Pulsed field ablation, recently approved by the FDA, reduces the risk of complications compared to traditional ablation methods.


Summary: Pulsed field ablation has been confirmed as a safe and effective treatment for atrial fibrillation by a study led by the Icahn School of Medicine at Mount Sinai. The study, involving over 17,000 patients, showed no significant risk of esophageal damage, pulmonary vein stenosis, or persistent phrenic nerve injury, unlike traditional thermal ablation methods. PFA uses high-energy electrical pulses instead of temperature, providing precise treatment with fewer complications.

Key Takeaways:

  • Pulsed field ablation has a low complication rate, with no significant risks of esophageal damage, pulmonary vein stenosis, or phrenic nerve injury.
  • The study supports pulsed field ablation as a precise and effective alternative to traditional ablation methods for atrial fibrillation.
  • Major complications were rare, with pericardial tamponade in 0.36%, stroke in 0.12%, and death in 0.03% of patients.

Pulsed field ablation is safe for treating patients with common types of atrial fibrillation, according a study on this new technology, led by the Icahn School of Medicine at Mount Sinai.  

The MANIFEST-17K international study shows safety outcomes in a large patient population, including no significant risk of esophageal damage, with pulsed field ablation. Pulsed field ablation is the latest ablation modality approved by the Food and Drug Administration that can be used to restore a regular heartbeat. 

Researchers say the findings, published in Nature Medicine, could lead to more frequent use of pulsed field ablation instead of conventional therapies to manage atrial fibrillation patients.

Advantages Over Traditional Ablation Methods

“MANIFEST-17K provides confidence that, unlike conventional thermal ablation, pulsed field ablation with the pentaspline catheter does not cause the most feared complication of [atrial fibrillation] ablation—esophageal damage—nor does it cause pulmonary vein stenosis or persistent injury to the diaphragm,” says senior author Vivek Reddy, MD, The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai, in a release. 

Additionally, Reddys notes that the study found that other general complications were also rare, including pericardial tamponade occurring in approximately one in 200 patients, stroke in one in 1,000, and death in even less than one in 1,000 patients. “Given the relative novelty of pulsed field ablation, these are important safety outcomes,” he says in a release.

Patients with atrial fibrillation can undergo a catheter procedure, called catheter ablation, to treat this abnormal heart rhythm. This procedure involves making scars in small areas in the heart involved in the abnormal rhythm, which prevents abnormal electrical signals or rhythms from moving through the heart.

Study Findings and Implications

Two types of ablation are currently in common use: radiofrequency ablation, which uses heat energy to eliminate the problem area, and cryoablation, which uses cold energy. These ablation modalities are associated with increased risk of potential complications, including damage to the esophagus, pulmonary vein stenosis, and injury to the phrenic nerve, which controls the diaphragm and is essential for breathing. 

Pulsed field ablation does not use temperature, but instead short high-energy electrical pulses. This catheter procedure is more precise than radiofrequency and cryoablation and does not cause damage to the esophagus, pulmonary veins, or phrenic nerve.

This retrospective, observational study analyzed 17,642 patients with paroxysmal and persistent atrial fibrillation after undergoing pulsed field ablation procedures at 106 centers in 2021. Procedures were performed with pentaspline pulsed field ablation catheter, the most commonly used pulsed field ablation catheter worldwide. 

Researchers found no energy-specific complications among patients, including no esophageal damage, pulmonary vein stenosis, or persistent phrenic nerve injury. There was a 1% overall major complication rate, and more specifically, rates of 0.36% for pericardial tamponade, 0.30% for vascular complications, 0.12% for stroke, and 0.03% for death. Unexpected complications of pulsed field ablation were coronary arterial spasm (0.14%) and hemolysis-related acute renal failure necessitating hemodialysis (0.03%).

Conclusion and Future Vigilance

“While we should continue to remain vigilant to identify any other rare complications of pulsed field ablation that may be identified in the future, these favorable safety outcomes in over 17,000 patients increase our confidence in the use of this [pulsed field ablation] catheter technology,” says Reddy in a release.

Reddy serves as an unpaid consultant to Boston Scientific, the manufacturer of the pulsed field ablation catheter technology studied in this manuscript.

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