The use of the Amplatzer Vascular Plug in the prevention of endoleaks during abdominal endovascular aneurysm repair: A systematic literature review on current applications

Abstract

Objectives

The Amplatzer Vascular Plug (AVP) is a vascular occlusion device designed to provide optimal embolization in several fields of the endovascular surgery. A full literature review was conducted to analyze AVPs in comparison with coils for the prevention of endoleaks during endovascular abdominal aortic aneurysm repair.

Methods

A systematic review was designed under PRISMA statement guidelines for systematic reviews and meta-analyses. The results were updated with a subsequent electronic search using Medline and Scopus databases up to December 2019.

Results

Eighteen articles making this comparison were found. In 79.7% of the cases, the target vessel was the internal iliac artery; in 1.6%, the common iliac artery; and in 16.7%, the inferior mesenteric artery. Risk of complications (buttock claudication, groin hematoma, endoleaks, and erectile dysfunction) after AVP was low. A cost comparison revealed that the mean cost for coils was around US$2262, while the average cost for the AVP was US$310.

Conclusions

The AVP is an effective and safe device for occluding peripheral vessels, proved to have lower complications rates. Compared with coil embolization, the AVP technique is potentially associated with lower procedural costs.

Keywords

Abdominal aortic aneurysm endovascular aneurysm repair endoleak embolization

Introduction

Endovascular aneurysm repair (EVAR) is a way to treat the abdominal aortic aneurysm (AAA). Residual blood leaks back into the aneurysm sac—known as endoleaks—are the most frequent complication following EVAR, occurring in 10–45% of cases, and can lead to aneurysm enlargement and rupture.¹

Endoleaks are classified into 5 types² and the object of our interest is type II. In particular, Type II endoleaks result from retrograde perfusion into the aneurysmal sac from the aneurysmal side branches³ and rarely cause aortic rupture after EVAR. However, one-third of these cases occur in the absence of aneurysm sac expansion.⁴

The embolization using coils has been the standard procedure for occlusion of the internal iliac artery (IIA) or other collateral branches prior to EVAR, yet the procedure usually requires deployment of many coils and is time consuming and costly.⁵ For this reason, the current use of other devices, such as Amplatzer Vascular Plug (AVP—Abbott Vascular, Saint Paul, MN, USA), can be advantageous in terms of costs and number of devices used.

The AVP is an embolic device for peripheral vascular embolization and has been widely adopted since its approval by the United States Food and Drug Administration (FDA) in 2004. Over the last decade, the AVP device has evolved from a single device to a group of 4 models that can be used for various types of anatomy, hemodynamics, and lesion entities.⁶ Recent studies report the advantages of vascular plug occlusion of vessels over coils during EVAR to prevent type II endoleaks.^5,6 The purpose of this review is to report and clarify common AVP applications and techniques in comparison with coils during an EVAR procedure.

Technical aspects

The AVP device is used in the occlusion of medium and large vessels but has multiple uses beyond the occlusion of vessels to prevent endoleaks during EVAR.^7–9 There are 4 models on the market and all models consist of 2 components: the plug itself and a delivery wire. The plug is made with nitinol interweave, giving it a self-expanding property. The differences in the 4 models in the AVP family are due to the number of lobes; in fact, AVP has a single lobe, and AVP II has 3 lobes, while AVP III and IV have 2 lobes each. The specific characteristics of each AVP family models will be briefly listed below.

AVP is the initial model of the AVP family and is a device with a single-layer cylindrical, which is available in range of 4–16 mm; usually, it is employed for limited length landing zones.⁶

AVP II was approved by the FDA in 2007 and is composed of 3 segments including the central lobe and 2 discs. Therefore, the particular tri-lobar design gives it better occlusive properties, thanks to the 6 layers of mesh. The conformation of the device allows for better sealing and fitting into short landing zones (Figures 1 and 2) . AVP III was approved for clinical use in 2008, and its use is limited to treatment of paravalvular leakages.⁶

Figure 1.

