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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 20  |  Issue : 1  |  Page : 4-8

Vascular closure device in cardiac cath laboratory: A retrospective observational study


1 Department of Medicine and Cardiology, INHS Asvini, Mumbai, Maharashtra, India
2 Department of Medicine, INHS Asvini, Mumbai, Maharashtra, India

Date of Web Publication9-Jul-2018

Correspondence Address:
Surg Capt R Ananthakrishnan
Department of Medicine and Cardiology, INHS Asvini, Near R C Church, Colaba, Mumbai - 400 005, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmms.jmms_21_18

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  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


How to cite this article:
Kalra R, Ananthakrishnan R, Joshi S, Karanth JB. Vascular closure device in cardiac cath laboratory: A retrospective observational study. J Mar Med Soc 2018;20:4-8

How to cite this URL:
Kalra R, Ananthakrishnan R, Joshi S, Karanth JB. Vascular closure device in cardiac cath laboratory: A retrospective observational study. J Mar Med Soc [serial online] 2018 [cited 2018 Jul 19];20:4-8. Available from: http://www.marinemedicalsociety.in/text.asp?2018/20/1/4/236248


  Introduction Top


Vascular access site management is crucial to safe, efficient, comfortable, and cost-effective diagnostic or interventional percutaneous procedures. Coronary angiography (CAG) and percutaneous coronary intervention (PCI) are common methods for confirming the severity of coronary artery occlusion and treating coronary artery disease, respectively. Femoral artery access site complications following angiographic procedures range from 1% to 5%.[1],[2]

Before the introduction of arterial closure devices, all patients who had common femoral arterial (CFA) puncture required manual compression of the puncture site for up to 20 min and bed rest for up to 12 h to achieve hemostasis. This treatment was associated with rebleeding at the puncture site, was costly regarding staff and inpatient hospital stay and was dissatisfying for the patient.[3] To overcome these problems, arterial closure devices were developed for retrograde arterial puncture closure. Several such devices are now on the market including the Angioseal (St. Jude Medical), the Starclose (Abbott Vascular), the Perclose (Abbott Vascular), the Vasoseal (Datascope), and the Duett (Vascular Solutions). They are frequently used to achieve hemostasis postvascular puncture.

The angioseal vascular closure device (VCD) closes the defect in the CFA wall by percutaneous access through a sheath. It consists of an absorbable polymer anchor deployed intra-arterially, a small collagen plug positioned in the arteriotomy, and a suture trimmed below the skin. Hemostasis is achieved by sandwiching the collagen plug between the anchor and the suture.[4] The angioseal VCD has been shown to be safe and effective in reducing the time to hemostasis following angiographic or interventional procedures.[5]

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],[7],[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 a significantly lower rate of access-site complications (0.58% vs. 3.71%) at the expense of longer procedural duration and radiation exposure.[9]

The RIVAL one of the largest multinational and multicenter trial had included 7021 patients with acute coronary syndrome undergoing with or without PCI to assess and compare radial and femoral arterial access.[8] The investigators could not show a difference in “hard” clinical end-points, such as MI and death, or indeed in the overall incidence of major bleeding events. However, the incidence of access-site complications was significantly reduced with radial access but cross over to the other approach was significantly higher with radial than with femoral access. A 25% of patients in the femoral group received a VCD. The contrast load and median procedure time were similar in both groups, although median fluoroscopy time was higher with radial access.[8] Additional studies are necessary to further compare complications between radial 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.

Relatively few studies have been conducted in India to assess the safety and efficacy of the use of the arterial closure device in a local setting. This study is to share our experience of using Angioseal after anterograde femoral arterial access for CAG and PCI.


  Materials and Methods Top


A retrospective observational study was conducted at a tertiary care hospital of the Armed Forces. All patients in whom Angioseal (St. Jude Medical) was deployed after undergoing either diagnostic angiography or PCI through CFA access from January 2011 to December 2016 were included in the study. The aim of the study was to assess patient comfort and observe local site complication (s) postdeployment of the device.

All procedures were carried out under standard conditions by experienced interventional cardiologists, using the 6F and 8F Angioseal device [Figure 1]. In all patients, closure of the puncture site took place in the cath laboratory immediately after the procedure after confirming the suitability of the anatomy of the CFA for device deployment by taking an ipsilateral sheath angiography in two orthogonal views, i.e., the femoral artery puncture site at least 0.5 cm above the bifurcation. Guidewire provided with the Angioseal set was passed through the arterial sheath. Manual pressure was applied at the puncture site, and the sheath was carefully removed over the wire. A 6F/8F Angioseal sheath was then passed over the wire and placed into the artery. The anchor was set in position by deploying the device through the sheath. The anchor was then pulled back gently and the puncture sealed by pulling the self-tightening string. The string was then cut short to the skin. A sterile dressing with minimal pressure was given over the exit wound. The ipsilateral dorsalis pedis or posterior tibial artery pulsations were checked. The limb was immobilized for 4 h after which the patients were gradually mobilized.
Figure 1: Angioseal being deployed by a cardiologist in cath laboratory at tertiary care hospital of the Armed Forces

