JACC Real-World Study Reveals PFA May Not Be as Safe as Previously Thought

May 05, 2025 15:00 CST Updated 15:00

Medtronic

Medical Device Manufacturer

Johnson & Johnson

Medical Device R&D and Manufacturer

Farapulse

Atrial Fibrillation Treatment Catheter Tool Manufacturer

Affera

Medical Device Manufacturer

NowadaysPulse Field Ablation (PFA) is gaining increasing popularity among electrophysiologists. As a result, a large number of medical device companies in China and abroad have joined the R&D of PFA technology. Dozens of innovative PFA products have been continuously approved by drug regulatory authorities in various countries (NMPA alone has approved PFA products from 10 medical device companies). PFA technology has even been hailed as a revolutionary technology in electrophysiology.

The reason whyPFA is so popular mainly because it is safer compared to thermal ablation. Although the safety of PFA...Thermal ablation is better, but it doesn't mean PFA is absolutely safe. For instance, there was an overseas report earlier this year about PFA causing a stroke incident.

For this overseas researchThe team conducted a real-world study (NEMESIS-PFA) Analyze the safety of PFA and publish the research data in "JACC: Clinical Electrophysiology

This study (NEMESIS-PFA), included 8Clinical data of 71 patients who underwent atrial fibrillation ablation (average age 68.9 years, male proportion over 70%), of which 87.1% used Medtronic (PulseSelect, Affera), and...FDA-approved PFA products from Farapulse or Johnson & Johnson (Varipulse), the remaining patients received radiofrequency ablation treatment.

The main PFA products used are: Boston Scientific's Farapulse (70.9%), Medtronic's PulseSelect (14.1%), Medtronic's Affera (12.4%), and Johnson & Johnson's Varipulse (2.3%).

Specific Research Data

Compared with RFA, the changes in biomarkers after PFA were more significant: troponin (13551.0 vs. 127.5 ng/dL, p<0.001), lactate dehydrogenase (107.5 vs. 26.5 IU/L, p<0.001), haptoglobin (-102.0 vs. -33.5 mg/dL, p<0.001), and were dose-dependent.
There are also significant differences in marker changes between different PFA products.

The Farapulse group showed the greatest increase in cTn and LDH.

The plasma free hemoglobin (PFH) levels were highest in the Farapulse and Affera groups.

The decrease in left atrial ejection fraction was more significant in the PFA group (-20.0% vs. -5.0%, p<0.001).

Research Conclusion

Existing PFA technology results in higher risks of troponin release, hemolysis, and renal dysfunction compared to RFA.As PFA becomes a mainstream technology, further research is needed on its short-term and long-term impacts.。

Author's Evaluation

"Differences in electrode configuration and energy delivery schemes among various PFA products are noteworthy, as they lay the groundwork for establishing standardized monitoring protocols. From a technological development perspective, optimizations in catheter design and dosing regimens may reduce side effects without compromising efficacy."

In terms of biomarker changes and left atrial ejection fraction, PFA does have some shortcomings. However, the incidence of surgical complications with PFA remains low (3% in real-world vs 1%-2% in previous studies) and has not significantly impacted clinical outcomes.Higher complication rates in real-world settings are likely related to the learning curve. After gaining experience, PFA-related complications are expected to decrease.

However, for all clinicians, they hope that companies can improve the safety of PFA products through innovation, rather than leaving safety issues to doctors (to learn). As mentioned in the paper, catheter design,Design of energy delivery methods can enhance product safety. Both large and small manufacturers need to focus on improving safety.

At the same time, as PFA becomes the mainstream technique for treating arrhythmiaIn addition, clinicians and companies need to further research PFA.Short-term and long-term safety.