Interventional procedure overview of pulsed field ablation for atrial fibrillation

Comparative analysis of RCTs

3 RCTs

Minimum of 12 months

Review and meta-analysis

n=11 studies (n=3805 people)

Follow-up not reported.

All other deprioritised studies

Badertscher P, Mannhart D, Weidlich S, et al. (2024). Left atrial posterior wall isolation using pulsed-field ablation: procedural characteristics, safety, and mid-term outcomes. J Interv Card Electrophysiol 67: 1359–136.

Prospective observational study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=100

12 months

This study assessed the safety and outcomes of pulsed-field ablation (PFA) for posterior wall isolation (PWI) in 100 patients with persistent atrial fibrillation. PWI was achieved in all cases with no major complications. During a median follow-up of 144 days, 15% had recurrent AF. The results suggest PFA-PWI is safe and effective, with promising mid-term outcomes, though further trials are needed.

This was a single centre study from Switzerland. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence.

Badertscher P, Weidlich S, Knecht S, et al (2023). Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation. EP Europace 25: 1905–1913.

Prospective comparative clinical study, single centre

Farawave, Farapulse (Boston Scientific) PFA system vs Cryo (Boston Scientific)

n=181

12 months

This study compared PFA and cryoballoon for pulmonary vein isolation in 181 patients with atrial fibrillation. Procedure times, fluoroscopy times, and complications were similar between the two groups. After a median follow-up of 404 days, AF recurrence rates were also comparable (24% for PFA vs. 30% for CBA), indicating similar efficacy and safety for both techniques.

Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Bejinariu AG, Spieker M, Makimoto H, Augustin N, Kelm M, Rana OR (2024). A zero-exchange approach for left atrial access in pulmonary vein isolation with pulsed field ablation. J Cardiovasc Electrophysiol.

Prospective clinical study, single arm

Farawave, Farapulse PFA system (Boston Scientific)

n=166

48 hours

This study evaluated the safety and feasibility of direct transeptal puncture (TSP) using a Faradrive sheath for pulmonary vein isolation with PFA in 166 people with AF. The procedure was completed in a median of 60 minutes, with a median fluoroscopy dose of 595 cGy × cm², with one patient experiencing pericardial tamponade, managed with puncture.

This was a single centre study. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence.

Bianchini L, Schiavone M, Vettor G, et al. (2024). Hybrid-convergent procedure or pulsed field ablation in long-standing persistent atrial fibrillation. JACC: Clinical Electrophysiology 10: 1700-1710.

Prospective comparative clinical study, single-centre.

Farawave, Farapulse PFA system (Boston Scientific)

n=93

12 months

This study compared the efficacy and safety of the hybrid-convergent RF vs PFA of PVs and left atrial posterior wall in long-standing persistent atrial fibrillation (LSPAF). Hybrid-convergent and PFA share comparable arrhythmic outcomes in LSPAF. However, PFA showed a better safety profile with a lower rate of major periprocedural complications compared with hybrid ablation (12% vs 0%; p=0.028).

Larger multicentre studies were included in the main evidence.

Bisignani A, Schiavone M, Solimene F et al. (2024). National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety. J Interv Card Electrophysiol.

Prospective observational study, multicentre Italy

Farawave, Farapulse PFA system (Boston Scientific)

n=752

3 months

The study evaluated the learning curve for PFA in AF. Among 752 patients, procedural efficiency significantly improved after 10 PFA cases, with reduced time to pulmonary vein isolation (PVI) and fluoroscopy (p<0.0001 and p=0.0045, respectively). Compared to prior RF and cryoablation times, PFA was faster in 62.4% of cases and showed no major complications, highlighting rapid procedural improvements and acute effectiveness.

The is based ATHENA registry is structured to stratify data based on the learning curve of practitioners involved. Notably, it does not include comparative analyses with other ablation techniques.

Blockhaus C, Guelker JE, Feyen L et al. (2023) Pulsed field ablation for pulmonary vein isolation: real-world experience and characterization of the antral lesion size compared with cryoballoon ablation. J Interv Card Electrophysiol 66, 567–575.

Retrospective comparative clinical study, single-centre

Farawave, Farapulse PFA system (Boston Scientific)

n=43

12 months

In this cohort study of 43 people (23 PFA, 20 CBA), PFA demonstrated no early vein reconnection and a low complication rate, with no nerve injury or bleeding, though one stroke (4.34%) and episodes of transient hypotension and bradycardia requiring pacing were noted. PFA shows promise in treating AF with a high acute PVI success rate (100%) and larger antral lesions compared to CBA (67.03% compared to 57.39%, p=0.01).

This was a single centre comparative study. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence. This study was also included in both systematic review and meta-analyses in the main evidence.

Boersma LVA, Natale A, Haines D et al (2024). Prevalence, timing, and impact of early recurrence of atrial tachyarrhythmias after pulsed field ablation: A secondary analysis of the PULSED AF trial. Heart Rhythm: 1-7.

Secondary analysis of a prospective, multicentre, single arm trial (PULSED-AF)

PulseSelect (Medtronic)

n=294

12 months

This study explored the relationship between early recurrence (within the blanking period) of atrial tachyarrhythmias and late recurrence (after the blanking period) after PFA. They found early recurrence predicted late recurrence, but the association was weak; about 1 third of people with early recurrence go on to develop late recurrence.

This is a secondary analysis of the PULSED-AF trial. The main publication is included in the prioritised evidence. This study does not add to the discussion of safety and efficacy of the procedure so was deprioritised.

Bohnen M, Weber R, Minners J, et al. (2023). Characterization of circumferential antral pulmonary vein isolation areas resulting from pulsed-field catheter ablation. EP Europace, 25(1), 65–73.

Retrospective observational study, single-centre

Farawave, Farapulse PFA system (Boston Scientific)

n=40

Follow up: 6 months

In this study, PFA for PVI in AF patients was examined using high-density voltage mapping. Among 40 patients (62.5% with paroxysmal AF), insufficient isolation areas were frequently found in the left anterior antral PV segments (62.5 to 77.5% of cases), with the largest gaps in segments 2, 5, and 8. Additionally, enlarged isolation areas were observed on the posterior wall and roof in nearly all patients (89.5 to 100%), extending beyond the antral segments.

This primary aim of this study was visualising areas, rather than assessing the safety or efficacy of the device.

Chaumont C, Hayoun C, Savoure A. et al. (2024). Pentaspline pulsed field ablation catheter versus cryoballoon for atrial fibrillation ablation: results from a prospective comparative study journal of the American Heart Association 13(6): e033146.

Prospective comparative study, multicentre

Farawave, Farapulse PFA system vs CB

n=301

1 year

This study compared PFA and CBA for PVI in AF patients. Among 301 people, complete PVI was achieved in 96% of the CBA group and 100% of the PFA group (p=0.01). The CBA group had a longer procedure time and experienced phrenic nerve injuries (10%), which were absent in the PFA group. After one year, freedom from atrial arrhythmia was higher in the PFA group (87.9% compared to 77.7%; adjusted HR 0.53, 95% CI 0.30 to 0.96; p=0.037), suggesting PFA's potential for greater safety and long-term efficacy.

This was a multicentre comparative study. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence.

Chaumont C., McDonnell E., Boveda S, et al. (2024). Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience. Archives of cardiovascular diseases.

Prospective clinical study, single arm

Farawave, Farapulse PFA system (Boston Scientific)

n=311

This multicentre study evaluated PFA in 311 patients with AF across three French centres. The cohort included 53% with paroxysmal AF, 35% with persistent AF, and 11% with long-standing persistent AF. After 1 year, the overall freedom from arrhythmia recurrence was 77.6%, with significantly higher rates in paroxysmal AF patients (88.4%) compared to persistent AF (69.7%, p<0.001) and long-standing persistent AF (49.0%, p<0.001). Additional non-pulmonary vein ablation was performed in 104 patients. Major complications occurred in 2.6% of patients (4 tamponades, 2 strokes, and 1 coronary spasm). Factors predictive of recurrence included left atrium size, CHA2DS2-VASc score, AF type, and the presence of AF at the start of the procedure, with the latter independently associated with recurrence (HR 2.04, 95% CI 1.10 to 3.77).

