|Year : 2018 | Volume
| Issue : 1 | Page : 4-8
Vascular closure device in cardiac cath laboratory: A retrospective observational study
Ravi Kalra NM, VSM 1, R Ananthakrishnan1, Sudhir Joshi1, Jnanaprakash B Karanth2
1 Department of Medicine and Cardiology, INHS Asvini, Mumbai, Maharashtra, India
2 Department of Medicine, INHS Asvini, Mumbai, Maharashtra, India
|Date of Web Publication||9-Jul-2018|
Surg Capt R Ananthakrishnan
Department of Medicine and Cardiology, INHS Asvini, Near R C Church, Colaba, Mumbai - 400 005, Maharashtra
Source of Support: None, Conflict of Interest: None
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
| Introduction|| |
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%.,
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. 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. The angioseal VCD has been shown to be safe and effective in reducing the time to hemostasis following angiographic or interventional procedures.
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.,, 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.
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. 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. 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|| |
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|| |
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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|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. 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|| |
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. 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. 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. 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.
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.,, 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|| |
Our observations and experience with the angioseal VCD is a safe, efficient, and resulting in more favorable patient outcomes.
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.
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
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]