Device-Based Heart Failure Therapies in the Spotlight

A consensus statement from the Heart Failure Society of America (HFSA) outlines the unmet needs in chronic heart failure (HF) and provides a framework for incorporating novel device-based therapies. It emphasizes a personalized approach to patient care that uses pharmacological and device-based therapies, both earlier and in combination.

“The field of approved and investigational devices for heart failure has greatly expanded in recent years but there has been little guidance on how to integrate these novel therapies, until now,” states advanced heart failure specialist Jerry D. Estep, MD, FACC, FASE.

Based at Cleveland Clinic Weston Hospital, Dr. Estep serves as Division Chair of Cardiovascular Medicine for Cleveland Clinic’s regional health system in Florida. He is a leading heart failure researcher and was first author of the consensus statement published last fall in the Journal of Cardiac Failure.

“We hope our document will improve patient outcomes by providing a clinical framework to guide implementation of current and future FDA-approved device-based therapies and address the residual risk of adverse outcomes in patients with heart failure treated with medications alone," he says.

An unmet need

Approximately 6.7 million Americans over 20 years of age have HF, and the prevalence is expected to rise to 8.7 million in 2030, according to the latest HF epidemiology and outcomes data compiled by the HFSA. In 2021, there were 1.2 million primary HF hospitalizations in the United States, and it was a contributing cause in approximately 425,147 deaths that year.

“Despite improvements in pharmacological treatments, both hospitalization and mortality rates for heart failure are increasing,” says Dr. Estep. “Earlier consideration of device therapy is needed to alter the trajectory of heart failure in selected patients.”

Evolving device landscape

Outside implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT), which are established device therapies addressed in contemporary HF guidelines, the consensus statement authors reviewed seven different categories of novel device therapies consisting of more than 40 FDA-approved and investigational devices.

1. Remote monitoring devices
2. Valvular device-based therapies
3. Autonomic modulators
4. Electrophysiology modulators
5. Respiratory modulators
6. Structural device-based interventions
7. Left Ventricular assist devices (LVADs)

“Researchers are approaching the diagnosis and treatment of heart failure from many different angles,” reports Dr. Estep. He points to pulmonary artery pressure (PAP) monitoring, baroreflex activation therapy (BAT), cardiac contractility modulation (CCM), and left ventricular assist devices (LVADs), as some of the notable FDA-approved devices being used to improve care for patients with HF.

Pulmonary artery pressure monitoring

A number of different remote monitoring devices are used to guide HF management and prognosis. Some track weight and vital signs while others measure lung congestion, heart rhythms, and cardiac pressures. PAP monitoring using the CardioMEMS™ HF System is one of the most studied technologies and is the only FDA-approved invasive HF remote monitoring sensor, according to the consensus statement.

The implantable device is placed in the left lower lobe pulmonary artery using a catheter where it directly measures PAP. A special pillow is then used to take daily measurements from the sensor andtransmit them to the patient’s cardiologist.

“Increased pressure can be a sign the heart is becoming weaker or pumping less effectively,” explains Dr. Estep. “Our heart failure teams in Florida use remote hemodynamic monitoring to adjust treatment strategies, improve how patients feel, and safely keep them out of the hospital.”

Dr. Estep was a clinical investigator in the original CHAMPION trial, which found that hemodynamic-guided pharmacotherapy reduced HF-related hospitalizations for patients with New York Heart Association (NYHA) class III heart failure.

Baroreflex activation therapy

Baroreflex activation therapy (BAT) is a novel therapy that uses autonomic modulation to improve symptoms, quality of life (QOL), and functional status for certain patients with earlier stage HF (NYHA class II or III). It is designed to dampen sympathetic activity and boost parasympathetic activity to address the sympatho-vagal imbalance known to predict adverse prognoses and symptoms in heart failure with reduced ejection fraction (HFrEF).

The Barostim™ Neo System is the first FDA-approved neuromodulation technology for HFrEF. It received premarket approval based on data from the BeAT-HF trial, a multicenter, prospective, randomized, controlled trial that demonstrated improvement in effort capacity and QOL but did not show reduction in mortality or hospitalization.

The pacemaker-like device consists of a pulse generator implanted below the collarbone and a lead attached to the carotid sinus in the neck. It delivers electrical impulses to the baroreceptors, which sense changes in the pressure of the arterial walls and signal the brain to adjust heart rate and vascular resistance.

“This helps reduce blood pressure and improve heart function and is particularly beneficial for patients who are not candidates for cardiac resynchronization therapy,” explains Dr. Estep. He notes that Cleveland Clinic Indian River Hospital in Vero Beach offers BAT, becoming the first Cleveland Clinic hospital in Florida to use the novel therapy.

Cardiac contractility modulation

Cardiac contractility modulation (CCM) is another novel therapy that uses electrical signals to achieve a therapeutic effect for patients with HFrEF and who are not candidates for CRT. In this case, the small pacemaker-like device is designed to strengthen the heart's contractions without increasing myocardial oxygen requirements.

The FDA-approved Optimizer® Smart System is implanted under the skin and connected to the heart via leads placed in the cardiac veins. It delivers nonexcitatory electrical impulses that generate long-acting stimulation of the interventricular septum timed to occur during diastole.

“This novel mechanism improves contractility without elevating the heart rate by increasing the influx of calcium ions into the cardiac muscle cells,” describes Dr. Estep. “Patients experience improved exercise tolerance and quality of life.”

Cleveland Clinic Weston Hospital offers CCM therapy and is currently participating in the AIM HIGHer trial, which is evaluating the safety and efficacy of CCM therapy in patients with HF with left ventricular ejection fraction ranging between 40% and 60%.

Left ventricular assist device

The consensus statement also provides guidance on the use of LVAD therapy. This treatment option is offered to patients with advanced or end-stage HF (NYHA class IV) as a bridge to heart transplantation, as destination therapy for patients deemed transplant ineligible, and as a bridge to recovery in cases of HF that are potentially reversible.

The LVAD is a mechanical pump that helps move oxygen-rich blood out of the left ventricle and into the aorta, improving circulation to the rest of the body. “It’s a safe and effective therapy that can prolong survival and improve functional capacity and quality of life for selected patients with advanced heart failure,” says Dr. Estep.

The HeartMate3™ (HM3) is currently the only FDA-approved durable LVAD for use in adults. Unlike older versions of the device, this generation uses a magnetically suspended pump that has been shown to significantly reduce the risk of pump thrombus and strokes. According to the pivotal MOMENTUM 3 trial, 1-year and 5-year post-HM3 implant overall survival rates are 83% and 58%, respectively.

“LVADs now can provide 2-year survival rates that are comparable to contemporary post-heart transplant 2-year survival,” says Dr. Estep, who was a MOMENTUM 3 co-investigator and co-chaired the study’s Flow Optimization Subcommittee.

He serves as a national co-principal investigator in the Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure (TEAM-HF), which launched in the fall of 2024 and includes trial sites at Cleveland Clinic in Florida and Ohio. The new study will measure PAP using CardioMEMS to identify patients with advanced ambulatory HF at high risk of mortality who could potentially benefit from the earlier use of LVAD therapy.

For more information about HF-related clinical trials at Cleveland Clinic in Florida, please contact Cecelia Calvo at calvoc@ccf.org or 954.659.5637 ext. 55637.