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  Results Top


A total of 16,245 patients were taken up for femoral access for diagnostic procedures and PCI from 2011 to 2016. Out of this, 14,647 cases were for diagnostic and 1598 underwent intervention. Angioseal were deployed only after 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 within 5 mm of the bifurcation (97), calcified iliofemoral (2) and dissection of FA (5) or peripheral arterial disease (12). Of 1482 patients where we deployed angioseal, 1111 were male, and 371 were female [Table 1]. Mean age of the patient group was 55 years, with a range of 28–82 years. A total of 1482 CFA punctures performed. A total of 1393 patients (94%) had a right-sided puncture, 48 patients (3.2%) had a left-sided puncture, and 42 patients (2.8%) had bilateral punctures [Figure 3].
Figure 2: Femoral shoot taken under fluoroscopy before angioseal deployment

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Table 1: Patient profile (n=1482)

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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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VCD failure to deploy is dependents on the type of device employed and patient's characteristics. The VCD failure rate of deployment is low; however, the failure to deploy significantly increases the subsequent risk of vascular complication rates.[10] Out of 1482 Angioseal deployments, 4 (0.26%) devices failed to deploy. One patient had an acute femoral artery transmural tear with the failure of angioseal deployment when the traction for deployment was applied; the patient was managed with surgical repair of the rent in the femoral artery after measures-like balloon tamponade through the contralateral approach and glue application, etc., had failed. The patient was a 78-year-old elderly male who had undergone PCI twice earlier and was on antiplatelets. In other three patients, the femoral access site was manually compressed, and hemostasis was achieved [Table 2].
Table 2: Various complications with Angioseal observed in our study (n=1482)

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Five patients (0.33%) continued to have ooze after deployment of angioseal and manual pressure was applied for 49–120 min to achieve hemostasis and the patient was advised for immobilization of lower limb for up to 12 h duration. Out of the five, two patients had undergone angioplasty twice earlier and hence had multiple femoral punctures in the past with fibrosis in the groin area.

Eight patients (0.53%) developed local hematoma of more than 5 cm and required some additional manual compression with no surgical intervention. Of these, seven were on injection abciximab/eptifibatide infusion postangioplasty. In all the eight patients, a 7F sheath had been used, where 8F Angioseal was deployed. One patient had acute onset local site hemorrhage 48 h after deployment of Angioseal, which was managed with sustained manual pressure. No bleeding complications occurred with any 6F device.

Two patients (0.13%) developed lower limb ischemia. Both of them developed acute ischemia, developed pain in the right leg 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 follow-up, one patient complained of claudication and rest pain in the limb in which angioseal was deployed. The subsequent angiography had revealed significant narrowing of the CFA, which was managed with repeat ballooning.

One patient (0.07%) was found to have aneurysm in femoral artery and had to undergo vascular surgery.

Two patients (0.13%) had vasovagal response during deploying the angioseal device. The patient had a sudden onset of bradycardia with perspiration and hypotension. The patient was managed conservatively with atropine and other supportive measures.


  Discussion Top


The practice followed before the use of Angioseal VCD in our hospital was manual or mechanical compression over the puncture site which compelled the patient to be immobilized for at least 12 h following any procedure through femoral access. The disadvantages of above practice included patient discomfort from the groin pressure and bed rest resulting in complaints of low backache in elderly patients as well as increased workload for medical staff and a prolonged hospital stay.[11] The Angioseal VCD offers the advantages of rapid removal of the vascular sheath, immediate hemostasis, early ambulation, and hospital discharge, with less consumption of hospital staff time.

The cost of an Angioseal device is offset by the reduction in hospital stay and superior patient satisfaction with early ambulation postprocedure compared to manual compression. The exact time to ambulation was not uniformly recorded in literature; however, most of the studies have reported as 1–2 h.[12] We had restricted our patient from ambulation for 4 h. Eighty percent of patients who underwent diagnostic angiography and received an Angioseal were discharged from the hospital within 24 h.

The study done by Wu P-J at their center in Taiwan revealed overall complication rate of 3.8% with VCD group following transfemoral coronary procedures. However, the VCD was deployed only in 65 persons.[13] The Cochrane review of 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 pseudoaneurysm was lower with collagen-based VCDs than with extrinsic compression.[14]

We observed 98.52% success rate with Angioseal and a mere 1.48% complication rate [Figure 3]. The high efficacy, low complication rate, early patient discharge rate, and uncomplicated resting rate are comparable to those in previous studies.[12],[15],[16] Out of the complications observed only 2 (0.13%), patients had the serious complication of limb ischemia and the rest were all minor complications.


