Literature DB >> 27957211

CoolLoop® First: A First In Man Study To Test A Novel Circular Cryoablation System In Paroxysmal Atrial Fibrillation.

Markus Stuehlinger1, Simon Hoenig2, Karin Spuller1, Christian Koman1, Markus Stoeger1, Gerhard Poelzl1, Hanno Ulmer3, Otmar Pachinger1, Clemens Steinwender1.   

Abstract

INTRODUCTION: Pulmonary vein (PV) isolation is the mainstay of catheter treatment of paroxysmal atrial fibrillation (AF). The CoolLoop® cryoablation catheter (AFreeze® GmbH; Innsbruck, Austria) was developed to create wide and complete circular lesions around the PVs. In this study we evaluated feasibility and safety of this novel ablation system in humans.
METHODS: 10 patients (6M/4F; 57.6±7.6y) with paroxysmal AF were included in 2 referral centers. The CoolLoop® catheter was positioned at each PV antrum using a steerable transseptal sheath. Subsequently, 2-6 double-freezes over 5min were performed at each vein and PV-isolation was assessed thereafter using a circular mapping catheter. During cryoablation of the right PVs, pacing was used to monitor phrenic nerve function.
RESULTS: The CoolLoop® catheter could be successfully positioned at each PV. A mean of 5.6±1.8 cryoablations were performed in the LSPV, 5.2±1.6 in the LIPV, 6.3±2.5 in the RSPV and 5.4±1.6 in the RIPV, respectively. Mean procedure time was 251±60min and mean fluoroscopy time was 44.0±13.2min. 6 / 10 LSPV, 6 / 10 LIPV, 5 / 10 RSPV and 6 / 10 RIPV could be isolated exclusively using the novel cryoablation system. One patient developed groin hematoma and a brief episode of ST-elevation due to air embolism was observed in another subject. No other clinical complications occurred during 3 months of follow up.
CONCLUSIONS: PV-isolation for paroxysmal atrial fibrillation using the CoolLoop® catheter is feasible and appears safe. Clinical long term efficacy still needs to be evaluated and will be compared with established catheters used for AF ablation.

Entities:  

Keywords:  Ablation; Antrum; Cryothermia; Left Atrial Ablation; Pulmonary Vein Isolation

Year:  2015        PMID: 27957211      PMCID: PMC4955895          DOI: 10.4022/jafib.1287

Source DB:  PubMed          Journal:  J Atr Fibrillation        ISSN: 1941-6911


  14 in total

1.  Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial.

Authors:  Jason G Andrade; Paul Khairy; Laurent Macle; Doug L Packer; John W Lehmann; Richard G Holcomb; Jeremy N Ruskin; Marc Dubuc
Journal:  Circ Arrhythm Electrophysiol       Date:  2014-01-19

2.  Clinical presentation, investigation, and management of pulmonary vein stenosis complicating ablation for atrial fibrillation.

Authors:  Douglas L Packer; Paul Keelan; Thomas M Munger; Jerome F Breen; Sam Asirvatham; Laura A Peterson; Kristi H Monahan; Mary F Hauser; K Chandrasekaran; Lawrence J Sinak; David R Holmes
Journal:  Circulation       Date:  2005-02-08       Impact factor: 29.690

3.  Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial.

Authors:  Carlos A Morillo; Atul Verma; Stuart J Connolly; Karl H Kuck; Girish M Nair; Jean Champagne; Laurence D Sterns; Heather Beresh; Jeffrey S Healey; Andrea Natale
Journal:  JAMA       Date:  2014-02-19       Impact factor: 56.272

4.  Temporal relations of atrial fibrillation and congestive heart failure and their joint influence on mortality: the Framingham Heart Study.

Authors:  Thomas J Wang; Martin G Larson; Daniel Levy; Ramachandran S Vasan; Eric P Leip; Philip A Wolf; Ralph B D'Agostino; Joanne M Murabito; William B Kannel; Emelia J Benjamin
Journal:  Circulation       Date:  2003-05-27       Impact factor: 29.690

5.  Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study.

Authors:  Thomas Arentz; Reinhold Weber; Gerd Bürkle; Claudia Herrera; Thomas Blum; Jochem Stockinger; Jan Minners; Franz Josef Neumann; Dietrich Kalusche
Journal:  Circulation       Date:  2007-06-11       Impact factor: 29.690

6.  Atrial fibrillation as an independent risk factor for stroke: the Framingham Study.

Authors:  P A Wolf; R D Abbott; W B Kannel
Journal:  Stroke       Date:  1991-08       Impact factor: 7.914

7.  Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial.

Authors:  Douglas L Packer; Robert C Kowal; Kevin R Wheelan; James M Irwin; Jean Champagne; Peter G Guerra; Marc Dubuc; Vivek Reddy; Linda Nelson; Richard G Holcomb; John W Lehmann; Jeremy N Ruskin
Journal:  J Am Coll Cardiol       Date:  2013-03-21       Impact factor: 24.094

8.  Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary venous isolation?

Authors:  Vivek Y Reddy; Petr Neuzil; Andre d'Avila; Margaret Laragy; Zachary J Malchano; Stepan Kralovec; Steven J Kim; Jeremy N Ruskin
Journal:  Heart Rhythm       Date:  2007-11-07       Impact factor: 6.343

9.  Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.

Authors:  David J Wilber; Carlo Pappone; Petr Neuzil; Angelo De Paola; Frank Marchlinski; Andrea Natale; Laurent Macle; Emile G Daoud; Hugh Calkins; Burr Hall; Vivek Reddy; Giuseppe Augello; Matthew R Reynolds; Chandan Vinekar; Christine Y Liu; Scott M Berry; Donald A Berry
Journal:  JAMA       Date:  2010-01-27       Impact factor: 56.272

10.  Cryoballoon ablation for atrial fibrillation.

Authors:  Jason G Andrade; Marc Dubuc; Peter G Guerra; Laurent Macle; Lena Rivard; Denis Roy; Mario Talajic; Bernard Thibault; Paul Khairy
Journal:  Indian Pacing Electrophysiol J       Date:  2012-04-30
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