Percutaneous treatment option for mitral regurgitation shows promise
Approximately 5 million Americans suffer from heart failure. Roughly, half of these have heart failure with reduced ejection fraction (EF), of whom at least half have some degree of functional mitral regurgitation (FMR).
Functional mitral regurgitation is commonly found in patients with underlying myocardial dysfunction and results from decreased left ventricular (LV) closing forces and from distortion of the LV geometry tethering the structurally normal mitral leaflets. Severe FMR is associated with increased morbidity and mortality independent of both LV ejection fraction (LVEF) and clinical markers of heart failure.
The prognosis is poor for patients with heart failure who have mitral regurgitation due to left ventricular dysfunction. Conventional treatment options have included surgery to repair or replace the mitral valve or medication therapies to mitigate symptoms. Many of these patients are too high risk for surgical interventions. Medication therapies are helpful at treating heart failure symptoms but do not address the underlying structural defect. Despite advances in medical therapy, mortality rates remain high for patients with FMR.
Significant and rapidly evolving advancements in the treatment of FMR underscore the importance of ensuring patients have access to a multidisciplinary cardiology team that is not only skilled in treating the entire scope of heart disease, but also is helping to chart the course for innovative therapies, minimally invasive techniques and devices that lengthen mortality and improve quality of life.
In the last five to ten years, research has led to less invasive options for patients who are too high a risk for surgical interventions to treat heart disease. A percutaneous approach using the MitraClip in the treatment of degenerative mitral regurgitation has proven effective for high-risk patients or those at increased risk of death or hospitalization for heart failure.
A study published this fall in the New England Journal of Medicine indicates a transcatheter mitral-valve repair may also improve clinical outcomes in patients with FMR.
The COAPT study enrolled 614 patients at 78 sites in the U.S. and Canada. The study concluded, "Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone." (NEJM)
The trial was significant in that it was the first time any intervention for FMR has demonstrated a mortality benefit. The interventional procedure was performed in a catheterization lab under general anesthesia and patients were typically hospitalized overnight. In carefully selected patients treated with the MitraClip, incidence of hospitalization decreased from 67.9 percent to 35 percent and mortality decreased from 46.1 percent to 29.1 percent.
On the heels of this breakthrough news, TriStar Centennial Medical Center has been named the only site in the region to offer The CARILLON Trial and is currently evaluating the Carillon Mitral Contour System for patients with FMR. This percutaneous mitral annuloplasty technique allows interventional cardiologists to perform a procedure similar to what surgeons have been doing successfully for years, but less invasively to reduce risks for patients.
The trial device is placed in a vessel next to the base of the mitral valve and helps to align the leaflets to reduce the amount of regurgitation a patient may experience. In comparison to other trials of other therapies, this trial includes patients with a moderate leak or lesser degree of regurgitation to help determine if earlier intervention is helpful. While the impact these therapies may have to 'fix' the weakened heart muscle is still being determined, it is possible that reducing the amount of mitral regurgitation will prevent further negative remodeling by interrupting the cycle and have a positive impact on a patient's longevity.
TriStar Centennial Medical Center is currently enrolling patients in The CARILLON Trial who have an ejection fraction ≤ 50 percent and 2+ moderate or more mitral regurgitation. Centennial Heart expects to be a top enroller in the trial, which will include 450 patients internationally.
It is critical for patients suffering from complex heart disease to seek treatment where they can be afforded that full spectrum of treatment options. TriStar Centennial Medical Center offers patients a collaborative approach that includes heart failure specialists, structural heart interventionalists and cardiac surgeons who specialize in advanced cutting-edge treatment options to treat the most complex cardiac disorders.
For more information about the Carillon Mitral Contour System trial and to refer a patient for enrollment consideration, please call (615) 342-4636.
Sponsored content courtesy TriStar Centennial Medical Center. Andrew Goodman, MD, is an Interventional Cardiologist with Centennial Heart. For more information go online to tristarcentennial.com.