- Email: [email protected]
Retrospective cohort study on Angio-Seal closure device safety and effectiveness in antegrade superficial femoral artery punctures: A comparison with antegrade common femoral artery punctures
Accepted Manuscript Retrospective cohort study on Angio-Seal closure device safety and effectiveness in antegrade superficial femoral artery punctures: A comparison with antegrade common femoral artery punctures Tarig Adlan, Yousef Shahin, Peter Kember, John Isaacs, Richard Seymour PII:
S1743-9191(17)31420-6
DOI:
10.1016/j.ijsu.2017.11.003
Reference:
IJSU 4286
To appear in:
International Journal of Surgery
Received Date: 9 June 2017 Revised Date:
31 October 2017
Accepted Date: 1 November 2017
Please cite this article as: Adlan T, Shahin Y, Kember P, Isaacs J, Seymour R, Retrospective cohort study on Angio-Seal closure device safety and effectiveness in antegrade superficial femoral artery punctures: A comparison with antegrade common femoral artery punctures, International Journal of Surgery (2017), doi: 10.1016/j.ijsu.2017.11.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Retrospective cohort study on Angio-Seal closure device safety and effectiveness in antegrade superficial femoral artery punctures: a comparison
Short Title: Angio-Seal for antegrade SFA punctures
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with antegrade common femoral artery punctures
1
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Tarig Adlan1 MBBS MRCP MRCS(Ed) FRCR PGCE FHEA EDiR, Yousef Shahin2 MD MD (Res) MRCS PGC, Peter Kember1 MB ChB MRCP FRCR, John Isaacs1 MB BS MRCP FRCR, Richard Seymour1 MB BChir MA MRCP FRCR Department of Radiology, Torbay Hospital NHS, Torquay, United Kingdom
2
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Academic Unit of Radiology, University of Sheffield and Sheffield Teaching Hospitals NHS, Sheffield, United Kingdom
Word count: 1945 excluding tables and references.
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Corresponding author: Dr Yousef Shahin
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NIHR Academic Clinical Fellow and Specialist Registrar in Clinical Radiology
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Academic Unit of Radiology,
University of Sheffield, Glossop Road, Sheffield, S10 2JF, United Kingdom Tel: 0114 243 4343
Email: [email protected]
ACCEPTED MANUSCRIPT
Abstract: Purpose: This retrospective study evaluates the effectiveness and safety of the Angio-Seal
femoral artery (CFA) antegrade punctures.
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closure device in superficial femoral artery (SFA) antegrade punctures compared to common
Methods: Over a period of 46 months from January 2012, consecutive patients who
SC
underwent antegrade CFA or SFA punctures using Angio-Seal as a closure device in a single centre were studied. Patients were identified by reading all the individual reports on our
M AN U
radiology system for all patients who underwent any angiographic examination during the study period, and their individual case notes were subsequently reviewed. A retrospective analysis of prospectively collected data on patients’ demographics, type of intervention, clinical indication, Angio-Seal size, haemostasis status and complications was performed.
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Results: Overall, 194 patients (mean (s.d.) age 74(12) years, 123(44%) males) underwent CFA or SFA antegrade punctures. A total of 228 (CFA group, n =70, SFA group, n=158)
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antegrade punctures were performed. Clinical characteristics of the two groups were comparable. Angio-Seal size 6F was deployed in 69(99%) antegrade CFA punctures and
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155(98%) antegrade SFA punctures (P=1.000). Haemostasis was achieved in 65(93%) antegrade CFA punctures compared to 156(99%) antegrade SFA punctures (P=.030).
Conclusion: Angio-Seal closure device is safe and effective method of haemostasis both in antegrade SFA and CFA punctures with no significant complications or delayed discharge.
Keywords: Angio-Seal, safety and efficacy, superficial femoral artery, antegrade puncture, common femoral artery, vascular closure device.
1
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1.Introduction The advances in percutaneous and endovascular treatment of peripheral arterial disease have revolutionised treatment of this group of patients replacing conventional surgical
RI PT
interventions. Percutaneous vascular interventions can be performed using retrograde or antegrade approaches. As more complex endovascular interventions are required, a nonorthodox access to lower limbs arteries for endovascular procedures has been adopted.
SC
Antegrade puncture of the superficial femoral artery (SFA) offers easier vascular access
particularly in patients with unfavourable body habitus and high body mass index with some
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controversy over achievement of haemostasis. Traditionally, haemostasis of arterial punctures has been achieved through manual compression of the punctures sites. Manual compression has been superseded with the advents of vascular closure devices which have
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the added benefits of early ambulation and hastened discharge.
The Angio-Seal closure device (St.Jude Medical, St.Paul, Minnesota) efficacy and safety in CFA retrograde and antegrade endovascular interventions is widely established [1-4].
