Christoher U. Meduri, MD, MPH, can be reached at Christopher.Meduri@piedmont.org.
Tell us about the transcatheter aortic valve replacement (TAVR) program at Piedmont Heart Institute.
We are very fortunate that a few years ago businessman and philanthropist Bernie Marcus supported Piedmont in its quest to build a top-notch heart valve reference center for the southeastern United States. He donated more than $20 million dollars to help build the Marcus Heart Valve Center (MHVC). The MHVC is a multidisciplinary comprehensive reference center for valvular heart disease diagnosis and treatment. It provides patients an easily accessible point of entry for coordinated, best practice care, and it gives other providers an opportunity to learn about valvular heart disease diagnosis and about the latest and most advanced treatment options. As a result, we are able to provide what we believe is world-class, optimized care for our patients.
This vision allows for many unique approaches at our valve center. Myself, one of my interventional colleagues, Dr. Vivek Rajagopal, and several of our cardiac surgeons, Jim Kauten, Morris Brown, and Fred Milla, have a multi-disciplinary clinic on Mondays. Our other two cardiac surgeons, John Gott and David Dean, share our vision and actively support our efforts. Further, our imaging cardiologists, Drs. Mani Vannan and Randy Martin, are assisting in imaging studies during these days. This facilitates streamlined decisions for our patients right then and there. We also have wonderful schedulers and valve coordinators who can arrange for echos, computed tomography (CT) scans and other diagnostic tests to be done the same day, so we can get patients the answers they need on the day that they visit. It affords us the opportunity to initiate better care downstream as well. A large number of our patients are from regional referrals. We will have all of the testing that has already been performed, such as echos and caths, uploaded and prepared up front so that we can have a very efficient evaluation of the patient on their initial clinic visit. We believe this is the true essence of a “heart team.”
Can you tell us about the recent changes to Piedmont’s TAVR program?
The changes we made revolved around TAVR procedural and post procedural care. When I arrived at Piedmont over a year ago, our team was already making great strides in changing certain aspects of TAVR care, such as length of stay. Initially, Piedmont’s length of stay was around the national average of 6 to 7 days and we felt there was room for improvement. Our goal was a shorter length of stay and better outcomes for our TAVR patients, which was accomplished via a three-tiered approach. First was education and getting buy-in from those involved: nursing staff, all the physical therapy/occupational therapy (PT/OT) providers, social workers, care coordinators, and other cardiologists and cardiac surgeons. Secondly, we looked at the TAVR procedure to determine if we could optimize any aspects. A big change was to move from general anesthesia to light conscious sedation with fentanyl and versed. Third and final was implementing a pathway streamlining care for the patient after the procedure, which we consider a very important change.
How did you begin?
Sidney Kirscher, now the CEO of Piedmont Physicians, and our physician leaders Drs. Charlie Brown and Bill Blincoe, all believed in the vision that we could transform things to a large degree. It helps to have the top level of administration supporting what you are trying to do. Also, my colleagues, Dr. Vivek Rajagopal and Jim Kauten, are fantastic. I cannot emphasize how fortunate I am to have them as colleagues. They were just as instrumental in building this up and making change happen. As a group, we held a logical, open discussion with the other shareholders, communicating that by moving to conscious sedation and mobilizing TAVR patients earlier, we would reduce our length of stay, decrease complications, and improve patient outcomes and satisfaction. We shared a few examples, and with everybody championing those examples, it became a very quick buy-in.
It is also important to mention how helpful our dedicated clinical pathway team is. This team consists of 4 nurses exclusively dedicated to developing and implementing clinical pathways for cardiac conditions. I think this team is a testament to the leadership’s investment in providing world-class care for patients. As soon as I started at Piedmont, I sat down with the clinical pathway team and we developed an implementation plan moving forward. The team is fantastic and continues to fund itself, because the hospital sees how it saves money and patient care is improved. They have been instrumental in helping to build on our three-tier approach. They knew the right staff and physicians to target and make champions in order to make those things happen more effectively. This could not have been accomplished without their assistance.
