Abstract 14123: AF Ablation Using a Novel “Single-Shot” Map-and-Ablate Spherical Array Pulsed Field Ablation Catheter: Impact of Application Repetition on PV Isolation Durability in the <i>PULSE-EU Study</i>
Bibliographic record
Abstract
Introduction: Preclinical studies have revealed that pulse field ablation (PFA) lesion dimension increases with consecutive applications at a similar electric field. Whether durability of pulmonary vein isolation (PVI) is predicated on repetitive PFA applications is unknown. In the first-in-human PULSE-EU clinical trial (NCT05164107), the ability of this map-and-ablate PFA catheter to achieve durable PVI was assessed, both with single vs repetitive PFA applications. Methods: Under general anesthesia, paroxysmal AF pts underwent PVI using the spherical array PFA catheter (Globe; Kardium Inc, Canada) delivered with a deflectable 19Fr transeptal sheath and ICE-guidance. Using a custom mapping system, the PFA catheter rendered contact and voltage anatomic maps ( Figure ). The spherical array is positioned at the PV ostium and PFA is performed (1.6-2 kV/lesion, ungated 3s pulses). Follow-up was post-procedure EGD and brain MRI within 1 day, and invasive remapping at ⁓2 months. Results: A total of 21 pts (age 63±11 years; M/F 33%/67%) underwent PVI in 2 groups: Gp1-single PF application/PV, and Gp2-3 PF applications/PV. In Gp1 (n=11 pts) and Gp2 (n=10 pts), PVI was acutely successful in 100% of PVs in both groups. Pulse delivery times and total procedure times were 75.2±7.4 sec/pt vs 24.5±5.5 sec/pt and 73.2±13.7 mins vs 93.7±18.5 mins in Gp2 vs Gp1. There was no stroke/TIA, pericardial effusion, phrenic nerve injury, or esophageal complications. EGD was normal in all 9/9 pts. Brain MRI showed silent cerebral lesions (DWI+/FLAIR-) in 3/16 (18.8%) pts. PV remapping revealed durable PVI in 25/40 (62.5%) PVs in 10 pts in Gp1, compared with all 34/34 (100%) PVs in 9 pts in Gp2; this translates to all PVs being durably isolated in 27% vs 100% (p<0.05) of pts in Gp1 and Gp2. Conclusion: The “single-shot” map-and-ablate spherical array PFA catheter can safely isolate PVs. Repetitive PFA applications is key for lesion consolidation to improve PVI durability.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".