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MANIFEST 17-K multicenter registry

MANIFEST 17-K multicenter registry

About the study

A retrospective observational safety registry of the real-world commercial use of the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter in more than 17,500 patients.

Key findings

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The major event rate was less than 1% with no reports of esophageal fistula or dysmotility, pulmonary vein stenosis, or persistent phrenic nerve injury.

Design and methods

  • Center-level data was collected from 106 centers and 413 operators (91.4% of all commerical centers used FARAPULSE)
  • 17,642 total patients (35% PersAF)
  • Results reflect a 2-year window of patients treated (03/2021-03/2023)

Conclusions

  • This data expands beyond the initial 24 centers involved in the MANIFEST-PF2 registry, showing that the low rate of safety events continues as the technology is adopted by additional centers.
  • One of the goals of this registry was to look for any unusual adverse events that would only occur after thousands of procedures. Two rare events were noted: coronary spasm and hemolysis.
    • The rate of coronary spasm was 0.14% with a majority (88%) being proximity related occurring with off-label use of the catheter during mitral isthmus MI or CTI ablation. There were 3 reports of generalized spasm (0.02%) which is lower than the cited thermal (RFA/CBA) rate of 0.19%. 
    • Hemolysis resulting in acute renal failure was rare, managed with hydration and associated with a high number of lesions applied.

  • Evidence of learning curve at both the physician/site level and within the EP community was seen in the significant decrease in rates of pericardial tamponade and minor vascular complications and improvements in stroke and transient phrenic nerve paresis rates from the initial MANIFEST-PF registry to MANIFEST-17K.

References

1 Ekanem, E., Neuzil, P., Reichlin, T. et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). https://doi.org/10.1038/s41591-024-03114-3

2 Ekanem, Emmanuel, et al. "Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)." Europace 24.8 (2022): 1256-1266.