Contact-force local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from an international multicenter clinical setting.

Atrial fibrillation Catheter ablation Contact force Lesion formation Local impedance PVI

Journal

Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
ISSN: 1572-8595
Titre abrégé: J Interv Card Electrophysiol
Pays: Netherlands
ID NLM: 9708966

Informations de publication

Date de publication:
08 Jul 2024
Historique:
received: 30 01 2024
accepted: 12 06 2024
medline: 8 7 2024
pubmed: 8 7 2024
entrez: 7 7 2024
Statut: aheadofprint

Résumé

The combination of highly localized impedance (LI) and contact force (CF) may improve tissue characterization and lesion prediction during radiofrequency (RF) pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). We report the outcomes of our acute and long-term clinical evaluation of CF-LI-guided PVI in consecutive AF ablation cases from an international multicenter clinical setting. Three hundred twenty-four consecutive patients from 20 European centers undergoing RF catheter ablation with the Stablepoint™ catheter were enrolled in the CHARISMA registry. Of these, 275 had a minimum follow-up of 1 year and were included in the primary analysis. The mean procedure duration was 115 ± 47 min, and the mean fluoroscopy time was 9.9 ± 6 min. At the end of the procedures, all PVs had been successfully isolated in all study patients. Minor complications were reported in 12 patients (4.4%). At 1 year, 36 (13.1%) patients had had an AF recurrence, and freedom from antiarrhythmic drugs and AF recurrence was achieved in 228 (82.9%) patients. The recurrence rate was higher in patients with persistent AF (21/116, 18.1%) than in those with paroxysmal AF (15/159, 9.4%; p = 0.0459). On multivariate logistic analysis adjusted for baseline confounders, only time > 6 months from first diagnosis of AF to ablation (HR = 2.93, 95%CI 1.03 to 8.36, p = 0.0459) was independently associated with recurrences. An ablation strategy for PVI guided by CF-LI technology proved safe and effective and resulted in a low recurrence rate of AF over 1-year follow-up, irrespective of the underlying AF type. Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice. (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Sections du résumé

BACKGROUND BACKGROUND
The combination of highly localized impedance (LI) and contact force (CF) may improve tissue characterization and lesion prediction during radiofrequency (RF) pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).
OBJECTIVE OBJECTIVE
We report the outcomes of our acute and long-term clinical evaluation of CF-LI-guided PVI in consecutive AF ablation cases from an international multicenter clinical setting.
METHODS METHODS
Three hundred twenty-four consecutive patients from 20 European centers undergoing RF catheter ablation with the Stablepoint™ catheter were enrolled in the CHARISMA registry. Of these, 275 had a minimum follow-up of 1 year and were included in the primary analysis.
RESULTS RESULTS
The mean procedure duration was 115 ± 47 min, and the mean fluoroscopy time was 9.9 ± 6 min. At the end of the procedures, all PVs had been successfully isolated in all study patients. Minor complications were reported in 12 patients (4.4%). At 1 year, 36 (13.1%) patients had had an AF recurrence, and freedom from antiarrhythmic drugs and AF recurrence was achieved in 228 (82.9%) patients. The recurrence rate was higher in patients with persistent AF (21/116, 18.1%) than in those with paroxysmal AF (15/159, 9.4%; p = 0.0459). On multivariate logistic analysis adjusted for baseline confounders, only time > 6 months from first diagnosis of AF to ablation (HR = 2.93, 95%CI 1.03 to 8.36, p = 0.0459) was independently associated with recurrences.
CONCLUSION CONCLUSIONS
An ablation strategy for PVI guided by CF-LI technology proved safe and effective and resulted in a low recurrence rate of AF over 1-year follow-up, irrespective of the underlying AF type.
CLINICAL TRIAL REGISTRATION BACKGROUND
Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice. (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Identifiants

pubmed: 38972960
doi: 10.1007/s10840-024-01849-0
pii: 10.1007/s10840-024-01849-0
doi:

Banques de données

ClinicalTrials.gov
['NCT03793998']