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Limited number of studies evaluated the effectiveness and safety of the Angio-Seal closure device in SFA antegrade punctures, which is outside the manufacturers’ IFU. Kweon et al[5]
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compared outcomes between CFA and SFA antegrade punctures in patients undergoing infrainguinal arterial occlusive disease with no focus on the safety and effectiveness of the Angio-Seal closure device. The aim of this study is to evaluate the safety and effectiveness of the Angio-Seal closure device in antegrade SFA punctures compared to antegrade CFA punctures in a wide range of lower limbs vascular interventions for a variety of clinical indications.
2
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2. Materials and methods This is a retrospective cohort study of prospectively collected data in a single centre. Between January 2012 and October 2015, 194 consecutive patients who underwent
RI PT
antegrade SFA (SFA group) or CFA punctures (CFA group) for an arterial intervention were studied. Local Research and development department advised that ethical approval was not required as this review was service evaluation of existing practice. Patients were included in
SC
the study if they had an antegrade SFA or CFA punctures for any intervention on the lower limbs using Angio-Seal as a closure device. Patients were identified by reviewing every single
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report for any arterial procedure conducted in the study period. Patients were excluded from the study if they underwent retrograde arterial interventions or if any other closure device apart from Angio-Seal was deployed or indeed if any other method of haemostasis was used. Types of interventions and clinical indications are listed in table 1. Data on the
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SFA and CFA groups including patients’ demographics, type of intervention, clinical indication, Angio-Seal closure device size, haemostasis status following intervention and on
EP
discharge and any minor or major complications was collected and analysed. Data was collected through reviewing every individual patient’s hospital notes. All performed
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punctures were ultrasound guided. The suitability of the vessel for Angio-Seal deployment was assessed with ultrasound, decided by the vessel size (a minimum of 6 mm) and absence of atherosclerotic plaques on the anterior vessel wall. The effectiveness of the Angio-Seal was defined by its ability to adequately achieve haemostasis over the puncture site. The safety was defined by the presence of any associated complications. This study was reported in line with the STORBE and STROCCS statements [6,7].
3
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2.1. Statistical analysis A Statistical Package for the Social Sciences Program (SPSS) version 24 for Windows (SPSS Inc. Chicago, IL) was used for statistical analysis. Continuous variables were expressed as
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mean (s.d.) for parametric variables and median (interquartile range) for non-parametric variables. Categorical data was presented as the number of subjects and percentage.
Comparison between the groups (CFA and SFA) was performed using unpaired t-test for
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parametric variables and Mann-Whitney U test for non-parametric variables as appropriate. Categorical variables were compared using Fisher’s exact probability test and Pearson’s Chi-
was considered to be significant.
3. Results
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square test as appropriate. All statistical tests were two-sided and a P value of less than .050
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Over a period of 46 months from January 2012, 194 patients (mean age (s.d.) 74(12) years, 123(44%) males) were included in the analysis. Patients underwent a total of 228 antegrade
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arterial punctures with 228 Angio-Seals deployed (CFA group; n=70, SFA group; n=158). The target vessel (CFA and SFA) were purposefully punctured. 19 G Seldinger access needle was
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used in 100% of our patient’s cohort. There was no significant difference between the clinical characteristics, Angio-Seal size, type of interventions and clinical indications for interventions between the two groups (Table 1). 11(6%) patients had bilateral Angio-Seals deployed (CFA group; n=3, SFA group; n=8, P=.457). All patients had 3000 IU of intra-arterial heparin intraoperatively which is a standard dose in our institution for anticoagulation for lower limb arterial intervention. All procedures were performed by interventional radiologists.
4
ACCEPTED MANUSCRIPT Angio-Seal median size in the two groups was comparable (6-French, range (6-8), P=.798). Angio-Seal size 6F was deployed in 69(99%) antegrade punctures in the CFA group and 155(98%) punctures in the SFA group (P=1.000). Haemostasis was achieved in 65(93%) antegrade punctures in the CFA group compared to 156(99%) punctures in the SFA group
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(P=.030). Three (4%) antegrade punctures in the CFA group and nine (6%) punctures in the SFA group resulted in small haematomas (P=.660) which resolved spontaneously with 1 (1%)
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puncture in the CFA group resulting in slow ooze from the puncture site requiring manual compression. 1 (0.6%) puncture in the SFA group resulted in a large haematoma which did
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not require intervention with no resultant delay in discharge. There were no major complications requiring further intervention in the two groups. There were three cases of probable access site stenosis. Two of these cases were in the CFA group (2.9%) and one case in the SFA group (0.6%). The difference between the two groups was statistically
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insignificant (P=.226).
Follow-up imaging for all patients was reviewed for a minimum period of 16 months
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(excluding those deceased) to identify cases of probable Angio-Seal related access site stenosis. Three cases in total were identified. Interestingly two of these patients (2.9%) were
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in the CFA group and one (0.6%) in the SFA group. The probable access site stenosis was identified at 25, 85 and 33 days post procedure respectively. There was no statistical difference between the two groups (P=.226). All three patients were managed conservatively.
