Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures—A randomized controlled trial

doi:10.1016/j.ejrad.2006.09.007

European Journal of Radiology

Volume 61, Issue 2, February 2007, Pages 332-334

https://doi.org/10.1016/j.ejrad.2006.09.007 Get rights and content

Abstract

The aim of this study was to compare the angioseal device to manual compression for femoral artery puncture following peripheral vascular procedures, in the context of day case vascular procedures.

One hundred patients were prospectively randomised to haemostasis using the angioseal device or manual compression following arterial puncture for peripheral vascular diagnostic or intervention procedures. Data were collected regarding time to haemostasis and complications immediately post-procedure, at 1 h, 2 h and at 1 week.

There were 50 patients in each group. There were no significant differences in demographic variables, or in complication rates immediately, at 1 h, 2 h and at 1 week (Chi-squared). The only significant difference between the two groups was time to haemostasis. The mean time to haemostasis in the compression group was 10.6 min and 2.0 min in the angioseal group (t-test p < 0.0001). In conclusion, no significant differences in complications were found between manual compression and angioseal. However, there was a significant difference in time to haemostasis.

Introduction

Traditionally haemostasis following arterial puncture is obtained using direct manual compression at the puncture site for a variable length of time, which can be uncomfortable for both patient and operator. The patient is then required to undergo a period of prolonged bed rest prior to ambulation. With the provision of too few days case beds in many centres, this can significantly limit the number of cases carried out. There are however many commercially available devices to obtain haemostasis. A number of studies and two recent meta-analyses have been published regarding the use of compression versus haemostatic devices. These however are predominantly with regard to cardiac investigations. There are few publications regarding this subject in peripheral vascular disease. We have carried out a prospective randomised study of manual compression against the angioseal device (St. Jude Medical, Stratford Upon Avon, UK).

Section snippets

Materials and methods

Following ethics committee approval (NHS number Co2.245) 100 consecutive patients undergoing retrograde femoral arterial puncture were consented and randomised to manual compression or haemostasis with the angioseal device. All patients had blood coagulation times within the normal range for our unit. Fifty patients were randomised to each group. A consultant interventional radiologist or specialist registrar under consultant supervision undertook all procedures. All consultant operators had

Results

Fifty patients were randomised to each group (Table 1).There were no significant differences regarding age (p = 0.56, unpaired t-test) or sex of patients (p = 0.67, Chi-squared). There were also no significant differences regarding procedure undertaken (p = 0.53, Chi-squared), calcification of vessels (p = 0.77, Chi-squared) or in overall complications between the two groups at any of the time periods as tabulated below (Table 2).

Complications are defined as minor and major. Minor complications include

Discussion

Manual femoral compression has traditionally been used for haemostasis for many years. Although highly successful in the majority of patients, it can be time consuming and requires prolonged bed rest. These factors, with the need for ever increasing efficiency in the use of hospital beds has stimulated the development of percutaneous arterial closure devices.

The angioseal device was developed in 1995 as an alternative haemostatic technique to replace the labor-intensive technique of manual

