Transarterial Embolization and Thermal Ablation for Hepatocellular Carcinoma

BY CHUKWUSOMNAZU E. NWANZE, MD; MICHAEL A. BEVILACQUA, MD;AND ERIC K. HOFFER, MD

CASE PRESENTATION

A 61-year old man with an otherwise unremarkable medical history presented to orthopedic surgery for chronic left shoulder pain, sequelae of a remote left shoulder trauma from a fall. He was planned for left shoulder arthroplasty. Routine preoperative clearance workup revealed incidental thrombocytopenia (platelet count was 47,000/μL). Due to this finding, the planned left shoulder surgery was deferred pending a comprehensive workup for the etiology of the isolated thrombocytopenia.

Further workup revealed an aspartate aminotransferase (AST) level of 53 U/L (normal range, 0-39 U/L), a normal alanine aminotransferase (ALT) of 40 U/L, alkanine phosphatase (ALP) level of 90 U/L, total bilirubin of 1.3 mg/dL, negative hepatitis serology, normal renal function, alpha-fetoprotein (AFP) level of 8.9 μg/L, carcinoembryonic antigen (CEA) of 7.4 μg/L, and a mildly elevated iron panel. CT imaging of the abdomen demonstrated splenomegaly with perisplenic and gastroesophageal varices. Multiple liver lesions were also found on CT.

A follow-up MRI of the abdomen confirmed a 4.9-cm segment 6 mass classified as LR-M, a 2.3-cm segment 6 LI-RADS 5 lesion, and a 2-cm segment 8 LI-RADS 3 lesion. The MRI also confirmed the previous CT findings of splenomegaly with perisplenic and gastroesophageal varices. The patient had no family history of liver disease. Social history was significant for alcohol use.

Due to the LR-M classification of the dominant segment 6 mass, he underwent a percutaneous CT-guided liver biopsy that confirmed histologically a well-differentiated hepatocellular carcinoma (HCC) (Figure 1).
Figure 1. CT-guided liver biopsy confirmed the diagnosis of HCC
Figure 1. CT-guided liver biopsyconfirmed the diagnosis of HCC
The patient’s working diagnosis was multifocal HCC in the setting of Child-Pugh class A cirrhosis with a MELD score of 9. Preliminary assessment was intermediate (BCLC stage B) HCC. He was active, working, and fully functional (ECOG 0). The multidisciplinary liver tumor board consensus was a recommendation for locoregional therapy, with the goal of tumor destruction to prevent disease progression with the potential for downstaging and consideration of liver transplant in the future. The options of bland embolization, chemoembolization, and radioembolization combined with thermal ablation were discussed with the patient, and he agreed with the recommendation for transarterial bland embolization (TAE) followed by microwave ablation of the segment 6 and segment 8 lesions.

PROCEDURE DESCRIPTION

The patient’s procedure was essentially uncomplicated with standard left radial access technique after a Barbeautest per protocol. A 5-F, 125-cm radial artery catheter was used to select the celiac trunk (Figure 2). After the celiacaxis was selected, a 3-F Renegade® HI-FLO™ Microcatheter (Boston Scientific Corporation) was advanced into the right hepatic artery and on to the target lesions in segment 6 (Figure 3). The arteries were embolized to occlusion with a mix of ethiodol (to facilitate ablation targeting) and 100-µm Embozene™ Microspheres (Boston Scientific Corporation) (Figure 4).

