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, Mattias; Potter, Tom De; Grimaldi, Massimo; Anić, Ante; Vijgen, Johan; Neužil, Petr; Herendael, Hugo Van; Skanes, Allan C.; Scherr, Daniel; Pürerfellner, Helmut; Račkauskas, Gediminas; Jaı̈s, Pierre; Reddy, Vivek Y.

doi:10.1161/circep.122.011780

Cited by 68 publications

(76 citation statements)

References 21 publications

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“…In the MANIFEST-PF registry, the rate of major procedure-associated adverse events was low and consistent with other contemporary AF ablation studies using PFA and did not differ significantly between the sex groups (female: 2.5% vs male: 1.5%). Major adverse events mostly consisted of cardiac tamponade (female: 1.4% vs male: 1.0%; P = .46) and stroke (0.4% vs 0.4%, P >.99).…”

Section: Discussionsupporting

confidence: 89%

“…The primary effectiveness outcome of freedom from atrial arrhythmia recurrence (>30 seconds after blanking) was 79.0% in male patients and 76.3% in female patients at 12 months of follow-up, with greater overall effectiveness in the paroxysmal AF cohort (male: 82.5% vs female: 80.2%; P = .30) than in the persistent AF/long-standing persistent AF cohort (male: 73.3% vs female: 67.3%; P = .40). These effectiveness rates compare favorably with early clinical experience with PFA . However, none of the previous studies examining PFA for AF reported clinical outcomes according to sex.…”

Section: Discussionmentioning

confidence: 99%

“…Importantly in clinical trials, PFA has demonstrated a unique safety profile, with no reported instances of pulmonary vein stenosis or evidence of esophageal injury . Beyond the favorable safety profile, the first in-human PFA trials demonstrated an effectiveness ranging from 55% to 92% at 1 year depending on AF type, PFA technology used, and intensity of AF monitoring …”

Section: Introductionmentioning

confidence: 99%

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Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Turagam,

Neuzil,

Schmidt

et al. 2023

JAMA Cardiol

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ImportancePrevious studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile.ObjectiveTo compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry.Design, Setting, and ParticipantsThis was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF.ExposurePFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator.Main Outcomes and MeasuresThe primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (&lt;7 days postprocedure) and chronic (&gt;7 days) major adverse events (MAEs).ResultsOf 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P &lt; .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P &lt; .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P &lt; .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19).Conclusion and RelevanceResults of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Turagam,

Neuzil,

Schmidt

et al. 2023

JAMA Cardiol

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“…14,15,23 The other clinical effectiveness data published with PFA were from the recently published inspIRE study (A Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System with Irreversible Electroporation) using a different circular PFA catheter system: 186 patients with paroxysmal AF underwent PFA at 13 centers, and the 1-year Kaplan-Meier estimate of freedom from AF/AFL/AT was 70.9%. 24 Also reported recently, the 1-year clinical effectiveness in the PULSED AF study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) using yet another circular PFA catheter system was 66.2% and 55.1% for paroxysmal and persistent AF, respectively. 23 In comparing these various studies, one should be cognizant that the observed higher freedom from atrial tachyarrhythmia recurrence in MANIFEST-PF may reflect differences in monitoring intensity.…”

Section: Discussionmentioning

confidence: 76%

“…14,15,23 The AF underwent PFA at 13 centers, and the 1-year Kaplan-Meier estimate of freedom from AF/AFL/AT was 70.9%. 24 Also reported recently, the 1-year clinical effectiveness in the PULSED AF study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) using yet another circular PFA catheter system was 66.2% and 55.1% for paroxysmal and persistent AF, respectively. 23 In comparing these various studies, one should be cognizant that the observed higher freedom from atrial tachyarrhythmia recurrence in MANIFEST-PF may reflect differences in monitoring intensity.…”

Section: Clinical Effectivenessmentioning

confidence: 76%

Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry

Turagam

Neužil

Schmidt³

et al. 2023

Circulation

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BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA 2 DS 2 -VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289–421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%–80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P =0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

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Focal pulsed field ablation and ultrahigh-density mapping — versatile tools for all atrial arrhythmias? Initial procedural experiences

Ruwald

Johannessen

Hansen

et al. 2023

J Interv Card Electrophysiol

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Background Focal pulsed field ablation (FPFA) is a novel and promising method of cardiac ablation. The aim of this study was to report the feasibility, short-term safety, and procedural findings for a broad spectrum of ablated atrial arrhythmias. Methods Patients (n = 51) scheduled for ablation of atrial arrhythmias were prospectively included and underwent FPFA using the Galvanize CENTAURI generator with energy delivery through commercially available ablation catheters with ultrahigh-density (UHDx) 3D electroanatomic voltage/local activation time map evaluations. Workflow, procedural data, and peri-procedural technical errors and complications are described. Results Planned ablation strategy was achieved with FPFA-only in 48/51 (94%) of the cases. Ablation strategy was first-time pulmonary vein isolation (PVI) in 17/51 (36%), repeat ablation in 18/51 (38%), PVI + in 13/51 (28%), and cavotricuspid isthmus block (CTI)-only in 3/51 (6%). The mean procedure time was 104 ± 31 min (first-time PVI), 114 ± 26 min (repeat procedure), 152 ± 36 min (PVI +), and 62 ± 17 min (CTI). Mean UHDx mapping time to assess lesion formation and block after ablation was 7 ± 4 min with 5485 ± 4809 points. First pass acute (linear) isolation with bidirectional block for anatomical lesion sets was 120/124 (97%) for all PVs, 17/17 (100%) for (any) isthmus, and 14/17 (82%) for left atrium posterior wall (LAPW). We observed several time-consuming integration errors with the used ablation system (mean 3.4 ± 3.7 errors/procedure), one transient inferior ST elevation when ablating CTI resolved by intravenous nitroglycerine and one transient AV block requiring temporary pacing for > 24 h. Conclusions FPFA was a highly versatile method to treat atrial arrhythmias with high first-pass efficiency. UHDx revealed acute homogenous low-voltage lesions in ablated areas. More data is needed to establish lesion durability and limitations of FPFA.

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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

Cited by 68 publications

References 21 publications

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry

Focal pulsed field ablation and ultrahigh-density mapping — versatile tools for all atrial arrhythmias? Initial procedural experiences

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