News | Embolic Protection Devices | April 11, 2017

PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device

Pennsylvania hospital system is one of 27 worldwide testing device meant to reduce stroke risk during TAVR

PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device

April 11, 2017 — Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device designed to reduce risk of stroke during transcatheter aortic valve replacement (TAVR).

Aortic stenosis is one of the most common and most serious heart valve diseases. Left untreated, aortic stenosis gradually diminishes quality of life and leads to heart failure and death. The gold standard for treating aortic stenosis has been surgical aortic valve replacement; however, changes in cardiovascular medicine have led to the minimally invasive, catheter-based TAVR procedure for patients deemed too high risk for surgery. Patients having either type of aortic valve replacement are at risk of brain injury that may range from memory loss and speech challenges to debilitating strokes.

The international clinical trial, called REFLECT, studies the safety and efficacy of the Keystone Heart TriGuard cerebral embolic protection device to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures. TriGuard is designed to reduce the amount of embolic debris from traveling through the blood stream to the brain for patients undergoing TAVR. If this debris travels through the blood stream to the brain, it could possibly cause damage that may lead to a stroke or neurocognitive dysfunction, such as memory loss and speech challenges.

"As physicians, we see firsthand the debilitating effects of brain injury following TAVR can have on our patients," stated Mubashir Mumtaz, M.D., FACS, FACC, chief of cardiothoracic surgery, surgical director of structural heart and principal investigator for the trial at PinnacleHealth. "PinnacleHealth CardioVascular Institute is honored to be selected for this elite global trial, studying a major patient safety initiative."

"This device presents the opportunity to minimize brain injury following TAVR and supports our goal to preserve quality of life," stated Hemal Gada, M.D., MBA, interventional cardiologist and medical director of structural heart at PinnacleHealth.

The TriGuard device is shaped to accommodate anatomic variations of the aortic arch in order to provide full coverage to all brain territories.  It is placed via one of the femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site. 

PinnacleHealth is one of 27 hospital systems in the world, and the only hospital in Pennsylvania, enrolling patients in this trial.

Read the article from TCT 2016 “Delirium Significantly Associated With Brain Lesions in Patients Post-TAVR.”

For more information: www.keystoneheart.com

Related Content

Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
Videos | Cath Lab | September 14, 2018
A discussion with Nicolas Bevins, Ph.D., vice chair, physics and research, and Jessica Harrington, RCIS.
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Overlay Init