Figure 2. A 5-F, 125-cm radial artery catheter was used to select the celiac trunk.
Figure 2. A 5-F, 125-cm radial arterycatheter was used to select the celiac trunk.
Figure 3. Right hepatic arteriogram through a 3-F Renegade® HI-FLO™ Microcatheter placed coaxially.
Figure 3. Right hepatic arteriogram through a3-F Renegade® HI-FLO™ Microcatheter placedcoaxially.
Figure 4. Right hepatic arteriogram performed after selective catheterization and embolization of the lower right lobe segmental arteries.
Figure 4. Right hepatic arteriogram performedafter selective catheterization and embolizationof the lower right lobe segmental arteries.
The patient returned 1 month later for theplanned thermal ablation of the  aforementionedtumors. This procedure was performed undergeneral anesthesia using CT fluoroscopy and 3D-reconstructed images for an oblique approachfor the LeVeen CoAccess™ Electrode System (Boston Scientific Corporation) (Figure 5). Follow-up MRI 6 months after ablationcategorized the treated lesions as LR-TRnonviable (treated, probably or definitely notviable), consistent with successful treatment of multifocal HCC by combination of bland TAE and thermalablation (Figure 6). At 1-year follow-up, with no newfindings, the patient was considered downstaged and iscurrently listed for transplant.
Figure 5. Contrast-enhanced CT after ablation of the right lobe lesions with the LeVeen CoAccess™ Electrode System. Residual lipiodol remained in the tumors.
Figure 5. Contrast-enhanced CT after ablationof the right lobe lesions with the LeVeenCoAccess™ Electrode System. Residual lipiodolremained in the tumors.
Figure 6. Follow-up MRI at 6 months showed no enhancement of the treated lesions.
Figure 6. Follow-up MRI at 6 months showedno enhancement of the treated lesions.

FOLLOW-UP AND DISCUSSION

The indications for TAE in this presented patient’s case were unresectable HCC outside the Milan criteria for livertransplant with intermediate BCLC stage B disease, and the possibility of downstaging to resection or transplant criteria. With a fully functional performance status and no evidence of hematological dysfunction, encephalopathy, or other clinical findings suggesting poorly compensated advanced liver dysfunction, the patient was an excellent candidate for TAE.

HCC is a significant cause of morbidity and mortality inpatients with liver cirrhosis. Transarterial chemoembolization(TACE) is currently recommended as the standard of care in patients with unresectable HCC by the National Comprehensive Cancer Network and the American Association for the Study of Liver Diseases.1 Both TACE and bland TAE without the delivery of chemotherapeutic agents are based on hepatic physiology and anatomy. While the hepatic parenchyma receives most of its blood supply from the portal vein, neoplastic hepatocytes receive their blood supply principally from the hepatic artery due to tumor associated angiogenesis and neovascularity. Therefore, the embolization of the hepatic artery branches preferentially impacts tumor cells over normal hepatocytes. Randomized controlled trials have demonstrated the superiority of TACE over best supportive care and the equivalence of bland embolization with TACE.2,3 The combination of ablation with embolization appears to extend the efficacy of ablation for larger (> 3 cm) tumors.4

 

Chukwusomnazu E. Nwanze, MD
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Disclosures: None

Michael A. Bevilacqua, MD
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Disclosures: None.

Eric K. Hoffer, MD
Director, Vascular and Interventional Radiology
Associate Professor of Radiology Geisel School of Medicine, Dartmouth
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Disclosures: None.

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

 

 

Renegade HI-FLO 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 HI-FLO 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, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

CONTRAINDICATIONS None Known.

WARNINGS The Renegade Microcatheter and Microcatheter Kit are 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

90960755 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

LeVeen Needle Electrode Family

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 LeVeen Needle Electrode Family is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. These procedures should only be performed by physicians and staff familiar with the equipment and techniques involved.

PRECAUTION Before using, inspect the package for any breach to the sterile barrier and inspect product for any damage. If package is broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific.

WARNINGS •The colored insulated cannula must be used at all times when accessing tissue. Use of the electrode without the colored insulated cannula may result in serious burns to the patient and/or user. •Damage to the insulation of the introducer may result in serious burns to the patient and/or user. •Precaution: The LeVeen Needle Electrode Family must be used in conjunction with the Boston Scientific RF 3000 ™ Generator. •For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.

ADVERSE EVENTS The complications that may result from a peripheral embolization procedure include, but are not limited to: •Abscess •ARDS (Acute Respiratory Distress Syndrome) •Arrhythmia •Ascites •Biloma •Burn •Death •Delayed hemorrhage into ablated tissue •Diarrhea •Electric Shock •Fistula, including biliary fistula •Hematoma •Hemorrhage •Infection •Liver Failure •Liver Insufficiency •Pain •Perforation •Peritonitis •Persistent Fever > 39° C •Pleural Effusion •Renal Failure •Tumor Recurrence •Tumor Seeding

90960743 Rev/Ver. AB

 

 

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