HotBalloon Ablation of the Pulmonary Veins for Paroxysmal Atrial fibrillation (PAF) – A Multicenter Randomized Trial in Japan

Do you experience chest pain, lightheadedness, and heart palpitations? Are there moments when you can’t catch your breath?

If so, you may have atrial fibrillation (AF). AF occurs when the atria, or upper chambers of the heart, lose their normal beat and rhythm drastically. It’s commonly known as AF or AFib. When it happens, blood flows through the heart and body inefficiently. Inefficient flow can cause the blood to pool inside the upper chambers of the heart, which increases the risk of blood clots. AF is the most common arrhythmia lasting for more than 30 seconds. Paroxysmal AF (PAF), also termed intermittent AF, is defined as an episode of AF that terminates spontaneously or with intervention in less than seven days.

Several novel balloon technologies have been developed to treat AF. Development of a novel radiofrequency HotBalloon catheter started since 2000 in Japan. This unique balloon catheter has elastic with high compliant membrane allows us to achieve single-shot pulmonary vein (PV) isolation by fitting to a variety of PV size and shapes. It brings tailor-made treatments adjusting finely to PVs which anatomical structure is completely different in each case. Balloon size is available from 26 to 33mm by injecting 10-20ml of the mixture of saline and contrast medium.

Point-by-point catheter ablation is an established treatment for drug-refractory paroxysmal atrial fibrillation (PAF). However, it is time consuming, requires excellent technique to achieve complete PV isolation, and is associated with severe complications. The purpose of Hiroshi Sohara and his team is to evaluate the safety and effectiveness of a HotBalloon Ablation (HBA) compared with antiarrhythmic drug therapy (ADT) for the treatment of PAF.

A prospective multicenter randomized controlled study was conducted in Japan by Hiroshi Sohara and his team. Patients with symptomatic PAF refractory to antiarrhythmic drugs (Class I to IV) were randomized to HBA or ADT at a 2:1 ratio and assessed for effectiveness in a comparable 9-month follow-up period.

Results

A total of 100 patients in the HBA group and 43 patients in the ADT group received treatment at 17 sites. HBA procedure produced acute complete PV isolation in 98.0% (392 of 400) of the PVs and in 93.0% (93 of 100) of patients in the HBA group. The chronic success rates after the 9-month effective evaluation period were 59.0% in the HBA group (n =100) and 4.7% in the ADT group (n =43; p < 0.001). The incidences of PV stenosis (>70%) and transient phrenic nerve injury were 5.2% and 3.7%, respectively.However it was associated with the balloon deploy in the distal PV. The mean fluoroscopy time was 49.4 ±26.6 (min (n =134), and the mean procedure duration was 113.9 ±31.9 min (n =133). 

Conclusion

This study demonstrates the superiority of HotBalloon Ablation (HBA) compared with Antiarrhythmic drug therapy (ADT) for treatment of patients with Paroxysmal Atrial fibrillation (PAF), and a favorable safety profile.

Hiroshi Sohara, MD, PHD,

Tohru Ohe, MD, PHD,

Ken Okumura, MD, PHD,

Shigeto Naito, MD, PHD,

Kenzo Hirao, MD, PHD,

Morio Shoda, MD, PHD,

Youichi Kobayashi, MD, PHD,

Yasuteru Yamauchi, MD,

Yoshio Yamaguchi, MD,

Taishi Kuwahara, MD, PHD,

Haruo Hirayama, MD, PHD,

Chun YeongHwa, MD,

Kengo Kusano, MD, PHD,

Kazuaki Kaitani, MD,

Kimikazu Banba, MD, PHD,

Satoki Fujii, MD,

Koichiro Kumagai, MD, PHD,

Hisashi Yoshida, MD, PHD,

Masashi Matsushita,

Shutaro Satake, MD, PHD,

Kazutaka Aonuma, MD, PHD

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