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Background/Objectives: Single-shot devices are important tools for efficient pulmonary vein isolation (PVI) in atrial fibrillation (AF). In addition to the standard cryo-balloon (CB) catheter, a novel multi-electrode radiofrequency balloon-catheter (RFB, Heliostar, Biosense Webster, Irvine, CA, USA) with 3D-mapping-integration is available. Currently, there is no evidence allowing for a direct comparison between RFB-PVI and CB-PVI in a matched population. The study aimed to assess the procedural data, safety profiles, and outcomes of RFB-PVI versus CB-PVI. Methods: In this prospective registry study, symptomatic AF patients undergoing first-time PVI from January 2019 to April 2023, using RFB or CB, were included, with patients matched in a 1:2 ratio to reduce potential confounders. Results: The results from 171 consecutive RFB patients and 342 matched CB patients showed comparable recurrence-free survival after 12 months (81.3% RFB vs. 76.8% CB, p = 0.359). The RFB group had a longer procedure duration (88 vs. 73 min, p < 0.001) and longer fluoroscopy time (18.9 vs. 14.5 min, p < 0.001). Conclusions: In conclusion, the novel RFB system enables efficient and safe PVI, which is broadly comparable to the established CB system. However, the 3D-mapping integration in RFB did not reduce fluoroscopy time compared to CB. [ABSTRACT FROM AUTHOR]

Previous clinical studies on pulmonary vein isolation (PVI) with radiofrequency balloons (RFB) reported safe and effective procedures for a 20 s RF delivery via posterior electrodes. Recent recommendations from the manufacturer suggest reducing the application time to 15 s on the posterior wall (PW) when facing the esophagus region. Here, we retrospectively assess whether 15 s of RF delivery time on posterior electrodes is safe while still ensuring lesion metrics of sufficient quality. This retrospective study included 133 patients with paroxysmal and persistent atrial fibrillation who underwent PVI using an RFB (Heliostar, Biosense Webster, Inc., Irvine, CA, USA) at two European centers. The ablation protocol was set for an RF duration of 20 s/60 s for the posterior/anterior electrodes. A multielectrode temperature probe was systematically used. In the case of an esophageal temperature rise (ETR) above 42 °C (ETR+), an endoscopic evaluation was performed. All posterior electrode lesion metric dynamics (temperature (T) and impedance (Z)) were collected from the RFB generator and analyzed offline. In total, 2435 posterior electrode applications were analyzed. With an RF delivery of 19.8 (19.7–19.8) s, the median impedance drop was 18.4 (12.2–25.2) Ω, while the temperature rise was 11.1 (7.1–14.9) °C. Accordingly, impedance (84.6 (79.3–90.2) Ω) and temperature plateaus (38 (35.3–41.1) °C) were reached at 13.9 (10.6–16) s and 16.4 (12.6–18.5) s, respectively. Overall, 99.6% and 95.8% of electrodes reached 90% (16.6 Ω) and 95% (17.5 Ω) of their impedance drops within 15 s of RF delivery, while 97.2% and 92.8% achieved 90% (34.2 °C) and 95% (36.1 °C) of their temperature rise to reach the plateaus within 15 s of RF delivery. An ETR >42 °C occurred in 37 (30.1%) patients after 17.7 ± 2.3 s of RF delivery. In the ETR+ group, the impedance drop and temperature rise on the posterior electrodes were higher compared to patients where ETR was <42 °C. Two asymptomatic thermal esophageal injuries were observed. In conclusion, 15 s of RF delivery on the posterior electrodes provides a good balance between safety, with no esophageal temperature rise, and efficacy with high-profile lesion metrics. [ABSTRACT FROM AUTHOR]

