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189]

Original Article

Vascular Closure Device in Cardiac Cath Laboratory:

A Retrospective Observational Study
Surg R Adm Ravi Kalra, NM, VSM1, Surg Capt R. Ananthakrishnan1, Surg Cdr Sudhir Joshi1, Dr Jnanaprakash B. Karanth2
Departments of 1Medicine and Cardiology and 2Medicine, INHS Asvini, Mumbai, Maharashtra, India

Abstract
Objective: This study is to share our experience of using vascular closure device (VCD) after anterograde femoral arterial access at cardiac
cath lab. Background: Vascular access site management is crucial to safe, efficient, comfortable, and cost‑effective diagnostic or interventional
percutaneous cardiac procedures. As per the literature, femoral artery access site complications following angiographic procedures range from
1% to 5%. The Angioseal VCD has been shown to be safe and effective in reducing the time to hemostasis following angiographic or other
cardiac interventional procedures. Materials and Methods: This is a retrospective, observational study carried out at a tertiary care hospital of
the Armed Forces. All patients in whom Angioseal (St. Jude Medical) were deployed after undergoing either diagnostic coronary angiography
or percutaneous coronary intervention (PCI) through common femoral artery access. All patients from January 2011 to December 2016 in
whom VCD was either deployed or attempted were included in the study. Results: A total of 16245 patients were taken up for femoral access
for diagnostic procedures and PCI from 2011 to 2016. We observed 98.52% success rate with Angioseal and a mere 1.48% complication rate.
Out of the complications observed, only 2 (0.13%) patients had the serious complication of limb ischemia rest were all minor complications.
Conclusion: Our observations and experience with the Angioseal VCD are a safe, efficient, and resulting in more favorable patient outcomes.

Keywords: Angioseal – St Jude’s vascular closure device, coronary angiography, percutaneous coronary intervention, vascular
closure device

Introduction Starclose (Abbott Vascular), the Perclose (Abbott Vascular),

the Vasoseal (Datascope), and the Duett (Vascular Solutions).
Vascular access site management is crucial to safe, efficient,
They are frequently used to achieve hemostasis postvascular
comfortable, and cost‑effective diagnostic or interventional
puncture.
percutaneous procedures. Coronary angiography (CAG) and
percutaneous coronary intervention (PCI) are common methods The angioseal vascular closure device (VCD) closes the
for confirming the severity of coronary artery occlusion and defect in the CFA wall by percutaneous access through a
treating coronary artery disease, respectively. Femoral artery sheath. It consists of an absorbable polymer anchor deployed
access site complications following angiographic procedures intra‑arterially, a small collagen plug positioned in the
range from 1% to 5%.[1,2] arteriotomy, and a suture trimmed below the skin. Hemostasis
Before the introduction of arterial closure devices, all patients is achieved by sandwiching the collagen plug between the
who had common femoral arterial (CFA) puncture required anchor and the suture.[4] The angioseal VCD has been shown
manual compression of the puncture site for up to 20 min and to be safe and effective in reducing the time to hemostasis
bed rest for up to 12 h to achieve hemostasis. This treatment following angiographic or interventional procedures.[5]
was associated with rebleeding at the puncture site, was
costly regarding staff and inpatient hospital stay and was Address for correspondence: Surg Capt (Dr) R. Ananthakrishnan,
dissatisfying for the patient.[3] To overcome these problems, Department of Medicine and Cardiology, INHS Asvini, Near R C Church,
arterial closure devices were developed for retrograde Colaba, Mumbai ‑ 400 005, Maharashtra, India.
E‑mail: anantha25@yahoo.com
arterial puncture closure. Several such devices are now on
the market including the Angioseal (St. Jude Medical), the
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DOI: How to cite this article: Kalra R, Ananthakrishnan R, Joshi S,

10.4103/jmms.jmms_21_18 Karanth JB. Vascular closure device in cardiac cath laboratory: A
retrospective observational study. J Mar Med Soc 2018;20:4-8.

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Kalra, et al.: VCD – Our experience