This was a single arm multicentre study. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence.

Cochet H, Nakatani Y, Sridi-Cheniti S et al. (2021). Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. Europace 23(9): 1391-1399.

Prospective clinical study, comparative

Farawave, Farapulse PFA system (Boston Scientific)

n=41

3 months

This study compared extra-atrial injuries after PVI using PFA versus thermal methods (radiofrequency and cryoballoon) in 41 paroxysmal AF patients. Cardiac magnetic resonance (CMR) imaging before, acutely (less than 3 hours), and 3 months post-ablation assessed oesophageal, aortic, and phrenic nerve injuries. Thermal methods caused a high rate of oesophageal lesions (43%) due to direct contact with the oesophagus, while no oesophageal lesions occurred with PFA (0%, p<0.001), despite similar contact rates. Aortic lesions were observed in 43% of thermal ablation patients and 33% of PFA patients (p=0.52). Three-month follow-up showed complete resolution of oesophageal and aortic injuries with no clinical complications in any patient.

This was a small comparative clinical study. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence. This study was also included in the systematic review and meta-analysis by Amin (2024) in the main evidence.

Davong B, Adeliño R, Delasnerie H et al. (2023). Pulsed-field ablation on mitral isthmus in persistent atrial fibrillation. JACC: Clinical Electrophysiology 9: 1070-1081.

Prospective single arm preliminary data study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=45

Mean 107.8 days (3.5 months)

This study evaluated the feasibility and safety of mitral isthmus (MI) ablation in addition to PVI and PW ablation with PFA. Everyone achieved complete MI block. Three people presented with complications, including 2 cases (4.4%) of reversible and nonfatal coronary spasm.

Comparative evidence from larger multicentre studies was included in the main evidence.

De Becker B, Haddad M, De Smet M, et al. (2024). Procedural performance and outcome after pulsed field ablation for pulmonary vein isolation: comparison with a reference

radiofrequency database. European Heart Journal Open 4: 1-8.

Retrospective, propensity score matched study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=322

6 months

This study evaluated the procedural performance, efficacy, safety, and durability of PFA compared with a dataset of patients receiving optimised RFA. Pulsed field ablation–guided PVI was obtained in everyone with a procedure time of 47 minutes (compared to 71 minutes in RFA, p<0.0001) and a fluoroscopy time of 15 minutes (compared to 11 minutes in RFA, p<0.0001).

Prospective comparative and randomised evidence with longer follow up was included in the main evidence.

Della Rocca DG, Marcon L, Magnocavallo M et al (2024). Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison. Europace 26: 1-10.

Retrospective, propensity score-matched study

n=1572

Mean 12.3 months

Farawave, Farapulse PFA system (Boston Scientific)

PVI-only ablation outcomes were compared with CBA and RFA in people with PAF. First pass isolation of PVs was statistically significantly higher in PFA (98.8%), compared with CBA (81.5%) and RFA (73.1%, p<0.001). Overall complication rates approached statistical significance in favour of PFA (3.4%), compared with CBA (8.6%) and RFA (5.5%, p=0.052). No statistically significant difference in 1-year estimates of freedom from any atrial arrhythmia in PFA (79.3%), CBA (72.4%) and RFA (72.4%, p=0.24).

This study was only based in Italy and used retrospective propensity score-matched data. EU-wide registry data and UK-based real-world evidence was included in the prioritised evidence. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Dello Russo A, Tondo C, Schillaci, V et al. (2023). Intracardiac echocardiography-guided pulsed-field ablation for successful ablation of atrial fibrillation: a propensity-matched analysis from a large nationwide multicenter experience. Journal of interventional cardiac electrophysiology 67: 1257–1266

Retrospective propensity-matched analysis

n= 556

Farawave, Farapulse PFA system (Boston Scientific)

Follow up not reported.

This study aimed to assess whether the use of intracardiac echocardiography could improve procedural parameters in a people having PAF. No major procedure-related adverse events were reported. The authors conclude that use of intracardiac echocardiography to guide PFA was not associated with an improvement in procedural metrics.

Larger studies with prospective registry or randomised evidence for this technology was included in the key evidence.

Dello Russo A, Compagnucci P, Anselmino M, et al. (2024). Pulsed field vs very high-power short-duration radiofrequency ablation for atrial fibrillation: Results of a multicenter, real-world experience. Heart Rhythm 21: 1526-1536.

Retrospective propensity-matched analysis study of prospectively collected data, multi-centre

Farawave, Farapulse PFA system (Boston Scientific)

n=534

Median 12 months

This study compared PFA with very high-power short-duration RFA for the treatment of paroxysmal or persistent AF. PFA was associated with more common use of general anaesthesia (p<0.001), shorter procedural times (70 minutes for PFA; 100 minutes for RFA; p<0.001), and longer fluoroscopy exposure (15 minutes for PFA; 7 minutes for RFA; p<0.001) compared with very high-power short-duration RFA ablation. The 12-month survival free from recurrent atrial tachyarrhythmia was similar between groups, both overall (75% for PFA; 76% for RFA; log-rank p=0.73) and in propensity score-matched people (n=342; 75% for PFA; 77% for RFA; log-rank p=0.980).

Larger prospective studies that compared with current NHS standard of care were included in the main evidence.

Del Monte A, Fernández C, Vetta M, et al. (2023). Quantitative assessment of transient autonomic modulation after single-shot pulmonary vein

isolation with pulsed-field ablation. Journal of Cardiovascular Electrophysiology 34: 2393-2397.

Prospective clinical study, comparative, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=76

Periprocedural outcomes

This study sought to investigate the degree and acute vagal modulation induced during PVI compared with single-shot thermal ablation. The vagal response after PVI almost disappeared in the thermal ablation group but persisted in the PFA group. Intraprocedural vagal reactions occurred more frequently with PFA than thermal ablation (70% compared to 28%, p=0.001). Heart rate 24 hours post-PVI increased more with thermal ablation than with PFA (16.5 vs 2.6 bpm, p<0.001). PVI with the Farapulse system is associated with only transitory and short-lasting vagal effects which recover almost completely within a few minutes after ablation.

Larger prospective and randomised clinical studies for this technology were included in the main evidence. Clinical outcomes at longer follow ups were also reported in the studies in the main evidence.

Del Monte A, Giovanni Della Rocca D, Pannone L, et al (2024). Pulsed field ablation of the right superior pulmonary vein prevents vagal responses via anterior right ganglionated plexus modulation. Heart Rhythm 21: 780-787.

Prospective clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=76

Median 8 months

This study aimed to assess whether PFA-induced transient anterior-right ganglionated plexus modulation when targeting the right superior PV before any other PVs effectively prevents intraprocedural vagal responses. It was concluded that PVI with PFA frequently induced vagal responses when initiated from the left superior PV. It was also noted that a right superior PV-first approach promoted transient heart rate increase and reduced vagal response occurrence.

Larger prospective or randomised studies with longer follow up and more clinical outcomes were included in the main evidence.

Ekanaem E, Reddy VK, Schmidt B et al (2022). Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace 24: 1256 -1266.

Retrospective survey study (part of the MANIFEST-PF study)

n=1758

Follow-up not reported

Farawave, Farapulse PFA system (Boston Scientific)

There were no oesophageal complications or phrenic nerve injuries reported in this centre-level analysis of 24 EU centres. Major complication rate was 1.6%, including pericardial tamponade (1%), stroke (0.4%), and stroke-related death. Minor complications were primarily vascular. Rare complications included coronary artery spasm, haemoptysis and dry cough.

This was a centre-level analysis of the 24-centres included in the MANIFEST-PF study. A more recent, patient-level analysis of the same centres was included in the prioritised evidence.