5
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4. Discussion This is the first study with a large cohort of patients which specifically compared Angio-Seal arterial closure device outcomes between antegrade CFA and SFA punctures for a variety of
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clinical indications and a variety of endovascular interventions. Our standard practice for antegrade punctures is to use the SFA in preference if suitable (Adequate vessel size and absence of plaque) with Angio-Seal device for closure. Traditionally the CFA has been the
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preferred site of vascular access for peripheral arterial interventions, mostly due to vessel size and the ease to achieve haemostasis through conventional manual compression against
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the underlying bony femoral head. Most of the anxiety with direct SFA punctures arises from the lack of an underlying bony surface that provides the necessary support to achieve haemostasis through manual compression [8]. In our cohort of patients, the use ultrasound to assess the access vessel (minimum of 6 mm vessel diameter and absence of anterior
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vessel wall atheroma) meant that we could be reassured of the safety and efficiency of our approach. The routine use of ultrasound has been proven to enhance the safety profile in
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direct SFA punctures [9]. Whilst all of our punctures were ultrasound guided, we do not routinely use ultrasound for Angio-Seal deployment and hence none of our Angio-Seal
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deployments were under ultrasound guidance. We also believe that direct SFA access can potentially reduce the overall procedure time and subsequent radiation dose; although this was not formally assessed as it was outside the remit of this study. If the proximal SFA is not suitable our second choice is CFA with subsequent Angio-Seal for closure. If neither is suitable then we use a 4F low-profile system and manual compression. In this retrospective study of prospectively collected data on 228 antegrade punctures of the CFA and SFA, we evaluated the effectiveness and safety of the Angio-Seal closure device in antegrade SFA
6
ACCEPTED MANUSCRIPT punctures compared to CFA antegrade punctures. 19 G needle was used as an access needle in 100% of our patients’ cohort. Gutzeit et al [10], compared the use of 21G to 19G needle in antegrade femoral access demonstrating a slightly higher rate of pseudo aneurysms in the
was significantly shorter in the 19G group.
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19G group. This was not statistically significant however. On the other hand, access time
Kweon et al [5] compared outcomes between CFA and SFA antegrade punctures in
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infrainguinal arterial occlusive disease where several types of closure devices were used. The Angio-Seal closure device was used in one patient who underwent a CFA antegrade
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puncture. The same study demonstrates higher rate of haemorrhagic complications including one case of retroperitoneal haemorrhage requiring emergency evacuation in the CFA group. In another study [1], the safety and efficacy of the Angio-Seal was assessed in 60 patients who underwent antegrade CFA punctures. The Angio-Seal proved to be effective
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and safe in antegrade CFA punctures, however, the SFA punctures were not assessed. Cicuto et al[11] evaluated the efficacy and safety of the Angio-Seal device in 50 antegrade punctures of the SFA in 30 patients with critical limb ischaemia. The Angio-Seal closure
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device was safe and effective in achieving haemostasis; nevertheless, there was no
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comparison with a CFA antegrade punctures group and the sample size was too small to draw any definitive conclusions. Lupattelli et al assessed the use of Angio-Seal closure device in a large diabetic population with critical limb ischemia demonstrating its safety and efficacy in both antegrade and retrograde CFA access [12]. The CIRSE vascular closure device registry examined 1107 closure device deployment (both retrograde and antegrade) in the period between January and August 2009. 84.7% of access type was retrograde with only 15.3% of antegrade type. There was a deployment success in excess of 97%. Deployment failure was 1.8% in the retrograde group compared to 8.8% in the antegrade 7
ACCEPTED MANUSCRIPT group (P=.001). No statistically significant difference in complications between the two groups, emphasizing the safety profile of both approaches [13].
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Limitations of this study should be acknowledged. This was a retrospective study of
prospectively collected data of a non-randomised design. Retrospective studies lack exposure control or the reporting on some variables and introduce selection and
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manner which reduces selection and information bias.
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misclassification bias. However, the data in our study was collected in a prospective robust
To conclude, this study demonstrates that the use of Angio-Seal closure device is a safe and effective method of haemostasis in antegrade punctures in both SFA and CFA groups. Ultrasound guided antegrade SFA punctures provide safe and quick access particularly in
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patients with challenging groins or unfavourable body habitus which could pose additional
[1]
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5. References
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hazard and further compromise the ability to attain haemostasis [14].
Looby S, Keeling AN, McErlean A, Given MF, Geoghegan T, Lee MJ. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol. 2008;31:558-562
[2]
Das R, Ahmed K, Athanasiou T, Morgan RA, Belli AM. Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: A systematic review and meta-analysis. Cardiovasc Intervent Radiol. 2011;34:723-738 8
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Lupattelli T, Tannouri F, Garaci FG et al. Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther. 2010,;17(3):366-75 Lucatelli P, Fanelli F, Cannavale A et al. Angioseal VIP® vs. Starclose SE® closure
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[4]
devices: a comparative analysis in non-cardiological procedures. J Cardiovasc Surg
[5]
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(Torino). 2013 Dec 5. [Epub ahead of print]
Kweon M, Bhamidipaty V, Holden A, Hill AA. Antegrade superficial femoral artery
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versus common femoral artery punctures for infrainguinal occlusive disease. J Vasc Interv Radiol. 2012;23:1160-1164 [6]
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology
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(STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7 [7]
Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, Orgill DP; STROCSS Group.
