Keywords
brachial access - Perclose ProGlide/ProStyle - Suture-mediated closure device
Introduction
Brachial artery is superficial and easy to access for interventions where a femoral access is not suitable or difficult, when additional access sites are needed to femoral for complex aortic cases, or for interventions in caudally directed visceral vessels.[1] Low brachial artery access at the antecubital fossa is preferred to high brachial or axillary arteries, which have higher complication rates.[1]
[2] Achieving postintervention access site hemostasis for the brachial artery is challenging due to the mobility of the artery and a limited bone surface to compress upon. Manual compression has long been used as the standard method of achieving hemostasis, but it is inconvenient and bears a complication rate of 1.2 to 8%, which include bleeding, pseudoaneurysm, median nerve injury from hematoma, and brachial artery thrombosis.[2]
[3]
[4]
[5]
There has been an increase in the number of procedures through the brachial artery needing larger sheath sizes, requiring thrombolysis infusion, and/or with more patients on anticoagulants and antiplatelet drugs before the endovascular procedure. A form of immediate and efficacious closure of the brachial artery without complications would be an attractive option to prevent prolonged postprocedure sheath indwelling time and prevent the discomfort and complications of manual compression.
There are reports of different vascular closure devices (VCDs) being used for percutaneous brachial artery closure. The Perclose ProGlide/ProStyle closure system has been used for brachial artery closure in a few studies with variable success. Successful application of this suture-based closure device on the brachial artery in a considerable number of patients has not been described in the literature. This study is intended to assess the feasibility and safety of brachial artery closure with the ProGlide/ProStyle suture-based device using a modified technique with ultrasound guidance.
Materials and Methods
This was a retrospective single-center study conducted on all patients who had a brachial access for interventions between June 2019 and June 2024. Off-label usage of the ProGlide/ProStyle suture-based device for the brachial artery was discussed with the vascular surgical, hospital governance, and quality and safety teams and approval was obtained. Retrospective evaluation of the data collected from this study was approved by the local ethics committee and Health Research Authority.
The outer diameter of the brachial artery at the antecubital fossa was measured before the procedure in two orthogonal axes, and the patients were excluded for brachial artery closure with Perclose ProGlide/ProStyle if the average of the diameters was less than 4 mm. A total of 42 brachial artery accesses were evaluated for ProGlide/ProStyle suture-based access closure postprocedure, and 23 brachial arterial access (21 patients) were found suitable with a brachial artery outer diameter ≥4 mm. Patient demographics, usage of anticoagulants and antiplatelet drugs, recent usage of thrombolytics, indication for brachial access, and sheath size were recorded.
Procedure
All the access closures in this study were performed by an interventional radiologist who had an extensive experience with ProGlide and, later, the ProStyle system on more than 300 small and large hole (up to 20 Fr) femoral access closures; the main interventional radiology procedure including obtaining the brachial access was performed by one of six interventional radiology consultants. Even though the technique for closure in this study was slightly different, there was no learning curve involved. All the cases were performed in the interventional radiology theater. All the patients gave consent for the interventional radiology procedure and the use of the closure device. The vascular surgeon on call was informed before closure and requested to be available in case surgical management was needed for an inadvertent access site complication. Brachial access in all cases was obtained in the lower brachial artery at the antecubital fossa, after measurement of the diameter at two orthogonal axes, using a micropuncture access set followed by the vascular sheath needed for intervention.
