There is a persistent gap in heart failure care regarding administration of life-saving therapies outlined in clinical practice guidelines and consensus documents, noted James Jacuzzi, MD, of Harvard Medical School and an ACC trustee.
There is an ongoing persistent gap in heart failure care regarding administration of life-saving therapies outlined in clinical practice guidelines and consensus documents, noted James Jacuzzi, MD, Hutter Family Professor of Medicine, Harvard Medical School; staff cardiologist at Massachusetts General Hospital; trialist at the Boehm Institute for Clinical Research; and trustee of the American College of Cardiology (ACC) in an interview prior to the ACC’s 70th Scientific Session, which will be held May 15-17.
Januzzi is principal investigator of the TRANSFORM HFrEF study, 1 of 3 studies that are the focus of a partnership between the ACC and HealthReveal first announced on April 28. Through this partnership, artificial intelligence (AI) from HealthReveal will be used to achieve 3 main goals: increase physician adherence to guideline-directed medical therapy, preempt future adverse cardiovascular events among patients, and improve patient outcomes.
During the TRANSFORM studies, patients will be continuously monitored by HealthReveal so that its personalized AI solution can automatically apply the most recent care guidelines for clinicians to make real-time treatment recommendations as needed. These “Reveals” are meant to facilitate a seamless flow of care for clinicians and patients participating in the studies.
Can you briefly outline the ACC/HealthReveal partnership and your role within it?
The partnership between the ACC and HealthReveal is one based on shared goals to improve the heart health of patients with cardiovascular disease. In particular, HealthReveal is partnering with the American College of Cardiology to execute the TRANSFORM family of clinical trials. Presently, we have studies focused on heart failure [and] diabetes, and soon to be announced, an atrial fibrillation trial as well. In each of these cases, the artificial intelligence–leveraged information that comes from HealthReveal will facilitate the clinicians seeing patients in these 3 trials to more accurately and more efficiently deliver optimal cardiovascular care.
Can you tell us about the 2 trials that you mentioned?
So, the 2 trials that we’ve already begun working on include a study called the TRANSFORM HFrEF study. So HFrEF in cardiology refers to heart failure with a reduced ejection fraction. This is a form of heart failure associated with a reduced squeezing strength of the left ventricle and a diagnosis associated with high risk for hospitalization and death.
Optimistically, we have many therapies that reduce risk for heart failure with reduced ejection fraction, but unfortunately studies would suggest that there is a glaring gap in adherence to clinical practice guidelines and consensus documents, with respect to administration of these life-saving therapies. So the goal of the TRANSFORM HFrEF study is to evaluate the ability of the logic from the American College of Cardiology Expert Consensus Decision Pathway document for heart failure care, leveraged with an artificial intelligence delivery platform—specifically HealthReveal—vs usual care for closing the gaps in treatment among our patients with heart failure, as well as impacting their health status and quality of life.
As well, we plan to utilize the patient-facing materials from the College, from the CardioSmart suite of different documents, in order to provide important information regarding the diagnosis of heart failure to the patients that are enrolled in the intervention arm of the TRANSFORM HFrEF study. The ultimate goal is to transform the 20-minute visit such that clinicians and patients will enter the exam room armed with the knowledge not only of the diagnosis, in the patient’s case, but also knowledge of where opportunities for optimal therapy may exist.
The second trial, specific to the TRANSFORM study that we’re proceeding forwards with, is a study called the Cardiovascular Eisk in dDiabetes trial, so TRANSFORM CVRiD.In patients with diabetes, there’s a high risk for cardiovascular events. Treatment with specific therapies in diabetes—specifically the glucagon-like peptide-1 receptor agonists, or GLP-1 receptor agonists, and sodium glucose cotransporter 2 inhibitors, or SGLT2 inhibitors—reduce cardiovascular risk. However, much like in other areas of modern cardiovascular and cardiometabolic disease states, large gaps with respect to use of these life-saving therapies in patients with higher-risk cardiovascular profiles in diabetes exist.
So the TRANSFORM CVRiD study is proposing to focus on closing gaps in adherence to specific recommendations, including use of a GLP-1 receptor agonist or an SGLT2 inhibitor, in patients who should be receiving these therapies.
Will information from these 2 studies enable physicians to more easily prescribe newer therapies?
I give a lot of credit to the American College of Cardiology in their effort to transform cardiovascular care and improve heart health. One important aspect to this is working very carefully but very diligently toward understanding the impact of novel therapies that are articulated in the current Clinical Practice Guidelines and Expert Consensus Decision Pathway documents in order to show that these recommendations can actually improve heart health. By proxy, by improving heart health, we’re obviously reducing costs of care.
Therefore, these efforts, not only the publication of policy documents, but actually showing where the rubber meets the road—that these policy documents can improve heart health—is a natural equation toward convincing payers to not only cover these therapies but encourage clinicians to utilize them, rather than the occasional barriers to their prescription that clinicians sometimes encounter.
As a clinical trialist, I give the American College of Cardiology a lot of credit for their efforts toward improving the delivery of care for patients with cardiovascular disease and with diabetes. It’s rather unusual to see an international society actually performing clinical trials to prove that their policy documents can actually improve heart health. But that’s at the core of the mission for the American College of Cardiology.
And so as we perform these clinical trials, it’s not just about showing that the therapies themselves work, but in fact [that] the framework that the American College of Cardiology recommends their use is also effective in improving the outcomes for our patients with cardiovascular disease.