Heart Rhythm Society

Heart Rhythm Society

Source:

Tung R, et al. Late Breaking Clinical Trials: Clinical Innovations. Presented at: Heart Rhythm 2022; April 29-May 1, 2022; San Francisco (hybrid meeting).

Disclosures: Tung reports no relevant financial disclosures.
April 30, 2022
2 min read
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Catheter-based cardioneural ablation safe, effective for recurrent fainting

Source:

Tung R, et al. Late Breaking Clinical Trials: Clinical Innovations. Presented at: Heart Rhythm 2022; April 29-May 1, 2022; San Francisco (hybrid meeting).

Disclosures: Tung reports no relevant financial disclosures.
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A novel catheter-based cardioneural ablation procedure reduced symptoms of vasovagal syncope by as much as 80% for patients with symptoms despite medical intervention and behavioral modification who did not desire permanent pacing.

Early published reports of cardioneural ablation have shown promise for the relief of autonomically mediated bradycardia; however, cases are typically performed on a compassionate basis and there is a paucity of data on of multicenter experiences, according to Roderick Tung, MD, FHRS, chief of cardiology at the University of Arizona College of Medicine, Phoenix.

heart beat drawing
Source: Adobe Stock

Neuromodulation ‘paradigm shift’

“When we do catheter ablation, we are usually going after an arrhythmia, usually tachycardia,” Tung said during a press conference at Heart Rhythm 2022. “To use the same catheter tools and try to do neuromodulation is a paradigm shift. There is a particular group of patients that is relatively young and may experience a simple faint, which we call vasovagal syncope. Those people have a very severe cardioneural reflex. There are few good solutions for autonomic bradycardia. There is behavioral modification and medial therapy has failed. The idea that we can take a catheter and rebalance the neural wiring of the autonomic state of the heart is very novel.”

In a retrospective, nonrandomized study, Tung and colleagues analyzed data from 76 cardioneural ablation procedures performed for 71 patients across 13 U.S. centers from 2016 to 2022. The mean age of patients was 47 years and 51% were women. Of the procedures, 63% were performed as concomitant with primary ablation (86% AF/atrial flutter ablation; 7% ventricular tachycardia or premature ventricular contraction; and 7% supraventricular tachycardia).

Rate of complications low

Within the cohort, 82% remained free from syncope after a single procedure at a median of 8.5 months, showing a reduction of median episodes (6 to 0 episodes; P < .001) after cardioneural ablation. Researchers observed an increase in heart rate of more than 5 bpm in 70% of patients. Five patients underwent repeat ablations.

“By ablating six unique areas where the nervous system plugs into the heart, we were able to change the milieu of the heart and show acceleration of the heart rate after the procedure,” Tung said. “Those patients went on to have 80% freedom from fainting.”

Tung noted there are several limitations; there is currently no standard of care for cardioneural ablation and there was no uniformity in diagnosis, approach and follow-up. The duration of therapeutic effect is unknown and a multicenter, randomized, sham-controlled trial is needed to learn more, he said.

The rate of complications was low, Tung said.

“There were two patients who had some stunting of the heart rhythm that ordinarily would take a pacemaker, but many of them would get a pacemaker anyway,” Tung said. “It is an interesting study. There is no labeling for this and it is not FDA-approved, but we were able to accumulate these as-needed, compassionate-basis [cases] that have been done across different centers.”