(a) Preoperative AVP II plug deployment in the right internal iliac artery (IIA) through contralateral access. (b) AAA and right common iliac aneurysm exclusion by EVAR. The preoperative plug deployment in IIA prevents a retrograde type II endoleak when the distal landing zone is on the external iliac artery. Note: AAA: Abdominal Aortic Aneurysm; AVP: Amplatzer Vascular Plug; EVAR: endovascular aneurysm repair.

Figure 2.

Different roles of AVP II during aortouniiliac EVAR to treat AAA. (a) The occlusion of external iliac artery entails the treatment of aortic aneurysm with an aortouniiliac endograft and preoperative plug deployment to the CIA, preventing a type II endoleak. (b) Concomitant AAA and left CIA aneurysm treated with an aortouniiliac endograft and femoro-femoral bypass to guarantee the perfusion of the lower limb and one of the right IIA. The preoperative plug deployment to the CIA and contralateral hypogastric prevents a type II endoleak. (c) Simultaneous AAA, right CIA aneurysm, and ipsilateral occlusion of the EIA treated with an aortouniiliac endograft and femoro-femoral bypass to guarantee the perfusion of the lower limb. The preoperative AVP II plug deployment to the right IIA prevents a type II endoleak. Note: AVP: Amplatzer Vascular Plug; EVAR: endovascular aneurysm repair; CIA: common iliac artery; IIA: internal iliac artery; EIA: external iliac artery.

AVP IV was approved for clinical use in 2009 and is available in 5 sizes, from 4 mm to 8 mm. An important feature of AVP IV is that it can be delivered through a standard 0.038-inch diagnostic catheter without the need to exchange it. Thanks to its conformation, it can be used to embolize small, tortuous vessels⁶ (Figure 3).

Figure 3.

(a) Preoperative AVP IV plug deployment to the IMA. (b) AAA exclusion by EVAR. The preoperative plug deployment to the IMA prevents a type II endoleak due to retrograde sac perfusion. Note: AVP: Amplatzer Vascular Plug; IMA: inferior mesenteric artery; EVAR: endovascular aneurysm repair.

The release of all these devices is achieved by unscrewing the plug from the delivery wire by counterclockwise rotation, and when compared to coils, the AVP can be very accurately placed within the target vessel; radiopaque platinum markers allow for a good viewing of the device.¹⁰

For delivering AVP and AVP II to the target vessel, a minimum of a 4-Fr sheath or 5-Fr guiding catheter is required. AVP III requires a 4-Fr sheath or 6-Fr guiding catheter, while AVP IV can be delivered through a 4-Fr diagnostic catheter which allows for its use in smaller vessels.¹⁰ The main features of the different AVPs are depicted in Table 1.

Table 1.

Amplatzer Vascular Plug (AVP) types (Abbott, Plymouth, MN, US).

	AVP	AVP II	AVP III	AVP IV
Amplatzer vascular plug family
Lobes	1	3	2	2
Size (mm)	4–16	3–22	2.8–8.4	4–8
Sheath (Fr)	4–6	4–7	4–7	4–5
Guide catheter (Fr)	5–8	5–9	6–9	4–5 (inner = 0.038)
Landing zone	Shortest	Medium/long	Long	Short
Advantage	High radial force; short landing zone	Most versatile; faster occlusion	Fastest occlusion; paravalvular leak	Tortuous and small vessels; delivery via diagnostic catheter

Methods

Literature search

A literature review was carried out in the available PubMed/MEDLINE and Scopus databases. This review was performed according to the PRISMA statement guidelines.¹¹ We planned to include all the studies evaluating the prevention of type II endoleaks using AVPs and coils in patients undergoing EVAR for AAA. Studies were excluded if they did not fit the research question or if they had insufficient data. Keywords employed were “AAA,” “aortic aneurysm,” “abdominal aneurysm,” “aneurysm,” “amplatzer plug,” “amplatzer vascular,” “vascular plug,” “endoleak,” “type II endoleak,” and “type II” in combination with the Boolean operators. Only the literature from 1999 to 2019 published in the English language was considered. Titles and abstracts were screened by three authors (UMB, MA, and RS) to identify potentially relevant studies. All potentially eligible studies were subsequently evaluated by one reviewer and three authors (UMB, MA, RS, and MP) through consideration of the full text. Reference lists of recovered articles were also searched for relevant publications. Bibliographies of relevant articles and reviews were manually screened to identify additional studies.

