Original Article

Amplatzer vascular plug for rapid vessel occlusion in interventional neuroradiology

Interventional Neuroradiology 0(00) 1–6 ! The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1591019915609626 ine.sagepub.com

Jillian C Banfield and Jai Jai Shiva Shankar

Abstract The purpose of this paper is to report different uses of endovascular Amplatzer vascular plug (AVP) treatment for rapid vessel occlusion in the field of interventional neuroradiology. We retrospectively reviewed our interventional neuroradiology database from November 2010 to July 2015 and found nine patients who were treated with endovascular AVP. AVP was used for rapid vessel occlusion of common carotid artery (1 patient), internal carotid artery (5 patients), vertebral artery (2 patients), and internal jugular vein (1 patient). A median of three AVPs were used with almost immediate occlusion and no thromboembolic complications. Use of AVP is feasible, safe, rapid, and potentially cost-effective method for rapid occlusion of larger size vessels in the head and neck region for different indications.

Keywords Cerebrovascular occlusion, medical device, vascular diseases Received 17 August 2015; accepted 7 September 2015

Introduction

Method

The Amplatzer vascular plug (AVP, St. Jude Medical) has been used for transcatheter embolizations in peripheral vasculature, occlusion of abnormal vessel communications, and other neurovascular conditions.1–3 The AVP was designed for occlusion in the peripheral vascular system.1 AVP is a self-expanding, cylindrical device consisting of 144 nitinol mesh wires and is available in sizes ranging from 4 to 16 mm in 2 mm increments. AVP is advanced from a loader through a 5 F to 8 F guiding catheter. The AVP has platinum markers on both ends. A stainless steel micro-screw is welded to the proximal platinum marker band with screw attachment to the 135 cm-long delivery wire. It is delivered by retracting the guiding catheter while holding the wire steady, resulting in vessel occlusion when it resumes the cylindrical shape. It is detached by rotating the delivery wire counter-clockwise. There are now four versions of the AVP, each with a different design to suit various clinical scenarios.4 Use of AVP in interventional neuroradiology is relatively recent and there are only a few case reports describing its use.2–9 The purpose of this paper is to report our clinical experience using endovascular AVP treatment for rapid vessel occlusion in interventional neuroradiology. Our hypothesis was that the AVP treatment is safe and efficient for rapid vessel occlusion in interventional neuroradiology.

We retrospectively reviewed our interventional neuroradiology database from November 2010 to July 2015. The study, including a waiver of consent to obtain participant data, was approved by the Nova Scotia Health Authority Research Ethics Board (2015-334). All patients for whom AVP was used for neuroendovascular treatment were collected. The demographic information, indications, procedural details, and immediate follow-up were recorded (Table 1).

AVP deployment We deployed AVPs using standard deployment steps. The size and type of the AVP was chosen based on the vessel type and vessel diameter. The diameter of the AVP was selected to be at least one and a half times that of the target vessel diameter. This could be two times that of the target vessel diameter in cases when the target vessel was a vein. We deployed AVPs either through a 5 F or 6F Envoy guiding catheter in the target vessel. We used road map guidance for

Department of Diagnostic Imaging, QE II Health Sciences Centre, Halifax, NS, Canada Corresponding author: Jai Shankar, Department of Diagnostic Radiology, QE II Hospital, 1796 Summer St, Halifax, NS B3H 3A7, Canada. Email: [email protected]

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Table 1. Details of the patients treated with vessel occlusion using AVPs. Age (years) 50

History and presentation

Oropharyngeal carcinoma with intractable epistaxis/ hemoptysis* 61 Oropharyngeal carcinoma with intractable epistaxis/ hemoptysis 67 Cervical spinal tumor encasing vertebral artery for preoperative occlusion 37 Intractable epistaxis 65 ICA encasement from laryngeal carcinoma for preoperative occlusion 58 Oropharyngeal carcinoma with intractable epistaxis/ hemoptysis 35 Cervical ICA large, partially thrombosed aneurysm 48 SAH from dissecting vertebral artery aneurysm 38 Iatrogenic injury to left ICA Average (SD)

Target vessel

Preparation time (min:sec)

Occlusion time (min:sec)

Total time (min:sec)