Introduction: Pulsed‐field ablation (PFA) and the multielectrode radiofrequency balloon (RFB) are two novel ablation technologies to perform pulmonary vein isolation (PVI). It is currently unknown whether these technologies differ in lesion formation and lesion extent. We compared the acute lesion extent after PVI induced by PFA and RFB by measuring low‐voltage area in high‐density maps and the release of biomolecules reflecting cardiac injury. Methods: PVI was performed with a pentaspline catheter (FARAPULSE) applying PFA or with the compliant multielectrode RFB (HELIOSTAR). Before and after PVI high‐density mapping with CARTO 3 was performed. In addition, blood samples were taken before transseptal puncture and after post‐PVI remapping and serum concentrations of high‐sensitive Troponin I were quantified by immunoassay. Results: Sixty patients undergoing PVI by PFA (n = 28, age 69 ± 12 year, 60% males, 39.3% persistent atrial fibrillation [AF]) or RFB (n = 32, age 65 ± 13 year, 53% males, 21.9% persistent AF) were evaluated. Acute PVI was achieved in all patients in both groups. Mean number of PFA pulses was 34.2 ± 4.5 and mean number RFB applications was 8.5 ± 3 per patient. Total posterior ablation area was significantly larger in PFA (20.7 ± 7.7 cm²) than in RFB (7.1 ± 2.09 cm²; p <.001). Accordingly, posterior ablation area for each PV resulted in larger lesions after PFA versus RFB (LSPV 5.2 ± 2.7 vs. 1.9 ± 0.8 cm², LIPV 5.5 ± 2.3 vs. 1.9 ± 0.8 cm², RSPV 4.7 ± 1.9 vs. 1.6 ± 0.5 cm², RIPV 5.3 ± 2.1 vs. 1.6 ± 0.7 cm,² respectively; p <.001). In a subset of 38 patients, increase of hsTropI was higher after PFA (625 ± 138 pg/mL, n = 28) versus RFB (148 ± 36 pg/mL, n = 10; p =.049) supporting the evidence of larger lesion extent by PFA. Conclusion: PFA delivers larger acute lesion areas and higher troponin release upon successful PVI than multielectrode RFB‐based PVI in this single‐center series. [ABSTRACT FROM AUTHOR]

Aims Cryoballoon (CB) ablation is the mainstay of single-shot pulmonary vein isolation (PVI). A radiofrequency balloon (RFB) catheter has recently emerged as an alternative. However, these two technologies have not been compared. This study aims to evaluate the freedom from atrial tachyarrhythmias (ATas) at 1 year: procedural characteristics, efficacy, and safety of the novel RFB compared with CB for PVI in patients with paroxysmal atrial fibrillation (AF). Methods and results This prospective multi-centre study included consecutive patients with symptomatic drug-resistant paroxysmal AF who underwent PVI with RFB or CB between July 2021 and January 2022 from three European centres. A total of 375 consecutive patients were included, 125 in the RFB group and 250 in the CB. Both groups had comparable clinical characteristics. At 12.33 ± 4.91 months, ATas-free rates were 83.20% and 82.00% in the RFB and CB groups, respectively (P > 0.05). Compared with the CB group, the RFB group showed a shorter procedure time [59.91 (45.80–77.12) vs. 77.0 (35.13–122.71) min (P < 0.001)], dwell time [19.59 (14.41–30.24) vs. 27.03 (17.11–57.21) min (P = 0.04)], time to isolation, and thermal energy delivery in all pulmonary veins (P < 0.001). First-pass isolation was comparable. No major complications occurred in either group, with no stroke, atrio-oesophageal fistula, or permanent phrenic nerve injury. Transient phrenic nerve palsy occurred more frequently with CB than RFB (7.20% vs. 3.20%; P = 0.02). Oesophageal temperature rise occurred in 21 (16.8%) patients in the RFB group, and gastroscopy showed erythema in two of them with complete recovery after 30 days. Conclusions The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times. [ABSTRACT FROM AUTHOR]