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The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery.
[8]
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Int J Surg. 2017;46: 198–202. Spiliopoulos S, Kitrou P, Christeas N, Karnabatidis D. Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients. Diagn Interv Radiol. 2016 Nov-Dec;22(6):542-547 [9]
Gutzeit A, Schoch E, Sautter T, Jenelten R, Graf N, Binkert CA. Antegrade access to the superficial femoral artery with ultrasound guidance: feasibility and safety. J Vasc Interv Radiol. 2010 Oct;21(10):1495-500. 9
ACCEPTED MANUSCRIPT [10]
Gutzeit A, Schoch E, Reischauer C, Hergan K, Jenelten R, Binkert CA. Comparison of a 21G micropuncture needle and a regular 19G access needle for antegrade arterial access into the superficial femoral artery. Cardiovasc Intervent Radiol. 2014 Apr;37(2):343-7. K. Cicuto, D. Mittleider, P. Kim. Safety and efficacy of the angioseal closure device
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[11]
with antegrade superficial femoral artery (SFA) access. Abstract. . J Vasc Interv
[12]
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Radiol. 2013;24:S118
Lupattelli T, Tannouri F, Garaci FG, Papa G, Pangos M, Somalvico F, Caravaggi C,
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Faglia E. Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther. 2010 Jun;17(3):366-75.
Jim A. Reekers, Stefan Müller-Hülsbeck, Martin Libicher, Eli Atar, Jens Trentmann,
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[13]
Pierre Goffette, Jan Borggrefe, Kamil Zeleňák, Pieter Hooijboer, Anna-Maria Belli.
50–53
Minko P, Katoh M, Gräber S, Buecker A. Obesity: an independent risk factor for
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[14]
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CIRSE Vascular Closure Device Registry. Cardiovasc Intervent Radiol. 2011 Feb; 34(1):
insufficient hemostasis using the AngioSeal vascular closure device after antegrade puncture. Cardiovasc Intervent Radiol. 2012 Aug;35(4):775-8.
Funding sources: The authors declare that there are no sources of funding for this work. Conflict of interest: None.
10
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Acknowledgements: None. CFA punctures
SFA punctures
n=70
n=158
Age (years)a
71.6(13.9)
75.4(11.2)
.050§
Male, n (%)
33(55)
90(67)
.110‡
6
69(99)
155(98)
1.000
8
1(1)
3(2)
1.000
57(81)
Angiogram
8(11)
113(72)
.113‡
27(17)
.274‡
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Angioplasty
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Intervention, n (%)
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Angio-Seal size (F), n (%)
P†
Angioplasty + stent
3(4)
10(6)
.539‡
Embolization
1(1)
5(3)
.669
Viabahn stent
1(1)
3(2)
1.000
67(96)
150(95)
.800‡
0(0)
5(3)
.327
1(1)
2(1)
1.000
1(1)
1(0.6)
.521
1(1)
0(0)
.307
Probable access site stenosis, n (%) Infection, n (%)
2(2.9)
1(0.6)
.226
0(0)
0(0)
---------
Embolisation, n (%)
0(0)
0(0)
---------
Indication, n (%)
AVM PAA Bone metastasis
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PVD
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Graft thrombosis
Table 1: Patients’ characteristics and antegrade punctures in the two groups. a Values are mean (s.d.), CFA; common femoral artery, SFA; superficial femoral artery, PVD; peripheral vascular disease, AVM; arteriovenous malformation, PAA; popliteal artery aneurysm. †Fisher’s exact probability test, except ‡ Pearson’s Chi-square test and §unpaired t-test. 11
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Highlights: Angio-Seal closure device is safe and effective in antegrade SFA and CFA punctures
•
Antegrade SFA puncture offers easier access in patients with unfavourable body habitus
•
Haemostasis and access site stenosis were comparable between the two groups
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•
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International Journal of Surgery Author Disclosure Form The following additional information is required for submission. Please note that failure to respond to these questions/statements will mean your submission will be returned. If you have nothing to declare in any of these categories then this should be stated.
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Please state any conflicts of interest
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None
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Please state any sources of funding for your research
None
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Please state whether Ethical Approval was given, by whom and the relevant Judgement’s reference number
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This study did not need ethical approval as it is retrospective and was done for service provision.
