YORK, Pa. — A clinical trial studying innovative technology to correct atrial fibrillation shows the new treatment is just as effective and safe as prior methods. FOX43 talked to the first person in Pennsylvania to receive the system and the doctor who performed it.
The promising outcomes of the study were presented at ESC Congress 2023, the annual meeting of the European Society of Cardiology, and simultaneously published in The New England Journal of Medicine on August 27, 2023.
Bob Skalkowski, from Central Pa., is the first patient in Pennsylvania to be enrolled in the clinical trial. Shortly after his retirement, Bob, a freelance photographer since 1976 in the commercial industry, was diagnosed with AFib.
Unfortunately, AFib is not a stranger to the Skalkowski family.
Both of Bob’s parents had AFib and had to take blood thinners to mitigate the risk of stroke. He thought of his parents and how he would need to live with AFib for the rest of his life. Like his parents, he had to go on blood thinners and was prescribed one of the novel anticoagulant therapies.
Unlike Coumadin, there is no reversal for the novel anticoagulant therapies, and as an active guy, Bob was concerned that he could hurt himself and bleed out. He did suffer some of the physical effects of AFib, but he found that AFib was even more taxing emotionally.
He says the experience also weighed on his wife, who worried about him constantly. After living with AFib for years, Bob became the first patient in Pennsylvania to participate in the clinical trial for the FARAPULSE Pulsed Field Ablation System- or PFA.
"After a few days I felt great and I've been AFib-free ever since," Skalkowski told FOX43.
"This is like a new block, this is iPhone 1 vs iPhone 14," said Dr. Chinmay Patel of UPMC. He was one of the principal investigators in the national ADVENT trial for PFA.
He says the non-thermal ablation treatment delivers microsecond high-voltage electrical fields to selectively ablate heart tissue while potentially limiting damage to other tissues. For that reason, he says the trial found the PFA system to be as effective and as safe as conventional methods, if not more.
"The fact that there was very little chance of collateral damage to the other part of my heart and other parts of my organs was a big selling point that I grasped immediately," said Bob. He says he wasn't even hesitant to be the first test patient when Dr. Patel asked him to participate in the study.
Bob told FOX43 that he's glad he did, calling the procedure a miracle.
Dr. Patel says the PFA system works, but it's still not being widely used. at this time. However, there's hope for the future, with the study's findings being published in the New England Journal of Medicine this past August.
For more information on this trial's findings, click here.