Medtronic AFAPRO28 Technical Manual

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Arctic Front Advance Pro™ AFAPRO23, AFAPRO28
Cardiac Cryoablation Catheter
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
Achieve™, Arctic Front Advance Pro™, Arctic Front Advance™, Arctic Front™, CryoConsole™, FlexCath™
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The following list of symbols and abbreviations applies to various products. Refer to the package labels to see which symbols apply to this product.
Lot number
Reorder number
Use-by
Sterilized using ethylene oxide
Do not re-use
Do not resterilize
Do not use if package is damaged
Package contents
Cardiac Cryoablation Catheter
Consult instructions for use
Fragile, handle with care
Keep dry
Product documentation
Humidity limitation
Storage temperature
Transit temperature
Manufacturer
Authorized representative in the European Community
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1 Description

The Arctic Front Advance Pro Cardiac Cryoablation Catheter (the catheter or the Arctic Front Advance Pro Cryoballoon) is a flexible, over-the-wire balloon catheter used to ablate cardiac tissue. It is used together with a compatible Medtronic 12 Fr inner diameter sheath (the sheath), the CryoConsole, and related components. For device compatibility questions, contact Medtronic Technical Support.
The balloon reaches cryoablation temperatures when refrigerant is injected from the CryoConsole to the balloon segment. A thermocouple positioned inside the balloon provides temperature reading capability. The catheter is introduced into the vasculature by traditional, minimally invasive techniques.
There are two radiopaque markers on the catheter to confirm the position of the balloon using fluoroscopy. The proximal radiopaque marker is located approximately 10 mm (0.394 in) proximal to the balloon. The distal radiopaque marker is located at the end of the injection tube.
Note: The 12 Fr FlexCath sheath is compatible with the catheter. There is one radiopaque marker on the FlexCath sheath, located approximately 5 mm (0.197 in) proximal to the tip of the sheath (see Figure 1). When the catheter’s proximal radiopaque marker and the FlexCath sheath’s radiopaque marker are aligned, the balloon is approximately 5 mm (0.197 in) outside of the FlexCath sheath. There are two shaft markers on the proximal section of the catheter shaft to visually confirm the position of the balloon within the FlexCath sheath. When the distal marker on the shaft of the catheter is aligned with the handle of the FlexCath sheath, the balloon segment is located inside the FlexCath sheath. When the proximal marker on the shaft of the catheter is aligned with the handle of the FlexCath sheath, the balloon segment is outside the FlexCath sheath (see Figure 1).

Figure 1. Arctic Front Advance Pro Cardiac Cryoablation Catheter

1 Distal catheter radiopaque marker 2 Deflated balloon segment 3 Proximal catheter radiopaque marker 4 FlexCath sheath radiopaque marker
The Arctic Front Advance Pro Cardiac Cryoablation Catheter is available in 2 models, as described in the following table:
Model
AFAPRO23 23 mm (0.91 in) AFAPRO28 28 mm (1.10 in)
For details about the CryoConsole and how to use it with the catheter to perform cryoablation procedures, see the CryoConsole Operator’s Manual.
5 Proximal catheter shaft marker 6 Distal catheter shaft marker 7 Deflection mechanism 8 Blue push button
Inflated balloon diameter

1.1 Contents of package

The catheter is supplied sterile. The package contains the following items:
• 1 Arctic Front Advance Pro Cardiac Cryoablation Catheter
• product documentation

2 Indications for use

The Arctic Front Advance Pro Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months).
The Arctic Front Advance Pro Cardiac Cryoablation Catheter is also indicated for the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.

3 Contraindications

The Arctic Front Advance Pro Cardiac Cryoablation Catheter is contraindicated as follows:
• in the ventricle because of the danger of catheter entrapment in the chordae tendineae
• in patients with active systemic infections
• in conditions where the manipulation of the catheter within the heart would be unsafe (for example, intracardiac mural thrombus)
• in patients with cryoglobulinemia
• in patients with one or more pulmonary vein stents