BTO

No. of AVPs

AVP type

CCA

No

4

I

0

IJV

No

8

I, II, IV

0

VA

Yes

4

I, IV

1

01:38

19:45

21:23

ICA ICA

Yes Yes

2 4

I I, II

8 8

11:32 00:54

04:28 18:33

16:00 19:27

ICA

No

3

I, IV

0

34:14

10:37

44:51

ICA

Yes

3

II

0

28:39

01:24

30:03

VA

No

2

II

0

08:58

06:21

15:19

ICA

No

2

II

10

02:02 13:39 (12:57)

01:57 8:29 (7:10)

03:59 25:41 (15:31)

Coils

21:14

NA

04:46

NA

26:00

54:08

AVP: Amplatzer vascular plug; BTO: balloon test occlusion; CCA: common carotid artery; IJV: internal jugular vein; ICA: internal carotid artery; NA: not available; No.: number; VA: vertebral artery. *This patient was the same case as described in reference3.

deployment of AVP. The AVPs were back-loaded in the guide catheter and pushed through for deployment. They were delivered by retracting the guiding catheter while holding the wire steady. The AVPs were detached by rotating the delivery wire counterclockwise. In need of short segment occlusion, after deploying the AVP, the guide catheter was advanced while holding the delivery wire to compact the AVP. The AVP was detached after achieving the desired compaction of the device. In cases of residual flow after deployment of the first AVP, more AVPs were deployed till desired flow arrest was achieved. The ‘‘preparation time’’ for the AVP was calculated as the time between the last diagnostic angiogram and deployment of the first AVP. This time includes the opening of the device, plus getting it ready to be used and deployed. The ‘‘occlusion time’’ was calculated as the time between deployment of the first AVP and the final occlusion. The ‘‘total time’’ was calculated by adding the preparation and occlusion times. These time points were calculated to assess the rapidity of vessel occlusion using AVPs. Patients underwent systemic heparinization, similar to endovascular coiling, whenever we performed balloon test occlusion. All other patients were treated without intravenous heparin, as they presented with active bleeding. None of these patients received posttreatment anti-platelet medication.

Results Nine patients (see Table 1) received endovascular AVP treatment with a median of 3 (range 2–8) AVPs used per case. In four of the nine patients, coils were used in addition to the AVPs. In all cases, more than one AVP were used with no thromboembolic complications. As reported in Table 1, the average occlusion time was less than 10 minutes, the average preparation time was less than 15 minutes, and the average total time was just over 25 minutes. The occlusion time was mainly a function of the number of AVPs used. For example, the average occlusion time was 4:15 minutes when two AVPs were used and 6:05 minutes when three AVPs were used. There was no mortality or morbidity associated with the use of AVPs. Our last patient developed watershed infarction in the left anterior and middle as well as middle and posterior cerebral artery watershed zone after the occlusion of the left internal carotid artery (ICA). The left ICA needed to be occluded after iatrogenic injury (Table 1) without balloon test occlusion (BTO). The watershed infarct possibly resulted from the failed hemodynamic response in this case, perhaps due to a post-operative hypotensive episode, despite having good collateral through the anterior communicating artery.

Banfield and Shankar

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Figure 1. A 37-year-old patient presented with intractable epistaxis (a). The left ICA angiogram showed irregular appearance of the proximal cavernous segment with appearance of pseudo-aneurysms (arrow). Considering this to be the bleeding site, the ICA was trapped using coils (arrows) for occlusion distal and at the level of the pseudo-aneurysms (b, c) and two type I AVPs (arrows) proximally in the cervical segment of the ICA (d).

Coils were used in only four of the nine patients. Of these, a single coil was used in Patient 3 to act as an anchor for the AVP. In all other patients, coils were used when the artery was trapped. In these cases, the distal occlusion was done using coils and proximal occlusion was done with AVPs. Only the last three patients in our series underwent brain imaging after the AVP treatment. Barring the last patient described above, none of them showed any evidence of thromboembolic events. Other patients did not undergo any post-treatment brain imaging as they did not have any clinical complications.

