CATCH+ THROMBOEMBOLECTOMY SYSTEM

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1 CATCH+ THROMBOEMBOLECTOMY SYSTEM CATCH+ MINI & VASCO+10 CATCH+ & VASCO+18 Longitudinal slit CATCH+ MAXI & VASCO+21 VASCO+ Stable pusher wire Superior technology that significantly benefits the patient * Years * Superior technology compared to the 1st CATCH version. Jeffrey L. Saver et al. Stent-Retriever Thrombectomy after Intravenous t-pa vs. T-PA Alone in Stroke. The NEJM.org. 2015; DOI: /NEJMoa The CATCH+ Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-pa) or who fail IV t-pa therapy are candidates for treatment. The CATCH+ Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. The CATCH+ and VASCO+ are manufactured by BALT EXTRUSION 10, rue de la Croix Vigneron Montmorency. The content of this document, in particular data, information, trademarks and logos are BALT INTERNATIONAL S.A.S and affiliates sole property. Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and would be considered a violation of BALT INTERNATIONAL S.A.S and affiliates copyrights and other intellectual proprietary rights 2016 BALT INTERNATIONAL S.A.S and affiliates all rights reserved. This document with associated pictures are non-contractual and are solely dedicated to healthcare professionals and BALT INTERNATIONAL S.A.S and supplier s distributors. The products shall exclusively be used in accordance with the package inserts which have been updated and included in the boxes. The BALT products listed above are class III CE marked (LNE/G-Med CE0459) according to the Medical Device Directive 93/42/EEC. ADI2016/026.

2 Case Report Endovascular treatment of vein of Galen aneurysmal malformation using rapid ventricular pacing: A case report Interventional Neuroradiology 2017, Vol. 23(1) ! The Author(s) 2016 Reprints and permissions: sagepub.co.uk/journalspermissions.nav DOI: / journals.sagepub.com/home/ine Birgitta Ramgren 1, Olof Rask 2, Jan Gelberg 3, Petru Liuba 2, Per Undrén 1 and Johan Wassélius 1 Abstract The treatment of choice of vein of Galen aneurysmal malformation (VGAM) involves endovascular procedures that can be difficult to perform in high-flow fistulas. We describe the use of rapid ventricular pacing (RVP), a well-known cardiologic technique, to safely treat a high-flow fistula in an infant with VGAM. Keywords Endovascular treatment, high-flow fistula, rapid ventricular pacing, vein of Galen aneurysmal malformation Received 25 July 2016; revised: 5 October 2016; accepted 5 October 2016 Introduction Vein of Galen aneurysmal malformation (VGAM) is a rare congenital disease caused by arteriovenous shunts between the choroidal arteries and the ectatic porencephalic vein. There are two main types of angioarchitecture: 1 a choroidal and a mural type. The choroidal type consists of multiple arterial feeders, something like a nidus, that drain into the dilated vein, and the mural type has direct arteriovenous (AV) fistulas. The clinical presentation of symptoms 2 differs depending on age. In neonates (<1 month), congestive heart failure, with or without multiorgan failure, is often seen. In infants (1 month to 2 years), hydrovenous disorders such as hydrocephalus and macrocrania can be seen. Endovascular techniques are primarily used for treating VAGM and staged procedures are often necessary, 3 i.e. controlled devascularization of the AV fistulas to prevent massive venous thrombosis. The timing of the treatment depends on clinical symptoms. There are several endovascular treatment options, and an important factor during embolization is flow control, to be able to occlude the fistula without displacing embolization material. Rapid ventricular pacing (RVP) reduces cardiac output, and both blood pressure and blood pressure amplitude are decreased without cardiac arrest. RVP has been used during catheter interventional procedures for congenital aortic stenosis 4 and is a wellknown method for balloon aortic valvuloplasty. 