Evidence map›Paper›PMID 41099984›Full record

ReviewJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2026

Microbubble and thermal profile of an eight-spline pulsed field ablation system in a pre-clinical model.

Ben Niemiera, Ravi Ranjan, Jonathan P Piccini, John Nguyen, Lakshya Mittal, Catherine Pipenhagen, Jed Overmann, Taylor Spangler, Sri Sundaram

Abstract readReview
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In one paragraph

Review in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Ben NiemieraAbbott Laboratories, 5050 Nathan Lane, Plymouth, MN, 55442, USA.
Ravi RanjanCardiac Electrophysiology, University of Utah, 50 Medical Drive North, Salt Lake City, UT, 84132, USA.
Jonathan P PicciniDuke University Medical Center, Duke Clinical Research Institute, Durham, NC, 27701, USA.
John NguyenAllina Health/Metropolitan Heart and Vascular Institute, 4040 Coon Rapids Blvd., Suite 120, Coon Rapids, MN, 55433, USA.
Lakshya MittalAbbott Laboratories, 5050 Nathan Lane, Plymouth, MN, 55442, USA.
Catherine PipenhagenAbbott Laboratories, 5050 Nathan Lane, Plymouth, MN, 55442, USA.
Jed OvermannAbbott Laboratories, 5050 Nathan Lane, Plymouth, MN, 55442, USA.
Taylor SpanglerBayside Preclinical Services Inc., 5231 Cowell Boulevard, Davis, CA, 95618, USA.
Sri SundaramSouth Denver Cardiology Associates, 1000 SouthPark Drive, Littleton, CO, 80111, USA. sris@southdenver.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulsed field ablation (PFA) has become a clinically accepted energy modality for catheter ablation of atrial fibrillation. As PFA catheters improve and evolve, iatrogenic cerebral events remain an important consideration when evaluating the safety of new devices. Several factors unique to each PFA system have the potential to lead to embolic events, including but not limited to thermal effects leading to char or coagulum formation and microbubble production.

objectivesTo characterize the thermal profile and microbubble production from an 8-spline balloon-in-basket PFA catheter.

methodsPFA applications from a 12.5 F, over-the-wire, balloon-in-basket PFA catheter were performed on non-perfused ex vivo bovine tissue. Fiber-optic thermometry probes were used to assess temperature (surface, 3 mm, and 7 mm intramurally) after 8, 16, and 70 consecutive PFA applications. Gross and histopathological assessments were completed to assess for indicators of thermal tissue damage. Microbubble production was evaluated using an extracorporeal blood loop (left femoral vein and right femoral artery loop in N = 6 swine) with an ultrasonic bubble counter and flow meter. For each application, microbubble quantity, size, and gas volume were measured.

resultsNone of the ablations resulted in a tissue temperature above 50 °C. A single ablation produced, on average, 187 microbubbles and 30.3 nL of gas. The PFA system produced bubbles with an average diameter of 43 µm. All measures were significantly below the RF derived thresholds of 1174 microbubbles, 1128 nL, and 49 µm, respectively.

conclusionThis 12.5 F, over-the-wire, balloon-in-basket PFA catheter and associated therapy did not lead to clinically significant temperature rises that may cause thermal necrosis, char, and coagulum. In addition, this PFA catheter produced fewer and smaller microbubbles with less total gas volume compared to radiofrequency (RF) devices with available data.

Indexed as

Catheter AblationMicrobubblesAnimalsCattleEquipment DesignEquipment Failure AnalysisIrreversible Electroporation TherapySwineAtrial fibrillationMicrobubble formationPulsed field ablationSafety

Identifiers

PMID41099984

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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.