Background/Objectives: Single-shot devices are important tools for efficient pulmonary vein isolation (PVI) in atrial fibrillation (AF). In addition to the standard cryo-balloon (CB) catheter, a novel multi-electrode radiofrequency balloon-catheter (RFB, Heliostar, Biosense Webster, Irvine, CA, USA) with 3D-mapping-integration is available. Currently, there is no evidence allowing for a direct comparison between RFB-PVI and CB-PVI in a matched population. The study aimed to assess the procedural data, safety profiles, and outcomes of RFB-PVI versus CB-PVI. Methods: In this prospective registry study, symptomatic AF patients undergoing first-time PVI from January 2019 to April 2023, using RFB or CB, were included, with patients matched in a 1:2 ratio to reduce potential confounders. Results: The results from 171 consecutive RFB patients and 342 matched CB patients showed comparable recurrence-free survival after 12 months (81.3% RFB vs. 76.8% CB, p = 0.359). The RFB group had a longer procedure duration (88 vs. 73 min, p < 0.001) and longer fluoroscopy time (18.9 vs. 14.5 min, p < 0.001). Conclusions: In conclusion, the novel RFB system enables efficient and safe PVI, which is broadly comparable to the established CB system. However, the 3D-mapping integration in RFB did not reduce fluoroscopy time compared to CB.

Aims The multielectrode radiofrequency balloon catheter (RFB) has been developed to achieve safe and effective pulmonary vein isolation (PVI) for atrial fibrillation (AF) ablation. This single-centre study aimed to evaluate the midterm clinical outcome and predictors of single-shot PVI with the novel RFB. Methods and results All consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with the RFB were prospectively included. Clinical and procedural parameters were systematically collected. The primary safety endpoint was defined as any major periprocedural complications. The primary efficacy endpoint consisted of freedom from any atrial tachyarrhythmias (ATas) lasting >30 s during the follow-up after a 3-month blanking period. Persistent single-shot PVI was defined as PVI achieved with a single RFB application without acute reconnection. A total of 104 consecutive patients (mean age 64.3 ± 11.4 years, 56.7% males) were included. 15 patients (14.4%) presented with persistent AF. The procedure time was 59.0 min with a dwell time of 20.0 min. One major complication occurred in one patient. At a mean follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. ATas occurred in 14 patients, 11/69 patients (15.9%) with paroxysmal AF and 3/13 (23.1%) with persistent AF. The best cut-offs to predict persistent single-shot PVI were impedance drop >19.2 Ω [area under the receiver operator characteristic curve (AUC) 0.74] and temperature rise >11.1° C (AUC 0.77). Conclusion In a large cohort of patients undergoing PVI with the RFB, the complication rate was 1%. At a mid-term follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. Specific cut-offs of impedance drop and temperature rise may be useful to predict persistent single-shot isolation. [ABSTRACT FROM AUTHOR]

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.

Previous clinical studies on pulmonary vein isolation (PVI) with radiofrequency balloons (RFB) reported safe and effective procedures for a 20 s RF delivery via posterior electrodes. Recent recommendations from the manufacturer suggest reducing the application time to 15 s on the posterior wall (PW) when facing the esophagus region. Here, we retrospectively assess whether 15 s of RF delivery time on posterior electrodes is safe while still ensuring lesion metrics of sufficient quality. This retrospective study included 133 patients with paroxysmal and persistent atrial fibrillation who underwent PVI using an RFB (Heliostar, Biosense Webster, Inc., Irvine, CA, USA) at two European centers. The ablation protocol was set for an RF duration of 20 s/60 s for the posterior/anterior electrodes. A multielectrode temperature probe was systematically used. In the case of an esophageal temperature rise (ETR) above 42 °C (ETR+), an endoscopic evaluation was performed. All posterior electrode lesion metric dynamics (temperature (T) and impedance (Z)) were collected from the RFB generator and analyzed offline. In total, 2435 posterior electrode applications were analyzed. With an RF delivery of 19.8 (19.7–19.8) s, the median impedance drop was 18.4 (12.2–25.2) Ω, while the temperature rise was 11.1 (7.1–14.9) °C. Accordingly, impedance (84.6 (79.3–90.2) Ω) and temperature plateaus (38 (35.3–41.1) °C) were reached at 13.9 (10.6–16) s and 16.4 (12.6–18.5) s, respectively. Overall, 99.6% and 95.8% of electrodes reached 90% (16.6 Ω) and 95% (17.5 Ω) of their impedance drops within 15 s of RF delivery, while 97.2% and 92.8% achieved 90% (34.2 °C) and 95% (36.1 °C) of their temperature rise to reach the plateaus within 15 s of RF delivery. An ETR >42 °C occurred in 37 (30.1%) patients after 17.7 ± 2.3 s of RF delivery. In the ETR+ group, the impedance drop and temperature rise on the posterior electrodes were higher compared to patients where ETR was

