Pulsed Field Ablation for Atrial Fibrillation — Joint EHRA/HRS/APHRS/LAHRS/CHRS Scientific Statement (2026)
Authors, Journal, Affiliations, Type, DOI
- First author: Michael Kühne (University Hospital Basel); 26-author writing committee of electrophysiologists, engineers and trialists, plus the EHRA Scientific Document Committee
- Journal: Europace 2026;28:euag080; received 27 February 2026, accepted 13 March 2026, published ahead of print 12 April 2026
- Affiliations: Basel, Vancouver, Split, Frankfurt (CCB), Ancona, Bordeaux (LIRYC), IKEM Prague, Freiburg, Royal Papworth, Madrid, Ljubljana, Austin, Essen, Concepcion, Duke, Bern, Tel Aviv, Copenhagen, Brussels, Graz, Hamburg, Fukui, Athens, McGill, New South Wales, Linz
- Type: Multi-society scientific statement, endorsed by EHRA/ESC, HRS, APHRS, LAHRS and CHRS
- DOI: 10.1093/europace/euag080
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
- PFA disrupts membrane integrity with high-voltage short-duration pulses, creating nanoscale pores and disturbing cellular homeostasis; because myocardium has a lower electroporation threshold than surrounding structures, injury is relatively selective.
- Justification is the residual hazard of thermal ablation: atrio-oesophageal fistula and PV stenosis are rare but potentially fatal, and phrenic nerve palsy is morbid even when non-fatal.
- Whether PFA alters strategies beyond PVI, improves durability at non-PV targets, or safely extends the treatable atrial substrate remains unresolved.
Biophysics — background and development
- 2007 marks the origin (two independent publications); the first systems used DC/monophasic pulses (exponentially decaying or monophasic 100 µs) and achieved 2–5 mm lesion depth for PVI.
- Depth ceiling: current systems achieve ventricular lesion depths of only 6–8 mm irrespective of waveform or catheter design — the single most important biological constraint on ventricular PFA.
- Waveform parameters are mostly undisclosed proprietary information, which the committee identifies as an obstacle to comparison and collective learning.
Mechanism of action
- The applied field is highest at the electrode and falls rapidly with distance; current density peaks at sharp edges and between adjacent electrodes. The poorly conductive lipid bilayer amplifies the field across the membrane (~0.5 V over 5 nm ≈ 10⁸ MV/m), causing pore formation, water and reactive oxygen species entry, lipid oxidation and transmembrane protein damage.
- Transient effects precede cell death: increased membrane permeability renders a larger area unexcitable and unable to propagate action potentials (reflected in the rapid fall in bipolar electrogram amplitude), but membrane resealing makes some cells excitable again within minutes. Recovery is unpredictable.
- Any cell can be electroporated at sufficient field strength, so stunning or damage of nerves and the conduction system is possible despite "selectivity".
- Cell death is not instantaneous; the pathway depends on waveform and amplitude.
- Electroporation also causes transient microvascular changes — temporary capillary flow reduction and increased endothelial permeability — with oedema; the extracellular matrix is preserved provided temperature does not rise significantly, and preserved microcirculation is what enables faster lesion maturation than RF or cryo.
- Thermal injury still occurs at the catheter–tissue interface. At high field and current density, catheter and tissue heat up depending on duty cycle; the endothelium (and the phrenic nerve in epicardial ablation) may be damaged thermally. Blood is a better conductor than tissue, so the field extends into the blood pool and electroporates blood cells — the mechanism of haemolysis with increasing application numbers.
- Electroporation also activates platelets and modulates neutrophil activation in vitro.
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
- hs-cTnT, myoglobin and CK-MB rise more and with different temporal dynamics after PFA than after RF; the magnitude differs between PFA systems (electrode surface area, geometry, blood–electrode interaction, field distribution).
- Reduced glomerular filtration amplifies these effects; haemolysis severity correlates with procedural factors and catheter design.
- CRP rise is similar after PFA and RF, but normalises faster after PFA. Renal function and electrolyte markers fluctuate only slightly.
- Three functional groups: circumferential/large-area "single-shot" systems for rapid PVI (simplest, best safety data); large-footprint catheters integrated with 3D mapping (adaptable, usable for linear and ventricular lesions, but need mapping and have limited clinical experience); and conventional small-tip contact-force RF catheters delivering PFA (versatility and lab integration, at the cost of point-by-point workflow).
