AIMS: To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI). METHODS AND RESULTS: This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7 days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12 months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of ≥1 PVs after adenosine/isoproterenol challenge was observed in 9.3% (30/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12 months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12 months. CONCLUSION: PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT03437733.

Biosense Webster Inc 29b Technology Dr Irvine CA USA

Department of Cardiology Na Homolce Hospital Roentgenova 37 150 00 Praha 5 Czechia

Department of Cardiology Ospedale Generale Regionale F Miulli Strada Prov 127 Acquaviva Santeramo Km 4 70021 Acquaviva delle Fonti BA Italy

Department of Cardiology St Bartholomew's Hospital W Smithfield London EC1A 7BE UK

Department of Electrophysiology Division of Cardiology Icahn School of Medicine at Mount Sinai 1 Gustave L Levy Pl New York NY USA

Heart Rhythm Management Center Universitair Ziekenhuis Brussels Avenue du Laerbeek 101 1090 Jette Belgium

Liverpool Heart and Chest Hospital Thomas Dr Liverpool L14 3PE UK

Monzino Cardiology Center University of Milan Via Carlo Parea 4 20138 Milano MI Italy

See more in PubMed

Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L. et al.; Document Reviewers. HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace 2018;20:e1–160. PubMed PMC

Metzner A, Wissner E, Lin T, Ouyang F, Kuck KH.. Balloon devices for atrial fibrillation therapy. Arrhythm Electrophysiol Rev 2015;4:58–61. PubMed PMC

Dhillon GS, Honarbakhsh S, Di Monaco A, Coling AE, Lenka K, Pizzamiglio F. et al. Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-month outcomes of the RADIANCE study. J Cardiovasc Electrophysiol 2020;31:1259–69. PubMed

R Reddy VY, Schilling R, Grimaldi M, Horton R, Natale A, Riva S. et al. Pulmonary vein isolation with a novel multielectrode radiofrequency balloon catheter that allows directionally tailored energy delivery: short-term outcomes from a multicenter first-in-human study (RADIANCE). Circ Arrhythm Electrophysiol 2019;12:e007541. PubMed

Holmes DN, Piccini JP, Allen LA, Fonarow GC, Gersh BJ, Kowey PR. et al. Defining clinically important difference in the atrial fibrillation effect on quality-of-life score. Circ Cardiovasc Qual Outcomes 2019;12:e005358. PubMed

Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG. et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol 2013;61:1713–23. PubMed

Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT. et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol 2014;64:647–56. PubMed

Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J. et al. Randomized, controlled trial of the safety and effectiveness of a contact force-sensing irrigated catheter for ablation of paroxysmal atrial fibrillation: results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) study. Circulation 2015;132:907–15. PubMed

Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T. et al. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: the CLOSE to CURE study. Heart Rhythm 2020;17:535–43. PubMed

Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L. et al.; For the CIRCA-DOSE Study Investigators. Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial. Circulation 2019;140:1779–88. PubMed

Duytschaever M, Vijgen J, De Potter T, Scherr D, Van Herendael H, Knecht S. et al. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial. Europace 2020;22:1645–52. PubMed

Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H. et al. Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. J Am Coll Cardiol 2019;74:315–26. PubMed

Providencia R, Defaye P, Lambiase PD, Pavin D, Cebron JP, Halimi F. et al. Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: is cryoablation more reproducible? Europace 2017;19:48–57. PubMed

Büsing KA, Schulte-Sasse C, Flüchter S, Suselbeck T, Haase KK, Neff W. et al. Cerebral infarction: incidence and risk factors after diagnostic and interventional cardiac catheterization—prospective evaluation at diffusion-weighted MR imaging. Radiology 2005;235:177–83. PubMed

Deneke T, Nentwich K, Krug J, Müller P, Grewe PH, Mügge A. et al. Silent cerebral events after atrial fibrillation ablation—overview and current data. J Atr Fibrillation 2014;6:996. PubMed PMC

Miyazaki S, Kajiyama T, Yamao K, Hada M, Yamaguchi M, Nakamura H. et al. Silent cerebral events/lesions after second-generation cryoballoon ablation: how can we reduce the risk of silent strokes? Heart Rhythm 2019;16:41–8. PubMed

Nakamura K, Sasaki T, Take Y, Okazaki Y, Inoue M, Motoda H. et al. Postablation cerebral embolisms in balloon-based atrial fibrillation ablation with periprocedural direct oral anticoagulants: a comparison between cryoballoon and HotBalloon ablation. J Cardiovasc Electrophysiol 2019;30:39–46. PubMed

Lickfett L, Hackenbroch M, Lewalter T, Selbach S, Schwab JO, Yang A. et al. Cerebral diffusion-weighted magnetic resonance imaging: a tool to monitor the thrombogenicity of left atrial catheter ablation. J Cardiovasc Electrophysiol 2006;17:1–7. PubMed

Dorian P, Burk C, Mullin CM, Bubien R, Godejohn D, Reynolds MR. et al. Interpreting changes in quality of life in atrial fibrillation: how much change is meaningful? Am Heart J 2013;166:381–7.e8. PubMed

Dorian P, Jung W, Newman D, Paquette M, Wood K, Ayers GM. et al. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol 2000;36:1303–9. PubMed

Practical guidance to reduce radiation exposure in electrophysiology applying ultra low-dose protocols: a European Heart Rhythm Association review

See more in PubMed

ClinicalTrials.gov
NCT03437733