Results of the systematic review

After researching MEDLINE and Scopus, 74 nonduplicated citations were found. The flowchart of the study selection is reported in Figure 4. After all the rigorous steps of selection, a total of 18 records were included in the qualitative analysis. Only 5 articles reported an analysis related to the costs of both the AVP and coil procedures and were included in a separate analysis. The main characteristics of the 18 articles selected from the literature review are reported in Table 2. In these studies, the AVP device was used in the vast majority of cases preoperatively for the prevention of type II endoleaks in patients undergoing EVAR, whereas in few cases, they have been used intraoperatively (Tables 2 and 3). None of the studies included in our analysis have used AVP for the treatment of endoleaks. The results related to the type of AVP that was most used and the target vessel are also reported together with information about the mean age of patients and the mean period of follow-up.

Figure 4.

Flowchart of the systematic review.

Table 2.

Summary of the eighteen articles resulted from the systematic review.

Author	Year	Country	N patients	N vessels	Mean age	Type of AVP	Follow-up	Mean cost	Target vessel	Preoperative embolization
Ha and Calcagno¹²	2005	USA	5	5	78	AVP	2 months	US$375	IIA (5)	Yes
Kickuth et al.¹³	2007	Switzerland	9	9	75	AVP	12 months		IIA (9)	Yes
Ratnam et al.¹⁴	2008	UK	23	18	71	AVP	6 months		IIA (16), CIA (2)	Yes
Pellerin et al.¹⁵	2008	France	13	7	73	AVP	26 months	€507	IIA (7)	No
Resnick et al. ¹⁶	2008	USA	10	10	70	AVP	1 month		IIA (10)	No
Vandy et al. ¹⁷	2008	USA	23	23	72	AVP	6 months	US$470	IIA (23)	No
Grenon et al.¹⁸	2009	Canada	20	20	70	AVP	12 months		CIA (7), IIA (13)	Yes
Wu et al.¹⁹	2011	China	101	114	78	AVP	6 months		IIA (114)	Yes
Libicher et al.⁵	2012	Germany	32	15	64	AVP II	12 months	US$657	IIA (15)	Yes
Ryer et al.²⁰	2012	USA	28	28	64	AVP	36 months	US$1300	IIA (28)	Yes
Muller-Wille et al.²¹	2013	Germany	31	31	79	AVP IV	6 months		IMA (31)	No
Burbelko et al.¹	2014	Germany	33	45	70	AVP II (1), AVP IV (44)	36 months	€300	IMA (33), LA (8), ARA (2), GA (1), PA (1)	No
Jean-Baptiste et al.²²	2014	France	23	18	71	AVP	4 months		IIA (18)	Yes
Vink et al.²³	2014	The Netherlands	1	1	78	AVP	6 months		IIA (1)	No
Warein et al.²⁴	2016	France	169	169	75	AVP	20 months		IIA (169)	No
Morikage et al.⁴	2017	Japan	33	33	70	AVP IV	6 months	€130	IMA (33)	No
Dierks et al.²⁵	2017	Germany	22	9	73	AVP	15 months	US$510	IIA (9)	Yes
Saengprakai et al.²⁶	2017	The Netherlands	57	25	72	AVP	12 months		IIA (25)	Yes

Note: US$: United States dollars; €: euros; AVP: Amplatzer Vascular Plug; IIA: internal iliac artery; CIA: common iliac artery.

Table 3.

Complications during follow-up reported by each study.

Author	Buttock claudication (%)	Groin hematoma	Endoleak	Erectile dysfunction	Type of procedure
Ha and Calcagno¹²	40.0	20.0	20.0 (2b)	0	AVP/COIL
Kickuth et al.¹³	33.3	0	0	0	AVP
Ratnam et al.¹⁴	13.0	0	8.7 (2b)	0	AVP
Pellerin et al.¹⁵	7.7	0	0	0	COIL
Resnick et al.¹⁶	10.0	0	0	0	AVP
Vandy et al.¹⁷	8.7	0	0	0	AVP
Grenon et al.¹⁸	0	0	20.0 (2b)	0	AVP
Wu et al.¹⁹	11.9	0	1.9 (1b)	4.0	AVP/COIL
Libicher et al.⁵	6.3	0	0	0	AVP/COIL
Ryer et al.²⁰	7.1	0	10.7 (2b)	0	AVP/COIL
Muller-Wille et al.²¹	0	0	25.8 (1 ,2, 3)	0	AVP
Burbelko et al.¹	0	0	0	0	AVP
Jean-Baptiste et al.²²	5.7	0	4.3 (1b)	0	AVP/COIL
Vink et al.²³	0	0	1.0 (3b)	0	AVP
Warein et al.²⁴	1.0	0	0	0	AVP
Morikage et al.⁴	0	0	0	0	AVP
Dierks et al.²⁵	13.6	0	0	13.6	AVP/COIL
Saengprakai et al.²⁶	10.5	0	3.5 (2a)	0	AVP/COIL

Note: AVP: Amplatzer Vascular Plug.

AVP was employed in 78.6% of the cases; AVP II, in 2.8% of the cases; and AVP IV, in 18.6% of the cases (Figure 5), while AVP III is only for cardiological use and therefore excluded from the analysis. The mean age of all patients was 72.4 years, while the mean period of follow-up was 12.4 months.

Figure 5.

Mean percentages of Amplatzer Vascular Plug types used in the study populations evaluated.

The target vessels for embolization were IIA in 462 (79.7%) cases, the common iliac artery (CIA) in 1.6% (N = 9) of the cases, the inferior mesenteric artery (IMA) in 16.7% (N = 97) of the cases and the lumbar artery (LA) in 1.4% (N = 8) of the cases (Figure 6). Other vessels such as the accessory renal artery (ARA), gluteal artery (GA), and pudendal artery (PA) represented the target for embolization in less than 1% of the cases (Figure 6). When complications which occurred during follow-up had been analyzed (Table 3), we found that the overall risk for complications was low. The most frequent complication was represented by buttock claudication (9.4%) as compared with groin hematoma (1.1%), endoleaks (5.3%), and erectile dysfunction (1.0%).

Figure 6.

Principal target vessels in the studies evaluated. Note: IIA: internal iliac artery; CIA: common iliac artery; IMA: inferior mesenteric artery; LA: lumbar artery; ARA: accessory renal artery; GA: gluteal artery; PA: pudendal artery.

A cost analysis was mentioned in only 5 articles. In all those studies, the trend of costs associated with AVPs and coils was favorable to the use of AVP (Table 4). In fact, the mean weighted cost for AVP (US$310) was lower than that spent for coils (US$2262). In terms of p-value, 2 out 5 studies also observed that plugs were significantly cheaper than coils despite the fact that both devices are effective.^5,15 Costs of additional wires and catheters were not considered.

Table 4.

Cost analysis from the five articles comparing AVP versus coils.

	Mean cost coils	Mean cost AVP	p value
Libicher et al.⁵	US$1071 ± 507	US$657 ± 159	<0.02
Ha and Calcagno¹²	US$3500	US$375
Pellerin et al.¹⁵	€1746 ± 995	€507 ± 6	<0.05
Vandy et al.¹⁷	US$1496.82	US$470.03	0.16
Ryer et al.²⁰	US$3121 ± 1616	US$2159 ± 762	0.7

Note: AVP: Amplatzer Vascular Plug.

Discussion

The present review examined the target vessel, the type of device used, and costs related to the AVP and coil procedures. The original AVP (the initial model) was employed in about eighty percent of the cases, but this is probably due to the presence of this device in the market since 2004.

We found that the most embolized target vessels were the IIA and the IMA^10,21 Bosanquet et al.¹⁰ in their meta-analysis on the effect of IIA exclusion for patients undergoing EVAR reported that buttock claudication after IIA coverage happened in one-third of the patients, but when the contralateral IIA was also covered, this effect was reduced. Another complication is erectile dysfunction, which occurred in 10% of the patients. Conversely, gluteal/bowel/spinal ischemia were rare complications.¹⁰

The type II endoleak of the IMA was evaluated by Muller-Wille et al.²¹ which concluded that AVP IV is a safe and effective embolization device for selective IMA embolization before EVAR (Figure 3).

