Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy
Florian Straube,Uwe Dorwarth,Juergen Vogt,Malte Kuniss,Karl-Heinz Kuck,Juergen Tebbenjohanns,Arcadi Garcia Alberola,Kyoung Ryul Julian Chun,Joseph J. Souza,Taoufik Ouarrak,Jochen Senges,Johannes Brachmann,Thorsten Lewalter,Ellen Hoffmann +13 more
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TLDR
Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure, and the safety profile remains favourable with a non-significant trend for more phrenic nerve palsies.Abstract:
Aims Cryoballoon (CB) ablation with the second-generation cryoballoon (CBG2) seems to be more effective than its predecessor [first-generation cryoballoon (CBG1)], but phrenic nerve palsies were observed more frequently. The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a substudy of the prospective multicentre, multinational FREEZE Cohort Study.
Methods and results Periprocedural data were analysed, and a total of 532 patients with paroxysmal atrial fibrillation (AF) were examined ( n = 224 for CBG1 and n = 308 for CBG2). Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 ( P < 0.0001), and pulmonary vein isolation (PVI) was achieved in 97.8 and 97.6% of PVs with CBG1 and CBG2 ( P = 0.77), respectively. The need for dual-balloon usage within a procedure dropped (20.1 vs. 9.0%, P < 0.001), and the fluoroscopy time was reduced when operating the CBG2. Atrial fibrillation recurrence rates until discharge were similar (5.0 vs. 5.8%, P = 0.69). Comparable low rates of major complications were observed with both CBs, and there was a non-significant trend for more phrenic nerve palsies.
Conclusion Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure. The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies. If the enhancements lead to a higher clinical benefit has to be determined. The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue.
Clinical Trials.gov Identifier: NCT01360008.read more
Citations
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Journal ArticleDOI
2017 HRS / EHRA / ECAS / APHRS / SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation
Hugh Calkins,Gerhard Hindricks,Riccardo Cappato,Young Hoon Kim,Eduardo B. Saad,Luis Aguinaga,Joseph G. Akar,Vinay Badhwar,Josep Brugada,John Camm,Peng Sheng Chen,Shih Ann Chen,Mina K. Chung,Jens Cosedis Nielsen,Anne B. Curtis,D. Wyn Davies,John D. Day,Andre d'Avila,N. M. S. de Groot,Luigi Di Biase,Mattias Duytschaever,James R. Edgerton,Kenneth A. Ellenbogen,Patrick T. Ellinor,Sabine Ernst,Guilherme Fenelon,Edward P. Gerstenfeld,David E. Haines,Michel Haïssaguerre,Robert H. Helm,Elaine M. Hylek,Warren M. Jackman,José Jalife,José Jalife,Jonathan M. Kalman,Josef Kautzner,Hans Kottkamp,Karl Heinz Kuck,Koichiro Kumagai,Richard Lee,Thorsten Lewalter,Bruce D. Lindsay,Laurent Macle,Moussa Mansour,Francis E. Marchlinski,Gregory F. Michaud,Hiroshi Nakagawa,Andrea Natale,Stanley Nattel,Ken Okumura,Douglas L. Packer,Evgeny Pokushalov,Matthew R. Reynolds,Prashanthan Sanders,Mauricio Scanavacca,Richard J. Schilling,Claudio Tondo,Hsuan Ming Tsao,Atul Verma,David J. Wilber,Teiichi Yamane +60 more
TL;DR: This 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group, convened by these five international societies.
Journal ArticleDOI
Comparison between radiofrequency with contact force-sensing and second-generation cryoballoon for paroxysmal atrial fibrillation catheter ablation: a multicentre European evaluation
Fabien Squara,Alexandre Zhao,Eloi Marijon,Decebal Gabriel Latcu,Rui Providência,Giacomo Di Giovanni,Gaël Jauvert,François Jourda,Gian-Battista Chierchia,Carlo de Asmundis,Giuseppe Ciconte,Christine Alonso,Caroline Grimard,Serge Boveda,Bruno Cauchemez,Nadir Saoudi,Pedro Brugada,Jean Paul Albenque,Olivier Thomas +18 more
TL;DR: Pulmonary vein isolation using CF-guided RF and second-generation CB leads to comparable single-procedure arrhythmia-free survival at up to 18 months with similar overall complication rate.
Journal ArticleDOI
2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation
Hugh Calkins,Gerhard Hindricks,Riccardo Cappato,Young Hoon Kim,Eduardo B. Saad,Luis Aguinaga,Joseph G. Akar,Vinay Badhwar,Josep Brugada,John Camm,Peng Sheng Chen,Shih Ann Chen,Mina K. Chung,Jens Cosedis Nielsen,Anne B. Curtis,D. Wyn Davies,John D. Day,Andre d'Avila,N. M. S. de Groot,Luigi Di Biase,Mattias Duytschaever,James R. Edgerton,Kenneth A. Ellenbogen,Patrick T. Ellinor,Sabine Ernst,Guilherme Fenelon,Edward P. Gerstenfeld,David E. Haines,Michel Haïssaguerre,Robert H. Helm,Elaine M. Hylek,Warren M. Jackman,José Jalife,Jonathan M. Kalman,Josef Kautzner,Hans Kottkamp,Karl Heinz Kuck,Koichiro Kumagai,Richard Lee,Thorsten Lewalter,Bruce D. Lindsay,Laurent Macle,Moussa Mansour,Francis E. Marchlinski,Gregory F. Michaud,Hiroshi Nakagawa,Andrea Natale,Stanley Nattel,Ken Okumura,Douglas L. Packer,Evgeny Pokushalov,Matthew R. Reynolds,Prashanthan Sanders,Mauricio Scanavacca,Richard J. Schilling,Claudio Tondo,Hsuan Ming Tsao,Atul Verma,David J. Wilber,Teiichi Yamane +59 more
TL;DR: The next generation of teachers and researchers will shape the future of teaching and learning in the developing world through a generation of interpreters and interpreters.