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Références

Hindricks G, Potpara T, Dagres N, et al. ESC Scientific Document Group. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the task force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42:373–498
Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: executive summary. Europace. 2018;20:157–208.
doi: 10.1093/europace/eux275 pubmed: 29016841
Sulkin MS, Laughner JI, Hilbert S, et al. Novel measure of local impedance predicts catheter-tissue contact and lesion formation. Circ Arrhythm Electrophysiol. 2018;11:1–11.
doi: 10.1161/CIRCEP.117.005831
Segreti L, De Simone A, Schillaci V, et al. A novel local impedance algorithm to guide efective pulmonary vein isolation in atrial fibrillation patients: preliminary experience across diferent ablation sites from the CHARISMA pilot study. J Cardiovasc Electrophysiol. 2020;31:2319–27.
doi: 10.1111/jce.14647 pubmed: 32613661
Das M, Luik A, Shepherd E, Sulkin M, et al. Local catheter impedance drop during pulmonary vein isolation predicts acute conduction block in patients with paroxysmal atrial fibrillation: initial results of the LOCALIZE clinical trial. Europace. 2021;23:1042–51.
doi: 10.1093/europace/euab004 pubmed: 33550380 pmcid: 8286855
Solimene F, Giannotti Santoro M, De Simone A, et al. Pulmonary vein isolation in atrial fibrillation patients guided by a novel local impedance algorithm: 1-year outcome from the CHARISMA study. J Cardiovasc Electrophysiol. 2021;32:1540–8.
doi: 10.1111/jce.15041 pubmed: 33851484
Garrott K, Laughner J, Gutbrod S, et al. Combined local impedance and contact force for radiofrequency ablation assessment. Heart Rhythm. 2020;17:1371–80.
doi: 10.1016/j.hrthm.2020.03.016 pubmed: 32240822
Solimene F, De Sanctis V, Maggio R, et al. When local impedance meets contact force: preliminary experience from the CHARISMA registry. J Interv Card Electrophysiol. 2022;63:749–58.
doi: 10.1007/s10840-022-01163-7 pubmed: 35322330 pmcid: 9151535
Lepillier A, Maggio R, De Sanctis V, et al. Insight into contact force local impedance technology for predicting effective pulmonary vein isolation. Front Cardiovasc Med. 2023;10:1169037.
doi: 10.3389/fcvm.2023.1169037 pubmed: 37476572 pmcid: 10354239
Duytschaever M, Vijgen J, De Potter T, et al. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial. EP Europace. 2020;22(11):1645–52.
doi: 10.1093/europace/euaa157
Stabile G, Lepillier A, De Ruvo E, et al. Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry. J Cardiovasc Electrophysiol. 2020;31:1694–701.
doi: 10.1111/jce.14531 pubmed: 32369225
Solimene F, Strisciuglio T, Schillaci V, et al. One-year outcomes in patients undergoing very high-power short-duration ablation for atrial fibrillation. J Interv Card Electrophysiol. 2023;66(8):1911–7.
doi: 10.1007/s10840-023-01520-0 pubmed: 36897460 pmcid: 10570155
Osorio J, Hussein AA, Delaughter MC, et al. Q-FFICIENCY trial investigators. Very high-power short-duration, temperature-controlled radiofrequency ablation in paroxysmal atrial fibrillation: the prospective multicenter Q-FFICIENCY trial. JACC Clin Electrophysiol. 2023;9:468–80.
doi: 10.1016/j.jacep.2022.10.019 pubmed: 36752484
Khairy P, Hammache N, Petzl A, et al. Procedure-related complications of catheter ablation for atrial fibrillation. J Am Coll Cardiol. 2023;81:2089–99.
doi: 10.1016/j.jacc.2023.03.418 pubmed: 37225362
Pallisgaard JL, Gislason GH, Hansen J, et al. Temporal trends in atrial fibrillation recurrence rates after ablation between 2005 and 2014: a nationwide Danish cohort study. Eur Heart J. 2018;39:442–9.
doi: 10.1093/eurheartj/ehx466 pubmed: 29020388
Stabile G, Trines SA, Arbelo E, et al. Atrial fibrillation history impact on catheter ablation outcome Findings from the ESC-EHRA atrial fibrillation ablation long-term registry. Pacing Clin Electrophysiol. 2019;42:313–20.
doi: 10.1111/pace.13600 pubmed: 30632196
Andrade JG, Deyell MW, L, Macle, EARLY-AF investigators, et al. Progression of atrial fibrillation after cryoablation or drug therapy. N Engl J Med. 2023;388(2):105–16.
Marrouche NF, Wilber D, Hindricks G, et al. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014;311(5):498–506.
doi: 10.1001/jama.2014.3 pubmed: 24496537
Marrouche NF, Wazni O, McGann C, et al. Effect of MRI-guided fibrosis ablation vs conventional catheter ablation on atrial arrhythmia recurrence in patients with persistent atrial fibrillation: the DECAAF II randomized clinical trial. JAMA. 2022;327(23):2296–305.
doi: 10.1001/jama.2022.8831 pubmed: 35727277 pmcid: 9214588
Haissaguerre M, Shah AJ, Cochet H, et al. Intermittent drivers anchoring to structural heterogeneities as a major pathophysiologic mechanism of human persistent atrial fibrillation. J Physiol. 2016;594(9):2387–98.
doi: 10.1113/JP270617 pubmed: 26890861 pmcid: 4850206
Jadidi AS, Cochet H, Shah AJ, et al. Inverse relationship between fractionated electrograms and atrial fibrosis in persistent atrial fibrillation: combined magnetic resonance imaging and high-density mapping. JACC. 2013;62:802–12.
doi: 10.1016/j.jacc.2013.03.081 pubmed: 23727084
Yagishita A, Sparano D, Cakulev I, et al. Identification and electrophysiological characterization of early left atrial structural remodeling as a predictor for atrial fibrillation recurrence after pulmonary vein isolation. J Cardiovasc Electrophysiol. 2017;28:642–50.
doi: 10.1111/jce.13211 pubmed: 28387462
Stiles MK, John B, Wong CX, et al. Paroxysmal lone atrial fibrillation is associated with an abnormal atrial substrate: characterizing the “second factor.” J Am Coll Cardiol. 2009;53:1182–91.
doi: 10.1016/j.jacc.2008.11.054 pubmed: 19341858
Lim H, Denis S, Middeldorp M, et al. Persistent atrial fibrillation from the onset: a specific subgroup of patients with biatrial substrate involvement and poorer clinical outcome. JACC Clin Electrophysiol. 2016;2:129–39.
doi: 10.1016/j.jacep.2015.12.014 pubmed: 29766861
Ballesteros G, Ravassa S, Bragard J, et al. Association of left atrium voltage amplitude and distribution with the risk of atrial fibrillation recurrence and evolution after pulmonary vein isolation: an ultrahigh-density mapping study. J Cardiovasc Electrophysiol. 2019;30:1231–40.
doi: 10.1111/jce.13972 pubmed: 31077505
Haines DE. The biophysics of radiofrequency catheter ablation in the heart: the importance of temperature monitoring. Pacing Clin Electrophysiol. 1993;16:586–91.
doi: 10.1111/j.1540-8159.1993.tb01630.x pubmed: 7681962