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Research Registration Unique Identifying Number (UIN) Please enter the name of the registry and the unique identifying number of the study. You can register your research at http://www.researchregistry.com to obtain your UIN if you have not already registered your study. This is mandatory for human studies only.
researchregistry3219
1
ACCEPTED MANUSCRIPT Author contribution Please specify the contribution of each author to the paper, e.g. study design, data collections, data analysis, writing. Others, who have contributed in other ways should be listed as contributors.
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TA collected that data and wrote the manuscript; YS analysed the data and wrote the manuscript; PK revised and corrected the manuscript; JI revised and corrected the manuscript; RS revised and corrected the manuscript.
Guarantor The Guarantor is the one or more people who accept full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
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EP
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TA, YS, RS
2
S1743-9191(17)31420-6
DOI:
10.1016/j.ijsu.2017.11.003
Reference:
IJSU 4286
To appear in:
International Journal of Surgery
Received Date: 9 June 2017 Revised Date:
31 October 2017
Accepted Date: 1 November 2017
Please cite this article as: Adlan T, Shahin Y, Kember P, Isaacs J, Seymour R, Retrospective cohort study on Angio-Seal closure device safety and effectiveness in antegrade superficial femoral artery punctures: A comparison with antegrade common femoral artery punctures, International Journal of Surgery (2017), doi: 10.1016/j.ijsu.2017.11.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Retrospective cohort study on Angio-Seal closure device safety and effectiveness in antegrade superficial femoral artery punctures: a comparison
Short Title: Angio-Seal for antegrade SFA punctures
RI PT
with antegrade common femoral artery punctures
1
SC
Tarig Adlan1 MBBS MRCP MRCS(Ed) FRCR PGCE FHEA EDiR, Yousef Shahin2 MD MD (Res) MRCS PGC, Peter Kember1 MB ChB MRCP FRCR, John Isaacs1 MB BS MRCP FRCR, Richard Seymour1 MB BChir MA MRCP FRCR Department of Radiology, Torbay Hospital NHS, Torquay, United Kingdom
2
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Academic Unit of Radiology, University of Sheffield and Sheffield Teaching Hospitals NHS, Sheffield, United Kingdom
Word count: 1945 excluding tables and references.
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Corresponding author: Dr Yousef Shahin
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NIHR Academic Clinical Fellow and Specialist Registrar in Clinical Radiology
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Academic Unit of Radiology,
University of Sheffield, Glossop Road, Sheffield, S10 2JF, United Kingdom Tel: 0114 243 4343
Email: [email protected]
ACCEPTED MANUSCRIPT
Abstract: Purpose: This retrospective study evaluates the effectiveness and safety of the Angio-Seal
femoral artery (CFA) antegrade punctures.
RI PT
closure device in superficial femoral artery (SFA) antegrade punctures compared to common
Methods: Over a period of 46 months from January 2012, consecutive patients who
SC
underwent antegrade CFA or SFA punctures using Angio-Seal as a closure device in a single centre were studied. Patients were identified by reading all the individual reports on our
M AN U
radiology system for all patients who underwent any angiographic examination during the study period, and their individual case notes were subsequently reviewed. A retrospective analysis of prospectively collected data on patients’ demographics, type of intervention, clinical indication, Angio-Seal size, haemostasis status and complications was performed.
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Results: Overall, 194 patients (mean (s.d.) age 74(12) years, 123(44%) males) underwent CFA or SFA antegrade punctures. A total of 228 (CFA group, n =70, SFA group, n=158)
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antegrade punctures were performed. Clinical characteristics of the two groups were comparable. Angio-Seal size 6F was deployed in 69(99%) antegrade CFA punctures and
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155(98%) antegrade SFA punctures (P=1.000). Haemostasis was achieved in 65(93%) antegrade CFA punctures compared to 156(99%) antegrade SFA punctures (P=.030).
Conclusion: Angio-Seal closure device is safe and effective method of haemostasis both in antegrade SFA and CFA punctures with no significant complications or delayed discharge.
Keywords: Angio-Seal, safety and efficacy, superficial femoral artery, antegrade puncture, common femoral artery, vascular closure device.
1
ACCEPTED MANUSCRIPT
1.Introduction The advances in percutaneous and endovascular treatment of peripheral arterial disease have revolutionised treatment of this group of patients replacing conventional surgical
RI PT
interventions. Percutaneous vascular interventions can be performed using retrograde or antegrade approaches. As more complex endovascular interventions are required, a nonorthodox access to lower limbs arteries for endovascular procedures has been adopted.
SC
Antegrade puncture of the superficial femoral artery (SFA) offers easier vascular access
particularly in patients with unfavourable body habitus and high body mass index with some
M AN U
controversy over achievement of haemostasis. Traditionally, haemostasis of arterial punctures has been achieved through manual compression of the punctures sites. Manual compression has been superseded with the advents of vascular closure devices which have
TE D
the added benefits of early ambulation and hastened discharge.
The Angio-Seal closure device (St.Jude Medical, St.Paul, Minnesota) efficacy and safety in CFA retrograde and antegrade endovascular interventions is widely established [1-4].