Erhard N, Englert F, Prommersberger S, et al. (2024). Focal pulsed field ablation in complex atrial tachycardia: First clinical experience and 1-year outcome. Heart Rhythm: 1-8

Retrospective single arm study, single centre

Centauri PFA system with TactiCath

catheter (Abbott) or INTELLANAV STABLEPOINT catheter (Boston Scientific)

n=34

12-month

This study assessed the feasibility, safety, and long-term outcome of focal PFA for ablation of complex atrial tachycardia (AT). Focal PFA of complex AT substrates was found to be safe and efficient. Acute procedural success was accomplished in everyone. Mean procedural duration was 102.7 minutes, with left atrial dwell time of 75.0 minutes. Mean fluoroscopy duration was 8.7 minutes. No complications occurred and recurrence of any AT occurred in 15 people (44.1%).

A larger prospective study with this technology was included in the main evidence.

Falasca Zamponi A, Olsen J, Scheel S et al. (2024). Procedural efficiency is enhanced combining the pentaspline pulsed field ablation catheter with three-dimensional electroanatomical mapping system for pulmonary vein isolation. Journal of interventional cardiac electrophysiology.

Retrospective comparative analysis

Farawave, Farapulse PFA system

n=248

Periprocedural outcomes only

This study aimed to evaluate the effects of integration of 3D-electroanatomical mapping with PFA during PVI, compared with conventional fluoroscopic guidance. There was no statistically significant difference in overall procedure time between groups (p=0.22). Acute procedural success was achieved in all people and there were no major complications in either group.

Larger, prospective studies with more clinical outcomes and longer follow up were included in the main evidence.

Futing A, Reinsch N, Höwel D (2022). First experience with pulsed field ablation as routine treatment for paroxysmal atrial

fibrillation. Europace 24: 1084–1092.

Prospective single arm clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=30

90 days

This study was the first-in-human study of PVI using this CE-marked PFA system and assessed phrenic nerve function, both pre and post ablation. It was observed that PVI using PFA for PAF appears to be safe and feasible. Procedure times were found to be homogeneous (median 116 minutes), and Left atrial dwell time short (median 29 minutes) with a median fluoroscopy time of 26 minutes. There were no in-hospital and 30-day follow up adverse events and 97% of patients were in sinus rhythm after 90 days.

Larger, more recent prospective and randomised studies with longer follow up were included in the main evidence.

Futing A, Reinsch N, Brokkaar L, et al. (2023). Bronchial safety after pulsed field ablation for paroxysmal atrial fibrillation. Circulation: Arrhythmia and Electrophysiology 16: 191-196.

Prospective single arm clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=30

30 days

This study aimed to assess the bronchial effects after pulmonary vein isolation using PFA for paroxysmal atrial fibrillation. Pulmonary vein isolation using PFA for paroxysmal atrial fibrillation was not found to cause thermal lesions in the bronchial system. It was identified that use of a straight-tip, extra stiff guide wire for the over-the-wire PFA catheter can lead to asymptomatic bleeding in the bronchial system without clinical relevance at 30-day follow-up (experienced by 12 of 30 patients). However, all patients were asymptomatic with clinically stable haemoglobin levels at 30-days.

Larger, prospective studies with longer follow up were included in the main evidence.

Gerstenfeld EP, Mansour M, Whang W et al (2024). Autonomic effects of pulsed field vs thermal ablation for treating atrial fibrillation: Subanalysis of ADVENT. JACC: Clinical Electrophysiology 7: 1634-1644.

Secondary analysis of an RCT (ADVENT)

n=379

12 months

Farawave, Farapulse PFA system (Boston Scientific)

This study explored the relationship between heart rate, heart rate variability and autonomic function after PFA compared with TA. They found the effect of PFA on the autonomic nervous system was attenuated compared with TA but the relationship with long-term freedom from AF and symptomatic bradycardia/pauses after AF ablation could not be answered with this study.

This is a secondary analysis of the ADVENT RCT. The main publication is included in the prioritised evidence. This study does not add to the discussion of safety and efficacy of the procedure so was deprioritised.

Gunawardene M, Frommeyer G, Ellermann C, et al (2023). Left atrial posterior wall isolation with pulsed field ablation in persistent atrial fibrillation. J. Clin. Med 12: 6304 - 6322

Prospective clinical study, multi-centre

Farawave, Farapulse PFA system (Boston Scientific)

n=79

Mean 354 days

This study explored the efficacy and safety of left atrial posterior wall isolation performed by non-thermal pulsed field ablation in catheter ablation for persistent atrial fibrillation. The authors identified no difference regarding acute procedural and clinical outcome compared to the PVI-only cohort. Left atrial posterior wall isolation was performed successfully in everyone, only two minor complications occurred, and freedom from atrial arrhythmias was reported among 79.3% of people. From these findings, left atrial posterior wall isolation guided by PFA was reported to be feasible and safe in people undergoing catheter ablation for persAF and demonstrate favourable outcomes.

Larger prospective and randomised clinical studies for this technology were included in the main evidence.

Gunawardene M, Harloff T, Jularic M, et al. (2024). Contemporary catheter ablation of complex atrial tachycardias after prior atrial fibrillation ablation: pulsed field vs. radiofrequency current energy ablation guided by high-density mapping. Europace 26: euae072.

Prospective propensity score matched clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=56

Median 401 days

This study aimed to explore the efficacy of PFA vs RFA in people undergoing repeat catheter ablation. It was reported that PFA of post-ablation left atrial tachycardia using a pentaspline catheter is feasible, safe (no major complications), and faster (PFA: 121 vs. RFA: 190 minutes, p<0.0001) but less effective (arrhythmia free survival PFA for 63% compared to 87% for RFA [HR 2.91, p=0.0473]) compared to standard RFA ablation after one year of follow-up.

Larger, randomised studies in this technology have been included in the main evidence.

Guo F, Wang J, Deng Q, et al. (2023). Effects of pulsed field ablation on autonomic nervous system in paroxysmal atrial fibrillation: A pilot study. Heart Rhythm 20: 329-338.

Prospective pilot clinical study, single centre

LEAD-PFA system (Jinjiang Electronic Science and Technology Co.)

n=18

8 months

This study evaluated the effect of a PFA system for performing PVI on the autonomic nervous system. It was reported that PFA does not induce nerve injury during pulmonary vein isolation for paroxysmal AF. Acute electrical isolation was achieved in 100% of people. Mean procedural time was 64.1 minutes, and mean fluoroscopy time was 12.3 minutes. Serum nerve injury biomarkers did not show any changes either immediately, or 24 hours post procedure (p>0.05), and heart rate variability did not differ pre or post-ablation (p>0.05).

This technology was not prioritised into the main evidence as it is not used in the UK yet. Larger, randomised studies with longer follow up for other technologies were included.

Katov L, Teumer Y, Bothner C, et al. (2024). Pulmonary vein isolation with pulsed field ablation and size-adjustable cryo-balloon: a comparative procedural analysis of first-time use. J. Clin. Med 13: 3113.

Prospective comparative clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=100

24 hours

This study compared the procedural data and safety of two new PVI techniques in first-time users – the thermal size-adjustable CBA and PFA system. It was concluded that both systems demonstrate good effectiveness (acute PVI was achieved in all cases for both PFA and CBA) and safety (PFA 0% complications compared to CBA 4%, p=0.213) during PVI. However, the PFA group had a significantly shorter procedure duration (59 minutes for PFA compared to 76.5 minutes for CBA).

Larger, randomised studies for this technology with longer follow up were included in the main evidence.

Kawamura I, Neuzil P, Shivamurthy P, et al. How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)? EP Europace. 2021;23(11):1757‐1766

Propensity score matched study

Farawave, Farapulse PFA system (Boston Scientific)

n=59

75 days

This study compared PVI success between PFA and TA. After 75 days, there was no statistically significant difference in isolation success in the left and right sided PV areas. The authors conclude that catheter-based PVI with PFA creates chronic PV antral isolation areas as encompassing as thermal energy ablation.

Prospective, large registry or randomised evidence was prioritised for this technology. This study was also included in the systematic review and meta-analysis by de Amin (2024) in the main evidence.

Kordic L, Jurišić Z, Brešković T, et al. (2024). Safety and effectiveness of additional left atrial posterior wall ablation using pulsed field ablation for persistent and long‐standing persistent atrial fibrillation patients. J. Cardiovasc. Electrophysiol 35: 1525–1535.

