Radiofrequency Ablation A Patient s Guide
TITLE Introduction to This Guide Each year, 530,000 people worldwide are diagnosed with liver disease.* Sometimes, the disease occurs first in the liver and is called primary liver disease. In other cases, a lesion may develop in the liver due to the spread of disease from another part of the body a process called metastasis. In either case, a variety of approaches have been developed to treat the disease. You and your doctors have selected an approach which uses a technology called radiofrequency ablation to destroy cancer cells in the liver. This guide was designed to provide some answers to questions you may have about your procedure. Remember to call your doctor or nurse with any specific questions and always follow the instructions that they give you. Table of Contents What is Radiofrequency Ablation? 2 Is RFA an experimental procedure? 4 How is the RFA procedure done? 5 How long does the procedure take? 6 Will I be asleep for the procedure? 6 How long will I have to stay in the hospital? 7 What do I do after the procedure? 7 * Brown, D. Soulen M. SIR Position Statement on ChemoEmbo of Hepatic Malignancies. 1
What is Radiofrequency Ablation? Radiofrequency ablation (RFA) uses radiofrequency energy, a form of electrical current that can be used safely in the body. The radiofrequency energy is supplied by a generator which is attached to a device called a needle electrode. Then, the generator is turned on and the radiofrequency energy is passed from the tines of the electrode into the lesion. The energy creates heat which destroys the cells in the area. First, the needle electrode is positioned within the lesion and opened allowing the multiple tines to spread out. Electrode tines deliver radiofrequency energy to the lesion. Electrode tines spread out within the lesion. The result is destruction (ablation) of the liver lesion. After a period of time, the liver absorbs the destroyed tumor cells. Heat within the tissue destroys the cells, ablating the liver lesion. 2 3
Is RFA an experimental procedure? No, it is not. Destruction of tissue, using heat, is a treatment approach that has been used for many years. Your physician will be using the RF 3000 Radiofrequency Ablation System, comprised of three components: LeVeen or Soloist Needle Electrodes RF 3000 Radiofrequency Generator Patient Return Electrodes How is the RFA procedure done? RFA is be performed percutaneously, which is through the skin. In this technique, the LeVeen Electrode is inserted through a small puncture in the abdominal wall. Your doctor will use ultrasound or perform CT scanning when inserting the needle electrode. This is to ensure that the electrode is in proper position in the tumor. The LeVeen or Soloist Needle Electrode and the RF 3000 Generator are designed to allow the radiofrequency energy to be evenly distributed within the liver tissue for complete destruction of the lesion. 4 5
How long does the procedure take? The duration of the procedure is dependent upon many factors, including the number of tumors to be treated, their location, and the approach that is used percutaneous, or surgical. Typically, a percutaneous procedure takes 1 to 1 1/2 hours. How long will I have to stay in the hospital? This will depend on how the procedure is performed. Your hospitalization could be as short as an overnight stay. Again, be sure to discuss this with your physician. Will I be asleep for the procedure? The type of anesthesia or sedation that you will receive will be determined by the approach that is to be used. For example, if your procedure is to be done percutaneously, you may be awake. However, an intravenous catheter will be inserted into your vein and you will be given medication to relax you and reduce any pain. If RFA is to be done during surgery, you will be given general anesthesia. Your doctor will discuss this with you and answer any questions you may have. What do I do after the procedure? Your doctor will give you specific instructions when you are discharged from the hospital. You will also be scheduled for follow-up visits so your doctor can monitor your progress with blood tests and imaging techniques such as x-rays, CT scans or MRI. We hope you find this information valuable. In all cases, be sure to ask any questions that you may have when you see your doctor or nurse. 6 7
8 Notes
