• June 2023

    New devices help bridge gap in guideline-directed medical therapy

Guideline-directed medical therapy (GDMT) for patients with heart failure consists of rapid initiation of beta blockers, angiotensin receptor-neprilysin inhibitors (ARNIs), mineralcorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i). However, a gap occurs when patients are put on these medications but still have symptomatic heart failure. A new set of support devices approved by the FDA in the last three years is helping to bridge this gap in GDMT.

“Once a patient is on all four pillars of GDMT at maximum tolerated dose, if they don’t move to functional class 1, he or she should be considered for other types of therapy,” says Shelley Hall, MD, FACC, FHFSA, FAST, chief of transplant cardiology, mechanical circulatory support and advanced heart failure, Baylor University Medical Center at Dallas (Baylor Dallas), part of Baylor Scott & White Health. “But many of these patients with heart failure are not advanced enough to be considered for an LVAD or a transplant or may not be eligible for other reasons. These new devices are helping improve our management of these patients.”

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The first device is a sensor that is inserted in the pulmonary artery to continuously measure changes in pulmonary artery pressure, an early indicator of worsening heart failure. The patient lies on a pillow every night that downloads the data from the sensor into the cloud, which is reviewed by heart failure nurses. Data has shown that the device can detect future symptoms up to two weeks in advance.

“By making simple adjustments to care, such as increasing diuretics or changing medications, we can prevent heart failure deterioration,” Dr. Hall says. “With this device, there is a marked decrease in hospitalizations and improvement in the patient’s quality of life.”

The second device is the first medical technology approved by the FDA to use neuromodulation to improve the symptoms of patients with systolic heart failure. Implanted by a vascular surgeon, the device is placed under the collarbone and attached with thin leads to the carotid artery. The device harmonizes the sympathetic and parasympathetic nervous systems, which improves heart failure symptoms.

A third innovative therapy is delivered by cardiac contractility modulators. Similar to a pacemaker, the device has a generator and two leads and is implanted by an electrophysiologist on the right side of the heart. The device delivers precisely timed (30 times per minute) electrical impulses to the heart to improve calcium uptake in the heart muscle. Calcium uptake leads to better contractility, which allows perfusion of more oxygen-rich blood.

Preparations are underway at Baylor Dallas to participate in a clinical trial of a transcatheter therapy that treats the enlarged left ventricle. The device is put in by a structural interventional cardiologist under the mitral valve to reduce the size of the left ventricle. Preliminary results of the trial show that the device improves heart failure symptoms and decreases the rate of deterioration.

“All of these devices are overlapping therapies,” says Amarinder Bindra, MD, an advanced heart failure and transplant cardiologist on the medical staff at Baylor Dallas. “For patients with advanced heart failure, we pick and choose which device we think will help a certain patient by looking at anatomy and reviewing the patient’s EKG and echocardiogram. “These are very new devices, so time will tell how effective they are long term. We don’t have data that shows they decrease mortality, but the data does show reductions in heart failure symptoms and hospitalizations, as well as improved quality of life. The data is still coming in, but patients do benefit.”

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