At the recent American Heart Association Scientific Sessions, researchers have announced positive results in a clinical study of the InterAtrial Shunt Device (IASD) from Corvia Medical, which allows blood to travel between the atria of the heart, to safely alleviate the symptoms of diastolic heart failure. Much of the work has been carried out at the Ohio State Ross Heart Hospital.
Diastolic heart failure (DHF) occurs when, due to heart muscle stiffness, blood backs up in the heart chambers on the left side of the heart and in the lungs. This increased pressure leads to shortness of breath and decreased quality of life. “The therapies we use for people with systolic heart failure don’t work as well for people with DHF. For decades, we’ve only been able to manage the symptoms of DHF with diuretics,” says Rami Kahwash, a cardiologist involved in the study.
The IASD is designed for minimally invasive delivery to the heart using transcatheter systems. The dime-sized device is inserted into the septal wall between the atrial chambers, and allows blood to travel from the left atrium to the right atrium. The idea is to reduce the pressure in the left atrium, helping to alleviate symptoms. “This device represents a novel therapy for diastolic heart failure, a condition characterized by lifestyle-limiting breathlessness, and one in which traditional heart failure therapies have not proven effective,” says Scott Lilly, another cardiologist involved in the study.
The study involved 44 DHF patients, who either received the device or a sham operation. The patients that received the device showed a significant improvement in pulmonary capillary wedge pressure, which is elevated with increasing heart failure severity. Ohio State Ross Heart Hospital has already begun to recruit patients for the next phase of the clinical trials.
“If the initial experience is substantiated through ongoing clinical trials, this interatrial shunt device may be an opportunity to improve quality of life and exercise capacity for patients that currently have few other options,” says Lilly.
See how the system works in this video…
Study in Circulation: A Transcatheter InterAtrial Shunt Device for the Treatment of Heart Failure with Preserved Ejection Fraction (REDUCE LAP-HF I): A Phase 2, Randomized, Sham-Controlled Trial…