4 Warnings and precautions

Anticoagulation therapy – Administer appropriate levels of peri-procedural anticoagulation
therapy for patients undergoing left-sided and transseptal cardiac procedures. Administer anticoagulation therapy during and post-procedure according to the institution’s standards. The Arctic Front Advance Pro Cryoballoon was not studied for the safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation.
Balloon inflation or deflation – Do not inflate the balloon inside the sheath. Always verify with fluoroscopy or other appropriate visualization techniques that the balloon is fully outside the sheath before inflation to avoid catheter damage.
• Do not inflate the balloon 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. Inflating the balloon in the pulmonary vein may result in vascular injury.
• 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).
Biohazard disposal – Discard all used catheters and sterile components in accordance with hospital procedures.
Cardioversion or defibrillation during ablation procedure – Disconnect the catheter’s electrical connection before cardioversion or defibrillation. Failure to do so may trigger system messages indicating a need for catheter exchange.
Catheter handling – Use extreme care when manipulating the catheter. Lack of careful attention may result in injury such as perforation or tamponade.
• Do not use excessive force to advance, withdraw, or rotate the catheter, especially if resistance is encountered. Excessive force may lead to catheter damage, including kinking of the guide wire lumen within the balloon segment.
• Do not use the catheter if it is kinked, damaged, or cannot be straightened.
• Straighten the shaft before inserting or withdrawing the catheter.
• Do not at any time preshape or bend the catheter shaft or balloon segment. Bending or kinking the catheter shaft may damage internal structures and increase the risk of catheter failure. Prebending of the distal curve may damage the catheter.
• Catheter advancement should be performed using fluoroscopy or other appropriate techniques.
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• Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary vein stenosis.
Catheter integrity – Do not use the catheter if it is kinked or damaged. If the catheter becomes kinked or damaged while in the patient, remove it and use a new catheter. Before injecting, the physician should ensure that there is no kink in the catheter.
Circular mapping catheter compatibility – Use only Medtronic circular mapping catheters compatible with the inner lumen of the Arctic Front Advance Pro Cryoballoon. Use of another mapping catheter may damage the catheter or compromise the procedure.
Contrast media – Use appropriate levels of contrast media in patients with comorbidities such as recent history of renal disease. Follow contrast labeling and institutional procedures regarding the appropriate medical strategies to minimize risk when using contrast media.
Correct guide wire or circular mapping catheter insertion and positioning – 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. Failure to do so may result in catheter damage.
Cryoablation near prosthetic heart valves – Do not pass the catheter through a prosthetic heart valve (mechanical or tissue). The catheter may become trapped in the valve, damaging the valve and causing valvular insufficiency or premature failure of the prosthetic valve.
Cryoadhesion – 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. This may lead to tissue injury. Before moving these components, use appropriate techniques to ensure that the balloon catheter and circular mapping catheter are not adhered to tissue.
Damage to lung or tracheobronchial tree – Damage to the lung or tracheobronchial tree has been observed in some subjects who have undergone left atrial ablation with the Arctic Front family. The physician should consider appropriate medical strategies to minimize the risk of damage to the lung or tracheobronchial tree.
Do not resterilize – Do not resterilize this device for the purpose of reuse. Resterilization may compromise the structural integrity of the device or create a risk of contamination from the device that could result in patient injury, illness, or death.
Embolism risk – Introducing any catheter into the circulatory system entails the risk of air or gas embolism, which may occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism.
Environmental limits – Perform cryoablation procedures only within the environmental parameters. Operating outside these parameters may prevent the start or completion of a cryoablation procedure. Refer to Chapter 8, Specifications, page 7 for environmental parameters.
Esophageal injury – Esophageal ulcerations have been observed in some subjects who have undergone left atrial ablation with the Arctic Front family. As with other forms of left atrial ablation, the physician should consider appropriate medical strategies to minimize the risk of esophageal injury.
Fluid incursion – Do not expose the catheter handle or coaxial and electrical connectors to fluids or solvents. If these components get wet, the system may not function properly. This may lead to patient injury.
Fluoroscopy required for catheter placement – The use of fluoroscopy during catheter ablation procedures presents the potential for significant x-ray exposure to both patients and laboratory staff. Extensive exposure may result in acute radiation injury and increased risk for somatic and genetic effects. Only perform catheter ablation after giving adequate attention to the potential radiation exposure associated with the procedure, and taking steps to minimize this exposure. Give careful consideration before using the device in pregnant women.
For single use only – This device is intended only to be used once for a single patient. Do not reprocess or resterilize this device for the purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
Frequent flushing of the guide wire lumen – 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 heparinized saline after each contrast injection.
Guide wire compatibility – Use only 0.081 cm (0.032 in) or 0.089 cm (0.035 in) guide wires with the catheter. Using another guide wire may damage the catheter or compromise the procedure.
Improper connection – Do not connect the cryoablation catheter to a radiofrequency (RF) generator or use it to deliver RF energy. This may cause catheter malfunction or patient injury.
Induced arrhythmias – Catheter procedures may mechanically induce arrhythmias.
Leakage current from connected devices – Use only isolated equipment (IEC 60601-1 Type
CF equipment, or equivalent) with the CryoConsole and catheters or patient injury or death may occur.
Other catheters, devices, or wires – Avoid catheter entanglement with other catheters, devices, or wires. Such entanglement may necessitate surgical intervention.
Patient population – 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, see Chapter 5 for instructions to find clinical study information.
Phrenic nerve impairment – To reduce the potential for phrenic nerve impairment, perform the following steps:
• Position the balloon as antral as possible and not in the tubular portion of the pulmonary vein. To ensure proper catheter position, observe the balloon shape and the balloon position within the anatomy.
• Monitor the status of the phrenic nerve continuously during right-sided pulmonary vein applications using an appropriate monitoring technique. One common monitoring technique is to continuously pace the phrenic nerve throughout each cryoablation application of the right pulmonary veins. While pacing, monitor diaphragm contraction by placing a hand on the abdomen to assess for loss of capture or changes in the strength of the diaphragmatic contraction.
• Stop ablation immediately if phrenic nerve impairment is observed.
Post-ablation period – Closely monitor patients undergoing cardiac ablation procedures during the post-ablation period for clinical adverse events.
Pressurized refrigerant – The catheter contains pressurized refrigerant during operation. Release of this gas into the circulatory system due to equipment failure or misuse may result in gas embolism.
Pulmonary vein narrowing or stenosis – Catheter ablation procedures inside or near pulmonary veins may induce pulmonary vein narrowing or stenosis. Do not ablate in the tubular portion of the pulmonary vein. The occurrence of this complication may necessitate percutaneous angioplasty or surgical intervention. (See Chapter 5 for instructions to find clinical study information.)
Qualified users – This cryoablation system should be used only by or under the supervision of physicians trained in cryoablation procedures.
Required use environment – Cryoablation procedures should be performed only in a fully equipped facility.
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RF ablation – Before powering up an RF generator or applying RF energy, disconnect the cryoablation catheter from the CryoConsole to avoid an error message and unnecessary catheter replacement.
Septal damage – Always deflate the balloon and withdraw the balloon into the transseptal sheath before removing the balloon from the left atrium. Crossing the septum while the balloon is unsheathed, inflated, or inflating in the septal puncture site may cause serious septal damage.
Steerable sheath compatibility – Use only a compatible Medtronic 12 Fr inner diameter sheath with the Arctic Front Advance Pro Cryoballoon. Using another sheath may damage the catheter or balloon segment.
Sterile package inspection – Inspect the sterile packaging and catheter before use. If the sterile packaging or catheter is damaged, do not use the catheter. Contact your Medtronic representative.
System compatibility – Use only Medtronic cryoablation catheters, refrigerant tanks, and components with the CryoConsole. The safety and use of other catheters or components has not been tested.