Sheath removal and ProGlide/ProStyle suture deployment was performed at the completion of the vascular interventional procedure without delay. A slow injection of 100 µg of nitroglycerin was administered through the sheath into the brachial artery before removal. One percent lidocaine was infiltrated at the puncture site for postthrombolysis cases. A pair of curved mosquito forceps was used to blunt-dissect the puncture site around the wire after removal of the sheath for smooth passage of the closure device and avoiding inclusion of dermis in the suture. The ProGlide/ProStyle device was introduced over the guidewire until the guidewire exit port was at the skin puncture site. The guidewire was removed. The device was held with the right hand, while the left hand was used to hold the ultrasound probe just cranial to the skin puncture site oriented along the axis of the brachial artery. The initial floppy “sheath” part of the ProGlide/ProStyle device was seen as a smooth line without a shadow ([Fig. 1]). The rigid plastic footplate housing, which is slightly bent, which followed the “sheath” was seen as a curvilinear echogenic structure ([Fig. 1]) and the device was introduced at an approximately 20-degree tilt till this structure was seen to be entirely within the brachial artery, followed by the distal guide, and a trickle of blood was seen at the Marker lumen. Keeping the device at a 20-degree tilt, the lever of the ProGlide/ProStyle device was lifted partially till the cranial end of the foot was seen slightly indenting the superficial wall of the brachial artery ([Fig. 2]). The caudal part of the foot, which would simultaneously get partly deployed, was not visible because of acoustic shadowing by the echogenic footplate housing. The device was gently retracted keeping it at an approximately 20-degree tilt until resistance was felt and the cranial part of the footplate was seen to have reached the puncture site in ultrasound. Maintaining a gentle retractile force, two maneuvers were performed simultaneously: gradually fully lifting the lever and raising the device to a 45-degree tilt. Holding the device in a stable position with a continuous gentle traction using the right hand at a 45-degree tilt, the ultrasound probe was now placed to the side of the device oriented along the axis of the brachial artery, slightly tilted away from the device to focus on the foot of the closure device and the brachial artery puncture site—at this stage, both the cranial and the caudal parts of the foot could be seen and apposition of the entire footplate to the proximal wall of the brachial artery was confirmed ([Fig. 3]). The plunger was depressed maintaining the position and retraction of the device, the plunger and the needles were pulled out completely, and the suture was trimmed using the QuickCut mechanism of the device. After this step, the device was relaxed, and the two maneuvers performed simultaneously to “open” the foot was performed in reverse to “close” the foot—gently gradually lowering the lever and depressing the device to a 20-degree tilt. Removal of the device and further suture management was performed as per the instructions for use and routine practice. A guidewire was reinserted through the guidewire exit port before device removal to retain access to reinsert the vascular sheath in case puncture site closure failed. Suture tightening was performed gently as per instructions for use. [Fig. 4] shows a schematic representation of the above-described technique.
Fig. 1 Ultrasound image showing the “sheath” part of the Prostyle device as a smooth line (arrows) and the plastic footplate housing seen as a curvilinear echogenic structure (arrowheads) inserted fully within the brachial artery. The puncture site in the artery is indicated by the asterisk.
Fig. 2 Ultrasound image showing the partially deployed cranial part of the footplate (arrow) indenting the superficial/anterior wall of the brachial artery (arrowheads).
Fig. 3 Ultrasound image taken after fully deploying the footplate by positioning the probe medial/lateral to the ProGlide/ProStyle device and tilted slightly away from the closure device to direct the ultrasound toward the footplate showing the entire length of the footplate (arrows) abutting the anterior/superficial wall of the brachial artery (arrowheads).
Fig. 4 Schematic of the ultrasound-guided modified technique of vascular access site closure with the Prostyle device. (A) The ProGlide/ProStyle device is inserted under ultrasound guidance until the footplate housing is completely within the artery. (B) The footplate is partially deployed under continuous ultrasound guidance till it makes a small indentation in the anterior wall of the artery. (C) The device is withdrawn slowly till resistance is felt, which indicates that the footplate has reached the puncture site. (D) The footplate is deployed fully with simultaneous lifting of the device to achieve a 45-degree angle of the device with the blood vessel (white curved arrows in C). (E) The ultrasound probe is placed aside the closure device tilted mildly to focus on the footplate to confirm adequate apposition of the footplate to the superficial wall of the artery without inclusion of its deeper wall. (F) After the sutures are deployed on the vessel wall, the footplate is withdrawn into the footplate housing and the device is taken down to a shallow angle simultaneously (white curved arrows in E).
The closure site was examined visually for bleeding and the radial pulse was checked. If the closure appeared successful and there was no arterial bleed, the guidewire was removed maintaining a gentle tightening force on the suture tightening device followed by cutting the suture with the cut mechanism of the suture tightening device as per the device's instructions for use. A short period of manual compression for a few minutes was performed if there was a minor ooze at the puncture site. Brachial artery puncture site was examined with ultrasound and Doppler. No compression bandage was used. Ultrasound and Doppler of the brachial artery was performed the day after closure. The patients were seen in the vascular clinic 60 days postprocedure and were examined clinically for brachial and radial pulses and for signs of any access site complications.
The primary end point was the incidence of reintervention from device failure, and the secondary end point was the incidence of brachial access site complications.
Results
A total of 23 brachial artery punctures in 21 patients were closed using the Perclose ProGlide/ProStyle suture-mediated VCD.
Patient demographics, indications for brachial access, and usage of antiplatelets, thrombolytics, and anticoagulants are provided in [Table 1].
