Introduction
In recent years, the number
of patients undergoing peripheral endovascular interventions has increased.(1)
The commonest access site for endovascular interventions is the common femoral artery,(2,3)
which is used as a port to deliver catheters, balloons, and stents.
Accessing the femoral artery can be associated with
complications that can result in significant patient discomfort, and may
require more advanced clinical interventions, such as blood transfusion or even
vascular surgery.(2,4)
Hemostasis at the femoral access site is classically
achieved by manual compression.(1,5) However, in recent years
we have witnessed the emergence of a variety of vascular closure devices, which
are used to achieve hemostasis at the femoral access site, decreasing the risk
of bleeding and the time to ambulation, particularly in high risk patients.(2,6-9)
This is a retrospective review, of a single center
study, conducted at King Hussein Medical
Center to assess the results of
Starclose Vascular Closure System (Abbott Vascular, Redwood City, CA)
used to manage the femoral arterial access site in 69 patients. The technical
success of the device, as well as associated complications were evaluated.
Methods
During the year 2009, a total of 244 patients
underwent transfemoral peripheral endovascular intervention at King Hussein
Medical Center.
Of these patients, 213 patients underwent therapeutic (angioplasty, stenting,
and/or intra arterial thrombolysis) transfemoral peripheral endovascular
intervention, via a retrograde approach. The right common femoral artery was
accessed in 136 patients,and the left common femoral artery was accessed in 77 patients. A single-wall puncture technique was used. The access sheath size was 6 or 7 Fr.
In 175 patients, the common
femoral artery access sheath was pulled out after the procedure, and manual
compression was used to achieve hemostasis.
In 69 patients who were considered to be at high risk for
bleeding from the access site a percutaneous vascular clip closure device was
used to close the femoral access in our study group. The indications for use of
vascular clip closure device are shown in Table I. The device was deployed
according to the technique recommended by the manufacturer, and approved by the
Food and Drug Administration.
Achieving hemostasis after the deployment of the
device, with or without applying three minutes or less of manual compression
was considered as immediate hemostasis. Technical success of the device was
defined as successful deployment of the device followed by immediate hemostasis.
Unsuccessful deployment of the device or failure to achieve immediate hemostasis
was considered as technical failure of the device.
A 2 hour bed rest was advised after successful
deployment of the device. A 6 hours bed rest was advised following device
failure, or for patients treated primarily by manual compression.
The success of the device
was evaluated, as well as complications related to the use of the device.
The angiographic and
interventional procedures were performed in the interventional radiology
section. Advanced medical treatments, or surgical interventions were carried
out in the Vascular Surgery Department.
Results
Technical success was
encountered in 65 patients (94%). Failure to deploy the device occurred in one
patient. In 3 patients there was persistent bleeding from the access site after
deploying the device for more than 3 minutes despite manual compression. Manual
compression was used to achieve hemostasis in cases of device failure.
In the group of patient who
met the definition of technical device success, two patients presented with non
expanding groin hematoma within 48 hours of the procedure, and were treated
conservatively. Another patient represented with a retroperitoneal hematoma
that necessitated admission to the hospital, and blood transfusion. The patient
had no progression in the heamatoma, and was discharged after 3 days.
In the group who met the
definition of technical device failure, one patient presented with a common
femoral artery pseudoaneurysm, which was treated by compression under
ultrasound guidance. The technical device success and failure, along with
encountered complications are shown in Table II.
Our study shows a high technical success rate of the
device with the advantage of early mobilization of the patients, and with
acceptable complication rates.
Discussion
Recent technical advances in
the endovascular interventional field, combined with the increase in the number
of peripheral vascular patients have resulted in establishing peripheral
endovascular interventions as a major part of the clinical practice in most of
the world's medical centers.
In the majority of these
interventions, the common femoral artery is primary vascular access,(2,3)
because of its anatomical accessibility, and the ability to achieve hemostasis by
compression against the head of femoral bone.
Accessing the femoral artery can result in
complications. Minor complications
include bleeding not requiring transfusion or surgical intervention, hematoma
(<5 cm), and pain at puncture site. Major complications include hematoma
(>5 cm), bleeding requiring transfusion or surgical intervention,
pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage, plug embolization,
and groin infection.(10)
Minor access site related complications occur in about
to 10% of patients undergoing transfemoral endovascular interventions, and 1-2%
of these complications require vascular surgical intervention or blood
transfusion.(2)
Many studies have suggested that several factors
including concomitant anticoagulation or antiplatelets therapy tends to
increase the risk of complications in the vascular access sites when only
manual compression is used.(2,11)
Bleeding at the access site
is a commonest encountered complication, and over the years, several vascular
closure devices have been developed to help achieve hemostasis especially in
patients who are at a higher risk of bleeding.(7,12)
The increase in the number of performed interventional
procedures, as well as the more liberal use of new anti-platelet agents, has
resulted in increased risk of bleeding with resultant increase in the frequency
of closure devices usage.(13-15)
The StarClose Vascular Closure System (Abbott Vascular,
Redwood City, CA) is a unique vascular closure device,
currently used in our institute, which utilizes a nitinol clip to achieve
vascular closure.(16-18)
In this retrospective review conducted at King Hussein
Medical Center,
we have included patients who have underwent transfemoral endovascular
intervention during the year 2009. In patients who were considered to be at high
risk for bleeding, the femoral access was managed by Starclose device at the
end of the procedure. The success of the device to achieve hemostasis, as well
as the occurrence of complications at the access site was evaluated.
