Metastatic Neuroendocrine Tumor Using Direxion™ Microcatheter and Embozene™ Microspheres

BY EDWARD KIM, MD 

CASE PRESENTATION

A 72-year-old man had a metastatic neuroendocrine tumor to the liver that had undergone radioembolization 2 years prior; he presented with an enlarging 4-cm solitary lesion in Couinaud segment 5 visible on recent 3-month follow-up surveillance MRI. Of note, the patient had a prior history of surgery with ligation of the common hepatic artery origin. A history and physical examination was performed without evidence of encephalopathy or abdominal ascites. The patient’s performance status assessment indicated an Eastern Cooperative Oncology Group (ECOG) score of 0. Laboratory studies revealed unremarkable liver function tests, total bilirubin of 0.6 mg/dL, and albumin level of 4.2 g/dL. The coagulation profile and platelet levels were unremarkable. MRI demonstrated multiple lesions throughout the noncirrhotic liver with an enlarging solitary lesion in segment 5 (Figure 1). The patient was reviewed in a multidisciplinary neuroendocrine conference, and it was decided to proceed with embolization using 40-μm Embozene™ Microspheres (Boston Scientific Corporation) for palliative treatment of oligometastatic disease.

Figure 1. MRI demonstrated multiple lesions throughout the noncirrhotic liver with an enlarging solitary lesion in segment 5.
Figure 1. MRI demonstrated multiple lesions throughout thenoncirrhotic liver with an enlarging solitary lesion in segment 5.
Figure 2. Initial superior mesenteric angiography was performed from radial access and identified a reconstitution of the RHA arising through the pancreaticoduodenal arcade.
Figure 2. Initial superior mesenteric angiography wasperformed from radial access and identified a reconstitution ofthe RHA arising through the pancreaticoduodenal arcade.

PROCEDURE DESCRIPTION

Angiography was performed to identify the tumor vascular supply and determine the optimal route for delivery of embolic materials. Through radial access, initial superior mesenteric angiography was performed, which identified a reconstitution of the right hepatic artery (RHA) arising through the pancreatico-duodenal arcade (Figure 2). Catheterization of the celiac artery was performed and reconstitution of the RHA arising from the right gastric artery was demonstrated (Figure 3).

Figure 3. Catheterization of the celiac artery was performed, and reconstitution of the RHA arising from the right gastric artery was demonstrated.
Figure 3. Catheterization of the celiac artery was performed, and reconstitution of the RHA arising from the right gastric artery was demonstrated.
The RHA and segmental branch artery were selectively catheterized with a 2.4-F Direxion™ Microcatheter (Boston Scientific Corporation) over a Fathom®-16Guidewire (Boston Scientific Corporation) (Figure 4). 
Figure 4. The RHA (A) and segmental branch artery (B) were selectively catheterized with a 2.4-F Direxion™ Microcatheter over a Fathom®-16 Guidewire.

Embolization was performed with 40-μm Embozene™ Microspheres until stasis was achieved. Confirmation postembolization angiography as well as cone-beam CT were performed (Figure 5). A 4-week postprocedure liver MRI demonstrated 100% complete response (Figure 6). Figure 6.

A 4-week postprocedure liver MRI demonstrated 100% complete response. Follow-up laboratory studies were unremarkable and without treatment toxicity.

Figure 5. Embolization was performed with 40-μm Embozene™ Microspheres until stasis. Confirmation postembolization angiography (A) and cone-beam CT were performed (B).
Figure 6. A 4-week postprocedure liver MRI demonstrated 100% complete response.
Figure 6. A 4-week postprocedure liver MRI demonstrated 100% complete response.