Journal ArticleDOI
One-year clinical success of a 'no-bonus' freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation.
Erik Wissner,Christian-Hendrik Heeger,Hanno Grahn,Bruno Reissmann,Peter Wohlmuth,Christine Lemes,Peter Rausch,Shibu Mathew,Andreas Rillig,Sebastian Deiss,Tillman Maurer,Tina Lin,Roland Richard Tilz,Feifan Ouyang,Karl-Heinz Kuck,Andreas Metzner +15 more
TL;DR: A 'no-bonus'-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate, suggesting a bonus freeze cycle following successful PVI may not be essential to superior clinical outcome.
Journal ArticleDOI
First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation
Florian Straube,Uwe Dorwarth,Sonia Ammar-Busch,Timo Peter,Georg Noelker,Thomas Massa,Malte Kuniss,Niels Christian Ewertsen,Kyoung Ryul Julian Chun,Juergen Tebbenjohanns,Roland Tilz,Karl-Heinz Kuck,Taoufik Ouarrak,Jochen Senges,Ellen Hoffmann +14 more
TL;DR: Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results.
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2012 focused update of the ESC Guidelines for the management of atrial fibrillation
A. John Camm,Gregory Lip,Raffaele De Caterina,Irene Savelieva,Dan Atar,Stefan H. Hohnloser,Gerhard Hindricks,Paulus Kirchhof,Jeroen J. Bax,Helmut Baumgartner,Claudio Ceconi,Veronica Dean,Christi Deaton,Robert Fagard,Christian Funck-Brentano,David Hasdai,Arno W. Hoes,Juhani Knuuti,Philippe Kolh,Theresa McDonagh,Cyril Moulin,Bogdan A. Popescu,Željko Reiner,Udo Sechtem,Per Anton Sirnes,Michal Tendera,Adam Torbicki,Alec Vahanian,Stephan Windecker,Panos Vardas,Nawwar Al-Attar,Ottavio Alfieri,Annalisa Angelini,Carina Blomström-Lundqvist,Paolo Colonna,Johan De Sutter,Sabine Ernst,Andreas Goette,Bulent Gorenek,Robert Hatala,Hein Heidbuchel,Magnus Heldal,Steen Dalby Kristensen,Jean-Yves Le Heuzey,Hercules Mavrakis,Lluís Mont,Pasquale Perrone Filardi,Piotr Ponikowski,Bernard Prendergast,Frans H. Rutten,Ulrich Schotten,Isabelle C. Van Gelder,Freek W.A. Verheugt +52 more
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Journal ArticleDOI
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design
Hugh Calkins,Karl-Heinz Kuck,Riccardo Cappato,Josep Brugada,A. John Camm,Shih Ann Chen,Harry J.G.M. Crijns,Ralph J. Damiano,D. Wyn Davies,John P. DiMarco,James R. Edgerton,Kenneth A. Ellenbogen,Michael D. Ezekowitz,David E. Haines,Michel Haïssaguerre,Gerhard Hindricks,Yoshito Iesaka,Warren M. Jackman,José Jalife,Pierre Jaïs,Jonathan M. Kalman,David Keane,Younghoon Kim,Paulus Kirchhof,Paulus Kirchhof,George J. Klein,Hans Kottkamp,Koichiro Kumagai,Bruce D. Lindsay,Moussa Mansour,Francis E. Marchlinski,Patrick M. McCarthy,J. Lluis Mont,Fred Morady,Koonlawee Nademanee,Hiroshi Nakagawa,Andrea Natale,Stanley Nattel,Douglas L. Packer,Carlo Pappone,Eric N. Prystowsky,Antonio Raviele,Vivek Y. Reddy,Jeremy N. Ruskin,Richard J. Shemin,Hsuan Ming Tsao,David J. Wilber,Niv Ad,Jennifer E. Cummings,A. Mark Gillinov,Hein Heidbuchel,Craig T. January,Gregory Y.H. Lip,Steven M. Markowitz,Mohan Nair,I. Eli Ovsyshcher,Hui Nam Pak,Takeshi Tsuchiya,Dipen Shah,Teo Wee Siong,Panos E. Vardas +60 more
TL;DR: This 2012 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a Task Force, convened by the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society and charged with defining the indications, techniques, and outcomes of this procedure.
Journal ArticleDOI
Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation
Riccardo Cappato,Hugh Calkins,Shih Ann Chen,Wyn Davies,Yoshito Iesaka,Jonathan M. Kalman,You Ho Kim,George J. Klein,Andrea Natale,Douglas L. Packer,Allan C. Skanes,Federico Ambrogi,Elia Biganzoli +12 more
TL;DR: When analyzed in a large number of electrophysiology laboratories worldwide, catheter ablation of AF shows to be effective in ≈80% of patients after 1.3 procedures per patient, with ≈70% of them not requiring further antiarrhythmic drugs during intermediate follow-up.
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