Discussion In the past, detachable balloons were used for rapid vessel occlusion in many of the indications reported here. Consistent with other reports,5,6,8 we found that AVPs are a useful and potentially cheaper alternative to detachable balloons and coils for rapid vessel occlusion in many clinical scenarios. Although reports of the rapidity of occlusion with AVP vary,4 our experience suggests that the time to achieve occlusion with AVP is much less than with coils. On average, we achieved occlusion in our patients in 8.5 minutes (range 1:24–18:33). The occlusion time was mainly a function of the number of devices used for occlusion. Detachable balloons were previously used for vessel occlusion, but they carried the risks of unintentional detachment or early deflation.3,5 Advantages of detachable balloons include immediate vessel occlusion, flow directed placement (specifically useful for arteriovenous shunts), and options for intracranial occlusion. Disadvantages of detachable balloons include limited

availability (not available in North American market), perceived technical difficulty, and concerns about distal embolization and delayed deflation. These concerns can be mitigated with appropriate training and proper technique (i.e. rapid deployment of additional proximal devices to stabilize the first device). Moreover, there was a steep learning curve for use of detachable balloons. With the recent unavailability of detachable balloons in the market,6 there is a need for a device with potential for rapid vessel occlusion. Occlusion with coils can be time consuming and expensive.5,9 Coils are not ideal in cases where vessel occlusion needs to be done rapidly in potentially life-threatening situations. Based on our experience, the number of coils used for occlusion of major vessels of head and neck is usually more than 10, depending on the type of the coils and type of the vessel. Considering that each AVP is more cost effective than any given detachable coil, a median of three AVPs used per case for vessel occlusion makes AVPs a potentially economical means for vessel occlusion. The AVPs are very easy to use and have virtually no learning curve. AVP has been used for parent vessel occlusion where balloons could have been used.5,6,9 Hoit et al.,6 however, did not use the AVP as an occlusive device by itself because of concern that the mesh design could result in thromboembolism. Others also worried that using a single AVP could result in thromboembolism because of the delayed time to occlude a parent artery.2,5,8 Hence, Ong et al. suggested using multiple AVPs to promote rapid occlusion.8 Indeed, Mihlon et al. noted adequate occlusion time when they used multiple second-generation AVPs to occlude common carotid, internal carotid, and vertebral arteries.7 Shankar et al. had good results in deploying multiple

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Figure 2. A 66-year-old patient presented with left arm pain, weakness, and numbness. MRI showed an extradural homogenously enhancing tumor extending out through the exit foramina at C4 to C5 level (a). This was also encasing the left vertebral artery in this segment (b) and showed some irregularity on angiogram (c). The left vertebral artery was tested with balloon occlusion (d) and later trapped using single coil and 2 AVPs above (arrow) and 2 AVP (arrow) below the level of the tumor (e).

AVPs to provide occlusion in a patient suffering from life-threatening carotid blowout.3 Our experiences are consistent with these reports, showing that deploying multiple AVPs (median of 3) results in rapid occlusion with no thromboembolic complications. None of the reported case series regarding the use of AVP in interventional neuroradiology have reported complications. Our series with no thromboembolic complications highlights the safety profile of AVPs. It is notable that in most of our patients, vessel occlusion was carried out without BTO as the procedure was considered an emergency and the result of BTO would have not changed the treatment decision.

In cases of ICA occlusion (Figure 1), any type of AVP (I, II, or IV) can be used depending on the diameter of the artery. The selected device should have a diameter at least one and a half times that of the target vessel diameter. We found types I and II AVPs most effective in ICA occlusion. In vertebral artery occlusion, type IV AVP is more suitable, given the smaller diameter of the vertebral arteries (Figure 2). In cases of venous occlusion (Figure 3), it is preferable to use an AVP that is double the diameter of the vein to prevent proximal migration of the AVP. The only time we experienced some migration of the first AVP was in the occlusion of

Banfield and Shankar

5 was the limited length of the pusher wire for AVP in reaching a distal point. Despite its utility for rapid occlusion, AVP cannot be used at this time for intracranial use because the current length of the pusher wire renders it too short. If AVP can be manufactured with a longer pusher wire for intracranial use, it could be used in more cases when rapid occlusion is necessary. A similar device called the Woven EndoBridge (WEB) aneurysm embolization system can be deployed intracranially, but is not primarily intended for intracranial vessel occlusion.10 Use of the WEB for vessel occlusion in the head and neck region remains to be seen. Other newer vessel occlusion devices introduced specifically for this purpose include Penumbra occlusion device and Micro Vascular Plug System. Both are currently at the evaluation stage and their use for this purpose remains to be seen. In conclusion, use of AVP is feasible, safe, fast, and potentially cost-effective method for rapid occlusion of larger size vessels in the head and neck region for different indications. Declaration of conflicting interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The authors received no financial support for the research, authorship, and/or publication of this article.

