WellSpan Is at the Heart of TAVR Innovation

Thursday, June 4, 2020

Over the years since physicians began performing Transcatheter Aortic Valve Replacement (TAVR) procedures, many changes and innovations have improved the lives of many patients.

During valve-in-valve TAVR, a high pressure balloon is used to fracture the failing prosthetic valve and allow for complete expansion and proper function of the new TAVR valve that is put in place.

Originally created as an alternative for high-risk aortic stenosis surgical patients, TAVR is now appropriate for patients with severe aortic valve stenosis at all surgical risk levels.

“When our predominant patient population was in their 80s and 90s, they were all high risk, so it wasn’t an issue to offer TAVR as an alternative,” says James Harvey, MD, MSc, Director of the Structural Heart Program and interventional cardiologist at WellSpan. “But now it has been approved in low-risk patients, and many of our patients are in their 60s and 70s.”

The main access approach for TAVR in its inception was the transfemoral approach through an incision in the leg. While this is still the common approach, TAVR can now be performed through an incision in the shoulder, ribs or upper chest.

In addition, TAVR is also appropriate for many patients who have had a prior surgical aortic valve replacement with a bioprosthetic surgical valve and now have a failing surgical bioprosthesis. For these patients, WellSpan offers bioprosthetic valve fracturing, a newly developed procedure that uses a high-pressure balloon during valve-in-valve TAVR to fully expand the failing prosthetic valve and allow for complete expansion and proper function of the new TAVR valve.

WellSpan has an internationally recognized TAVR program and is Pennsylvania’s top provider of bioprosthetic valve fracturing. “About 10% of patients who come to WellSpan for TAVR are here because they have a failing prosthetic valve,” says Dr. Harvey. “And 10 to 20% of those have a valve opening of 23 millimeters or smaller. This typically indicates a need for fracturing because otherwise these patients would have worse symptoms and a shorter life.”

This illustration shows the placement of the Edwards SAPIEN Transcatheter Heart Valve through a transfemoral approach, which is performed through an incision in the leg or slightly higher. The valve is delivered to the aorta via guide wire.

Advances have also help address risks associated with TAVR procedure such as the need for pacemaker implant and the increased risk of stroke within the first year after a TAVR procedure. WellSpan’s program has helped its patients fare very well in both areas.

WellSpan is a leader when it comes to preventing the need for a pacemaker implant after a TAVR. Nationally, 17% of patients require a pacemaker following TAVR, however at WellSpan, just 3% of our patients fall into this category. Given this industry-leading differential, WellSpan and Dr. Harvey have been asked to participate in a 46-site trial to share our best practices.

Additionally, national averages for the risk of a stroke in the year after a procedure is about 2-5%. In the eight plus years WellSpan physicians have been performing TAVRs, their patients’ stroke rate is consistently less than 1%.

TAVR is a non-surgical procedure that involves the insertion of a catheter into the patient’s femoral artery, a vessel that provides blood to the leg. Through this catheter, a new valve is delivered to the heart through the aorta. The new valve consists of bovine or porcine heart tissue supported by an expandable metal cage. This new valve is then placed inside the diseased valve to replace the old one with a new and normally functioning valve. Because of the minimal invasiveness of the procedure, most patients are able to go home within 1 to 3 days after the procedure. Patients who receive this new valve usually feel much better within a few days.

Since the inception of TAVR, WellSpan physicians were involved with many of the pivotal research trials that helped bring this new therapy to approval by the FDA.

“WellSpan remains on the forefront of medical technology by staying involved in multiple current local, national and international trials involving TAVR and other structural heart therapies,” Dr. Harvey says, “which enables us to offer world-class, cutting-edge technology right here in our communities.”

WellSpan’s Structural Heart program requires rigorous collaboration between Dr. Harvey’s team and other providers to ensure patient safety.

“We’re confident in the procedures we perform, but we’re also appropriately cautious,” Dr. Harvey says. “We’re in constant communication with other centers to be certain we’re all learning and continuing to improve these cutting edge therapies.”

“Regionally, nationally and now internationally, our hospital has been renowned for continuing to stay on the leading edge of technology and advancing structural heart procedures,” Dr. Harvey says.

o learn more about how WellSpan is advancing TAVR and other structural heart procedures, visit wellspan.org/hv or call (717) 812-3617.