Heart failure affects 6.2 million adults in the United States alone annually. Now at Penn State Health and Penn State College of Medicine, cardiologists, cardiac surgeons and researchers investigate a less invasive treatment for this dangerous condition impacting so many people. This novel therapy doesn’t involve an open heart surgery but rather involves excluding damaged heart tissue, the result of previous heart attacks, from the rest of the heart so that the organ can function more efficiently. Known as the ALIVE trial, the study investigates the use of the BioVentrix Revivent TC Transcatheter Ventricular Enhancement System.
Heart disease is the leading cause of death for both men and women in America, leading to about one in every four death, reports the U.S. Centers for Disease Control and Prevention (CDC). This condition results when the heart cannot pump blood and oxygen sufficiently to the body. The result of a heart attack includes symptoms such as fatigue, shortness of breath, and other physical constraints experienced by the patient, reports Penn State News. Treatment options for those individuals experiencing heart failure include open heart surgery for the implantation of a left ventricular assist device or heart transplantation, both of course invasive options.
What is LIVE Therapy?
Known as LIVE or the Less Invasive Ventricular Enhancement Therapy study, this investigational procedure uses the BioVentrix Revivent TC Transcatheter Ventricular Enhancement System and represents the first catheter-based procedure designed to close off the damaged portion of the heart that results from a previous heart attack, so the healthy portion can pump better and hence bring more blood and oxygen to the other parts of the body. After all, improve this organ’s ability to pump blood, and heart function improves as does quality of life and overall life span.
The ALIVE trial (NCT02931240) led by Dr. Michael Pfeiffer, a cardiologist at Penn State Heart and Vascular Institute as well as Penn State Health Milton S. Hershey Medical Center, is designed for patients who have had a heart attack and suffer from heart failure who are not yet candidates for more invasive procedures, or who seek out a less invasive alternative, reports Penn State News.
Hershey Medical Center is one of the 25 LIVE trial sites in the United States participating in this institutional review board-approved study, which overall is planned to include 126 patients.
According to Penn State News’ recent entry, they have performed the procedure on two patients to date. The first procedure occurred on Dec. 17, 2020. Principal investigator Dr. Pfeiffer reports that these patients enrolled in the study and are of course followed over time as the investigational team evaluates whether the therapy actually improves health failure symptoms, quality of life, and ability to exercise more. Also, they seek to answer the question whether this procedure prevents hospital readmissions and overall safety.
PI Point of View: Why Participate in the ALIVE study?
Dr. Pfeiffer reports that “Participating in the ALIVE Trial enables us to be on the front lines of research into the most innovative therapies with potential to help patients in central Pennsylvania and beyond who suffer from the limitations of heart failure.” He continued, “We are excited about the prospect of treating patients in a less invasive way that may help them avoid some of the risks inherent to open heart surgery and afford them a quicker recovery.”
The Trial Site: Hershey Medical Center
Penn State’s flagship 564-bed medical center—Hershey Medical Center—represents central Pennsylvania’s only locally based academic medical center. A Magnet-designated hospital since 2007, it provides high-level, patient-focused medical care. Known formally as the Milton S. Hershey Medical Center, its actually the only such medical facility in Pennsylvania to be accredited as a Level 1 trauma center for both children and adults. The center is part of the Hershey campus with Penn State Children’s Hospital, Penn State Cancer Institute, and Penn State College of Medicine.
This facility includes a broad range of scientific and medical talent, reports Dr. Pfeiffer, making participation in “leading-edge research possible.” He continued, “Structural heart and research coordinators, cardiologists with expertise in heart failure, imaging and interventional procedures, and our cardiothoracic surgeons and anesthesiologists all play an important role in bringing this innovative, investigational treatment to our patients.”
Note that Penn State Clinical and Translational Science Institute under a grant developed a version of a clinical trial matching system known as Study Finder. This ALIVE study and others at the research center can be found in this online search tool.
The Study Sponsor
Based in San Ramon, California (“East Bay” in SF Bay), BioVentrix is a privately held medical device company on a mission to improve and expand the treatment available for congestive heart failure (CHF) caused by ischemic cardiomyopathy via the development of less invasive, catheter-based approaches. The company seeks to offer benefits to all stakeholders in heart failure, from patient (improved survival, quality of life), to payor (reduced hospitalizations and avoidance of more expensive, highly invasive procedures such as transplant) and LVAD provider (become pioneer in heart failure and offer unique solutions to patients in the growing and most expensive disease state worldwide).
Founded nearly two decades ago by Arthur Bertolero, and Dr. Lon S. Annest, the company has raised $100 million in investment capital. They were formally known as CHF Technologies.
The study utilizing the Revivent TC Transcatheter Ventricular Enhancement System is funded by BioVentrix, and Pennsylvania State University cannot endorse, promote or recommend this product.
Note, for the entire multi-site study, the following principal investigators lead the effort:
· Andrew S. Wechsler, MD, Drexel University College of Medicine
· Gregg W. Stone, MD, Icahn School of Medicine at Mount Sinai, New York, NY
· Jerry D. Estep, MD, The Cleveland Clinic
Call to Action: Patients in the central PA region who have had a heart attack and continue to suffer from heart failure symptoms could consider seeing the researcher/physicians at Penn State to determine if they could be a candidate for this procedure—call 717-531-5967 or email [email protected]