Article Impact Level: HIGH Data Quality: STRONG Summary of Nature Medicine, 1–10. https://doi.org/10.1038/s41591-024-03114-3 Dr. Emmanuel Ekanem et al.
Points
- The MANIFEST-17K study evaluated the safety of pulsed-field ablation (PFA) for treating atrial fibrillation, utilizing a pentaspline catheter across 106 centers involving 17,642 patients.
- The cohort consisted mainly of patients with paroxysmal (57.8%) and persistent (35.2%) atrial fibrillation, with an average age of 64 years, and included 34.7% females.
- The study reported no esophageal complications, pulmonary vein stenosis, or persistent phrenic palsy and only a minimal occurrence of transient phrenic palsy (0.06%).
- Major complications occurred in about 1% of the patients, including pericardial tamponade (0.36%), vascular events (0.30%), stroke (0.12%), and rare instances of death (0.03%).
- The findings suggest that PFA offers a favorable safety profile by minimizing collateral damage common with conventional thermal ablation techniques, marking a potential advancement in managing atrial fibrillation.
Summary
The MANIFEST-17K study evaluated the safety of pulsed-field ablation (PFA), an innovative technology for treating atrial fibrillation (AF), focusing on its post-approval application. The study collected data from 106 out of 116 centers (91.4% participation) that utilized a pentaspline catheter for PFA, encompassing 17,642 patients (mean age 64, 34.7% female). The patient cohort was composed of 57.8% with paroxysmal AF and 35.2% with persistent AF. The study reported no esophageal complications, pulmonary vein stenosis, or persistent phrenic palsy. Only transient phrenic palsy occurred in a minimal fraction of cases (0.06%; 11 of 17,642).
As detailed in the MANIFEST-17K study, the safety profile of PFA highlighted major complications in approximately 1% of the patient pool (173 out of 17,642). These included pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Other rare complications noted were stroke (0.12%; 22 of 17,642) and death (0.03%; 5 of 17,642). Additionally, unexpected complications were observed, such as coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure requiring hemodialysis in 0.03% of patients (5 of 17,642).
Overall, the MANIFEST-17K study corroborates that PFA maintains a favorable safety profile by avoiding the collateral damage typically associated with conventional thermal ablation techniques. These findings suggest that PFA could significantly transform the management of patients with AF, providing a safer alternative by effectively targeting myocardial tissue without harming adjacent structures.
Link to the article: https://www.nature.com/articles/s41591-024-03114-3
References Ekanem, E., Neuzil, P., Reichlin, T., Kautzner, J., van der Voort, P., Jais, P., Chierchia, G.-B., Bulava, A., Blaauw, Y., Skala, T., Fiala, M., Duytschaever, M., Szeplaki, G., Schmidt, B., Massoullie, G., Neven, K., Thomas, O., Vijgen, J., Gandjbakhch, E., … Reddy, V. Y. (2024). Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nature Medicine, 1–10. https://doi.org/10.1038/s41591-024-03114-3