Auteurs

Franscesco Solimene (F)

Department of Cardiac Electrophysiology and Arrhythmology, Clinica Montevergine, Mercogliano, Italy.
Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy.

Ruggero Maggio (R)

Laboratorio Di Elettrofisiologia, Infermi Hospital, 29, Rivoli, Italy. ruggero.maggio@gmail.com.

Valerio De Sanctis (V)

IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy.

William Escande (W)

Centre Cardiologique du Nord, Saint-Denis, France.

Maurizio Malacrida (M)

Boston Scientific, Milan, Italy.

Giuseppe Stabile (G)

Mediterranea Cardiocentro, Naples, Italy.

Cyril Zakine (C)

Clinique NCT, St Cyr Sur Loire, France.

Laure Champ-Rigot (L)

Normandie Univ, UNICAEN, CHU de Caen Normandie, Caen, France.

Matteo Anselmino (M)

Division of Cardiology, Department of Medical Sciences, "Città Della Salute E Della Scienza Di Torino" Hospital, University of Turin, Turin, Italy.

Anna Ferraro (A)

Laboratorio Di Elettrofisiologia, Infermi Hospital, 29, Rivoli, Italy.

Massimo Mantica (M)

IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy.

Giulio Zucchelli (G)

Second Division of Cardiology, Cardiac-Thoracic-Vascular Department, New Santa Chiara Hospital, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.

Gabriele Dell'Era (G)

Azienda Ospedaliera Universitaria "Maggiore Della Carità", Novara, Italy.

Giuseppe Mascia (G)

IRCCS San Martino Polyclinic Hospital, Genoa, Italy.

Renata Ricci Maga (R)

Boston Scientific, Milan, Italy.

Claudio Pandozi (C)

San Filippo Neri Hospital, Rome, Italy.

Pietro Rossi (P)

Fatebenefratelli Isola Tiberina - Gemelli Isola Hospital, Rome, Italy.

Marco Scaglione (M)

Cardinal Massaia Hospital, Asti, Italy.

Gianluca Zingarini (G)

S. Maria Della Misericordia Hospital, Perugia, Italy.

Fabien Garnier (F)

Centre Hospitalier de Dijon Bourgogne, Dijon, France.

Maria Luisa Loricchio (ML)

Sandro Pertini Hospital, Rome, Italy.

Gemma Pelargonio (G)

Istituto Di Cardiologia Università Cattolica del Sacro Cuore, Rome, Italy.
Department of Cardiovascular Sciences, Arrhythmology Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy.

Antoine Lepillier (A)

Centre Cardiologique du Nord, Saint-Denis, France.

Classifications MeSH