Arctic Front Advance Cardiac Cryoablation Catheter

Cardiac Ablation for Atrial Fibrillation

Overview

The Arctic Front AdvanceTM Cardiac Cryoablation Catheter (or Cryoballoon) is part of the Arctic Front Advance™ Cardiac Cryoablation Catheter System and is used in conjunction with the CryoConsole and the FlexCath™ Advance Steerable Sheath.

With its low complication risk and a proven efficacy, the Arctic Front Advance Cryoballoon is the leading cryoballoon approved in the U.S. to treat drug refractory, recurrent, symptomatic, paroxysmal AF (PAF).1 The cryoballoon is used for AF physiological intervention that delivers a consistent, simple pulmonary vein isolation (PVI) ablation procedure with safe cryo technology so you can take more decisive action against the advancement of AF. Over a quarter of a million patients worldwide have been treated with the cryoballoon.2

Cryoballoon cross-section

1. Guide wire lumen. Facilitates injection of contrast to confirm occlusion of the vein. Placement of the guide wire through the lumen helps direct the catheter to the targeted vein.

2. Outer balloon. Safety feature to contain the refrigerant in the unlikely event that the inner balloon is compromised. The outer balloon is maintained under constant vacuum.

3. Inner balloon. Refrigerant is delivered into the inner balloon and vacuumed back into the console to achieve the freezing process.

4. Pull wires. Help deflect the catheter 45 degrees in either direction.

5. Thermocouple. Monitors the temperature of the vaporized refrigerant.

6. Injection tube. Refrigerant is distributed toward the inner balloon surface through the injection tube.

BENEFITS OF CRYOABLATION

Cryo energy offers several unique features:

  • Cryoadhesion improves contact and stability3
  • Preserves the extracellular matrix and endothelial integrity4
  • Decreases risk of thrombus formation4
  • Demonstrates well demarcated lesions4

The cryoballoon uses cryo energy, offering several unique features:

  • The cryoballoon creates wide antral lesions5, creating a difficult path for conduction to cross.
  • Among centers with varying annual ablation volume, cryoballoon demonstrated more consistent outcomes and procedure times.6
  • In the FIRE AND ICE Trial, the cryoballoon met the primary endpoints and a predefined secondary analyses demonstrated significant improvements in patient outcomes which favored cryoballoon over radiofrequency.7

BUILDING ON A PROVEN PLATFORM

PVI is the cornerstone of AF ablation

WHY PVI?

Pulmonary vein isolation is the cornerstone of paroxysmal AF ablation. The HRS Consensus Statement states that “PVI is now widely accepted as the cornerstone of AF ablation procedures. Electrical isolation of the PVs is recommended during all AF ablation procedures.”8

Growing Body of Published Literature
Five randomized controlled trials demonstrated no benefit in ablation strategy beyond PVI for AF (n > 1,100).9-13

 

AN EFFICIENT APPROACH TO PVI

The Arctic Front Advance Cryoballoon is anatomically designed for PVI. Focal radiofrequency (RFC), by comparison, has been adapted to create PVI via a point-by-point approach. When EPs have both Cryo and RF capabilities, they may have the ability to treat a broader base of patients.

The Cryoballoon:

  • Is an anatomical approach for PVI, creating long contiguous circumferential lesions surrounding the pulmonary vein4
  • Has shorter, more predictable procedure times14 which may allow you to treat more patients in the same amount of time

A PROVEN APPROACH TO PVI

Safe and Effective Alternative After Anti-Arrhythmic Drug Therapy

The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial demonstrated that cryoballoon ablation is a safe and effective alternative to anti-arrhythmic medication for the treatment of patients with symptomatic paroxysmal AF, for whom at least one anti-arrhythmic drug has failed. Cryoballoon demonstrated freedom from AF at 12 months of 69.9% (114/163) and 7.3% (6/82) for the drug arm.15

Real-World Results With Current Generation

Results from the STOP AF Post Approval Study (PAS) demonstrated Arctic Front Advance Cryoballoon safety, efficacy, and lesion durability in patients with drug-refractory recurrent symptomatic PAF. Freedom from AF was 82.2% at 12 months and 75.3% at 24 months (n=344) on or off anti-arrhythmic drugs.16

A New Gold Standard in AF Ablation

In the FIRE AND ICE Trial, the cryoballoon met the non-inferiority endpoint and did so with shorter and more consistent procedure times compared to radiofrequency (RFC).14 In a predefined secondary analysis, relative to RFC, Cryoballoon demonstrated significantly fewer cardiovascular hospitalizations and repeat ablations.7

cryoablation vs. radiofrequency

A SAFE APPROACH TO PVI

Designed With PVI In Mind:

Cryo energy safely removes heat from the tissue to create durable lesions.17

STOP AF 12-Month Safety Results:

The cryoablation procedure event rate was 3.1% overall. There were 3.1% major AF events in the ablation arm (5/163), compared to the drug arm at 8.5% (7/82).15

STOP AF Post Approval Study (PAS) 24-Month Safety Results:

The cryoablation major adverse event rate was 5.8% (20/344).16

FIRE AND ICE 12-Month Safety Results:

The cryoballoon event rate was 10.2% (40/374) compared to an event rate of 12.8% (51/376) with Radiofrequency (RFC).14

Phrenic Nerve Injury

The most commonly reported adverse event with cryoballoon was phrenic nerve injury. Advancements in experience and technology have shown these rates to decrease over time.