DISCUSSION

Catheterization and navigation through collateral vessels with microcatheter and wire manipulation may be challenging due to difficulty in selection and tracking of the microcatheter. As demonstrated in this case, the shapeable tip of the Fathom®-16 Guidewire and stable support in combination with the trackability of the Direxion™ Microcatheter allowed ease of catheterization of a RHA through the left and right gastric arteries despite surgical ligation of the common hepatic artery. Further subselection of segment 5 of the RHA was possible from radial access without an issue with length despite multiple turns. Tightly calibrated 40-μm Embozene™ Microspheres allowed distal embolization of the target tumor vessels with complete response on follow-up MRI.

Edward Kim, MD
Division of Interventional Radiology
Mount Sinai Health System
New York, New York
Disclosures: None..

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

View Full Supplement

 

 

Direxion and Direxion HI-Flo 

CAUTION Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

CONTRAINDICATIONS None known.

WARNINGS Never advance or withdraw an intravascular device against resistance until the cause of resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in damage or separation of the microcatheter or guidewire tip, or vessel perforation. •This Direxion Microcatheter family is not intended for use in the coronary vasculature or neurovasculature. •The Direxion HI-FLO Microcatheter is not designed for the delivery of embolic coils. •Use of excessive force to manipulate the microcatheter against resistance can cause a fracture in the nitinol shaft. Take care not to over-torque the microcatheter, and to relieve any tension before withdrawal by rotating the microcatheter in the opposite direction. 

PRECAUTIONS •This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures. •Do not introduce the microcatheter without guidewire support as this may cause damage to the proximal shaft of the catheter. •Because the microcatheter may be advanced into narrow sub-selective vasculature, repeatedly assure that the microcatheter has not been advanced so far as to interfere with its removal. 

ADVERSE EVENTS The Adverse Events include, but are not limited to: •Allergic reaction •Death •Embolism •Hemorrhage/Hematoma •Infection •Pseudoaneurysm •Stroke •Vascular thrombosis •Vessel occlusion •Vessel spasm •Vessel trauma (dissection, perforation, rupture) 

90960724 Rev/Ver. AB

Fathom-16 Steerable Guidewire

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 

INTENDED USE/INDICATIONS FOR USE The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

CONTRAINDICATIONS None known.

WARNINGS The FATHOM Steerable Guidewire is not intended for use in the coronary vasculature or the neuro vasculature.

ADVERSE EVENTS Complications attributed to endovascular procedures are the following: •Vessel trauma •Vessel damage •Embolism (catheter/device, air bubble, plaque, thrombus, air embolism, thromboembolism) •Pseudoaneurysm •Seizure/stroke •Vessel dissection •Hematoma at the puncture site •Nerve injury •Infection •Perforation of the vessel •Vessel spasm •Hemorrhage •Vascular thrombosis •Vessel occlusion •Death •Bleeding •Failed treatment •Inability to position guidewire •Damage to the catheter

92289650 Rev/Ver. 

Embozene Microspheres

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE Embozene Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).The device is not intended for neurovascular use.

MAGNETIC RESONANCE IMAGING Embozene Microspheres are MR safe.

CONTRAINDICATIONS Embolization procedures shall not be performed if: •Patient is unable to tolerate vascular occlusion procedures. •Vascular anatomy precludes correct catheter placement or embolic injection. •Presence or likely onset of vasospasm. •Presence of a blood coagulation disorder that would prohibit arterial punctures. •Presence of severe atheromatous disease that would preclude correct catheter placement. •Presence of patent extra-to-intra-cranial anastomoses or shunts from the arterial to the venous circulation. •Presence of collateral vessel pathways which could potentially endanger non-targeted tissue during an embolization procedure. •Presence of any vasculature where Embozene Microspheres could pass directly into the central nervous system, central circulatory system or other non-target territories. •Patient has high-flow arteriovenous shunt with diameter greater than the selected Embozene Microspheres. •Patient is pregnant. •Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene or IV radiopaque contrast agent.

CONTRADICTIONS SPECIFIC TO UFE In addition to the general embolization contraindications, uterine fibroid embolization procedures shall not be performed if: •Presence of suspected or active pelvic inflammatory disease. •Presence of malignancy of the pelvic region. •Presence of endometrial neoplasia or hyperplasia. •Presence of submucosal fibroids with more than 50% growth into the uterine cavity. •Presence of pedunculated serosal fibroid as the dominant fibroid(s). •Presence of fibroids with significant collateral feeding by vessels other than the uterine arteries.

