My name is Bernie Blocker. I am a registered cardiovascular invasive specialist (RCIS) and one of the first people in the U.S. southwest to put their hands an investigational device made by Medtronic called the CoreValve. I was excited to hear from our cath lab director, Dr. Timothy Byrne, that our lab was chosen to be part of the percutaneous implantable aortic valve trial. We are one of a few clinical trial sites in the western half of the U.S. out of 40 total sites in the entire country. Our site is located at the Banner Good Samaritan Medical Center’s Cardiac Cath Lab in Phoenix, Arizona, which is the only cath lab within 5 states implanting this investigational device. Medtronic’s stringent site selection criteria covers the physicians implanting the device, and the hospital, cath lab, staff, and research coordinators involved with the study. It was a very large undertaking and one that Medtronic felt “Good Sam” could handle – and thus, we were chosen. Quickly, we realized there was some work to do in order to get ready for this monumental occasion, including educating, training, and negotiating. One of the earliest struggles that came up was, who gets to implant this industry-changing device? Who gets the glory, recognition, and fame (okay, maybe not fame), the OR or the cath lab? Of course, after many, many meetings, countless emails, and phone conversations, the cath lab was chosen, due to factors such as x-ray imaging quality and accessibility to the necessary equipment (i.e., guide wires, catheters, and balloons). However, we could not do these procedures alone, so the OR sends a team to the cath lab to assist with all of our device implants. We are a proud group with wonderful, dedicated staff members who work very well together.
Once the dust settled, we got to work on making sure everyone who is involved in this process received the proper education appropriate to their role. We are talking about a lot of people, including the pre-procedure nurses, select cath lab and OR staff, and the post-procedure nursing unit. Medtronic asked us to set aside a couple of days so we could have everyone who was involved get the company presentation and general rundown on the device. The hospital’s education team, including me, made sure all team members who would be taking care of these patients knew what to expect and the kind of work we were doing. In addition, my colleague, Michael LeGal, RN, Clinical Educator, and I began getting the education process started to ensure all of the participating cath lab team members were ready for the first device implants. Michael and I provided education/training sessions designed to prepare our teams for the added complexity of incorporating general anesthesia into a procedure that was both brand new and higher risk than our standard procedures.
I was chosen by Dr. Byrne to be one of the valve loaders, because I have 11 years of experience as an RCIS (over half with the doctors at my current hospital) and my level of experience with complex, infrequently performed procedures. I received specialized practical training from one of the Medtronic clinical valve loading trainers. I was honored to begin learning the 28 steps necessary to load the CoreValve onto the delivery catheter. After a few attempts, I had it down and was ready to get one of these devices implanted. The valve loading is surprisingly simple, but it still requires one to pay close attention to detail. Basically, the fully expanded nitinol frame to which the valve is attached sits in a glass jar filled with a tissue preservative until it is ready to be loaded onto the catheter. Utilizing a series of tapered, plastic cones and tubes, the valve is compressed and secured to the catheter. An outer sleeve (think of self-expanding peripheral stents) encloses the now compressed valve while it waits to be deployed. Currently, we have successfully deployed valves into 12 patients and many more are waiting to see if they qualify for the study.
Next time, I will talk about the process involved in working with the OR team, performing CoreValve procedures, and using general anesthesia in the cath lab.
The Medtronic CoreValve U.S. clinical trial will enroll a total of more than 1,200 patients at 40 U.S. clinical sites, including Banner Good Samaritan. Patients interested in learning about the qualifications for the clinical trial at Banner Good Samaritan should contact the research office at (602) 839-5674.