Aims: Previous clinical studies on pulmonary vein isolation (PVI) with a radiofrequency balloon (RFB) reported safe and effective procedures using conventional ablation settings with 20/60 s RF delivery via posterior/anterior (PST/ANT) electrodes. The latest evidence suggests that reducing the application time to 15 s (s) on the posterior wall when facing the oesophageal region is as effective as applying 20 s. To prospectively assess whether reducing RF time on PST/ANT segments to 15/45 s can ensure sufficient quality of lesion metrics and compare the new shortened ablation settings with the conventional one in terms of safety, and effectiveness at 1-year., Methods and Results: A total of 641 patients from seven European centres were enrolled in a collaborative registry, with 374 in the conventional RF delivery group and 267 in the shortened RF delivery group. Procedural outcomes, lesion metrics, and safety profiles were assessed and compared between the groups. Freedom of any atrial tachycarrythmias at one year was 85.4% and 88.2% in the SHRT and CONV groups, respectively. The shortened RF delivery strategy was associated with significantly shorter procedure times (median 63.5 vs. 96.5 min, P < 0.001) and shortened fluoroscopy exposure (median 10.0 vs. 14.0 min, P < 0.001) compared to conventional delivery. Efficacy metrics, including first-pass isolation rates and time to isolation, were comparable between groups. Shortened RF delivery was associated with a lower incidence of procedural complications (1.4% vs. 5.3%, P = 0.04) and optimized thermal characteristics., Conclusion: Analyses from the COLLABORATE registry demonstrate that shortening RF energy delivery times to 15/45 s (PST/ANT) during PVI with the RFB resulted in comparable freedom from recurrent atrial tachyarrhythmia compared to conventional delivery times with comparable efficiency and safety., Competing Interests: Conflict of interest: A.A. received institutional compensation for teaching and proctoring from Medtronic, Abbott, Boston Scientific, and Biosense Webster. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. C.d.A. received research grants from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus; C.d.A. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. The authors have no conflicts of interest to declare., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The RADIANCE first‐in‐man study evaluated acute (3‐month) safety and design concept in terms of utility of a new multi‐electrode radiofrequency (RF) balloon catheter (HELIOSTAR, Biosense Webster) to achieve pulmonary vein isolation (PVI). After study conclusion, a subset of patients was followed up to 12 months. Methods: Patients with drug refractory paroxysmal atrial fibrillation were enrolled. Neurological assessment, cardiac and cerebral magnetic resonance imagings were performed pre and post procedure. Ablation was delivered at 15 Watts to each PV for 60 seconds (electrodes adjacent to the posterior wall limited to 20 seconds). Adenosine or isoproterenol was administered to confirm PVI. Esophageal endoscopy was performed 48 hours post procedure. Patients were clinically followed up for 12 months. Results: Thirty‐nine patients underwent catheter ablation from four centers. Mean age was 60.7 ± 10.0 years with 23 (57.5%) being male. Confirmation of PVI was performed in all PVs treated (152/152). Confirmation of isolation after one delivery was performed solely on 137 of 152 PVs of which 79.6% (109/137) achieved isolation with a single delivery of RF energy. Acute PV reconnection was seen in 4.6% (7/150) of PVs. Freedom from documented atrial arrhythmia at 12 months in those followed up was 86.4% (32/37). A total of 75.7% (28/37) of patients were free from atrial arrhythmia and off antiarrhythmic medications. Conclusion: The HELIOSTAR RF balloon catheter allows for rapid and safe PVI with majority of PVs only requiring one application. [ABSTRACT FROM AUTHOR]

Pulmonary vein isolation (PVI) is widely accepted as the mainstay of interventional treatment of atrial fibrillation. Ablation with radiofrequency (RF) point-by-point catheters is highly operator dependent and may fail because of ineffective lesions or gaps. Several balloon-based catheter ablation technologies have emerged as an alternative to effect PVI. Cryoballoon ablation is widely used, and current iterations of the technology show comparable acute and long-term efficacy to RF ablation. Techniques such as time to isolation have emerged to improve efficacy and safety. Laser balloon is a highly compliant variably sized balloon that has been validated as an effective strategy for PVI. [ABSTRACT FROM AUTHOR]

