While completing his medical fellowship at the University of Iowa in 2012, Dr. Steven Mikkelsen came up with a new way to treat a heart disease called atrial fibrillation.

His idea to use pulsed electric fields to remove problem heart cells with less collateral damage than techniques that use heat or cold was developed by Boston Scientist, which won FDA approval in January. It is the core of Fick’s new medical device Farapulse.

More than a decade after the idea first came to mind, the electrophysiologist who now works at Scripps Health in San Diego has yet to use the technology to treat his own patients. .

“For me, it was always a struggle to participate in clinical trials until FDA approval,” Mikkelsen said. “Now I’m allowed to use it. I’m excited to be part of something that is transformative in the field I work in.”

Watching his colleagues use Farapulse during the exam was a bit torturous, but also exhilarating, he said.

“That’s the way regulatory science is going. Even if you truly believe as an inventor, researcher, physician that it’s a good technology, you have to wait for science to prove it, so it’s not going to last forever.” It takes time,” Mikkelsen said. “Using new technology to conduct prospective randomized trials of standard treatments is a real undertaking.”

Farapulse follows the same route in the body as existing technology, which is the standard of care. The surgical team threads a long, thin wire called a catheter through a blood vessel, starting with a puncture in the groin and into the left atrium, the upper chamber of the heart that collects oxygen-rich blood from the lungs to nourish the body. reach.

In some cases, cells at the back of this chamber can become damaged, causing the atria to shake instead of contracting, causing dizziness and chest pain, and increasing the chance of blood clots and stroke. Removing these dysfunctional cells can significantly reduce the occurrence of this condition, most commonly referred to as ‘afib’, and radiofrequency has been used to generate heat to remove the cells. . This cell removal process, called ablation, also typically uses extremely low temperatures.

Dr. Nicholas Olson holds a pulse-field ablation catheter Thursday at Scripps Memorial Hospital.

(San Diego Union-Tribune)

Farapulse and another recently approved device from Medtronic called PulseSelect use high-speed electrical signals to create holes in cell walls, a phenomenon called “electroporation.” Heart cells are particularly susceptible to this phenomenon, while other types of tissue are unaffected. Sharp Healthcare is currently participating in yet another pulsed-field trial with medical device company Biosense Webster.

Heat and cold are not very specific, notes Dr. Douglas Gibson, an electrophysiologist at Scripps who was the first to use Farapulse in the San Diego area and participated in the device’s clinical trial process.

“The problem with heat and cold is that they can destroy everything in your body,” Gibson says. “So we’ve had to worry about collateral damage for the last 20 years.”

For example, the esophagus passes just behind the heart where the ablation is performed, so too much treatment can have dire consequences.

“Using heat can trigger an inflammatory response that can damage the heart and esophagus, and that response can cause structures to stick together,” Gibson says.

Although such reactions are rare, thermal cardiac ablation has been significantly improved, and the ability to more easily avoid collateral damage is considered a major advantage. The use of pulsed energy is faster than other methods and allows more patients to be treated in the same amount of time. Also, because the damage to the tissue is less traumatic, the body will not work as hard to heal the injury and will probably be less likely to need her second treatment.

A computer model shows the treatment area for a pulsed field ablation procedure performed Thursday at Scripps Memorial Hospital in San Diego.

(Nelvin C. Cepeda/San Diego Union-Tribune)

Gibson said patients who undergo thermal ablation often develop flu-like symptoms after the procedure because of the inflammation that occurs after the procedure. However, in clinical trial cases, these symptoms appear to be less common with pulsed field treatment.

“More than once, patients have told us that they didn’t feel like we actually did much,” Gibson said.

Mikkelsen said he expects to administer the first treatments using the technology he helped invent within a week or two. But he and Gibson are already collaborating on next-generation pulsed-field technology.