5 The aim was to use RVP to reduce the cardiac output in our patient and facilitate embolization of the high-flow fistula. Patient description The patient was born full term with no symptoms at birth, but after 12 hours, was tachypneic and a cardiac murmur was heard. Cardiac ultrasound revealed tricuspid insufficiency and a suspected cardiomyopathy. Diuretic treatment was started. At 3 months of age, the patient again had tachypnea. On ultrasound examination through the anterior fontanel, a dilated central vein was seen. Magnetic resonance imaging (MRI) and angiography (MRA) showed a VGAM, mural type with direct AV fistulas (Figure 1). Because of enlargement of the heart and the elevated lung pressure, about mmhg, prompt endovascular treatment was deemed necessary. The first attempt to treat the VGAM was undertaken when the infant was 3.5 months old (Figure 2). At that time, occlusion of the most prominent fistula from the left posterior choroidal 1 Department of Diagnostic Radiology, Clinical Sciences Lund, Faculty of Medicine, Lund University and Skåne University Hospital, Sweden 2 Department of Pediatrics, Clinical Sciences Lund, Faculty of Medicine, Lund University and Skåne University Hospital, Sweden 3 Department of Pediatric Anesthesiology and Intensive Care, Clinical Sciences Lund, Faculty of Medicine, Lund University and Skåne University Hospital, Sweden Corresponding author: Birgitta Ramgren, Section of Neuroradiology, Department for Medical Imaging and Physiology, Skåne University Hospital Lund, Lund, Sweden. birgitta.ramgren@skane.se

3 98 Interventional Neuroradiology 23(1) Figure 1. Magnetic resonance imaging, flair, to the left, and 3D time-of-flight angiography, to the right, both sagittal views, indicating a vein of Galen aneurysmal malformation in the infant at 3 months of age. Figure 2. Internal carotid artery contrast injection left side (lateral and frontal projection above) and right internal carotid artery (lateral and frontal projection below) before endovascular treatment, showing bilateral arteriovenous fistulas, the most prominent on the left side. artery was not possible. First, glue consisting of a mixture of 50% n-butylcyanoacrylate (NBCA) and ethiodized oil (Lipiodol), 0.4 ml through the microcatheter, did not adhere to the vessel wall. No venous outflow obstruction was seen. A small amount of glue was seen in the pulmonary arteries, but there was no effect on saturation. An attempt with contrast injection through a double-lumen balloon (Scepter TM compliant balloon 4 10 mm, Microvention Europe, Saint-Germain-en- Laye, France) did not give sufficient support to

4 Ramgren et al. 99 reduce the high blood flow. A smaller fistula from the right posterior choroidal artery was occluded with coils. After the first partly unsuccessful procedure, the patient did well but was still on diuretic treatment. It was therefore decided to attempt a new treatment when the child was 6 to 7 months of age and to use RVP during the procedure. Treatment with RVP General anesthesia was performed by a team consisting of a pediatric anesthesiologist and nurses with experience in pediatric cardiac intervention and surgery. A 4-French introducer sheath was placed in the femoral artery for treatment access, and a 5-French introducer sheath in the femoral vein, for the temporary pacemaker electrode. Intravenous heparin 300 IE (50 IE/kg body weight) was administered. A pediatric cardiologist (P.L.) introduced a temporary bipolar pacemaker electrode (Pacel TM bipolar pacing catheter 5-Fr 110 cm, St Jude Medical, Zaventem, Belgium) into the trabecular portion of the right ventricle. A test was performed with an external pacemaker by the anesthesiologist (J.G.), with pacing up to 220 beats/minute, to confirm the position of the electrode and determine the frequency necessary to induce override and reduction of blood pressure. The goal of RVP was to reduce heart stroke volume and cardiac output, thereby reducing blood pressure by at least 50%. During superselective contrast injections (Omnipaque 300 mgi/ml, GE Healthcare AS, Oslo, Norway) diluted with saline, through microcatheter Headway Duo (Microvention Europe, Saint-Germain-en-Laye, France) in the left posterior choroidal artery, the position of the microcatheter was stabilized. To confirm the optimal position of the microcatheter and to access blood flow during RVP, angiography was performed a couple of times during RVP at beats/minute, between 20 to 30 seconds each. The patient recovered to normal sinus rhythm after each episode of RVP. When a satisfactory position of the microcatheter was reached (Figure 3), a mixture of 50% NBCA and Lipiodol was prepared, and 3 ml glucose 10% was used to clear the hub and flush the microcatheter. RVP