Indications, Safety, and Warnings
Indications (or intended use)
The Arctic Front Advance™ and Arctic Front Advance Pro™ cardiac cryoablation catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months).
The Arctic Front Advance™ and Arctic Front Advance Pro™ cardiac cryoablation catheters are also indicated for the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.
Contraindications
Use of the cryoballoon is contraindicated: 1) In the ventricle because of the danger of catheter entrapment in the chordae tendineae, 2) In patients with one or more pulmonary vein stents, 3) In patients with cryoglobulinemia, 4) In patients with active systemic infections, and 5) In conditions where the manipulation of the catheter within the heart would be unsafe (e.g., intracardiacmural thrombus).
Warnings and precautions
Do not reprocess or resterilize this device for the purpose of reuse. Administer appropriate levels of peri-procedural anticoagulation therapy for patients undergoing left-sided and transseptal cardiac procedures. The Arctic Front family of cryoballoons have not been studied for the safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. Atrial fibrillation patients with significant left ventricular dysfunction, advanced heart failure, severe left atrial enlargement or significant structural heart disease were excluded from the clinical trials that supported the approved indications. For baseline demographics and clinical characteristics of the patients studied, please see the Clinical Summaries listed in the instructions for use. Do not inflate the balloon inside the sheath or while the catheter is positioned inside a pulmonary vein. Always inflate the balloon in the atrium and then position it at the pulmonary vein ostium. If the balloon cannot be inflated or deflated using the CryoConsole, have a Manual Retraction Kit on hand during the procedure. (Refer to the CryoConsole Operator’s Manual for more detailed instructions on the Manual Retraction Kit). Disconnect the catheter’s electrical connection before cardioversion or defibrillation.
Catheter handling:
Use extreme care when manipulating the catheter.
Do not use excessive force to advance, withdraw, or rotate the catheter, especially if resistance is encountered.
Do not use the catheter if it is kinked, damaged, or cannot be straightened.
If the catheter becomes kinked or damaged while in the patient, remove it and use a new catheter.
Straighten the shaft before inserting or withdrawing the catheter.
Do not at any time preshape or bend the catheter shaft or balloon segment.
Catheter advancement should be performed using fluoroscopy or other appropriate techniques.
Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein.
Do not advance the balloon beyond the guide wire or circular mapping catheter to reduce the risk of tissue damage. Ensure that the guide wire or circular mapping catheter is inserted into the catheter and through the balloon portion for adequate support during vascular access insertion. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue). Do not pull on the balloon catheter, circular mapping catheter, sheath, umbilical cables, or CryoConsole while the balloon catheter or circular mapping catheter are frozen to tissue. Before moving these components, use appropriate techniques to ensure that the balloon catheter and circular mapping catheter are not adhered to tissue.
Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not expose the catheter handle or coaxial and electrical connectors to fluids or solvents. The use of fluoroscopy during catheter ablation procedures presents the potential for significant x-ray exposure to both patients and laboratory staff. Give careful consideration before using the device in pregnant women. Flush the guide wire lumen before initial insertion and then frequently throughout the procedure to prevent coagulation of blood in the lumen. Flush the guide wire lumen with saline after each contrast injection. Use only 0.081 cm (0.032 in) or 0.089 cm (0.035 in) guide wires with the catheter. Do not connect the cryoablation catheter to a radiofrequency (RF) generator or use it to deliver RF energy. Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent) with the CryoConsole and catheters. Avoid catheter entanglement with other catheters, devices, or wires.
Before powering up an RF generator or applying RF energy, disconnect the cryoablation catheter from the CryoConsole. Always deflate the balloon and withdraw the balloon into the transseptal sheath before removing the balloon from the left atrium. If the sterile packaging or catheter is damaged, do not use the catheter. Use only Medtronic cryoablation catheters, 12 FR inner diameter sheaths, circular mapping catheters, refrigerant tanks, and components with the CryoConsole. Closely monitor patients undergoing cardiac ablation procedures during the post-ablation period for clinical adverse events. This cryoablation system should be performed only in a fully equipped facility under the supervision of physicians trained in cryoablation procedures.
Potential adverse events or potential complications
Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to, the following: Access site complications (e.g., bruising, ecchymosis); Anemia; Anxiety; Arrhythmia (e.g., atrial flutter, bradycardia, heart block, tachycardia); Back pain; Bleeding from puncture sites; Bronchial constriction; Bronchial fistula; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Coronary artery spasm; Cough; Death; Diarrhea; Dizziness; Embolism; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension/Hypertension; Infection (e.g., pericarditis, sepsis, urinary); Lightheadedness; Myocardial infarction; Nausea/vomiting; Perforation; Pericardial effusion; Phrenic nerve injury; Pleural effusion; Pneumonia; Pneumothorax; Pseudoaneurysm; Pulmonary edema; Pulmonary hemorrhage; Pulmonary vein dissection; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Transient ischemic attack; Vagal nerve injury (e.g., gastroparesis); Vasovagal reaction; Visual Changes (e.g., blurred vision).
Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com .
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
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