Penn Heart & Vascular: First to Offer Embolic Protection Device during TAVR for Stroke Prevention in Philadelphia

In 2007, transcatheter valve replacement (TAVR), an innovative treatment for aortic stenosis, was introduced to the Philadelphia region when Penn Medicine’s Howard Herrmann, MD, and Joseph Bavaria, MD, helped lead the landmark PARTNER clinical trial.

In the past 11 years, TAVR has become the gold standard treatment for severe aortic stenosis in patients at medium or high risk for mortality and morbidity with surgery, and is an alternative to surgery for intermediate and high risk patients. Concurrently, Penn Heart & Vascular has become one of the highest volume treatment centers in the United States and the most experienced TAVR provider in the Philadelphia region, led by Herrmann and the program’s surgical director, Wilson Szeto, MD.

Stroke Risk and TAVR

All cardiovascular interventions are associated with risks specific to technique and approach. TAVR is no exception: since the early trials, post-TAVR stroke has been a concern, occurring in between 2% and 3% of patients within 30 days (not very different than the risk with surgery). Studies show that the cause of stroke in TAVR is multifactorial, but that most occur early and are embolic in nature.

Demonstrating an acumen for proactive response, researchers at Penn were the first in the region to participate in a clinical trial evaluating the Sentinel® cerebral protection system (Claret Medical), which places filters in the heart during TAVR to collect embolic debris.

Among them was Dr. Howard Herrmann, Director of Interventional Cardiology and the Cardiac Catheterization Laboratories at Penn Medicine.

“We made the decision to use the device early on,” Dr. Herrmann said. “And for some time, we were the only TAVR site in three states who could justifiably claim to be trying to prevent stroke.” Since its introduction at Penn Medicine by Saif Anwaruddin, MD, principal investigator for the SENTINEL trial at Penn, several other sites have followed Penn’s lead.

A Sentinel to the Heart

The Sentinel device is delivered percutaneously from the right radial artery to the heart, where it places a proximal embolic filter in the brachiocephalic artery and a distal embolic filter in the left common carotid artery.

The device remains in place throughout the procedure to catch debris originating in the arteries and the calcified aortic valve. At the procedure’s conclusion, the filters and collected debris are drawn into the catheter and removed.

In the SENTINEL trial, patients protected by the Sentinel device experienced 42% fewer brain lesions in protected areas than patients not using the device, and had a 38% overall reduction in stroke risk. Although the FDA panel recommendation was based on safety and trends toward benefit rather than specific outcomes, Dr. Anwaruddin and the entire Penn team advocated for its use at Penn Medicine.

“We adopted a strategy to use the Sentinel device in as many people as possible, to prevent as many strokes as possible, and achieve the best possible outcomes for our TAVR patients,” Herrmann said recently. “As the largest provider of TAVR in the region, with the greatest access to novel investigational devices, we have both the wherewithal and incentive to make TAVR safer and more efficacious for a greater population.”

The Penn TAVR team is currently awaiting the FDA approval of TAVR in low-risk patients, anticipated in 2019, and is actively involved in the development of later generation and novel devices for stroke prevention in TAVR.

Consult with Penn Valve Disease Clinical Team

Refer a patient to Dr. Herrmann

 



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