Composite Index Tagging for PVI in Paroxysmal AF

Biase, Luigi Di; Monir, George; Melby, Daniel P.; Tabereaux, Paul B.; Manyam, Harish; Athill, Charles A.; Delaughter, Craig; Patel, Ankit; Gentlesk, Philip J.; Liu, Christopher; Arkles, Jeffrey; McElderry, H. Thomas; Osorio, José

doi:10.1016/j.jacep.2022.06.007

Cited by 16 publications

(31 citation statements)

References 30 publications

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“…For example, the 12-month success rates from 2 large tag-index ablation studies were 78% and 82% with freedom from repeat ablation between 90% and 94%. 19,20 As a new ablation energy modality, there have been few reports to date of 12-month effectiveness of PFA in patients with paroxysmal AF; these have ranged between 79% and 87%. [8][9][10] It is important to note, however, that these studies incorporated a mandatory remap and reablation strategy at 3 to 4 months regardless of recurrence, which may have overestimated the true long-term single-procedure success rate.…”

Section: Twelve-month Effectivenessmentioning

confidence: 99%

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

Duytschaever

Potter

Grimaldi

et al. 2023

Circ: Arrhythmia and Electrophysiology

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Background - The inspIRE study evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation (AF). Methods - Subjects underwent pulmonary vein isolation (PVI) with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions (SCLs), and PV stenosis. Wave II (pivotal phase) tested i) primary safety - incidence of early onset primary adverse events (PAEs), and primary effectiveness - confirmed PVI with freedom from documented atrial arrhythmia at 12-months (12M). The study design specified an interim analysis to determine early success once 30 subjects reached 12M follow-up (FU) and all subjects reached 3M FU. Results - Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations and received PFA (Wave I: 40; Wave II: 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral MRI, SCLs were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10s pause between PFA applications was implemented; subsequently, only 4 of 33 subjects had SCLs. In the Wave II phase, no PAE was reported. Upon declaring early success, 83 subjects reached 12M FU. With 100% entrance block, PVI without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness endpoint per Kaplan Meier at the time of interim analysis was 70.9%; 12M freedom from symptomatic AF/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1 ± 27.7 min and 26.7 ± 14.0 min, respectively. Conclusions - The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.

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Section: Twelve-month Effectivenessmentioning

confidence: 99%

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

Duytschaever

Potter

Grimaldi

et al. 2023

Circ: Arrhythmia and Electrophysiology

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“…Baseline patient characteristics were similar to that of the STSF patient cohort with mean age of 62.7 years, 55.1% female, and mean CHA 2 DS 2 -VASc score of 1.9. 3 Symptomatic atrial fibrillation duration was slightly lower for the ST cohort at 31 months versus 37 months in the STSF group. 3 Mean procedure time was 202.1 minutes with a mean fluoroscopy time of 8.06 minutes.…”

mentioning

confidence: 86%

“…3 Symptomatic atrial fibrillation duration was slightly lower for the ST cohort at 31 months versus 37 months in the STSF group. 3 Mean procedure time was 202.1 minutes with a mean fluoroscopy time of 8.06 minutes. The fluid delivered via catheter for the ST and STSF patient cohorts were 1256.8±641.0 mL and 670.7±260.1 mL, respectively.…”

mentioning

confidence: 86%

“…1 The advent of the VISITAG SURPOINT Module has improved safety and effectiveness as demonstrated in 2 prospective multicenter studies from the Europe, Middle East, Africa, and US regions. 2,3 The Europe, Middle East, and Africa trial included patients treated with both THERMOCOOL SMARTTOUCH SF (STSF), a porous tip contact force catheter, and THERMOCOOL SMART-TOUCH (ST). Meanwhile, the US trial included patients treated with STSF.…”

mentioning

confidence: 99%

“…Additional details on the eligibility criteria, ablation procedure, and end points have been previously reported. 3 Fifty patients were enrolled in the ST patient cohort between April 2019 and June 2020. One patient withdrew from the study; therefore, 49 patients were included in the safety and the effectiveness populations.…”

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confidence: 99%

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