Allegheny General Hospital (AGH), the academic and research flagship of Pittsburgh-based Allegheny Health Network (AHN), announced today it has become the top clinical investigational site in the world, by patient volume, for the implantation of a new investigational heart failure device from global medical device company, Impulse Dynamics.
The new technology is designed to treat people with heart failure in two important ways integrating a defibrillator with cardiac contractility modulation therapy (CCM). The defibrillator component protects against sudden cardiac death, while CCM is a device-based therapy that can improve the quality of life for people suffering from heart failure. Each technology is available as separate devices yet combining them allows the best of each technology to complement one another in this new investigational therapeutic approach.
George Shaw, MD, an AHN electrophysiologist, and other members of the cardiac electrophysiology and heart failure teams within the AHN Cardiovascular Institute are now studying the safety and efficacy of the device.
“If the trials are successful, this device will represent one of the most significant advancements in implantable defibrillator technologies in decades, and it has the potential to improve the lives of so many patients experiencing debilitating heart failure symptoms,” said Dr. Shaw, who is AGH’s principal site investigator with the clinical trial, called INTEGRA-D.
CCM therapy, proprietary to Impulse Dynamics, delivers synchronous electrical impulses with the heart’s natural rhythm to improve contractions and increase the amount of oxygenated blood throughout the body for individuals with heart failure. Over time, it has been shown to significantly rehabilitate the heart by improving its size, shape and functionality.
“By combining these therapeutic approaches, this new device has the potential to not only repair the heart over time by improving ejection fraction, but it also works to prevent sudden cardiac arrest caused by heart arrhythmias,” Dr. Shaw said. “Most patients will go home on the same day of the implant procedure, and because of this technology’s uniquely long battery life, the need for replacement procedures should also be reduced.”
The new investigational device has a rechargeable battery with an expected lifespan of 20 years, compared to 7-12 years for other non-rechargeable defibrillators.
Previous iterations of this combined therapeutic approach required separate defibrillator and CCM devices, two batteries, and additional wires in the heart. Reducing the number of leads and batteries also reduces the number of future procedures and the cost and risk of infection that accompanies additional surgical procedures.
Mike Franczak, 62-year-old of Jefferson Hills, Pa., underwent the procedure in April 2023 and has seen an improvement in his ejection fraction—the overall percentage of blood leaving the heart with each contraction—and subsequently a noticeable reduction of his heart failure-related symptoms.
Symptoms of heart failure include shortness of breath, swelling, extreme fatigue and increased heart rate.
“Mike is just one of 5.7 million Americans living with heart failure, and according to the American Heart Association, that number is poised to reach epidemic proportions in the coming years, taking a tremendous toll on quality of life as well as longevity,” said Hayah Kassis-George, MD, advanced heart failure cardiologist at AHN. “That’s why advancements to treating medication-resistant heart failure are so critical in this field and why, as an Institute, we prioritize this area of research and discovery – locally and globally.”
As a stand-alone therapy, CCM was officially approved by the Food and Drug Administration in 2019, and just one year later, AGH cardiologists were the first in the region to utilize the therapy, delivered via Impulse Dynamics’ Optimizer Smart System.
“Allegheny General Hospital has a longstanding legacy of advancing new therapies, devices and surgical applications, which work to treat complex cardiovascular diseases,” said Stephen Bailey, MD, cardiothoracic surgeon and chair of AHN Cardiovascular Institute. “We’re proud to work with innovative organizations within the field to deliver new, innovative solutions for patients suffering from debilitating heart disease and heart failure.”
The INTEGRA-D trial is a multicenter study of 300 subjects from 75 centers that will evaluate the combination of CCM and ICD therapy in a single device via the investigational Optimizer Integra CCM-D System.
The study will assess the safety and performance of the investigational CCM-D device in effectively treating episodes of ventricular tachycardia and ventricular fibrillation while also providing CCM treatment for heart failure. Patients enrolled in the study will receive the investigational Optimizer Integra CCM-D System and will be followed for at least two years. The first implant took place at Cleveland Clinic in May 2023.
About the Allegheny Health Network:
Allegheny Health Network (AHN.org), is an integrated healthcare delivery system serving the greater Western Pennsylvania region. The Network is composed of 14 hospitals, ambulatory surgery centers, Health + Wellness Pavilions, multiple employed physician organizations, home and community-based health services, a research institute, and a group purchasing organization. The Network provides patients with access to a complete spectrum of advanced medical services, including nationally recognized programs for primary and emergency care, trauma care, cardiovascular disease, organ transplantation, cancer care, orthopedic surgery, neurology and neurosurgery, women’s health, diabetes, autoimmune disease and more.
AHN employs approximately 22,000 people, has more than 2,600 physicians on its medical staff and serves as a clinical campus for Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.
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