PNI at discharge

NOTE: The FIRE AND ICE Trial included both Arctic Front and Arctic Front Advance cryoballoons.


Important Safety Information

Catheter ablation should only be conducted in a fully equipped electrophysiology laboratory by trained physicians.

Phrenic Nerve Injury (PNI) can be minimized by positioning Arctic Front as antral as possible and vigilantly monitoring the phrenic nerve with pacing during cryotherapy delivery. Stop ablation immediately if evidence of phrenic nerve impairment is observed.

In most cases, including STOP AF, PNI with cryotherapy is a transient complication. PV stenosis can be minimized by not positioning Arctic Front within the tubular portion of the pulmonary vein. Do not inflate the balloon while the catheter is positioned inside the pulmonary vein. Always inflate the balloon in the atrium and then position at the pulmonary vein ostia.

Potential complications, while infrequent, can occur during catheter ablation. Please review the device manual for detailed information regarding contraindications, warnings, precautions, and potential complications.


For more detailed product information about the Arctic Front Advance Cryoballoon, including specs, visit Medtronic Academy.


References

1

Okumura K, et al. Safety and Efficacy of Cryoballoon Ablation for Paroxysmal Atrial Fibrillation in Japan- Results From the Japanese Prospective Post-Market Surveillance Study. Circ J. 2016 Jul 25;80(8):1744-9.

2

Medtronic data on file.

3

Okumura et al. Mechanistic insights into durable pulmonary vein isolation achieved by second-generation cryoballoon ablation. J Atrial Fibrillation. 2017; 9:6.

4

Sarabanda AV, et al. Efficacy and safety of circumferential pulmonary vein isolation using a novel cryothermal balloon ablation system. J Am Coll Cardiol. 2005;46(10):1902-1912.

5

Kenigsberg D, et al. Quantification of Cryoablation Zone Demarcated by Pre- and Post-Procedural Electroanatomical Mapping in Atrial Fibrillation Patients Using the 28 mm Second Generation Cryoballoon. Heart Rhythm. 2014; 12(2):283-90.

6

Providencia R., Defaye P., Lambiase P.D., Pavin D., Cebron J.-P., Halimi F., FAnselme R., Srinivasan N., Albenque J.-P., Boveda S. Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: Is cryoablation more reproducible? Europace. 2017;19(1):48-57.

7

Kuck KH, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016; Oct 7;37(38): 2235-45

8

Calkins H, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm. 2017 May 12. [Epub ahead of print]

9

Verma A., Jiang C.-Y., Betts T.R., Chen J., Deisenhofer I., Mantovan R., Macle L., Morillo C.A., Haverkamp W., Weerasooriya R., Albenque J.-P., Nardi S., Menardi E., Novak P., Sanders P. Approaches to catheter ablation for persistent atrial fibrillation. New England Journal of Medicine. 2015;372(19):812-822.

10

Wong K.C.K., Paisey J.R., Sopher M., Balasubramaniam R., Jones M., Qureshi N., Hayes C.R., Ginks M.R., Rajappan K., Bashir Y., Betts T.R. No Benefit of Complex Fractionated Atrial Electrogram Ablation in Addition to Circumferential Pulmonary Vein Ablation and Linear Ablation: Benefit of Complex Ablation Study. Circulation: Arrhythmia and Electrophysiology. 2015;8(6):1316-1324.

11

Verma A., Sanders P., MacLe L., Champagne J., Nair G.M., Calkins H., Wilber D.J. Selective CFAE targeting for atrial fibrillation study (SELECT AF): Clinical rationale, design, and implementation. Journal of Cardiovascular Electrophysiology. 2011;22(5):541-547.

12

Dixit S., Marchlinski F.E., Lin D., Callans D.J., Bala R., Riley M.P., Garcia F.C., Hutchinson M.D., Ratcliffe S.J., Cooper J.M., Verdino R.J., Patel V.V., Zado E.S., Cash N.R., Killian T., Tomson T.T., Gerstenfeld E.P. Randomized ablation strategies for the treatment of persistent atrial fibrillation RASTA study. Circulation: Arrhythmia and Electrophysiology. 2012;5(2):287-294.

13

Vogler J., Willems S., Sultan A., Schreiber D., Lüker J., Servatius H., Schäffer B., Moser J., Hoffmann B.A., Steven D. Pulmonary Vein Isolation Versus Defragmentation the CHASE-AF Clinical Trial. Journal of the American College of Cardiology. 2015;66(24):2743-2752.

14

Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23): 2235-45.

15

Packer DL, et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013;61(14): 1713-23.

16

Knight B, et al. Second Generation Cryoballoon Ablation in Paroxysmal Atrial Fibrillation Patients: 24 Month Safety and Efficacy from the STOP-AF Post Approval Study. Presented at HRS 2017 (Abstract).

17

Ahmed, H., Neuzil, P., Skoda, J., et al. The permanency of pulmonary vein isolation using balloon cryoablation catheter. J Cardiovasc. Electrophysiol. July 2010; 21 (7): 731-737.