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American Heart Association

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Final ID: MP2415

Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure Using WATCHMAN FLX Pro: A Preclinical Evaluation of Procedural Compatibility and Tissue Response

Abstract Body (Do not enter title and authors here): Background: Pulsed field ablation is a novel non-thermal energy source for pulmonary vein isolation that offers potential procedural and safety advantages over thermal modalities. However, its acute anatomical effects and compatibility with same-session left atrial appendage closure remain insufficiently characterized.

Objective: To evaluate the feasibility, safety, and anatomical response of combining PFA-based PVI with LAAC using the WATCHMAN FLX Pro device in a healthy canine model.

Methods: Nine canines underwent PVI with either PFA (n=6) or radiofrequency ablation (RFA; n=3), followed by LAAC with the WATCHMAN FLX Pro in a single session. Procedural success, tissue remodeling, device compression, and peri-device leaks were assessed using serial transesophageal echocardiography and computed tomography over a 45-day period, with terminal pathological analysis.

Results: All procedures were completed without complications, and LAAC met PASS criteria in all animals. TEE confirmed complete seal at implant and at 45 days in both groups. PFA was associated with greater post-ablation reduction in LAA diameters and significantly higher device compression (23±8% vs. 13±4% by TEE) despite smaller average device sizes. CT demonstrated greater early compression loss in the PFA group, with gradual recovery by Day 45. Two minor peri-device leaks (<5 mm) were identified on CT in the PFA group only. Ridge edema and anatomical remodeling were pronounced acutely in the PFA group but resolved by 45 days. No thrombus, embolic events, or device dislodgement occurred at any point during the study.

Conclusion: In this preclinical study, the combination of PFA and LAAC using the WATCHMAN FLX Pro device was feasible and acutely safe. PFA was associated with greater acute anatomical remodeling compared to RFA, including more pronounced tissue edema and device compression. These changes resolved over time without compromising device seal or position. Small peri-device leaks (<5 mm) were observed on follow-up CT but not TEE imaging in the pulsed field ablation group only. Further studies are warranted to assess the long-term implications of PFA–associated remodeling and its potential impact on device performance.
  • Noujaim, Charbel  ( Cleveland Clinic Foundation , Cleveland , Ohio , United States )
  • Jaber, Wael  ( CLEVELAND CLINIC FOUNDATION , Cleveland , Ohio , United States )
  • Natale, Andrea  ( TEXAS CARDIAC ARRHYTHMIA INST , Austin , Texas , United States )
  • De Lurgio, David  ( EmoryHealthcare , Atlanta , Georgia , United States )
  • Mikaelian, Brad  ( Memorial Hospital , Colorado Springs , Colorado , United States )
  • Caldwell, Austin  ( Boston Scientific , Saint Paul , Minnesota , United States )
  • Baldo, Caroline  ( Boston Scientific , Saint Paul , Minnesota , United States )
  • Hynes, Erin  ( Boston Scientific , Saint Paul , Minnesota , United States )
  • Saliba, Walid  ( CLEVELAND CLINIC , Cleveland , Ohio , United States )
  • Author Disclosures:
    Charbel Noujaim: DO NOT have relevant financial relationships | Wael Jaber: DO have relevant financial relationships ; Consultant:Boston Scientific:Active (exists now) ; Consultant:Pfizer:Active (exists now) | Andrea Natale: DO have relevant financial relationships ; Consultant:Abbott:Active (exists now) ; Consultant:Pulse Bioscience:Active (exists now) ; Consultant:Medtronic:Active (exists now) ; Consultant:iRhythm:Active (exists now) ; Consultant:Field Medical:Active (exists now) ; Consultant:Boston Scientific:Active (exists now) ; Consultant:Biosense Webster:Active (exists now) ; Consultant:Biotronik:Active (exists now) | David De Lurgio: No Answer | Brad Mikaelian: DO have relevant financial relationships ; Advisor:Boston Scientific:Active (exists now) ; Consultant:Johnson & Johnson:Active (exists now) | Austin Caldwell: No Answer | Caroline Baldo: No Answer | Erin Hynes: No Answer | Walid Saliba: DO have relevant financial relationships ; Advisor:Boston Scientific:Active (exists now)
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Sealing the Source: Innovations and Outcomes in LAA Closure

Monday, 11/10/2025 , 01:45PM - 02:45PM

Moderated Digital Poster Session

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