Inserting a tiny clip into the hearts of patients with severe heart failure significantly reduced patient death rates, according to a study published Sunday in the New England Journal of Medicine.
Severe heart failure affects about two million U.S. residents. It is a debilitating condition that impedes blood flow throughout the body and can make it difficult for patients to breathe when undertaking physical activities as simple as walking across a room.
The condition often is triggered by a heart attack or other cardiovascular event that damages the heart's ability to pump efficiently. To make up for the inefficiency, the heart becomes enlarged, tearing the mitral valve, which controls blood flow from the heart to the rest of the body. As a result, blood leaks through the valve into the heart and lungs.
Drugs can help patients with severe heart failure manage the symptoms of their disease, but until now, there has been no direct way to fix the problem, as these patient usually are considered too sick to have open-heart surgery to replace the mitral valves. As a result, most patients with severe heart failure see their condition worsen and do not live for a long period of time, the New York Times reports.
But doctors say the new study could illuminate a new treatment option for severe heart failure patients.
The clinical trial focused on Abbott's MitraClip—a device that is inserted into a blood vessel in the groin and, from there, guided to the heart's mitral valve, where it can clip the torn flaps together.
For the study, which was paid for by Abbott and reviewed by outside experts, researchers randomly assigned 614 patients with severe heart failure either to undergo the transcatheter mitral-valve repair with standard care or to receive only standard care.
Among the patients who underwent the procedure, the researchers found 92 were hospitalized for heart failure and 28 died, compared with 151 hospitalizations and 61 deaths among those who only received standard care. The researchers also said patients who underwent the procedure experienced drastic improvements in their quality of life.
Cardiologists optimistic about the path forward
The study's findings have left researchers optimistic, the Times reports.
Mathew Williams—director of the heart valve program at NYU Langone Health, which enrolled a few patients in the clinical trial—said, "This is a game changer. This is massive. This will change how we treat these patients."
Howard Herrmann—director of interventional cardiology at the University of Pennsylvania, which also enrolled patients in the trial—said, "It's a huge advance. It shows we can treat and improve the outcomes of a disease in a way we never thought we could."
According to the Times, the device is not yet FDA-approved for treating patients with severe heart failure, but experts predict it will not be long before the agency signs off and insurers, such as Medicare, cover the device's use. The device currently costs $30,000, which does not include the cost of the procedure (Kolata, New York Times, 9/23).
Advisory Board's take
Megan Tooley, Practice Manager, Cardiovascular Roundtable
The results of this trial (COAPT) have been quite exciting for both the structural heart and heart failure communities. My colleague Nadeem Farooqi is currently at the Transcatheter Cardiovascular Therapeutics 2018 conference where the results were presented, and reported that when Dr. Gregg Stone announced the results, the audience gave an audible gasp and broke into applause.
“When Dr. Gregg Stone announced the results, the audience gave an audible gasp and broke into applause. ”
I expect this study will likely provide a much-needed boost to proponents of transcatheter mitral valve repair which, largely due to restrictive indications and questions over efficacy, has struggled to achieve the rapid growth seen by its sister procedure, transcatheter aortic valve replacement (TAVR).
Coming on the heels of disappointingly neutral or even negative trials testing cardiovascular interventions—like CABANA, which evaluated the impact of AFib ablation, and ORBITA, which looked at percutaneous coronary intervention (PCI) in certain patient groups—COAPT has surprisingly significant results. However, that doesn't mean there aren't critics. The trial was actually so well-designed and structured that some question if the results will be replicable in the real-world, where operators are less experienced, patients are less likely to adhere to the concurrent medical therapy, and patient selection is less strictly defined. This argument is bolstered by the recent results of the MITRA-FR trial, which showed no significant improvement for patients treated with MitraClip, although it was tested with a different patient group.
Regardless, structural heart programs across the country should be taking note, particularly those who have already invested in MitraClip and have been eagerly awaiting an increase in potential patients. MitraClip may be a game-changer for some patients with heart failure, and the results of COAPT may nudge the FDA toward expanding indications to encompass this group.
“Expanding MitraClip [use] will require greater alignment between structural heart and heart failure programs”
Expanding MitraClip to this group of patients will require greater alignment between structural heart and heart failure programs, which often function in a siloed nature. To see these results, patients will also need to be on optimal heart failure medical support, which was central to success of COAPT. It will also be crucial to manage patient expectations; this is not a cure for heart failure be any means, but a way to extend and improve life.
Our research team, the Cardiovascular Roundtable, is investigating heart failure and advanced heart failure programs as part of our 2018-19 national meeting which will launch this October. Join us at this meeting to learn more about these developments, and much more about advances in heart failure programs.In the meantime, be sure to read our Playbook for Optimizing Structural Heart Programs, which leads you though the best practices for developing a high-value, patient-centered structural heart center.