Literature DB >> 33854004

Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation - The Prospective ICE-AGE-X Study.

Roland Richard Tilz1,2, Roza Meyer-Saraei1, Charlotte Eitel1, Thomas Fink1, Vanessa Sciacca1, Lisbeth Delgado Lopez1, Bettina Kirstein1, Michael Schlüter3, Julia Vogler1, Karl-Heinz Kuck1,3, Christian-H Heeger1,2.   

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℃ vs. -57±7℃, 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.

Entities:  

Keywords:  Acute efficacy; Atrial fibrillation; Cryoballoon; Pulmonary vein isolation

Mesh:

Year:  2021        PMID: 33854004     DOI: 10.1253/circj.CJ-21-0094

Source DB:  PubMed          Journal:  Circ J        ISSN: 1346-9843            Impact factor:   2.993


  9 in total

Review 1.  [Catheter ablation : Developments and technique selection].

Authors:  L Yahsaly; J Siebermair; R Wakili
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2022-02-18

2.  Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study.

Authors:  Andrew Martin; Marina Fowler; Toni Breskovic; Alexandre Ouss; Lukas Dekker; Sing-Chien Yap; Rohit Bhagwandien; Elizabeth M Albrecht; Nele Cielen; Elizabeth Richards; Binh C Tran; Nigel Lever; Ante Anic
Journal:  J Interv Card Electrophysiol       Date:  2022-04-12       Impact factor: 1.900

Review 3.  [Practical guide for safe and efficient cryoballoon ablation for atrial fibrillation : Practical procedure, tips and tricks].

Authors:  Julian Chun; Tilman Maurer; Andreas Rillig; Stefano Bordignon; Leon Iden; Sonia Busch; Daniel Steven; Roland R Tilz; Dong-In Shin; Heidi Estner; Felix Bourier; David Duncker; Philipp Sommer; Nils-Christian Ewertsen; Henning Jansen; Victoria Johnson; Livio Bertagnolli; Till Althoff; Andreas Metzner
Journal:  Herzschrittmacherther Elektrophysiol       Date:  2021-11-04

4.  Optimization of the transseptal procedural workflow using a novel integrated dilator and needle during a cryoballoon procedure.

Authors:  Sing-Chien Yap; Tamas Szili-Torok
Journal:  HeartRhythm Case Rep       Date:  2021-11-09

Review 5.  A tale of two balloons: technical and procedural difference between cryoballoon systems.

Authors:  Emrie Tomaiko-Clark; Rong Bai; Mateen Khokhar; Wilber W Su
Journal:  Curr Opin Cardiol       Date:  2022-01-01       Impact factor: 2.161

Review 6.  Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis.

Authors:  Amira Assaf; Rohit E Bhagwandien; Tamas Szili-Torok; Sing-Chien Yap
Journal:  Int J Cardiol Heart Vasc       Date:  2022-09-05

7.  Impact of pulmonary vein variant anatomy and cross-sectional orifice area on freedom from atrial fibrillation recurrence after cryothermal single-shot guided pulmonary vein isolation.

Authors:  Denise Guckel; Philipp Lucas; Khuraman Isgandarova; Mustapha El Hamriti; Leonard Bergau; Thomas Fink; Vanessa Sciacca; Martin Braun; Moneeb Khalaph; Guram Imnadze; Georg Nölker; Philipp Sommer; Christian Sohns
Journal:  J Interv Card Electrophysiol       Date:  2022-06-28       Impact factor: 1.759

8.  Comparison of procedural efficacy, balloon nadir temperature, and incidence of phrenic nerve palsy between two cryoballoon technologies for pulmonary vein isolation: A systematic review and meta-analysis.

Authors:  Amira Assaf; Rohit Bhagwandien; Tamas Szili-Torok; Sing-Chien Yap
Journal:  J Cardiovasc Electrophysiol       Date:  2021-07-26       Impact factor: 2.942

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

Authors:  Denise Guckel; Philipp Lucas; Khuraman Isgandarova; Mustapha El Hamriti; Leonard Bergau; Thomas Fink; Vanessa Sciacca; Guram Imnadze; Martin Braun; Moneeb Khalaph; Georg Nölker; Philipp Sommer; Christian Sohns
Journal:  J Cardiovasc Dev Dis       Date:  2022-01-08
  9 in total

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