CONTRAINDICATIONS SPECIFIC TO PAE In addition to the general embolization contraindications, Prostatic Artery Embolization (PAE) procedures for benign prostatic hyperplasia shall not be performed if: •Evidence of prostatic cancer or bladder cancer. •Urethral stricture. •Prostate size (less than) 40 grams. •Active prostatitis. •Interest in the preservation of fertility. •Patients with renal impairment. •Peak urinary flow rate (greater than) 12 ml/sec. •Large bladder diverticulas or stones. •Neurogenic bladder. •Detrusor failure.

WARNINGS •Vascular embolization is a high risk procedure. The procedure should be performed by specialized physicians trained in vascular embolization procedures. •Care must be taken to choose larger sized Embozene Microspheres when embolizing arteriovenous malformations with large shunts to avoid passage of the microspheres into the venous and subsequently to the pulmonary circulation. •Extreme caution should be used for any procedures above the neck, and risk benefit assessment should be performed to avoid non-target embolization complications. •Risks of radiation from angiography and fluoroscopy used to visualize the blood vessels during embolization, which may include a radiation burn and risks to future fertility. •Do not use Embozene Microspheres in conjunction with embolization devices based on organic solvents such as ethyl alcohol or dimethyl sulfoxide (DMSO) at the same embolization site. •Do not use ionic contrast agent with this product. Ionic contrast agents could alter the microsphere characteristics resulting in microsphere deformation and procedure failure. •Do not use heparinized saline as this could lead to microsphere agglomeration. Agglomeration may impede microsphere delivery through the catheter or result in non-target embolization. •Should catheter obstruction occur, remove the catheter from the patient. Do not use forceful injection, guidewires or other instruments to dislodge the blockage.

WARNINGS SPECIFIC TO UFE •Do not use microspheres smaller than 500 μm. •The diagnosis of uterine sarcoma could be delayed by taking a nonsurgical approach (such as UFE) to treating fibroids. It is important to pay close attention to warning signs for sarcoma (e.g., rapid tumor growth, postmenopausal with new uterine enlargement, MRI findings) and to conduct a more thorough work-up of such patients prior to recommending UFE. Recurrent or continued tumor growth following UFE should be considered a potential warning sign for sarcoma and surgery should be considered.

WARNINGS SPECIFIC TO UFE AND PREGNANCY There is no long-term data on the effects of UFE on the ability to become pregnant and carry a fetus to term, and on the development of the fetus. This procedure should only be performed on women who do not intend future pregnancy. Women who become pregnant following UFE may be at increased risk for the following: •Postpartum hemorrhage •Preterm delivery •Caesarean delivery •Malpresentation •Abnormal placentation •Devascularization of the uterine myometrium resulting from UFE may increase the risk of uterine rupture of women who subsequently become pregnant following

UFE.WARNINGS SPECIFIC TO PAE •An appropriate urological work-up should be performed on all patients (e.g., urological history and appropriate testing, such as Prostate-Specific Antigen test and, when appropriate, biopsy to rule out carcinoma). •The effect of prostatic embolization on male fertility has not been determined. Therefore, this procedure should only be performed on men who are willing to accept the risk of future infertility. •Three-dimensional planning imaging (e.g., magnetic resonance angiography [MRA], computed tomographic angiography [CTA] should be performed prior to embolization on patients who have had any previous invasive treatment to the prostate (e.g., surgery, ablation, etc.) or pelvic irradiation.

