Date: November 15,2017

Source: The OhioState University Wexner Medical Center

Summary: A newdevice, proven safe and effective, has been developed to treat diastolic heartfailure.

Next to adime for perspective, this small wire device is designed to hold open asurgically created hole in the heart of diastolic heart failure patients.

Credit: The Ohio State University WexnerMedical Center

Results presented today at theAmerican Heart Association Scientific Sessions and published in Circulation show that anew device designed to treat diastolic heart failure is safe and effective. Thefirst patient in the randomized, blinded study was enrolled at The Ohio StateUniversity Ross Heart Hospital, which also enrolled the most patients in thetrial.

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

"The therapies we use forpeople with systolic heart failure don't work as well for people with DHF. Fordecades, we've only been able to manage the symptoms of DHF withdiuretics," said Dr. Rami Kahwash, an advanced heart failure cardiologistand director of the Heart and Vascular Research Organization at Ohio State RossHeart Hospital.

Kahwash and Dr. Scott Lilly, aninterventional cardiologist and director of the Structural Heart DiseaseProgram at Ohio State, were part of the Phase II study that evaluated adime-size implant intended to relieve the high pressure created by bloodbacking up from the heart into the lungs. During a heart catheterization,doctors inserted the tiny, interatrial shunt device in an opening they createdbetween the upper left and right chambers. This diverts some of the blood fromthe high pressure left atrial chamber to the low pressure right atrial chamber,much like a detour around a traffic jam.

The study randomized 44 DHFpatients at multiple centers nationwide. Participants received either thetreatment device or a sham procedure. After one month, patients were evaluatedby comparing pulmonary capillary wedge pressure (PCWP) readings during rightheart catheterization exercise. Elevated PCWP readings indicate failure of theleft ventricle.

Researchers reported that theinteratrial shunt device reduced PCWP readings by 3.5 mmHg, compared to areduction of 0.5 mmHg in the control group.

"This device represents anovel therapy for diastolic heart failure, a condition characterized bylifestyle-limiting breathlessness, and one in which traditional heart failuretherapies have not proven effective. If the initial experience is substantiatedthrough ongoing clinical trials, this interatrial shunt device may be anopportunity to improve quality of life and exercise capacity for patients thatcurrently have few other options," Lilly said.

Risk factors for DHF include highblood pressure, diabetes, obesity and age. Kahwash said it's estimated thatwithin the next five years, DHF will account for more than half of all heartfailure cases, and be responsible for more hospital admissions than systolicheart failure.

StorySource:

Materials provided by The Ohio State University Wexner Medical Center. Note:Content may be edited for style and length.

JournalReference:

1.    Ted Feldman, Laura Mauri, Rami Kahwash, Sheldon Litwin,Mark J. Ricciardi, Pim van der Harst, Martin Penicka, Peter S. Fail, David M.Kaye, Mark C. Petrie, Anupam Basuray, Scott L. Hummel, Rhondalyn Forde-McLean,Christopher D. Nielsen, Scott Lilly, Joseph M. Massaro, Daniel Burkhoff, SanjivJ. Shah. A Transcatheter InterAtrial Shunt Device for theTreatment of Heart Failure with Preserved Ejection Fraction (REDUCE LAP-HF I):A Phase 2, Randomized, Sham-Controlled Trial. Circulation, 2017;CIRCULATIONAHA.117.032094 DOI: 10.1161/CIRCULATIONAHA.117.032094