was started at the same time as the glue injection (0.6 ml over seconds) began in the microcatheter. During the glue embolization, the systolic blood pressure was 40 mmhg (compared to 75 mmhg without RVP) and mean arterial pressure (MAP) was 30 mmhg (compared to 55 mmhg without RVP). A glue cast was formed in the fistula and in the venous pouch, with reduced residual flow through the fistula. We estimated that the fistula was reduced by 75%. A second embolization was performed without RVP using 0.5 ml 50% NBCA and Lipiodol. After the second embolization, only minimal contrast passed through the treated fistula, and we considered the treatment to be satisfactory. Figure 3. A digital subtraction angiogram at 7 months of age, showing superselective contrast injection in a left side high-flow fistula, during rapid ventricular pacing at 240 beats/minute. Follow-up At the age of 16 months, the patient was scheduled for a control MRI and treatment of a remaining fistula from the right posterior choroidal artery. Since this remaining fistula was smaller, treatment was scheduled to be performed without RVP. The control angiogram showed a complete occlusion of the previously treated fistulas (Figure 4), and the remaining fistula on the right side was occluded with coils. A post-treatment angiogram revealed only a minimal fistula from a perforating artery. Control with MRI and MRA at the age of 20 months showed no evidence of any fistula (Figure 5) and the patient is scheduled for a control digital subtraction angiography at age 2 3 years. At the latest follow-up, the patient was doing well without medication and showed normal psychomotor development. Discussion The infant described in this case report is, to our knowledge, the first in whom a VGAM was treated using an endovascular procedure with the support of RVP to achieve flow control during embolization. Since RVP enforces ventricular tachycardia, causing a high heart rate, the ventricular filling is compromised, and there is an absent atrioventricular synchrony. The reduction of stroke volume and cardiac output leads to decreased blood pressure and decreased blood pressure amplitude, 4 i.e. a reduction of blood flow. Another way of managing high-flow fistulas in VGAM is the use of double-lumen balloon

5 100 Interventional Neuroradiology 23(1) Figure 4. Digital subtraction angiography, frontal projection and lateral projections at 16 months of age, showed no remaining arteriovenous fistula. Figure 5. Magnetic resonance imaging, flair, to the left, and 3D time-of-flight angiography, to the right, showing no remaining arteriovenous fistulas at the age of 20 months. microcatheters 6 and ethylene vinyl alcohol copolymer ONYX TM (Medtronic, Minneapolis, MN, USA). The balloons are inflated in the arteries to reduce the blood flow during the embolization. The advantage of using ONYX instead of NBCA mixed with Lipiodol is the chemical difference, allowing longer and repeated injections with less risk of the glue adhering to the microcatheter. With a double-lumen balloon microcatheter, compatible with ONYX, a controlled flow arrest in the catheterized vessel can be achieved. The disadvantage is the complex system, with two arterial long 4-Fr introducers, and to occlude the VAGM, two double-lumen balloons microcatheters are used, one in the common carotid artery and the other in the vertebral artery. There is a risk of arterial dissection, and also a risk of vessel rupture when inflating the balloons. In our infant, at the first treatment at 3.5 months of age, achievement of flow arrest with a double-lumen balloon microcatheter was not possible because of an inability to inflate the artery without expanding it while achieving sufficient flow arrest. A technique called a kissing microcatheter technique is a combination of a transvenous and a transarterial approach 7 at the same time, aiming at detaching coils in the high-flow fistula to occlude it. The embolization is performed by first putting the coils through the transvenous microcatheter, against the high blood flow, into the artery of the fistula, and then proceeding transarterially by coiling the feeding artery. With this technique, one arterial and one venous introducer are used, as in our patient. The advantage with this system is the possibility to detach the coils in a controlled way, without risk of material in the venous outflow. On the other hand, perforation of arteries has been described. The use of intravenous adenosine to produce flow arrest through near asystole during treatment with NBCA of a high-flow fistula in VGAM has been