Retrospective observational study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=94

Median 13 months

This study assessed the long‐term freedom from atrial fibrillation, atrial flutter, and atrial tachycardia, as well as the safety and feasibility of left atrial posterior wall PFA. It was concluded that the addition of posterior wall ablation to PVI using multipolar PFA was safe and did not significantly influence the ablation time. The acute ablation success rate was 100%. The best outcomes were observed in people without extensive LA fibrosis.

Prospective, large registry or randomised evidence was prioritised for this technology.

Kueffer T, Baldinger S, Servatius H, et al. (2022). Validation of a multipolar pulsed-field ablation catheter for endpoint assessment in pulmonary vein isolation procedures. Europace 24: 1248–1255.

Prospective registry study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=56

3.2 months

This study aimed to validate the performance of a multipolar PFA catheter compared to a standard pentaspline 3D mapping catheter for endpoint assessment of PVI. It was concluded that the PFA catheter allows reliable endpoint assessment for PVI. Acute PVI was achieved in 100% of PVs and the accuracy of PV assessment with the PFA catheter after the standard ablation protocol was 91%.

Prospective comparative evidence from larger registry or randomised studies were prioritised for this technology.

Kueffer T, Madaffari A, Thalmann G, et al (2023). Eliminating transseptal sheath exchange for pulsed field ablation procedures using a direct over-the-needle transseptal access with the Faradrive sheath. Europace 25: 1500–1502.

Prospective clinical study, multi-centre

Farawave, Farapulse PFA system (Boston Scientific)

n=100

Follow-up NR

This study aimed to evaluate the feasibility and safety of a simplified workflow using the PFA sheath. It was concluded that an over-the-needle transseptal puncture directly with the PFA sheath proved feasible (successfully performed in all patients) and safe (no observed complications). It was noted that the simplified workflow has the potential to reduce the risk of air embolism, shorten procedure time, and reduce costs.

Larger, comparative and randomised evidence for this technology was prioritised.

Kueffer T, Bordignon S, Neven K et al (2024). Durability of pulmonary vein isolation using pulsed-field ablation: results from the multicenter EU-PORIA registry. JACC: Clinical Electrophysiology 10: 698-708.

Secondary analysis of EU-PORIA

n=144

Median 5 months

Farawave, Farapulse PFA system (Boston Scientific)

This study reported PVI durability in people who had redo procedures after index PFA (median 7 months after first procedure; subgroup of EU-PORIA Registry). Durable isolation was observed in 71% of the pulmonary veins during the redo procedure, and 38% of all people showed durable isolation of all pulmonary veins.

Most outcomes reported in this study were reported in Schmidt (2023) in the main evidence. This study does not add to the discussion of safety and efficacy of the procedure so was deprioritised.

Kueffer T, Stefanova A, Madafari A, et al (2024). Pulmonary vein isolation durability and lesion regression in patients with recurrent arrhythmia after pulsed‑field ablation. Journal of Interventional Cardiac Electrophysiology 67: 503–511.

Retrospective observational study, single centre

Farapulse PFA system (Boston Scientific)

n=341

12 months

This study aimed to assess PVI durability on a per-vein and per-person level. In those people with arrhythmia recurrence after PFA PVI using a first-generation PFA device, durable isolation was observed in 63% of the veins and 21% of the people showed durable isolation of all previously isolated veins. Reconnection was not different with different catheter sizes, with observations of 5/18 (28%) reconnections for the 35 mm device and 35/92 (38%) reconnections for the 31 mm device (p=0.575).

Prospective evidence from larger, randomised studies with this technology were prioritised.

Kueffer T, Stettler R, Maurhofer J et al (2024). Pulsed-field vs cryoballoon vs radiofrequency ablation: Outcomes after pulmonary vein isolation in patients with persistent atrial fibrillation. Heart Rhythm 21: 1227-1235.

Prospective registry study (single centre, Switzerland)

Farawave, Farapulse PFA system (Boston Scientific)

n=533

12 months

In this study, people with persistent AF had PVI with PFA, RFA or CBA. There was no statistically significant difference in acute safety events: 2.3%, 2.6% and 0.8% of PFA, CBA and RFA groups, respectively. Estimated freedom from atrial arrhythmia at 1 year was 62.1%, 55.3% and 48.3% for CBA, PFA and PFA, respectively. There was a statistically significant difference favouring PFA (p=0.010) and CBA (p=0.009) over RFA but no statistically significant difference between CBA and PFA (p=0.79)

This was a single centre study. Evidence from larger, multicentre or UK based real-world studies has been included in the prioritised evidence.

Kueffer T, Tanner H, Madaffari A, et al. (2024). Posterior wall ablation by pulsed-field ablation: procedural safety, efficacy, and findings on redo procedures. Europace 26: 1–10.

Retrospective observational study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=215

12 months

This study aimed to provide data on the safety and efficacy of pulsed-field ablation for posterior wall ablation. It was concluded that posterior wall ablation with the pentaspline PFA catheter can be safely and efficiently performed, with a high durability observed during redo procedures. Posterior wall ablation was successful in everyone and 1-year arrhythmia-free outcome was 53%. Severe adverse events (cardiac tamponade and vascular access complication) were observed in 1 person (0.9%) and 26 people (12%) had redo procedures.

Prospective evidence from larger, randomised studies with this technology were prioritised.

Kuroki K, Whang W, Eggert C, et al. (2020). Ostial dimensional changes after pulmonary vein isolation: Pulsed field ablation vs radiofrequency ablation. HeartRhythm 17: 1528-1535.

Retrospective observational study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=80

3 months

This study compared the effect of PFA compared to RFA on the incidence and severity of PV narrowing or stenosis. It was concluded that the incidence and severity of PV narrowing or stenosis after PV isolation is virtually eliminated with PFA. PV ostial diameters decreased significantly (p<0.001) less with PFA than with RFA. Mild, moderate or severe narrowing was not observed in any of the PV cohort after PFA compared with between 1.2% and 9% of the RFA cohort (p<0.001).

Prospective evidence from larger, randomised studies with this technology were prioritised. This outcome was also reported in detail in other prioritised studies.

Lee X, Freeman B, Gunthorpe N, et al. (2024). Pulsed field ablation of atrial fibrillation: an initial Australian single centre experience. Heart, Lung and Circulation 33: 46-54.

Prospective clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=97

6 months

This study aimed to present an initial single-centre Australian experience of PFA for AF ablation. It was concluded that pulsed field ablation can be performed safely and efficiently, with encouraging efficacy in early follow-up. All pulmonary veins were successfully isolated acutely. The median procedure time was 74 minutes and two (2%) pseudoaneurysm vascular access complications occurred.

Prospective evidence from larger, randomised studies with longer follow up for this technology were prioritised.

Lemoine M, Fink T, Mencke C, et al. (2023). Pulsed‑feld ablation‑based pulmonary vein isolation: acute safety, efficacy and short‑term follow‑up in a multi‑center real world scenario. Clinical Research in Cardiology 112: 795–806.

Prospective single arm observational study, multi centre

Farawave, Farapulse PFA system (Boston Scientific)

n=138

12 months

This study aimed to assess the efficacy, safety and follow-up of PFA-based PVI in an early adopter routine care setting. It was concluded that PFA-based PVI is acutely highly effective and associated with a beneficial safety and low recurrence rate. PVI was achieved in all everyone with a mean procedure time of 78 minutes. The 1-year follow-up showed freedom of arrhythmia in 90% in people with paroxysmal AF and 60% with persistent AF (p=0.015).

Prospective evidence from larger, randomised studies with this technology were prioritised. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Magni F, Mulder B, Groenveld H, et al. (2022). Initial experience with pulsed field ablation for atrial fibrillation. Front. Cardiovasc. Med 9:01-09.

Prospective single arm clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=100

12 months

This study aimed to describe procedural findings and acute safety and efficacy in the first 100 people treated with the PFA catheter. It was concluded that use of the PFA catheter for pulmonary vein isolation (PVI) is safe, fast, and easy to learn. In everyone (100%), all PVs were confirmed to be isolated, no difference in procedure times was observed between senior and junior operators (46.9 compared to 45.9 minutes), and the only complications observed were 2 cases of bleeding at the site of percutaneous access.