Background: The 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., Methods: The 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., Results: 157/157 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., Conclusion: Rapid 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 Registration: ClinicalTrials.gov; Identifier NCT0560361., Competing Interests: MZ reports lecture fees/honoraria, educational grants and travel support by Medtronic, Boston Scientific, Bayer Vital, ZOLL CMS and Pfizer. AR reports educational grants and travel support by Medtronic, Biosense Webster and Boston Scientific. DT reports receiving lecture fees/honoraria from AstraZeneca, Bayer Vital, Boehringer Ingelheim Pharma, Bristol-Myers Squibb, Daiichi Sankyo, Medtronic, Pfizer Pharma, Sanofi-Aventis, St. Jude Medical and ZOLL CMS. PL reports receiving lecture fees/honoraria from Bayer Vital, Boston Scientific, Biosense Webster, Pfizer and Medtronic. NF reports lecture fees/honoraria from AstraZeneca, Bayer Vital, Boehringer Ingelheim Pharma, Daiichi Sankyo, Novartis and Pfizer Pharma. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Zylla, Starrach, Rahm, Thomas, Frey and Lugenbiel.)

Aims: Cryoballoon (CB) ablation is the mainstay of single-shot pulmonary vein isolation (PVI). A radiofrequency balloon (RFB) catheter has recently emerged as an alternative. However, these two technologies have not been compared. This study aims to evaluate the freedom from atrial tachyarrhythmias (ATas) at 1 year: procedural characteristics, efficacy, and safety of the novel RFB compared with CB for PVI in patients with paroxysmal atrial fibrillation (AF)., Methods and Results: This prospective multi-centre study included consecutive patients with symptomatic drug-resistant paroxysmal AF who underwent PVI with RFB or CB between July 2021 and January 2022 from three European centres. A total of 375 consecutive patients were included, 125 in the RFB group and 250 in the CB. Both groups had comparable clinical characteristics. At 12.33 ± 4.91 months, ATas-free rates were 83.20% and 82.00% in the RFB and CB groups, respectively (P > 0.05). Compared with the CB group, the RFB group showed a shorter procedure time [59.91 (45.80-77.12) vs. 77.0 (35.13-122.71) min (P < 0.001)], dwell time [19.59 (14.41-30.24) vs. 27.03 (17.11-57.21) min (P = 0.04)], time to isolation, and thermal energy delivery in all pulmonary veins (P < 0.001). First-pass isolation was comparable. No major complications occurred in either group, with no stroke, atrio-oesophageal fistula, or permanent phrenic nerve injury. Transient phrenic nerve palsy occurred more frequently with CB than RFB (7.20% vs. 3.20%; P = 0.02). Oesophageal temperature rise occurred in 21 (16.8%) patients in the RFB group, and gastroscopy showed erythema in two of them with complete recovery after 30 days., Conclusions: The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times., Competing Interests: Conflict of interest: A.A. received research grants and compensation for teaching purposes from Abbott, Biosense-Webster, Medtronic, and Microport. A.S. received research grants from Daiichi-Sankyo and Bayer; he has received speaker fees from Menarini and Bayer. M.E.H. is a consultant for Biosense-Webster Inc. not related to this work. S.B. is a consultant for Medtronic, Boston Scientific, Microport, and Zoll. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. C.d.A. received research grants from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus; C.d.A. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. All remaining authors have declared no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: A novel multielectrode radiofrequency balloon (RFB) catheter has been released for pulmonary vein isolation (PVI)., Methods and results: In this observational study consecutive patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) undergoing first-time PVI were enrolled in 2 high-volume ablation centers. All procedures were conducted in conjunction with a 3D-mapping system. Clinical, procedural and ablation parameters were systematically analyzed. 105 patients (58% male; 52% paroxysmal AF, 68±11.3 years mean age, left atrial volume index 38.6±14.8 mL/m 2 ) were included. 241/412 (58.5%) PVs were successfully isolated with a single shot (SS), with a time-to-isolation of 11.6±8 s. Total number of radiofrequency applications was 892 (mean 2.2/PV), resulting in successful isolation of 408/412 (99%) PVs at the end of the procedure. Mean electrodes' impedance drop was significantly higher in the SS-PVI compared with non-SS applications (21.5±6.6 vs. 18.6±6.5 Ohm). Concordantly, higher temperature rise was observed in the SS vs. non-SS applications (10.9±4.9℃ vs. 9.6±4.7℃)., Conclusions: In this multicenter real-world study, mean impedance drop and temperature rise were associated with successful SS-PVI applying the novel RFB catheter. These parameters may help to guide efficient usage of the new RF balloon.

