in the registry. Thenumber of included patients per country varied between438 and 16. Lowest inclusion per center was 1 and highestinclusion per center was 172. Of the included patients, 676were male. Mean age distribution was between 55 and75 years, with no difference between male and femalepatients. A total of 80.4% of all patients were on some formof antithrombotic medication. A total of 44.3% werereceiving aspirin, 57.7% unfractionated heparin, and 10.7%clopidogrel. A total of 84.7% of all procedures were per-formed with retrograde arterial access and 15.3% withantegrade access. A total of 34.4% [95% confidenceinterval (95% CI) 27.2–42.2] of all patients with antegradeaccess had diabetes. For retrograde punctures, this was22.5% (95% CI 19.8–25.4). This difference was highlysignificant, with a P-value of 0.002. There was no differ-ence in type of access between male and female patients.The percentage of obese patients (body mass index of[25)was equal in antegrade and retrograde access, with 23.9and 25.1%, respectively.Deployment success was 97.2%. Failures were due tocalcifications (n = 5), device problems (n = 7), and otherunspecified (n = 16). Deployment failure specified toaccess type was 8.8% (95% CI 5.0–14.5) for antegradeaccess and 1.8% (95% CI 1.1–2.9) for retrograde access(P = 0.001). There was no difference in deployment fail-ure related to sheath size or French size of the closuredevice (6F or 8F). Nor was deployment success related tolocal PVD at the access site. Calcification was a reason fordeployment failure in only \0.5% of patients.Postdeployment bleeding occurred in 6.4%, and most ofthese (51.5%) could be managed with light manual com-pression. Pressure dressing was only applied in 22.1%. In71.6% of the pressure dressing population, the pressure wasapplied for \1 h.There were 26 reported complications, of which 13(1.2%) were reported as serious: two false aneurysms, sixhematoma [5.9 cm, 1 significant bleeding, two vesselocclusion, and two vessel dissections. Access site compli-cations were generally equal for antegrade and retrogradeaccess, at 4% (95% CI 1.6–8.8) and 2.3% (95% CI1.4–3.6), respectively. This difference was not significant(P = 0.342).J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 51123Time to ambulation was more than 1 h in 94.8% ofpatients. A total of 43.7% of all patients were dischargedbetween 9 and 24 h after the procedure, and 52.3% weredischarged after more than 24 h. The closure device onlyshortened the anticipated discharge time in 12.2% ofpatients. Discharge was delayed after closure device in0.9%.During follow-up, other device-related complicationswere reported in 1.3% (n = 15): seven false aneurysms,three hematoma [5.9 cm, two vessel occlusions, one par-tial occlusion of the vessel, and two severe pain at theaccess site.We have looked at the data concerning complicationsand could not find a difference between high and lowinclusion centers. However, the number of complications istoo small to draw any scientific conclusions.DiscussionThe current negative view of the use of closure devices inperipheral vascular disease has been heavily influenced bythe anecdotal reporting of complications. These compli-cations should be viewed in the context of the overall usageof these devices in interventional practice to get a trueincidence of these complications. To get a better under-standing of the safety and the possible advantages of rou-tine use of these devices after an interventional radiologyprocedure, CIRSE embarked on an independent closuredevice registry, which included more than 1,100 patientsover a period of 7 months, demonstrating that these devicesare widely used in interventional radiology. Most devices(84.7%) are still used after retrograde access, probablyincluding many over the bifurcation procedures. Almost allpatients in this registry ([80%) were receiving some formof antithrombotic therapy, which implies that the deviceswere used after some form of vascular intervention.Antegrade access is more commonly used in patients withdiabetes, where below-the-knee pathology can be moreeasily reached than through an over-the-bifurcationprocedure.Deployment success was [97%. There is a significantdifference in deployment success, with more failures in theantegrade access group: 8.8% in the antegrade and 1.8% inthe retrograde group. Other parameters such as obesity,sheath size, and local calcifications did not seem to bepredictors for deployment failure. The latter is in contra-diction to the instructions for use by the manufacturer ofthe device. Access site complications were equal in bothantegrade and retrograde access. Minor postdeploymentbleeding was seen in 6.4% and was easily handled. Thiswas probably due to the mismatch between anchor andplug, which can be seen after a puncture has been too steep.There were 1.2% serious complications before dis-charge, with no difference between antegrade or retrogradeaccess. There is one small prospective randomized trial thatcompares manual compression and Angio-Seal in day-carepatients