News | Heart Failure | March 01, 2016

Ohio State Evaluates First Transcatheter Diastolic Heart Failure Implant

Trial will enroll total of 40 patients at 28 sites worldwide

interatrial shunt, diastolic heart failure, DHF, Wexner Medical Center Ohio State, first patient enrolled

March 1, 2016 — For the first time in the United States, a clinical trial is underway that’s evaluating a device designed to treat diastolic heart failure. The first patient enrolled in the randomized, blinded study is being treated at The Ohio State University Wexner Medical Center.

Diastolic heart failure (DHF) occurs when the heart muscle becomes stiff and doesn’t relax enough to allow blood to flow from the lungs into the heart. This causes blood to back up in the lower left chamber, then the upper left chamber and into the lungs, causing shortness of breath.

“Over the last few decades, we’ve tried many therapies that we’ve used with systolic heart failure — a condition when the heart doesn’t contract strongly enough to push blood out to the body. None of these therapeutic options have worked for DHF, thus we can only try to manage the symptoms of DHF with diuretics,” said Rami Kahwash, M.D., a cardiologist and the study investigator at The Ohio State University Richard M. Ross Heart Hospital.

Kahwash and Ohio State cardiologist Scott Lilly, M.D., are part of a multi-center study that’s evaluating a dime-size implant intended to relieve the high pressure created by blood backing up from the heart into the lungs. During a heart catheterization, doctors create a small path between the left and right upper chambers of the heart. They insert the tiny, inter-atrial shunt device to keep the path open to divert some of the blood from the high pressure left atrial chamber to the low pressure right atrial chamber. This could potentially lower the pressure in the left upper chamber, decrease the pressure in the lungs and thereby improve the symptoms of heart failure.

“It’s just like when you have a traffic jam. Instead of backing up all the way back to the lungs, we’re creating a detour that’s taking the blood around another route and relieving the pressure,” Kahwash said.

That’s exactly what Janet Wickham of Senacaville, Ohio, was hoping for when she volunteered for the trial. Neither she nor the doctors will know whether she got the device until the study is complete. The 69-year-old tries to stay active, but she says having DHF means sometimes it’s hard to leave her house.

“You can’t breathe, you can’t move, you just can’t function. I want to feel better, so if there’s something new I want to try it. I’m just taking a chance,” Wickham said.

Kahwash said finding new treatment options for DHF is crucial because it’s a growing public health problem. Risk factors include high blood pressure, diabetes, obesity and age. Kahwash said it’s estimated that within the next five years, DHF will account for more than half of all heart failure cases, and be responsible for more hospital admissions than systolic heart failure.

The transcatheter interatrial shunt device is made by Corvia Medical Inc., which is funding the randomized trial. In all, 40 DHF patients will be randomized at up to 28 sites around the world.

For more information:

Related Content

Videos | Cath Lab| January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab| January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab| November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab| November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab| November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Three-Year Quality of Life Improvements Similar for PCI and CABG in Left Main Disease
News | Cath Lab| October 30, 2017
October 30, 2017 — New study results from the EXCEL trial comparing the quality of life (QoL) of patients with left m
Corindus Evaluates Incorporating HeartFlow Technology With CorPath GRX System
Technology | Cath Lab| October 26, 2017
Corindus Vascular Robotics Inc. announced that it will incorporate the HeartFlow FFRct (fractional flow reserve-...
Shockwave Medical Announces $35 Million in New Financing
News | Cath Lab| October 24, 2017
October 24, 2017 — Shockwave Medical reported $35 million in new financing, an extension of the company’s previously
Overlay Init