References Figure 3. A 61-year-old patient with longstanding right-sided oropharyngeal squamous cell carcinoma presented with intractable epistaxis/ hemoptysis. He underwent packing of oral cavity by ENT surgeons. CT Neck showed the tumor (a) and a small ulceration (arrows) of the right internal jugular vein, confirmed by a right internal jugular venogram (b). All 3 types of AVPs (arrows) were used to occlude the right internal jugular vein (c).

the internal jugular vein in Patient 2. The subsequent AVPs used were double the diameter of the vein and prevented any further migration of the first AVP with adequate hemostasis (Figure 3). We used coils in only four of the nine patients. In one patient (Patient 3), a single coil was used to prevent feared distal migration of the AVP. In retrospect, the coil was unnecessary and we did not use coils for this purpose afterwards. If the diameter of the AVP is chosen appropriately, there is virtually no chance of distal migration of the AVP. In the other three patients, the coils were used when we had to trap the artery (Figure 1). In these cases, the distal occlusion was done using coils, as we feared crossing the segment of the artery with pseudoaneurysm with larger caliber catheter to deploy AVPs distally. The other concern

1. Cil B, Canyigit M, Ozkan O, et al. Bilateral multiple pulmonary arteriovenous malformations: endovascular treatment with the Amplatzer vascular plug. J Vasc Interv Radiol 2006; 17: 141–145. 2. Geyik S, Cil B, Yavuz K, et al. Neuroapplication of Amplatzer vascular plug: a novel device for parent artery occlusion. Neuroradiology 2008; 50: 179–183. 3. Shankar J, Maloney W and Vandorpe R. Amplatzer vascular plug for occlusion of parent artery in carotid blowout with active extravasation. Interv Neuroradiol 2011; 17: 224–227. 4. Wang W, Li H, Tam M, et al. The Amplatzer vascular plug: a review of the device and its clinical applications. Cardiovasc Interv Radiol 2012; 35: 725–740. 5. Gralla J, Schroth G, Kickuth R, et al. Closing the gap between coil and balloon in the neurointerventional armamentarium? Initial clinical experience with a nitinol vascular occlusion plug. Neuroradiology 2008; 50: 709–714. 6. Hoit D, Schirmer C and Malek A. Use of the Amplatzer vascular plug as an anchoring scaffold for coil-mediated parent vessel occlusion: technical case report. Neurosurgery 2006; 59: ONS–E171. 7. Mihlon F, Agrawal A, Nimjee S, et al. Enhanced, rapid occlusion of carotid and vertebral arteries using the Amplatzer vascular plug II device: the Duke Cerebrovascular Center experience in 8 patients with 22 Amplatzer vascular plug II devices. World Neurosurg 2015; 83: 62–68.

6 8. Ong C, Lam D, Ong M, et al. Neuroapplication of Amplatzer vascular plug for therapeutic sacrifice of major craniocerebral arteries: an initial clinical experience. Ann Acad Med Singapore 2009; 38: 763–768. 9. Ross I and Buciuc R. The vascular plug: a new device for parent artery occlusion. Am J Neuroradiology 2007; 28: 385–386.

Interventional Neuroradiology 0(00) 10. Pierot L, Turjman F, Herbreteau D, et al. WEB treatment of intracranial aneurysms: feasibility, complications, and 1-month safety results with the WEB DL and WEB SL/SLS in the French observatory. Am J Neuroradiol 2015; 36: 922–927.

Amplatzer vascular plug for rapid vessel occlusion in interventional neuroradiology.

The purpose of this paper is to report different uses of endovascular Amplatzer vascular plug (AVP) treatment for rapid vessel occlusion in the field ...
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