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Puncture site complications in neuro-endovascular therapy, which represent a significant cause of morbidity, are often difficult to treat. Vascular closure devices have evolved in endovascular therapy. We analyzed risk factors for puncture site complications and examined the efficacy of hemostasis methods in neuro-endovascular therapy.
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The objective of this study was to evaluate the annual costs and budget impact of using a vascular closure device to achieve hemostasis following femoral access endovascular procedures in England, compared with manual compression.
A budget impact model was developed in Microsoft® Excel, based on the estimated number of peripheral endovascular procedures eligible for day-case management performed annually by the National Health Service in England. The clinical effectiveness of vascular closure devices was captured based on the requirement for inpatient stays and the incidence of complications. Data for endovascular procedures, time to hemostasis, length of hospital stay, and complications were collected from public sources and the published literature. There were no patients involved in this study. Model outcomes are reported as estimated number of bed days and annual costs to the National Health Service for all peripheral endovascular procedures in England, and the average cost per procedure. The robustness of the model was tested in a sensitivity analysis.
The model estimated savings for the National Health Service of up to £4.5 million annually if vascular closure devices were used in every procedure instead of manual compression. The model estimated an average cost saving of £176 per procedure for vascular closure devices over manual compression, primarily due to fewer inpatient stays. The sensitivity analysis demonstrated that the proportion of day-case procedures for vascular closure devices and manual compression was a key driver of costs and savings.
The use of vascular closure devices for achieving hemostasis after peripheral endovascular procedures may be associated with lower resource use and cost burden, compared with manual compression, based on shorter time to hemostasis and ambulation and an increased likelihood of a day-case procedure.
Risk of Ipsilateral Deep Vein Thrombosis After Use of AngioSeal Closure Device in Aneurysmal Subarachnoid Hemorrhage Patients
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Deep vein thrombosis (DVT) is a known complication in patients with aneurysmal subarachnoid hemorrhage (aSAH). This study investigated the association between use of the AngioSeal (St. Jude Medical, Minnetonka, MN) vascular closure device and the risk of ipsilateral and any DVT event after angiography in patients with aSAH.
We conducted a review of our institutional cerebral angiography database for the years 2005–2018 to identify all adult patients who underwent angiography for aSAH. We compared the incidence of DVT (occurring within 14 days) between aSAH patients who underwent manual compression versus the AngioSeal closure device.
A total of 459 aSAH patients underwent angiography; 262 underwent manual compression (57.1%) and 197 received AngioSeal (42.9%). There was a 3.4% rate of ipsilateral DVT in the manual compression group and 7.6% in the AngioSeal closure device group (χ2 test, P = 0.04). Similarly, the rate of any DVT was 8.8% for manual compression and 16.8% for patients who received AngioSeal (χ2 test, P = 0.01). On multivariate analysis, AngioSeal remained a significant independent predictor of ipsilateral DVT (odds ratio 2.4, P = 0.04) and any DVT (odds ratio 2.3, P = 0.01).
In aSAH patients undergoing cerebral angiographic procedures with access through the femoral artery, the use of AngioSeal closure device was found to be associated with a significantly increased risk of ipsilateral DVT within 14 days.
Aspiration Thrombectomy–Assisted Endovascular Retrieval of an Embolized Angio-Seal Device Causing Claudication
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The Angio-Seal vascular closure device is used to reduce time to hemostasis after femoral artery puncture. Although rare, complications associated with Angio-Seal are significant, including infection, pseudoaneurysm formation, symptomatic femoral artery stenosis, and separation and embolization, leading to limb-threatening ischemia. This report describes Angio-Seal polymer anchor embolization to the tibioperoneal trunk successfully retrieved using the 8-French Indigo Aspiration System.
The FREEDOM Study: A Pilot Study Examining the Feasibility and Safety of Early Walking following Femoral Manual Compression after Endovascular Interventions Using 5F Sheath–Compatible Devices
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Citation Excerpt :
Consequently, these devices have contributed extensively to the development of outpatient stays for cardiology, vascular, and neuroradiology procedures. However, several studies have concluded that ACD use was equivalent or associated with higher risks of puncture point complications compared to manual compression.16–19 Moreover, very few studies have evaluated the safety of manual compression with early resumption of walking.7,20
Increasing prevalence of peripheral arterial disease (PAD) burning and pressure to reduce costs and promote patient empowerment make outpatient endovascular procedures an attractive alternative to conventional hospitalization. For outpatient peripheral endovascular procedures, femoral manual compression could replace the use of arterial closure devices for small-bore punctures. Presently, safety and feasibility evidence for femoral manual compression is still lacking. FREEDOM is a pilot study designed to demonstrate the feasibility and safety of early walking after femoral manual puncture point compression following a therapeutic endovascular procedure for PAD.
From May to August 2015, all patients requiring endovascular treatment for PAD were prospectively screened. Those patients that received therapeutic endovascular procedures involving retrograde femoral punctures with a 5F sheath were included. Manual compression and pressure dressing of the femoral puncture points was applied. The primary end point was defined as the walking ability 5 hr after index procedure (H5), which was assessed by a walk test.
In total, 129 consecutive patients were screened, and 30 patients met the study criteria. The mean age was 66 ± 11 years. The mean duration of the procedure and of the manual compression was 63 ± 24 min and 12.8 ± 4 min, respectively. At 5 hr following the procedure, 97% of the patients were able to walk 100 m. Two patients failed to walk due to cardiac arrhythmia and to a false aneurysm at the femoral puncture site. No further complications were observed at 1 month, and quality of life assessed by EQ-5D test was significantly increased compare to baseline (72.3 vs. 60.4; P = 0.001).
This pilot study demonstrated the benefits of manual compression to close arterial punctures over procedures using 5F shealth-compatible endovascular devices. A sufficiently powered randomized controlled trial is needed to further characterize the potential benefits of manual compression following use of low-profile devices.
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Small published series suggest a higher failure rate for Angio-Seal vascular closure device (VCD) deployment after antegrade femoral puncture, despite the need for shorter haemostasis times, early discharge, and possibly higher turnover. We seek to compare the deployment efficacy and complications of the Angio-Seal VCD between antegrade and retrograde femoral arterial deployments.
Radiological data was retrospectively analysed from prospective databases from the hospitals' Computerised Radiology Information System (CRIS) over 2010–2012. Angio-Seal gauge, Rutherford class (as applicable), puncture mode (used to classify deployment as antegrade/retrograde), sheath sizes, and deployment success/failures were recorded. Numerical/statistical analyses were undertaken using Microsoft Excel 10/SISA software.
A total of 519 Angio-Seal VIP VCDs were deployed in 470 patients over 2010–2012 (13 other patients could not be analysed due to incomplete data). Sheath sizes for antegrade/retrograde femoral puncture were 5F, n = 22/9; 6F, n = 244/223; 7F, n = 1/5; 9F, n = 4/0. 8F Angio-Seal VIPs were used for 9F punctures only, 6F for the remainder. The overall deployment success rate was 93.7%. In total, 247 (91.1%) successful antegrade deployments were undertaken with 24 (8.9%) failures, compared with 229 (96.6%) successful retrograde deployments with eight (3.4%) failures. Antegrade/retrograde failures were classed as failure to deploy, n = 15/5; bleeding despite successful deployment requiring supplementary compression, n = 6/1; haematoma formation, n = 2/1; groin pain, n = 0/1; vessel stenosis, n = 1/0. Higher deployment failures were noted with antegrade deployment (p < .02, chi-square test).
Angio-Seal deployment is successful for both antegrade/retrograde femoral punctures albeit with a higher antegrade failure rate.

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