First insight into a novel irrigated radiofrequency ablation balloon

Abstract Funding Acknowledgements Type of funding sources: None. Background A novel irrigated RF balloon (RFB) for pulmonary vein isolation (PVI) was recently released in selected centers . It is a 28 mm open irrigated balloon with 10 unipolar electrodes on its surface to deploy a circular ostial lesion set around the PVs. An inner lumen spiral catheter allows for real time PVI visualization during the ablation. Methods Data from consecutive RFB procedures were collected and analysed. After a single transseptal puncture and selective PV angiograms a 3D map of the left atrium was acquired. Sequential PVI was performed using the RFB: each application lasted 60 seconds, the posterior electrodes were identified to stop the energy delivery after 20 seconds. Real time to isolation data were acquired. A 3D bipolar remap was finally performed to observe the level of isolation. A temperature probe was used to monitor the local esophageal temperature (LET) with a cut off of 39°C. Acute procedural data and complication were collected. Endoscopy was scheduled the day after procedure. Results Data from 10 consecutive RFB procedures were analyzed: 6/10 patients were male, 67 ± 9 years old, 8/10 with history of paroxysmal AF. A total of 36 PVs were targeted and isolated with the RFB, with a mean of 7,3 ± 4,0 applications per patient and 2,0 ± 1,2 applications per PV. First pass "single shot" isolation was achieved in 22/36 (61%), time to isolation during the first application was observed in 29/36 (80%) PVs, but an acute reconnection was observed in 10/29 (35%) isolated PVs. Mean time to sustained isolation was 13 ± 5 sec., mean time to non-sustained isolation was significantly longer (29 ± 17 sec; p = 0,001). Procedure time was 57 ± 16 min., left atrial dwell time 50 ± 14 min, ablation phase time 29 ± 14 min and fluoroscopy time was 10 ± 4 minutes. An esophageal temperature above 39°C was recorded in 2/36 PVs. No phrenic nerve palsy was recorded. 7/10 patients underwent endoscopy and no thermal lesions were detected. No other complications were recorded. Conclusion The novel irrigated RFB seems to allow an effective, safe and fast pulmonary vein isolation. More studies are needed to optimize energy dosing to possibly increase the rate of durable single shot PVI.

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High rates of single shot pulmonary vein isolation and real time pulmonary vein potential visualization using the second generation 28mm Cryoballoon

European Heart Journal ◽

10.1093/eurheartj/eht310.p5641 ◽

2013 ◽

Vol 34 (suppl 1) ◽

pp. P5641-P5641

Author(s):

S. Bordignon ◽

A. Fuernkranz ◽

A. Konstantinou ◽

B. Schulte-Hahn ◽

B. Nowak ◽

...

Keyword(s):

Real Time ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Second Generation ◽

Single Shot

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Esophageal temperature change and esophageal thermal lesions after pulmonary vein isolation using the novel endoscopic ablation system

Heart Rhythm ◽

10.1016/j.hrthm.2011.01.022 ◽

2011 ◽

Vol 8 (6) ◽

pp. 815-820 ◽

Cited By ~ 30

Author(s):

Andreas Metzner ◽

Boris Schmidt ◽

Alexander Fuernkranz ◽

Erik Wissner ◽

Roland Richard Tilz ◽

...

Keyword(s):

Pulmonary Vein ◽

Temperature Change ◽

Pulmonary Vein Isolation ◽

The Novel ◽

Esophageal Temperature ◽

Thermal Lesions ◽

Endoscopic Ablation

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Pulmonary vein isolation for AF: does technique influence outcome?

EP Europace ◽

10.1093/europace/euab116.060 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

