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Are the data in terms of safety and effectiveness of electroporation ablation confirmed in real life?
Key messages
- Confirmation of very good security profile
- 0.4% hemolysis linked in part to the number of applications
- Procedure carried out under AG in 59% of cases
Introduction
Electroporation represents a technological leap for the percutaneous treatment of arrhythmias.
All companies in the field are developing their solutions but unlike radiofrequency, the effectiveness and safety profiles can be very different from one system to another depending on the catheter and the electroporation parameters used.
Randomized studies are essential, but real-life registries make it possible to include more patients and therefore to have a more reliable idea of uncommon adverse effects.
This presentation describes the population and the procedures after the end of the inclusions, the follow-up is ongoing.
Methodology and results
Population
1173 patients (64 years old, 33% women, LA diameter: 44mm, CHADS-VaSC score: 2) from 48 centers having had paroxysmal (65%) or persistent (35%) AF ablation
Design
Prospective real-life registry with 3-year follow-up.
Judgment criteria
Safety: adverse events related to the system or procedure
Efficacy: isolation of all pulmonary veins + absence of recurrence of AF/AT/atrial flutter
Main result
Safety: 4% of adverse effects mainly due to vascular access, rare cases of hemolysis (0.4%) seeming to be linked to the number of applications, no coronary spasm noted.
No communication on the effectiveness criterion because recent inclusions have ended and there is no sufficient monitoring for the moment.
Secondary endpoint results
Lesions applied outside the pulmonary veins in 26% of cases (posterior wall n=180, left isthmus n=45, cavo-tricuspid isthmus n=30).
Procedures performed under AG in only 59%. (Figure 1 and 2)
Figure 2
Conclusion
The safety profile of the Farapulse system for AF ablation is confirmed in this real-life register with an adverse event rate of 4% mainly linked to vascular access and not to the system.
We would have to wait until 2025 for the first effectiveness results (1 year of follow-up).
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