5 Clinical studies

Information regarding clinical studies that are applicable to Arctic Front Advance Pro are available on the Medtronic Manual Library website:
1. Point your browser to www.medtronic.com/manuals.
2. Select the geography and language, and then search by product name for Arctic Front Advance Pro. The catheter technical manual and any applicable studies are listed. If you do not have web access, you can order printed copies of the clinical study summaries from your Medtronic representative or by calling the toll-free number located on the back cover.

6 Adverse events

Potential adverse events associated with cardiac catheter cryoablation procedures include, but are not limited to, the following conditions:
• Access site complications (such as bruis­ing or ecchymosis)
• Anemia
• Anxiety
• Arrhythmia (such as atrial flutter, bradycar­dia, heart block, or tachycardia)
• Back pain
• Bleeding from puncture sites
• Bronchial constriction
• Bronchial fistula
• Bronchitis
• Bruising
• Cardiac ischemia
• Cardiac tamponade
• Cardiopulmonary arrest
• Cerebral vascular accident
• Chest discomfort, pain, or pressure
• Cold feeling
• Coronary artery spasm
• Cough
• Death
• Diarrhea
• Dizziness
• Embolism
• Entrapment
• Esophageal damage (including atrio­esophageal fistula)
• Fatigue
• Fever
• Headache
• Hemoptysis
• Hypotension or hypertension
• Infection (for example, sepsis or urinary)
• Lightheadedness
• Nausea or vomiting
• Perforation
• Pericardial effusion
• Pericarditis
• Phrenic nerve injury
• Pleural effusion
• Pneumonia
• Pneumothorax
• Pseudoaneurysm
• Pulmonary edema
• Pulmonary hemorrhage
• Pulmonary vein dissection
• Pulmonary vein stenosis
• Renal insufficiency or renal failure
• Shivering
• Shortness of breath
• Sore throat
• Tissue infarction (such as myocardial infarction or renal infarction)
• Transient ischemic attack
• Vagal nerve injury (such as gastroparesis)
• Vasovagal reaction
• Visual changes (such as blurred vision)