How has using conscious sedation for TAVR affected your procedures?
We initially struggled with the idea of conscious sedation, because there were not many examples in the U.S. from which to draw, and how do you even select your first patients? Initially, everybody wanted to do the safest patients, those thought to be lowest risk, under conscious sedation. We decided to do a few of the simplest patients up front, which went very well, and then everybody agreed to transition fully. We feel strongly that it facilitates a quicker recovery for patients with a reduction in complications.
Are you using a hybrid lab?
Right now, we are doing three TAVRs a day two days a week and we flip back and forth between the hybrid OR and the cath lab in order to do the procedures more efficiently. Our first case is in the OR, second case in cath lab, and back to OR for the third case. This has been going on for some time. Despite initial resistance, we now have broad buy-in. Given the seamless transition between cases, we will be moving to four cases a day in the next few months.
How many patients undergo non-femoral access?
For classic aortic stenosis, I would estimate 10% non-femoral access. The delivery systems are all small enough now most can be performed transfemoral. As a side note, we have done a fair number of sheathless CoreValves (Medtronic), prior to commercial release of Evolut R. We can work with fairly small arteries where we go without the sheath. I think Piedmont has one of the larger U.S. experiences, since we have done at least 20 cases. It is essentially a 14 French system, works well in more challenging patients, and remains applicable for those patients requiring a 31mm CoreValve. For our mitral valve-in-valve, mitral valve-in-ring and mitral valve-in-MAC cases we are still primarily using transapical access, though we occasionally will perform them transeptally with a rail across the aortic valve.
Can you tell us about the changes to post procedure care?
A large part of the change began with identifying champions within the ICU and floor nursing staff, then building and optimizing the pathways and checklists. We remained hypervigilant. The key component is to stress the importance of early ambulation. It was commonly accepted that TAVR patients would be in the hospital for 7 days, i.e., treated like surgical patients. Now, when I see a patient in clinic, the first thing I tell them is, we love providing a great result for you, but we don’t want to forget that you are also a person. We are not just fixing a valve. We want a good technical result and we want you to have a quick recovery and be better than baseline.
Patients are told to anticipate a hospital stay of 1-2 days. “You are not going to rehab, you are not going to need additional in-home help.” “You are going to be better than baseline.” The families embrace that, and then their expectation is that this is not a surgical procedure, but a catheter-based procedure, and that their loved one is going home in a few days and right back to activities. When families and patients set their expectations for a quick recovery, they do get better quickly. I have 92-year-olds on oxygen that look at me in their room a few hours after the procedure, asking, “Can I go home”? And I say, “No, you can’t go home tonight,” but we start the process. Our patients are sitting in a chair 4 hours after a procedure and walking 6 hours after the procedure. This is almost without exception. When you use light sedation, the patients do so well, because, as we tell them, they don’t really have anything to recover from. They just had a brief bed rest, and now they are up, moving around again. After almost 200 conscious sedation TAVRs, we still have not had any vascular issues from early ambulation.
It is a huge difference from dealing with the complications that can otherwise come downstream, due to patients sitting around and their lungs not expanding fully. In addition to early ambulation, the other important pathway component has been the avoidance of any kind of narcotics, unless needed for severe pain relief. These patients, especially transfemoral, should not have much pain, and if there is, it could be a sign of something more serious. This has been a true cultural change, as it was routine for patients with pain to receive narcotics. These are elderly patients and if you give them narcotics, they are at a high risk for delirium and many other setbacks. Avoiding these drugs is very important.
What about timing of the TAVR procedure from the patient’s first visit?
Normally from the clinic visit to valve replacement, time duration is 4-6 weeks. We recognize that it is important to get the valve quickly for a variety of reasons. Studies show that waiting more than 2 months for TAVR can increase mortality. While patients are waiting we tell them to keep moving, and that if they do this now, it will pay off down the road. It is amazing how much of a difference mobilization and a positive mental attitude before the procedure makes in the end result.
