Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation

Huo, Yan; Gaspar, Thomas; Schönbauer, Robert; Wójcik, Maciej; Fiedler, Lukas; Roithinger, Franz Xaver; Martinek, Martin; Pürerfellner, Helmut; Kirstein, Bettina; Richter, U; Ulbrich, Stefan; Mayer, Julia; Krahnefeld, Olaf; Agdirlioglu, Tolga; Zedda, Angela Maria; Piorkowski, Judith; Piorkowski, Christopher

doi:10.1056/evidoa2200141

Cited by 115 publications

(115 citation statements)

References 44 publications

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“…17 PVI alone, however, is effective at treating 50% of unselected patients with persistent AF. [1][2][3] An alternative strategy is to combine PVI with so-called substrate modulation. However, to date, only one randomised study has shown that additional ablation beyond PVI is superior to PVI alone while all others have failed to show any difference between the two ablation strategies.…”

Section: Discussionmentioning

confidence: 99%

“…However, to date, only one randomised study has shown that additional ablation beyond PVI is superior to PVI alone while all others have failed to show any difference between the two ablation strategies. [3][4][5][6] This explains why substrate modulation as an adjunct to PVI is still an ESC Class IIb recommendation only. 18 In this respect, the Marshall-PLAN set has yielded promising results.…”

Section: Discussionmentioning

confidence: 99%

“…AF: atrial fibrillation; EC: electric cardioversion; SR: sinus rhythm; PVI: pulmonary vein isolation; LAA: left atrial appendage. 1 Weight, height, body mass index, blood pressure, heart rate 2 Hypertension, diabetes, vascular disorder, cardiomyopathy 3 Left atrial volume (ml), left atrial posterior wall, mitral isthmus (endocardial line, sinus rhythm (SR, ethanolisation of Marshall's vein, left atrial voltage in normal SR) 4 False aneurysm or fistulas at the puncture sites, pericarditis reaction 5 Tamponade, stroke 6 Atrio-esophageal fistula…”

Section: Acknowledgmentsmentioning

confidence: 99%

“…1,2 Considerable efforts have therefore been invested in adjunctive ablation strategies beyond PVI, among which only a recent randomized study proved to be successful while the others have all failed to demonstrate any significant benefit. [3][4][5][6] A recent lesion set entitled the Marshall-PLAN (Marshall bundle elimination, PVI and Line completion for ANatomical ablation of persistent AF: Marshall-PLAN) has yielded encouraging results. This combination of ablation steps could effectively treat ≈78% of unselected patients with persistent AF.…”

Section: Introductionmentioning

confidence: 99%

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Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design

Bortone

Marijon

Limite

et al. 2022

Cardiovasc electrophysiol

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Introduction Pulmonary vein isolation (PVI) is effective at treating 50% of unselected patients with persistent atrial fibrillation (AF). Alternatively, PVI combined with a new ablation strategy entitled the Marshall‐PLAN ensures a 78% 1‐year sinus rhythm (SR) maintenance rate in the same population. However, a substantial subset of patients could undergo the Marshall‐PLAN unnecessarily. It is therefore essential to identify those patients who can be treated with PVI alone versus those who may truly benefit from the Marshall‐PLAN before ablation is performed. In this context, we hypothesized that electrical cardioversion (EC) could help to select the most appropriate strategy for each patient. Methods In this multicentre, prospective, randomized study, patients with AF recurrence within 4 weeks after EC will be randomized 1:1 to PVI alone or the Marshall‐PLAN. Conversely, patients in whom SR is maintained for ≥4 weeks after EC will be treated with PVI only and included in a prospective registry. The primary endpoint will be the 1‐year SR maintenance rate after a single ablation procedure. Results and Conclusion The Marshall‐PLAN might be necessary in patients with an advanced degree of persistent AF (i.e., where SR is not maintained for ≥4 uninterrupted weeks after EC). Conversely, in patients with mild or moderate persistent AF (i.e., where SR is maintained for ≥4 weeks after EC), PVI alone might be a sufficient ablation strategy. The PACIFIC trial is the first study designed to assess whether rhythm monitoring after EC could help to identify patients who should undergo adjunctive ablation strategies beyond PVI.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Acknowledgmentsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design

Bortone

Marijon

Limite

et al. 2022

Cardiovasc electrophysiol

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“…Nevertheless, these cutoffs are commonly used in clinical practice and have been applied to guide ablation. With a recent randomized-controlled trial showing clinical benefit of a substrate-based ablation strategy compared to PVI only, a standardized characterization and categorization independent of the type of catheter is urgently needed 5.…”

mentioning

confidence: 99%

Left atrial substrate characterization based on bipolar voltage electrograms acquired with multipolar, focal and mini-electrode catheters– the CHAZE-Substrate study