Prospective evidence from larger, randomised studies with this technology were prioritised.

Malyshev Y, Neuzil P, Petru J, et al. (2024). Nitroglycerin to ameliorate coronary artery spasm during focal pulsed-field ablation for atrial fibrillation. JACC: Clinical Electrophysiology 10: 885 – 896.

Prospective single arm clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=39

Follow up NR

This study aimed to assess the vasospastic potential of a focal PFA catheter with a narrower electrical field and develop a preventive strategy with nitroglycerin. It was concluded that ablation of the Cavo tricuspidisthmus using a focal PFA catheter routinely provokes right coronary vasospasm, with moderate-severe vasospasm observed in 80% of people who were treated without nitroglycerin. Pretreatment with high doses of parenteral nitroglycerin prevents severe spasm, with no observed cases of severe spasm and only 20% of people experiencing mild-moderate vasospasm.

Prospective evidence from larger, randomised studies with this technology were prioritised.

Mansour M, Gerstenfeld EP, Patel et al (2024). Pulmonary vein narrowing after pulsed field versus thermal ablation. Europace 26: 1-9.

Secondary analysis of an RCT (ADVENT)

n=607

12 months

Farawave, Farapulse PFA system (Boston Scientific)

This study explored methods of measuring PV narrowing after PFA. Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location.

PV narrowing outcomes were already reported in the primary publication from this RCT, and this has been included in the prioritised evidence. This is an exploratory analysis.

Maurhofer J, Tanner H, Kueffer T, et al. (2024). Pulsed-field ablation for repeat procedures after failed prior thermal ablation for atrial fibrillation. Heart Rhythm 5: 257-265.

Prospective single arm clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=186

12 months

This study aimed to summarise the initial experiences of people undergoing repeat procedures using PFA. The authors concluded that PFA is a versatile and safe option for repeat procedures after failed prior thermal ablation. Major complications occurred in 1 person (transient ischemic attack 0.5%) and freedom from arrhythmia recurrence in Kaplan-Meier-analysis was 78% after 6 months and 54% after 12 months.

Prospective evidence from larger, randomised studies with this technology were prioritised.

Maurhofen J, Kueffer T, Madaffari A, et al. (2024). Pulsed‑field vs. cryoballoon vs. radiofrequency ablation: a propensity score matched comparison of one‑year outcomes after pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Journal of Interventional Cardiac Electrophysiology 67:389–397.

Propensity score matched registry study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=200

12 months

This study compared procedural and 1-year follow-up data of people with paroxysmal atrial fibrillation (AF) undergoing PVI using PFA, cryoballoon ablation (CBA) and radiofrequency ablation (RFA). It was concluded that freedom from any atrial tachyarrhythmia 1 year after PVI using PFA was favourable and at least as good as for PVI with CBA or RFA (85% for PFA compared to 66.2% for CBA and 73.8% for RFA).

Prospective evidence from larger registries or randomised studies with this technology were prioritised. This study was also included in both of the systematic review and meta-analyses in the main evidence.

Metzner A, Fiala M, Vijgen J, et al. (2024). Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study. Europace 26: 1-6.

Prospective clinical study, multi centre

Farawave, Farapulse PFA system (Boston Scientific)

n=180

12 months

This study aimed to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF. It was concluded that PVI using a pentaspline PFA catheter was effective in treating PAF (all PVs were successfully isolated) and also demonstrated favourable safety (safety endpoints were only demonstrated in 2 people (1%), including 1 tamponade and 1 transient ischaemic attack).

Prospective evidence from larger, randomised studies with this technology were prioritised.

Musikantow D, Neuzil P, Petru J, et al. (2023). Pulsed field ablation to treat atrial fibrillation. JACC: Clinical Electrophysiology 9: 481-493.

Combined retrospective and prospective clinical study, multi centre

Farawave, Farapulse PFA system (Boston Scientific)

n=120

3 months

This study aimed to assess the impact of pulsed field ablation on the ganglionated plexi in patients undergoing PVI. It was concluded that PFA has minimal effect on GP. Unlike with thermal ablation, the mechanism by which PFA treats atrial fibrillation is mediated solely by durable PVI.

Prospective evidence from larger, randomised studies with longer follow up done with this technology were prioritised. This study was also included in the systematic review and meta-analysis by Amin (2024) in the main evidence.

My I, Lemoine M, Butt M, et al. (2023). Acute lesion extension following pulmonary vein isolation with two novel single shot devices: Pulsed field ablation versus multielectrode radiofrequency balloon. J Cardiovasc Electrophysiol 34: 1802–1807.

Prospective clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=60

12 months

This study aimed to compare the acute lesion extent after PVI induced by PFA and RF balloon ablation (RFB). It was concluded that PFA delivers larger acute lesion areas and higher troponin release upon successful PVI than multielectrode RFB‐based PVI in this single‐centre series. Acute PVI was achieved in everyone in both groups. The total posterior ablation area was significantly larger in PFA than RFB (20.7 cm² vs. 7.1 cm²; p<0.001). The posterior ablation area for each PV resulted in larger lesions after PFA versus RFB.

Prospective evidence from larger, randomised studies with this technology were prioritised. This is not a comparator that is used routinely in the NHS. This study was also included in both the systematic review and meta-analyses (2024) in the main evidence.

Nakatani Y, Sridi-Cheniti S, Cheniti G, et al. (2021). Pulsed field ablation prevents chronic atrial fibrotic changes and restrictive mechanics after catheter ablation for atrial fibrillation. Europace 23: 1767-1776.

Prospective clinical study, multi centre

Farawave, Farapulse PFA system (Boston Scientific)

n=63

9 months

This study aimed to compare the left atrial structural and mechanical characteristics after PFA compared to thermal ablation. It was concluded that pulsed field ablation induces large acute late gadolinium enhancement without microvascular damage or intramural haemorrhage. In the acute stage, late gadolinium enhancement volume was 60% larger after PFA vs. thermal ablation (p<0.001), and oedema on T2 imaging was 20% smaller (p=0.002). In the chronic stage, most acute late gadolinium enhancement had disappeared after PFA, whereas most late gadolinium enhancement persisted after thermal ablation.

Prospective evidence from larger, randomised studies with more clinical outcomes for this technology were prioritised. This study was also included in both the systematic review and meta-analyses in the main evidence.

Ollitrault P, Chaumont C, Font J, et al. (2024). Superior vena cava isolation using a pentaspline pulsed-field ablation catheter: feasibility and safety in patients undergoing atrial fibrillation catheter ablation. Europace 26: 1-7.

Prospective clinical study, multi centre

Farawave, Farapulse PFA system (Boston Scientific)

n=105

3 months

This study aimed to assess the feasibility and safety of PFA-based superior vena cava isolation. It was concluded that superior vena cava isolation using a pentaspline PFA catheter is feasible and safe. Acute superior vena cava isolation was achieved in everyone. Transient high-degree sinus node dysfunction occurred in 5 out of 105 (4.7%) people, with no recurrence, and at the 3-month follow-up visit, no complication occurred.

Prospective evidence from larger, randomised studies with longer follow up and broader scope for this technology were prioritised.

Orczykowski M, Urbanek P, Bodalski R, et al. (2024). Acute safety and efficacy of pulsed field ablation for atrial fibrillation in a Polish cohort of patients. Polish Heart Journal (Kardiologia Polska) 82: 658-659.

Prospective cohort study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=150

6 months

This study aimed to assess acute safety, efficacy, and feasibility of ablation with the use of PFA in a high-volume Polish centre. It was concluded that the procedure is safe, feasible and effective. The procedure was not observed to entail any serious complications. Most pulmonary veins were successfully isolated (99.3%) and first-pass PVI was achieved using the multispline PFA catheter in most people (96.6%), with a mean time of 25 minutes between first and last ablation.

Prospective evidence from larger, multicentre randomised studies with longer follow up for this technology were prioritised.