  Conclusion Top


Our observations and experience with the angioseal VCD is a safe, efficient, and resulting in more favorable patient outcomes.

Study limitations

Few limitation of our study is it is a retrospective, observational study. The complications of VCD deployment with manual compression used for hemostasis following femoral access were not compared. The benefit of VCD with radial access for CAG and PCI was not assessed. Only one brand of VCD (collagen based) was used in our study; hence, the results cannot be generalized to other VCD.

Recommendation

Further work is necessary to compare the advantages and complication associated with the deployment of VCD against manual compression to achieve hemostasis following femoral access. A study for analysis of advantages and benefits of VCD over radial access for coronary intervention may be carried out. A study to evaluate the efficacy of various types of VCD may be carried out.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Heintzen MP, Strauer BE. Peripheral arterial complications after heart catheterization. Herz 1998;23:4-20.  Back to cited text no. 1
    
2.
Meyerson SL, Feldman T, Desai TR, Leef J, Schwartz LB, McKinsey JF, et al. Angiographic access site complications in the era of arterial closure devices. Vasc Endovasc Surg 2002;36:137-44.  Back to cited text no. 2
    
3.
Duda SH, Wiskirchen J, Erb M, Schott U, Khaligi K, Pereira PL, et al. Suture-mediated percutaneous closure of antegrade femoral arterial access sites in patients who have received full anticoagulation therapy. Radiol 1999;210:47-52.  Back to cited text no. 3
    
4.
O'Sullivan GJ, Buckenham TM, Belli AM. The use of the angio-seal haemostatic puncture closure device in high risk patients. Clin Radiol 1999;54:51-5.  Back to cited text no. 4
    
5.
Ratnam LA, Raja J, Munneke GJ, Morgan RA, Belli AM. Prospective nonrandomized trial of manual compression and angio-seal and starclose arterial closure devices in common femoral punctures. Cardiovasc Intervent Radiol 2007;30:182-8.  Back to cited text no. 5
    
6.
Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, et al. Transradial cardiac catheterization: A review of access site complications. Catheter Cardiovasc Interv 2011;78:840-6.  Back to cited text no. 6
    
7.
Chase AJ, Fretz EB, Warburton WP, Klinke WP, Carere RG, Pi D, et al. Association of the arterial access site at angioplasty with transfusion and mortality: The M.O.R.T.A.L study (Mortality benefit of reduced transfusion after percutaneous coronary intervention via the arm or leg). Heart 2008;94:1019-25.  Back to cited text no. 7
    
8.
Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): A randomised, parallel group, multicentre trial. Lancet 2011;377:1409-20.  Back to cited text no. 8
    
9.
Brueck M, Bandorski D, Kramer W, Wieczorek M, Höltgen R, Tillmanns H, et al. A randomized comparison of transradial versus transfemoral approach for coronary angiography and angioplasty. JACC Cardiovasc Interv 2009;2:1047-54.  Back to cited text no. 9
    
10.
Vidi VD, Matheny ME, Govindarajulu US, Normand SL, Robbins SL, Agarwal VV, et al. Vascular closure device failure in contemporary practice. JACC Cardiovasc Interv 2012;5:837-44.  Back to cited text no. 10
    
11.
Park Y, Roh HG, Choo SW, Lee SH, Shin SW, Do YS, et al. Prospective comparison of collagen plug (Angio-seal) and suture-mediated (the closer S) closure devices at femoral access sites. Korean J Radiol 2005;6:248-55.  Back to cited text no. 11
    
12.
Mukhopadhyay K, Puckett MA, Roobottom CA. Efficacy and complications of angioseal in antegrade puncture. Eur J Radiol 2005;56:409-12.  Back to cited text no. 12
    
13.
Wu PJ, Dai YT, Kao HL, Chang CH, Lou MF. Access site complications following transfemoral coronary procedures: Comparison between traditional compression and angioseal vascular closure devices for haemostasis. BMC Cardiovasc Disord 2015;15:34.  Back to cited text no. 13
    
14.
Robertson L, Andras A, Colgan F, Jackson R. Vascular closure devices for femoral arterial puncture site haemostasis. Cochrane Database Syst Rev 2016;3:CD009541.  Back to cited text no. 14
    
15.
Looby S, Keeling AN, McErlean A, Given MF, Geoghegan T, Lee MJ, et al. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol 2008;31:558-62.  Back to cited text no. 15
    
16.
Smilowitz NR, Kirtane AJ, Guiry M, Gray WA, Dolcimascolo P, Querijero M, et al. Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures. Am J Cardiol 2012;110:177-82.  Back to cited text no. 16
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2]



 

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