Cardiovasc Intervent Radiol DOI 10.1007/s00270-014-0889-y

TECHNICAL NOTE

Microvascular Plug: A New Embolic Material for Hepatic Arterial Skeletonization Olivier Pellerin • Geert Maleux • Carole De´an • Simon Pernot • Jafar Golzarian • Marc Sapoval

Received: 22 October 2013 / Accepted: 2 March 2014 Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2014

Abstract Arterial skeletonization before radioembolization or hepatic artery port catheter placement for chemotherapy is a crucial step to prevent side effects. Coils are commonly used as an embolic material for hepatoenteric arterial occlusion. Herein is reported for the first time the clinical use of a new detachable microvascular plug (MVP) suitable for occlusion of 1–3 mm diameter vessels. The MVP allows vessel embolization even in challenging anatomy such as the right gastric artery. Furthermore, immediate and stable vessel occlusion was observed in our pilot study of 16 MVP placements. Keywords Arterial intervention  Chemoembolization  Embolization  Interventional oncology  Radioembolization  Transarterial chemoembolization

Electronic supplementary material The online version of this article (doi:10.1007/s00270-014-0889-y) contains supplementary material, which is available to authorized users.

Introduction Complications resulting from yttrium-90 radioembolization or intra-arterial hepatic chemotherapy are widely reported [1, 2]. The most common complication of both techniques is the nontarget dispersion of yttrium-90 or chemotherapy into the gastrointestinal tract or into the skin resulting in gastrointestinal ulcers, pancreatitis, and dermatitis [2–4]. Careful hepatic arterial skeletonization is a crucial step to avoid such complications and must be performed before radioembolization or intra-arterial hepatic port catheter placement. The currently preferred materials are coils as a result of efficacy and wide availability [4, 5]. However, the target vessels besides the gastroduodenal artery are usually small, tortuous, and recursive, and therefore extremely challenging to embolize. The Reverse Medical Corporation (Irvine, CA, USA) has recently developed a new microvascular plug (MVP), CE Mark and U.S. Food and Drug Administration cleared, that allows resheathing, controlled detachment, and navigation through standard microcatheters. The purpose of this study was to describe our

O. Pellerin  C. De´an  S. Pernot  M. Sapoval Faculte´ de Me´decine, Universite´ Paris Descartes Paris Cite´ Sorbonne, Paris, France

G. Maleux Department of Radiology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium

O. Pellerin  C. De´an  M. Sapoval INSERM U970, Paris, France

S. Pernot Department of Digestive Oncology, Assistance Publique– Hoˆpitaux de Paris, Georges Pompidou European Hospital, Paris, France

O. Pellerin (&)  C. De´an  M. Sapoval Interventional Radiology Department, Assistance Public– Hoˆpitaux de Paris, Georges Pompidou European Hospital, 20 rue Leblanc, Cedex 15, 75908 Paris, France e-mail: [email protected]

J. Golzarian Department of Radiology, Division of Interventional Radiology and Vascular Imaging, University of Minnesota, Minneapolis, Minnesota, USA

G. Maleux Department of Imaging and Pathology, KU Leuven, Leuven, Belgium

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O. Pellerin et al.: New Embolic Material for Hepatic Arterial Skeletonization Table 1 Patient characteristics Characteristic

Value

No. of patients

14

Age (years) [range]

62 ± 9 [49–78]

Sex (M/F)

7/7 2

Body mass index (kg/m )

24 ± 4 [18–32]

ECOG performance status (0/1)

13/1

Child-Pugh class (A/B)

12/2

HCC/CRCLM/breast liver metastases

3/8/3

Radioembolization

7

Intra-arterial hepatic port catheter placement for chemotherapy

7

Target arteries No. of MVP devices

Fig. 1 The Reverse Medical microvascular plug (MVP) is a controlled, detachable embolic material. The cage design is composed of nitinol covered by PTFE at the proximal portion (black star). The MVP is connected to a 0.018-inch nitinol pusher wire by an electrochemical resorbable weld (black arrow)

preliminary multicenter experience with this new device in radioembolization assessment and in intra-arterial hepatic port catheter placement for chemotherapy (IAHPCP).

