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

EP Europace ◽  
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.

scholarly journals News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

2022 ◽  
Vol 9 (1) ◽  
pp. 16
Author(s):  
Denise Guckel ◽  
Philipp Lucas ◽  
Khuraman Isgandarova ◽  
Mustapha El Hamriti ◽  
Leonard Bergau ◽  
...  
Keyword(s):  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Pulmonary Veins ◽  
Major Complication ◽  
Single Shot ◽  
The Novel ◽  
Clinical Experiences ◽  
Front Advance ◽  
Arctic Front ◽  
Cold Chamber

Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 ± 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 ± 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 ± 23.2 min, AFA 100.9 ± 21.3 min; p < 0.001) and fluoroscopy time (POLARx 10.5 ± 5.9 min, AFA 4.8 ± 3.6 min; p < 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx −57.7 ± 0.9 °C, AFA −45.1 ± 2.6 °C; p < 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures.

scholarly journals Myocardial injury after pulmonary vein isolation: fire versus ice

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.

scholarly journals Short tip–more function? Atrial fibrillation ablation using the novel third-generation cryoballoon in resected pulmonary vein

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Shaojie Chen ◽  
Boris Schmidt ◽  
Stefano Bordignon ◽  
Fabrizio Bologna ◽  
K. R. Julian Chun
Keyword(s):  
Atrial Fibrillation ◽  
Real Time ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Pulmonary Veins ◽  
Cryoballoon Ablation ◽  
Third Generation ◽  
The Novel ◽  
Case Presentation ◽  
Pulmonary Surgery

Abstract Background Cryoballoon ablation is an established procedure for atrial fibrillation (AF). Patients who had previous pulmonary surgery undergoing pulmonary vein isolation (PVI) were seldom reported. Case presentation We describe an AF ablation using the novel short-tip third-generation cryoballoon in a patient with resected pulmonary vein. All pulmonary veins were successfully isolated without complication. The short-tip third-generation cryoballoon shows advantageous profile in PVI for AF patients with previous pulmonary surgery. Conclusions This report indicates that for AF patient who had previous resected PV surgery, the short-tip CB 3 provides an ideal device option for real-time PVI.

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

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

scholarly journals Pulmonary vein isolation for AF: does technique influence outcome?

EP Europace ◽  
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 &lt; 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&lt;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

scholarly journals Real time assessment of pulmonary vein isolation using the novel Achieve mapping catheter during cryoablation

2013 ◽  
Vol 34 (suppl 1) ◽  
pp. P516-P516
Author(s):  
R. P. Martins ◽  
O. Cesari ◽  
N. Behar ◽  
R. Bacquelin ◽  
J. Lacaze-Gadonneix ◽  
...  
Keyword(s):  
Real Time ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
The Novel ◽  
Time Assessment ◽  
Mapping Catheter

scholarly journals First insight into a novel irrigated radiofrequency ablation balloon

EP Europace ◽  
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.

scholarly journals Left Atrial Fibrosis after Single Shot Guided Pulmonary Vein Isolation

2021 ◽  
Vol 10 (19) ◽  
pp. 4478
Author(s):  
Shibu Mathew ◽  
Islam Saboukh ◽  
Parminder Singh ◽  
Bastian Fries ◽  
Victoria Johnson ◽  
...  
Keyword(s):  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Pulmonary Veins ◽  
Posterior Wall ◽  
Outcome Data ◽  
Fourth Generation ◽  
Cycle Duration ◽  
Single Shot ◽  
Term Outcome ◽  
Long Term Outcome

Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment modality for patients with atrial fibrillation (AF) with encouraging acute and long-term outcome data. However, the size of collaterally created lesion sets adjacent to the pulmonary veins (PVs) remains unclear, especially when CB ablation is performed with individualized time-to-isolation (TTI) protocols. This study seeks to investigate the extension of lesions at the posterior wall and the roof of the left atrium (LA). Thirty patients with paroxysmal or persistent AF underwent ablation with a fourth-generation CB. The individual freeze-cycle duration was set at TTI + 120 s. A total of 120 PVs were identified, and all were successfully isolated. A three-dimensional electroanatomical high-density (HD) mapping of the LA was performed in every patient before and after PVI. The surface areas of the posterior wall and LA roof were measured and compared with lesion extension after PVI. After CB ablation, 65.6 ± 16.9% of the posterior wall and 75.4 ± 18.4% of the LA roof remained unablated. In addition, non-antral lesion formation was observed in every patient in at least one PV. After CB ablation, anterior antral parts of the superior PVs showed the greatest unablated areas compared with the other antral areas. HD re-mapping after CB-based PVI demonstrated that major regions of the posterior wall and roof remained electrically normal and unaffected. Unablated antral areas were localized predominantly in the anterior segments of the superior PVs and may be partly responsible for AF recurrence.