Osmancik P Bacova B, Hozman M, et al. (2024). Myocardial damage, inflammation, coagulation, and platelet activity during catheter ablation using radiofrequency and pulsed-field energy. JACC: Clinical Electrophysiology 10: 463-474.

Prospective randomised controlled trial, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=65

24 hours

This study aimed to compare the systemic response in people undergoing pulmonary vein isolation using pulsed-field and radiofrequency energy. It was concluded that pulsed-field ablation was associated with a similar degree of platelet/coagulation activation (more than 50%), and slightly lower inflammatory response than people undergoing PVI using radiofrequency. However, pulsed-field ablation was associated with increased myocardial damage.

Prospective evidence from larger, randomised studies with longer follow up and more clinical outcomes for this technology were prioritised. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Osmancik P, Bacova B, Herman D, et al. (2024). Periprocedural intravascular hemolysis during atrial fibrillation ablation. JACC: Clinical Electrophysiology 10: 1660-1671.

Prospective observational clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=70

1 day

This study aimed to compare the potential for haemolysis during PVI with PFA vs RFA. It was concluded that PFA is associated with significant periprocedural haemolysis but the likelihood of significant renal injury is uncommon. At 24 hours with PFA, the concentration of lactate dehydrogenase and indirect bilirubin increased, whereas haptoglobin decreased significantly (all p<0.001), whereas RFA caused only small changes in lactate dehydrogenase and haptoglobin concentrations (p=0.03) and no change in bilirubin.

Prospective evidence from larger, randomised studies with longer follow up and more clinical outcomes for this technology were prioritised. Also Mohanty (2024) in the main evidence explored the same research question around haemolysis and acute kidney injury.

Plank K, Bordignon S, Urbanek L, et al. (2023). Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation. J. Cardiovasc. Electrophysiol 34: 2425–2433.

Retrospective analysis, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=231

Median 367 days

This study aimed to report the rate of early recurrences and their effect on clinical midterm outcomes following PFA‐based PVI. It was concluded that was an independent predictor for LR and was recorded in 21% of people after PFA‐PVI (HR 3.370: p<0.001). No difference in the rate of LRs among people experiencing early recurrence of atrial tachycardia before or after 45 days was observed.

Prospective evidence from larger, randomised studies for this technology were prioritised.

Popa M, Bahlke F, Kottmaier M, et al. (2023). Myocardial injury and inflammation following pulsed field ablation and very high‐power short‐duration ablation for atrial fibrillation. J. Cardiovasc. Electrophysiol 35: 317-327.

Retrospective analysis, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=179

12 months

This study aimed to determine the extent of myocardial injury and systemic inflammation following PFA, high power short duration, and standard RFA using established biomarkers. It was concluded that PFA was associated with the highest myocardial injury and the lowest inflammatory reaction among the investigated ablation techniques. Post ablation high sensitivity cardiac troponin release was significantly higher with PFA (p<0.001), creatine kinase and creatine kinase-MB release increased significantly with PFA compared to RFA (p<0.001), and PFA was associated with the lowest elevation in white blood cell count (p<0.001).

Prospective evidence from larger, randomised studies with more clinical outcomes for this technology were prioritised. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Rattka M, Mavrakis E, Vlachopoulou D, et al. (2024). Pulsed field ablation and cryoballoon ablation for pulmonary vein isolation: insights on efficacy, safety and cardiac function. Journal of Interventional Cardiac Electrophysiology 67: 1191–1198.

Prospective case control study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=114

12 months

This study aimed to compare outcomes of people undergoing either PFA or CBA for primary PVI. It was concluded that CBA and PFA for PVI are of similar efficacy when it comes to AF recurrence after 12 months (PFA: 70% compared to CBA: 61% free from AF/AT; p=0.470). However, PFA rather than CBA might induce left atrial reverse remodelling thereby contributing to left ventricular systolic function.

Evidence from larger, randomised studies for this technology were prioritised. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Reddy V, Neuzil P, Koruth J, et al. (2019). Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. Journal of the American College of Cardiology 74: 315-326.

Prospective clinical study, multicentre

Farawave, Farapulse PFA system (Boston Scientific)

n=81

12 months

This study aimed to determine whether PFA allows durable PVI without damage to collateral structures. It was concluded that PFA preferentially affected myocardial tissue, allowing facile ultra-rapid PV isolation with excellent durability and chronic safety. All PVs were acutely isolated with an average procedure time of 92.2 minutes and a fluoroscopy time of 13.1 minutes. Only 1 procedure-related pericardial tamponade was observed, with no other additional primary adverse events, and a 12-month freedom from arrhythmia estimate of 87.4%.

Prospective evidence from larger, randomised studies for this technology were prioritised.

Reddy V, Rackauskas G, Peich P, et al. (2020). Lattice-tip focal ablation catheter that toggles between radiofrequency and pulsed field energy to treat atrial fibrillation. Circ Arrhythm Electrophysiol 13: 483-495.

Prospective single arm clinical study, multi centre

Sphere-9 Affera

n=76

12 months

This study aimed to assess the capability of the lattice-tip catheter to permit focal PFA. It was concluded that the novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach or an entirely PF approach. All lesion sets were acutely successful and no device-related complications were observed. However, postprocedural esophago-gastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 people with RF/PF.

A more recent publication of the same trials, but with more data was included in the main evidence for this technology. This study was also included in the systematic review and meta-analysis by Amin (2024) in the main evidence.

Reddy V, Dukkipati S, Neuzil P, et al. (2021). Pulsed field ablation of paroxysmal atrial fibrillation. JACC: Clinical Electrophysiology 7: 614-627.

Prospective single arm clinical study analysis, multi centre

Farawave, Farapulse PFA system (Boston Scientific)

n=121

12 months

This study sought to determine whether durable PVI using pulsed field ablation PFA translates to freedom from atrial fibrillation recurrence without an increase in adverse events. It was concluded that PVI with a "single-shot" PFA catheter results in excellent PVI durability and acceptable safety with a low 1-year rate of atrial arrhythmia recurrence. PVI was achieved in 100% of PVs with PFA alone. Primary adverse events occurred in 2.5% of people (2 pericardial effusions or tamponade, 1 haematoma); with 1 transient ischaemic attack. Kaplan-Meier estimates for freedom from any atrial arrhythmia at 12-months were 78.5% for the entire cohort and 84.5% for the optimised biphasic energy PFA waveform cohort.

Prospective evidence from larger, randomised studies for this technology were prioritised.

Reinsch N, Futing A, Howel D, et al. (2022). Cerebral safety after pulsed field ablation for paroxysmal atrial fibrillation. Heart Rhythm 19: 1813-1818.

Prospective clinical study, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=30

30 days

This study aimed to investigate the occurrence of neurological deficits and SCL and/or SCE after PFA in paroxysmal atrial fibrillation. It was concluded that the incidence of MRI-detected asymptomatic thromboembolic cerebral events or lesions was as low as 3% among people treated with PFA for symptomatic paroxysmal AF. No neurological deficits occurred. Cerebral MRI scans were normal in 97% of people. While a single 7-mm cerebellar lesion was observed among 1 person (3%), the lesion had completely regressed at follow-up.

Prospective evidence from larger, randomised studies for this technology were prioritised. Data focusing on cerebral events has been covered in the prioritised publications.

Reinsch N, Futing A, Hartl S, et al. (2024). Pulmonary vein isolation using pulsed field ablation vs. high-power short-duration radiofrequency ablation in paroxysmal atrial fibrillation: efficacy, safety, and long-term follow-up (PRIORI study). Europace 26: 2-7.

Retrospective analysis, single centre

Farawave, Farapulse PFA system (Boston Scientific)

n=410

12 months

This study aimed to the efficacy of PFA-PVI versus. high power short duration-RF PVI in terms of single-procedure arrhythmia-free outcome and safety in a real-world setting. It was concluded that both PFA and high-power short duration-RF were highly efficient and effective in achieving PVI in paroxysmal AF. The arrhythmia-free survival is comparable between treatments (PFA: 85% compared to high power short duration-RF: 79%; p=0.160). The PV reconnection rate was not different (PD: 30% compared to high power short duration-RF: 38%; p=0.372).

