Symptoms of Atrial Fibrillation

Symptoms of atrial fibrillation vary depending on what type of AF you have, its cause, and your overall health. You may notice one or more of these symptoms:

• Irregular, rapid, fluttering or pounding heartbeat
• Chest discomfort or pain
• Fatigue, shortness of breath, or weakness
• Dizziness

You may not have symptoms but still be diagnosed with AF at a doctor’s appointment. Even without symptoms, AF can be a serious medical condition. Treating AF may prevent stroke, fatigue, and heart failure.

There are three types of AF

• Paroxysmal (occasional) AF occurs for minutes or days at a time
• Persistent AF lasts for more than seven days and will not correct on its own
• Permanent AF is a consistently high, erratic heart beat that cannot be corrected

Speak to your physician to determine if you have atrial fibrillation.

Common Causes of AF

The causes of atrial fibrillation are often unclear. AF may be the result of

• Heart abnormality from birth
• Damage to the heart structure from a heart attack
• Heart valve problem

People with otherwise normal hearts may also develop AF. To help prevent atrial fibrillation, some risk factors may be controlled or modified:

Controllable Risk Factors

• Follow a healthy diet
• Maintain a healthy weight
• Monitor high blood pressure
• Manage High cholesterol
• Reduce the risks of heart disease
• Don't smoke
• Reduce Caffeine
• Reduce alcohol intake
• Some medications
• Sleep apnea

Non-controllable Risk Factors

• Family history
• Advancing age
• Heart disorder

Diagnosis

Detecting atrial fibrillation and quantifying it can be challenging. Your doctor may use one or more of the following tests to determine if you have atrial fibrillation.

• Electrocardiogram (ECG)
• Stress test
• Longer-term monitoring devices (Event recorder, Holter monitor, Insertable cardiac monitor)

Treatment

Seeking treatment is important. AF is a progressive disease.⁷ Earlier treatment with catheter ablation has shown the potential for improved outcomes.⁸

The Goal of AF Treatment is to

• Relieve AF symptoms and improve your quality of life
• Prevent blood clots to decrease the risk of stroke
• Control heart rate to allow the ventricles (lower heart chambers) enough time to fill with blood
• Reset the heart rhythm to allow the atria (upper chambers of the heart) and ventricles to work together more efficiently

Treatments for AF include

• Medications
• Minimally invasive cryoballoon or RF ablation
• Electrical cardioversion
• Pacemaker and defibrillators
• Surgery

Medication

When you are diagnosed with AF, your doctor may start you on a course of medications to prevent stroke and control your heart rate and rhythm. You will want to communicate closely with your doctor to monitor your condition and see if the drugs are working for you or not. Some issues to consider include:

• Whether you continue to have episodes of AF
• Side effects from your medications, and how they affect your daily activities

Minimally Invasive Catheter Ablation

Ablation is generally considered to be a safe, effective treatment for paroxysmal atrial fibrillation (PAF). Some patients who received ablation therapy had a lower rate of PAF disease progression compared with drug therapy alone.⁸ Generally, after antiarrhythmic drugs (AADs), the earlier your PAF is treated with ablation, the more successful it may be.⁹

Performed by a specialist called an electrophysiologist (EP), ablation is used for pulmonary vein isolation (PVI).

Electrical Cardioversion

In this procedure, low frequency electrical current is transmitted through patches applied to the chest wall to attempt to reset the heart to a normal rhythm.

Pacemaker

A small device that is inserted in the chest by an EP. A pacemaker is used to treat slow heart rate (bradycardia) and other issues that can accompany AF.

Surgery

Surgical procedures for PAF are performed by a cardiac surgeon, who makes incisions to create lesions that block abnormal electrical circuits causing atrial fibrillation.

Once atrial fibrillation is thought to be suppressed or treated, care must still be taken to monitor for recurrences of AF. Even if there are no symptoms, atrial fibrillation may cause a stroke.

Not every treatment may be right for you. Discuss treatment options with your physician.

Types of Ablation for PVI

There are two types of minimally invasive ablation used in PVI: cryoballoon ablation and radiofrequency (RF) ablation. They use different technologies and have different advantages. For that reason, it’s important to go to an EP who is experienced with both procedures. Your doctor will discuss the risks and benefits of these treatments with you.

Cryoballoon ablation

The Arctic Front Advance™ Cryoballoon catheter uses cold energy to remove heat from the area around the pulmonary veins, freezing the tissue and disabling unwanted signals.

Radiofrequency ablation

RF uses heat at the end of a catheter to disable unwanted signals through several point by point applications to form a line of scar tissue around the pulmonary vein.

