BACKGROUND: Recently, a nonmagnetic robotic navigation system (RN, Hansen-Sensei) has been introduced for remote catheter manipulation. OBJECTIVE: To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial. METHODS:Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 +/- 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 +/- 7.6 years). A 3-dimensional mapping system (NavX) was used in both groups. RESULTS:Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 +/- 3.4 vs 22 +/- 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 +/- 2.1 vs 22 +/- 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 +/- 2.4 vs 17 +/- 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 +/- 44.4 vs 134 +/- 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]). CONCLUSION: The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up.
RCT Entities:
BACKGROUND: Recently, a nonmagnetic robotic navigation system (RN, Hansen-Sensei) has been introduced for remote catheter manipulation. OBJECTIVE: To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial. METHODS: Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 +/- 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 +/- 7.6 years). A 3-dimensional mapping system (NavX) was used in both groups. RESULTS: Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 +/- 3.4 vs 22 +/- 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 +/- 2.1 vs 22 +/- 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 +/- 2.4 vs 17 +/- 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 +/- 44.4 vs 134 +/- 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]). CONCLUSION: The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up.
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; 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; Jose 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: J Interv Card Electrophysiol Date: 2012-03 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: 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