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FARAPULSE™

Pulsed Field Ablation System*

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MANIFEST-17K Multicenter Registry1

The largest real-world safety registry of any pulsed field ablation system with 106 centers and 413 operators reporting on 17,642 patients treated commercially with FARAPULSE™ Pulsed Field Ablation. Major adverse event rates were low (<1%) and there was a negligible learning curve. 

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Farapulse clinical compendium
 

IMPULSE, PEFCAT, and PEFCAT II

Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II2

0%
AE Fistulas, Phrenic Nerve Damage, PV Stenosis2
96%
PVs isolated at ~3 months2
85 ± 5%
Kaplan-Meier estimated freedom from atrial arrhythmias at 1 year2
 

Acute isolation does not equal durable lesions; remapping data validates dose2

In three multi-center studies, the safety, PV isolation rate, and 1-year freedom from atrial arrhythmias was assessed.

  • There was no PV stenosis, persistent phrenic nerve damage, or AE fistulas.
  • With the optimized biphasic FARAPULSE waveform and workflow, there was a 96% PV isolation rate at ~3 months.
  • The KM estimate for freedom from atrial arrhythmias at one year was 85 ± 5%.
 

The 5S Study3

Objective

Studied the adoption and the process of streamlining ablation procedures with the FARAPULSE™ PFA System.

Methods

  • 191 patients: 62% paroxysmal and 38% persistent AF
  • 25 patient validation phase, 166 patient streamlined phase
  • Esophageal endoscopy was performed on 52 patients
  • Cerebral MRI was performed on 53 patients

Results

  • 100% acute PV isolation
  • 39 ± 14 min average procedure time
  • 9 ± 4 min average fluoroscopy time
  • During the streamline phase had a significantly shorter skin-to-skin procedure time
  • Low complication rates
  • 94.2% 6-month recurrence free-free rates (69 pts)
*Any symptomatic documented atrial tachyarrhythmia lasting >30 sec

0% thermal esophageal injury

No esophageal temperature rise

0% permanent phrenic nerve injury

0% pulmonary vein stenosis

Conclusions

  • This study documented the first 191 patients treated with the FARAPULSE PFA system in a single center with multiple operators.
  • The learning curve was short with significantly shorter procedure times in the streamlined phase, 38 ± 14 min.
  • The overall procedural complication rate was low and the incidence of asymptomatic cerebral lesions was similar to traditional modalities studied in the authors’ center.
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Multicenter Real-World Study4

Objective

Two high-volume centers assessed the efficacy and safety of FARAPULSE™ Pulsed Field Ablation in an early adopter setting inclusive of learning curve.

Methods

  • 138 atrial fibrillation (AF) patients (38% paroxysmal AF) underwent PVI

Results

 

Conclusions

In this real-world study, inclusive of learning curve, PVI with FARAWAVE Pulse Field Ablation resulted in:

  • A low rate of acute complications
  • A low rate of arrhythmia recurrence
  • Efficient and consistent LA dwell times
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FARAPULSE Pulsed Field Ablation System Indications, Safety and Warnings

References

  1. Reddy & Ekanem, et al. Multi-National Survey on the Safety of the Post-Approval Clinical Use of Pulsed Field Ablation in 17,000+Patients (MANIFEST-17K). AHA 2023.
  2. Reddy VY, Dukkipati SR, Neuzil P, et al. Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT,and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-27.
  3. Schmidt B, Bordignon S, Tohoku S, et al. 5S study: safe and simple single shot pulmonary vein isolation with pulsed field ablation usingsedation. Circ Arrhythm Electrophysiol. 2022 Jun;15(6):e010817.
  4. Lemoine MD, Fink T, Mencke C, et al. Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term followupin a multi-center real world scenario. Clin Res in Cardiol. 2022 Sep 22. Online ahead of print.

 

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