September 23, 2020 – A team of cardiologists at Allegheny General Hospital (AGH), part of Allegheny Health Network (AHN), are now among a select group of clinicians in the country and the first in western Pennsylvania to treat chronic, moderate to severe heart failure with a first-of-its-kind implantable device. The Optimizer Smart System improves heart function and reduces debilitating symptoms associated with the disease, including fatigue and shortness of breath.
The new technology from Impulse Dynamics and was approved by the FDA in 2019 after clinical studies demonstrated its potential to improve a patient’s exercise capacity and quality of life.
Heart failure occurs when the heart muscle becomes weakened and unable to supply the body with the circulated, oxygenated blood it needs to function normally. A typical measurement for heart failure is known as the ejection fraction (EF), which looks at the overall percentage of blood leaving the heart with each contraction. While a normal EF is above 55 percent, this is typically reduced in many patients living with heart failure.
Implantation and management of the device, led by George Shaw, M.D. and Matt Lander, M.D., is an ongoing collaboration of the electrophysiology (EP) and advanced heart failure divisions within the AHN Cardiovascular Institute. The first implantation was performed by Shaw at AGH in July.
“Unlike a traditional pacemaker, which monitors and restores a heart’s rhythm if it falters, the Optimizer Smart device actually helps the heart muscle contract. The technology delivers electrical pulses that over time can improve the size, shape, and function of the heart which can reduce the debilitating symptoms of heart failure,” Lander explained. “The electrical impulses are known as cardiac contractility modulation (CCM), and the technology works by emitting energy surges in synchronization with the heartbeat’s natural cycle.”
The Optimizer Smart system is comprised of several components including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to two energy delivering leads that are implanted in the heart. The procedure typically lasts one hour and most patients can go home on the same day. Patients recharge their device weekly and the system will last for roughly 15 years.
According to a study published in the Journal of American College of Cardiology, CCM delivered via electrical pulses significantly improved the quality of life and exercise tolerance in a designated treatment group consisting of patients with a starting EF between 25 and 45 percent. Furthermore, the study showed the use of CCM in patients decreased cardiac-related deaths and reduced hospitalization rates from 10 to two percent.
“This unique device fills an unmet need for patients who are no longer responding to medical therapies but have not yet progressed to a more severe state which would require us to use a left ventricular assist device to essentially replace the function of a failing heart,” Shaw said. “We’re thrilled to be the first in the region to offer this advanced capability and further expand our portfolio of therapeutic options for patients with complex cardiovascular needs.”
According to the American Heart Association (AHA), about 5.7 million Americans are living with heart failure and it is one of the most common reasons adults over 65 years are hospitalized.
“The disease remains the leading cause of hospitalizations among Medicare beneficiaries in the United States, and there’s currently no cure. However, with innovative treatments and important lifestyle changes, patients can live longer, healthier lives,” said Srinivas Murali, M.D., FACC, chairman of the department of cardiovascular medicine at AHN Cardiovascular Institute. “The Optimizer Smart System is one such example; it’s an exciting advancement for patients living with this disease as it’s proven to improve clinical outcomes, reduce hospitalizations and positively impact a patient’s overall quality of life.”
The Optimizer Smart System is covered by most major insurance carriers. For more information on the AHN Cardiovascular Institute, visit ahn.org.
1. William T. Abraham, Karl-Heinz Kuck, Rochelle L. Goldsmith, et al. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC: Heart Failure. Volume 6, Issue 10, October 2018.DOI: 10.1016/j.jchf.2018.04.010.