admIRE

Footnotes:

*N=277. Adverse events could include pericarditis, tamponade, TIA/stroke, access complications.

**admIRE trial n=85; peak primary effectiveness defined in a post-hoc analysis which included: 12 month freedom from documented AF/AT/ AFL episodes, failure to achieve PVI/ use of a non-study catheter for PVI, and post blanking: repeat procedures, a new or higher dose AAD and DCCV.

a. Primary adverse events were defined as device- or procedure-related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation procedure. Primary adverse events also included cardiac tamponade/perforation occurring up to 30 days postprocedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%.

b. Primary effectiveness was defined as 12-month freedom from documented atrial arrhythmia recurrence (AF/AT/AFL) episodes of ≥30 seconds duration based on rhythm monitoring (ie, ECG, TTM, Holter) during the postblanking evaluation period and freedom from protocol defined failure modes: failure to achieve entrance block in all PVs; >1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and/or to ablate left atrial non-PV AF targets during the index procedure, or to perform a repeat procedure during the 3-month blanking period; taking a new or previously failed Class I/III AADs at a greater dose during the evaluation period; continuous AF/AT/AFL of unknown origin during the evaluation period; or DCCV during the evaluation period for AF/AT/AFL recurrences. The protocol-defined performance goal was 50%.

c. Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255).

d. First-pass isolation was defined as achievement of entrance block after first encirclement evaluated prior to the adenosine challenge (979/1004 of targeted veins, n=255).

e. n=213.

f. Transpired PFA time is the time transpiring between the first PFA application to the time of the last application, including idle time in between. Total time of application extracted from the generator files, including catheter handling. n=276 with energy delivery.

h. Reporting data from 6-months prior to enrollment and months 6–12 during follow-up for direct current cardioversion and cardiovascular hospitalization; reporting baseline and months 6–12 during follow-up data for Class I/III antiarrhythmic drugs.

Abbreviations:

AAD, antiarrhythmic drug; AF, atrial fibrillation; AFEQT, Atrial Fibrillation Effect on Quality-of-Life; AFL, atrial flutter; AT, atrial tachycardia; CCS-SAF, Canadian Cardiovascular Society - Severity of Atrial Fibrillation; CI, confidence interval; CTI, cavotricuspid isthmus; CV, cardiovascular; DCCV, direct current cardioversion; ECG, electrocardiogram; ICE, intracardiac echocardiography; IDE, investigational device exemption; LA , left atrium; PFA, pulsed-field ablation; PV, pulmonary vein; PVI, pulmonary vein isolation.

Reference:

1. Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. 2024;150(15):1174-1186

Additional VARIPULSE™ Platform publications:

• De Potter T, Grimaldi M, Duytschaever M, et al. 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.
• 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.
• 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.
• Valeriano C, Buytaert D, Addeo L, et al. Evaluating autonomic outcomes after pulmonary vein isolation: The differential effects of pulsed-field and radiofrequency energy. Heart Rhythm. 2024;21(8):1250-1252.
• Nair D, Gomez T, De Potter T. VARIPULSE: a step-by-step guide to pulmonary vein isolation. J Cardiovasc Electrophysiol. 2024;35(9):1817-1827
• Di Biase L, Marazzato J, Gomez T, et al. Application repetition and electrode-tissue-contact results in deeper lesions using a pulsed-field ablation circular variable loop catheter. Europace. 2024;26(9):euae220
• Hsu JC, Banker RS, Gibson DN, et al. Comprehensive dose–response study of pulsed field ablation using a circular catheter compared with radiofrequency ablation for pulmonary vein isolation: a preclinical study. Heart Rhythm O2. 2023;4(10):662-667.
• Grimaldi M, Di Monaco A, Gomez T, et al. Time course of irreversible electroporation lesion development through short- and long-term follow-up in pulsed-field ablation–treated hearts. Circ Arrhythm Electrophysiol. 2022;15(7):e010661.
• Hsu JC, Gibson D, Banker R, et al. In vivo porcine characterization of atrial lesion safety and efficacy utilizing a circular pulsed-field ablation catheter including assessment of collateral damage to adjacent tissue in supratherapeutic ablation applications. J Cardiovasc Electrophysiol. 2022;33(7):1480-1488.
• Yavin H, Brem E, Zilberman I, et al. Circular multielectrode pulsed field ablation catheter lasso pulsed field ablation: lesion characteristics, durability, and effect on neighboring structures. Circ Arrhythm Electrophysiol. 2021;14(2):e009229.

Disclosures:

The VARIPULSE™ Catheter and the TRUPULSE™ Generator have received FDA approval in the United States, and CE mark for use in the European Union.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.

The THERMOCOOL SMARTTOUCH™ SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF) and for drug refractory recurrent symptomatic persistent AF (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO™ 3 System.



Always verify catheter tip location using common clinical practice for real-time verification (inspection of IC signals, direct imaging guidance such as fluoroscopy or ultrasound, etc.) and consult the CARTO™ 3 System User Guide regarding recommendations for fluoroscopy use.

Canpolat, U. et al (2020). State of Fluoroless Procedures in Cardiac Electrophysiology Practice. J Innov Cardiac Rhythm Management. 11(3), 4018–4029.
 Sommer, P. et al (2018) Safety profile of near-zero fluoroscopy atrial fibrillation ablation with non-fluoroscopic catheter visualization: experience from 1000 consecutive procedures, EP Europace, Volume 20, Issue 12, Pages 1952–1958.

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