Contact force-sensing catheter safe, effective for persistent AF
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Ablation with a porous tip contact force-sensing catheter was safe and effective in patients with persistent atrial fibrillation, according to data from the PRECEPT study presented at the virtual Heart Rhythm Society Annual Scientific Sessions.
“This is an important study in the field of atrial fibrillation because it is the first multicenter FDA-sponsored AF ablation study for persistent atrial fibrillation,” Moussa Mansour, MD, director of the atrial fibrillation program at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, said in a press conference. “We know that there are many studies for paroxysmal atrial fibrillation. We understand the outcome of paroxysmal AF, but the safety and effectiveness of catheter ablation of persistent AF using a contact force-sensing catheter has not been shown or demonstrated yet.”
The results were simultaneously published in JACC: Clinical Electrophysiology.
Patients with persistent AF
Researchers enrolled 381 patients from 27 sites with symptomatic persistent AF who were intolerant or nonresponse to one or more antiarrhythmic drug. After excluding 33 patients, there was a safety population (n = 348; mean age, 65 years; 71% men) and an effectiveness population (n = 333; mean age, 65 years; 71% men). All patients underwent pulmonary vein isolation with ablation using a porous tip contact force-sensing catheter (Thermocool Smarttouch, Biosense Webster).
Follow-up was conducted at 1, 3, 6, 9, 12 and 15 months after ablation. Arrhythmia recurrences were monitored periodically throughout follow-up using 24-hour Holter monitoring, ECGs and transtelephonic monitoring.
“The reason for the 15 months was in addition to the conventional 3 months blanking period, there was another 3 months of consolidation period because some investigators may want to use some medication in the first 3 months after ablation, and we don’t [want] the effect of medication to affect the ablation outcome,” Mansour said during the press conference.
The primary safety endpoint was incidence of primary adverse events within 7 days of using the catheter and included cardiac tamponade/perforation, death, MI, thromboembolism, stroke/cerebrovascular accident and pericarditis. The primary effectiveness endpoint for this study was freedom from documented recurrence atrial tachycardia/atrial flitter/AF of 30 seconds or longer and freedom from five failure modes at 15 months, including use of a nonstudy catheter, acute procedural failure, use of new or higher-dose antiarrhythmic drugs, repeat procedures and surgical ablation. Secondary effectiveness outcomes were also assessed in the study, including single and acute procedure success.
Researchers defined clinical success as freedom from documented symptomatic atrial flutter/AF/atrial tachycardiac recurrence at 15 months.
There were 14 primary adverse events observed in 13 patients, which equaled a rate of 3.8%.
“The performance goal for the primary safety endpoint was met,” Mansour said during the press conference.
The primary effectiveness endpoint was also met. Based on Kaplan-Meier analyses, the primary effectiveness success rate was 61.7%. In addition, the clinical success rate, which is a more relevant clinical measure in persistent AF, was 80.4% at 15 months.
“We found it was also important to show an endpoint that was defined as clinical success because for persistent atrial fibrillation, the 30 seconds of atrial fibrillation may not be clinically relevant,” Mansour said during the press conference.
At 15 months, there were also decreases in cardioversion use by 82.7% and the use of class I or III antiarrhythmic drugs by 74.5%. Kaplan-Meier estimates also showed freedom from repeat ablation of 86.1% and freedom from CV hospitalization of 84.2% (95% CI, 80.2-88.2).
These patients had improvements in quality of life at 15 months.
Potential for FDA approval
In a related editorial published in JACC: Clinical Electrophysiology, Edward P. Gerstenfeld, MD, chief of cardiac electrophysiology and arrhythmia at University of California, San Francisco, and Joshua D. Moss, MD, cardiologist and electrophysiologist at University of California, San Francisco, wrote: “The authors should be congratulated for demonstrating the necessary safety and effectiveness to likely gain FDA approval for a catheter to ablate persistent AF to the benefit of our patients. However, there is still not enough evidence to warrant ablation of persistent AF in an asymptomatic patient.” – by Darlene Dobkowski
References:
Mansour M, et al. LBCT01-04. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).
Gerstenfeld EP, et al. JACC Clin Electrophysiol. 2020;doi:10.1016/j.jacep.2020.05.004.
Mansour M, et al. JACC Clin Electrophysiol. 2020;doi:10.1016/j.jacep.2020.04.024.
Disclosures: The study was funded by Biosense Webster. Mansour reports he consulted for Abbott, Biosense Webster, Boston Scientific, Janssen, Medtronic, Novartis, Philips and Sentre Heart; received research grants from Abbott, Biosense Webster, Boehringer Ingelheim, Boston Scientific, Medtronic and Pfizer, and has equity interest in Affera, EPD Solutions and NewPace Ltd. Gerstenfeld reports he received lecture honoraria and research grants from Biosense Webster. Moss reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Peter Weiss, MD
This was a nonrandomized multicenter trial for Biosense Smarttouch sensing force catheter in persistent AF to get FDA indication for persistent AF. This catheter is commonly used off-label in clinical practice.
This trial included typical patient population and outcome measures and met prespecified safety and effectiveness endpoints. These patient outcomes were fairly typical of trials in similar patients, with the caveat of experienced operators.
The whole safety endpoint was met, although a rate of 1.5% for cardiac tamponade remains worrisome, especially with experienced operators. Also, there was no comparison group with another ablation technology.
Overall, this reassures that what is current standard practice in many labs is reasonable, and FDA indication may follow. However, this is not likely to change practice much, as this is already widely used. Highlights are needed for ongoing caution with a significant rate of cardiac perforation events, especially as we consider use of this catheter by less-experienced operators in real-world practice.
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Mansour M, et al. LBCT01-04. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).
Gerstenfeld EP, et al. JACC Clin Electrophysiol. 2020;doi:10.1016/j.jacep.2020.05.004.
Mansour M, et al. JACC Clin Electrophysiol. 2020;doi:10.1016/j.jacep.2020.04.024.
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