- Harmonised classification proposed by catheter dimension in contact with tissue: regional >12 mm, large-tip focal >4 to ≤12 mm, focal ≤4 mm (replacing "single-shot", "lattice-tip", "wide-area focal" and similar terms).
| 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 |
- Further systems (Adagio, Lotos, nsPFA, Optishot, Arga) are listed in the statement but are not yet approved; no complete list is possible because devices are under continuous development.
Energy delivery and dosing
- Defined by pulse amplitude (typically 500–3000 V), duration (nanosecond to microsecond), number, repetition frequency and waveform (monophasic vs biphasic; monopolar vs bipolar; square vs sine).
- Bipolar delivery and biphasic waveforms reduce charge buildup and muscle stimulation; monopolar delivery and monophasic waveforms produce deeper lesions.
- Catheter design (electrode geometry, interelectrode spacing, array) shapes field distribution, lesion morphology and consistency; irrigation affects thermal management rather than the primary mechanism.
- ECG gating has been abandoned in most atrial platforms because biphasic pulses proved to have low arrhythmogenicity in large studies.
- Safe practice requires avoiding unintended arcing, monitoring for conduction-system capture, avoiding overlapping high-intensity fields near critical structures, and adhering to device-specific dosing.
Dual-energy (PFA/RF) systems
- A single catheter and generator with unified power management that switches between RF output and high-voltage PF trains; solid-state switching or H-bridge inverters reconfigure the output stage, with impedance, temperature and voltage feedback governing delivery.
- Affera Sphere-9 (9 mm tip on an expandable nitinol lattice) and ThermoCool SmartTouch SF Dual Energy with the TRUPULSE generator (integrated with CARTO-3) are the named systems.
- The rationale is complementarity — PFA for thin-walled structures, RF for thicker myocardium and where coronary spasm is a concern, and combined PF+RF lesions for greater depth. Comparative outcome data are awaited.
Primary uses and patient selection
- De novo paroxysmal AF: >500,000 pentaspline procedures worldwide without a single reported AEF; PV narrowing exceedingly rare and not linked to symptoms; PFA already at least matches thermal efficacy as a first-generation technology.
- Early persistent AF with minimal remodelling: PVI alone is appropriate. More advanced disease: PVI-only remains acceptable but yields lower success and may need additional lesions.
- Persistent AF evidence is less mature: ADVANTAGE AF (PVI + posterior wall, continuous ICM follow-up in phase 2) reported 1-year effectiveness of 65–75% with low adverse events; SPHERE Per-AF showed non-inferior efficacy/safety with greater efficiency versus RF.
- Redo procedures: remapping durability ranges from very high PVI durability to results comparable with thermal ablation; reconnection clusters at the LSPV and RIPV, with differences between PFA systems. Posterior wall isolation with PFA shows high durability in first reports.
- No PFA-specific contraindications have been identified beyond the general contraindications to catheter ablation.
Procedural workflow
- Anaesthesia: early monophasic systems required general anaesthesia for skeletal muscle capture; biphasic waveforms allow deep sedation in most cases. MANIFEST-PF (>17,000 patients) shows >80% under deep sedation; EU-PORIA (1,233 patients, 80% sedation vs 20% GA) found shorter skin-to-skin and fluoroscopy times with sedation, identical serious adverse events and essentially identical 1-year freedom from AF/AT (~74%). No randomised evidence favours GA. Terminology is inconsistently reported; clearer reporting of agents and neuromuscular blockade is needed.
- Imaging: pre-procedural CT/MRI characterises PV anatomy and may be fused with mapping/fluoroscopy, and may guide device sizing though evidence is lacking; it is most useful early in the learning curve and in complex anatomy. Fluoroscopy-only workflows are used safely in high-volume centres and shorten procedure times without affecting outcomes, at the cost of radiation dependence. Catheter contact can be inferred from spline indentation or shape change, and optimised by pacing from the PFA catheter and adjusting to atrial capture.
- 3D mapping: early systems required a separate multipolar catheter and sheath exchange; display is now impedance-based (simplified) or fully integrated. EAM is particularly useful in redo procedures and atypical anatomy, and is what allows lesion-overlap assessment — essential for durability.
- CIEDs: large series show no clinically significant interference, lead dislodgement or device malfunction, but ablation immediately adjacent to leads should be avoided and devices interrogated before and after. Exceptions exist: permanent CRT-D failure and transient software reset with apparent battery depletion of a leadless atrial pacemaker when monopolar PFA was delivered in presumed contact with the SVC coil; and PFA-induced VF in a patient with a dual-coil ICD, likely from unintended myocardial capture via electromagnetic induction near the RV lead.
