Pulsed Field Ablation (PFA) for the Treatment of Atrial Fibrillation
Pulsed field ablation (PFA) is a minimally invasive procedure that uses targeted high-voltage electrical pulses to eliminate the abnormal heart tissue that causes atrial fibrillation (AFib). PFA can restore a normal heart rhythm for many AFib patients, reducing symptoms and the need for lifelong medication.
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Quick Facts
- PFA is becoming the preferred ablation method for eligible AFib patients.
- About 70-85% of patients who get PFA are free from AFib one year after the procedure.
- PFA is more targeted than thermal ablation methods (radiofrequency and cryoablation), reducing risk of damaging nearby tissues like the esophagus and phrenic nerves.
- PFA has shorter procedure times than other ablation methods.
- PFA has lower risk of serious complications such as stroke than other ablation methods.
- University Hospitals (UH) Harrington Heart & Vascular Institute has long-term AFib procedure success rates that are equal to or surpass other leading centers worldwide.
What Is Pulsed Field Ablation (PFA)?
PFA is a minimally invasive procedure that uses high-voltage electrical pulses to create small holes in the cell membranes of AFib-triggering tissue, killing those cells. The procedure is offered as an alternative to traditional thermal catheter ablations methods that use either heat and cold energy to destroy the diseased cells instead.
PFA is FDA-approved, and it’s becoming the preferred ablation method for eligible patients. About 70-85% of patients who get PFA are free from AFib one year after the procedure. Less than 2% of PFA patients experience complications.
UH Harrington Heart & Vascular Institute has evaluated several PFA technologies. To date, the FARAPULSE PFA is the most widely adopted PFA system. This highly evidence-backed system has been used to treat AFib in over 500,000 patients. The effectiveness and safety of FARAPULSE has been demonstrated by more clinical data than any other PFA system based on studies, registries and patient results from real-world use.
Who Is a Candidate for PFA?
Candidates for PFA include patients who have:
- Paroxysmal AFib (a type of AFib that lasts a few hours or days but no longer than a week.)
- Early persistent AFib (a type of AFib that lasts from one week to 3 months).
- AFib that can’t be controlled with medication. Some studies show that roughly 7 out of 10 AFib patients do not find symptom relief with medication alone.
- Both AFib and congestive heart failure.
- A higher risk of complications from traditional thermal ablation methods (radiofrequency and cryoablation).
- AFib, are unable to take blood thinners long-term, and could benefit from getting a left atrial appendage closure at the same time their PFA for AFib is performed.
Because PFA has a lower risk of complications and shorter general anesthesia and procedure times than other ablation methods, it’s often recommended for older patients.
Benefits of PFA
- A newer, emerging technique that has shown a strong safety profile.
- Much more targeted than thermal ablation methods (radiofrequency and cryoablation), which reduces risk of damaging nearby tissues like the esophagus and phrenic nerves.
- Shorter procedure times than other ablation methods.
- Lower risk of serious complications such as stroke than other ablation methods.
- Similar long-term outcomes at one year as thermal ablation methods.
Why Choose University Hospitals for PFA?
UH Harrington Heart & Vascular Institute’s board-certified, fellowship-trained specialists have successfully treated patients with AFib for decades using the latest in heart catheterization and other treatment methods.
- Our long-term AFib procedure outcomes are equal to, or surpass, the expected procedural success rates of other highly experienced centers worldwide.
- Since we first began offering FARAPULSE PFA in late 2024, we use the treatment for about 50% to 60% of all catheter ablations performed at UH Harrington Heart & Vascular.
- We perform PFA and other catheter ablation procedures at our dedicated cardiac electrophysiology labs at:
- In 2023, we opened a new $1.3 million state-of-the-art cardiac electrophysiology lab at UH Parma Medical Center. This large space contains a new electroanatomical 3D mapping system and fluoroscopy equipment across the hall from our catheterization lab, where we perform PFA and other procedures.
How Pulsed Field Ablation Works
- Preparation: A nurse inserts an intravenous (IV) line in your arm for medication administration. They also clean and shave the area where catheters (thin flexible tubes) will be inserted into your body, usually through the groin.
- Anesthesia: You receive general anesthesia or deep sedation to put you in a sleep-like state during the procedure.