EP
Limited number of studies evaluated the effectiveness and safety of the Angio-Seal closure device in SFA antegrade punctures, which is outside the manufacturers’ IFU. Kweon et al[5]
AC C
compared outcomes between CFA and SFA antegrade punctures in patients undergoing infrainguinal arterial occlusive disease with no focus on the safety and effectiveness of the Angio-Seal closure device. The aim of this study is to evaluate the safety and effectiveness of the Angio-Seal closure device in antegrade SFA punctures compared to antegrade CFA punctures in a wide range of lower limbs vascular interventions for a variety of clinical indications.
2
ACCEPTED MANUSCRIPT
2. Materials and methods This is a retrospective cohort study of prospectively collected data in a single centre. Between January 2012 and October 2015, 194 consecutive patients who underwent
RI PT
antegrade SFA (SFA group) or CFA punctures (CFA group) for an arterial intervention were studied. Local Research and development department advised that ethical approval was not required as this review was service evaluation of existing practice. Patients were included in
SC
the study if they had an antegrade SFA or CFA punctures for any intervention on the lower limbs using Angio-Seal as a closure device. Patients were identified by reviewing every single
M AN U
report for any arterial procedure conducted in the study period. Patients were excluded from the study if they underwent retrograde arterial interventions or if any other closure device apart from Angio-Seal was deployed or indeed if any other method of haemostasis was used. Types of interventions and clinical indications are listed in table 1. Data on the
TE D
SFA and CFA groups including patients’ demographics, type of intervention, clinical indication, Angio-Seal closure device size, haemostasis status following intervention and on
EP
discharge and any minor or major complications was collected and analysed. Data was collected through reviewing every individual patient’s hospital notes. All performed
AC C
punctures were ultrasound guided. The suitability of the vessel for Angio-Seal deployment was assessed with ultrasound, decided by the vessel size (a minimum of 6 mm) and absence of atherosclerotic plaques on the anterior vessel wall. The effectiveness of the Angio-Seal was defined by its ability to adequately achieve haemostasis over the puncture site. The safety was defined by the presence of any associated complications. This study was reported in line with the STORBE and STROCCS statements [6,7].
3
ACCEPTED MANUSCRIPT
2.1. Statistical analysis A Statistical Package for the Social Sciences Program (SPSS) version 24 for Windows (SPSS Inc. Chicago, IL) was used for statistical analysis. Continuous variables were expressed as
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mean (s.d.) for parametric variables and median (interquartile range) for non-parametric variables. Categorical data was presented as the number of subjects and percentage.
Comparison between the groups (CFA and SFA) was performed using unpaired t-test for
SC
parametric variables and Mann-Whitney U test for non-parametric variables as appropriate. Categorical variables were compared using Fisher’s exact probability test and Pearson’s Chi-
was considered to be significant.
3. Results
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square test as appropriate. All statistical tests were two-sided and a P value of less than .050
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Over a period of 46 months from January 2012, 194 patients (mean age (s.d.) 74(12) years, 123(44%) males) were included in the analysis. Patients underwent a total of 228 antegrade
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arterial punctures with 228 Angio-Seals deployed (CFA group; n=70, SFA group; n=158). The target vessel (CFA and SFA) were purposefully punctured. 19 G Seldinger access needle was
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used in 100% of our patient’s cohort. There was no significant difference between the clinical characteristics, Angio-Seal size, type of interventions and clinical indications for interventions between the two groups (Table 1). 11(6%) patients had bilateral Angio-Seals deployed (CFA group; n=3, SFA group; n=8, P=.457). All patients had 3000 IU of intra-arterial heparin intraoperatively which is a standard dose in our institution for anticoagulation for lower limb arterial intervention. All procedures were performed by interventional radiologists.
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ACCEPTED MANUSCRIPT Angio-Seal median size in the two groups was comparable (6-French, range (6-8), P=.798). Angio-Seal size 6F was deployed in 69(99%) antegrade punctures in the CFA group and 155(98%) punctures in the SFA group (P=1.000). Haemostasis was achieved in 65(93%) antegrade punctures in the CFA group compared to 156(99%) punctures in the SFA group
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(P=.030). Three (4%) antegrade punctures in the CFA group and nine (6%) punctures in the SFA group resulted in small haematomas (P=.660) which resolved spontaneously with 1 (1%)
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puncture in the CFA group resulting in slow ooze from the puncture site requiring manual compression. 1 (0.6%) puncture in the SFA group resulted in a large haematoma which did
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not require intervention with no resultant delay in discharge. There were no major complications requiring further intervention in the two groups. There were three cases of probable access site stenosis. Two of these cases were in the CFA group (2.9%) and one case in the SFA group (0.6%). The difference between the two groups was statistically
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insignificant (P=.226).
