Pulsed field ablation technologies to treat AF successful in two trials
Two pulsed field ablation technologies successfully treated patients with atrial fibrillation, according to results presented at the virtual Heart Rhythm Society Annual Scientific Sessions.
In a first-in-human trial of a technology performing point-by-point pulmonary vein encirclement, pulsed field ablation and radiofrequency ablation were performed successfully, Vivek Y. Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and the Mount Sinai Health System and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai, said during a press conference.
included a novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip (Affera).
“The major improvement of this technology is that [it] extends the safety profile for the ablation procedure for atrial fibrillation while also increasing the efficacy,” study investigator Elad Anter, MD, associate section head of cardiac electrophysiology at Cleveland Clinic and director of the Mark Josephson and Andy Wit Translational Electrophysiology Research Laboratory, told Healio.
The study included 76 patients (mean age, 59 years; 66% men), of whom 21 had persistent AF and the rest had paroxysmal AF. Among the cohort, 40 patients had radiofrequency ablation anteriorly and pulsed field ablation posteriorly (RF/PF) and the rest had pulsed field ablation anteriorly and posteriorly (PF/PF).
All patients had pulmonary vein isolation, and linear lesions were ablated at the discretion of the operator, Reddy said during the press conference.
Mean pulmonary vein isolation therapy time was 22.6 minutes, with a mean of 50.1 lesions per patient, according to the researchers. There were 14 mitral linear lesions (mean therapy duration, 5.1 minutes), 34 left atrial root linear lesions (mean therapy duration, 1.8 minutes) and 44 cavotricuspid isthmus linear lesions (mean therapy duration, 2.4 minutes).
All lesion therapies were successful and mean fluoroscopy time was 4.7 minutes, Reddy said.
There were no device-related complications, cases of cardiac tamponade or strokes, but two patients had minor mucosal thermal injury, and postprocedural brain MRIs revealed asymptomatic brain lesions in eight patients, according to the researchers.
“We found that using this technology, pulmonary vein isolation and additional linear lines were achieved successfully in all patients,” Anter told Healio. “This success was achieved more rapidly compared to other technologies and was achieved with a higher safety profile. Importantly, there was no effect on the esophagus or the phrenic nerve, which are the two organs we are most concerned about when doing AF ablation.”
The device is not yet approved for commercial use in the United States, but the next step is a larger U.S.-based study, Anter said in an interview, noting that the technology could potentially be applied to ablation of other arrhythmias, including ventricular tachycardia.
For the PULSED AF study of a novel pulsed field ablation system (PulseSelect, Medtronic), researchers analyzed 30-day results from a cohort of 14 patients.
“Pulsed field ablation is a bipolar, biphasic energy modality that enables lesion formation through the mechanism of irreversible electroporation,” Atul Verma, MD, director of the heart rhythm program at Southlake Regional Health Centre in Newmarket, Ontario, Canada, said during a press conference.
Acute procedure success was achieved in all patients and on all 56 pulmonary veins treated, Verma said during the press conference, noting there was an average of 7.4 energy applications per vein.
Mean procedure time was 212 minutes and mean fluoroscopy time was 31 minutes, according to Verma.
He said there were no serious adverse events, including esophageal or phrenic nerve injuries, but one patient had groin bleeding related to the procedure but not the pulsed field ablation system.
“We were able to achieve 100% pulmonary vein isolation without any serious adverse events,” Verma said during the press conference. “We will be launching into a much larger pivotal trial in the very near future.”
- Reddy VY, et al. LBCT02-04.
- Verma A, et al. LBCT02-03. Both presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).