- LAA occlusion: plug-type (e.g. Watchman) and surgical clip closure appear compatible; lobe-and-disc occluders (e.g. Amplatzer Amulet) interfere — one-third of such patients had aborted left-sided applications from device proximity, because the protruding disc distorts the local field and triggers the system's safety interruption. PFA should precede implantation whenever possible. Concomitant PFA + LAAO is feasible but controversial; OPTION showed lower non-procedure-related bleeding versus oral anticoagulation without superiority for major bleeding, and met non-inferiority for stroke/systemic embolism/death only.
- Other intracardiac devices: ASD/PFO occluders, AtriClip and prosthetic valves have been treated safely, but arcing, electromagnetic interference and difficulty delivering energy next to metallic valve components are the risks.
- Step-by-step:
- Femoral venous access with ultrasound (reduces vascular complications); ACT ≥300–350 s, and ≥350 s before left atrial manipulation for some systems; uninterrupted oral anticoagulation advised.
- Standard J-tipped guidewire suffices for over-the-wire devices; extra-stiff wires increase perforation risk; straight-tip guidewires have been associated with asymptomatic bronchial bleeding, J-tip wires have not.
- Posterior transseptal puncture is standard; anterior puncture can ease right inferior PV access when the LA is not enlarged. Over-the-needle puncture directly with the PFA sheath ("zero-exchange") has been described in 100 patients.
- Air embolism prevention: meticulous de-airing, continuous saline flushing, zero-exchange designs that also shorten fluoroscopy and LA dwell time. Negative LA pressure under sedation may facilitate air ingress through open haemostasis valves.
- Vagal responses occur in 30–70%, especially at the LSPV, usually self-limited; atropine 1.0 mg or rarely temporary pacing. Prophylactic parasympatholytics are contraindicated in glaucoma and benign prostatic hyperplasia (urinary retention). RSPV-first ablation reduced vagal reactions from 78% to 13%.
- Contact assessment: coaxial antral alignment, no deep PV positioning; surrogates are tactile feedback, fluoroscopic spline indentation, pacing capture, ICE and EAM impedance markers (good contact gave 100% transmurality in vivo). PFA is less forgiving of intermittent contact than RF because ultra-short delivery lacks thermal latency — proximity must be present at the instant of delivery. Field-induced myocardial or phrenic capture can destabilise the catheter and contribute to reversible lesions and reconnection.
- Dosing: manufacturer-defined minimum applications per PV, with limited evidence — clinical studies have not shown a clear association between application number and long-term durability. DOPPIO (NCT07021313) tests whether more targeted applications improve arrhythmia-free survival.
- Projections: LAO for left PVs, RAO for right PVs; biplane may help.
- ICE: not inferior to TEE for excluding LAA thrombus; safe transseptal puncture in lipomatous septal hypertrophy, septal aneurysm or prior repair; reduces radiation and procedure time; confirms contact and catheter position relative to the ostium; several reports show improved PVI durability and fewer reconnections with the pentaspline catheter. It is nevertheless invasive, needs additional skills and access, and risks vascular injury and perforation. Zero-fluoroscopy workflows are feasible.
- Troubleshooting: automatic energy interruption occurs with unsafe geometry, abnormal impedance behaviour or interaction with metallic implants; electrical arcing is rare and occurs with electrode–electrode or electrode–metal contact. Typical triggers: multi-spline loops (touching splines, loss of antral alignment, electromagnetic interaction with implants); variable-loop catheters (diameter below validated range); focal/lattice tips (temperature overshoot or impedance rise when wedged); balloon systems (partial loss of wall contact, air/saline/blood mixing). Lobe-and-disc LAA occluders are the only formally described implant cause of interrupted delivery.
- Procedural endpoint: dense scar and preserved far-field make near-field/far-field discrimination harder after PFA, and discrimination varies with electrode size and spacing. Durable entrance and exit block remain the universal endpoint. Adenosine is of little value (even stunned, incompletely isolated veins may not show dormant conduction) and a standard waiting time is of low value. Adhere to manufacturer protocols and limit extra applications to avoid overtreatment.
- Post-procedural care: continue uninterrupted anticoagulation ≥2 months then by CHA₂DS₂-VA. Most centres have abandoned routine proton-pump inhibitor therapy. Same-day discharge is supported by registries, an admIRE sub-analysis and an EHRA meta-analysis in appropriately selected patients, but not after complications or in significant comorbidity.
