Catheter ablation of atrial fibrillation with a multi‐electrode radiofrequency balloon; first and early two centre experience in Europe

Kanthasamy, Vijayabharathy; Berndt, Alexander; Schilling, Richard J.; Höfer, Daniel; Tiongco, Benny; Ang, Richard; Hunter, Ross J.; Earley, Mark J.; Ahsan, Syed; Mangiafico, Valentina; Honarbakhsh, Shohreh; Ahluwalia, Nikhil; Maclean, Edd; Creta, António; Finlay, Malcolm

doi:10.1111/jce.15799

Cited by 7 publications

(9 citation statements)

References 18 publications

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“…This may be due to further optimizations in the workflow introduced by the manufacturer since the first trials. In comparison to a recently published real-world experience from two European centers, procedure and LA dwell times were also shorter in our cohort, whereas fluoroscopy duration was higher (8). Two other recently published studies including real-world patient data from experienced, high-volume centers describe similar procedural characteristics in comparison to our data (9,10).…”

Section: Discussionsupporting

confidence: 81%

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice—operator learning curve and procedural outcome at a high-volume center

Zylla,

Starrach,

Rahm

et al. 2023

Front. Cardiovasc. Med.

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BackgroundThe novel multielectrode radiofrequency (RF) balloon catheter (HELIOSTAR™. Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining RF-ablation and 3D-mapping visualization with the concept of a “single-shot”-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the multielectrode RF-balloon at a high-volume center.MethodsThe first 40 patients undergoing PVI by multielectrode RF-balloon catheter at Heidelberg University Hospital were included in this prospective study. Procedural outcome was analyzed over the course of increasing experience with the device.Results157/157 pulmonary veins (PVs) were successfully isolated with the RF-balloon catheter, in 73.2% by a single RF-application. Median time to isolation (TTI) was 11.0 s (Q1 = 8.0 s; Q3 = 13.8 s). Median procedure time was 62.5 min (Q1 = 50.0 min; Q3 = 70.5 min). LA-dwell time was 28.5 min (Q1 = 23.3 min; Q3 = 36.5 min). Median fluoroscopy duration was 11.6 min (Q1 = 10.1 min; Q3 = 13.7 min). No serious procedure-related complications were observed, apart from one case of unclear, post-procedural acute-on-chronic kidney injury. With increasing operator experience, an additional reduction in procedure duration was observed.ConclusionRapid implementation of a “single shot”-ablation device combining RF-ablation and 3D-mapping can be achieved with high acute procedural efficacy and safety at a high-volume center. Previous experience with “single-shot” ablation devices may be advantageous for time-efficient introduction of the novel RF-balloon catheter into clinical practice.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT05603611.

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Section: Discussionsupporting

confidence: 81%

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice—operator learning curve and procedural outcome at a high-volume center

Zylla,

Starrach,

Rahm

et al. 2023

Front. Cardiovasc. Med.

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“…The PNP resolved completely within 48 h. In this case, phrenic nerve pacing from the balloon was accidentally not performed prior to the energy delivery at the RSPV. The overall PNP rate of this study (0.6%) can be declared ‘low’ in comparison to other RFBC-PVI studies (0.7–3.3%) [ 8 , 9 , 10 , 11 , 12 , 13 ]. Interestingly, in these studies, the PNP rate seems to be lower if PN pacing from the balloons’ electrodes is performed before the energy delivery at the RSPV [ 8 , 9 , 10 , 11 , 12 , 13 ], just like in our study.…”

Section: Discussioncontrasting

confidence: 76%

“…The overall PNP rate of this study (0.6%) can be declared ‘low’ in comparison to other RFBC-PVI studies (0.7–3.3%) [ 8 , 9 , 10 , 11 , 12 , 13 ]. Interestingly, in these studies, the PNP rate seems to be lower if PN pacing from the balloons’ electrodes is performed before the energy delivery at the RSPV [ 8 , 9 , 10 , 11 , 12 , 13 ], just like in our study. This can be the reason for the low PNP rate in this study.…”

Section: Discussioncontrasting

confidence: 76%

“…The RADIENCE study has shown PVI feasibility with the RFBC [ 8 ]. The SHINE study [ 9 ] and other publications [ 10 , 11 , 12 ] generated the initial evidence on acute efficacy and safety of the RFBC, but only limited data are available on RFBC-PVI outcomes [ 8 , 9 , 10 , 11 ]. Based on these data, the reported patient numbers are relatively small, and evidence concerning the treatment of persistent AF is sparse.…”

Section: Discussionmentioning

confidence: 99%

“…Another cue for the single-shot character of the RFBC is the high SSI rate of 70.6%, which is competitive compared to the CB-PVI [ 16 ]. In contrast to the CB, acute PV isolation seems to be achievable more quickly with the RFBC documented in numerical shorter-mean TTIs (10–12.5 s versus 42–46 s) [ 6 , 9 , 10 , 11 , 12 , 13 , 16 ]. It is worth mentioning that the RFBC opens new opportunities in comparison to a standard single-shot catheter.…”

Section: Discussionmentioning

confidence: 99%

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Atrial Fibrillation Ablation with a Novel Fully 3D-Mapping-Integrated Multi-Electrode Radiofrequency Balloon Catheter

Teumer,

Miesbichler,

Hauke

et al. 2023

JCM

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Pulmonary vein isolation (PVI), as the cornerstone of atrial fibrillation (AF) ablation, has emerged a widely used therapy for patients suffering from AF. To improve PVI efficiency, single-shot catheters (SSCs) have been developed. Regrettably, SSCs are not integrated into 3D-mapping technology. In that regard, a novel radiofrequency balloon catheter (RFBC, Heliostar, Biosense Webster) with full integration into 3D-mapping technology has been developed. The aim of this study was to assess operative and follow-up outcomes of the RFBC in AF patients. In this monocentric prospective registry, patients with a first-time PVI using the RFBC were included. Follow-up visits were scheduled 3, 6, 12 and 24 months after ablation and in case of symptoms. A total of 171 patients (36.8% female) were included, with a mean age of 68.5 ± 10.2 years. Among them, 63 patients (36.8%) presented with persistent AF. Notably, no major periprocedural complications were observed. The mean follow-up period was 287 ± 157 days. In the Kaplan–Meier analysis, the estimated recurrence-free survival after 12 months was 81.8%. Based on our data, PVI with the fully 3D-mapping-integrated RFBC seems to be safe and effective and to have a favorable 12-month outcome in patients with paroxysmal and persistent AF.

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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

van den Bruck,

Wörmann,

Sultan

et al. 2024

Clin Res Cardiol

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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 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 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 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. Graphical Abstract

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Catheter ablation of atrial fibrillation with a multi‐electrode radiofrequency balloon; first and early two centre experience in Europe

Cited by 7 publications

References 18 publications

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice—operator learning curve and procedural outcome at a high-volume center

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice—operator learning curve and procedural outcome at a high-volume center

Atrial Fibrillation Ablation with a Novel Fully 3D-Mapping-Integrated Multi-Electrode Radiofrequency Balloon Catheter

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

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