Feature | December 23, 2013| Peter Fail, M.D., FACC, FACP

Redefining the Need for TAVR Programs

Is TAVR’s rise in popularity shaping the future of cardiovascular care?

Terrebonne General Medical Center uses a large cath lab for its TAVR procedures guided by a high-quality bi-plane angiography system.

Your patient is too sick for open-heart surgery, their aortic valve opening is narrowing, and without intervention, the odds are not good. With traditional medical treatment alone, half of the people with these conditions will die within two years.
 
Are there other options?
 
Although surgical aortic valve replacement is the standard therapy for severe aortic stenosis, about one-third of patients are not candidates, due to unacceptable surgical risk. Transcatheter aortic valve replacement (TAVR) may be an alternative. This less invasive procedure can replace the aortic valve with a new valve while the heart is still beating.
 
The TAVR Halo Effect
TAVR has received praise throughout the industry because of its ability to treat sick patients less invasively. Many clinicians believe that TAVR is the latest and greatest procedure for treating and repairing severe aortic stenosis. 
 
Device companies are touting the procedure and its ability to create a “halo” effect for hospitals. However, in my opinion, the industry needs more time to quantify the benefits of a successful program. 
 
As a site with a TAVR program, it is very difficult to clarify the types of patients being treated at other facilities without TAVR programs and compare their results.
 
At Terrebonne General Medical Center (TGMC), our TAVR program started as part of a research project in our structural heart department. It was an opportunity to offer advanced patient care and determine the effectiveness of TAVR on patients experiencing severe aortic stenosis, who were deemed inoperable by two cardiac surgeons.
 
It was not until we began planning that we realized just how involved TAVR programs are – they require much more work than we originally anticipated.
 
Collaboration is Key
While everyone on our staff was excited about offering TAVR procedures to our patients, we could not begin to understand the enormity of the project until we went through it. 
 
For a TAVR program to be successful, it requires a high volume of both interventional and surgical procedures. This requirement makes it difficult for many facilities to implement a program, because of either their patient mix or the interventional or surgical volume at their site.
 
To execute a successful TAVR program without major barriers, buy-in from other departments is critical. TAVR is not just a collaboration between surgery and interventional cardiology departments, but also involves many others at the hospital. From the interventional cardiologist and cardiac surgeon to the anesthesiologist, echocardiographer, critical care staff, surgical nurse and perfusionist, to rehab and physical therapy, TAVR procedures require a much larger group participation than standard cath lab procedures.
 
In our experience, the benefits ultimately outweigh the downside of creating a TAVR program. Today, our program runs relatively smoothly, but you cannot be naive about the amount of work it entails. We currently have five nurses in our research department; three spend the majority of their time related to TAVR, both pre- and post-procedure. As we have learned, it is much more involved than just putting in a stent.
 
Evaluating the Pros and Cons: One Size Does Not Fit All
For hospitals that have the infrastructure and procedure volume to implement a TAVR program, there are still other factors to consider.
In general, TAVR procedures are straightforward. It is everything that goes along with them that takes time and effort.
 
Creating a TAVR program requires a financial investment from the hospital. It is difficult to break even from TAVR, but depending on your geography, it is possible. Factors to consider include location, as major urban areas tend to have higher patient volume, which can sustain a program long-term. In addition, hospitals affiliated with well-respected universities have potential for additional resources and the draw of a positive reputation to pull in patients from far-off destinations.
 
Not only do patients have to qualify for the procedure from an anatomic and physiologic respect, but we need to ensure that they will get a long-term quality-of-life improvement. When there are significant confounding factors prohibiting the likelihood of a quality-of-life improvement, we have to make tough decisions about whether to proceed. While it is never easy to turn down a patient, this is a reality of running a TAVR program.  
 
TAVR procedures are also time-consuming for physicians and their cardiology departments. TAVR must be pre-planned, sometimes four to six weeks in advance, and will affect the way you approach, schedule and perform all of your cases. 
 
While there are many factors to consider, we have had a positive experience and the pros do outweigh the cons. We have witnessed firsthand that TAVR procedures are life-changing and can dramatically improve the life of some very sick patients, even if patients may stay in the hospital for several weeks or so afterward. We have also seen that TAVR has reduced readmission rates, although pinpointing its exact impact and benefits requires additional time and study.
 
Imaging Technology a Critical Component to TAVR Success
Imagine wearing glasses with the wrong prescription. Visualization is impaired. The same is true for TAVR procedures. The right imaging systems are required to perform successful procedures, enabling clear visualization and proper placement of the valve.
 
Research emphasizes that TAVR procedures be conducted in a hybrid lab. But, realistically, only five percent of hospitals have a hybrid OR lab, because they do not have the surgical or interventional patient volume to make the financial investment worthwhile.
 
With a very busy interventional practice, patients come to TGMC for treatment of conditions associated with cardiovascular disease. Although our facility is not equipped with a hybrid OR, we can conduct all TAVR procedures in a very large cath lab using a Toshiba Infinix DP-i angiography imaging system. The angiography system is the central tool used to guide these procedures and should include: 
 
Excellent Image Quality — Our system uses advance imaging processing to enables us to perform more complex procedures through better visualization. The improved image quality during fluoroscopic intervention allows us to see more clearly and enhances device guidance, creating safer, faster and more comprehensive exams. 
Optimizing Rooms — The system has two C-arms that optimize room utilization. The system nicely accommodates TAVR procedures and the clinical staff and ancillary equipment needed during the procedures. When we don’t have TAVR cases, we can use the system to perform various cardiac and peripheral interventional procedures. 
Safer Exams — A high-quality imaging system should allow clinicians to perform more complete procedures with lower radiation dose and less contrast.
 
The Future of TAVR
TAVR procedures are evolving the same way endovascular aortic repair (EVAR) did 10 years ago. The procedures started in select hospitals and then migrated out more and more as technology advanced and the patient sets expanded. Right now, we are working with first- and second-generation TAVR valves, but as the technology evolves over the next seven to 10 years, more programs will open up, enabling more patients to qualify.
While TAVR is more challenging to implement than widely perceived, when managed correctly and with the right investment in resources and technology, it has great potential to be the solution for patients experiencing severe aortic stenosis. With the benefit of less invasive procedures and quicker recovery times, TAVR can improve the quality of life for patients. In our business, there is nothing more rewarding than that.
 
Editor’s note: Peter Fail is an interventional cardiologist, director of cardiac cath lab and interventional research, and CT medical director at Terrebonne General Medical Center.  He is a fellow of the American College of Cardiology, American College of Physicians, Society of Cardiac Angiography and Intervention, American College of Chest Physicians and a member of the American Medical Association. He is a pioneer in structural procedures, having performed them since 2001.
 

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