Material and Method This was a two-center prospective pilot study. This study was approved by our institutional review board as a retrospective observational study of regular practice and was compliant with the Insurance Portability and Accountability Act. Between April 2013 and June 2013, all consecutive patients referred for radioembolization or intrahepatic artery port catheter placement were considered eligible for MVP use. The MVP is a controlled detachable, resheathable embolic device. The cage design is composed of nitinol covered by polytetrafluoroethylene (PTFE) membrane at the proximal portion (Fig. 1). The MVP is connected to a 0.018-inch nitinol pusher wire by an electrochemical resorbable weld (Fig. 1). The system is deliverable through 0.021-inch inner diameter microcatheters. An external generator operates the detachment process. The generator is connected (through sterile cables) to the patient and to the proximal pusher wire. The first generation MVP is indicated for vessels between 1 and 3 mm in diameter and 12–17 mm long.

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16

Right gastric artery

12

Pancreaticoduodenal artery

3

Segment IV artery

1

ECOG Eastern Cooperative Oncology Group, HCC hepatocellular carcinoma, MVP microvascular plug Data are presented as n or as mean ± standard deviation [range]

Through 4F or 5F femoral access, a selective catheterization of the celiac trunk and the superior mesenteric artery was performed as previously described [5, 6]. A detailed hepatic angiography was then performed to identify hepatoenteric supply. As an intention-to-treat evaluation, all B3 mm arteries that needed to be occluded were selected for MVP use, whatever the anatomy and tortuosity. Selective microcatheterization was performed with a 2.7F Progreat (Terumo Europe, Leuven, Belgium), a 2.8F Maestro (Merit Medical Systems, South Jordan, UT, USA), or a 2.8F Renegade Hi-Flo (Boston Scientific, Natick, MA, USA) in the target arteries. The MVP delivery was performed through the microcatheter. Before MVP detachment, a control angiogram was systematically performed though the microcatheter by using a Y hemostatic valve and a 1 ml syringe. This angiogram was performed to assess the position of the device and occlusion of the target artery. In case of suboptimal placement, the device was resheathed by pinning the guide wire and advancing the microcatheter over the MVP device. The MVP could then be redeployed for optimal placement. All procedure data concerning navigation, delivery, and detachment were prospectively collected for further analysis. Follow-up angiography was performed before the yttrium-90 microsphere injection (7 days later), or before intra-arterial chemotherapy (1 month later directly through the port). We sought to evaluate the performance of the MVP for the occlusion of arteries B3.0 mm in diameter.

O. Pellerin et al.: New Embolic Material for Hepatic Arterial Skeletonization b Fig. 2 A 68-year-old man with liver colorectal cancer metastases

was referred to intra-arterial hepatic port catheter placement for further chemotherapy. Through a 4F femoral sheath, a 4F shepherd catheter was placed in the left gastric artery for access to the right gastric artery. This artery was then catheterized with a 2.7F. A Right gastric arterial takeoff arising from the left hepatic artery (black arrow). MVP potential landing area (double arrow). The MVP was then easily pushed into the microcatheter. Delivery and detachment were completed after angiographic control was performed with a Y hemostatic valve connected to the microcatheter to ensure correct position in the target artery. B, c MVP proximal and distal markers after detachment (short, thin black arrows). C Complete occlusion of the right gastric artery on the final angiogram performed through the port catheter. Numerous coils (long arrow) were used to entrap the port catheter into the gastroduodenal artery to provide stability. The port catheter side hole is located at the gastroduodenal arterial takeoff (short arrow)

