Balloon technologies for pulmonary vein isolation-12-month outcome and comparison of the novel radiofrequency balloon with the cryoballoon in patients with paroxysmal atrial fibrillation.
Atrial fibrillation
Cryoballoon ablation
Heliostar™
Radiofrequency balloon
Single shot pulmonary vein isolation
Journal
Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123
Informations de publication
Date de publication:
13 Mar 2024
13 Mar 2024
Historique:
received:
18
06
2023
accepted:
09
02
2024
medline:
13
3
2024
pubmed:
13
3
2024
entrez:
13
3
2024
Statut:
aheadofprint
Résumé
The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™, Biosense Webster, CA, USA) promises the advantages of a balloon technology in combination with 3D mapping. To assess procedural data and outcome, all patients undergoing RF-balloon PVI were included and compared with data from consecutive patients undergoing CB PVI for paroxysmal AF. A total of 254 patients (63 ± 13 years, 54% male) were included: 30 patients undergoing RF-balloon and 224 patients CB PVI. Baseline parameters were comparable. Procedure duration (104.3 ± 35.3 min vs. 69.9 ± 23.1 min; p ≤ 0.001) and fluoroscopy time (16.3 ± 7.1 min vs. 11.6 ± 4.9 min; p ≤ 0.001) were longer using the RF-balloon; ablation time (43.5 ± 17.9 vs. 36.4 ± 15.6; p = 0.08) did not differ, and time-to-isolation (TTI) was shorter (18.2 ± 7.0 s vs. 62.8 ± 35.1 s; p ≤ 0.001). Second-generation RF-balloon cases showed shorter ablation time and TTI at comparable procedure duration and fluoroscopy time. One pericardial effusion occurred with the RF-balloon due to complicated transseptal access. During CB PVI in 4/224 patients (1.8%), a phrenic nerve palsy was observed. After 12 months, 78% of patients after RF-balloon and 81% of patients after CB PVI (p = 0.5) were free from atrial arrhythmias. The RF-balloon was safe and effective. Compared with the CB, TTI was shorter, but procedure durations and fluoroscopy times were longer. This can be attributed to a learning curve and the initial necessity for separate 3D map preparation. Considering the results with the second-generation RF-balloon, more experience is needed to determine the potential benefits.
Sections du résumé
BACKGROUND
BACKGROUND
The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™, Biosense Webster, CA, USA) promises the advantages of a balloon technology in combination with 3D mapping.
METHODS
METHODS
To assess procedural data and outcome, all patients undergoing RF-balloon PVI were included and compared with data from consecutive patients undergoing CB PVI for paroxysmal AF.
RESULTS
RESULTS
A total of 254 patients (63 ± 13 years, 54% male) were included: 30 patients undergoing RF-balloon and 224 patients CB PVI. Baseline parameters were comparable. Procedure duration (104.3 ± 35.3 min vs. 69.9 ± 23.1 min; p ≤ 0.001) and fluoroscopy time (16.3 ± 7.1 min vs. 11.6 ± 4.9 min; p ≤ 0.001) were longer using the RF-balloon; ablation time (43.5 ± 17.9 vs. 36.4 ± 15.6; p = 0.08) did not differ, and time-to-isolation (TTI) was shorter (18.2 ± 7.0 s vs. 62.8 ± 35.1 s; p ≤ 0.001). Second-generation RF-balloon cases showed shorter ablation time and TTI at comparable procedure duration and fluoroscopy time. One pericardial effusion occurred with the RF-balloon due to complicated transseptal access. During CB PVI in 4/224 patients (1.8%), a phrenic nerve palsy was observed. After 12 months, 78% of patients after RF-balloon and 81% of patients after CB PVI (p = 0.5) were free from atrial arrhythmias.
CONCLUSION
CONCLUSIONS
The RF-balloon was safe and effective. Compared with the CB, TTI was shorter, but procedure durations and fluoroscopy times were longer. This can be attributed to a learning curve and the initial necessity for separate 3D map preparation. Considering the results with the second-generation RF-balloon, more experience is needed to determine the potential benefits.
Identifiants
pubmed: 38478088
doi: 10.1007/s00392-024-02401-w
pii: 10.1007/s00392-024-02401-w
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C et al (2020) ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020:1–126
Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J et al (2021) Cryoablation or drug therapy for initial treatment of atrial fibrillation. N Engl J Med 384:305–315
doi: 10.1056/NEJMoa2029980
pubmed: 33197159
Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S et al (2021) Cryoballoon ablation as initial therapy for atrial fibrillation. N Engl J Med 384:316–324
doi: 10.1056/NEJMoa2029554
pubmed: 33197158
Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun J et al (2016) Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med 374:2235–2245
doi: 10.1056/NEJMoa1602014
pubmed: 27042964
Fortuni F, Casula M, Sanzo A, Angelini F, Cornara S, Somaschini A et al (2020) Meta-analysis comparing cryoballoon versus radiofrequency as first ablation procedure for atrial fibrillation. Am J Cardiol 125:1170–1179
doi: 10.1016/j.amjcard.2020.01.016
pubmed: 32087997
Dhillon GS, Honarbakhsh S, Di Monaco A, Coling AE, Lenka K, Pizzamiglio F et al (2020) 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 31:1259–1269
doi: 10.1111/jce.14476
pubmed: 32250514
Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F et al (2021) Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace 23:851–860
doi: 10.1093/europace/euaa382
pubmed: 33450010
pmcid: 8186540
Kanthasamy V, Breitenstein A, Schilling R, Hofer D, Tiongco B, Ang R et al (2023) Catheter ablation of atrial fibrillation with a multi-electrode radiofrequency balloon; first and early two centre experience in Europe. J Cardiovasc Electrophysiol 34(6):1350–1359
doi: 10.1111/jce.15799
pubmed: 36598422
Del Monte A, Almorad A, Pannone L, Della Rocca DG, Bisignani A, Monaco C et al (2023) Pulmonary vein isolation with the radiofrequency balloon catheter: a single centre prospective study. Europace 25:896–904
Almorad A, Chierchia GB, Pannone L, Osorio TG, Sorgente A, Bisignani A et al (2022) The optimized clinical workflow for pulmonary vein isolation with the radiofrequency balloon. J Interv Card Electrophysiol 64:531–538
doi: 10.1007/s10840-021-01094-9
pubmed: 34791605
Scheurlen C, van den Bruck JH, Filipovic K, Wörmann J, Arica Z, Erlhöfer S et al (2022) Procedural and outcome impact of obesity in cryoballoon versus radiofrequency pulmonary vein isolation in atrial fibrillation patients. J Interv Card Electrophysiol 65:403–410
doi: 10.1007/s10840-022-01210-3
pubmed: 35415815
pmcid: 9640436
Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L et al (2019) Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial. Circulation 140:1779–1788
doi: 10.1161/CIRCULATIONAHA.119.042622
pubmed: 31630538