Biotechnology

The new device gently moves the esophagus, making cardiac ablation safer, study


A new device invented with the help of an electrophysiologist at Ohio State University Wexner Medical Center making cardiac procedures safer for patients suffering from atrial fibrillation (AFib), a common irregular heart rhythm.

A new device invented with the help of an electrophysiologist at Ohio State University Wexner Medical Center making cardiac procedures safer for patients suffering from atrial fibrillation (AFib), a common irregular heart rhythm.

AFib affects millions of people worldwide and greatly increases the risk of stroke and heart failure. To treat AFib, doctors use cardiac ablation to help restore heart rhythm. The hot or cold energy sent through the catheter destroys heart tissue, causing a fast and irregular heartbeat. While this procedure is effective in treating AFib, the energy from the catheter tip is used only a few millimeters from the esophagus. There is a risk that the energy could cause a rare, but often fatal, hole between the esophagus and heart called an atrioesophageal fistula.

To reduce the risk of esophageal damage, Emile DaoudMD, chief of the cardiac electrophysiology program and professor of internal medicine at medical School, helped develop the concept of physically moving the esophagus away from the catheter tip during the AFib ablation procedure. Using funds from the Accelerator Award from Ohio State University’s Keenan Center for Entrepreneurship, Daoud helped design and test a device called ESOlution. A clinical trial in the United States and Argentina showed that using the device significantly reduced esophageal injuries without side effects. The trial results were presented Saturday during the Heart Rhythm Society’s annual meeting.

“It is very frustrating not to have an effective method of protecting the esophagus while channeling the ablation energy to the desired location. Using suction, we can retract the esophagus and then move the entire segment sideways for only an inch or so. This creates a safe pathway to provide care,” said Daoud.

A clinical trial of 120 cardiac ablation patients found that without the device, more than a third had an esophageal injury, but when the device was used, less than 5% had an esophageal injury, Daoud said. If approved by the FDA for commercial use, this device will be the first therapy to be developed and tested specifically to prevent esophageal injury associated with detachment. Ohio State has part of the technology being developed by S4 Medical Corp. Daoud is one of the founders of the medical company.

“How to protect the esophagus safely has been a well-recognized issue for at least 15 years. There are techniques like taking the temperature inside the esophagus and using ultrasound or CT imaging to see where it is but we still have esophageal injuries. This device is effective, inexpensive and connected to vacuum suction, which is already present in every electrophysiology laboratory,” said Daoud.

Although this has not been tested, Daoud believes that moving the esophagus may also increase the effectiveness of this procedure. By removing the esophagus, the doctor can safely deliver greater amounts of ablation energy when needed.

Understanding where the esophagus is displaced relative to the location of the ablation catheter tip can also help manage and assess patients who have symptoms that are worrying after ablation. Safe esophageal deviation means that injury to the esophagus is unlikely to be the cause of the patient’s post-procedure symptoms.

Amanda Mitchem, 59, of Mount Vernon, Ohio participated in a clinical trial at Ohio State and was randomly selected to insert the device during her ablation. She suffers from AFib and simple daily tasks like washing clothes and dishes tire her out. When medication and light electric shocks to the heart didn’t work, he underwent ablation.

“The next day was like day and night. I breathe a lot better, and I haven’t felt so good in maybe a year,” he said. “Before, I could just sit back and feel like I had run 10 miles.”

Now she’s traveling back to West Virginia to play with her grandchildren and share her story with friends and family.

“Now I can go grocery shopping or to flea markets or yard sales. I can literally stand up and have a conversation without getting out of breath,” he says.

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