Evidence from larger, studies for this technology were prioritised.

Ruwald, Martin H, Johannessen, Arne, Hansen, Morten Lock et al. (2024). Focal pulsed field ablation and ultrahigh-density mapping - versatile tools for all atrial arrhythmias? Initial procedural experiences Journal of interventional cardiac electrophysiology 67(1): 99-109.

Prospective single arm clinical study

n=51

14 days

CENTAURI, Galvanize

This study included people with a range of atrial arrhythmias not just AF. First pass PVI rate was 97%, 100% isolation for any isthmus and 82% for left atrial posterior wall. One person had transient ST segment elevation, and 1 person had transient atrioventricular block.

Studies with focus on only atrial fibrillation were included in the main evidence. Studies with longer follow up and comparative evidence were also included in the main evidence.

Ruwald MH, Johannessen A, Hansen M et al. (2023). Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings. Journal of interventional cardiac electrophysiology 66(8): 1837-1848.

Prospective cohort study

n=121

Mean 308 days

Farawave, Farapulse PFA system

PVI was achieved with PFA-only in 119 (98%). 1 person had phrenic nerve palsy with only partial remission at follow-up. 18.2% of people had clinically significant recurrence or started anti-arrhythmic drugs. Kaplan–Meier event-free estimate at 365 days was 80% (88% for paroxysmal versus 69% for persistent).

Larger, randomised studies for this technology were included in the main evidence.

Schiavone M, Solimene F, Moltrasio M et al. (2024). Pulsed field ablation technology for pulmonary vein and left atrial posterior wall isolation in patients with persistent atrial fibrillation. Journal of cardiovascular electrophysiology 35: 1101-1111.

Prospective single arm trial

n= 249

Median 273 days

Farawave, Farapulse PFA system

All people in this analysis had left atrial posterior wall isolation during a redo procedure in a single centre. The authors reported that this approach with PFA was feasible, and safe in real world practice, and was a viable alternative for people with PersAF. No major complications occurred. During a median follow‐up of 273 days 17% of people had arrhythmic recurrence.

A larger, subgroup analysis of a multicentre registry study that focused on left atrial posterior wall isolation, with comparative and longer-term evidence was included in the main evidence.

Schipper, Jan-Hendrik, Steven, Daniel, Luker, Jakob et al. (2023). Comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation. Journal of cardiovascular electrophysiology 34: 2019-2026.

Retrospective comparative study

n=108

Mean 273 days

Farawave, Farapulse PFA system

This study compared outcomes from PFA and CBA. 1 person had transient phrenic nerve palsy in the CBA group. PFA procedures were shorter on average but this wasn't statistically significant (p=0.07). Two cardiac tamponades occurred in the PFA group (p= 0.495). There was no statistically significant difference in pain, assessed by amount of analgesic prescribing (p=0.598). Atrial arrhythmia freedom was 74% in PFA and 72% in CBA after 273 days on average. The PFA group had statistically significantly higher heart rate after 3 months (p=0.008).

Larger, prospective studies with longer follow-up were included in the key evidence. This study was also included in both the systematic review and meta-analyses in the main evidence.

Schmidt B, Bordignon S, Neven K et al (2023). EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry. Europace 25: 1-11.

This publication reports findings from the multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry study. Median procedure time was 58 minutes, Major complication rate was 1.7%, including pericardial tamponade (1.1%), transient ischaemic attack or stroke (0.6%), of which 1 was fatal. 1-year Kaplan-Meier estimates of arrhythmia free survival was 74%, but differed depending on whether people had PAF (80%) or PersAF (66%). Reintervention was needed for recurrence of AF in 12% of people.

A registry study of similar size which collected data prospectively and at a patient-level, was included in the main evidence (MANIFEST-PF). The findings of this study align with the findings of MANIFEST-PF.

Soubh N, Gronwald J, Haarmann H et al. (2024). Next-generation atrial fibrillation ablation: clinical performance of pulsed-field ablation and very high-power short-duration radiofrequency. Journal of interventional cardiac electrophysiology.

Retrospective comparative study

n=82

6 months

Farawave, Farapulse PFA system

RFA was compared with high-power short-duration radiofrequency ablation. At 6 months, there was no statistically significant difference in AF recurrence between groups (p=0.138), and both groups had statistically significant improvements in AF symptoms. Procedure time was statistically significantly shorted in the PFA group (p<0.001). There were no statistically significant differences in complications (p=0.366).

Larger, prospective studies with longer follow-up were included in the main evidence for this technology.

Stojadinovic P, Wichterle D, Peichl P et al. (2022). Autonomic changes are more durable after radiofrequency than pulsed electric field pulmonary vein ablation. JACC. Clinical Electrophysiology 8(7): 895-904.

Prospective comparative observational study

n=31

Periprocedural outcomes only

Sphere-9, Affera

This study investigated whether PVI with PFA compared with RFA had less effect on the cardiac autonomic nervous system. The response of the sinoatrial and atrioventricular node to extracardiac high-frequency, high-output, right vagal nerve stimulation was assessed at baseline and during and at the end of the ablation procedure. PFA caused significantly weaker and less durable suppression of cardiac autonomic regulations.

Larger studies with longer follow up and more clinical outcomes were included in the main evidence.

Tilz, RR, Vogler J, Kirstein B et al. (2023). Pulsed field ablation-based pulmonary vein isolation using a simplified single-access single-catheter approach - the fast and furious PFA study. Circulation journal 87(12): 1722-1726.

Prospective single arm clinical study

n=50

Mean 6.5 months

Farawave, Farapulse PFA system

100% acute PVI rate was seen. Mean procedure time was 27.4 minutes and time to ambulation was 3.3 hours. No severe complications were seen. At a mean of 6.5 months, 82% had maintained sinus rhythm.

Larger, randomised studies with longer follow-up and more clinical outcomes were included in the main evidence.

Tilz RR, Heeger CH, Vogler J et al. (2023). Wide antral circumferential vs. ostial pulmonary vein isolation using pulsed field ablation- the butterfly effect. Frontiers in cardiovascular medicine 10: 1217745.

Prospective comparative study

n=30

12 months

Farawave, Farapulse PFA system

This study compared outcomes between wide angle circumferential ablation compared with ostial PVI. The wide angle circumferential approach was associated with neither increased procedure nor statistically significant differences in 1-year rhythm outcome.

Larger, randomised studies with more clinical outcomes were included in the main evidence for this technology.

Tohoku S, Bordignon S, Schaack D et al. (2024). Initial real-world data on catheter ablation in patients with persistent atrial fibrillation using the novel lattice-tip focal pulsed-field ablation catheter. Europace 26: euae129.

Prospective observational single arm study

n=28

90 days

Sphere-9, Affera

This study presents early real world data on the Sphere-9 catheter. PVI was successful in acute phase for 100%. Median procedure time was 97 minutes and early recurrent AF within 90 days was seen in 15%. No major or minor AEs were seen.

Larger studies with longer follow-up for this technology were included in the key evidence.

Tohoku S, Schmidt B, Schaack D et al (2023). Impact of pulsed-field ablation on intrinsic cardiac autonomic nervous system after pulmonary vein isolation. JACC Clinical electrophysiology 9: 1864-1875.

Prospective non-randomised comparative study

n=97

6 months

Farawave, Farapulse PFA system

The impact of PFA compared with CBA on the intrinsic cardiac nervous system was assessed with a biomarker in this study (s100). Statistically significantly lower S100 release following PFA PVI vs CBA (p<0.0001). Vagal response during PFA was not associated with S100 release. This indicated lower nervous tissue destruction with PFA than CBA.

Larger, randomised studies reporting more clinical outcomes at longer follow up were included in the main evidence. This study was also included in the systematic review and meta-analysis by de Amin (2024) in the main evidence.

Tohoku S, Chun KRJ, Bordignon S et al (2023). Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation. Europace 25: 433-440.

Retrospective observational study

n=360

Mean 4.8 months

Farawave, Farapulse PFA system (Boston Scientific)

25 of 360 people had repeat ablation within 6.1 months; 16 had atrial tachycardia, 8 had AF and 1 atrial flutter.