- Catheter insertion: Your doctor makes a small puncture with a needle at the insertion site, inserts the catheters into a vein and guides them through your circulatory system toward your heart’s left atrium with the aid of imaging technology such as 3D mapping, X-ray or ultrasound.
- Pulse delivery: After the catheters are in proper position, short electrical pulses are delivered to the target tissues through the electrodes at one of the catheter’s tip to eliminate the source of the irregular heartbeats. Your doctor may rotate or reposition the catheter to treat all target areas. These areas are usually treated at least twice to improve the effectiveness of the procedure.
- Confirmation: Your doctor will confirm that the procedure has successfully blocked the abnormal electrical pulses that caused the AFib.
- Catheter removal: The catheters are removed, and the incision site is sealed.
Pulse Field Ablation Success Rates and Effectiveness
According to the most recent clinical trial and registry data:
- 8 out of 10 patients show no recurrence of AFib symptoms one year after getting the FARAPULSE procedure.
- 7 out of 10 patients do not have to resume taking AFib medications one year after getting the FARAPULSE procedure.
- 93% of patients are satisfied with their AFib symptom relief one year after getting the FARAPULSE procedure.
- Only 2.1% of patients experienced any serious complications within one year after getting the FARAPULSE procedure.
Success Rates by AFib Type
The most recent clinical data (including the ADVENT and IMPULSE studies and MANIFEST-17K registry) indicates that the FARAPULSE system shows a high degree of effectiveness in treating both paroxysmal and persistent AFib:
- Paroxysmal AFib: Percentage of paroxysmal AFib patients who did not experience AFib episodes during the first year after getting the procedure: between 70% and 81%.
- Persistent AFib: Percentage of persistent AFib patients who did not experience AFib episodes during the first year after getting the procedure: between 71.5% and 85.3%.
Long-Term Safety of PFA
PFA is newer than radiofrequency and cryoablation. Medical researchers are still gathering long-term follow-up data on its safety and effectiveness. However, based on the most current data from large multi-center registries and clinical trials, PFA is considered to be safer overall than traditional thermal ablation methods. The procedure uses non-thermal electrical pulses that selectively target heart muscle cells, which minimizes risk of damage to the pulmonary veins, the esophagus, phrenic nerves and other surrounding structures.
- Based on recent clinical data, only 2.1% of patients experience any serious complications within one year after getting the FARAPULSE PFA procedure.
- At the UH Harrington Heart & Vascular Institute, the complication rate is < 1%.
Are You a Good Candidate for Pulsed Field Ablation?
The best candidates for PFA are patients with paroxysmal or early persistent AFib whose disease is not helped by medication.
If you answer “yes” to any of the following questions, you may be a good candidate for PFA:
- Do you have paroxysmal AFib that currently causes symptoms but is not helped by medication?
- Do you have early persistent AFib that currently causes symptoms but is not helped by medication?
- Do you have both AFib and tachycardia-mediated cardiomyopathy (a prolonged rapid heartrate that weakens the heart’s pumping ability) and cannot tolerate taking beta blockers?
- Do you have both AFib and congestive heart failure?
- Are you an AFib patient looking for a minimally invasive solution that offers quicker recovery times than other ablation methods?
- Are you an AFib patient who is at higher risk of complications from traditional thermal ablation methods?
- Are you an AFib patient seeking to eliminate or control your AFib while discontinuing use of your blood thinner?
If you feel you might be a candidate for PFA, call 216-844-3800 to schedule an appointment with a UH atrial fibrillation specialist today.
What to Expect Before, During, and After Pulsed Field Ablation (PFA)
Before the Procedure
Once you and your doctor decide that PFA is the best treatment for your AFib, your doctor will:
- Review your current medications and allergies and instruct you on whether your medications need to be adjusted in the time leading up to your procedure.
- If necessary, order certain tests, including those that allow your doctor to get a better look at your heart and assess your overall health. These tests may include an echocardiogram, Cardiac CT scan and/or MRI blood tests. Your doctor may also order a blood test to determine how long it takes your blood to clot.
Your doctor will explain the PFA procedure to you and answer any questions you have. They will give you specific instructions to prepare for your PFA. For example, you’ll be asked to:
- Avoid eating or drinking after midnight on the day of your procedure.
