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New device makes a heart procedure safer for patients with atrial fibrillation

A revolutionary device, created in collaboration with an electrophysiologist from The Ohio State University Wexner Medical Center, enhances the safety of a crucial heart procedure for patients grappling with atrial fibrillation (AFib) – a prevalent irregular heart rhythm disorder.

AFib, affecting millions worldwide, substantially elevates the risk of stroke and heart failure among patients. To address AFib, medical professionals employ cardiac ablation to restore normal heart rhythm. This procedure involves delivering heat or cold energy through a catheter to destroy problematic heart tissue responsible for rapid and irregular heartbeats. Although effective, the energy emitted by the catheter tip is in close proximity, a mere few millimeters away, from the esophagus. Consequently, there exists a potential hazard where the energy could create a rare yet life-threatening complication known as an atrioesophageal fistula – a hole between the esophagus and the heart.

In order to mitigate the risk of esophageal damage, Dr. Emile Daoud, the section chief of the cardiac electrophysiology program and a professor of internal medicine in the College of Medicine, collaborated on the development of a pioneering approach. The concept involved physically moving the esophagus away from the catheter tip during AFib ablation procedures. Through the utilization of funding obtained from an Accelerator Award provided by The Ohio State University's Keenan Center for Entrepreneurship, Dr. Daoud played a vital role in designing and testing the device known as ESOlution. A clinical trial conducted in the United States and Argentina demonstrated that the use of this device significantly reduced esophageal injuries without any adverse effects. The findings of the trial were presented during the Heart Rhythm Society's annual meeting held on Saturday.

''It has been frustrating to not have an effective method to protect the esophagus while delivering the ablation energy at the desired location. By using suction force, we're able to pull in the esophagus and then move the entire segment to the side by only about an inch. This creates a safe pathway to deliver the treatment."

According to Dr. Emile Daoud, the clinical trial involving 120 patients undergoing heart ablation revealed that without the device, more than one-third of the participants experienced esophageal injuries. However, when the device was utilized, less than 5% of patients suffered any esophageal injury. If granted approval by the FDA for commercial use, this device would be the first therapy specifically developed and tested to prevent ablation-related esophageal injuries. The technology being developed by S4 Medical Corp, which owns a portion of the device, is affiliated with Ohio State. Dr. Daoud, serving as a co-founder of the medical company, is actively involved in its development.

Addressing the long-standing issue of safely protecting the esophagus during ablation procedures, Dr. Daoud acknowledged that various techniques, such as measuring esophageal temperature or using ultrasound or CT imaging, have been employed in the past. Despite these efforts, esophageal injuries still occur. However, the newly developed device offers an effective and affordable solution by connecting to a vacuum suction, a standard component found in every electrophysiology laboratory.

While it has not yet been tested, Dr. Daoud speculates that the movement of the esophagus facilitated by the device may also enhance the procedure's efficacy. By safely repositioning the esophagus, doctors could potentially administer larger amounts of ablation energy when necessary, further optimizing the treatment.

Gaining insight into the relocated position of the esophagus in relation to the ablation catheter tip can also aid in the management and evaluation of patients experiencing worrisome symptoms following the ablation procedure. When the esophagus is safely moved away, the likelihood of esophageal injury as the cause of a patient's post-procedure symptoms diminishes.

Amanda Mitchem, a 59-year-old resident of Mount Vernon, Ohio, took part in the clinical trial conducted at Ohio State and was randomly chosen to have the device inserted during her ablation procedure. Prior to the intervention, she had been enduring the effects of AFib, experiencing exhaustion even with simple daily tasks like doing laundry and dishes. When medications and mild electrical shocks to the heart proved ineffective, she opted for the ablation procedure.

"The following day was like a complete transformation. I could breathe so much better, and I hadn't felt that good in probably a year," she shared. "Before that, I would be sitting down and feel as if I had just run 10 miles."

Now, Amanda has regained her ability to travel to West Virginia to spend quality time with her granddaughter and is enthusiastically sharing her success story with friends and family.

"Now I can breeze through grocery shopping or enjoy browsing at the flea market or yard sales. I can engage in conversations without gasping for breath," she happily declared.


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