Results Between April 2013 and September 2013, a total of 14 consecutive patients (mean ± standard deviation age, 62 ± 9 years; range, 49–78 years) were referred for radioembolization assessment (7 patients) or referred for IAHPCP (7 patients). Table 1 summarizes the patient clinical characteristics. Target arteries were the right gastric artery, pancreaticoduodenal artery, and segment IV artery (blood flow redistribution), respectively, in 12 cases, 3 cases, and 1 case. Two patients had two arteries occluded. The diameter of the target artery was 2.1 ± 0.5 mm (range, 1.5–3 mm). Only one MVP was used per target artery. It was possible to navigate and deploy the device in all cases despite the anatomy of the arterial network. The microcatheter was stable; no significant movement or dislodgment from the target site was reported. Video 1 in Supplementary materials shows an example of tortuous anatomy with the microcatheter in place before MVP delivery. The MVP was successfully deployed by unsheathing or pulling back the microcatheter in all cases. No significant friction or undesired movement was observed. In order to optimize placement in the target artery, the MVP was successfully resheathed, relocated, and redeployed in 5 cases (30 %). Immediate target vessel occlusion was observed in all cases before the detachment procedure. The release or detachment of the MVP was obtained in a median time of 38 s (range, 28–80 s). In one case, the MVP was deployed distal to the first side branch of the right gastric artery. An additional microcoil (Vortx 4 9 4 mm, Boston Scientific, Natick MA, USA) was placed proximal to the MVP to also occlude this first side branch.

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O. Pellerin et al.: New Embolic Material for Hepatic Arterial Skeletonization

The last control angiography performed (mean ± standard deviation, 22 ± 3 days; range, 22–42 days) confirmed permanent arterial occlusion in all cases; intrahepatic artery chemotherapy or radioembolization could be performed as planned, with no delay. No additional coils were needed during implantation or follow-up angiographic control. No secondary MVP device dislodgement was observed during follow-up.

Discussion Mechanical embolic agents are numerous; the most commonly used are coils and plugs. Fibered and nonfiber coils, hydrocoils, and detachable or pushable coils are used in our daily practice. The main drawback of the coils is the quantity and time needed to obtain immediate and stable vessel occlusion [7]. Coils can also result in undesired embolization as a result of various mechanisms, including coil migration (mostly for pushable coils), a phenomenon known as coil dribbling. In the mid term, recanalization can also be a clinical problem in bleeding situations or in cases where permanent occlusion is important, as in IAHPCP and radioembolization [8]. Plugs have been available in various sizes and lengths for several years. A recent development is the availability of the Amplatzer Vascular Plug 4 (St Jude Medical Inc., Saint Paul, MN, USA), which navigates through a 4F catheter (0.38-inch inner diameter lumen). These devices allow occlusion of arteries down to 4 mm [9]. However, there is no vascular plug that is able to navigate through a microcatheter and through tortuous arteries. Here we report what is to our knowledge the first clinical use of the MVP. We found several clinically relevant device features. First is efficacy; the MVP allowed an immediate and stable target vessel occlusion. Second is compatibility; MVP is compatible with many 2.7F microcatheters commonly used in peripheral embolization procedures. Third is navigability: the MVP is deliverable to selected distal targets in tortuous anatomy, such as right gastric artery or pyloroduodenal artery (Fig. 2). Fourth is resheathability: the device can be easily and completely resheathed without device disruption to ensure ideal vessel occlusion; it is also possible to proceed before device detachment with angiography through the microcatheter to assess efficacy and location. Fifth is stability: when the MVP was delivered to the target artery, no resulting displacement was observed. One advantage of the use of MVP over coils is that the MVP is a single device, compared to multiple devices (e.g., coils) required to embolize an artery. Compared to coils and other vascular plugs, the MVP allows immediate vessel occlusion from a single implant. Further, immediate