scholarly journals Is there a change in P wave parameters following pulmonary vein isolation (PVI) using radiofrequency ablation (RF) vs. cryoballoon ablation (CRYO) for paroxysmal atrial fibrillation (PAF)?

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
I Antoun ◽  
S Bharat ◽  
A Mavilakandy ◽  
V Pooranachandran ◽  
GA Ng
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
P Wave ◽  
Cryoballoon Ablation ◽  
Single Shot ◽  
P Waves ◽  
Significant Difference ◽  
Before And After

Abstract Funding Acknowledgements Type of funding sources: None. Pulmonary vein isolation (PVI) is an effective and established therapy for paroxysmal atrial fibrillation (PAF) . PVI can be performed using point by point ablation with radiofrequency (RF) or with single shot techniques such as cryoballoon (CRYO). As P waves represent atrial depolarization, we aimed to study whether P wave metrics may change after PVI and if there are differences between RF and CRYO approaches. Methods We studied 88 matched patients who had PVI for PAF between January 2017 and December 2018 (RF = 44, CRYO = 44). Each patient was in sinus rhythm (SR) prior to ablation. Patients on amiodarone and those who had additional linear ablation were excluded. Patients had continuous ECG monitoring using Labsystem Pro (Boston Scientific Inc). Sampled at 1kHz during the procedure. One-minute recordings before and after PVI were exported and analysed using custom-written software using MatLab (v2018, bandpass 1-50Hz) to annotate P wave onset, peak and end. P wave duration was heart rate corrected (PWDc) by using the Hodges formula and P wave amplitude (PWA). Results P wave metrics were comparable before PVI between both cohorts. Successful PVI was achieved in all patients. There was a trend towards an increase in PWDc in some ECG leads with either RF or CRYO but no significant difference in P wave metrics as a result of PVI ablation or between both ablation modalities. Conclusion In this study, there was no significant change seen in PVI with RF or CRYO and no difference between the 2 ablation modalities. P wave metrics comparison, RF vs CRYO PWDc (ms) PRE, RF (n = 44) POST, RF (n = 44) P PRE, CRYO (n = 44) POST CRYO (n = 44) P P (RF vs CRYO) I 134.7 ± 32 133.5 ± 35 0.813 131.9 ± 36 132.7 ± 39 0.9 0.81 II 140.9 ± 34 144.1 ± 37 0.56 139.4 ± 42 134.4 ± 40 0.51 0.41 III 131.5 ± 31 143.3 ± 37 0.04 132.8 ± 41 130.6 ± 36 0.68 0.074 AVF 137 ± 32 144.7 ± 36 0.15 137.5 ± 42 127.4 ± 37 0.11 0.141 V1 143.9 ± 33 151.8 ± 37 0.17 133.6 ± 37 143.8 ± 38 0.09 0.745 PWA (mV) PRE, RF (n = 44) POST, RF (n = 44) P PRE, CRYO (n = 44) POST CRYO (n = 44) P P (RF vs CRYO) I 0.125 ± 0.08 0.09 ± 0.06 0.002 0.13 ± 0.08 0.14 ± 0.09 0.59 0.076 II 0.238 ± 0.1 0.238 ± 0.1 0.98 0.232 ± 0.1 0.278 ± 0.2 0.1 0.212 III 0.149 ± 0.1 0.153 ± 0.1 0.83 0.189 ± 0.1 0.187 ± 0.1 0.97 0.86 AVF 0.195 ± 0.1 0.196 ± 0.1 0.92 0.197 ± 0.1 0.247 ± 0.1 0.066 0.132 V1 0.122 ± 0.1 0.151± 0.1 0.05 0.138 ± 0.1 0.193 ± 0.2 0.002 0.543 PWDc and PWA comparison following RF vs CRYO.

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