PRECAUTIONS To maintain safety, the following precautions shall be considered: •Safety and effectiveness of Embozene Microspheres in the treatment of uterine fibroids has not been established •Safety and effectiveness of Embozene Microspheres for hepatic and renal embolization uses has not been established. •The physician should carefully select the size and quantity of Embozene Microspheres according to the lesion to be treated based on the physician’s education and training and currently available scientific evidence. •Physicians must decide the most appropriate time to stop the infusion of Embozene Microspheres. Typically the artery will accept fewer Embozene Microspheres as the treatment progresses. Proximal slowing or termination of flow may indicate that the vessel or the target area is occluded by Embozene Microspheres. Careful fluoroscopic monitoring is required. •Microparticle embolization must be performed slowly. The injection speed and manner must be controlled. Excessive injection rate may result in retrograde flow in the vessel leading to embolization of other non-target healthy tissue or organs •The color of the Embozene Microspheres may be visible through the skin if injected into superficial arteries. •If arteriovenous anastomoses, branch vessels which lead away from the targeted embolization area, or emergent vessels not evident prior to embolization are present, it can lead to non-targeted embolization and cause severe complications for the patient. •Microspheres smaller than 100 μm can migrate to distal anastomotic feeders and embolize circulation to distal tissue. For this reason, smaller microspheres have a greater likelihood of causing unwanted ischemic injury. This should be considered prior to starting the embolization procedure. •Ischemia of tissue adjacent to the targeted area may result from post-embolization swelling. Therefore, special care should be taken to avoid such ischemia of non-tolerant, non-targeted tissue such as the nervous system. •Consider upsizing Embozene Microspheres if angiographic appearance of embolization does not quickly appear during injection of the microspheres. •If there are any symptoms of unwanted embolization during injection, consider stopping the procedure to evaluate the possibility of shunting. Such symptoms may include changes in patient vital signs, such as hypoxia or central nervous system changes.

INTERACTION WITH PHARMACEUTICALS There are no known chemical interactions between Embozene Microspheres and pharmaceuticals.

ADVERSE EVENTS Potential adverse events associated with the use of Embozene Microspheres include, but may not be limited to: •Allergic reaction •Capillary bed saturation and tissue damage •Cerebrovascular accident (CVA) •Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the microcatheter and subsequent dislodgement, vasospasm, nerve injury, vessel trauma [e.g., dissection, perforation, rupture]) •Death •Foreign body reactions (e.g., pain, rash, fever, inflammation) •Hemorrhage •Incomplete occlusion of vascular beds or territories may give rise to the possibility of post-procedural hemorrhage, development of alternative vascular pathways, recanalization, or recurrence of symptoms •Infection •Ischemia at an undesirable location •Ischemic infarction •Neurological deficits including cranial nerve palsies •Post-embolization syndrome •Pulmonary embolization •Thrombosis •Undesirable reflux, passage/migration or placement of Embozene™ Microspheres, resulting in non-target embolization •Vessel or lesion rupture

POTENTIAL ADVERSE EVENTS SPECIFIC TO UFE: •Hysterectomy •Infection of the pelvic region •Premature ovarian failure (i.e., menopause) •Temporary or permanent stopping of menstrual bleeding •Tissue passage, fibroid sloughing, or fibroid expulsion post-UFE •Uterine rupture •Uterine/Ovarian necrosis •Vaginal discharge •Worsening of fibroid-related symptoms or the onset of new symptoms •Potential adverse events specific to PAE: •Acute urinary retention •Bladder ischemia or necrosis requiring surgical intervention •Diarrhea •Hematuria/Hematospermia •Rectal Bleeding •Rectal or lower colonic strictures •Sexual dysfunction or impaired fertility •Urethral or anal burning sensation •Urethral stricture •Urinary incontinence •Urinary symptoms (e.g. dysuria, urgency, frequency)

91148411 Rev/Ver. AB.6

 

 

Customer Support

Customer Support

If you need any additional information or have questions, feel free to reach out to our support team.

Button
Request a Rep

Request a Rep

To learn more about our products and services, enter your info and a sales representative will contact you.

Button
Sign up for the PI POV newsletter

Join Our Community

Sign up to receive our newsletter.

Button
Top