A study of patients suffering heart failure due to left ventricular dysfunction has found great promise in a new minimally invasive approach, reports The New York Times. The new research was presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and published in The New England Journal of Medicine.
The study examined the effectiveness of the Abbott MitraClip in the treatment of patients with mitral regurgitation due to left ventricular dysfunction. In a transcatheter mitral valve repair procedure, the MitraClip is delivered to the heart and essential cinches the damaged valve to make it functional again.
There was skepticism about whether this simple repair would have a significant positive impact on patients. The results of the study exceeded the most optimistic hopes.
“It’s a huge advance,” Howard Herrmann, MD, the director of interventional cardiology with the University of Pennsylvania health system, explains to the Times. “It shows we can treat and improve the outcomes of a disease in a way we never thought we could.”
The study enrolled 614 patients. Roughly half received the MitraClip, and the others were solely treated with medical therapy. In the two year period following treatment, 67.9 percent of patients without the MitraClip were hospitalized with heart failure. Only 35.8 percent of MitraClip patients were similarly admitted during the same period.
Researchers reported similar disparities in mortality rates (28 patients with the MitraClip died, and 61 patients without the MitraClip died), quality of life, and functional capacity.
Abbott provided financial support to the research, but it also went through the customary review process by individuals without a financial stake in the device’s success rate.
Mathew Williams, MD, the director of interventional cardiology with NYU Langhorne Health, tells the Times the new research points to a pending transformation in treating cardiac patients. He theorizes the minimally invasive approach may allow doctors to address problems with the mitral valve before patients have been weakened by heart failure.
“Maybe we need to start intervening earlier,” says Williams.
The MitraClip currently has FDA clearance only for patients deemed too frail for open heart surgery. With the new research in hand, Abbott is expected to earn expanded clearance for the MitraClip, allowing for procedures on healthier patients.