Scripps Cardiologist First in County to Use Newly Approved Device Targeting Heart Cells to Treat Irregular Heartbeat

Pulsed field ablation avoids surrounding tissue, reducing potential complications

An image of a newly approved device that treats irregular heartbeat, which a Scripps physician was first to use in SD county.

Pulsed field ablation avoids surrounding tissue, reducing potential complications

Scripps Clinic cardiac electrophysiologist Douglas Gibson, MD, has become the first in San Diego County to treat a common irregular heartbeat with newly approved technology that targets specific cells in the heart without damaging surrounding tissue.

The procedure was performed on a 71-year-old San Diego man at Scripps Memorial Hospital La Jolla on Feb. 20, about three weeks after the Farapulse pulsed field ablation system was approved by the U.S. Food and Drug Administration. The technology had been granted breakthrough device designation by the FDA in 2019, a move that expedited its development and regulatory review.

The Boston Scientific technology is currently cleared to treat intermittent, or paroxysmal, atrial fibrillation (AFib), which involves a rapid, erratic heart rate that begins suddenly then stops on its own within a few days. The condition is caused by abnormal heart muscle that generates rapid, disorganized electrical signals in the upper chambers of the heart. AFib can lead to blood clots in the heart, stroke and heart failure in addition to causing disabling symptoms.

"Pulsed field ablation represents a significant advance in the way we treat intermittent atrial fibrillation."

Douglas Gibson, MD

“Pulsed field ablation represents a significant advance in the way we treat intermittent atrial fibrillation,” Gibson said. “By specifically targeting the cells in the heart responsible for an irregular heartbeat, pulsed field ablation reduces the risk of collateral tissue damage that can occur with other technologies. It also increases the speed and efficiency of delivering treatment.”

Scripps was the only regional site to participate in the pivotal clinical trial that led to FDA approval of Farapulse, with Dr. Gibson being the lead investigator. Scripps Clinic cardiologists Nicholas Olson, MD, and Steven Mickelsen, MD, also have significant experience with the technology and will be offering pulsed field ablation to appropriate patients in their clinical practices.

During the minimally invasive procedure, a catheter enters a small puncture in the patient’s groin and is threaded through a vein. Once the device reaches the heart, targeted cells are disrupted with micro-second bursts of electrical energy as opposed to delivering heat or cold with traditional ablation technologies. This nonthermal approach targeting specific heart muscle cells results in more durable ablation lesions. 

“Pulsed field ablation represents a paradigm shift in how we treat millions of patients with AFib,” said Dr. Mickelsen, who invented the foundational technology for Farapulse (originally Iowa Approach) and led its development before the company was acquired by Boston Scientific. “With as many as 6 million people in the United States suffering from AFib, having access to a technology that is safer and easier to use is absolutely critical for taking care of more of those patients.”

Scripps La Jolla was one of 34 study centers in the United States that enrolled 607 patients to participate in the pivotal ADVENT clinical trial of the Farapulse system, which was the first randomized study to directly compare the efficacy and safety of Farapulse with the standard heart ablation technologies.

In findings published last fall in the New England Journal of Medicine, investigators reported that 12-month outcomes in Farapulse patients were as good as those in patients who received the other procedures, despite this being a new modality for physician operators. Electrophysiologists performing pulsed field ablation took an average of 29 minutes to complete the procedure, significantly less than the 50-minute average seen with the other methods.

Farapulse was approved by regulators in Europe in 2021, and the system has been used to treat more than 25,000 patients globally, according to Boston Scientific.

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Keith Darce

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