Knecht

Schlageter

Badertscher

et al. 2023

Preprint

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Background Bipolar voltage (BV) electrograms for left atrial (LA) substrate characterization depend on catheter design and electrode configuration. The aim of the study was to investigate the relationship between the BV amplitude (BVA) using four different catheters and to identify their specific LA cutoffs for scar and healthy tissue. Methods Consecutive high-resolution electroanatomic mapping was performed using a multipolar Orion catheter (Orion-map), a duo-decapolar variable circular mapping catheter (Lasso-Map) and an irrigated focal ablation catheter with minielectrodes (Mifi-map). Virtual remapping using the Mifi-map was performed with a 4.5 mm tip-size electrode configuration (Nav-map). BVAs were compared in voxels of 3x3x3 mm3. The equivalent BVA cutoff for every catheter was calculated for established reference cutoff values of 0.1 mV, 0.2 mV, 0.5 mV, 1.0 mV, and 1.5 mV. Results We analyzed 25 patients (72% men, age 68{plus minus}15 years). For scar tissue, a 0.5 mV cutoff using the Nav corresponds to a lower cutoff of 0.35 mV for the Orion and of 0.48 mV for the Lasso. Accordingly, a 0.2 mV cutoff corresponds to a cutoff of 0.09 mV for the Orion and of 0.14 mV for the Lasso. For a healthy tissue cutoff at 1.5 mV, a larger BVA cutoff for the small electrodes of the Orion and the Lasso was determined of 1.68 mV and 2.21 mV, respectively. Conclusions When measuring LA BVA in scar and healthy tissue, relevant differences were seen between focal, multielectrode and mini-electrode catheters. Adapted cutoffs for scar and healthy tissue are required

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Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation

Kistler

Chieng

Sugumar

et al. 2023

JAMA

147

116

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ImportancePulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with paroxysmal AF. The left atrial posterior wall may contribute to maintenance of persistent AF, and posterior wall isolation (PWI) is a common PVI adjunct. However, PWI has not been subjected to randomized comparison.ObjectiveTo compare PVI with PWI vs PVI alone in patients with persistent AF undergoing first-time catheter ablation.Design, Setting, and ParticipantsInvestigator initiated, multicenter, randomized clinical trial involving 11 centers in 3 countries (Australia, Canada, UK). Symptomatic patients with persistent AF were randomized 1:1 to either PVI with PWI or PVI alone. Patients were enrolled July 2018-March 2021, with 1-year follow-up completed March 2022.InterventionsThe PVI with PWI group (n = 170) underwent wide antral pulmonary vein isolation followed by posterior wall isolation involving linear ablation at the roof and floor to achieve electrical isolation. The PVI-alone group (n = 168) underwent wide antral pulmonary vein isolation alone.Main Outcomes and MeasuresPrimary end point was freedom from any documented atrial arrhythmia of more than 30 seconds without antiarrhythmic medication at 12 months, after a single ablation procedure. The 23 secondary outcomes included freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures, freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures, AF burden between study groups at 12 months, procedural outcomes, and complications.ResultsAmong 338 patients randomized (median age, 65.6 [IQR, 13.1] years; 76.9% men), 330 (97.6%) completed the study. After 12 months, 89 patients (52.4%) assigned to PVI with PWI were free from recurrent atrial arrhythmia without antiarrhythmic medication after a single procedure, compared with 90 (53.6%) assigned to PVI alone (between-group difference, –1.2%; hazard ratio [HR], 0.99 [95% CI, 0.73-1.36]; P = .98). Of the secondary end points, 9 showed no significant difference, including freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures (58.2% for PVI with PWI vs 60.1% for PVI alone; HR, 1.10 [95% CI, 0.79-1.55]; P = .57), freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures (68.2% vs 72%; HR, 1.20 [95% CI, 0.80-1.78]; P = .36) or AF burden (0% [IQR, 0%-2.3%] vs 0% [IQR, 0%-2.8%], P = .47). Mean procedural times (142 [SD, 69] vs 121 [SD, 57] minutes, P &lt; .001) and ablation times (34 [SD, 21] vs 28 [SD, 12] minutes, P &lt; .001) were significantly shorter for PVI alone. There were 6 complications for PVI with PWI and 4 for PVI alone.Conclusions and RelevanceIn patients undergoing first-time catheter ablation for persistent AF, the addition of PWI to PVI alone did not significantly improve freedom from atrial arrhythmia at 12 months compared with PVI alone. These findings do not support the empirical inclusion of PWI for ablation of persistent AF.Trial Registrationanzctr.org.au Identifier: ACTRN12616001436460

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Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation

Cited by 115 publications

References 44 publications

Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design

Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design

Left atrial substrate characterization based on bipolar voltage electrograms acquired with multipolar, focal and mini-electrode catheters– the CHAZE-Substrate study

Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation

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