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: www.wexnermedical.osu.edu

Related Content

Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
News | Cath Lab

November 10, 2021 — Shockwave Medical a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely ...

Home November 10, 2021
Home
News | Cath Lab

November 10, 2021 — Philips Healthcare announced North American availability of new innovations in its portfolio of ...

Home November 10, 2021
Home
News | Cath Lab

October 6, 2021 — Boston Scientific Corp. announced it entered into a definitive agreement to acquire Baylis Medical ...

Home October 06, 2021
Home
News | Cath Lab

September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device ...

Home September 21, 2021
Home
Feature | Cath Lab | By Aaron Detate and Lars Thording

In the electrophysiology (EP) lab, hundreds of thousands of used devices are sent to reprocessors every year to get ...

Home September 14, 2021
Home
News | Cath Lab

July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of ...

Home July 22, 2021
Home
Subscribe Now