TCAI physicians participate in clinical trial for potential life-saving device for patients with heart rhythm disorders
AUSTIN, TEXAS—Physicians with the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center are among the first in the world to participate in a clinical trial to evaluate a new esophageal protection device designed to make ablation procedures safer for patients with atrial fibrillation (A Fib), the most common type of cardiac arrhythmia. Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI, and Amin Al-Ahmad, M.D., cardiac electrophysiologist at TCAI, recently participated in the first-in-human trials in Europe.
Given the close proximity of the esophagus to the posterior wall of the left atrium of the heart, thermal energy may enter into the esophagus during ablation, causing an atrio-esophageal (AE) fistula, which is an abnormal connection between the esophagus and atrium. It is among the most serious and life-threatening complications from ablation. This device works by using suction to pull the esophagus away using negative pressure during ablation procedures.
“While esophageal injury is uncommon during ablation, perforation of the esophagus can lead to sepsis, which is often fatal,” Dr. Natale said. “This new device may allow us to better protect the esophagus during ablation, further reducing the risk of complication to ensure best possible outcomes for our patients.”
TCAI physicians tested the esophageal protection device on approximately 10 patients in Europe, with plans to make it available to TCAI patients upon FDA approval. This technology could be available in the United States in two to three years.
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St. David’s Medical Center
St. David’s Medical Center, which is part of St. David’s HealthCare, is a full-service medical center offering comprehensive medical care at three locations—St. David’s Medical Center, Heart Hospital of Austin and St. David’s Georgetown Hospital.
Located in Central Austin, St. David’s Medical Center includes a 426-bed acute care hospital and a 64-bed rehabilitation hospital providing comprehensive inpatient and outpatient care. It is home to the internationally renowned Texas Cardiac Arrhythmia Instituteand St. David’s Neuroscience & Spine Institute. The hospital provides a complete range of women’s services, including its acclaimed maternity unit, maternal-fetal medicine, a high-risk maternal and neonatal transport team, the region’s largest Level IV Neonatal Intensive Care Unit and The Breast Center; complex surgical services; a comprehensive Bariatric Surgery Center; and a 24-hour emergency department.
Texas Cardiac Arrhythmia Institute
Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center is one of the world’s preeminent centers dedicated to the latest treatment advances for correcting abnormal heart rhythms such as Atrial Fibrillation (A Fib). The center is led by Executive Medical Director Andrea Natale, M.D., a world-renowned expert in the field. Natale is at the forefront of advancing treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures.
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February 5, 2021
St. David's HealthCare