Pulsed Field Ablation for Atrial Fibrillation — Joint EHRA/HRS/APHRS/LAHRS/CHRS Scientific Statement (2026)

Authors, Journal, Affiliations, Type, DOI

Overview

The first comprehensive international statement on pulsed field ablation for atrial fibrillation, covering biophysics, catheter platforms, dosing, procedural workflow, efficacy, safety, training and future applications. It records that PFA has reached >500,000 procedures worldwide with no reported atrio-oesophageal fistula, while insisting that PFA is not a class effect — waveform, voltage, pulse duration, catheter geometry and dosing differ enough between systems that platform-specific evidence and training are required. It is unusual among consensus documents in disclosing the field's weak points: dosing thresholds are manufacturer-defined rather than evidence-defined, non-PV durability is poor (LAA isolation reconnects in 95%, mitral isthmus block persists in only 5.5–68%), no PFA-specific procedural variable predicts durable lesion formation, and no long-term (>1 year) outcome data exist. The writing committee's position is that PFA is a first-line technology for PVI in AF, an adjunct to rather than a substitute for electrophysiological expertise, and should be taught through competency-based pathways.

Keywords

Pulsed field ablation; atrial fibrillation; electroporation

Key Takeaways

Introduction

Biophysics — background and development

Mechanism of action

Comparison with other ablation technologies

Ablation method Energy delivery and propagation Cell damage Microvasculature Extracellular matrix Healing
Radiofrequency (thermal) Volumetric heating and thermal diffusion Indiscriminate protein denaturation Highly thrombogenic, indiscriminate thermal damage Coagulation Delayed, from periphery
Cryoablation (freeze–thaw) Thermal diffusion Crystal formation, membrane damage, osmotic imbalance Microvascular clogging and damage Preserved Delayed, from periphery
Pulsed field (electroporation) Electric field effect and volumetric heating Membrane lipid oxidation and protein damage Preserved, with transient perfusion reduction and increased permeability Preserved Enabled/facilitated; lesion accessible by preserved microcirculation

Biomarker release

Available platforms and classification

Platform (manufacturer) Architecture Size / diameter Mode Amplitude Application duration
Farapulse (Boston Scientific) Pentaspline, over the wire 12 F, 31/35 mm Bipolar biphasic 1.8–2.0 kV/µs 2.5 s; ≥8 per PV advised
PulseSelect (Medtronic) Circular array, over the wire 9 F, 25 mm Bipolar biphasic 1.5 kV/µs 4–5 s; ≥8 per PV advised
Varipulse (Biosense Webster) Variable-loop circular 8.5 F, 25–35 mm Bipolar biphasic 1.8 kV/µs ~22 s per ablation (3 applications); 4 per PV advised
Volt (Abbott) Basket, contact sensing by impedance 13 F, 28 mm Bipolar biphasic 1.5–1.8 kV/µs ~20 s (10 R-wave-gated bursts)
Globe PF (Kardium) Spherical array 16 F, 30 mm Bipolar biphasic 1.7 kV/µs 2 s per train, 2–6 trains
Sphere 360 (Medtronic) Spherical array 8 F, 34 mm Monopolar biphasic 1.3–2.0 kV/µs 5–6 s; 4 per PV advised
Sphere-9 (Medtronic) Lattice tip, 3D integrated, dual energy 8 F, 9 mm Monopolar biphasic 2 kV/µs 4 s
Omnypulse (Biosense Webster) Large-tip focal, 3D integrated 7.5 F, 12 mm Bipolar biphasic 1.2–1.5 kV/µs Up to 12 applications, duration varies by PF index
Faraflex (Boston Scientific) Large-tip focal, 3D integrated 8 F, 9 mm Monopolar/bipolar 2 kV/µs 2.5 s
QuickShot (CardioFocus) Large-tip focal 8.5 F, 10 mm Monopolar biphasic 3.5 kV/µs 3 s (QS) / 6.8 s (QS+)
Centauri (CardioFocus) RF-style focal, CF sensing 8 F Monopolar biphasic 19–25 A/µs 3 s (19 A) / 5 s (22 A) / 7 s (25 A)
STSF Dual Energy (Biosense Webster) RF-style focal, CF sensing, dual energy 8 F Monopolar biphasic 1.0–1.5 kV/µs Up to 24 applications
TactiFlex Dual Energy (Abbott) RF-style focal, CF sensing, dual energy 8 F Monopolar biphasic 1.9–2.2 kV/µs ~5 s (2.2 kV) / ~10 s (1.9 kV)
Farapoint (Boston Scientific) RF-style focal 8 F Bipolar biphasic 1.4–2.0 kV/µs 2.5 s

Energy delivery and dosing

Dual-energy (PFA/RF) systems

Primary uses and patient selection

Procedural workflow

Clinical outcomes — the five randomised controlled trials

Trial Population PFA catheter vs comparator N Efficacy (freedom from AF/AT) Safety endpoint Procedure time Monitoring
ADVENT Paroxysmal Pentaspline vs thermal 607 73.3% vs 71.3% 2.1% vs 1.5% 106 vs 123 min Intermittent
SINGLE SHOT CHAMPION Paroxysmal Pentaspline vs cryoballoon 210 62.9% vs 49.3% 1.0% vs 1.9% 55 vs 73 min Continuous ICM
BEAT PAROX-AF Paroxysmal Pentaspline vs RF 289 77.2% vs 77.6% 4.8% vs 7.6% 56 vs 95 min Intermittent
INSIGHT PFA Paroxysmal Lotus (nanosecond biphasic) vs RF 287 66.7% vs 67.4% 18.3% vs 17.9% 99 vs 113 min Intermittent
SPHERE Per-AF Persistent Lattice-tip dual-energy vs RF 420 73.8% vs 65.8% 1.4% vs 1.0% 101 vs 126 min Intermittent

Single-arm registries

Registry N Major adverse events Tamponade Death Stroke Persistent PNI Coronary spasm Haemolysis
MANIFEST-PF 1,568 1.9% 1.1% 0.06% 0.4% 0 0.1% NR
MANIFEST-17K 17,642 0.9% 0.36% 0.03% 0.12% 0 0.14% 0.03%
EU-PORIA 1,233 1.7% 1.1% 0 0.41% 0 0.1% NR

Blanking period

Autonomic nervous system effects

Long-term follow-up

Training and education

Emerging applications

Gaps in evidence

Writing committee position and conclusion

Limitations of the document

Key Concepts Mentioned

Key Entities Mentioned

Wiki Pages Updated