7 Instructions for use

7.1 Connecting the Arctic Front Advance Pro Cardiac Cryoablation Catheter

Use standard aseptic technique when removing the product from its sterile barrier and handling the catheter. During connection of the catheter, keep the connections dry at all times. Fluid incursion may lead to system malfunction. To connect the catheter, follow these steps. (For more detailed instructions, see the CryoConsole Operator’s Manual.)
1. Connect the auto connection box to the CryoConsole. Note: The ECG cable is not required for an Arctic Front Advance Pro Cryoballoon
procedure, and should not be connected to the auto connection box.
2. Connect the catheter to a sterile electrical umbilical cable and then pass the other end of the cable out of the sterile field and connect it to the auto connection box.
3. Connect the catheter to a sterile coaxial umbilical cable and then pass the other end of the cable out of the sterile field and connect it to the CryoConsole.
4. Enable vacuum on CryoConsole.

7.2 Cryoablation

To use the catheter for a cryoablation procedure, follow these steps. (For more detailed instructions, see the CryoConsole Operator’s Manual.)
Notes:
• Before introducing the catheter into the patient, test the deflection mechanism on the handle to ensure it is operational.
• Always use the deflection mechanism on the handle to straighten the shaft before insertion or withdrawal of the catheter.
• The Achieve family of mapping catheters is compatible for use with the Medtronic Arctic Front Advance Pro Cryoablation Catheter and may be used to support and position the catheter.
1. Using aseptic technique, create a vascular access with an appropriate introducer. Obtain left atrial transseptal access using a transseptal sheath, its dilator, and needle.
• Place standard diagnostic pacing catheters.
• Visualize left atrial anatomy to help select a balloon size. Select balloon size.
• Selection of balloon size should be based on pulmonary vein (PV) diameter and shape, the surrounding anatomy, and desired position of the balloon outside the tubular portion of the PV. PV diameter ranges are recommended as follows:
23 mm balloon: 10-21 mm 28 mm balloon: 16-30 mm
2. Remove the transseptal sheath and dilator, leaving the guide wire positioned preferably in the left superior pulmonary vein (LSPV).
3. Advance the sheath and dilator over the wire into the left atrium.
4. Slowly remove the guide wire and dilator from the sheath.
5. Aspirate and flush the sheath.
6. Obtain a catheter. Connect the y-connector and manifold to the push button Luer.
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7. Flush the guide wire lumen, ensuring there are no air bubbles in the guide wire lumen or connections.
8. Load the circular mapping catheter or guide wire into the guide wire lumen.
9. Pull the circular mapping catheter or guide wire back into the balloon catheter until it is just inside the balloon catheter tip.
10. Flush the guide wire lumen again, ensuring there are no air bubbles in the guide wire lumen or connections.
11. Retract the sleeve from the balloon onto the catheter shaft.
12. Submerge and rinse the balloon to remove trapped air bubbles.
13. Advance the sleeve back over the balloon while the balloon is still submerged.
14. Place the sleeve adjacent to the hemostasis valve of the sheath. Note: To avoid damaging the valve or introducing air, do not push the sleeve through the
valve opening.
15. Insert the catheter into the sheath.
Notes:
• Carefully grip the catheter shaft near the sleeve to help avoid kinking the catheter.
• Follow institutional procedures to aspirate and flush the sheath.
16. Advance the balloon until the distal tip of the catheter aligns with the distal tip of the sheath using fluoroscopic guidance or other appropriate visualization techniques.
17. Advance the circular mapping catheter or guide wire to the target pulmonary vein using fluoroscopic guidance or other appropriate visualization techniques.
18. Advance the balloon over the circular mapping catheter or guide wire into the left atrium using fluoroscopic guidance or other appropriate visualization techniques.
19. Inflate the balloon in the left atrium by pressing the Start button on the CryoConsole control panel for 2 s.
20. Position the catheter at the ostium of the target pulmonary vein (PV) and not inside the tubular portion of the PV.
21. Verify the balloon position by injecting a mixture of 50/50 contrast/heparinized saline into the catheter guide wire lumen port or by using other appropriate techniques. Be sure to flush the guide wire lumen with heparinized saline after each contrast injection.
Notes:
• To improve balloon position and support, reposition the circular mapping catheter. If a stable balloon position cannot be obtained, exchange the circular mapping catheter for a guide wire.
• Before exchanging the circular mapping catheter for a guide wire, retract the catheter into the sheath.
• When using an auto injector for contrast delivery, ensure that the pressure limit does not exceed 500 psig.
• Follow contrast labeling and institutional procedures regarding the appropriate medical strategies to minimize the risk to the patient associated with using contrast.
22. Perform the cryoablation.
Notes:
• During the initial ablation phase, monitor the balloon’s position using appropriate visualization techniques. Moisture in the system may cause the inflated balloon to deflate and then re-inflate during the initial transition phases.
• Set the ablation duration on the CryoConsole screen.
• Physicians may modify the preset ablation duration based on clinical judgment.
• The balloon’s outer diameter varies from inflation to cryoablation and may cause the balloon to shift.
23. Wait for the cryoablation phase to complete (at the end of the preset duration). The balloon remains inflated and the thawing phase begins.
Note: At any time, the ablation can be stopped by pressing the Stop Current Action button on the CryoConsole control panel or by pressing the Stop CryoAblation button on the screen.
24. During the thawing phase, observe the temperature indicator on the screen. The balloon deflates automatically when the temperature reaches 20°C.
25. Before moving the balloon, use appropriate techniques to ensure that the catheter is not adhered to tissue.
26. Determine effective ablation of the cardiac tissue by assessing electrical isolation of the pulmonary vein from the left atrium (entrance and exit block) after the cryoablation is complete.
Note: As needed, perform additional treatments by positioning the balloon differently in the same pulmonary vein.
27. Position the catheter at the ostium of the next target pulmonary vein using the sheath, circular mapping catheter, or guide wire. Return to Step 17 and continue ablation.
28. To retract the balloon into the sheath, perform the following steps: Note: Ensure that the distal tip of the catheter is free to move to its maximum length.
a. Use the deflection mechanism on the sheath handle to straighten the sheath. Use the
deflection mechanism on the catheter handle to straighten the catheter. b. Inflate the balloon. c. Perform the following two steps simultaneously:
Advance the blue push button on the catheter handle, as shown in Figure 2. This
causes the balloon to extend to maximum length and wrap tightly.
Deflate the balloon by pressing the Stop Current Action button on the CryoConsole
control panel, or by selecting the Deflate Balloon option on the screen. d. Retract the catheter into the sheath.

