Embozene™ Microspheres for Uterine AVM Embolization

BY JUAN FRANCISCO MORALES-LEON, MD; ROBERT J. RAYMOND, MD; MARY BROOKES EZELL, MD; BRUCE BORDLEE, MD; AND JAMES CARIDI, MD, FSIR 

CASE PRESENTATION

A 27-year-old woman who was gravida 3 para 2presented to an obstetrics and gynecology clinic with complaints of persistent pelvic pain and vaginal bleeding following medical termination of pregnancy with methotrexate (without dilation and curettage [D&C]) about 4 weeks earlier. Physical exam at that time was notable for a 12-week–sized marked lytender uterus. Pelvic ultrasound revealed a large, hypervascular uterus with a large uterine arteriovenous malformation (AVM) measuring at least 3.5 cm X 1 cm in the sagittal plane (Figure 1).

Figure 1. Sagittal ultrasound of the uterus showed a 3.5-cm X1-cm uterine AVM at the time of initial presentation.
Figure 1. Sagittal ultrasound of the uterus showed a 3.5-cm X1-cm uterine AVM at the time of initial presentation.
The patient had a past medical history significantfor systemic lupus erythematosus, arthritis, genital herpes, and cervicitis. Her most recent prior pelvic ultrasound was unremarkable (about 2 months prior top resentation). The AVM malformation was confirmed with a pelvic CTA, which also demonstrated dilated vessels within the endometrium raising the concern of retained products of conception (Figure 2). Because the patient desired future fertility, she was referred to the interventional radiology department for a possible uterine AVM embolization.
Figure 2. Pelvic CTA showing axial, coronal, and sagittal views of approximately 5-cm X 5-cm X 1.5-cm dilated disorganized vascular structures encompassing the anterior and lateral uterine walls and fundus.
Figure 2. Pelvic CTA showing axial, coronal, and sagittal views of approximately 5-cm X 5-cm X 1.5-cm dilated disorganized vascular structures encompassing the anterior and lateral uterine walls and fundus.

PROCEDURE DESCRIPTION

The embolization was performed as an outpatient procedure, utilizing a right groin access that was achieved under direct ultrasound guidance. A 4-F Omni™ Flushcatheter (AngioDynamics) was advanced through a 5-F Pinnacle® introducer sheath (Terumo Interventional Systems) into the distal abdominal aorta, with subsequent aortoiliac angiography demonstrating patent vessels with filling of a large uterine AVM, predominantly supplied by the left uterine artery (Figure 3).

Figure 3. Arterial (A) and venous (B) phase frontal aortoiliac angiogram demonstrated filling of a large uterine AVM, supplied by the left uterine artery without evidence of feeders from the right uterine artery (B).
Figure 3. Arterial (A) and venous (B) phase frontal aortoiliac angiogram demonstrated filling of a large uterine AVM, supplied by the left uterine artery without evidence of feeders from the right uterine artery (B).
The catheter was then manipulated into the left hypogastric artery (Figure 4). Subsequently, a straight 0.021-inch 130-cm Renegade® STC-18 Microcatheter (Boston Scientific Corporation) was then advanced into the distal left uterine artery over a Fathom®-16 Guidewire (Boston Scientific Corporation). Additional images were obtained (Figure 5) before delivering four vials of 700-μm Embozene™ Microspheres (Boston Scientific Corporation). Due to a small amount of residual flow to the AVM, a gelfoam slurry was then used for further embolization, after which, near stasis was achieved with no filling of the AVM (Figure 6). Interrogation of the right internal iliac artery was also performed and demonstrated no feeding vessels to the AVM. Because the patient desired future fertility and no flow to the malformation was identified, the decision was made to stop the procedure at this point.
Figure 4. Frontal angiography of a selective left hypogastric catheterization showed AVM filling..
Figure 4. Frontal angiography of aselective left hypogastric catheterizationshowed AVM filling.
Figure 5. Superselective angiogram of the distal left uterine artery with a straight Renegade® STC-18 Microcatheter exhibited filling of the AVM.
Figure 5. Superselective angiogramof the distal left uterine artery with astraight Renegade® STC-18 Microcatheterexhibited filling of the AVM.
Figure 6. Frontal angiographic image after the use of gelfoam for further embolization; no residual filling of the AVM was visible.
Figure 6. Frontal angiographic imageafter the use of gelfoam for furtherembolization; no residual filling of theAVM was visible.