Apart from 4 cases where we encountered failure of the
Starclose device, there was a high technical success rate in achieving immediate
hemostasis (94%).
Conclusion
Femoral arterial access clip
closure devices are both safe and effective, and are advised to be used in
patient at high risk of bleeding at the arterial access site.
References
1.Kalapatapu VR, Ali
AT, Masroor F, et al. Techniques for managing complications of arterial closure
devices. Vasc Endovascular Surg 2006; 40(5): 399-408.
2.Kim, H, Choo, S, Roh, H, et al. Efficacy
of Femoral Vascular Closure Devices in Patients Treated with Anticoagulant,
Abciximab or Thrombolytics during Percutaneous Endovascular Procedures. Korean J Radiol 2006; 7(1): 35–40.
3.Bangalore S, Arora N, Resnic F. Vascular Closure Device Failure:
Frequency and Implications: A Propensity Matched Analysis. Circ Cardiovasc
Interv 2009; 2(6): 549–556.
4.Kahn ZM, Kumar M,
Hollander G, Frankel R.
Safety and efficacy of the Perclose suture-mediated closure device after
diagnostic and interventional catheterizations in a large consecutive
population. Catheter Cardiovasc Interv 2002; 55:8-13.
5.Park Y, Roh H,
Choo S, et al. Prospective
Comparison of Collagen Plug (Angio-SealTM) and Suture-Mediated (the Closer STM)
Closure Devices at Femoral Access Sites. Korean J Radiol 2005;
6:248-255.
6.Grollman JH Jr. Percutaneous arterial access closure: now
do we have the be all and end all? not yet!. Catheter Cardiovasc Interv
2000; 49:148-149.
7.Assali AR,
Sdringola S, Moustapha A, et al. Outcome of access site in patients treated with platelet
glycoprotein IIb/IIIa inhibitors in the era of closure devices. Catheter
Cardiovasc Interv 2003; 58:1-5.
8.Hermann, L, Chow, E, Duvall WL. Iatrogenic claudication from a vascular closure
device after cardiac catheterization. West J Emerg Med 2010;
11(5):512-513.
9.Meyerson SL,
Feldman T, Desai TR, et al. Angiographic access site complications in the era of arterial
closure devices. Vasc Endovascular Surg 2002; 36(2); 137-44.
10.Lewis-Carey MB, Kee ST. Complications of arterial closure devices.
Tech Vasc Interv Radiol 2003; 6(2): 103-6.
11. Kresowik TF, Khoury
MD, Miller BV, et al. Aprospective study of the incidence and natural history of
femoral vascular complications after percutaneous transluminal coronary
angioplasty. J Vasc Surg 1991; 13:328-333.
12. Resnic FS, Blake
GJ, Ohno-Machado L, et al. Vascular closure devices and the risk of vascular complications
after percutaneous coronary intervention in patients receiving glycoprotein
IIb-IIIa inhibitors. Am J Cardiol 2001; 88:493-496
13. Michalis LK, Rees
MR, Patsouras D, et al. A prospective randomized trial comparing the safety and efficacy
of three commercially available closure devices (Angio-Seal, Vasoseal and
Duett). Cardiovasc Intervent Radiol 2002; 25:423-429.
14. Tiroch K, Matheny
M, Resnic F. Quantitative
Impact of Cardiovascular Risk Factors and Vascular Closure Devices on the
Femoral Artery after Repeat Cardiac Catheterization. Am Heart J 2010;
159(1):125.
15. Resnic, F, Arora
N, Matheny, M, et al. A Cost-Minimization Analysis of the Angioseal Vascular Closure Device
following Percutaneous Coronary Intervention. Am J Cardiol 2007; 99(6):
766–770.
16.Jaff MR, Hadley G,
Hermiller JB, et al. The safety and efficacy of the StarClose Vascular Closure
System: the ultrasound substudy of the CLIP study. Catheter Cardiovasc
Interv 2006; 68(5): 684-689.
17.Gray BH, Miller R,
Langan EM, et al. The utility of the StarClose arterial closure device in
patients with peripheral arterial disease. Ann Vasc Surg 2009; 23(3);
341-344.
18. Hermiller JB, Simonton C, Hinohara T, et al. The star close vascular closure system:
interventional results from the CLIP study. Catheter Cardiovasc Interv 2006;
68(5): 677-683.