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

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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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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Complications of Cryoballoon Pulmonary Vein Isolation

Arrhythmia & Electrophysiology Review ◽

10.15420/aer.2018.72.2 ◽

2019 ◽

Vol 8 (1) ◽

pp. 60-64 ◽

Cited By ~ 2

Author(s):

Shinsuke Miyazaki ◽

Hiroshi Tada

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

First Generation ◽

Standard Technique ◽

Collateral Damage ◽

Efficacy And Safety ◽

The World

Since the cryoballoon (CB) was introduced into clinical practice, more than 400,000 patients have undergone a pulmonary vein (PV) isolation with a CB throughout the world. Although the efficacy of the first-generation CB was limited, the recently introduced secondgeneration CB has achieved a greater uniformity in cooling, which has facilitated a shorter time to PV isolation, shorter procedural times, higher rates of freedom from atrial fibrillation and low rates of PV reconnections. Currently, a single short freeze strategy with a single 28 mm balloon has become the standard technique based on the balance of procedural efficacy and safety. However, enhanced cooling characteristics may also result in a greater potential for collateral damage to non-cardiac structures. Knowledge about the potential complications is essential when performing the procedure. In this article, we describe the important complications that should be noted during a CB procedure, and how to minimise the risk of complications based on our experience.

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Catheter ablation of atrial fibrillation without pulmonary vein isolation

EP Europace ◽

10.1093/europace/euab116.258 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

P Futyma ◽

L Zarebski ◽

A Wrzos ◽

M Futyma ◽

P Kulakowski

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Superior Vena ◽

Vena Cava ◽

Funding Sources ◽

The Right ◽

Ganglionated Plexus

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation (CA) of atrial fibrillation (AF), however, long-term efficacy of PVI is frequently below expectations. PVI is invasive, expensive and may be associated with devastating complications. It has been postulated that vagally-mediated AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation by means of radiofrequency CA (RFCA) of the right anterior ganglionated plexus (RAGP), however, data in literature and guidelines are lacking. Purpose To examine the efficacy of RFCA targeting RAGP without PVI in management of vagal AF. Methods We included consecutive 9 male patients with vagal AF who underwent RFCA of RAGP without PVI. RAGP was targeted anatomically from the right atrium (RA) at the postero-septal area below superior vena cava (SVC) and from the left atrium (LA) if needed. The aim was to achieve >30% increase in heart rate (HR) . The follow up consisted of regular visits and Holter ECG conducted every 3 months. Results A total number of 9 patients (age 52 ± 13) with vagally-mediated AF underwent RFCA of RAGP (mean RAGP RF time 147 ± 85, max power 34 ± 8W). The mean procedure time was 60 ± 29min. HR increase >30% was achieved in 8 (89%) patients (pre-RF vs post-RF: 58 ± 8bpm vs 87 ± 12bpm, p = 0.00002) . Transseptal to reach RAGP also from the LA was needed in 2 (22%) patients. There were no major complications during the procedures. The follow up lasted 6 ± 2 months. Antiarrhythmic drugs were discontinued in 8 (89%) patients. There was 1 (11%) AF recurrence in the patient in whom targeted HR acceleration during RFCA was not achieved. B-blockers were administered in 6 (67%) patients due to increased HR and such treatment was well tolerated by all. Conclusions Catheter ablation of RAGP without performing PVI is feasible and can be effective in majority of patients with vagally-mediated AF. Increased HR after such cardioneuroablation can be well controlled using b-blockers and is usually associated with mild symptoms. The role of cardioneuroablation for treatment of vagally-mediated AF needs to be determined in prospective trials. Abstract Figure. Cardioneuroablation in vagal AF

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Non-inducibility post-pulmonary vein isolation achieving exit block predicts freedom from atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehi507 ◽

2005 ◽

Vol 26 (23) ◽

pp. 2550-2555 ◽

Cited By ~ 66

Author(s):

Vidal Essebag ◽

Ferdinando Baldessin ◽

Matthew R. Reynolds ◽

Seth McClennen ◽

Jignesh Shah ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Exit Block

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Initial clinical experience of pulmonary vein isolation using the novel ultra-low temperature cryoablation catheter for patients with atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehab724.0355 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

S Tohoku ◽

S Bordignon ◽

S Chen ◽

B Schmidt ◽

K R J Chun

Keyword(s):

Atrial Fibrillation ◽

Low Temperature ◽

Pulmonary Vein ◽

Cooling Power ◽

The Novel ◽

Funding Sources ◽

Initial Application ◽

First Pass ◽

The Mean ◽

Ischemic Attack

Abstract Background The high cooling power and ultra-low temperature cryoablation (ULTC) catheter called “Adagio” has been recently launched. A combination of a newly exploited cryogen and interchangeable stylet enables flexible and continuous lesion creation applicable not only for atrial fibrillation (AF) but also for other tachyarrhythmia by optimizing catheter shape. The exclusive esophageal warming balloon in order to preserve esophageal temperature is encouraged to prevent the potential risk of esophageal complication during procedure. Aim To assess the initial clinical data on pulmonary vein (PV) isolation for patients with AF using the novel ULTC catheter. Methods Consecutive patients who underwent AF ablation using ULTC in our center were enrolled. We assessed the acute procedural data focusing on procedural feasibility and safety comprising “first-pass isolation” defined as successful PV isolation after the initial application. Results A total of 16 AF patients (53% male, age 67 years, 59% paroxysmal AF) were analyzed. Sixty-six out of 67 PVs (98.5%) were isolated with ULTC. The mean number of applications per PV was 2.3 1.1. Touch-up catheter was needed in one case at left inferior PV. The mean total procedure and fluoroscopy times were 79±30 and 14±7 mins, respectively. First-pass isolation was achieved in 34 PVs (50.7%) varying across PVs from left superior PV (43.8%) to right superior PV (58.8%). In none of the patients an acute thromboembolic event (stroke or transient ischemic attack), a pericardial effusion/tamponade and postprocedural esophageal complication occurred. A single transient phrenic nerve weakening was observed at right superior PV. Conclusion Sequential PV isolation using the novel ULTC catheter was achieved feasibly without compromising safety. First-pass isolation was accomplished about in a half of PVs. FUNDunding Acknowledgement Type of funding sources: None.

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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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First insight into a novel irrigated radiofrequency ablation balloon

EP Europace ◽

10.1093/europace/euab116.092 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

S Bordignon ◽

S Tohoku ◽

S Chen ◽

F Bologna ◽

C Throm ◽

...

Keyword(s):

Real Time ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Single Shot ◽

Esophageal Temperature ◽

Phrenic Nerve Palsy ◽

Funding Sources ◽

Thermal Lesions ◽

Ostial Lesion ◽

Mean Time

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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