FDA approves cutting-edge atrial fibrillation (AFib) treatment

Cardiologists at Mayo Clinic's Heart Rhythm Clinic have begun using an innovative energy source to treat a common type of heart arrhythmia known as atrial fibrillation (AFib). This new therapy, pulsed-field ablation (PFA), has gained approval from the Food and Drug Administration (FDA) and marks a significant advancement in managing AFib.

Atrial fibrillation is characterized by an irregular and often rapid heart rhythm, which can lead to blood clots in the heart, raising the risk of stroke. While medications and therapies can help reset heart rhythm, some cases of AFib persist and worsen over time.

Ablation therapy, which has been in use for about two decades, traditionally relies on heat or cold to modify heart tissue. However, PFA represents a different approach to this treatment.

PFA utilizes short bursts of high energy, known as irreversible electroporation, to target the heart tissue responsible for AFib. This technique was introduced at Mayo Clinic in Rochester, and since then, over 200 patients have been treated with PFA.

The development of PFA stems from the limitations of traditional thermal energy-based ablation techniques, which carry risks of injury to nearby structures like the esophagus and the phrenic nerve.

Dr. Suraj Kapa, a cardiac electrophysiologist at Mayo Clinic, explains that these risks inspired the search for a new energy source that could selectively impact cardiac tissue without causing harm to surrounding areas.

Mayo Clinic’s journey into ablative therapy research began under the guidance of Dr. Samuel J. Asirvatham, a cardiac electrophysiologist and inventor. His interest in developing novel energy sources led to the concept underlying PFA.

Dr. Kapa explains, "Depending on the makeup of cell membranes, different tissues have varying energy thresholds that can be 'deadened' or ablated while preserving other types of tissue. Research from hundreds of preclinical trials suggests that PFA allows for a heart tissue-specific approach to ablation, avoiding collateral injury to structures such as the esophagus or the phrenic nerve."

This research culminated in the development of two U.S.-approved systems designed to deliver pulsed field energy to the heart. Both systems have been approved to treat AFib through pulmonary vein isolation and have demonstrated similar efficacy to traditional radiofrequency ablation in clinical trials, according to Dr. Kapa.

PFA offers several advantages, including faster procedures, reduced anesthesia time, and a decrease in the risks associated with traditional ablation methods. Dr. Kapa emphasizes the importance of minimizing risk while making effective treatments more accessible. He notes, "Minimizing risk and making potentially effective treatments more broadly available is critical to providing therapy to the largest number of patients."

The need for advancements in AFib treatment is pressing. By 2030, it's estimated that 12.1 million people in the U.S. will be diagnosed with AFib, more than double the number in 2010. Globally, AFib diagnoses are also on the rise. Dr. Kapa highlights the growing evidence supporting more aggressive rhythm control through ablation, especially when initiated earlier in the course of the disease.

He states, "A growing body of evidence supports more aggressive rhythm control with ablation, whether earlier in a patient's AFib diagnosis to achieve better long-term outcomes or in the setting of other comorbidities such as heart failure, in which ablation has shown to reduce mortality."

Looking to the future, researchers are exploring how PFA could be applied to other arrhythmias, such as ventricular arrhythmias. Early preclinical data suggest that PFA may offer superior outcomes compared to current thermal energy-based approaches in this area.

Dr. Kapa anticipates rapid growth and evolution in pulsed field therapy, predicting that within the next year, several new catheters and systems utilizing pulsed field therapy will be introduced. These innovations will not only provide new research opportunities but also hold the potential to deliver transformative, curative care for patients with arrhythmic diseases.

This article brings to light the significant advancements in AFib treatment through the adoption of PFA, reflecting a promising shift towards safer and more effective cardiac care.

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