Evidence map›Paper›PMID 41328568›Full record

ArticleCirculation. Arrhythmia and electrophysiology2025

Real-Time Prediction of Irreversible Lesion Size During Pulsed Field Ablation: Prospective Validation of a Novel Ablation Index Based on Contact Force and Number of Applications in a Swine Beating Heart Model.

Hiroshi Nakagawa, Salman Farshchi-Heydari, Masafumi Sugawara, Atsushi Ikeda, Jennifer Maffre, Tushar Sharma, Philip Lam, Assaf Govari, Christopher T Beeckler, Andres Altmann and 8 more

Abstract readValidation Study
In one paragraph

Article in Circulation. Arrhythmia and electrophysiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Beyond speed: why "skin-to-skin" time should not define quality in atrial fibrillation ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Review
  5. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Hiroshi NakagawaDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0000-0001-9368-519X
Salman Farshchi-HeydariJohnson & Johnson MedTech, Irwindale, CA (S.F.-H., J.M., T. Sharma, P.L., C.T.B.).ORCID 0009-0003-5158-1482
Masafumi SugawaraDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0009-0002-8142-8000
Atsushi IkedaDepartment of Cardiology, Nihon University, Japan (A.I.).ORCID 0009-0006-7043-7795
Jennifer MaffreJohnson & Johnson MedTech, Irwindale, CA (S.F.-H., J.M., T. Sharma, P.L., C.T.B.).ORCID 0000-0001-7582-8409
Tushar SharmaJohnson & Johnson MedTech, Irwindale, CA (S.F.-H., J.M., T. Sharma, P.L., C.T.B.).
Philip LamJohnson & Johnson MedTech, Irwindale, CA (S.F.-H., J.M., T. Sharma, P.L., C.T.B.).
Assaf GovariJohnson & Johnson MedTech, Yokneam, Israel (A.G., A.A.).
Christopher T BeecklerJohnson & Johnson MedTech, Irwindale, CA (S.F.-H., J.M., T. Sharma, P.L., C.T.B.).
Andres AltmannJohnson & Johnson MedTech, Yokneam, Israel (A.G., A.A.).ORCID 0000-0002-8763-9370
Warren M JackmanHeart Rhythm Institute, University of Oklahoma (W.M.J.).ORCID 0000-0002-0023-7054
Michael R FranzGeorgetown University & Veteran Affairs Medical Centers (M.R.F.).ORCID 0009-0009-9644-2535
Taylor SpanglerBayside Preclinical Services, Davis, CA (T. Spangler).ORCID 0009-0009-9394-293X
Ayman A HusseinDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0000-0002-8359-1525
Shady NakhlaDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0000-0002-4495-3845
Pasquale SantangeliDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0000-0002-0023-9666
Walid I SalibaDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0000-0003-3324-8611
Oussama M WazniDepartment of Cardiovascular Medicine, Cleveland Clinic, OH (H.N., M.S., A.A.H., S.N., P.S., W.I.S., O.M.W.).ORCID 0000-0001-7115-7716

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a previous study, on pulsed-field ablation (PFA) in the swine ventricle, we found that lesion depth was described (±1 mm accuracy) by a logarithmic function of contact force (CF) and the number of PFA pulses (PF-ablation index). This study was designed to validate prospectively whether the novel PF-ablation index would allow PFA lesions to be created at depths of 3.5, 4.5, 5.5, and 6.5 mm with high prediction accuracy in a swine-beating heart model.

methodsA 7.5F catheter with a 3.5 mm ablation electrode and CF sensor (ThermoCool SmartTouch SF-Dual Energy) was connected to a PFA system (TRUPULSE 2). In 6 closed-chest swine, a biphasic PFA pulse was delivered between the ablation electrode and a skin patch at 123 separate ventricular sites at 5 different levels of CF (1) low (average CF: 4-15 g; median, 12 g; n=25), (2) moderate (16-30 g; median, 23 g; n=41); 3) high (31-45 g; median, 36 g; n=27), (4) very high (46-68 g; median, 52 g; n=18); or (5) no electrode contact, 1 to 2 mm from the endocardium (n=12). PFA application was terminated when the PF-ablation index reached a predicted lesion depth of 3.5 mm (27 sites), 4.5 mm (25 sites), 5.5 mm (29 sites), and 6.5 mm (30 sites). Swine were euthanized 2 hours after ablation. Lesion size was measured using triphenyl tetrazolium chloride staining.

resultsPredicted lesion depth by the PF-ablation index correlated well with actual lesion depthwith ±1.0 mm accuracy in 97/106 (92%) lesions and ±1.5 mm accuracy in all 106 lesions. There were no or poor relationships between intracardiac electrogram attenuation, impedance decrease, electrode temperature, and lesion size. No detectable lesions were created without electrode contact.

conclusionsA novel PF-ablation index incorporating CF and the number of PFA pulses provides high accuracy in predicting lesion depth in real-time. Intracardiac electrogram attenuation, impedance decrease, and electrode temperature are poor predictors of PFA lesion size.

Indexed as

Catheter AblationHeart VentriclesAnimalsCardiac CathetersDisease Models, AnimalEquipment DesignModels, AnimalPredictive Value of TestsProspective StudiesReproducibility of ResultsSwineTime Factorsatrial fibrillationcatheter ablationirreversible electroporationpulsed-field ablationventricular tachycardia

Identifiers

PMID41328568
PMCPMC12711265

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.