New heart failure treatment offers an alternative to LVAD implantation

A trial aimed at a less invasive heart failure treatment is currently underway at Penn State Health. Researchers hope to improve the quality of life for patients with ischemic heart failure, a condition that currently affects 6.2 million people in the U.S.¹ The ALIVE (American Less Invasive Ventricular Enhancement) trial utilizes a novel therapy aimed at removing damaged heart tissue caused by previous heart attacks, all while preserving the rest of the heart so it can work more efficiently.

ALIVE therapy was designed for patients who have had a heart attack and suffer from symptomatic heart failure or left ventricular scarring/aneurysms but are not candidates for more invasive treatments. Patients who desire a minimally invasive approach rather than open-heart surgery may also be candidates as the treatment does not require open-heart surgery.¹

Dr. Michael Pfeiffer, a cardiologist at Penn State Heart and Vascular Institute and Penn State Health Milton S. Hershey Medical Center, leads the ALIVE team and said, “We are excited about the prospect of treating patients in a less invasive way that may help avoid some of the risks innate to open-heart surgery and afford them a quicker recovery.”

ALIVE therapy involves the use of the Revivent TC™ Transcatheter Ventricular Enhancement System for patients with left ventricular scarring.² The procedure is the first of its kind designed to close off the damaged portion of the heart caused by a previous heart attack. The remaining healthy portion of the heart can pump more effectively to bring more blood and oxygen to the rest of the body.

The procedure requires a cardiac surgeon and an interventional cardiologist working simultaneously to reshape the heart into a more normal size, with the primary goal of improving the heart’s pumping efficiency.²

“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,” Pfeiffer said.

The Milton S. Hershey Medical Center is one of 25 U.S. centers participating in the ALIVE trial and Dec. 17, 2020, marked the first patient to undergo the procedure at Hershey Medical Center. A total of 126 patients are enrolled in the study, with 84 lined up to receive the treatment, and 42 patients in an active control group.

“We’re fortunate to have access to a broad range of expertise and skill sets that make our participation in this leading-edge research possible,” Pfeiffer said.

Enrollment criteria for the ALIVE trial:²

• A contiguous acontractile scar involving the septum and/or anterior, apical or anterolateral regions of the left ventricle
• Left ventricular ejection fraction < 45%
• Left ventricular end-systolic volume index ≥ 50 mL/m2
• NYHA functional class III to IV (ambulatory)

Exclusion criteria for the trial:²

• Having a cardiac resynchronization therapy device placed within 60 days
• Peak systolic pulmonary artery pressure > 60 mm Hg
• Myocardial infarction within 90 days
• Chronic renal failure (serum creatinine > 2.5 mg/dL or glomerular filtration rate < 30 mL/min)

Patients with a history of prior pericardiotomy, left thoracotomy or open-heart surgery do not qualify for the intervention but may enroll as control subjects.

Patients enrolled in the study will be followed over a 12-month period to evaluate whether the therapy improves ejection traction and other heart failure symptoms, quality of life and exercise capacity, which includes a six-minute walk test. The researchers will also investigate whether the therapy is safe and prevents hospital readmissions. Currently, nearly 1 in 4 patients with heart failure are readmitted to the hospital within 30 days of discharge, and as many as half of discharged heart failure patients are readmitted within six months.³

“Participating in the ALIVE Trial enables us to be on the front lines of research into the most innovative therapies with the potential to help patients in central Pennsylvania and beyond who suffer from the limitations of heart failure,” Pfeiffer said.

References

1. Researchers assess new heart failure treatment | Penn State University. Psu.edu. https://www.psu.edu/news/medicine/story/researchers-assess-new-heart-failure-treatment/. Published 2021. Accessed December 28, 2021.
2. ALIVE Trial Offers Hybrid Approach for Ischemic Cardiomyopathy With Residual Scar. Consult QD. https://consultqd.clevelandclinic.org/alive-trial-offers-hybrid-approach-for-ischemic-cardiomyopathy-with-residual-scar/. Published 2021. Accessed December 29, 2021.
3. Khan M, Sreenivasan J, Lateef N, Abougergi M, Greene S, Ahmad T, et al. Trends in 30- and 90-day readmission rates for heart failure. Circ.: Heart Failure. https://doi.org/10.1161/CIRCHEARTFAILURE.121.008335. 2021;14:e008335. Published 2021. Accessed January 11, 2022.