LEVEEN ELECTRODE INDICATIONS: The LeVeen Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. CAUTIONS: The effectiveness of this device for the use in the treatment of liver cancer or liver disease (i.e., improved clinical outcomes) has not been established. The LeVeen Electrode is intended only for use with Boston Scientific RF generators (peak voltage up to 200V max.) The power applied by the RF generator should be kept to the minimum necessary to achieve the desired clinical effect. Larger arrays may require higher power. RF 3000 RADIOFREQUENCY GENERATOR INDICATIONS: The RF 3000 Radiofrequency Generator is intended for use with separately cleared electrodes for thermal coagulation of soft tissue. CAUTIONS: The RF 3000 Generator is not MR compatible and should be kept outside the shielded MR scan room. The RF 3000 Generator emits signals that may interfere with MR imaging. Therefore, the Generator should be OFF when the MR scanner is acquiring image data. Ensure the Voltage Selector and the fuse block on the rear panel are set to the appropriate voltage before turning the main power switch on. Boston Scientific strongly recommends the use of Valleylab Polyhesive Disposable Patient Return Electrodes (Pads) with Cord. Use four pads and connect the return pad plugs to the RF 3000 Generator return receptacles, placing two pads on each leg. Be sure not to orient the pads improperly or to misalign the top edge of the pads. SOLOIST SINGLE NEEDLE ELECTRODE INDICATIONS: The Soloist Single Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. WARNINGS: Use of this device may result in elevated core body temperature. Patient s temperature should be monitored and appropriate clinical precautions taken to maintain normothermia. Use of this device during laparoscopic insufflation may result in a gas embolism. Use of this device results in localized elevated temperatures that can cause thermal injury to the skin if the electrode is placed in a shallow position. In addition, tissue or organs adjacent to the tissue being ablated may be injured thermally. To minimize the potential for thermal injury to the skin or adjacent tissues, temperature-modifying measures can be initiated at the physician s discretion. These may include applying a sterile ice pack or saline-moistened gauze to cool and/or separate tissues. The electrode is fabricated from materials that are not compatible with Magnetic Resonance (MR) imaging magnets. Do not use in MR suite. The skin must be incised prior to insertion of the introducer or needle to prevent damage to the insulation. Damage to the insulation of the introducer or needle may result in serious burns to the patient and/or user. Do not use in main biliary ducts, gallbladder or during pregnancy. CAUTIONS: As necessary, clean the needle tip between placements by rinsing the tip in sterile solution and gently wiping the tip to remove excess tissue. Use caution not to use an abrasive substance that may cause damage to the insulation. Accumulation of excess tissue on the tip may make needle removal difficult. Do not insert the needle at an angle such that the surrounding tissue is compressed. This may result in reduced perfusion and localized heating. Localized burns to the patient or physician may result from electrical currents being carried through conductive objects, such as metal cannulae or scopes, or from metal objects in close proximity to the electrode or needle tip. Safe use of the device requires adequate separation between the thermal lesion and adjacent anatomical structures. If the device is used in laparoscopic procedures, activation when not in direct contact with the target tissues, or in position to deliver energy to the target tissues (fulguration), may cause capacitive coupling with a metal trocar. This may result in patient burns. Electrodes and probes of monitoring, stimulating and imaging devices can provide paths for high-frequency currents even if these devices are battery operated, insulated, or isolated at 60Hz (or 50Hz). The risk of burns can be reduced, but not eliminated, by placing these electrodes or probes as far as possible from the electrosurgical site and the return electrode. If a needle guide is used, carefully advance the electrode through the needle guide, making certain not to bend the needle. Needle guides have edges that can cause damage to or removal of portions of the insulation on the needle electrode. A break in the insulation may result in tissue burns along the length of the electrode. The disposable patient return electrodes should be placed on intact skin over muscle tissue with good perfusion. There is a potential for superheating if the return electrodes are placed over implanted metal prostheses. Return electrodes should not be placed over superficial metal implants. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Persons depicted in this brochure are models and included for illustrative purposes only. LeVeen, Soloist and RF 3000 are unregistered or registered trademarks of Boston Scientific Corporation or its affiliates. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 www.bostonscientific.com/endoscopy Ordering Information 1.800.225.3226 2011 Boston Scientific Corporation or its affiliates. All rights reserved. ENDO-50410-AA XM December 2011