Follow-up imaging for all patients was reviewed for a minimum period of 16 months
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(excluding those deceased) to identify cases of probable Angio-Seal related access site stenosis. Three cases in total were identified. Interestingly two of these patients (2.9%) were
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in the CFA group and one (0.6%) in the SFA group. The probable access site stenosis was identified at 25, 85 and 33 days post procedure respectively. There was no statistical difference between the two groups (P=.226). All three patients were managed conservatively.
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4. Discussion This is the first study with a large cohort of patients which specifically compared Angio-Seal arterial closure device outcomes between antegrade CFA and SFA punctures for a variety of
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clinical indications and a variety of endovascular interventions. Our standard practice for antegrade punctures is to use the SFA in preference if suitable (Adequate vessel size and absence of plaque) with Angio-Seal device for closure. Traditionally the CFA has been the
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preferred site of vascular access for peripheral arterial interventions, mostly due to vessel size and the ease to achieve haemostasis through conventional manual compression against
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the underlying bony femoral head. Most of the anxiety with direct SFA punctures arises from the lack of an underlying bony surface that provides the necessary support to achieve haemostasis through manual compression [8]. In our cohort of patients, the use ultrasound to assess the access vessel (minimum of 6 mm vessel diameter and absence of anterior
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vessel wall atheroma) meant that we could be reassured of the safety and efficiency of our approach. The routine use of ultrasound has been proven to enhance the safety profile in
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direct SFA punctures [9]. Whilst all of our punctures were ultrasound guided, we do not routinely use ultrasound for Angio-Seal deployment and hence none of our Angio-Seal
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deployments were under ultrasound guidance. We also believe that direct SFA access can potentially reduce the overall procedure time and subsequent radiation dose; although this was not formally assessed as it was outside the remit of this study. If the proximal SFA is not suitable our second choice is CFA with subsequent Angio-Seal for closure. If neither is suitable then we use a 4F low-profile system and manual compression. In this retrospective study of prospectively collected data on 228 antegrade punctures of the CFA and SFA, we evaluated the effectiveness and safety of the Angio-Seal closure device in antegrade SFA
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ACCEPTED MANUSCRIPT punctures compared to CFA antegrade punctures. 19 G needle was used as an access needle in 100% of our patients’ cohort. Gutzeit et al [10], compared the use of 21G to 19G needle in antegrade femoral access demonstrating a slightly higher rate of pseudo aneurysms in the
was significantly shorter in the 19G group.
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19G group. This was not statistically significant however. On the other hand, access time
Kweon et al [5] compared outcomes between CFA and SFA antegrade punctures in
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infrainguinal arterial occlusive disease where several types of closure devices were used. The Angio-Seal closure device was used in one patient who underwent a CFA antegrade
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puncture. The same study demonstrates higher rate of haemorrhagic complications including one case of retroperitoneal haemorrhage requiring emergency evacuation in the CFA group. In another study [1], the safety and efficacy of the Angio-Seal was assessed in 60 patients who underwent antegrade CFA punctures. The Angio-Seal proved to be effective
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and safe in antegrade CFA punctures, however, the SFA punctures were not assessed. Cicuto et al[11] evaluated the efficacy and safety of the Angio-Seal device in 50 antegrade punctures of the SFA in 30 patients with critical limb ischaemia. The Angio-Seal closure
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device was safe and effective in achieving haemostasis; nevertheless, there was no
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comparison with a CFA antegrade punctures group and the sample size was too small to draw any definitive conclusions. Lupattelli et al assessed the use of Angio-Seal closure device in a large diabetic population with critical limb ischemia demonstrating its safety and efficacy in both antegrade and retrograde CFA access [12]. The CIRSE vascular closure device registry examined 1107 closure device deployment (both retrograde and antegrade) in the period between January and August 2009. 84.7% of access type was retrograde with only 15.3% of antegrade type. There was a deployment success in excess of 97%. Deployment failure was 1.8% in the retrograde group compared to 8.8% in the antegrade 7
ACCEPTED MANUSCRIPT group (P=.001). No statistically significant difference in complications between the two groups, emphasizing the safety profile of both approaches [13].
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Limitations of this study should be acknowledged. This was a retrospective study of
prospectively collected data of a non-randomised design. Retrospective studies lack exposure control or the reporting on some variables and introduce selection and
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manner which reduces selection and information bias.
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misclassification bias. However, the data in our study was collected in a prospective robust
To conclude, this study demonstrates that the use of Angio-Seal closure device is a safe and effective method of haemostasis in antegrade punctures in both SFA and CFA groups. Ultrasound guided antegrade SFA punctures provide safe and quick access particularly in
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patients with challenging groins or unfavourable body habitus which could pose additional
[1]
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5. References
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hazard and further compromise the ability to attain haemostasis [14].
