Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter Results of the Prospective, Multicenter SMART-AF Trial

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:64

Article

Natale, Andrea^1,2,3,4,5,6  Reddy, Vivek Y.⁷  Monir, George⁸  Wilber, David J.⁹  Lindsay, Bruce D.¹⁰  McElderry, H. Thomas¹¹  Kantipudi, Charan¹²  Mansour, Moussa C.¹³  Melby, Daniel P.¹⁴  Packer, Douglas L.¹⁵  Nakagawa, Hiroshi¹⁶  Zhang, Baohui¹⁷  Stagg, Robert B.¹⁷  Boo, Lee Ming¹⁷  Marchlinski, Francis E.¹⁸ 

[1] St Davids Med Ctr, Texas Cardiac Arrhythmia Inst, Austin, TX 78705 USA

[2] Stanford Univ, Div Cardiol, Stanford, CA 94305 USA

[3] Case Western Reserve Univ, Cleveland, OH 44106 USA

[4] Calif Pacific Med Ctr, EP Serv, San Francisco, CA USA

[5] Scripps Clin, San Diego, CA USA

[6] Univ Texas Austin, Dept Biomed Engn, Austin, TX 78712 USA

[7] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[8] Florida Hosp, Cardiovasc Inst, Orlando, FL USA

[9] Loyola Univ, Maywood, IL 60153 USA

[10] Cleveland Clin Fdn, Cleveland, OH 44195 USA

[11] Univ Alabama Birmingham, Birmingham, AL USA

[12] Piedmont Heart Inst, Atlanta, GA USA

[13] Massachusetts Gen Hosp, Boston, MA 02114 USA

[14] Minneapolis Heart Inst Fdn, Minneapolis, MN USA

[15] Mayo Clin, Rochester, MN USA

[16] Univ Oklahoma, Hlth Sci Ctr, Oklahoma City, OK USA

[17] Biosense Webster Inc, Diamond Bar, CA USA

[18] Hosp Univ Penn, Philadelphia, PA 19104 USA

关键词: atrial fibrillation;    catheter ablation;    contact force;    radiofrequency;   

DOI  :  10.1016/j.jacc.2014.04.072

来源: Elsevier

【 摘 要 】

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 (R) SMARTTOUCH (R) Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation; NCT01385202) (C) 2014 by the American College of Cardiology Foundation.

【 授权许可】

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