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

Roland Richard Tilz; Roza Meyer-Saraei; Charlotte Eitel; Thomas Fink; Vanessa Sciacca; Lisbeth Delgado Lopez; Bettina Kirstein; Michael Schlüter; Julia Vogler; Karl Heinz Kuck; Christian H. Heeger

doi:10.1253/circj.CJ-21-0094

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

Roland Richard Tilz^*, Roza Meyer-Saraei, Charlotte Eitel, Thomas Fink, Vanessa Sciacca, Lisbeth Delgado Lopez, Bettina Kirstein, Michael Schlüter, Julia Vogler, Karl Heinz Kuck, Christian H. Heeger^*

^*Corresponding author for this work

Department of Internal Medicine II

46 Citations (Scopus)

Abstract

Background: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4). Methods and Results: Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. 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). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications. Conclusions: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.

Original language	English
Journal	Circulation Journal
Volume	85
Issue number	8
Pages (from-to)	1296-1304
Number of pages	9
ISSN	1346-9843
DOIs	https://doi.org/10.1253/circj.CJ-21-0094
Publication status	Published - 2021

Funding

C.-H.H. received travel grants and research grants from Boston Scientific, Biosense Webster and Cardiofocus and Speaker´s Honoraria from Boston Scientific, Biosense Webster and Cardiofocus. R.R.T. is a consultant for Boston Scientific, Biotronik and Biosense Webster and received Speaker’s Honoraria from Biosense Webster, Medtronic, Boston Scientific and Abbot Medical. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, Biosense Webster outside submitted work. All other authors have no relevant disclosures to declare.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research Areas and Centers

Centers: Cardiological Center Luebeck (UHZL)

DFG Research Classification Scheme

2.22-12 Cardiology, Angiology

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10.1253/circj.CJ-21-0094

Cite this

@article{fa68a624538c44c4bd953b74f24593cf,

title = "Novel cryoballoon ablation system for single shot pulmonary vein isolation - The prospective ICE-AGE-X study",

abstract = "Background: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4). Methods and Results: Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. 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). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications. Conclusions: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.",

author = "Tilz, \{Roland Richard\} and Roza Meyer-Saraei and Charlotte Eitel and Thomas Fink and Vanessa Sciacca and Lopez, \{Lisbeth Delgado\} and Bettina Kirstein and Michael Schl{\"u}ter and Julia Vogler and Kuck, \{Karl Heinz\} and Heeger, \{Christian H.\}",

year = "2021",

doi = "10.1253/circj.CJ-21-0094",

language = "English",

volume = "85",

pages = "1296--1304",

journal = "Circulation Journal",

issn = "1346-9843",

publisher = "Japanese Circulation Society",

number = "8",

}

TY - JOUR

T1 - Novel cryoballoon ablation system for single shot pulmonary vein isolation - The prospective ICE-AGE-X study

AU - Tilz, Roland Richard

AU - Meyer-Saraei, Roza

AU - Eitel, Charlotte

AU - Fink, Thomas

AU - Sciacca, Vanessa

AU - Lopez, Lisbeth Delgado

AU - Kirstein, Bettina

AU - Schlüter, Michael

AU - Vogler, Julia

AU - Kuck, Karl Heinz

AU - Heeger, Christian H.

PY - 2021

Y1 - 2021

N2 - Background: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4). Methods and Results: Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. 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). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications. Conclusions: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.

AB - Background: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4). Methods and Results: Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. 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). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications. Conclusions: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.

UR - https://www.scopus.com/pages/publications/85111373723

U2 - 10.1253/circj.CJ-21-0094

DO - 10.1253/circj.CJ-21-0094

M3 - Journal articles

C2 - 33854004

AN - SCOPUS:85111373723

SN - 1346-9843

VL - 85

SP - 1296

EP - 1304

JO - Circulation Journal

JF - Circulation Journal

IS - 8

ER -

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

Abstract

Funding

UN SDGs

Research Areas and Centers

DFG Research Classification Scheme

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