Srinivas R Dukkipati1, Frank Cuoco2, Ilana Kutinsky3, Arash Aryana4, Tristram D Bahnson5, Dhanunjaya Lakkireddy6, Ian Woollett7, Ziad F Issa8, Andrea Natale9, Vivek Y Reddy10. 1. Icahn School of Medicine at Mount Sinai, New York, New York. 2. Medical University of South Carolina, Charleston, South Carolina. 3. William Beaumont Hospital, Royal Oak, Michigan. 4. Regional Cardiology Associates, Sacramento, California. 5. Duke Center for Atrial Fibrillation and the Clinical Cardiac Electrophysiology Section, Duke University Medical Center, Durham, North Carolina. 6. Mid-America Cardiology, Kansas City, Kansas. 7. Sentara Cardiovascular Research Institute, Norfolk, Virginia. 8. Prairie Heart Institute, Springfield, Illinois. 9. Texas Cardiac Arrhythmia Institute, Austin, Texas. 10. Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: vivek.reddy@mountsinai.org.
Abstract
BACKGROUND:Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. OBJECTIVES: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. METHODS:Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. RESULTS: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. CONCLUSIONS: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic AblationSystem-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).
RCT Entities:
BACKGROUND: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. OBJECTIVES: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. METHODS:Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. RESULTS: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. CONCLUSIONS: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).
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