Looby S, Keeling AN, McErlean A, Given MF, Geoghegan T, Lee MJ. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol. 2008;31:558-562
[2]
Das R, Ahmed K, Athanasiou T, Morgan RA, Belli AM. Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: A systematic review and meta-analysis. Cardiovasc Intervent Radiol. 2011;34:723-738 8
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Lupattelli T, Tannouri F, Garaci FG et al. Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther. 2010,;17(3):366-75 Lucatelli P, Fanelli F, Cannavale A et al. Angioseal VIP® vs. Starclose SE® closure
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[4]
devices: a comparative analysis in non-cardiological procedures. J Cardiovasc Surg
[5]
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(Torino). 2013 Dec 5. [Epub ahead of print]
Kweon M, Bhamidipaty V, Holden A, Hill AA. Antegrade superficial femoral artery
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versus common femoral artery punctures for infrainguinal occlusive disease. J Vasc Interv Radiol. 2012;23:1160-1164 [6]
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology
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(STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7 [7]
Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, Orgill DP; STROCSS Group.
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The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery.
[8]
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Int J Surg. 2017;46: 198–202. Spiliopoulos S, Kitrou P, Christeas N, Karnabatidis D. Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients. Diagn Interv Radiol. 2016 Nov-Dec;22(6):542-547 [9]
Gutzeit A, Schoch E, Sautter T, Jenelten R, Graf N, Binkert CA. Antegrade access to the superficial femoral artery with ultrasound guidance: feasibility and safety. J Vasc Interv Radiol. 2010 Oct;21(10):1495-500. 9
ACCEPTED MANUSCRIPT [10]
Gutzeit A, Schoch E, Reischauer C, Hergan K, Jenelten R, Binkert CA. Comparison of a 21G micropuncture needle and a regular 19G access needle for antegrade arterial access into the superficial femoral artery. Cardiovasc Intervent Radiol. 2014 Apr;37(2):343-7. K. Cicuto, D. Mittleider, P. Kim. Safety and efficacy of the angioseal closure device
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[11]
with antegrade superficial femoral artery (SFA) access. Abstract. . J Vasc Interv
[12]
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Radiol. 2013;24:S118
Lupattelli T, Tannouri F, Garaci FG, Papa G, Pangos M, Somalvico F, Caravaggi C,
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Faglia E. Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther. 2010 Jun;17(3):366-75.
Jim A. Reekers, Stefan Müller-Hülsbeck, Martin Libicher, Eli Atar, Jens Trentmann,
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[13]
Pierre Goffette, Jan Borggrefe, Kamil Zeleňák, Pieter Hooijboer, Anna-Maria Belli.
50–53
Minko P, Katoh M, Gräber S, Buecker A. Obesity: an independent risk factor for
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[14]
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CIRSE Vascular Closure Device Registry. Cardiovasc Intervent Radiol. 2011 Feb; 34(1):
insufficient hemostasis using the AngioSeal vascular closure device after antegrade puncture. Cardiovasc Intervent Radiol. 2012 Aug;35(4):775-8.
Funding sources: The authors declare that there are no sources of funding for this work. Conflict of interest: None.
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Acknowledgements: None. CFA punctures
SFA punctures
n=70
n=158
Age (years)a
71.6(13.9)
75.4(11.2)
.050§
Male, n (%)
33(55)
90(67)
.110‡
6
69(99)
155(98)
1.000
8
1(1)
3(2)
1.000
57(81)
Angiogram
8(11)
113(72)
.113‡
27(17)
.274‡
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Angioplasty
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Intervention, n (%)
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Angio-Seal size (F), n (%)
P†
Angioplasty + stent
3(4)
10(6)
.539‡
Embolization
1(1)
5(3)
.669
Viabahn stent
1(1)
3(2)
1.000
67(96)
150(95)
.800‡
0(0)
5(3)
.327
1(1)
2(1)
1.000
1(1)
1(0.6)
.521
1(1)
0(0)
.307
Probable access site stenosis, n (%) Infection, n (%)
2(2.9)
1(0.6)
.226
0(0)
0(0)
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Embolisation, n (%)
0(0)
0(0)
---------
Indication, n (%)
AVM PAA Bone metastasis
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PVD
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Graft thrombosis
Table 1: Patients’ characteristics and antegrade punctures in the two groups. a Values are mean (s.d.), CFA; common femoral artery, SFA; superficial femoral artery, PVD; peripheral vascular disease, AVM; arteriovenous malformation, PAA; popliteal artery aneurysm. †Fisher’s exact probability test, except ‡ Pearson’s Chi-square test and §unpaired t-test. 11
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Highlights: Angio-Seal closure device is safe and effective in antegrade SFA and CFA punctures
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Antegrade SFA puncture offers easier access in patients with unfavourable body habitus
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Haemostasis and access site stenosis were comparable between the two groups
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This study did not need ethical approval as it is retrospective and was done for service provision.
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TA collected that data and wrote the manuscript; YS analysed the data and wrote the manuscript; PK revised and corrected the manuscript; JI revised and corrected the manuscript; RS revised and corrected the manuscript.
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TA, YS, RS
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