The comparison between AVPs and coils is a topic discussed in many studies^5,10. Libicher et al., in their study, retrospectively compared the technical and clinical outcomes of patients who had undergone embolization of the IIA with coils or with a vascular plug. They found that, when the occlusion of the vessel is obtained using a single plug, reduction in the procedure time and fluoroscopy time is observed. This means a significant reduction in fluoroscopy time and dose area product when both variables are correlated with radiation exposure of the patient and the medical staff. Bosanquet et al.¹⁰ found that the frequency of erectile dysfunction and ischemic complications was higher among patients undergoing coiling than those undergoing plugging. One hypothesis that has been advocated to explain this difference was that coils, unlike the plug, can migrate into distal vessels, contributing to ischemic damage. Interestingly, they also reported a striking lower rate of buttock claudication, fluoroscopy time, and radiation dose when plugs were applied as proximally as possible, as compared to the distal plugs. Hence, the exact location of intervention may also influence the clinical outcome. From a technical perspective, the AVP embolization is also usually short, this characteristic being extremely important to warrant the collateral perfusion of arterial branches.¹²

With respect to cost analysis, this review revealed that a cost evaluation for both coil and AVP procedures was made in 5 studies only^{13,5,4,15,20,17}. The findings showed that, even with the same treatment efficacy, the overall procedure costs are reduced by using AVP when compared to coils. This can be explained with an intuitive technical reason namely because more coils are needed to obtain the same results as an AVP. In fact, in the analysis of Libicher and colleagues, less than 5 coils were used in 24% of the patients with lower costs when compared to a single plug. Nevertheless, in all these cases, procedure time and radiation exposure were significantly increased thus leading to an overall disadvantageous condition.⁵

It can therefore be stated that the use of different types of devices with different characteristics does not change the overall effectiveness of the procedure. In the comparison between coils and plugs, it was found that both devices are equally effective in the prevention of complications. In a previous study, the AVP technique proved easier and more feasible than that of the coil particularly because of the needs of lesser X-ray and lower contrast doses.²⁷ Also, other advantages of using an AVP may be the smaller number of devices necessary to occlude the vessels which also implies a reduction in the cost of the procedure and the ease in accurately locating the AVP device. Nevertheless, further intervention studies are needed to perform a better comparison between AVPs and coils as well as to detect the advantages of these procedures.

The AVP is a device that merits the vascular specialists’ attention due to its reported low complications rates, ease of use, precision in deployment to the target vessel, high resistance to migration, and low recanalization rate. The use of AVPs should be considered for vessel occlusions during EVAR to prevent type II endoleaks. The traditional embolization with coils over a microcatheter has some disadvantages compared to AVPs, such as a longer procedure and fluoroscopy times, risk of coil dislocation with a nontarget embolization or occlusion of relevant collateral vessels, and higher overall costs due to the necessity of using the microcatheter and several/numerous coils for vessel occlusion. For all these reasons, the AVP can be considered an excellent alternative to coils to embolize vessels.²⁸

Conclusion

Amplatzer Vascular Plug has proven to be a valid, very versatile device; in fact, it allows us to treat vessels of different diameters and therefore finds application not only in vascular surgery but also in interventional cardiology and radiology. The use of AVP for prevention of type II endoleak in patients undergoing EVAR has proven to be as effective as coils, but with the difference that the use of AVP requires a smaller amount of material as a single device is often enough to occlude the target vessel unlike the coils which require the release of a greater number of devices to occlude the vessel. All these findings may be translated to reduction in procedural costs even though further studies are needed to confirm this hypothesis. To date, the manufacturer continues to improve the product, and newer models have improved occlusion properties resulting in a smaller profile.

Footnotes

Declaration of conflicting interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The authors declare that there is no conflict of interest.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Raffaele Serra

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