First in Texas: Abbott's First-In-Class MitraClip® Device Implanted at Dallas Hospital

Treatment with Minimally Invasive Device Can Improve Quality of Life for Patients with Debilitating Mitral Valve Disease Who Are at Prohibitive Surgical Risk

On Wednesday, Nov.6, Paul Grayburn, MD, Medical Director of Non-Invasive Cardiology at Baylor Jack and Jane Hamiton Heart and Vascular Hospital and principal investigator for EVEREST II: REALISM Study, became the first Texas physician to use a new less-invasive device to treat mitral regurgitation (MR). The procedure took place at the Baylor Hamilton Heart and Vascular Hospital, Dallas, with James Choi, MD, and Robert F. Hebeler, MD, performing the procedure with Grayburn.

MR is a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart. The condition can raise the risk of irregular heartbeats, stroke, and heart failure, which can be deadly. The Abbott First-in-Class MitraClip gives cardiac surgeons another treatment option for patients who are too fragile or sick to survive the traditional invasive mitral valve replacement surgery. “Through research cardiology is evolving with new technologies that allow us to offer treatments to these patients we once could not effectively treat,” said Dr. Grayburn

Abbott had just announced Oct. 25 that its first-in-class, catheter-based MitraClip® therapy has received U.S. Food and Drug Administration (FDA) approval and will launch immediately in the United States, providing physicians with a breakthrough treatment option for patients suffering from mitral regurgitation (MR). Baylor Scott & White Health researchers were instrumental in testing the device. The study was Evalve Cardiovascular Valve Repair System (CVRS) Endovascular Valve Edge-2-Edge Repair Study or EVEREST II: REALISM.

"As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life," said Michael Mack, M.D., Director of Cardiovascular Surgery at The Heart Hospital Baylor Plano. "With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life."

The MitraClip device has been approved for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Prohibitive risk is determined by the clinical judgment of a heart team due to the presence of one or more documented surgical risk factors.

Mitral regurgitation is common, affecting more than 4 million Americans – nearly one in 10 people aged 75 and above. Open heart mitral valve surgery is the standard-of-care treatment, but many patients are at prohibitive risk for an invasive procedure. Medications for the condition are limited to symptom management and do not stop the progression of the disease.

Multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients. More than 11,000 patients in more than 30 countries have been treated with the MitraClip device.

"MitraClip is a breakthrough in the treatment of severe mitral regurgitation, a condition that is progressive and causes extreme fatigue and shortness of breath, eventually making even simple tasks virtually impossible, and increasing the risk of stroke, heart failure and death," said Ted Feldman, M.D., FSCAI, director, Cardiac Catheterization Laboratory and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill. "Clinical data and real-world international experience, dating back to 2003, have consistently shown that the MitraClip is a safe and effective therapy for patients unable to undergo mitral valve surgery, providing meaningful improvements in quality of life that are sustained over time. It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment." 

Abbott's MitraClip repairs the mitral valve without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. Patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays of two to three days.

"FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives," said Chuck Foltz, senior vice president, vascular, Abbott. "We look forward to making this technology available to specialized centers in the U.S. with multi-disciplinary teams experienced in the management of patients with heart valve disease, a model that facilitates dialogue across physician specialties and provides patients with the best treatment outcomes."

Abbott continues to conduct clinical trials of the MitraClip therapy through two landmark, prospective, randomized trials – COAPT in the United States and RESHAPE-HF in Europe – that will evaluate the impact of MitraClip treatment on the progression of heart failure. The studies also will generate important clinical and economic data that may support development of treatment guidelines, expanded indications and reimbursement. Both studies are currently enrolling patients.

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About Baylor Scott & White Health
As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit: BSWHealth.com