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UNCOVER-AF: Imaging system confers freedom from AF at 12 months after ablation
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A dipole density mapping and ultrasound imaging system in patients with persistent atrial fibrillation was safe and resulted in freedom from AF at 12 months and burden reduction, according to data from the UNCOVER-AF study presented at the AF Symposium.
“There has been a lot of discussion over the last 5 years about whether it is possible to do more than just pulmonary vein isolation for patients with persistent atrial fibrillation and whether doing additional ablation would actually improve outcomes and, furthermore, whether we can actually map individual phenomena or substrates within patients and use those as part of the ablation strategy,” Atul Verma, MD, director of the hearth rhythm program at Southlake Regional Health Center in Newmarket, Ontario, Canada, told Cardiology Today. “That’s been a controversial area, and what this trial does is that it says yes, we can get better results, and yes, it may be a very valid strategy and maybe it is something to incorporate into clinical practice.”
Patients with persistent AF
Researchers analyzed data from 127 patients with persistent AF who underwent atrial mapping before undergoing pulmonary vein isolation. The imaging system (AcQMap, Acutus Medical) was used to identify localized rotational, focal and irregular conduction patterns.
“This is a charge density technology that measures the electrical signals of the heart with a higher definition than traditional voltage mapping,” Verma said in an interview. “The technological breakthrough is important.”
Patients underwent cryoablation or ablation using radiofrequency.
Researchers measured freedom from AF for more than 30 seconds at 3, 6, 9 and 12 months with a continuous 24-hour ECG recording. Burden from AF was measured at all follow-up visits.
Freedom from AF after one procedure regardless of antiarrhythmic drugs was 72.5% at 12 months (95% CI, 63.9-80.3). This increased in patients who underwent one or two procedures at 12 months (93%; 95% CI, 87.1-97).
Of the patients who underwent one procedure (n = 96), most had no episodes of AF that lasted longer than 30 seconds (89.6%). This was also seen in patients who underwent one or two procedures (82.4%).
Predictors of events
Predictors of the freedom from AF at 12 months included the ablation of more than three rotational, irregular or focal patterns (OR = 9.39; 95% CI, 2-44.1). Patients who underwent ablation procedures that were terminated due to sinus rhythm were three times more likely to have sinus rhythm at 12 months (OR = 2.97; 95% CI, 1.06-8.29).
There were no major safety events related to the use of this system.
“We need to show in a head-to-head trial that this technology is going to perform better than standard traditional technologies that are available on the market,” Verma told Cardiology Today. “This is an early study, a feasibility study that was looking at whether it is even possible to do this with this new technology. The results are very promising, but it needs to be confirmed.”
In a press release, Vince Burgess, CEO of Acutus Medical, said: “These early results have only scratched the surface of potential. Unprecedented clarity with AcQMap could help physicians improve AF ablation outcomes by providing tailored therapy options and reducing the need for repeat procedures. That’s improvement that saves time, reduces financial burden and most importantly makes life better for patients.” – by Darlene Dobkowski
Reference:
Verma A, et al. Late-Breaking Clinical Trials and First Report Clinical Investigations. Presented at: AF Symposium; Jan. 24-26, 2019; Boston.
Disclosures: Verma reports he consults for Acutus without compensation or shares in the company and received consultant fees from Biosense Webster, Medtronic and other ablation technology companies. Burgess is an employee of Acutus Medical.