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PO-01-303 REAL-WORLD OUTCOMES OF CONCOMITANT PULSED FIELD ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE: ACUTE SAFETY, FEASIBILITY, AND 3-MONTH IMPLANTATION RESULTS FROM ALIGN-AF
Abstract   Open access   Peer reviewed

PO-01-303 REAL-WORLD OUTCOMES OF CONCOMITANT PULSED FIELD ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE: ACUTE SAFETY, FEASIBILITY, AND 3-MONTH IMPLANTATION RESULTS FROM ALIGN-AF

Amin Al-Ahmad, Byron J. Colley, Jose Osorio, Nischala Nannapaneni, John D. Day, Jasen Gilge, Anil Rajendra, John Allison, Khaled A. Awad, Nicholas O. Palmeri, …
Heart rhythm, Vol.23(4 Supplement), pp.S324-S325
04/2026
DOI: 10.1016/j.hrthm.2026.03.1841
url
https://doi.org/10.1016/j.hrthm.2026.03.1841View
Published (Version of record) Open Access

Abstract

Introduction Pulsed field ablation (PFA) is a safe and effective treatment for atrial fibrillation (AF) and left atrial appendage closure (LAAC) reduces AF-related stroke risk. While the OPTION study established the feasibility of concomitant AF ablation and LAAC, it relied on earlier-generation technologies, leaving a critical gap in real-world evidence for contemporary PFA and LAAC devices. This study evaluates procedural and 3-month safety and efficacy outcomes of concomitant PFA and LAAC in real-world practice. Methods ALIGN-AF (NCT07041125) is a prospective multicenter DISRUPT-AF sub-study evaluating concomitant procedures using the pentaspline PFA system and PVDF-HFP coated LAAC devices. Procedures followed site standard of care with collection of procedural and acute outcomes. Follow-up at 3, 6, and 12 months assesses stroke, arrhythmia recurrence, LAAC seal, and device-related thrombus (DRT). Comparisons with standalone PFA procedures from DISRUPT-AF will also be available by presentation. Results A total of 123 patients (74.2±6.8 years; 52.5% female; 71.3% paroxysmal AF) underwent concomitant procedures by 24 operators at 12 U.S. centers. Procedures lasted 77.7±28.7 mins, with 59.7±34.0 mins of LA dwell time. Imaging guidance was ICE-only in 41.4%, TEE-only in 24.1%, and ICE+TEE in 33.6% of cases. Operators delivered 56±14 PFA applications, including 38±10 applications in the pulmonary veins (PVs), achieving 100% acute PV isolation. LAA orifice edema occurred in 5 patients (4.3%); however, overall LAA diameter did not change significantly post-ablation (Δ +0.35±1.41 mm; p=0.72). All cases achieved complete LAAC seal during the procedure. Three-month imaging showed complete closure in 91.3%, with no significant leak (>3 mm), DRT, or instability. Among the 25 patients with complete monitoring at submission, 1 pericardial effusion occurred that did not require intervention; no coronary spasm, stroke, TIA, or phrenic nerve injury was reported. Data monitoring is ongoing. Application ALIGN-AF will provide the first monitored, prospective registry-based evaluation of contemporary concomitant PFA and LAAC. Early findings show the approach is safe, feasible, and preserves acute success, with stable, significant leak-free implants at 3 months. Ongoing follow-up will clarify the clinical value of this integrated strategy for patients and operators. Next Steps/Future Complete acute and 3-month data will be available by presentation. One-year follow-up will further assess stroke outcomes and freedom from AF.

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