- Shower with soap to reduce infection risk before the day of your procedure.
- Not wear makeup, nail polish or lotion the day of your procedure.
- Leave valuables such as cash and jewelry at home.
- Bring a photo ID, your insurance card, list of medications and a CPAP machine if you use one.
During the Procedure
- Preparation: A nurse inserts an intravenous (IV) line in your arm for medication administration. They also clean and shave the area where a catheter (a thin flexible tube) will be inserted into your body, usually at the groin.
- Anesthesia: You receive general anesthesia or deep sedation to put you in a sleep-like state during surgery.
- Catheter insertion: Your doctor makes a small puncture with a needle at the insertion site, inserts the catheters into a vein and guides them through your circulatory system toward your heart’s left atrium with the aid of imaging technology such as 3D mapping, X-ray or ultrasound.
- Pulse delivery: After the catheters are in proper position, short electrical pulses are delivered to the target tissues through the electrodes on one of the catheter’s tip to eliminate the source of the AFib. Your doctor may rotate or reposition the catheter to treat all target areas. These areas are usually treated at least twice to improve the effectiveness of the procedure.
- Confirmation: Your doctor will confirm that the procedure has successfully blocked the abnormal electrical pulses that caused the AFib.
- Catheter removal: The catheters are removed, and the incision site is sealed.
After the Procedure
Your care team will take you to a recovery area, where your heart rhythm and vital signs will be closely monitored for a few hours. Most people can go home the same day or the next day after PFA.
Medication After PFA
You may need to take antiarrhythmic medication to control abnormal heart beats and/or anticoagulants (blood thinners) to prevent blood clots for 2 to 3 months following your procedure:
- Antiarrhythmic medications often prescribed after PFA for AFib include flecainide, propafenone, dronedarone, dofetilide and sotalol.
- Anticoagulants typically prescribed after PFA for AFib include Direct Oral Anticoagulants (DOACs) such as Eliquis (apixaban), Xarelto (rivaroxaban) and Pradaxa (dabigatran); and the vitamin K antagonist Warfarin.
You may need to take antiarrhythmic or anticoagulant medication for several months or longer following your procedure, depending on your condition. Your doctor will let you know if you should keep taking medications you took before your procedure. You’ll receive any necessary prescriptions and medication instructions before your discharge.
Recovery Timeline Following PFA
Immediate and Short-Term Recovery (1 – 2 Weeks)
- Hospital Stay: You’ll spend a few hours in recovery following your ablation. Depending on your condition, you may go home the same day or spend a night at the hospital.
- Activity: Walk the evening of the procedure. Light activity at home is okay. Avoid driving for 1 to 2 days or until your doctor tells you it’s okay to drive. If your job does not involve heavy lifting or other physical labor, you should be able to return to work in five to seven days. You may need more time off if you have a physically demanding job.
- Symptoms: Bruising, soreness or small lumps at the catheter insertion sites are all normal during the first week or two and should go away in 3 to 4 weeks. Mild fatigue and chest discomfort are also normal symptoms at this time. You may also experience skipped or irregular heartbeats as your heart begins to heal.
- Restrictions: No soaking in water (baths, hot tubs, pools) for 7-10 days. Avoid strenuous exercise, heavy lifting (>10 pounds) and sex.
Full Recovery & Healing (Up to 3 – 6 Months)
- Internal Healing: Scar tissue forms, which can take up to 3 months.
- Symptoms: Arrhythmia episodes and mild fatigue may persist during this period.
Follow-Up Care
First Follow-Up Appointment
Your first check-up typically happens 2 – 4 weeks after your procedure to review medications and symptoms. You’ll typically see an electrophysiologist, specialized cardiologist or an advanced practice provider (nurse practitioner/physician assistant), who will:
- Check your heart with an electrocardiogram (ECG), echocardiogram or other tests.
- Review your medications.
- Ask you about any new or returning symptoms.
- Check for issues like fatigue, chest pain or groin discomfort.
- Examine your catheter insertion site.
At this visit, you may also receive a surveillance monitor that you will wear to track your heart rhythm for a prescribed amount of time that will vary depending on your condition and the device.