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 |
- In aggregate, freedom from atrial tachyarrhythmia after the blanking period was similar between randomised technologies — non-inferiority met, superiority not met except SINGLE SHOT CHAMPION. There was no difference in AF burden, quality of life or healthcare utilisation; complications were low and not significantly different; procedure times were shorter with PFA in every trial.
Single-arm registries
- Pivotal regulatory studies cover an irrigated variable-loop circular catheter (admIRE, inspIRE), an over-the-wire loop catheter (PULSED-AF), a dual-energy focal catheter (smartfIRE), a large-tip multielectrode catheter (Omny-IRE), the pentaspline catheter (IMPULSE, PEFCAT, PEFCAT II, ADVANTAGE) and a basket-in-balloon catheter (VOLT CE mark).
- Aggregated 1-year freedom from recurrent atrial tachyarrhythmia 55–80% (paroxysmal 66–82%, persistent 55–71%), with no significant difference in recurrence versus thermal energy (RR 0.85; 95% CI 0.64–1.14; P=0.29).
| 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
- The thermal-ablation blanking period was recently shortened from 3 months to 8 weeks; PFA has a different inflammatory profile and less profound acute changes.
- SINGLE SHOT CHAMPION: recurrence during blanking 38.1% PFA vs 58.1% cryoballoon on continuous monitoring.
- PULSED AF secondary analysis: early recurrence within 3 months predicts late recurrence — consistent with two studies in which recurrences in months 2–3 were universally associated with later failure.
- A 1-month blanking period may be reasonable for clinical decision-making after PFA, and the use of a blanking period in PFA trials should be reconsidered.
- The framing has shifted: PFA is tissue-selective, not cardioselective; contact-dependent; minimally thermal; voltage-dependent — with safety profiles that vary between platforms and applications.
- Haemolysis/AKI: correlates with application number, particularly with higher-voltage systems; incidence varies by platform (waveform, voltage, catheter design). Mitigate with mindful application numbers and pre-ablation hydration, especially in chronic kidney disease.
- Phrenic nerve injury: transient 0.006%, permanent 0% in MANIFEST-17K. Phrenic capture during delivery must be distinguished from injury.
- Coronary vasospasm: documented with cavotricuspid and mitral isthmus ablation, initially with the pentaspline catheter and later with other devices, indicating voltage/field-strength dependence. Onset is typically seconds to minutes, but delayed onset is reported — relevant to same-day discharge. Attenuated by nitroglycerine, 1–2 mg intracoronary for treatment or 1 mg intracoronary / 1–2 mg intravenous for prophylaxis. Mechanism (endothelial or smooth-muscle electroporation, autonomic effects, circulating vasoactive factors) is uncertain, and long-term coronary effects are unknown.
- PV stenosis: severe stenosis is rare and mild-to-moderate narrowing — frequent with thermal ablation — has not been observed with PFA-only devices; subclinical narrowing is not systematically assessed in practice.
- Oesophageal events: thermal oesophageal injury occurs with an incidence of 0.025% and 66% mortality; no oesophageal fistula has been reported after PFA in >500,000 patients.
- Conduction system: transient AV block or sinus node dysfunction has been reported after atrial flutter ablation or SVC isolation with PFA, but is rare; the full effect is unexplored.
- Pericarditis: 0–0.3% in multinational registries and prospective studies; 0–4.4% in studies designed to detect it, depending on definition; thermal comparators report 0–10.2%.
- Left atrial function: acute reduction in LA compliance and contractile markers (LA stunning) after PVI and after more extensive ablation; long-term, compliance markers return to baseline, though persistent contractile impairment at 3 months has been described. RF-PVI with extensive LA ablation causes long-term decline in compliance markers.
- Tamponade: 0–1.1% — similar to thermal ablation.
- Stroke/TIA: stroke 0–1%, TIA 0–0.3%, similar to thermal registries (0.1–1% combined). Post-market evaluation of the Varipulse variable-loop catheter led to updated instructions after a numerically higher early stroke/TIA rate. Silent cerebral events: 14% PFA vs 18% RF vs 21% cryoballoon — and should not be attributed to electroporation alone, since air embolism during exchanges, sheath/electrode thrombus, transient hypotension and anticoagulation management all contribute; risk varies between PFA platforms.
- Vascular access: 0–2.2%; ultrasound guidance in MANIFEST-17K was associated with a two-thirds reduction in access-site complications.
