Author + information
- Christopher M. O’Connor, MD, Editor-in-Chief, JACC: Heart Failure∗ ()
- ↵∗Address for correspondence:
Dr. Christopher M. O’Connor, Editor-in-Chief, JACC: Heart Failure, American College of Cardiology, Heart House, 2400 N Street NW, Washington, DC 20037.
We continue to see great gains from participation in randomized controlled clinical trials, such that the therapies that we offer our patients today will result in significant reductions in morbidity and mortality and improvements in quality of life and functional status. The additional gains could potentially add to the significant advances that we have made in the past 5 years.
Our problem as a community is implementation. Recent reports from the CHAMP-HF (Change the Management of Patients with Heart Failure) registry highlight the large opportunities for us to optimize therapies for our patients. In the CHAMP-HF registry, triple therapy with angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), or angiotensin receptor-neprilysin inhibitors (ARNi), beta-blockers, and mineralocorticoid receptor antagonist (MRA) was implemented in clinical practice in <10% of patients. Furthermore, the optimization of dose using these 3 classes of drugs occurred in <5% of the patients when combined data were analyzed (1).
As of this writing, 2 important approvals from the U.S. Food and Drug Administration (FDA) regarding device therapy for HF have occurred in the last month. The MitraClip (Abbott Laboratories, Lake Bluff, Illinois) has received an expanded indication when used for patients with moderate-to-severe functional mitral regurgitation in symptomatic HF, ejection fractions between 20% and 50%, and left ventricular end-systolic volume <70 mm. The symptoms and mitral regurgitation severity must persist despite maximum-tolerated guideline-directed medical therapy (GDMT) by a multidisciplinary heart team experienced in the evaluation and treatment of HF and mitral regurgitation (2).
In addition, the FDA approved the Optimizer Smart System device (Impulse Dynamics, Mt. Laurel, New Jersey) for the treatment of patients with chronic moderate-to-severe HF to restore normal timing patterns of the heartbeat. The device is indicated for patients who are not suited for treatment with other HF devices such as cardiac resynchronization therapy. The FDA gave the Optimizer Smart System device a breakthrough designation because it treats a life-threatening disease, HF, and addresses the medical needs of patients in whom standard treatments have failed to give adequate results and who have no alternative options. The patients must have marked limitations in physical activity and remain symptomatic despite receiving optimal medical therapy (3).
Given that these 2 new device therapies require optimal medical therapy and given the recent less-than-optimal track record we have had with GDMT as a HF community, it is time that we call for action, a greater emphasis on our clinical care to develop GDMT clinics. It should be and will be the norm that all subsequent therapies for medical and device therapies will be evaluated in the context of how well the background medical therapy was implemented. Despite good use of ACE inhibitors, angiotensin receptor blockers, or beta-blockers in clinical trials, there is significant underutilization of MRAs, and integration of ARNi therapy, which should be replacing ACE inhibitors or ARBs but is still prescribed in <15% of our patients. This is not a track record we should be proud of.
Today, we ask our community and professional societies to work with multidisciplinary stakeholders to develop a broad-based HF care model with focus on the optimization of medical therapy. This will require additional education and possibly certification with continued maintenance of understanding of what GDMT is and how to optimize drugs in a safe and efficient manner using a multidisciplinary approach. These clinics could also be recruiting centers for clinical trials that optimize therapy prior to randomization.
We cannot rely on the 1,000 board-certified HF physicians in this country if we want to tackle this important problem both nationally and globally. It will take a commitment from all stakeholders to foster the type of clinical environment and multidisciplinary approach to achieve these goals. We have hidden behind the excellent results of our clinical trials. We must now face the sobering information from our practice registries that we need to do a much better job of caring for our patients, which they so greatly deserve.
- 2019 American College of Cardiology Foundation
- Greene S.J.,
- Butler J.,
- Albert N.M.,
- et al.
- O’Connor C.M.
- Abraham W.T.,
- Kuck K.H.,
- Goldsmith R.L.,
- et al.