Second Follow-Up Appointment
Your second follow-up appointment is usually scheduled for three months after your ablation procedure. During this appointment, you’ll see your electrophysiologist or another provider, have a physical exam, and get an electrocardiogram, echocardiogram or other heart testing. If you’ve been wearing a surveillance monitor, your doctor will review the data from the device to determine how your heart has responded to treatment. Your provider may also change or stop some of your medications at this time.
Pulsed Field Ablation Safety Profile and Potential Risks
Serious complications from PFA are rare. However, as with any minimally invasive surgical procedure, there are some risks that should be considered. Patients should discuss the risks and benefits of PFA with their doctor before making the decision to go ahead with the procedure.
UH Harrington Heart & Vascular Institute’s overall complication rate for PFA is 1 – 2%. The most common complications of PFA are:
- Vascular access issues, including groin hematomas (pooling of blood outside a blood vessel) and bleeding at the catheter insertion site: *seen in 2.2% to 3.28% of cases
- Pericardial effusion (excess fluid buildup in the pericardium, which is the sac surrounding the heart) that does not require drainage or other medical intervention: *seen in >1% of cases
- Vasovagal response: a very common, usually benign drop in heartrate and blood pressure.
*Source: MANIFEST-17K Registry
More serious but rare PFA complications (occurring >1%) include:
- Blood clots, which can lead to stroke.
- Puncture of the heart wall.
- Pericardial tamponade: a life-threatening complication where fluid or blood builds up in the space between the heart and the pericardium.
Complications specific to PFA are rare (occurring >1%) but include:
- Hemolysis (destruction of red blood cells), which can affect kidney function.
- Spasms of the coronary artery.
In comparison to thermal ablation methods, research shows that PFA lowers the risk of the following complications:
- Esophagus damage
- Phrenic nerve damage
- Pulmonary vein stenosis (narrowing of the pulmonary veins)
In some cases, AFib may return after PFA and require additional procedures or treatments.
Who’s Most at Risk to Experience Serious Complications From PFA?
Patients who are at the highest risk of experiencing serious complications from PFA include those aged 75 years or older who have comorbidities such as hypertension, heart failure, previous stroke or kidney disease.
Frequently Asked Questions About Pulsed Field Ablation
- What should I expect after my pulsed field ablation?
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Most patients go home the same day or the day after their pulsed field ablation (PFA). Patients typically experience a faster recovery with less pain than traditional ablation methods. You can expect some fatigue, minor groin soreness and potential temporary irregular heartbeats as the ablated heart tissue heals. Stick to light activity during your first week home. Full recovery takes approximately 3 months.
- Is pulsed field ablation better than radiofrequency ablation?
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In general, PFA is considered superior to radiofrequency ablation for AFib due to its better safety profile (lower risk of damaging surrounding tissues like the esophagus or phrenetic nerve) and shorter procedural times.
- Does insurance cover pulsed field ablation?
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Yes, most insurance plans, including Medicare, cover pulsed field ablation for treating AFib when it is deemed medically necessary, usually after standard AFib medications have shown to be ineffective, are not tolerated or are contraindicated.
- Can AFib come back after PFA?
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Yes, AFib can return after any type of catheter ablation procedure, including PFA. However, PFA is highly effective, with studies showing most PFA patients are still AFib-free after one year. Temporary AFib recurrence can also happen within a 3-month “blanking period” as the heart tissue heals.
- How long is a hospital stay for heart ablation?
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Most patients go home the same day after their catheter ablation. Some patients stay overnight for monitoring, depending on their specific condition and at their doctor’s discretion.
- What should you not do after a heart ablation?
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After your heart ablation, refrain from:
- Driving for 24 to 48 hours.
- Intense exercise (jogging, cycling, strenuous workouts, etc.), sex and lifting anything heavier than 10 pounds for at least 7 days.
- Water immersion (baths, hot tubs, pools, etc.) for 7 to 10 days.
- Scrubbing and applying lotions or powder to your puncture sites.
- Straining at the puncture site (groin or arm) by deep bending, pushing or pulling.
Next Steps & Connect With UH
Call 216-844-3800 to schedule an appointment with a UH atrial fibrillation specialist today.