- Death: 0–0.3%, usually tamponade or stroke (thermal registries 0.02–0.46%). Rare delayed malignant arrhythmias, myocardial ischaemia and sudden death after PFA — particularly after ablation beyond the PVI — have been reported; causality is unproven but vigilance and mechanistic study are needed.
Autonomic nervous system effects
- Acutely, PF impulses during PVI often trigger vagal responses, probably from intense ganglionated plexus stimulation, especially at the LSPV; starting at the RSPV may suppress the anterior right GP and reduce later vagal responses.
- Chronically, durable neural injury appears minimal: unlike RF or cryo-PVI, PFA-PVI does not produce a significant post-procedural heart-rate rise or increase in neuronal injury markers (e.g. S100B).
Long-term follow-up
- Outcome data beyond 1 year are lacking — including the effect on progression from paroxysmal to persistent AF.
Training and education
- PFA procedures should be performed under the responsibility of physicians with recognised EP certification (e.g. EHRA EP certification); centres should provide structured team education and participate in national registries.
- Structured pathway: didactic biophysics and device-specific content, then simulators or animal models, then supervised clinical practice with mentoring and proctoring — which prevents unsafe extrapolation from RF or cryoballoon experience.
- Learning curve: acute PVI is reproducible after relatively few procedures and junior and senior electrophysiologists have similar registry outcomes (EU-PORIA), but the real curve includes ablation beyond the veins, redo procedures and non-PV arrhythmias. Cryoballoon adoption is the cautionary precedent: straightforward workflows do not compensate for poor case selection, incomplete anatomical understanding or neglected endpoints.
- Objective structured assessment covers: EP lab equipment and PFA biophysics; access, transseptal puncture, anticoagulation and imaging; system-specific catheter handling and antral positioning; performing PVI and managing phrenic capture and extracardiac stimulation; verifying entrance (and where appropriate exit) block with correct near-/far-field interpretation; recognising and managing vagal responses, conduction disturbance, coronary spasm, cough and device interactions; and using PFA for additional lesion sets.
Emerging applications
- Posterior wall isolation: RF is limited by oesophageal thermal risk and suboptimal transmurality; endocardial PW PFA transmurality has been verified by direct epicardial mapping, and PW ablation is feasible with pentaspline, lattice-tip and spherical-array systems without reported oesophageal injury. MANIFEST-PF found no improvement in 12-month freedom from AF with adjunctive PW ablation; PIFPAF-PFA (NCT05986526) is testing it prospectively.
- SVC isolation: achievable with pentaspline and circular multielectrode catheters; the role of empirical versus targeted isolation is untested and safety may differ between platforms.
- Mitral isthmus line: linear PFA may achieve deeper, more uniform lesions with less fat/scar attenuation and preserved microvasculature, but periannular coronary spasm is a concern. Pentaspline series reported high acute bidirectional block with 4–10% clinical and up to 40% subclinical coronary spasm (preventable with 1–2 mg IV isosorbide dinitrate), yet a large study found dormant conduction in 14.8% after adenosine and durable block in only 5.5% at LAA-occlusion remapping; a pentaspline-versus-RF registry showed similar reconnection and mid-term recurrence. The lattice-tip dual-energy catheter achieved 100% acute success with 68% durability at remapping (69% of patients) and 1.4% adverse events in SPHERE Per-AF.
- LAA isolation: feasible with the pentaspline catheter (average 16 applications in flower and basket configurations) with low complication risk, but 95% reconnection at 3-month remapping — durability is the limiting problem.
- Scar homogenisation: a focal PFA system achieved 100% acute success and 64% freedom from arrhythmia at 6 months in one single-centre study; randomised data are missing.
- Typical atrial flutter (CTI): pentaspline CTI ablation achieved 99.5% acute success with ~1.5% short-term recurrence off-label, but PF-induced right coronary artery spasm, occasionally with malignant ventricular arrhythmias, has been reported; CTI ablation with the pentaspline catheter should only be performed with IV nitroglycerine. Lattice-tip dual-energy CTI ablation achieved 100% acute success (mostly with RF). A focal Farapoint catheter produced consistent RCA vasospasm largely prevented by IV nitroglycerine; in ADVANTAGE-AF phase 2, CTI ablation after PVI + PW with 4±2 mg IV nitroglycerine gave near-universal block without complications. A CardioFocus focal system had more first-pass block and shorter procedures than RF, but 5% transient ST elevation and 2% transient complete AV block despite nitroglycerine.
