Catheter ablation with a contact force (CF)-sensing catheter may be safe and effective in treatment of persistent atrial fibrillation (AFib), according to results of the PRECEPT study presented as part of the 2020 Heart Rhythm Scientific Sessions and simultaneously published May 8 in JACC: Clinical Electrophysiology.

Moussa Mansour, MD, FACC, et al., evaluated the safety and effectiveness of the Thermocool Smarttouch SF (STSF) catheter for the treatment of drug-refractory symptomatic persistent AFib. The study's primary safety endpoint was incidence of primary adverse events within seven days of initial and repeat ablation procedures using the STSF catheter.

The primary effectiveness endpoint was freedom from AFib/atrial flutter or atrial tachycardiac episodes of 30 seconds or longer and freedom from five variables at 15 months post procedure: acute procedural failure, use of nonstudy catheter, repeat procedures, use of new or higher-dose antiarrhythmic drug, and surgical ablation.

The study enrolled 381 participants at 27 sites across the U.S. and Canada. All patients had symptomatic persistent AFib, as well as documented nonresponse or intolerance to one or more antiarrhythmic drug. After ablation with the STSF catheter, patients were followed up at one, three, six, nine, 12 and 15 months.

Electrocardiograms were obtained at baseline and discharge and at six, nine, 12 and 15 months, while 24-hour Holter monitoring was performed at baseline and at six, 12 and 15 months. In addition, transtelephonic monitoring transmissions were performed monthly or when symptoms occurred during the nine-month follow-up period.

Of the 381 participants, 348 had the STSF catheter inserted and underwent radiofrequency (RF) ablation, comprising the safety population. Of these patients, 13 (3.8%) experienced a primary adverse event.

The effectiveness population consisted of 333 patients. Of these, 330 (99.1%) achieved acute procedure success. After 15 months, the primary effectiveness success rate was 61.7% and the clinical success rate, defined as freedom from symptomatic AFib, was 80.4%.

According to the researchers, the findings demonstrate safety and effectiveness of persistent AFib ablation with CF-sensing catheters. Individualized ablation approaches based on a patient's clinical presentation could help optimize outcomes, they conclude.

The researchers note that future research is needed to determine the decrease in atrial arrhythmia following catheter ablation treatment for persistent AFib.

In an accompanying editorial comment, Edward P. Gerstenfeld, MD, MS, FACC, and Joshua D. Moss, MD, FACC, write that the findings will likely result in approval of the STSF catheter by the U.S. Food and Drug Administration but the "more interesting question is whether use of modern irrigated CF-sensing catheters has improved our overall results treating" persistent AFib. They add that treatment for persistent AFib has been "possibly further enhanced with the availability" of CF-sensing catheters.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, Atrial Flutter, Electrocardiography, Ambulatory, Patient Discharge, Incidence, Follow-Up Studies, Catheter Ablation, Anti-Arrhythmia Agents, Electrocardiography, Electrophysiology

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