Cardiac Surgeons at Pittsburgh’s Allegheny General Hospital First in the State to Successfully Implant New Device to Repair Leaky Tricuspid Heart Valve

Thursday, October 10, 2024

Press Releases Allegheny General Hospital Cardiovascular Institute

Tricuspid valve regurgitation can lead to enlarged heart, fatigue and heart failure; the condition affects 1.6 million Americans

PITTSBURGH - The cardiac team from Allegheny General Hospital (AGH), the academic flagship facility of Allegheny Health Network (AHN), today announced that they have successfully completed the implantation of a newly approved, first-of-its-kind device used to repair a leaky tricuspid valve, which controls blood flow between heart chambers.

The heart procedure, which utilizes the Abbott TriClip™ transcatheter edge-to-edge repair (TEER) system, was performed in August and led by David Lasorda, MD, Rachel Hughes-Doichev, MD and Walter McGregor, MD of the AHN Cardiovascular Institute. The AGH team is the first in the state to implant the TriClip system.

The TriClip system is meant to improve the function of the tricuspid valve. When the valve - which sits between the right ventricle and the right atrium, and is made of three flaps of tissue - doesn't close properly, blood flows backward in the heart, a condition called tricuspid valve regurgitation.

"Previously, patients who suffered with tricuspid regurgitation did not have many surgical intervention options or medical therapies that would significantly relieve associated symptoms, which can be debilitating," Dr. McGregor said. "We're extremely pleased to be the first medical center in the state to offer this new, minimally invasive treatment, which has proven to yield positive health outcomes and ultimately improve the quality of life for this patient population."

The condition affects about 1.6 million Americans, and tens of thousands in Western Pennsylvania.

When blood flows backward into the right atrium of the heart, blood volume and pressure on the heart's right side increases, often leading to an enlarged heart. Other tricuspid regurgitation (TR) symptoms include shortness of breath, fatigue, abdominal swelling, enlarged liver, active pulsing in the neck veins, and swollen legs, ankles and feet. If left untreated, TR may progress into conditions such as atrial fibrillation and heart failure, according to the American Heart Association.

"TriClip is an exciting advancement in cardiovascular therapies that provides a much-needed solution for patients diagnosed with such a complex heart condition," said Stephen Bailey, MD, cardiothoracic surgeon and Chair of AHN Cardiovascular Institute.

The TriClip is delivered to the heart via a catheter inserted through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve. By clipping the leaflets together, the heart valve properly closes, reducing the backflow of blood. The TriClip also varies in size, allowing for a precision fit no matter the size of the patient's heart valve.

On average, patients who undergo this procedure spend just one day in the hospital before returning home.

The TriClip TEER system received approval from the U.S. Food and Drug Administration in April 2024 following published research demonstrating its overall safety and efficacy.

Cardiothoracic surgeons and researchers from the Minneapolis Heart Institute led a clinical trial - TRILUMINATE Pivotal, of which AGH was a participant, that enrolled patients suffering from TR across 65 sites throughout the U.S., Canada and Europe. The study enrolled over 500 patients, with half of them in the control group (receiving medical therapy alone), and the other half in the group which received the TriClip.

Results, which were published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa2300525) showed that the experimental group saw significantly improved quality of life, and those improvements were sustained at both the 30-day and one-year marks. Patients in the TriClip group also saw more improvement in their tricuspid regurgitation, and the device itself was found to be a safe therapeutic intervention.

The average age of those enrolled in the TRILUMINATE Pivotal trial was 78, with over half of the patients enrolled being women, a cohort representative of the U.S. patient population diagnosed with TR. Many of these individuals, due to age and comorbidities, aren't suitable candidates for more invasive open-heart procedures, which is why the minimally invasive TriClip system is such an attractive option, explained Dr. McGregor.

AGH is an award-winning, nationally-recognized Center for the treatment of complex cardiovascular diseases, including the treatment of structural heart abnormalities and conditions.

In 2023, for the third consecutive year, the hospital was recognized as a Mitral Valve Repair Reference Center by the American Heart Association and Mitral Foundation. This distinction, awarded to just 21 programs nationwide, highlighted AGH's excellence in treating degenerative mitral valve disease and made it the only Pennsylvania hospital with this prestigious recognition.

Video and Animations for Download: https://www.multivu.com/players/English/9255151-abbott-receives-fda-approval-for-triclip-device-to-repair-leaky-tricuspid-heart-valve/

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