Last week, Brijeshwar Maini, MD, Cardiologist and Director of Cardiovascular Research and Education at PinnacleHealth, and Mubashir Mumtaz, MD, Chief of Cardiothoracic Surgery at PinnacleHealth, performed the first catheter-based valve repair with the MitraClip® in Pennsylvania following the device's FDA approval. The U.S. Food and Drug Administration (FDA) approved the MitraClip® therapy for use in the United States in October, providing physicians with a breakthrough treatment option for patients suffering from mitral regurgitation (MR).
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. 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.
"We see patients with severe mitral regurgitation who are technically candidates for surgery, but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life," says Dr. Maini. "With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery to regain their quality of life."
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.
"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," says Dr. Maini. "FDA approval of the MitraClip marks an important milestone for the treatment of cardiovascular diseases."
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 their quality of life. Patients undergoing MitraClip® treatment typically experience short recovery times and short hospital stays of two to three days.
PinnacleHealth CardioVascular Institute (PHCVI) continues to conduct clinical trials of the MitraClip® therapy through a landmark, prospective, randomized trial COAPT that will evaluate the impact of MitraClip® treatment on the progression of heart failure.