Stony Brook Heart Institute Selected For Intravascular Clinical Trial

Press release from Stony Brook Medicine:

April 18, 2022

Stony Brook Heart Institute cardiologists are continually exploring new approaches to care for heart and valve disease patients, especially those too ill for open-heart surgery or those who might have limited treatment options. In the latest chapter in Stony Brook’s state-of-the-art, minimally invasive frontline treatments, the Heart Institute has been selected to participate in the first-phase clinical trial for PerQseal®+ in advance of submission for approval by the U.S. Food and Drug Administration (FDA). Stony Brook is one of only five elite sites nationwide and the only facility on Long Island to be chosen to take part.

Approved for use in Europe in 2018, the first generation PerQseal® device is the first sutureless, fully-absorbable intravascular ‘patch’ that seals an artery from the inside after heart valve repair or replacement. PerQseal®+ has an enhanced bioabsorbable patch that is designed to address more complex patient anatomies.

For the first time in the U.S., this new arterial-closing technique was performed on March 8, 2022 by Henry J. Tannous, MD and Robert T. Pyo, MD, at Stony Brook University Hospital during a transcatheter aortic valve procedure (TAVR).

“This amazing arterial closure technique offers a hard-to-beat combination of safety, efficacy and ease-of-use. Not only does it offer less pain and faster recovery time, but all components are completely dissolvable and biodegradable. After about six months, there is no trace of the device,” said Robert T. Pyo, MD, Director, Interventional Cardiology; Medical Director, Structural Heart Program and Associate Professor, Renaissance School of Medicine at Stony Brook University.
Closing the artery has been a universal concern since less invasive techniques have been used for valve implantation. There was no optimal, universally accepted way to close the implantation hole, whether applying pressure for up to two hours or utilizing a suture.

“Safe, quick and effective blood vessel closure is key to a successful outcome in patients undergoing an endovascular heart valve procedure,” says Henry J. Tannous, MD, Co-Director, Stony Brook Heart Institute; Chief, Cardiothoracic Surgery; Surgical Director, Structural Heart Program; and General T.F. Cheng Chair, Cardiothoracic Surgery, Renaissance School of Medicine at Stony Brook University. “We are pleased to offer this impressive and innovative technology as another option to improve outcomes and quality of life.”

Minimally invasive, lifesaving techniques for at-risk patients, which include utilizing the Impella® ventricular support system and transcatheter aortic valve replacement (TAVR), have soared in use over the past decade. These approaches using compression or sutures to close the large-size percutaneous (through the skin) implantation holes, have not kept pace with the evolving technology. The PerQseal technology was designed to fill that gap.

This press release was produced by Stony Brook Medicine. The views expressed here are the author's own.