08/23/2024 | Press release | Archived content
Conemaugh Health System announced today that Lou Mastrine, DO and his team at Conemaugh Memorial Medical Center successfully performed ablation procedures using a novel energy source, Pulsed Field Ablation (PFA), to treat atrial fibrillation.
Atrial fibrillation (AF) is the most common heart rhythm disturbance. It causes debilitating and life-limiting symptoms such as palpitation, breathlessness, and fatigue.
Until now, catheter ablations to treat AF have primarily used thermal energy by either burning or freezing problematic heart tissue. However, this procedure risks damaging neighboring tissue, such as the esophagus or the phrenic nerve, which controls the diaphragm.
The FARAPULSE™ PFA system, which the U.S. Food and Drug Administration approved in January 2024, uses non-thermal electric field energy to make the cells causing AFib inactive rather than to destroy them and target heart tissue while avoiding damaging other structures.
"This technology represents a significant advancement in electrophysiology and could shape the future of atrial fibrillation treatment through catheter ablations," said Dr. Lou Mastrine.
"I am extremely proud of the team for establishing Conemaugh Health System as the first hospital in our area to offer this cutting-edge technology to benefit our AF patients across west-central Pennsylvania. I want to thank everyone involved for their hard work in making it happen."
PFA is a unique new alternative to standard-of-care thermal ablation. A non-thermal approach for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF), it is proven to be an effective treatment option for patients while minimizing risks associated with thermal ablation.
During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures - hot or cold - to destroy targeted areas in the heart associated with abnormal heart rhythms. PFA, however, relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.
PFA is a significantly quicker procedure, thereby reducing the time under anesthesia and minimizing some of the risks associated with traditional AFib ablation. "Reducing risk and expanding access to effective therapies is essential to treating the largest number of patients," says Dr. Mastrine.
By 2030, an estimated 12.1 million people (about twice the population of Arizona) in the U.S. are expected to be diagnosed with AFib, more than doubling the number from 2010. Globally, the prevalence of AFib continues to rise.
"An increasing body of evidence supports more aggressive rhythm control through ablation, whether performed earlier in a patient's AFib diagnosis to improve long-term outcomes or in the presence of comorbidities like heart failure, where ablation has been shown to reduce mortality" added Dr. Mastrine.
Positive 12-month data from the pivotal ADVENT clinical trial - the first randomized clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation - found that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quicker learning curve for physicians. Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury.