Author + information
- Received February 3, 2014
- Revision received April 1, 2014
- Accepted April 6, 2014
- Published online August 19, 2014.
- Andrea Natale, MD∗,†,‡,§,‖,¶∗ (, )
- Vivek Y. Reddy, MD#,
- George Monir, MD∗∗,
- David J. Wilber, MD††,
- Bruce D. Lindsay, MD‡‡,
- H. Thomas McElderry, MD§§,
- Charan Kantipudi, MD‖‖,
- Moussa C. Mansour, MD¶¶,
- Daniel P. Melby, MD##,
- Douglas L. Packer, MD∗∗∗,
- Hiroshi Nakagawa, MD†††,
- Baohui Zhang, MS, SM‡‡‡,
- Robert B. Stagg, PhD‡‡‡,
- Lee Ming Boo, PharmD‡‡‡ and
- Francis E. Marchlinski, MD§§§
- ∗Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas
- †Division of Cardiology, Stanford University, Stanford, California
- ‡Case Western Reserve University, Cleveland, Ohio
- §EP Services, California Pacific Medical Center, San Francisco, California
- ‖Interventional Electrophysiology, Scripps Clinic, San Diego, California
- ¶Department of Biomedical Engineering, University of Texas, Austin, Texas
- #Icahn School of Medicine at Mount Sinai, New York, New York
- ∗∗Florida Hospital Cardiovascular Institute, Orlando, Florida
- ††Loyola University, Maywood, Illinois
- ‡‡Cleveland Clinic Foundation, Cleveland, Ohio
- §§University of Alabama at Birmingham; Birmingham, Alabama
- ‖‖Piedmont Heart Institute, Atlanta, Georgia
- ¶¶Massachusetts General Hospital, Boston, Massachusetts
- ##Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
- ∗∗∗Mayo Clinic, Rochester, Minnesota
- †††University of Oklahoma Health Science Center, Oklahoma City, Oklahoma
- ‡‡‡Biosense Webster, Inc., Diamond Bar, California
- §§§Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- ↵∗Reprint requests and correspondence:
Dr. Andrea Natale, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, 3000 N. IH-35, Suite 700 (705Res Foundation), Austin, Texas 78705.
Background Catheter ablation is important for treatment of paroxysmal atrial fibrillation (PAF). Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation.
Objectives The study sought to assess the safety and effectiveness of an irrigated, contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF.
Methods A prospective, multicenter, nonrandomized study was conducted. Enrollment criteria included: ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug (Class I to IV). Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint.
Results A total of 172 patients were enrolled at 21 sites, where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application. Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade (n = 4), pericarditis (n = 3), heart block (n = 1, prior to radiofrequency application), and vascular access complications (n = 4). By Kaplan-Meier analyses, 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5%. The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80% of the time during therapy, outcomes were 4.25 times more likely to be successful (p = 0.0054; 95% confidence interval: 1.53 to 11.79).
Conclusions The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF, with no unanticipated device-related adverse events. The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence. Stable CF during radiofrequency application increases the likelihood of 12-month success. (THERMOCOOL® SMARTTOUCH® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation; NCT01385202)
The study is funded by Biosense Webster, Inc. The institutions of employment for Drs. Natale, Reddy, Monir, Wilber, Lindsay, McElderry, Kantipudi, Mansour, Melby, Packer, and Marchlinski have received compensation from Biosense Webster, Inc. to participate as investigators in the study; there were no personal fees provided to the investigators for participating in the study or the manuscript development. The Mayo Clinic and Dr. Packer have a financial interest in mapping technology that may have been used at some of the centers participating in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to St. Jude Medical, and the Mayo Clinic and Dr. Packer have received annual royalties >$10,000, the federal threshold for significant financial interest. Dr. Natale has received honoraria/consulting fees from Biosense Webster, Inc., St. Jude Medical, Medtronic, Boston Scientific, Biotronik, and Janssen outside the submitted work. Dr. Reddy has received grants from Biosense Webster, Inc. during the conduct of the study; personal fees from Biosense Webster, Inc. outside the submitted work; and consulting fees from St. Jude Medical. Dr. Monir has received personal fees from Biosense Webster, Inc. outside the submitted work. Dr. Wilber has received grants and lecture/consultant fees from Biosense Webster, Inc.; grants and consultant fees from Medtronichttp://dx.doi.org/10.13039/100004374; and lecture fees from St. Jude Medical, outside the submitted work. Dr. Lindsay has received honoraria fees for educational programs and serves on the scientific advisory board from Biosense Webster, Inc., outside the submitted work. Dr. McElderry has received personal fees from Biosense Webster, Inc.; grants and personal fees from Boston Scientific; and personal fees from St. Jude Medical, outside the submitted work. Dr. Mansour has received grant support from St. Jude Medicalhttp://dx.doi.org/10.13039/100006279, Boston Scientific, Biosense Webster, Inc., and MC10 outside the submitted work; and personal fees (consultation fee) from Biosense Webster, Inc. Dr. Packer has provided consulting services for Abiomed, Biosense Webster, Inc., Boston Scientific, CardioDX, CardioFocus, CardioInsight Technologies, Excerpta Medica, FoxP2 Medica LLC, InfoBionic, Inc., Johnson & Johnson Healthcare Systems, Johnson & Johnson, MediaSphere Medical, LLC, Medtronic CryoCath, OrthoMcNeill, Sanofi-Aventis, Siemens, St. Jude Medical, and Siemens AG, and has received no personal compensation for these consulting activities; has received research funding from Biosense Webster, Inc., Boston Scientific/EPT, Endosense, EpiEP, EP Advocate, Medtronic CryoCath LP, Minnesota Partnership for Biotechnology and Medical Genomics/University of Minnesota, National Institutes of Healthhttp://dx.doi.org/10.13039/100000002, CardioFocus, Hansen Medical, Siemens P4D, St. Jude Medicalhttp://dx.doi.org/10.13039/100006279, Siemens AcuNav, and Thermedical (EP Limited); and has received royalties from Blackwell Publishing and St. Jude Medical. Dr. Nakagawa has received grant support from Biosense Webster, Inc. during the conduct of the study as well as grants and personal fees from Biosense Webster, Inc. outside the submitted work. Ms. Zhang and Dr. Boo are employees of Biosense Webster, Inc. Dr. Stagg is an employee of Biosense Webster, Inc. and Johnson & Johnson, and owns stock (<$10,000) in Johnson & Johnson. Dr. Marchlinski has received consultant fees and lecture honoraria from Biosense Webster, Inc.
- Received February 3, 2014.
- Revision received April 1, 2014.
- Accepted April 6, 2014.
- American College of Cardiology Foundation