Exactly, there are a lot of hospitals that are still using the open-heart recovery pathway. It was a natural beginning. When TAVR first started, the only way valves had ever been replaced was surgically. Unfortunately, it is challenging to change practice patterns after they are established. Programs were comfortable having patients go to the ICU intubated and having them lie in a bed for a day or two, just as with surgical patients. I think the surgical pathway still continues in most hospitals in the U.S.
What about reimbursement?
We thought there was some initial resistance because Medicare’s policy with TAVR is a PACT (Post Acute Care Transfer) policy. Physicians tend to think, if I discharge a patient, and they end up needing rehab, then a huge financial penalty will result. As we know, TAVR centers on average are losing a significant amount of money even with the changes to the DRG, so everyone is very conscious of that. We found that our patients are doing so well, that a short hospitalization is the norm. Our goal is not to send patients out before they are ready, but to have them recover quickly so that when they are ready to go home, they are better than baseline, and do not need home help or rehab. This removes worry about any of the financial penalties of Medicare, because the concept is going home without any assistance and there is no financial penalty. It is a “win-win.” To help centers better understand this, we developed the “Post-TAVR Optimization” App which is available for free at post-tavr.com, and the Apple and Google Play app stores. The patients do better and do not need rehab, so there is no financial penalty to the hospital. Of course, financial penalties don’t guide our decisions. If the patient needs rehab, they are going to go. Less than 5% of our patients need any formal assistance after hospitalization. The national average is much higher at 32%.
After patients are done with the procedure, are they going to the floor or the ICU?
We are still sending them to the ICU now. We have done this, partly, because our ICU staff has been so well trained in the care of these patients and in our new pathways that we have not forced the issue. I would like to move away from the ICU, but I don’t think it’s a big difference, at least in our setting. Again, in our ICU, we are so aggressive with ambulation due to the pathway, it really may be best to monitor the patients closely. Our patients have no limitation in their ability to ambulate because they are in the ICU.
We do on average 18 TAVRs a month, and the reduction in length of stay opened up 55 hospital bed days a month at our hospital. It is a huge opportunity to allow more admissions because we are constantly at capacity. It is a large cost saving, so it was easy for administration to buy in. We addressed every angle and detail, and there was tremendous buy in.
What is your length of stay and what happens after discharge?
Our median length of stay for transfemoral cases is two days. We monitor patients very closely after discharge because of their short hospitalization. We give patients a discharge brochure and ask them to monitor their blood pressure, heart rate, and weight daily for the first month. Patients receive follow-up phone calls post discharge days 1, 5, 14, and 21. These are brief phone calls. Problems can be quickly addressed by phone, and if there are issues with blood pressure or weight, they will call us and these will be dealt with quickly. Appropriate follow-up is a crucial aspect of having an early discharge program. Constant surveillance is essential. We have rarely had issues, but there will be occasions where someone needs a little more or less diuretics, and staving off problems early can be really important. Our 30-day rate of readmission rate from TAVR is close to zero, and when combined with early discharge, a strong follow-up program goes a long ways towards preventing the escalation of any problems. To have our changes improve processes, with such a short of a length of stay and great outcomes — we have become quite proud of our results at Piedmont Heart.
Who are the other key components of your “Heart Team”?
It really is so much more than the physicians. I can’t begin to give enough credit to our staff. Each patient sent to us has their care coordinated through our office and Ellen Filer, Gwen Herndon, Meredith Brazell, Alyson Wood and Dawn Pittman do such a great job coordinating this care. Also, we have a robust research program and are currently leading the world in enrolling in REPRISE III trial, which is evaluating the Lotus valve (Boston Scientific). This is only possible with the assistance of our research coordinators Shelley Holt, Elisa Amoroso, and Nita Cadic.
Another thing I want to mention is that it is not only our team before and after the procedure, but also our team that does the procedure — our nursing staff, our cath lab staff, and our OR staff — they are just fantastic. They are “world-class” in the way that they work the procedure, come up with new ideas for challenges we face in the procedure, and have been big supporters and drivers of change. I definitely want to give them due credit. n