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occlusion after a single MVP placement was confirmed via angiography. Usually occlusion by coils or vascular plugs occur in 1–20 min [10–12]. Finally, the ability to confirm positioning, as well as resheathe and redeploy if needed for optimal placement, is unique to this device. The use of this MVP may be cost-effective, although this was not proven in our study. Some limitations of our study exist, however. First, the initial device is only indicated for arteries 1–3 mm in diameter. Second, a landing area length of 12–15 mm is needed to ensure correct device deployment. In conclusion, our two-center pilot study demonstrated the MVP device to be a useful tool to achieve satisfactory, fast, and permanent occlusion of small arteries through a single device deployed through a microcatheter. Further technical developments of larger devices to allow embolization of larger arteries are pending; more clinical and cost evaluations will be needed to define the place of this device in the armamentarium of the interventional radiologist. Conflict of interest Olivier Pellerin, Geert Maleux, Carole De´an, Simon Pernot, Jafar Golzarian and Marc Sapoval have no conflict of interest. Financial Disclosure Olivier Pellerin, Geert Maleux, and Marc Sapoval received consulting fees from Reverse Medical.

References 1. Deschamps F, Elias D, Goere D et al (2011) Intra-arterial hepatic chemotherapy: a comparison of percutaneous versus surgical implantation of port-catheters. Cardiovasc Interv Radiol 34: 973–979 2. Riaz A, Lewandowski RJ, Kulik LM et al (2009) Complications following radioembolization with yttrium-90 microspheres: a comprehensive literature review. J Vasc Interv Radiol 20: 1121–1130 3. Sjoquist KM, Goldstein D, Bester L (2010) A serious complication of selected internal radiation therapy: case report and literature review. Oncologist 15:830–835 4. Farouil G, Deschamps F, Barah A et al (2013) Interventional revisions of malfunctions affecting surgically implanted portcatheters for hepatic artery infusion. Surg Oncol 22:48–54 5. Kennedy A, Nag S, Salem R et al (2007) Recommendations for radioembolization of hepatic malignancies using yttrium-90 microsphere brachytherapy: a consensus panel report from the radioembolization brachytherapy oncology consortium. Int J Radiat Oncol Biol Phys 68:13–23 6. Deschamps F, Rao P, Teriitehau C et al (2010) Percutaneous femoral implantation of an arterial port catheter for intraarterial chemotherapy: feasibility and predictive factors of long-term functionality. J Vasc Interv Radiol 21:1681–1688 7. Maleux G, Deroose C, Fieuws S et al (2013) Prospective comparison of hydrogel-coated microcoils versus fibered platinum microcoils in the prophylactic embolization of the gastroduodenal artery before yttrium-90 radioembolization. J Vasc Interv Radiol 24:797–803

O. Pellerin et al.: New Embolic Material for Hepatic Arterial Skeletonization 8. Enriquez J, Javadi S, Murthy R et al (2013) Gastroduodenal artery recanalization after transcatheter fibered coil embolization for prevention of hepaticoenteric flow: incidence and predisposing technical factors in 142 patients. Acta Radiol 54:790–794 9. Bulla K, Hubich S, Pech M et al (2013) Superiority of proximal embolization of the gastroduodenal artery with the amplatzer vascular plug 4 before yttrium-90 radioembolization: a retrospective comparison with coils in 134 patients. Cardiovasc Interv Radiol 37:396–404 10. Pellerin O, Caruba T, Kandounakis Y et al (2008) Embolization of the internal iliac artery: cost-effectiveness of two different techniques. Cardiovasc Interv Radiol 31:1088–1093

11. Fohlen A, Ghegediban SH, Namur J et al (2012) Hydrogel-coated coils versus fibered coils in an animal model of peripheral embolization: mechanism of occlusion in a short-term study. Paper presented at: CIRSE, Lisbon 12. Salamat M, Brown PR, Magee CA, Reyes DK, Peters DN, Venbrux AC (2002) Experimental evaluation of a new transcatheter vascular embolization device in the swine model. J Vasc Interv Radiol 13:301–312

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Microvascular plug: a new embolic material for hepatic arterial skeletonization.

Arterial skeletonization before radioembolization or hepatic artery port catheter placement for chemotherapy is a crucial step to prevent side effects...
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