Pulsed field ablation gains momentum in Korea as game-changing atrial fibrillation treatment

Pulsed field ablation (PFA), which has emerged as a game changer in the treatment of atrial fibrillation, is rapidly gaining ground in clinical practice in Korea.

As it draws attention for its distinct advantages—such as shorter procedure time and minimized tissue damage—compared to existing radiofrequency ablation (RFA) and cryoballoon ablation (CBA), it is expected to see broader use with future health insurance coverage.

At a press conference for reporters covering the medical device industry held at Boston Scientific Korea's headquarters in Seoul on Monday, Professor On Young-keun of the Department of Cardiology at Samsung Medical Center and Professor Joung Bo-young of the Department of Cardiology at Severance Hospital shared the technical differences and real-world clinical applications of PFA, highlighting its potential as a new atrial fibrillation treatment strategy.

Atrial fibrillation is the most common arrhythmia, and its prevalence is rapidly increasing with the aging population. In Korea, it has more than doubled over the past decade, according to On. According to National Health Insurance Service (NHIS) data as of 2022, an estimated 2.2 percent of the population suffers from atrial fibrillation, and the risk of comorbidities such as stroke and heart failure increases, especially in people aged 65 and over.

“Despite this, only 1.2 percent of patients receive procedural treatment. Since atrial fibrillation accounts for 20 percent of stroke cases and more than doubles the risk of mortality and heart failure, early diagnosis and treatment are critical,” On noted.

Treatment of atrial fibrillation typically follows a stepwise approach, starting with medications such as antiarrhythmic drugs and progressing to ablation if the response is insufficient or side effects occur. The two most widely used ablation techniques are radiofrequency ablation using an electrode and cryoballoon ablation using cryogenic temperatures. Surgical ablation is usually performed in conjunction with valve surgery and is rarely used on its own.

PFA is drawing attention as a new alternative that may overcome the limitations of these conventional methods. In Korea, Boston Scientific’s Parapulse Pulsed Field Ablation System was the first to receive approval from the Ministry of Food and Drug Safety in September last year. Other companies, including Johnson & Johnson MedTech and Medtronic, are launching PFA products in Korea in succession.

While conventional electrode-based or cryogenic balloon-based ablation destroys diseased heart tissue using heat or cold, PFA uses electrical pulses to induce electrical damage to myocardial cell membranes, selectively removing only the diseased tissue. “Because it acts solely on the cell membrane, there is minimal damage to surrounding tissues such as the esophagus or phrenic nerves,” On said. “It is theoretically considered the safest ablation procedure.”

PFA has accumulated more than 17,000 clinical outcomes in the U.S. and Europe. The results of a study comparing PFA to cryoballoon ablation were recently presented at the European Heart Rhythm Association (EHRA) meeting. The study showed that procedure time was halved and the recurrence rate of atrial fibrillation was significantly lower.

“Whereas conventional ablation requires dozens or more manual radiofrequency shots inside the heart, PFA can treat the entire pulmonary veins with just a few electrical pulses, significantly reducing procedure time,” On said. “It also allows for faster patient recovery and reduced radiation exposure for physicians.”

“Once an operator becomes familiar with PFA, the actual electrical stimulation portion of the treatment takes less than 10 minutes. The entire procedure—including device insertion, positioning, and post-procedural observation—takes an average of one and a half hours. At our center, we are currently performing four to five cases a day and are close to surpassing 100 cases,” said Joung.

“In Europe, the technology has already matured to the point that procedures can be performed without echocardiography,” he added. “In Korea, practitioners are quickly gaining proficiency, and the use of PFA could expand to treat other arrhythmias, such as atrial flutter and those originating in the superior vena cava.” “There is also growing demand for PFA among patients with atrial fibrillation,” he said.

Patient satisfaction with outcomes is also high. “Many patients report pain or discomfort after conventional atrial fibrillation surgery, but those who undergo PFA often say, ‘The procedure was already over when I woke up,’” Joung said.

“Currently, we combine electrode ablation and cryoballoon ablation, but once PFA proves to be stable and convenient, it could account for more than 40 to 50 percent of all procedures,” On said. “This shift is already happening in the U.S. and Europe, and adoption in Korea will accelerate as soon as insurance coverage is provided.”

However, PFA is not currently covered by national health insurance, limiting access for many patients.

“Patients who are covered under fee-for-service private insurance are primarily undergoing the procedure, but for widespread adoption, national insurance coverage is essential. Furthermore, while the U.S., Europe, and Japan allow flexible combinations with 3D mapping or echocardiography, Korea imposes many restrictions due to its reimbursement criteria,” On noted. “We expect insurance coverage to be introduced by the end of this year or early next year.”

“If insurance coverage is achieved, PFA could become the new standard of care for atrial fibrillation,” Joung said.