Burgeoning Hybrid Atrial Fibrillation Program at THI Bolstered by FDA Approval of Innovative New EPi-Sense Treatment System
Dr. Jennifer Cozart Now Seeks to Further Expand THI’s Cutting-Edge Atrial Fibrillation Minimally Invasive Hybrid Treatment for Patients Suffering from the Common Cardiovascular Issue
HOUSTON, TX (April 30, 2021) – The Texas Heart Institute echoes the exciting FDA approval of innovative medical device company AtriCure’s EPi-Sense System for treating long-standing persistent atrial fibrillation (LSPAF) in heart patients. The authorization marks the first and only FDA approval of a minimally invasive surgical ablation therapy for these patients, which will improve the lives of more than 3.5 million patients in the United States living with LSPAF. Further, the announcement aligns with the local three-year efforts of THI’s Dr. Jennifer Cozart and her colleagues, who have been working arduously to develop and implement a Hybrid Atrial Fibrillation Program at the Institute.
The FDA approval comes following the CONVERGE clinical trial – a landmark prospective, superiority, and randomized controlled pivotal trial designed to evaluate the overall success of hybrid ablation compared to endocardial catheter ablation alone for patients with persistent or long-standing persistent atrial fibrillation (Afib). The procedure combines a minimally invasive, closed-chest epicardial ablation performed by a surgeon using the AtriCure EPi-Sense System in addition to endocardial radiofrequency catheter ablation performed by an electrophysiologist. The trial enrolled 153 patients at 27 locations (25 in the United States and two in the United Kingdom). Patients were randomized at a rate of 2:1 and received either the hybrid procedure or an endocardial catheter ablation alone. The hybrid procedure showed superior effectiveness compared with endocardial-only ablation in patients with advanced atrial fibrillation (AF). The study also underscored how the collaboration between electrophysiologists and cardiac surgeons helps to improve outcomes in these patients.
“This morning’s FDA approval of the EPi-Sense System for the treatment of long-standing persistent atrial fibrillation is a triumphant result and one that significantly supports the work that we have been doing here at the Texas Heart Institute to improve treatment for patients with atrial fibrillation,” Dr. Cozart emphasized. She added, “The EPi-Sense System will help patients with the most advanced stages of atrial fibrillation and will be a true game-changer as a hybrid treatment option. I am extremely hopeful for what today’s announcement means for the future of treatment for Afib, which affects over 33 million people around the globe.”
A cardiovascular surgeon with Surgical Associates of Texas, P.A. and a member of THI’s Professional Staff, Dr. Cozart holds a medical staff appointment at Baylor St. Luke’s Medical Center and Texas Heart Institute in Houston. She received her Doctor of Medicine degree from The University of Texas Medical Branch at Galveston, Texas in 2003 after receiving a Bachelor of Arts degree in 1998 from The University of Texas at Austin. Upon completion of a General Surgery Residency at The University of Texas Medical Branch in 2008, she completed a Cardiothoracic and Vascular Surgery Residency at the Texas Heart Institute and Baylor College of Medicine.
“I am ecstatic for Dr. Cozart and her team and look forward to seeing what amazing things they will be able to achieve treating patients utilizing the EPi-Sense System,” noted Dr. Stephanie Coulter, THI’s Assistant Medical Director. She added, “Long-standing persistent Afib patients have been waiting for a breakthrough treatment such as this to become a tangible reality, and Dr. Cozart is a leader in this field of cardiovascular study who has the experience and skill to capably implement its use.”
ABOUT TEXAS HEART INSTITUTE (THI)
The Texas Heart Institute, founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education, and improved patient care. THI’s scientists and physicians conduct fundamental biomedical, translational, and clinical research in cardiology, cardiovascular surgery, molecular-based medicine, stem cell and gene therapy, and regenerative medicine both independently and in collaboration with organizations worldwide. As global leaders of patient care for nearly six decades, Texas Heart Institute has been ranked among the top cardiovascular centers in the United States by U.S. News & World Report for the past 30 years. THI is dedicated to spreading awareness and sharing updates on ways to prevent, treat and defeat cardiovascular disease. With over 10 million visitors coming to its website from around the world every year, www.texasheart.org is just one of the ways THI is helping to educate people on the importance of heart health. For more information, please visit https://www.texasheart.org.
Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com
DeLurgio, D.B., et al. (2021). Hybrid epicardial-endocardial RF ablation vs. endocardial catheter ablation for long-standing persistent atrial fibrillation treatment: Results from CONVERGE randomized controlled trial. International AF Symposium.