with peripheral interventional procedures [7]. Inthis study, no significant differences in complications werefound between manual compression and Angio-Seal. Therewere no serious complications in either group, but therewas a 12% failure rate in deployment of the closure device.However, there was a significant difference in time tohemostasis to the advantage of a closure device. The 1.2%puncture site complications are low. One of the mainpromotional reasons for the use of a closure device after anarterial intervention in interventional radiology is earlyambulation with early discharge. However, even thoughthe closure device seems to be safe and effective, less than50% of all patients were discharged within 24 h. This isprobably more a reflection of local reimbursement policythan of concerns about the closure device, because theother 50% was discharged at between 9 and 24 h. Afterdischarge, a 1.3% incidence of serious complications canstill be expected at the access site, and patients should beinformed of this possibility.In general, the conclusion of this registry of closuredevices with an anchor and a plug is that the use of thisdevice in interventional radiology procedures is safe, with alow incidence of serious access site complications. Thereseems to be no difference in complications between ante-grade and retrograde access and other parameters. Theseresults are also supported by some small and large single-center publications [1–4, 8, 9]. There was early ambulation,but shortening of anticipated discharge could not be pro-ven, most likely due to external and local circumstances.Although not part of this registry, as a result of the designas an acute registration, patient comfort should also be animportant issue in the decision to use a closure device afteran interventional radiology procedure.Conflict of interest The authors declare that they have no conflictof interest.Open Access This article is distributed under the terms of theCreative Commons Attribution Noncommercial License which per-mits any noncommercial use, distribution, and reproduction in anymedium, provided the original author(s) and source are credited.References1. Kirchhof C, Schickel S, Schmidt-Lucke C, Schmidt-Lucke JA(2002) Local vascular complications after use of the hemostaticpuncture closure device Angio-Seal. Vasa 31:101–1062. Kapoor B, Panu A, Berscheid B (2007) Angio-seal in antegradeendovascular interventions: technical success and complications ina 55-patient series. Endovasc Ther 14:382–38652 J. A. Reekers et al.: CIRSE Vascular Closure Device Registry1233. Kadner A, Schmidli J, Schwegler I et al (2008) Complicationsassociated with the arterial puncture closure device—Angio-Seal.Vasc Endovasc Surg 42:225–2274. Looby S, Keeling AN, McErlean A et al (2008) Efficacy and safetyof the angioseal vascular closure device post antegrade puncture.Cardiovasc Intervent Radiol 31:558–5625. Eidt JF, Habibipour S, Saucedo JF et al (1999) Surgicalcomplications from hemostatic puncture closure devices. Am JSurg 178:511–5166. van der Steeg HJ, Berger P, Krasznai AG et al (2009) Acutearterial occlusion after deployment of the Angio-Seal closuredevice: is it as uncommon as we think? Eur J Vasc Endovasc Surg38:715–7177. Upponi SS, Ganeshan AG, Warakaulle DR et al (2007) Angiosealversus manual compression for haemostasis following peripheralvascular diagnostic and interventional procedures—a randomizedcontrolled trial. Eur J Radiol 61:332–3348. Katzenschlager R, Tischler R, Kalchhauser G et al (2009) Angio-Seal use in patients with peripheral arterial disease (ASPIRE).Angiology 60:536–5389. Mukhopadhyay K, Puckett MA, Roobottom CA (2005) Efficacyand complications of Angioseal in antegrade puncture. Eur JRadiol 56:409–412J. A. Reekers et al.: CIRSE Vascular Closure Device Registry 53123

A et al (2008) Efﬁcacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol 31:558–562

Acute arterial occlusion after deployment of the Angio-Seal closure device: is it as uncommon as we think?

Angio-seal in antegrade endovascular interventions: technical success and complications in a 55-patient series.

Efﬁcacy and complications of Angioseal in antegrade puncture.

Kalchhauser G et al (2009) AngioSeal use in patients with peripheral arterial disease (ASPIRE).

Local vascular complications after use of the hemostatic puncture closure device Angio-Seal. Vasa 31:101–106

Schwegler I et al (2008) Complications associated with the arterial puncture closure device—Angio-Seal. Vasc Endovasc Surg 42:225–227

Surgical complications from hemostatic puncture closure devices.

Warakaulle DR et al (2007) Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures—a randomized controlled trial.

CIRSE Vascular Closure Device Registry

Abstract

Similar works

Full text

Available Versions

Crossref

NARCIS

DIAL UCLouvain

Springer - Publisher Connector

NARCIS

UvA-DARE

Search4Dev

International Migration, Integration and Social Cohesion online publications

International Migration, Integration and Social Cohesion online publications