Comparison of cryoballoon and radiofrequency ablation

The FIRE AND ICE Trial ^10,11 is the largest prospective, 1:1 randomized, non-inferiority study (762 patients from 16 sites in 8 countries) that compared the efficacy and safety of PVI using cryoballoon vs. radiofrequency ablation in patients with PAF.

Primary Efficacy Endpoint: Time to first documented recurrence of AF > 30s/AT/AFL, prescription of AAD, or repeat ablation.

Primary Safety Endpoint: Time to first all-cause death, all-cause stroke/TIA or treatment-related serious AEs.

The Cryoballoon met the primary safety and efficacy endpoints.

Pre-defined secondary analyses from the FIRE AND ICE trial demonstrated significant improvements that favor cryoballoon group over radiofrequency group for clinically meaningful outcomes including

• Cardiovascular hospitalizations
• Repeat ablations

In summary, the FIRE AND ICE Trial demonstrated that cryoballoon ablation is comparable to radiofrequency (RF) ablation. Cryoballoon ablation is associated with significantly lower rates of repeat ablations and rehospitalizations than RF ablation.

Benefits

Catheter ablation may treat atrial fibrillation. In combination with a complete program of treatment, catheter ablation may improve your quality of life and eliminate or reduce the unpleasant symptoms of atrial fibrillation like shortness of breath, fatigue, or weakness. Be sure to speak with your doctor about your condition.

Risks

As with any medical procedure, there are benefits and risks with catheter ablation. Some of the risk include stroke, pericardial tamponade, narrowing of the pulmonary veins, phrenic nerve injury, damage to the blood vessels in your groin area, and a serious but rare risk of atrio-esophageal fistula.

Other risks include irritation, infection, or bleeding occurring where the catheter was inserted; the heart could be punctured; fluid may build up around the heart, or in rare cases death may occur.

Remember to talk to your doctor about all benefits and risks that are specific to your condition, and any concerns or questions you have. Although many patients benefit from catheter ablation, results may vary. Your doctor can help you decide if it is right for you.

References

1. Mozaffarian, et al. Heart disease and stroke statistics—2016 update. Circulation 133.4 (2016): e38-e360.
2. Dorian P, et al. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol. 2000; Oct;36(4):1303-9.
3. Miyasaka, Y., et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community based study. J Am Coll Cardiol. 2007; 49(9): p. 986-92.
4. Chen, L.Y., et al. Atrial fibrillation and its association with sudden cardiac death. Circ J. 2014; 78(11): p. 2588-93.
5. Wolf P, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991; 22(8):983 -988.
6. Lubitz, S.A., et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J AM Heart Assoc. 2013; 2(5): p. e000126.
7. de Vos CB, et al. Progression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol. 2010; Feb 23;55(8):725-731.
8. Jongnarangsin K, et al. Effect of catheter ablation on progression of paroxysmal atrial fibrillation. J Cardiovasc. Electrophysiol. 2012; Jan;23 (1):9-14.
9. Bunch TJ, et al. Increasing time between first diagnosis of atrial fibrillation and catheter ablation adversely affects long-term outcomes. Heart Rhythm. 2013;10(9):1257-62.
10. 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.
11. Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; June 9; 374(23):2235-2245.

Arctic Front Advance™ Cardiac Cryoablation Catheter

Indications

The Arctic Front Advance cardiac cryoablation catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.

Contraindications

Use of Arctic Front Advance 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., intracardiac mural thrombus).

Warnings/Precautions

Do not resterilize this device for purpose of reuse. Use only the 12 Fr FlexCath™ Steerable Sheath family with the Arctic Front Advance cryoballoon because using another sheath may damage the catheter or balloon segment. Do not inflate the balloon inside the sheath. Always verify with fluoroscopy or by using the proximal shaft visual marker that the balloon is fully outside the sheath before inflation to avoid catheter damage. Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary vein stenosis. Do not connect the cryoballoon to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can 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. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, this may lead to tissue injury. Do not advance the balloon beyond the guide wire to reduce the risk of tissue damage. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency, or premature failure of the prosthetic valve. Always inflate the balloon in the atrium, then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. To avoid nerve injury, place a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The Arctic Front Advance cryoballoon was not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility.

Potential Complications

Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Cough; Death; Diarrhea; Dizziness; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension/hypertension; Lightheadedness; Myocardial infarction; Nausea/vomiting; Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes.

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 medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. UC201804855 EN © Medtronic 2017.

Information on this site should not be used as a substitute for talking with your doctors. Always talk with your doctors about diagnosis and treatment options.