- Ventricular arrhythmias: see sources/avaar-registry-europace-2025 and concepts/Ventricular-PFA. The statement summarises early CENTAURI PVC cohorts, two small lattice-tip VT studies, the AVAAR registry (reasonable acute/mid-term success, 6% major complications), a 35-patient focal PFA series (91% acute success but 9-month success only 75% for PVC and 45% for VT), preclinical evidence that sequential colocalised RF + PFA increases ventricular lesion depth and width, and the VCAS first-in-human trial.
- Supraventricular tachycardia: focal PF systems studied in China; high acute and mid-term success with infrequent reversible AV block, but transient AV block in 17.5% with one bipolar focal catheter — data remain limited.
Gaps in evidence
- Evidence is mature for PVI and immature for every non-PV target. Lesion durability outside the PV is characterised only in small series and redo cohorts; prospective remapping with standardised endpoints is needed.
- PFA is not a class effect: waveform, voltage, pulse duration, geometry and dosing differ more between PFA systems than between RF systems.
- No PFA-specific procedural variable predicting irreversible lesion formation has been defined or validated, in contrast to RF contact force, impedance drop, temperature and stability.
- Quantitative tissue-selectivity profiles across myocardium, nerve, oesophagus and vessel need a harmonised framework; biomarkers and imaging markers (troponin, LGE) should be anchored to adjudicated outcomes.
- Priorities also include linear-lesion mapping validation, blanking-period criteria, silent cerebral events and air embolism, coronary/autonomic/renal effects, quality of life, radiation exposure, cost-effectiveness and global access.
- Health-economic data are limited; efficiency gains may offset higher device costs but robust cost-effectiveness analyses are lacking. Current evidence does not demonstrate superior effectiveness versus thermal energy.
Writing committee position and conclusion
- PFA is "a substantial technological evolution" and a departure from thermal ablation, achieving at least comparable outcomes with reduced oesophageal injury, PV stenosis and phrenic nerve damage, with procedural efficiency, short learning curves and reproducible durability.
- The variability across platforms warrants cautious, evidence-driven adoption of each system; training must be competency-based; institutions must support monitoring, device compatibility and registry participation.
- PFA is an adjunct to, not a substitute for, comprehensive electrophysiological expertise. The committee calls on manufacturers to disclose waveforms and technical detail to accelerate progress.
Limitations of the document
- Consensus statement, not a systematic review. No formal search strategy, risk-of-bias assessment or meta-analysis; recommendations reflect the writing committee's synthesis.
- Dominated by the pentaspline platform. Most randomised and registry evidence concerns the Farapulse pentaspline catheter; conclusions about "PFA" are frequently conclusions about one system.
- No long-term data. Nothing beyond 12 months informs durability, AF progression or late complications, and the statement says so explicitly.
- Safety denominators are uneven. The >500,000-procedure figure for absent oesophageal fistula is drawn from voluntary registry and survey reporting, so the true event rate is likely under-ascertained — a limitation the committee acknowledges but cannot quantify.
- Manufacturer involvement and undisclosed waveforms limit independent verification of platform-specific claims.
- Dosing and endpoints are manufacturer-defined. The statement concedes that application-number thresholds lack scientific support and that no validated lesion-effect marker exists.
Key Concepts Mentioned
Key Entities Mentioned
- Farapulse / Boston Scientific (pentaspline, Faraflex, Farapoint)
- Medtronic (PulseSelect, Sphere 360, Sphere-9 Affera, HexaPulse)
- Biosense Webster / Johnson & Johnson (Varipulse, Omnypulse, ThermoCool SmartTouch SF Dual Energy, TRUPULSE)
- Abbott (Volt, TactiFlex Dual Energy)
- Kardium (Globe PF), CardioFocus (Centauri, QuickShot), Adagio Medical, Lifetech (Lotos), Pulse Bioscience (nsPFA), Arga Medtech
- EHRA/ESC, HRS, APHRS, LAHRS, CHRS
Wiki Pages Updated
- Created:
wiki/sources/pfa-af-ehra-2026.md
- Created:
wiki/concepts/PFA-Atrial-Arrhythmias.md
- Created:
wiki/concepts/Ventricular-PFA.md
- Updated:
wiki/concepts/Pulsed-Field-Ablation.md (hub)
- Updated:
wiki/concepts/Catheter-Ablation-AF.md
- Updated:
wiki/sourceindex.md, wiki/wikiindex.md, Arrhythmia-index.md, log.md