Table 1
Patient demographics and procedural details
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Total no. of cases
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23 instances in 21 patients
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Age (y)
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49–81 (mean: 66.4)
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Gender
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17 males, 4 females (M:F = 4.25:1)
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Procedures
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Revascularization in chronic limb ischemia (8/23, 34.8%): 7 in the lower limb and 1 in the upper limb
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Thrombolysis for acute limb ischemia (4/23, 17.4%)
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Visceral artery interventions (6/23, 26.1%): 3/23 celiac artery/SMA stenting, 1/23 SMA thrombolysis, 1/23 type 2 endoleak embolization via the SMA, 1/23 GI bleed embolization through the SMA with infrarenal aortic occlusion
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Embolization of native aortic aneurysm post aorto-bifemoral surgical bypass (1/23, 4.3%)
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Brachial artery–covered stent placement for tumor-related bleed (2/23, 8.7%, twice in the same patient)
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Internal iliac artery stent graft in iliac branch device procedure (2/23, 8.7%) for treatment of a type 1B endoleak, and in another for an aorto-uni-iliac EVAR device
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Brachial artery size (mm)
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4–5.3 (mean: 4.5)
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Sheath size (Fr)
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5–9 (5 in 5/23, 6 in 13/23, 7 in 2/23, 8 in 1/23, and 9 in 2/23)
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Alteplase use and heparin infusion before closure
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5/22 (21.7%)
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Antiplatelets
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Low-dose aspirin (11/23, 47.8%)
Low-dose aspirin + clopidogrel (5/23, 21.7%)
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Abbreviations: EVAR, endo-vascular aortic repair; GI, gastrointestinal; SMA, superior mesenteric artery.
There was one instance where the needle in the device failed to engage with the suture; the puncture site was re-accessed with a guidewire introduced through the guidewire exit port of the device, and hemostasis was successfully achieved with another ProGlide device at the second attempt.
There were no major complications. Minor complications included temporary vasospasm in the brachial artery and local small hematoma. Temporary vasospasm in the brachial artery was the most common complication, which was observed in 10/23 (43.5%) cases despite intra-arterial administration of nitroglycerine prior to closure. None of them were symptomatic and the radial pulses were preserved, hence not treated. Localized perivascular hematoma was seen in 2/23 (8.7%) cases in ultrasound immediately and 1 day after the procedure. These caused mild pain and tenderness on palpation, without significant limb swelling or nerve injury. These were managed conservatively and did not require any surgical intervention or result in hospital stay prolongation and were asymptomatic at the 60-day follow-up. Both the cases with perivascular hematoma were patients who had undergone thrombolysis infusion till prior to the last check angiogram.
A 60-day clinical follow-up was available in 16 patients (17 instances), which included both the patients with postprocedure small hematoma. All 16 patients had preserved brachial and radial pulses, and had no swelling, tenderness, or signs of nerve injury at the puncture site. There were two mortalities not related to the vascular intervention; the patient who underwent superior mesenteric artery thrombolysis died on the sixth postprocedure day due to complications secondary to bowel gangrene, and the patient who underwent brachial artery–covered stent placement twice for tumor bleed died of cancer progression 5 weeks after the second procedure.
Discussion
The Perclose ProGlide/ProStyle device is a suture-mediated vascular puncture site closure device that works by deploying and tightening a knot with a suture that is threaded through tiny needle punctures made cranial and caudal to the vascular access site. The deployment mechanism has a foot; opening or closing it inside the blood vessel is controlled from outside the blood vessel and the patient with a lever. It has been very successfully used for small and large femoral arterial puncture sites for sheath sizes of 5 to 24 Fr.[6]
As per the instructions for use, this device is not recommended for vessels smaller than 5 mm in diameter. Using this device in smaller vessels is risky for many reasons: uncertainty whether the device is sufficiently intravascular during insertion since there may not be a brisk pulsatile flow in the marker lumen; stretching of blood vessel when the foot is opened or shear stress on the blood vessel wall when the open foot is moved within the vessel to bring the foot against the vessel wall at the puncture site can cause vessel trauma, dissection, occlusion, or rarely rupture; marked indentation of the blood vessel wall opposite to the puncture site by the caudal part of the foot can cause the posterior wall to be included in the suture causing vessel occlusion when the suture is tightened; inability to have a tactile confirmation whether the foot is placed against the vessel wall since the device does not move freely within a small vessel; and in the brachial artery, there is a possibility of tear of the vessel wall when excessive force is applied on the suture. Most of these can be circumvented by using real-time ultrasound guidance for deploying the Perclose ProGlide/ProStyle device.
