WellSpan Health’s Structural Heart Program is Pennsylvania’s top provider of bioprosthetic valve fracturing.
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.
With the FDA’s August 2019 approval of transcatheter aortic valve replacement (TAVR) for low-risk patients, TAVR is now appropriate for patients with severe aortic valve stenosis at all levels of surgical risk. 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, or “valve-in-valve” TAVR. However, in patients with small surgical valves, valve-in-valve TAVR can yield suboptimal results due to the existing surgical valve constraining the new TAVR valve. This can lead to worsening patient symptoms and shortened survival.
“When our predominant patient population was in their 80s and 90s, it was less of an issue,” says interventional cardiologist James Harvey, MD, MSc, Director of the Structural Heart Program at WellSpan. “But now it has been approved in low-risk patients, and many of our patients are in their 60s and 70s. In patients with a failed surgical aortic valve, it is critically important that they get an excellent result with TAVR.”
For those 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, allowing for complete expansion and proper function of the new TAVR valve.
Meeting a Growing Need
WellSpan has an internationally recognized TAVR program and treats a high volume of patients with surgical prosthetic valves.
“About 10% of patients who come to WellSpan for TAVR are here because they have a failing prosthetic valve,” Dr. Harvey says. “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.”
But, as an innovative procedure that has not been adopted by most TAVR institutions, bioprosthetic valve fracturing is an area of surgical need that requires rigorous collaboration between Dr. Harvey’s team and other providers to ensure patient safety.
“We’re confident in the procedure, but we’re also appropriately cautious with it,” Dr. Harvey says. “We’re in constant communication with other centers to be certain we’re all learning and continuing to improve this cutting-edge therapy.”
Pioneers in Interventional Techniques
The Structural Heart Program at WellSpan was built on decades of pioneering work by W. Jay Nicholson, MD, and his son, William Nicholson, MD, who is now Dr. Harvey’s partner and a world leader in complex coronary revascularization. Cardiologists from around the world travel to York to learn specialized interventional procedures offered at WellSpan. For example, the program is one of the few in the U.S. with significant experience in BASILICA (bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction), a technique for splitting valve leaflets prior to TAVR. WellSpan also offers MitraClip, paravalvular leak closure and standard interventional procedures.
“Regionally, nationally and now internationally, our hospital has been renowned for continuing to stay on the leading edge of technology and to advance the field,” Dr. Harvey says.
In addition to procedures and treatments already available at WellSpan, Dr. Harvey and his team now offer a new method for accessing the coronary arteries after TAVR.
“Because TAVR valve frames are typically larger than those of surgical valves, they can potentially cover the coronary arteries,” he says. “That makes it difficult to regain access to them if the patient later has a coronary artery blockage.”
In 2018, Dr. Harvey and his team developed a novel method to reaccess the coronary arteries after TAVR. As a result, he was asked to teach this technique at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. He is also frequently asked to visit hospitals around the country to teach this new technique.
“This is a real problem that needed a real solution,” he says. “You have a patient who’s sick and needs your help, and necessity is the mother of invention.”
To learn more about how WellSpan Health is advancing heart and vascular care, visit WellSpan.org/HV.