6 Ramgren et al. 101 described in a case report in an adult. 8 Adenosine is an antiarrhythmic agent that can be used as a transient flow arrest with hypotension. The half-life of adenosine is short, less than 10 seconds, and it can be difficult to calculate the dose in relation to the time needed for embolization, i.e. how long will the effect of adenosine last. In RVP, the time is determined by the external pacemaker, controlled by the pediatric anesthesiologist in collaboration with the neurointerventionist. Both methods have the risk of ventricular fibrillation and a need for defibrillation. In the same month as we used RVP in our patient, Nimjee et al. 9 published a case report describing the use of RVP during the surgical treatment of a basilar artery pseudoaneurysm in a 2-year-old boy. The patient underwent RVP five times between 34 to 45 sec during surgical dissection and three more times (74, 55 and 67 seconds) during clipping of the aneurysm. After the last time, ventricular fibrillation occurred, and electrical fibrillation was needed to return to sinus rhythm. It is a well-known risk, but in our patient, there was no need for defibrillation. One possible reason for the absence of ventricular fibrillation in our patient could be fewer and shorter bursts of RVP. There are relatively few neurointerventionists who treat VGAM. The experience varies as do the endovascular methods. Our patient had a technically challenging high-flow fistula from the left posterior choroidal artery, and the first treatment attempt to close the dominating fistula failed. RVP was then considered to improve the chance of a good outcome without significantly increased risk. Since pediatric interventional cardiology and cardiac surgery are located in our university hospital, it was possible to assemble a multidisciplinary team with experience in the use of RVP in pediatric endovascular procedures. The cooperation between the pediatric anesthesiologist, the pediatric cardiologist and the neurointerventional team was a key factor for success in our case. The importance of the right level of competence of all involved participants has been discussed by Li et al., 10 describing the Toronto experience regarding the treatment of VGAM. This case report illustrates that RVP is a safe and useful method during endovascular treatment of a highflow fistula in an infant with VGAM. 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 1. Lasjaunias PL, Chng SM, Sachet M, et al. The management of vein of Galen aneurysmal malformations. Neurosurgery 2006; 59(5 Suppl 3): S184 S194; discussion S3 S Roccatagliata L, Bracard S, Holmin S, et al. Pediatric intracranial arteriovenous shunts: A global overview. Childs Nerv Syst 2013; 29: Pearl M, Gomez J, Gregg L, et al. Endovascular management of vein of Galen aneurysmal malformations. Influence of the normal venous drainage on the choice of a treatment strategy. Childs Nerv Syst 2010; 26: Daehnert I, Rotzsch C, Wiener M, et al. Rapid right ventricular pacing is an alternative to adenosine in catheter interventional procedures for congenital heart disease. Heart 2004; 90: David F, Sa nchez A, Yánes L, et al. Cardiac pacing in balloon aortic valvuloplasty. Int J Cardiol 2007; 116: Pop R, Manisor M, Wolff V, et al. Flow control using Scepter TM balloons for ONYX embolization of a vein of Galen aneurysmal malformation. Childs Nerv Syst 2015; 31: Meila D, Hannak R, Feldkamp A, et al. Vein of Galen aneurysmal malformation: Combined transvenous and transarterial method using a kissing microcatheter technique. Neuroradiology 2012; 54: Tsimpas A, Chalouhi N, Halevy JD, et al. The use of adenosine in the treatment of a high-flow vein of Galen malformation in an adult. J Clin Neurosci 2014; 21: Nimjee SM, Smith TP, Kanter RJ, et al. Rapid ventricular pacing for a basilar artery pseudoaneurysm in a pediatric patient: Case report. J Neurosurg Pediatr 2015; 15: Li AH, Armstrong D and terbrugge KG. Endovascular treatment of vein of Galen aneurysmal malformation: Management strategy and 21-year experience in Toronto. J Neurosurg Pediatr 2011; 7: 3 10.