Radial arterial accesses are preferred over femoral access

in present‑day practice. Radial arterial access is associated
with lower rates of major vascular complications, earlier
ambulation, lower costs and bleeding, comparable rates of
major adverse cardiac events, and need for blood transfusions.
It has around 4%–8% crossover to femoral access.[6‑8] The
most common complication with radial arterial access is
asymptomatic radial artery occlusion, which rarely leads to
clinical events owing to dual collateral perfusion of the hand.
Although rare, complications such as perforation, spasm, and
nerve damage can have serious clinical sequelae and lead to
morbidity. Brueck et al. compared radial with femoral access
in 1024 patients undergoing percutaneous diagnostic or
interventional procedures. Interestingly, even though 93% of
patients undergoing femoral access PCI received a Vascular
Compression Device, the radial approach was associated with Figure 1: Angioseal being deployed by a cardiologist in cath laboratory
a significantly lower rate of access‑site complications (0.58% at tertiary care hospital of the Armed Forces
vs. 3.71%) at the expense of longer procedural duration and
radiation exposure.[9] after the procedure after confirming the suitability of the
anatomy of the CFA for device deployment by taking an
The RIVAL one of the largest multinational and multicenter
ipsilateral sheath angiography in two orthogonal views, i.e.,
trial had included 7021 patients with acute coronary syndrome
the femoral artery puncture site at least 0.5 cm above the
undergoing with or without PCI to assess and compare radial
bifurcation. Guidewire provided with the Angioseal set was
and femoral arterial access.[8] The investigators could not
passed through the arterial sheath. Manual pressure was applied
show a difference in “hard” clinical end‑points, such as MI
at the puncture site, and the sheath was carefully removed over
and death, or indeed in the overall incidence of major bleeding
the wire. A 6F/8F Angioseal sheath was then passed over the
events. However, the incidence of access‑site complications
wire and placed into the artery. The anchor was set in position
was significantly reduced with radial access but cross over to
by deploying the device through the sheath. The anchor was
the other approach was significantly higher with radial than
then pulled back gently and the puncture sealed by pulling the
with femoral access. A 25% of patients in the femoral group
self‑tightening string. The string was then cut short to the skin.
received a VCD. The contrast load and median procedure time
A sterile dressing with minimal pressure was given over the exit
were similar in both groups, although median fluoroscopy
wound. The ipsilateral dorsalis pedis or posterior tibial artery
time was higher with radial access.[8] Additional studies are
pulsations were checked. The limb was immobilized for 4 h
necessary to further compare complications between radial
after which the patients were gradually mobilized.
access and femoral access with either manual compression or
other assisted device. However, in our study, we did not include
patients undergoing procedure from radial arterial access. Results
Relatively few studies have been conducted in India to assess A total of 16,245 patients were taken up for femoral access
the safety and efficacy of the use of the arterial closure device for diagnostic procedures and PCI from 2011 to 2016.
in a local setting. This study is to share our experience of Out of this, 14,647 cases were for diagnostic and 1598
using Angioseal after anterograde femoral arterial access for underwent intervention. Angioseal were deployed only after
CAG and PCI. femoral shoot taken under fluoroscopy and ascertaining
the suitability [Figure 2]. Angioseal was not deployed in
116 patients as they had unfavorable anatomy, i.e., puncture
Materials and Methods within 5 mm of the bifurcation (97), calcified iliofemoral (2)
A retrospective observational study was conducted at a tertiary and dissection of FA (5) or peripheral arterial disease (12).
care hospital of the Armed Forces. All patients in whom Of 1482 patients where we deployed angioseal, 1111 were
Angioseal (St. Jude Medical) was deployed after undergoing male, and 371 were female [Table 1]. Mean age of the patient
either diagnostic angiography or PCI through CFA access from group was 55 years, with a range of 28–82 years. A total of
January 2011 to December 2016 were included in the study. 1482 CFA punctures performed. A total of 1393 patients (94%)
The aim of the study was to assess patient comfort and observe had a right‑sided puncture, 48 patients (3.2%) had a
local site complication (s) postdeployment of the device. left‑sided puncture, and 42 patients (2.8%) had bilateral
punctures [Figure 3].
All procedures were carried out under standard conditions
by experienced interventional cardiologists, using the 6F and VCD failure to deploy is dependents on the type of device
8F Angioseal device [Figure 1]. In all patients, closure of the employed and patient’s characteristics. The VCD failure rate of
puncture site took place in the cath laboratory immediately deployment is low; however, the failure to deploy significantly

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Kalra, et al.: VCD – Our experience

increases the subsequent risk of vascular complication rates.[10] femoral access site was manually compressed, and hemostasis
Out of 1482 Angioseal deployments, 4 (0.26%) devices failed was achieved [Table 2].
to deploy. One patient had an acute femoral artery transmural Five patients (0.33%) continued to have ooze after deployment
tear with the failure of angioseal deployment when the of angioseal and manual pressure was applied for 49–120 min to
traction for deployment was applied; the patient was managed achieve hemostasis and the patient was advised for immobilization
with surgical repair of the rent in the femoral artery after of lower limb for up to 12 h duration. Out of the five, two patients
measures‑like balloon tamponade through the contralateral had undergone angioplasty twice earlier and hence had multiple
approach and glue application, etc., had failed. The patient femoral punctures in the past with fibrosis in the groin area.
was a 78‑year‑old elderly male who had undergone PCI twice
earlier and was on antiplatelets. In other three patients, the Eight patients (0.53%) developed local hematoma of more
than 5 cm and required some additional manual compression

Table 1: Patient profile (n=1482)

Patient Profile Number of Patients
Gender
Male 1111
Female 371
Age
Mean 55
Range 28‑82
Access side (%)
Right 1393 (94)
Left 48 (3.2)
Bilateral 42 (2.8)
Procedure (angiography)
Diagnostic 96 cases
Figure 2: Femoral shoot taken under fluoroscopy before angioseal PCI 1386 cases
deployment PCI: Percutaneous coronary intervention

