Cath Lab Digest

This article features an interview with Lisa Walsh, RN, clinical research nurse supervisor for the Division of Cardiac Surgery at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania. It is the third in a series of six articles sponsored by Edwards Lifesciences.

The transcatheter aortic valve replacement (TAVR) program at the Hospital of the University of Pennsylvania (HUP) in Philadelphia, PA, was one of the first in the country. It started in 2007 as part of the Food and Drug Administration clinical trial program. Here, we find out how this early program has grown and implemented pioneering TAVR procedures. 

Can you share how your TAVR program has evolved over the past four-and-a-half years?

In January 2007, we held our first strategic planning session, which included the core heart team, administration and the clinical trial sponsor to identify what would be needed to develop a TAVR program.

The core heart team included two cardiac surgeons, two interventional cardiologists, a lead anesthesiologist, the surgery team, the cath lab team, a lead echocardiologist, a neurologist, an administrative assistant, and a lead research nurse as the valve coordinator for the program and trial. Our hybrid room had already been built, but modifications were made to accommodate the new technology. The hospital’s administration approved the project, and by November 2007, we had implanted our first valve.

Until November 2011, TAVR therapy was available only as part of an FDA clinical trial called the PARTNER Trial. Over the past four-and-a-half years, HUP has been part of this clinical trial that eventually led to the Food and Drug Administration’s approval of TAVR for the inoperable patient. We have greatly expanded our core team to better serve our patients, and we now offer TAVR at our main campus as well as at our sister location, Penn Presbyterian Medical Center. Many staff members are now trained to expedite and facilitate patient evaluation and care.

How have you educated your referring physicians?

In the early days, our TAVR team spent time meeting with our referring physicians to discuss the trial, device, procedure, and for whom it is appropriate. We invited many colleagues to observe cases so they could better understand the procedure. We made sure our referring physicians had our contact information — including cell phones and email. We also directed them to clinicaltrials.gov, the government website for all clinical trials. We sent educational videos available on the Edwards Lifesciences website that depict the procedure, along with contact information and screening worksheets.

Today, TAVR is much more widely known. Physicians often send patients with full workups for TAVR, and patients and families better understand the device and procedure.

What tests are done during patient evaluation?

We encourage our referring physicians to do much of the patient testing and send us the information before their visits. This lets our team review the data to determine a plan for when we see the patients. Otherwise, we have to spend clinic time doing a complete work-up for testing. Our heart team requests the following data on all patients:

• Right and left cardiac catheterization with lower-extremity aortogram [Note: if a patient has had previous coronary artery bypass graft surgery (CABG) with either a left or right internal mammary artery (LIMA or a RIMA), we ask for a lateral shot to note the location of the graft in relationship to the sternum];
• Echocardiogram, with attention to aortic valve area (AVA), aortic valve gradients, degree of aortic insufficiency, mitral regurgitation and ejection fraction; 
• Computed tomography angiography (CTA) of chest/abdomen and pelvis, 2 mm slices with and without contrast (if renal function is impaired, a non-contrast CT scan can be done);
• Pulmonary-function studies (full set, including lung volumes, spirometry and a room air arterial blood gas);
• Carotid duplex;
• Comprehensive metabolic panel and hematology lab studies;
• Dental clearance

We have been inclusive of our referring physicians, educating them to play active roles in screening and evaluating their patients. We provide tools and education so, if they choose, they can provide the testing required for their patients’ evaluations.

What kind of resources and support were required to get your program off the ground?

Most of the financial support and staffing for the PARTNER trial participation came from our cardiac surgery research program. However we did need support from our administration. While renovations to upgrade the hybrid suite in our OR were underway, negotiations for valve pricing and the clinical research budget took place. While administration had committed capital to the construction, we needed to cost-justify the valve clinic.

HUP has always prided itself on offering cutting-edge technology to patients. In today’s healthcare economy, we needed to help administration understand how this technology would change practice by bringing a life-saving treatment to an underserved population.

What were the challenges of setting up your program?