SA Reddy ◽

SL Nethercott ◽

BV Khialani ◽

MS Virdee

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

De Novo ◽

Outcome Data ◽

Adverse Event Rate ◽

Single Shot ◽

Funding Sources ◽

Significant Difference ◽

Single Centre Study ◽

Unselected Population

Abstract Funding Acknowledgements Type of funding sources: None. Background Over the last 20 years various techniques have been developed striving for safer and more durable pulmonary vein isolation (PVI). The three most commonly used tools are pulmonary vein ablation catheter (PVAC) and cryoballoon (‘single-shot’ techniques), and point-by-point (PBP) radiofrequency ablation using 3D electroanatomical mapping (EAM). Objective Evaluate the safety and efficacy of the different techniques in an unselected population undergoing de-novo ablation for persistent or paroxysmal atrial fibrillation (AF) at a single high-throughput centre. Method Retrospective, single-centre study of consecutive AF ablations between March 2017 and April 2018. Demographic, procedural and outcome data were analysed. Results Over the study period 329 first-time PVI procedures were performed. 37.4% were performed using PBP, 39.8% using cryoballoon and 22.8% using PVAC. There was no significant difference in age or sex between different ablation technique groups. 238 procedures were performed for paroxysmal AF and 91 for persistent AF. A higher proportion of the persistent cases were performed using point-by-point techniques compared to paroxysmal cases (58.2% vs 29.0%, p < 0.05). Procedural times were significantly longer in the group undergoing PBP ablation compared to cryoballoon or PVAC. However, there was no statistically significant difference in 12-month freedom from symptomatic AF or procedural complications between the groups. Conclusions PBP, PVAC and cryoballoon AF ablation all appeared equally efficacious in an unselected population, though PVAC and cryoballoon procedures were shorter. All procedures were associated with a low adverse event rate. Prospective examination is required to substantiate this finding. Table 1CARTOn= 123Cryoballoonn= 131PVACn = 75p-valueAge/years61.7 ± 9.259.5 ± 10.661.7 ± 9.70.14Male92 (74.8)88 (67.2)49 (61.3)0.80Paroxysmal AF70 (56.9)106 (78.6)62 (82.7)0.14Cardiovascular risk factors Hypertension Diabetes Ischaemic heart disease Cerebrovascular disease Heart failure Dyslipidaemia73 (59.3)23 (18.7)40 (32.5)2 (1.6)0 (0) 12 (9.8)79 (60.3)19 (14.5)45 (34.4)0 (0)1 (0.8)16 (12.2)43 (57.3)16 (21.3)22 (29.3)1 (1.3)0 (0)10 (13.3) 0.58 0.24 0.62 - - 0.71Left atrial diameter/cm4.2 ± 0.74.1 ± 0.73.9 ± 1.00.69Procedure time/mins191.3 ± 39126.7 ± 24117.4 ± 30<0.056 month success Paroxysmal Persistent50/66 (75.8)32/51 (62.7)78/103 (75.7)18/24 (75.0)48/61 (78.6)10/12 (83.3) 0.99 0.80Complications9 (7.3)3 (2.3)1 (1.3)0.07Patient demographics, procedural characteristics and outcomes for Carto, cryoballoon and PVAC cases. Values presented as mean ± SD or n (%)Abstract Figure. Time to arrhythmia recurrence

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Novel cryo-balloon ablation technology for pulmonary vein isolation in patients with atrial fibrillation: preliminary experience from a multicenter clinical practice

EP Europace ◽

10.1093/europace/euab116.201 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

C Tondo ◽

G Stabile ◽

P Filannino ◽

M Moltrasio ◽

A De Simone ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Single Shot ◽

Funding Sources ◽

Clinical Practice Setting ◽

The Mean ◽

Grade 3 ◽

Exit Block

Abstract Funding Acknowledgements Type of funding sources: None. Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). Recently, a new cryoablation system (POLARx) with unique features has been made available for clinical use. To date, no data exist on procedural characteristics of this system in a multicentric clinical practice. Purpose We aimed to characterize the initial experience of this technology in the Italian clinical practice. Methods Consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 5 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation (TTI) was not available. The ablation endpoint was PV isolation as assessed by entrance and exit block. Results Two-hundred sixty-two cryoapplications from 49 pts (194 PVs) were analyzed. PVI was achieved with cryoablation only in all pts. The mean number of freeze applications per pt was 5.3 ± 1.5 (1.3 ± 0.6 for LIPV, LSPV and RSPV, 1.6 ± 1.3 for RIPV), with 143 (73.7%) PVs treated in a single-shot fashion (38, 19.6% with 2 shots; 13, 6.7% with more than 2 shots). Sixteen (33%) pts were treated with a single freeze to each of the PVs. The mean nadir temperature was -55.5 ± 6.9 °C and was colder than -50°C in 83% of the PVs. TTI information was evaluable in 120 (46%) cryoapplications with a median TTI of 47 [32-75] sec (median temperature at TTI = -49 [-53 to -42] °C). The mean time to target -40 °C (TTT) was 30.1 ± 6.9 sec with a TTT < 60 sec achieved in 99.2% of the cryoapplications; the mean thaw time to 0 °C was 18.6 ± 5.8 sec (thaw time >15 sec in 70.3% of the cryoapplications). The mean PV occlusion grade (rank 1-4) was 3.6 ± 0.6 (grade 2 in 5.2% of the cases, grade 3 in 25.6% and grade 4 in 69.2%). No complications were observed at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, the novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. Cooling parameters seem to be slightly different from reference cryo-balloon technology.

