John Hummel1, Gregory Michaud2, Robert Hoyt3, David DeLurgio4, Abdi Rasekh5, Fred Kusumoto6, Michael Giudici7, Dan Dan8, David Tschopp9, Hugh Calkins10, Lucas Boersma11. 1. The Ohio State University, Columbus, Ohio. Electronic address: John.Hummel@osumc.edu. 2. Brigham and Women's Hospital, Boston, Massachusetts. 3. Iowa Heart Center, Des Moines, Iowa. 4. Emory Crawford Long Hospital, Atlanta, Georgia. 5. Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas. 6. St. Luke's Hospital, Mayo Clinic, Jacksonville, Florida. 7. Genesis Medical Center, Davenport, Iowa. 8. Piedmont Hospital, Atlanta, Georgia. 9. Austin Heart, Austin, Texas. 10. The John Hopkins Medical Institute, Baltimore, Maryland. 11. St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
Abstract
BACKGROUND: Persistent and long-standing persistent atrial fibrillation (AF) often requires extensive and/or repeat radiofrequency (RF) ablation procedures. OBJECTIVE: The Tailored Treatment of Persistent Atrial Fibrillation (TTOP-AF) study assessed the effectiveness and safety of the phased RF system in a randomized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-standing persistent AF. METHODS:Patients who had failed at least 1 antiarrhythmic drug (AAD) were randomized (2:1) to ablation management (AM) or medical management (MM). AM patients were allowed up to 2 ablations. Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms. MM patients received AAD changes and/or cardioversion. The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation. RESULTS: At 6 months, a greater proportion of AM patients achieved effectiveness off AAD (77 of 138 [55.8%]) compared to MM patients (19 of 72 [26.4%]) (P < .0001). Acutely, 92.8% (128/138) of the procedures were successful while 12.3% (17/138) experienced a serious procedure and/or device-related adverse event. The predefined acute safety end point was not met. The proportion of patients with chronic safety events did not differ significantly between groups. CONCLUSIONS: Catheter ablation of persistent/long-standing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM. More intense anticoagulation strategies, careful attention to catheter placement relative to the pulmonary vein ostia, and elimination of electrode interaction are expected to reduce the risk of stroke, pulmonary vein stenosis, and asymptomatic cerebral emboli.
RCT Entities:
BACKGROUND: Persistent and long-standing persistent atrial fibrillation (AF) often requires extensive and/or repeat radiofrequency (RF) ablation procedures. OBJECTIVE: The Tailored Treatment of Persistent Atrial Fibrillation (TTOP-AF) study assessed the effectiveness and safety of the phased RF system in a randomized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-standing persistent AF. METHODS:Patients who had failed at least 1 antiarrhythmic drug (AAD) were randomized (2:1) to ablation management (AM) or medical management (MM). AM patients were allowed up to 2 ablations. Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms. MMpatients received AAD changes and/or cardioversion. The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation. RESULTS: At 6 months, a greater proportion of AM patients achieved effectiveness off AAD (77 of 138 [55.8%]) compared to MMpatients (19 of 72 [26.4%]) (P < .0001). Acutely, 92.8% (128/138) of the procedures were successful while 12.3% (17/138) experienced a serious procedure and/or device-related adverse event. The predefined acute safety end point was not met. The proportion of patients with chronic safety events did not differ significantly between groups. CONCLUSIONS: Catheter ablation of persistent/long-standing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM. More intense anticoagulation strategies, careful attention to catheter placement relative to the pulmonary vein ostia, and elimination of electrode interaction are expected to reduce the risk of stroke, pulmonary vein stenosis, and asymptomatic cerebral emboli.
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