From 2011 to 2016,

16245 patients underwent coronary
intervention from femoralartery access

14763 Excluded
(VCD not deployed)
14647 patients
underwent diagnostic
procedure
1482 Patients VCD Deployed 116 patients with
• 1111 – Male coronary intervention
• 371 - Female excluded:
• Unfavorable anatomy (97)
• Calcified Iliofemoral
No complication artery(02)
1460 (98.52%) • Dissection of femoral
artery (05)
• Preexisting Peripheral artery
Complications observed disease (12)
22 (1.48%)

Failure of deploy Ooze of blood Aneurysm

Local Hematoma Limb ischemia
device post deployment of artery
08 (0.53%) 02 (0.13%)
04 (0.26%) 05 (0.33%) 01 (0.07%)

Vasovagal response
02 (0.13%)

Figure 3: Flow chart of patients enrolled and complications observed. Coronary angiography (CAG), percutaneous coronary intervention (PCI) and
Vascular Closure Device (VCD)

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Kalra, et al.: VCD – Our experience

1–2 h.[12] We had restricted our patient from ambulation for

Table 2: Various complications with Angioseal observed
4 h. Eighty percent of patients who underwent diagnostic
in our study (n=1482)
angiography and received an Angioseal were discharged from
Complication Number of patients (%) the hospital within 24 h.
Failure of deploy device 4 (0.26)
Ooze of blood postdeployment 5 (0.33)
The study done by Wu P‑J at their center in Taiwan revealed
Local hematoma 8 (0.53)
overall complication rate of 3.8% with VCD group following
Limb ischemia 2 (0.13) transfemoral coronary procedures. However, the VCD was
Aneurysm of artery 1 (0.07) deployed only in 65 persons.[13] The Cochrane review of
Vasovagal response 2 (0.13) 52 studies by Robertson et  al. revealed no differences in
the incidence of infection between collagen‑based VCD
and extrinsic compression. The rate of groin hematoma and
with no surgical intervention. Of these, seven were on injection pseudoaneurysm was lower with collagen‑based VCDs than
abciximab/eptifibatide infusion postangioplasty. In all the eight with extrinsic compression.[14]
patients, a 7F sheath had been used, where 8F Angioseal was
deployed. One patient had acute onset local site hemorrhage We observed 98.52% success rate with Angioseal and a
48 h after deployment of Angioseal, which was managed mere 1.48% complication rate [Figure 3]. The high efficacy,
with sustained manual pressure. No bleeding complications low complication rate, early patient discharge rate, and
occurred with any 6F device. uncomplicated resting rate are comparable to those in
previous studies.[12,15,16] Out of the complications observed
Two patients (0.13%) developed lower limb ischemia. Both of only 2 (0.13%), patients had the serious complication of limb
them developed acute ischemia, developed pain in the right leg ischemia and the rest were all minor complications.
and pale appearance, pulse was not palpable in the posterior
tibial artery. He had to undergo intervention by balloon
angioplasty urgently at DSA to relieve the symptoms. On
Conclusion
follow‑up, one patient complained of claudication and rest pain Our observations and experience with the angioseal VCD
in the limb in which angioseal was deployed. The subsequent is a safe, efficient, and resulting in more favorable patient
angiography had revealed significant narrowing of the CFA, outcomes.
which was managed with repeat ballooning. Study limitations
One patient (0.07%) was found to have aneurysm in femoral Few limitation of our study is it is a retrospective, observational
artery and had to undergo vascular surgery. study. The complications of VCD deployment with manual
compression used for hemostasis following femoral access
Two patients (0.13%) had vasovagal response during were not compared. The benefit of VCD with radial access
deploying the angioseal device. The patient had a sudden for CAG and PCI was not assessed. Only one brand of
onset of bradycardia with perspiration and hypotension. The VCD (collagen based) was used in our study; hence, the results
patient was managed conservatively with atropine and other cannot be generalized to other VCD.
supportive measures.
Recommendation
Further work is necessary to compare the advantages and
Discussion complication associated with the deployment of VCD against
The practice followed before the use of Angioseal VCD in manual compression to achieve hemostasis following femoral
our hospital was manual or mechanical compression over the access. A study for analysis of advantages and benefits of VCD
puncture site which compelled the patient to be immobilized over radial access for coronary intervention may be carried
for at least 12 h following any procedure through femoral out. A study to evaluate the efficacy of various types of VCD
access. The disadvantages of above practice included patient may be carried out.
discomfort from the groin pressure and bed rest resulting in
complaints of low backache in elderly patients as well as Financial support and sponsorship
increased workload for medical staff and a prolonged hospital Nil.
stay.[11] The Angioseal VCD offers the advantages of rapid Conflicts of interest
removal of the vascular sheath, immediate hemostasis, early There are no conflicts of interest.
ambulation, and hospital discharge, with less consumption of
hospital staff time.
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