Aims: The multielectrode radiofrequency balloon catheter (RFB) has been developed to achieve safe and effective pulmonary vein isolation (PVI) for atrial fibrillation (AF) ablation. This single-centre study aimed to evaluate the midterm clinical outcome and predictors of single-shot PVI with the novel RFB., Methods and Results: All consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with the RFB were prospectively included. Clinical and procedural parameters were systematically collected. The primary safety endpoint was defined as any major periprocedural complications. The primary efficacy endpoint consisted of freedom from any atrial tachyarrhythmias (ATas) lasting >30 s during the follow-up after a 3-month blanking period. Persistent single-shot PVI was defined as PVI achieved with a single RFB application without acute reconnection. A total of 104 consecutive patients (mean age 64.3 ± 11.4 years, 56.7% males) were included. 15 patients (14.4%) presented with persistent AF. The procedure time was 59.0 min with a dwell time of 20.0 min. One major complication occurred in one patient. At a mean follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. ATas occurred in 14 patients, 11/69 patients (15.9%) with paroxysmal AF and 3/13 (23.1%) with persistent AF. The best cut-offs to predict persistent single-shot PVI were impedance drop >19.2 Ω [area under the receiver operator characteristic curve (AUC) 0.74] and temperature rise >11.1° C (AUC 0.77)., Conclusion: In a large cohort of patients undergoing PVI with the RFB, the complication rate was 1%. At a mid-term follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. Specific cut-offs of impedance drop and temperature rise may be useful to predict persistent single-shot isolation., Competing Interests: Conflict of interest: A.B. is a consultant for Biotronik. A.S. received research grants from Daiichi Sankyo and Bayer; he has received speaker fees from Menarini and Bayer. P.B. received compensation for teaching purposes from Biotronik. M.L.M. is a consultant for Atricure. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, Acutus Medical. C.d.A. receives research grants on behalf of the centre from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus; C.d.A. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, Daiichi Sankyo. All remaining authors have declared no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Early experience with a novel multielectrode saline-irrigated radiofrequency balloon (RFB) catheter with an integrated camera system found that it was safe and effective in performing single-shot pulmonary vein isolation (PVI) for atrial fibrillation., Objective: The purpose of this study was to further assess potential treatment risks by looking for subclinical events., Methods: The study was performed at 2 sites. Patients underwent PVI by RFB. A control group underwent conventional point-by-point radiofrequency ablation. Stroke scale questionnaire and brain magnetic resonance imaging (MRI) were performed before and after the ablation procedure, and esophageal endoscopy was performed after the procedure in RFB patients only., Results: We enrolled 27 patients in the RFB group and 15 patients in the control group. The RFB and control groups were well matched [predominantly male: 62% vs 53%; CHA 2 DS 2 -VASc score: 1.9 ± 1.3 vs 1.5 ± 1.6; mean age 60 years in both groups]. All patients underwent successful ablation and completed study assessments. Clinically silent, new MRI diffusion weighted imaging cerebral lesions were observed in 8 patients (30%) in the RFB group and 1 patient (7%) in the control group, and 11 susceptibility weighted imaging lesions in the RFB group and 1 in the control group. Endoscopy showed a minor thermal injury in 1 patient in the RFB group., Conclusion: An increased rate of clinically silent cerebral events was seen in the RFB group. A low rate of esophageal thermal injury was observed., (© 2021 Heart Rhythm Society. Published by Elsevier Inc.)