Paroxysmal AF catheter ablation with a contact force sensing catheter: Results of the prospective, multicenter SMART-AF trial

Andrea Natale, Vivek Y. Reddy, George Monir, David J. Wilber, Bruce D. Lindsay, H. Thomas McElderry, Charan Kantipudi, Moussa C. Mansour, Daniel P. Melby, Douglas L Packer, Hiroshi Nakagawa, Baohui Zhang, Robert B. Stagg, Lee Ming Boo, Francis E. Marchlinski

Research output: Contribution to journalArticle

231 Citations (Scopus)

Abstract

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)

Original languageEnglish (US)
Pages (from-to)647-656
Number of pages10
JournalJournal of the American College of Cardiology
Volume64
Issue number7
DOIs
StatePublished - Aug 19 2014

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Catheter Ablation
Atrial Fibrillation
Catheters
Research Personnel
Therapeutics
Recurrence
Atrial Flutter
Heart Block
Pericarditis
Pulmonary Veins
Anti-Arrhythmia Agents
Kaplan-Meier Estimate
Tachycardia
Pharmaceutical Preparations
Multicenter Studies
Blood Vessels
Cardiac Arrhythmias
Electrodes
Confidence Intervals
Safety

Keywords

  • atrial fibrillation
  • catheter ablation
  • contact force
  • radiofrequency

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Paroxysmal AF catheter ablation with a contact force sensing catheter : Results of the prospective, multicenter SMART-AF trial. / Natale, Andrea; Reddy, Vivek Y.; Monir, George; Wilber, David J.; Lindsay, Bruce D.; McElderry, H. Thomas; Kantipudi, Charan; Mansour, Moussa C.; Melby, Daniel P.; Packer, Douglas L; Nakagawa, Hiroshi; Zhang, Baohui; Stagg, Robert B.; Boo, Lee Ming; Marchlinski, Francis E.

In: Journal of the American College of Cardiology, Vol. 64, No. 7, 19.08.2014, p. 647-656.

Research output: Contribution to journalArticle

Natale, A, Reddy, VY, Monir, G, Wilber, DJ, Lindsay, BD, McElderry, HT, Kantipudi, C, Mansour, MC, Melby, DP, Packer, DL, Nakagawa, H, Zhang, B, Stagg, RB, Boo, LM & Marchlinski, FE 2014, '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, vol. 64, no. 7, pp. 647-656. https://doi.org/10.1016/j.jacc.2014.04.072
Natale, Andrea ; Reddy, Vivek Y. ; Monir, George ; Wilber, David J. ; Lindsay, Bruce D. ; McElderry, H. Thomas ; Kantipudi, Charan ; Mansour, Moussa C. ; Melby, Daniel P. ; Packer, Douglas L ; Nakagawa, Hiroshi ; Zhang, Baohui ; Stagg, Robert B. ; Boo, Lee Ming ; Marchlinski, Francis E. / Paroxysmal AF catheter ablation with a contact force sensing catheter : Results of the prospective, multicenter SMART-AF trial. In: Journal of the American College of Cardiology. 2014 ; Vol. 64, No. 7. pp. 647-656.
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T2 - Results of the prospective, multicenter SMART-AF trial

AU - Natale, Andrea

AU - Reddy, Vivek Y.

AU - Monir, George

AU - Wilber, David J.

AU - Lindsay, Bruce D.

AU - McElderry, H. Thomas

AU - Kantipudi, Charan

AU - Mansour, Moussa C.

AU - Melby, Daniel P.

AU - Packer, Douglas L

AU - Nakagawa, Hiroshi

AU - Zhang, Baohui

AU - Stagg, Robert B.

AU - Boo, Lee Ming

AU - Marchlinski, Francis E.

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N2 - 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)

AB - 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)

KW - atrial fibrillation

KW - catheter ablation

KW - contact force

KW - radiofrequency

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