Partial opening of the footplate before moving it to bring it against the arterial wall reduces stretching and avoids shear stress, and confirmation of optimal approximation of the foot to the arterial wall by ultrasound reduces the chances of failure and avoids an unintended vessel occlusion by inclusion of the posterior wall in the suture. Stretching of the artery a few millimeters above the puncture site by the cranial part of the fully opened foot and the plastic foot housing is still not avoided in this technique. The length of a suture thread tied in vitro around the opened foot and the plastic foot housing measures 16 mm—this will be the minimum circumference of the artery once the foot is fully deployed, which corresponds to a diameter of approximately 5 mm. We assumed that a 4-mm brachial artery can be safely stretched to 5 mm without causing vessel dissection/injury, which was the basis of choosing 4 mm as the cutoff in our study, and we did not attempt to use this device in patients with any smaller arteries. We do not have any literature reference for the degree of safe stretching of a nonatherosclerotic blood vessel, but we can conclude from our experience in this study that a 4-mm brachial artery can be safely stretched to 5 mm without causing arterial rupture/dissection or occlusion.
There are a few studies where a suture-mediated closure device has been evaluated for usage in the lower brachial artery with variable success and complication rates ([Table 2]).
Table 2
Use of suture mediated closure device for brachial artery access closure
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Study
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No. of cases
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Sheath size (Fr)
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Device used
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Criteria
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Complications
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Current study
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23 punctures in 21 patients
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5–9
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ProGlide and ProStyle
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4 mm minimum diameter determined by ultrasound
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No major complications. Subclinical vasospasm in 10 and minor hematoma in 2
|
|
Meertens et al[17]
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7 punctures in 7 cases
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Not mentioned
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ProGlide
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4 mm minimum diameter of brachial artery
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4 patients developed 6 access site complications, 3 patients needed reintervention—surgical hematoma evacuation, thrombectomy and occluded brachial artery repair, and pseudoaneurysm repair
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Kulick and Rediker[18]
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4 punctures in 4 patients
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6–8
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Perclose by Prostar/Techstar
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Good flow around the sheath documented by angiogram
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1 small hematoma
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|
Kim et al[19]
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10 punctures in 8 patients
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6–7
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Perclose Techstar
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Arteriograms to define brachial artery diameter in some cases (no further details mentioned)
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1 hematoma needing surgery (knotted suture was found in the subcutaneous tissue) and 1 partial closure managed with additional manual compression
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The use of Perclose ProGlide VCD has been successfully described for closure of percutaneous axillary artery access up to 12 Fr using two Perclose ProGlide devices with device success rates of 97 to 100% when the axillary artery diameter was greater than 5 mm.[7]
[8] The use of other VCDs like Angio-Seal, Exo-Seal, and Mynx has been described in the literature and has been found to be safe and effective with a high technical success rate and no significant difference in rates of adverse events compared with manual compression.[9]
[10]
[11]
[12] Angio-Seal has been used most extensively for brachial artery access closure across multiple studies. Angio-Seal is known to cause significant periarterial and intra-arterial fibrosis, which can cause vascular narrowing and can complicate future surgical exposure or re-access in femoral arteries.[13]
[14] This fibrotic reaction is known to cause stenosis of the femoral artery; such a reaction would be more profound in brachial artery, given the difference in the sizes of the brachial and femoral arteries.
A study by Starnes et al[15] describes the usage of a suture-mediated closure device in femoral vessels with a diameter less than 5 mm, with the smallest vessel treated being 2.8 mm; however, the measurement was that of the anteroposterior dimension of the patent part of the blood vessel excluding the posterior wall atherosclerotic plaques. Even if the puncture was at the stenotic atherosclerotic site, opening of the footplate and most of the movement of the footplate would have happened cranial to the site of puncture where the artery might have been bigger, before bringing the deployed footplate to the puncture site. Given that full deployment of the footplate needs a vessel of at least 5 mm in diameter, usage of this device in very small vessels will cause a disproportionate degree of stretching, resulting in vascular injury, either dissection or tear, and is not recommended.
Usage of ultrasound in ProGlide deployment in femoral artery has been described in the literature, but the application was restricted to look at the anterior and posterior wall movement on actively pushing and pulling the device.[16] In our study, we used ultrasound throughout the deployment of the footplate and to visually confirm the approximation of the footplate to the anterior/superficial wall of the brachial artery.
Given the superiority of the Perclose ProGlide/ProStyle suture-mediated device over other commonly used vascular devices including its minimal intravascular footprint, absence of re-access restrictions, and absence of significant arterial wall/periadventitial fibrosis, this would be an ideal device for usage in medium-sized blood vessels like the brachial artery, if it can be safely used. With the use of ultrasound guidance and technical modification described in this study, we have showed a 100% success rate with no major complications in performing access closure using this device in the brachial artery up to 9 Fr in size if the diameter is ≥4 mm. To our knowledge, this is the largest series of successful usage of a suture-mediated closure device in the brachial artery.
Conclusion
The use of the Perclose ProGlide/ProStyle device is safe and effective for brachial artery closure with minor modifications of technique and ultrasound guidance.