RESULTS

Approximately 3 hours after the procedure, the patient began experiencing profuse vaginal bleeding followed by tachycardia and hypotension. The patient was sent for emergent repeat angiography (Figure 7). Because the right side was not embolized, the repeat bleeding was thought to come from that source, but was negative. Left uterine artery evaluation also revealed no radiographic evidence of bleeding. Ovarian artery interrogation was also negative. Products of conception were of primary concern after reviewing the imaging. An emergent D&C was then performed, revealing remaining products of conception as the source. Bleeding ceased following the procedure. The patient stabilized and the rest of her hospital course was unremarkable aside from mild pelvic pain. A 3-month follow-up pelvic ultrasound revealed complete resolution of the uterine AVM with a normal-appearing uterus and endometrium (Figure 8).

Figure 7. Repeated frontal angiogram demonstrated no filling of the uterine AVM.
Figure 7. Repeated frontal angiogram demonstrated no filling of the uterine AVM.
Figure 8. Pelvic ultrasound at 3-month follow-up showed complete resolution of the uterine AVM.
Figure 8. Pelvic ultrasound at 3-month follow-up showedcomplete resolution of the uterine AVM.

DISCUSSION

Uterine AVMs are almost always acquired and rarely congenital. They are typically seen in premenopausal women, and risk factors include multiple gestations, D&C, intrauterine devices, cesarean section, and infection. Uterine AVMs result from failed development of a primitive capillary plexus resulting in multiple intra- and extrauterine feeding arteries and large draining veins with an intervening vascular nidus. Acquired uterine AVMs result from abnormal communications between the intramural arterial branches and the myometrial venous plexus without an intervening vascular nidus.Acquired uterine AVMs are typically easier to treat with transarterial embolization due to a lack of extrauterine arterial supply with only one or both uterine arteries supplying one or two feeding vessels.

Uterine AVMs have the potential for life-threatening vaginal bleeding, mandating early diagnosis and treatment. It is important to note that treatment for uterine bleeding with D&C is contraindicated in the setting of a uterine AVM, as it can paradoxically worsen the bleeding. Depending on the severity of symptoms, uterine AVM treatment options range from watchful waiting and medical management to endovascular or surgical intervention. If asymptomatic, monitoring is preferred; spontaneous resolution is common. If symptoms are minimal, medical treatment with oral contraceptives or danazol is a potential option, with the reasoning that decreased blood flow to the uterus may permit the AVM to thrombose. For stable to unstable patients with acute to subacute bleeding, the patient’s desire for future fertility must be considered when determining surgical versus endovascular intervention. During instances of acute massive bleeding that require emergent intervention or if future fertility is no longer desired, hysterectomy should be considered as a definitive option. Catheter-directed uterine artery embolization is preferred when future fertility is desired.

When performing uterine AVM embolization, angiography of bilateral uterine arteries must be performed to evaluate for cross filling of feeder vessels. Furthermore, cross filling may not be apparent on initial angiography. Embolization can be performed with gelfoam, polyvinyl alcohol particles, microspheres, or glue. Complications of uterine artery embolization include pelvic pain, perianal skin sloughing, uterovaginalor rectovaginal fistulas, and lower extremity neurologic deficits. Retained products of conception can potentially result in profuse postprocedural bleeding under the guise of a failed intervention. Following a negative repeat angiogram, retained products of conception should be reconsidered as the source, especially in the setting of recent pregnancy.

Juan Francisco Morales-Leon, MD
Department of Radiology
Tulane University School of Medicine
New Orleans, Louisiana
Disclosures: None.
Robert J. Raymond, MD
Department of Radiology
Tulane University School of Medicine
New Orleans, Louisiana
Disclosures: None.
Mary Brookes Ezell, MD
Assistant Professor, Department of Radiology
Section Chief, Interventional Radiology
Tulane University School of Medicine
New Orleans, Louisiana
Disclosures: None.
Bruce Bordlee, MD
Associate Residency Program Director
Vascular & Interventional Radiology
Tulane University School of Medicine
New Orleans, Louisiana
Disclosures: None.
James Caridi, MD, FSIR
Chairman, Department of Radiology
Professor of Vascular & Interventional Radiology
Tulane University School of Medicine
New Orleans, Louisiana
Disclosures: None.

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

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Renegade STC 18 Microcatheter

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 Renegade STC 18 Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

CONTRAINDICATIONS None Known.

WARNING The Renegade STC 18 Microcatheter is not intended for use in the coronary vasculature or the neurovasculature.

PRECAUTIONS •This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures. •Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in separation of the microcatheter or guidewire tip, damage to the microcatheter or guidewire tip, or vessel perforation. •Because the microcatheter may be advanced into narrow subselective 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: •Vessel trauma •Embolism •Hemorrhage/Hematoma •Vasospasm •Infection •Air embolism •Allergic reaction

90960758 Rev/Ver. AB

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

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. 

 

 

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