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Novel cryoballoon ablation system for single shot pulmonary vein isolation: The prospective ICE-AGE-X Study

EP Europace ◽

10.1093/europace/euab116.229 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

RRT Tilz ◽

RMS Meyer-Saraei ◽

JV Vogler ◽

TF Fink ◽

VS Sciacca ◽

...

Keyword(s):

Real Time ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

The Arctic ◽

Fourth Generation ◽

Single Shot ◽

The Novel ◽

Efficacy And Safety ◽

Significant Difference ◽

Arctic Front

Abstract Funding Acknowledgements Type of funding sources: None. Background The arctic front cryoballon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome data. The POLARx cryoballoon incorporates unique features which may translate into improved efficacy and safety. Purpose To assess efficacy and safety of the novel POLARx cryoballoon in comparison to the fourth generation arctic front cryoballon (AF-CB4). Methods Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation (AF) were prospectively enrolled, underwent POLARx based PVI (POLARx group) and were compared to 25 consecutive patients treated with the fourth generation AF-CB (AF-CB4 group). Results A total of 100 (POLARx) and 97 (AF-CB4) pulmonary veins (PV) were identified and all PVs were successfully isolated utilizing the POLARx and AF-CB4, respectively. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (-50 ± 6°C vs. -57 ± 7°C, p = 0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (p < 0.001). Despite a certain learning curve utilizing the POLARx a trend towards shorter median procedure time (POLARx: 45 (39, 53) minutes vs. AF-CB4: 55 (50, 60) minutes (p = 0.062) was found. No differences were observed for periprocedural complications. Conclusions The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4.

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Incidence of Significant Delayed Esophageal Temperature Drop After Cryoballoon-Based Pulmonary Vein Isolation

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.13008 ◽

2016 ◽

Vol 27 (8) ◽

pp. 913-917 ◽

Cited By ~ 4

Author(s):

SEBASTIAN DEISS ◽

ANDREAS METZNER ◽

FEIFAN OUYANG ◽

ROLAND R. TILZ ◽

SHIBU MATHEW ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Temperature Drop ◽

Esophageal Temperature

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B-AB06-03 PRECLINICAL ASSESSMENT OF THE FEASIBILITY, SAFETY AND LESION DURABILITY OF A NOVEL “SINGLE-SHOT” PULSE FIELD ABLATION CATHETER FOR PULMONARY VEIN ISOLATION

Heart Rhythm ◽

10.1016/j.hrthm.2021.06.038 ◽

2021 ◽

Vol 18 (8) ◽

pp. S10-S11

Author(s):

Jacob S. Koruth ◽

Iwanari Kawamura ◽

Srinivas R. Dukkipati ◽

William Whang ◽

Mohit Turagam ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Pulse Field ◽

Single Shot ◽

Ablation Catheter

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Pulmonary vein isolation by irreversible electroporation: an efficacy and safety study in 20 patients with atrial fibrillation

EP Europace ◽

10.1093/europace/euab116.095 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

P Loh ◽

MHA Groen ◽

K Taha ◽

FHM Wittkampf ◽

PA Doevendans ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Conscious Sedation ◽