Figure 2. Catheter handle

29. Remove the catheter from the patient.
30. After the procedure, follow the instructions to “Shut down the system” in the CryoConsole Operator’s Manual. Follow the prompts to close the refrigerant tank and replace the cap on the coaxial port. Confirm these actions when prompted by the CryoConsole.

8 Specifications

Catheter shaft outer diameter Tip length 8 mm (0.31 in) Tip outer diameter 3.3 mm (9.9 Fr; 0.13 in) Recommended introducer sheath compatible Medtronic 12 Fr inner diameter
Inner diameter of guide wire lumen 1.27 mm (0.05 in) nominal Inflated balloon diameter AFAPRO23 – 23 mm (0.91 in)
Effective length (with balloon inflated) 95.0 ±2.0 cm (37.40 ±0.80 in) Number of thermocouples 1
3.5 mm (10.5 Fr; 0.14 in)
sheath
AFAPRO28 – 28 mm (1.10 in)
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Environmental parameters
Storage temperature 15°C to 30°C (59°F to 86°F) Transit temperature −35°C to 45°C (−31°F to 113°F); up to 85% rel-
Operation 15°C to 30°C (59°F to 86°F) at altitudes less
ative humidity (non-condensing)
than 2400 m (8000 feet) above sea level

9 Medtronic limited warranty

For complete warranty information, see the accompanying limited warranty document.

10 Service

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also maintains a professional staff to provide technical consultation to product users. For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate telephone number or address listed on the back cover.
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Medtronic, Inc.
*M009650C001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636
Technical manuals
www.medtronic.com/manuals
© 2021 Medtronic M009650C001 A 2021-06-24
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