Left ventricular cardiomyopathy is the most common type of heart failure in which the heart’s main chamber (the left ventricle) becomes enlarged and incapable of properly pumping blood out of the heart. Approximately Roughly 30% of patients with left ventricular cardiomyopathy go on to develop a secondary heart condition called severe mitral valve regurgitation. In this heart condition, the mitral valve, which controls the flow of blood from the left atrium into the left ventricle, becomes distorted from the enlarged left ventricle, resulting in its leaflets failing to close completely. This leads to blood leaking backwards, increasing pressure in the heart, and increasing the patient’s risk of hospitalization and death. In most cases, it is possible to treat this condition with a minimally invasive procedure called transcatheter edge-to-edge repair (TEER) that involves clipping the leaflets of the mitral valve together. The procedure is usually performed with a device called the MitraClip, manufactured by Abbott (Abbott Park, IL, USA)

Breakthrough findings from a new study led by the Icahn School of Medicine at Mount Sinai (New York City, NY, USA) suggest that the utilization of transcatheter mitral valve repair in heart failure patients with mitral regurgitation can lower the long-term hospitalization rate by almost 50% and reduce the risk of death by nearly 30% compared to heart failure patients who do not undertake the minimally invasive procedure. This multi-center trial is the largest trial to examine the safety and effectiveness of transcatheter mitral-valve repair in a heart failure population using Abbott’s MitraClip system. It shows the treatment option can significantly improve patient outcomes in those with heart failure who do not respond to conventional treatments.

In the “Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Device” study, or COAPT, researchers examined whether treating the severe secondary mitral valve regurgitation with TEER, which has no direct effect on the underlying weakened heart muscle, can improve outcomes in heart failure patients beyond medical therapy alone. The two-year results, published in 2018, showed for the first time that treating secondary mitral valve regurgitation improved patients’ symptoms, reduced hospitalizations, and led them to live longer. Now, their latest five-year results show further significant findings.

The study examined 614 patients recruited between December 27, 2012, and June 23, 2017, from 78 centers in the U.S. and Canada. All patients suffered from cardiomyopathy and secondary, severe mitral valve regurgitation, despite receiving optimal medical therapy for heart failure. Half of the patients continued their heart failure medication, while the other half underwent transcatheter valve repair involving the MitraClip, but continued with their heart failure medication. Over the course of five years following treatment, the annual rates of heart failure hospitalizations were found to be 33.1% in the MitraClip group compared to 57.2% in patients treated only with medication, signifying a 47% reduction. Moreover, there was a 29% decrease in deaths from heart failure in the MitraClip group compared to patients taking medication only, and a 28% reduction in all-cause death. Despite having decreased rates of hospitalizations and deaths with successful treatment, 73.6% of patients in the MitraClip group still experienced one or more heart failure hospitalizations or died at the end of five years (compared to 91.5% of patients in the medication-only group). Therefore, the researchers have emphasized the need for advanced therapies to treat these high-risk patients.

“Treating severe secondary mitral regurgitation in appropriate patients with cardiomyopathy is important - our study shows that five years after the MitraClip procedure, patients feel better, are hospitalized less frequently, and live longer,” said lead author Gregg W. Stone, MD, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at Icahn Mount Sinai. “It’s critical for physicians to recognize mitral regurgitation in patients with cardiomyopathy, then treat this secondary issue as early as possible to improve outcomes in this heart failure group.”

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