Brain Mri ◽

Irreversible Electroporation ◽

Cerebral Lesions ◽

Private Company ◽

Funding Sources ◽

Before And After

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background Irreversible electroporation (IRE) is a promising new non-thermal ablation technology for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). First in human studies demonstrated the feasibility and safety of IRE PVI. Objective Further investigate the safety of IRE PVI. Methods Twenty patients with symptomatic AF underwent IRE PVI under conscious sedation. Oral anticoagulation was uninterrupted and heparin was administered to maintain activated clotting time at 300-350 seconds. Non-arcing, non-barotraumatic 6 ms, 200 J IRE applications were delivered via a custom non-steerable 8 F, 14-polar circular IRE ablation catheter with a variable hoop diameter (16-27 mm). Voltage mapping of the left atrium and the PVs was performed before and after ablation with a conventional circular mapping catheter. For both catheters a single transseptal access (8 F introducer, Agilis NxTTM) was used. Adenosine testing was performed after a 30-minute waiting period. On day 1 after ablation, patients underwent esophagoscopy and brain MRI (DWI/FLAIR). If abnormalities were detected, examinations were repeated in due time. Results In 20 patients, all 80 PVs could be successfully isolated with a mean of 11,8 ± 1,4 IRE applications per patient. Average time from first to last IRE application was 22 ± 5 minutes, total procedure duration was 107 ± 13 minutes and total fluoroscopy time was 23 ± 5 minutes. One PV reconnection occurred during adenosine testing, re-isolation was achieved with 2 additional IRE pulses. No periprocedural complications were observed. Brain MRI on day 1 after ablation showed punctate asymptomatic lesions in 3/20 patients (15%). At follow-up MRI the lesion disappeared in 1 patient while in the other 2 patients 1 lesion persisted. Esophagoscopy on day 1 showed an asymptomatic esophageal lesion in 1/20 patients (5%), at repeat esophagoscopy on day 22 the lesion had resolved completely. Conclusion Acute electrical PV isolation could be achieved safely and rapidly by IRE ablation under conscious sedation in 20 patients with symptomatic AF. Acute silent cerebral lesions were detected in 3/20 patients (15%) and may be due to ablation or to changes of therapeutic and diagnostic catheters over a single transseptal access.

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Gastric Hypomotility After Luminal Esophageal Temperature Guided Second-Generation Cryoballoon Pulmonary Vein Isolation

Circulation Arrhythmia and Electrophysiology ◽

10.1161/circep.118.006691 ◽

2018 ◽

Vol 11 (8) ◽

Cited By ~ 1

Author(s):

Kanae Hasegawa ◽

Shinsuke Miyazaki ◽

Kaori Hisazaki ◽

Kenichi Kaseno ◽

Naoki Amaya ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Second Generation ◽

Esophageal Temperature

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Myocardial injury after pulmonary vein isolation: fire versus ice

European Heart Journal ◽

10.1093/eurheartj/ehab724.0368 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

A R Morgado Gomes ◽

N S C Antonio ◽

S Silva ◽

M Madeira ◽

P Sousa ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Troponin I ◽

Surrogate Marker ◽

High Sensitivity ◽

Cryoballoon Ablation ◽

Single Shot ◽

High Sensitivity Troponin ◽

Ablation Index ◽

Significant Difference

Abstract Introduction The cornerstone of atrial fibrillation (AF) catheter ablation is pulmonary vein isolation (PVI), either using point-by-point radiofrequency ablation (RF) or single-shot ablation devices, such as cryoballoon ablation (CB). However, achieving permanent transmural lesions is difficult and pulmonary vein (PV) reconnection is common. Elevation of high-sensitivity Troponin I (hsTnI) may be used as a surrogate marker for transmural lesions. Still, data regarding the comparison of hsTnI increase after PVI with RF or cryo-energy is controversial. Purpose The aim of this study is to compare the magnitude of hsTnI elevation after PVI with CB versus RF using ablation index guidance. Methods Prospective study of 60 patients admitted for first ablation procedure of paroxysmal or persistent AF in a single tertiary Cardiology Department. Thirty patients were submitted to PVI using CB and 30 patients were submitted to RF, using CARTO® mapping system and ablation index guidance. Patients with atrial flutter were excluded. Baseline characteristics were compared between groups, as well as hsTnI before and after the procedure. Results Mean age was 57.9±12.3 years old, 62% of patients were male and 77% had paroxysmal AF. There were no significant differences between groups regarding gender, age, prevalence of hypertension, dyslipidaemia, diabetes, obesity or AF type. There was also no significant difference in electrical cardioversion need during the procedure. HsTnI median value before ablation was 1.90±1.98 ng/dL. Postprocedural hsTnI was significantly higher in CB-group (6562.7±4756.2 ng/dL versus 1564.3±830.7 ng/dL in RF-group; P=0.001). Regarding periprocedural complications, there was only one case of mild pericardial effusion in RF-group associated with postablation hsTnI of 1180.0 ng/dL. Conclusions High-sensitivity Troponin I was significantly elevated after PVI, irrespective of the ablation technique. In CB-group, hsTnI elevation was significantly higher than in RF-group. This disparity may reflect more extensive lesions with cryoablation, without compromising safety. Longterm studies are needed to understand whether this hsTnI elevation is predictive of a lower AF recurrence rate. FUNDunding Acknowledgement Type of funding sources: None.

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