Srinivas R Dukkipati1, Ian Woollett2, H Thomas McELDERRY3, Marie-Christine Böhmer1, Shephal K Doshi4, Edward P Gerstenfeld5, Rodney Horton6, Andre D'Avila1, David E Haines7, Miguel Valderrabano8, J Michael Mangrum9, Jeremy N Ruskin10, Andrea Natale6, Vivek Y Reddy1. 1. Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Sentara Cardiovascular Research Institute, Norfolk, Virginia. 3. University of Alabama at Birmingham, Birmingham, Alabama. 4. Pacific Heart Institute, Santa Monica, California. 5. University of California San Francisco School of Medicine, San Francisco, California. 6. Texas Cardiac Arrhythmia Institute, Austin, Texas, USA. 7. William Beaumont Hospital, Royal Oak, Michigan. 8. The Methodist Hospital, Houston, Texas. 9. University of Virginia, Charlottesville, Virginia. 10. Massachusetts General Hospital, Boston, Massachusetts.
Abstract
INTRODUCTION: Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. METHODS: Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ≥1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. RESULTS: A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. CONCLUSIONS: This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation.
INTRODUCTION: Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. METHODS:Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ≥1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. RESULTS: A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. CONCLUSIONS: This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation.
Authors: Srinivas R Dukkipati; Petr Neuzil; Josef Kautzner; Jan Petru; Dan Wichterle; Jan Skoda; Robert Cihak; Petr Peichl; Antonio Dello Russo; Gemma Pelargonio; Claudio Tondo; Andrea Natale; Vivek Y Reddy Journal: Heart Rhythm Date: 2012-01-28 Impact factor: 6.343
Authors: Rukshen Weerasooriya; Paul Khairy; Jean Litalien; Laurent Macle; Meleze Hocini; Frederic Sacher; Nicolas Lellouche; Sebastien Knecht; Matthew Wright; Isabelle Nault; Shinsuke Miyazaki; Christophe Scavee; Jacques Clementy; Michel Haissaguerre; Pierre Jais Journal: J Am Coll Cardiol Date: 2011-01-11 Impact factor: 24.094
Authors: Andreas Metzner; Erik Wissner; Boris Schmidt; Julian Chun; Gerhard Hindricks; Christopher Piorkowski; Feifan Ouyang; Karl-Heinz Kuck Journal: J Cardiovasc Electrophysiol Date: 2012-09-11
Authors: Thomas Arentz; Reinhold Weber; Gerd Bürkle; Claudia Herrera; Thomas Blum; Jochem Stockinger; Jan Minners; Franz Josef Neumann; Dietrich Kalusche Journal: Circulation Date: 2007-06-11 Impact factor: 29.690
Authors: Douglas L Packer; Robert C Kowal; Kevin R Wheelan; James M Irwin; Jean Champagne; Peter G Guerra; Marc Dubuc; Vivek Reddy; Linda Nelson; Richard G Holcomb; John W Lehmann; Jeremy N Ruskin Journal: J Am Coll Cardiol Date: 2013-03-21 Impact factor: 24.094
Authors: Vivek Y Reddy; Petr Neuzil; Andre d'Avila; Margaret Laragy; Zachary J Malchano; Stepan Kralovec; Steven J Kim; Jeremy N Ruskin Journal: Heart Rhythm Date: 2007-11-07 Impact factor: 6.343
Authors: Faisal M Merchant; Mathew R Levy; Shahriar Iravanian; Edward C Clermont; Heval M Kelli; Robert L Eisner; Mikhael F El-Chami; Angel R Leon; David B Delurgio Journal: J Interv Card Electrophysiol Date: 2016-01-26 Impact factor: 1.900