Karl-Heinz Kuck1, Boris A Hoffmann2, Sabine Ernst2, Karl Wegscheider2, Andras Treszl2, Andreas Metzner2, Lars Eckardt2, Thorsten Lewalter2, Günter Breithardt2, Stephan Willems2. 1. From the Department of Cardiology, Asklepios Hospital St. Georg, Hamburg, Germany (K.-H.K., S.E., A.M.); Department of Cardiology-Electrophysiology, University Heart Center, Hamburg, Germany (B.A.H., S.W.); Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.W., A.T.); Division of Rhythmology, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany (L.E., G.B.); and Department of Cardiology, University Hospital Bonn, Bonn, Germany (T.L.). k.kuck@asklepios.com. 2. From the Department of Cardiology, Asklepios Hospital St. Georg, Hamburg, Germany (K.-H.K., S.E., A.M.); Department of Cardiology-Electrophysiology, University Heart Center, Hamburg, Germany (B.A.H., S.W.); Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.W., A.T.); Division of Rhythmology, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany (L.E., G.B.); and Department of Cardiology, University Hospital Bonn, Bonn, Germany (T.L.).
Abstract
BACKGROUND:Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients. It is not known whether complete pulmonary vein isolation (PVI) is superior to incomplete PVI with regard to the patients' clinical outcome. METHODS AND RESULTS: Patients with drug-refractory, symptomatic paroxysmal AF were randomly assigned to either incomplete (group A) or complete PVI (group B). In group A, a persistent gap was intentionally left within the circumferential ablation line, whereas in group B, complete PVI without any gaps was intended. At 3 months, all patients underwent invasive reevaluation to assess the rate of persistent PVI. Clinical follow-up was based on daily 30-s transtelephonic ECG transmissions. Primary study end point was the time to first recurrence of (symptomatic or asymptomatic) AF. A total of 233 patients were enrolled (116 in group A and 117 in group B). AF recurrence within 3 months was observed in a total of 161 patients (136 [84.5%] with symptomatic and 25 [15.5%] with asymptomatic AF); AF recurred in 62.2% of group B patients and 79.2% of group A patients (P<0.001), for a difference in favor of complete PVI of 17.1% (95% confidence interval, 5.3%-28.9%). Invasive restudy in 103 group A patients and 93 group B patients revealed conduction gaps in 92 (89.3%) and 65 (69.9%) patients, respectively. CONCLUSIONS: This study proves the superiority of complete PVI over incomplete PVI with respect to AF recurrence within 3 months. However, the rate of electric reconduction 3 months after PVI is high in patients with initially isolated PVs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov; Unique identifier: NCT00293943.
RCT Entities:
BACKGROUND: Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients. It is not known whether complete pulmonary vein isolation (PVI) is superior to incomplete PVI with regard to the patients' clinical outcome. METHODS AND RESULTS:Patients with drug-refractory, symptomatic paroxysmal AF were randomly assigned to either incomplete (group A) or complete PVI (group B). In group A, a persistent gap was intentionally left within the circumferential ablation line, whereas in group B, complete PVI without any gaps was intended. At 3 months, all patients underwent invasive reevaluation to assess the rate of persistent PVI. Clinical follow-up was based on daily 30-s transtelephonic ECG transmissions. Primary study end point was the time to first recurrence of (symptomatic or asymptomatic) AF. A total of 233 patients were enrolled (116 in group A and 117 in group B). AF recurrence within 3 months was observed in a total of 161 patients (136 [84.5%] with symptomatic and 25 [15.5%] with asymptomatic AF); AF recurred in 62.2% of group B patients and 79.2% of group A patients (P<0.001), for a difference in favor of complete PVI of 17.1% (95% confidence interval, 5.3%-28.9%). Invasive restudy in 103 group A patients and 93 group B patients revealed conduction gaps in 92 (89.3%) and 65 (69.9%) patients, respectively. CONCLUSIONS: This study proves the superiority of complete PVI over incomplete PVI with respect to AF recurrence within 3 months. However, the rate of electric reconduction 3 months after PVI is high in patients with initially isolated PVs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov; Unique identifier: NCT00293943.
Authors: Andrew Grace; Stephan Willems; Christian Meyer; Atul Verma; Patrick Heck; Min Zhu; Xinwei Shi; Derrick Chou; Lam Dang; Christoph Scharf; Günter Scharf; Graydon Beatty Journal: JCI Insight Date: 2019-03-21
Authors: 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; André d'Avila; N M S Natasja 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 Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose 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 Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: Heart Rhythm Date: 2017-05-12 Impact factor: 6.343
Authors: Hugh Calkins; Karl Heinz Kuck; Riccardo Cappato; Josep Brugada; A John Camm; Shih-Ann Chen; Harry J G Crijns; Ralph J Damiano; D Wyn Davies; John DiMarco; James Edgerton; Kenneth Ellenbogen; Michael D Ezekowitz; David E Haines; Michel Haissaguerre; Gerhard Hindricks; Yoshito Iesaka; Warren Jackman; José Jalife; Pierre Jais; Jonathan Kalman; David Keane; Young-Hoon Kim; Paulus Kirchhof; George 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 Prystowsky; Antonio Raviele; Vivek Reddy; Jeremy N Ruskin; Richard J Shemin; Hsuan-Ming Tsao; David Wilber Journal: Heart Rhythm Date: 2012-03-01 Impact factor: 6.343
Authors: 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; André d'Avila; N M S Natasja 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 Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose 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 Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: Europace Date: 2018-01-01 Impact factor: 5.214
Authors: 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; André d'Avila; N M S Natasja 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 Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose 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 Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: J Interv Card Electrophysiol Date: 2017-10 Impact factor: 1.900
Authors: 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; André d'Avila; N M S Natasja 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 Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose 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 Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: J Arrhythm Date: 2017-09-15