Larger prospective studies with longer follow up and more clinical outcomes were included in the main evidence.

Turagam MK, Neuzil P, Petru J et al (2023). PV isolation using a spherical array PFA catheter: application repetition and lesion durability (PULSE-EU Study). Jacc: Clinical Electrophysiology. 9: 638-648.

Prospective single arm trial

Globe PF System (Kardium)

n=21

Mean 93 days

This was a first in human trial of the Globe PFA catheter. They found 100% acute PVI, and 62.5% durability in people who had 1 application versus 100% in people who had 3 PFA applications. No stroke, transient ischaemic attack, pericardial effusion, phrenic nerve injury or oesophageal complications. Asymptomatic brain lesions were seen on MRI for 3 of 16 people.

This is a small study with short follow-up in a catheter that is not currently in use in the UK.

Turagam MK, Neuzil P, Schmidt B et al (2023). Clinical outcomes by sex after pulsed field ablation of atrial fibrillation. JAMA Cardiology 8: 1142-1151.

Secondary retrospective analysis of a registry (MANIFEST PF)

n=1568

1 year

Farawave, Farapulse PFA system (Boston Scientific)

This study aimed to explore whether there were differences in outcome after PFA by sex because of mixed findings in the literature about other ablative methods for AF. The study concluded there were no significant sex differences in clinical effectiveness or safety events.

This was a secondary analysis of the MANIFEST-PF registry. Two publications with patient level outcomes from this registry were included in the prioritised evidence. The findings of this study do not substantially add to the overall conclusions for this assessment.

Turagam MK, Neuzil P, Schmidt B et al (2024). Safety and effectiveness of pulsed field ablation for atrial fibrillation in patients with heart failure: a MANIFEST-PF sub-analysis. JACC. Clinical electrophysiology 10: 1675-1686.

Secondary retrospective analysis of a registry (MANIFEST PF)

n= 1381

1 year

Farawave, Farapulse PFA system (Boston Scientific)

This is a sub analysis of the MANIFEST-PF study. This study focused on the efficacy of PFA in heart failure. The authors concluded that PFA appears to be safe and effective in AF with heart failure. Freedom from atrial arrhythmia post-PFA was higher in people without a history of heart failure.

This was a secondary analysis of the MANIFEST-PF registry. Two publications from this registry were included in the prioritised evidence. The findings of this study do not substantially add to the overall conclusions for this assessment.

Urbanek L, Bordignon S, Schaack D et al (2023). Pulsed field versus cryoballoon pulmonary vein isolation for atrial fibrillation: efficacy, safety, and long-term follow-up in a 400-patient cohort. Circulation: Arrhythmia and Electrophysiology 16: e011920.

Retrospective comparative cohort study

n=400

12 months

Farawave, Farapulse PFA system

This study compared RFA with CBA. Acute PVI was achieved in 100% of people with PFA and 98% of CBA (p=0.123). Median procedure time was statistically significantly shorter in PFA (p<0.001). Overall complications did not differ statistically (p=0.1). There were more incidents of phrenic nerve palsy in the CBA arm. Freedom from AF was similar for CBA and PFA but rates were higher for both groups in the PAF group (CBA 83.1%, PFA 80.3%; p=0.724) than PersAF (CBA 71%, PFA 66.8%, p=0.629)

Larger, multicentre prospective, randomised studies were included in the main evidence for this technology. This study was also included in both the systematic review and meta-analyses in the main evidence.

van de Kar MRD, Slingerland SR, van Steenbergen GJ et al (2024). Pulsed field versus cryoballoon ablation for atrial fibrillation: a real-world observational study on procedural outcomes and efficacy. Neth Heart J 32: 167-172.

Retrospective comparative cohort study

n=1714

6 months

Farawave, Farapulse PFA system

PFA was compared with CBA in this study. People who had CBA had higher incidence of phrenic nerve palsy than the PFA group (p=0.02). Procedure duration was shorter in PFA (p<0.001).

Prospectively collected EU real world evidence with longer follow up was included in the main evidence. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Verma A, Boersma L, Haines DE et al. (2022). First-in-human experience and acute procedural outcomes using a novel pulsed field ablation system: the PULSED AF pilot trial. Circulation. Arrhythmia and electrophysiology 15: e010168.

Prospective single arm pilot trial (PULSED AF)

n=38

30 days

PulseSelect, Medtronic

This is the pilot trial associated with the PULSED AF study included in the main evidence. They found that acute PVI was achieved in 100%. Average procedure time was 160 minutes and no serious adverse events, including phrenic nerve injury, oesophageal injury, stroke, or death were observed.

This is the pilot trial associated with the PULSED AF study included in the main evidence.

Wahedi R, Willems S, Feldhege J et al (2023). Pulsed‐field versus cryoballoon ablation for atrial fibrillation—Impact of energy source on sedation and analgesia requirement. J. Cardiovasc. Electrophysiol 35: 162-170.

Prospective comparative study

n=100

Follow-up was not reported.

Farawave, Farapulse PFA system

This study compared outcomes for people who had deep sedation with either PFA or CBA. Requirement of propofol, midazolam, and sufentanyl was significantly higher in the PFA group compared to CBA (p<0.002 across outcomes). Sedation and non-sedation-associated complications did not differ between both groups (p>0.99)

Larger, randomised studies with more clinical outcomes were included in the main evidence. Studies in the main evidence did include deep sedation protocols. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Wenzel JP, Lemoine MD, Rottner L. et al (2023). Repeat pulmonary vein isolation and anterior line ablation using a novel point-by-point pulsed-field ablation system. Heart Rhythm 21: 250-257.

Prospective single arm study

n=24

Follow up was not reported but appears to be peri-procedural only.

Centauri PFA system with THERMOCOOL SMARTTOUCH catheter

This study assessed feasibility, safety, and lesion characteristics of point-by-point PFA in consecutive people undergoing repeat ablation of atrial fibrillation (AF). 100% of PVs were successfully reisolated. Anterior line ablation was done in 19 people and acute reconduction rate was 42%. No major or minor complications were seen.

Larger, comparative studies with longer follow-up and more clinical outcomes reported were included in the key evidence.

Weyand S, Adam V, Biehler P et al (2024). Focal pulsed field ablation for atrial arrhythmias: efficacy and safety under deep sedation. Journal of Clinical Medicine 13: 576.

Retrospective observational study

n=30

30 days.

Centauri NAVISTAR SMARTTOUCH, Biosense

Webster/ TACTICATH QUARTZ, Abbott Laboratories

This study assessed outcomes from PFA under deep sedation. Not everyone had AF. The authors concluded that focal PFA is an effective approach for complex left atrial ablations under deep sedation, offering both high efficacy and efficiency with a reliable safety profile.

Not all people in this study were being treated for AF. Follow-up was short and few people were included in the study.

Wormann J, Schipper JH, Luker J et al (2023). Comparison of pulsed‐field ablation versus very high power short duration‐ablation for pulmonary vein isolation. J. Cardiovasc. Electrophysiol 34: 2417-2424.

Retrospective comparative study

n=114

12 months

Farawave, Farapulse PFA system

This study compared PFA with CHPSD ablation. PVI was successful in 100% of people. PFA has statistically significantly shorter procedure duration (p<0.01). There was no statistically significant difference in atrial arrhythmia at a median of 125 days (p=0.819).

Larger studies, and prospective randomised comparative evidence for this technology was included in the key evidence. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.

Yang M, Wang P, Hao Y et al (2023). A real‑world case–control study on the efficacy and safety of pulsed field ablation for atrial fibrillation. European Journal of Medical Research 28: 519

Case-control study compared with RFA

n=36

6 months

LEAD-PFA catheter (Sichuan Jinjiang Electronic Technology Co.)

There were no statistically significant differences in recurrence rate between PFA and RFA groups at 6 month follow-up. Procedure time was statistically significantly shorter in the PFA group than the RFA group (p<0.001)

This was a small study short follow-up. Larger studies with longer-follow-up were included in the main evidence. This study was also included in the systematic review and meta-analysis by de Campos (2024) in the main evidence.