Evidence map›Paper›PMID 33650743›Full record

ArticleJournal of cardiovascular electrophysiology2021

Safety and chronic lesion characterization of pulsed field ablation in a Porcine model.

Mark T Stewart, David E Haines, Damijan Miklavčič, Bor Kos, Nicole Kirchhof, Noah Barka, Lars Mattison, Matt Martien, Birce Onal, Brian Howard and 1 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of cardiovascular electrophysiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 2 pooled it
13.2field-weighted citation impact, top 1% of its field
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

64 citing papers in PubMed, 2 syntheses or guidelines pooled it, 112 citations in OpenAlex.

  1. Pulsed field ablation for the interventional treatment of atrial fibrillation: a scientific statement of the European Heart Rhythm Association of the European Society of Cardiology, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society, and the Canadian Heart Rhythm Society.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 · 2026
    Guideline
  2. Pooled it
  3. Pulmonary vein isolation durability in a randomized trial comparing fluoroscopy-only vs. electroanatomic mapping strategies for pulmonary vein isolation with balloon-in-basket pulsed-field ablation.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 · 2026
    Trial
  4. Trial
  5. Article
  6. Optimizing electrode spacing of a pentaspline pulsed field ablation catheter for high-precision 3D mapping.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  7. Article
  8. Single-shot ablation for AF: Real-world procedural and one-year outcomes with the newly adopted PulseSelect PFA compared with cryoballoon from the 1STOP project.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  9. Review
  10. Article
  11. Article
  12. Latest Advances and Ongoing Challenges in Pulsed Field Ablation.Arrhythmia & electrophysiology review · 2026
    Review
  13. Article
  14. Observational
  15. Article
  16. Controversy: pulsed field ablation is the standard technique for all the candidates for atrial fibrillation ablation.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
    Review
  17. Acute outcomes and learning curve from the initial patients treated with the PulseSelect system: a real-world multicenter experience of pulsed field ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025
    Article
  18. Pulsed Field Ablation for Atrial Fibrillation in Fontan Palliation.Journal of cardiovascular electrophysiology · 2025
    Article
  19. Article
  20. Article

4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 3 countries.

Mark T StewartCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.ORCID 0000-0003-1717-195X
David E HainesBeaumont Health System, Div of Cardiology, EP Services, Oakland University William Beaumont School of Medicine, Royal Oaks, Michigan, USA.
Damijan MiklavčičFaculty of Electrical Engineering, University of Ljubljana, Ljubljana, Slovenia.
Bor KosFaculty of Electrical Engineering, University of Ljubljana, Ljubljana, Slovenia.
Nicole KirchhofCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.
Noah BarkaCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.
Lars MattisonCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.
Matt MartienCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.
Birce OnalCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.ORCID 0000-0001-8961-8939
Brian HowardCardiac Rhythm Management, Medtronic, Inc., Minneapolis, Minnesota, USA.
Atul VermaSouthlake Regional Health Centre, Arrhythmia Services, University of Toronto, Newmarket, Ontario, Canada.ORCID 0000-0002-1020-9727
Medtronic (United States) · USUniversity of Ljubljana · SIOakland University · USSouthlake Regional Health Center · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulsed field ablation (PFA) has been identified as an alternative to thermal-based ablation systems for treatment of atrial fibrillation patients. The objective of this Good Laboratory Practice (GLP) study was to characterize the chronic effects and safety of overlapping lesions created by a PFA system at intracardiac locations in a porcine model.

methodsA circular catheter with nine gold electrodes was used for overlapping low- or high-dose PFA deliveries in the superior vena cava (SVC), right atrial appendage (RAA), and right superior pulmonary vein (RSPV) in six pigs. Electrical isolation was evaluated acutely and chronic lesions were assessed via necropsy and histopathology after 4-week survival. Acute and chronic safety data were recorded peri- and post-procedurally.

resultsNo animal experienced ventricular arrhythmia during PFA delivery, and there was no evidence of periprocedural PFA-related adverse events. Lesions created in all anatomies resulted in electrical isolation postprocedure. Lesions were circumferential, contiguous, and transmural, with all converting into consistent lines of chronic replacement fibrosis, regardless of trabeculated or smooth endocardial surface structure. Ablations were non-thermally generated with only minimal post-delivery temperature rises recorded at the electrodes. There was no evidence of extracardiac damage, stenosis, aneurysms, endocardial disruption, or thrombus.

conclusionPFA deliveries to the SVC, RAA, and RSPV resulted in complete circumferential replacement fibrosis at 4-week postablation with an excellent chronic myocardial and collateral tissue safety profile. This GLP study evaluated the safety and efficacy of a dosage range in preparation for a clinical trial and characterized the non-thermal nature of PFA.

Indexed as

Atrial FibrillationCatheter AblationPulmonary VeinsAnimalsEndocardiumHumansSwineVena Cava, Superioratrial fibrillationcatheter ablationelectroporationpulsed electric field modelingpulsed field ablation

Identifiers

PMID33650743
PMCPMC8048690
OpenAlexW3134407919

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.