________________________________________

¹

???????????????????????????????????????????????

²

?????????????????????????????????????????????????? 29 ??????????????????? inspIRE ?????????? 60 ??????????????????? inspIRE ????? ???????????????????????????????????????????????????????????????????????????????????????????????????????????? ?????????????????????????????????????????????????????

³

???????????????????????????????????????????????????????????????????????????? (???????????????????????????????????????????? [AF]/?????????????????????????????????????????????? [AT]/????????????????????????????????????? [AF]) ?????????????? (?????????????????????) ???????? 12 ????? ?????????????? ≥30 ?????? ??????????????????????????????????????????????????????????????????????? (?????? 91-365) ???????????????????????????????? ? ???? ??????????????????????? PV ???????, ??????????? >1 ???????????????????????????????????????????????????????????????? 3 ????? ???????????????? ? ???????????????? ????????????????????????????????????? PVs ???/?????????????????????? AF ????????? PV ???????????????????????????????????????????????????????????????????????? 3 ????? ?????? AAD ???? I/III ???????????????????????????????????????????? ? ?????????????????????? AF/AT/AFL ?????????????????????????????????????????????????????? ????????????????????????????????????????????????????????? AF/AT/AFL ?????????? ????????????????????????????????????????? 50%

⁴

?????????????????????????? ?????? ?????????????????????????????????????????????? ?????????????????????????????????????????????????????????? ?????????????????? ???????????????????? ??????????? ??????????????????????????? ???????????????? ??????????????? ???????????????????? ???????????????? ???????????????????????????????/?????????????????????????????? 7 ?????????????????????????? ????????? ???????????????????????????????????/?????????????????????????? 30 ???????????????? ????????????????????????????????????????????????????? 90 ???????????????? ?????????????????????????????????????????????????????????????????? 12 ????? ????????????????????????????????????????? 12%

⁵

??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? (n=255)

⁶

??????????????? ICE ??????? CARTO? 3

⁷

??. Okumura ???????????????????????????? Johnson & Johnson ??????????????????????????????????????

________________________________________

ⁱ

Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023;16(3):e011780. doi:10.1161/CIRCEP.122.011780 pg 4

ⁱⁱ

Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8

ⁱⁱⁱ

Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303–2310 (2024). //doi.org/10.1038/s41591-024-03022-6 pg 2

^iv

Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016/j.hroo.2023.03.001. PMID: 37323994; PMCID: PMC10264259. Pg 6

^v

VOLT CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3

^vi

Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093/europace/euaf012. Pg 4 results section

^vii

Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1

^viii

Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197

^ix

Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111/pace.15177. Epub ahead of print. PMID: 40153431.

^x

Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland

^xi

Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517

^xii

Di Biase L, Zou F, Lin AN, et al. Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211.

^xiii

Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783

^xiv

Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8.

^xv

Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8.

^xvi

Grimaldi M, Quadrini F, Caporusso N, et al. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023;25(9):euad222. doi:10.1093/europace/euad222. PMID: 37470452; PMCID: PMC10434733.

^xvii

De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Pürerfellner H, Rackauskas G, Jais P, Reddy VY, et al; inspIRE Trial Investigators. Predictors of success for pulmonary vein isolation with pulsed-field ablation using a variable-loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024;17(5):e012667. doi:10.1161/CIRCEP.123.012667. Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320.

^xviii

Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston.

^xix

Reddy V, Calkins H, Mansour M, et al. . Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333.

^xx

Bessière F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA.

^xxi

Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from //ghdx.healthdata.org/gbd-results-tool.

^xxii

American Heart Association . (2024, August 12). What are the symptoms of atrial fibrillation?. www.heart.org. //www.heart.org/en/health-topics/atrial-fibrillation/what-are-the-symptoms-of-atrial-fibrillation-afib-or-af

^xxiii

Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161/CIR.0000000000001193