Hi, my name is Misty Theriault, and I'm a registered nurse and valve clinic coordinator for the TAVR program at Lake Charles Memorial Hospital in Lake Charles, Louisiana. Our TAVR program was the first in the nation to obtain the American College of Cardiology or the ACC's transcatheter valve certification. Throughout this presentation, I'll be talking about our experience with this process and how it has affected our program. I'm very thankful to the ACC for this opportunity to help others, as this was such a positive experience for us and our facility. I also want to sincerely thank Amy Westfall with the ACC and Joan Michaels with the TVT Registry for all of their guidance, assistance, collaboration, and compassion. I know 2020 has been quite a difficult year for everyone, with the COVID-19 pandemic in our area recently being devastated by Hurricane Laura. Through these difficult times, it's important for us to come together, help each other, and remember that we will rebuild, restore, and recover. I'll begin by going over the objectives for the presentation, which include reviewing the value of participating in the ACC's transcatheter valve or TCV certification and program improvements that we noted afterwards, along with the value of having a site champion. This is the individual at a facility who will oversee and manage the certification process. As an introduction, I wanted to explain the demographics of our area and a little about our facility. Lake Charles, Louisiana has a population near 80,000. We are located approximately two hours southeast from Houston, Texas, which was the main location that we would refer patients to for TAVR before we began our program. Lake Charles Memorial Hospital, the main campus of Lake Charles Memorial Health System, is an acute care community hospital with 314 patient beds. It is also the largest of three hospitals in the area. Our cardiology group, the Heart and Vascular Center, consists of seven cardiologists and one cardiovascular and thoracic surgeon. The cardiologists provide care to surrounding cities through satellite clinics, increasing our service area to approximately 200,000. As pictured on the right, our TAVR physicians include two interventional cardiologists, Dr. Edward Bergen and Dr. Christopher Thompson, and one cardiovascular and thoracic surgeon, Dr. Gregory Lugo. I'm very thankful for our TAVR physicians as we work very well together, have mutual respect, and always put our patients first. This certification process would not have been possible without their support and collaboration. These three physicians share the role of program medical directors as they equally oversee all aspects of our program. I am the only coordinator for our program and do everything from the TBT data entry and analysis, pre-sorting, scheduling, patient and staff education, recently taking care of the TAVR patients post-operatively due to staffing shortages, and monitoring coding and reimbursement. My background is in critical care, mainly caring for post-operative cardiovascular surgery patients. I absolutely loved being a bedside nurse and was not looking for another job, but somehow it found me, and now I cannot imagine a more fulfilling job and rewarding career. We began our TAVR program in May 2018 and performed the TAVR cases in a hybrid cath lab room. With the addition of low-risk patients now able to have TAVR, we were on track to complete more cases this year, but due to COVID-19 and now the devastation from Hurricane Laura, that has been affected. Regardless of these difficult times, we will continue to be there for our patients and keep patient care as our top priority. As I mentioned on the first slide, our TAVR program was the first in the nation to become certified through the ACC. The following slides will discuss more about that process. Another question regarding the differences between the ACC's certification versus accreditation comes up quite a bit, so the ACC provided the following definitions to help clarify. A certification focuses on the initial structure of a program to ensure that there is strong leadership in governments, appropriate staffing and education, as well as focusing on quality monitoring and data. The two sections of a certification include governance and quality. An accreditation, however, covers the entire care continuum to include governance, quality, pre-procedure, peri-procedure, post-procedure, and a clinical quality section for PI or performance improvement projects related to data. Per the ACC's oversight committee and leadership, the transcatheter valve certification will remain a certification at this time. The next update will include all transcatheter therapies and then will move towards an accreditation afterwards. I know that I'm not alone in saying that it is overwhelming when beginning a TAVR program or even to maintain one at times. Yes, we have made sure that we are following all the CMS requirements, but there is more of a gray area when it comes to structuring a valve program itself and truly how to improve efficiency. We decided to pursue the ACC's transcatheter valve certification to help streamline our processes, ensure that TAVR best practices are being followed, to track and analyze data to identify opportunities for program improvement and patient outcomes, also to advance staff education and to be recognized for having a proficient program, which is something that we have worked very hard towards. So I wanted to share our timeline of certification completion to show how long the process took. The ACC provides 30 days to complete the baseline gap analysis and one year total to complete the certification. It is a three-year certification, which means that it would need to be renewed after that point. However, an annual payment is required and specifics regarding that can be provided by the ACC. For our facility, the certification process took two months from the date of submitting the application to the date that certification was granted. As you can see on the process map, once our gap analysis was completed, we were able to meet all of the requirements and have a video site visit one month later. The video site visit was really a great experience and something that we felt well prepared for as I was provided with a suggested list of members to be in attendance and an outline for the meeting. A special thanks is owed to Kim Pfeiffer, our ACC review specialist, who was truly amazing at helping to keep us on track and was very knowledgeable. We really couldn't have completed the process so quickly if it weren't for her drive and assistance. She also did a great job during the video site visit to engage with each member present to get their perspective on the process and the overall experience. When I have talked to other programs about the timeline for certification completion and expected workload for the facility site champion, I feel as though six months would be a realistic timeframe. I would recommend striving to have it completed before the one-year mark in case one of the requirements takes more time than anticipated or there is something to restructure within the program to meet the requirement. Once certification is achieved, there are requirements that need to be met in order to maintain, such as uploading certain documents on a regular basis or continuing to have certain meetings, then uploading the meeting minutes. This has not been difficult as the ACC provides a clear outline of the expectations. I've had other programs ask how we were able to get started with a certification, especially so quickly. The discussion began in April 2019 upon the ACC's initial announcement regarding the upcoming certification. I discussed it with our TAVR physicians, who then had a discussion with our hospital administration. All were immediately supportive and interested. I was designated as the certification site champion to help manage the process. Since everyone was already in agreeance, we were able to submit our application in July as soon as it was available. Once access to the online site was obtained, I reviewed the requirements with the TAVR physicians and made a timeline, which is on the right side of the slide. We felt as though we could complete the certification within 30 days, which I will admit that Kim laughed at this idea initially, but she was quickly on board with helping us to meet that goal. I also involved multiple departments from the beginning to assist with meeting certain requirements. I tried to begin with the requirements that would take more time, such as creating new policies or updating documents that would require a meeting amongst hospital administration to approve. In the meantime, I worked on catching up on our meeting minutes, which wasn't too difficult of a process, but it was time consuming. We have a weekly HART team meeting, which occurs every Friday, unless we have TAVR cases during the week. Then we have a briefing meeting prior to beginning. Our TAVR physicians attend every meeting, along with myself and other pertinent HART team members. The ACC also provides an outline of required and suggested members that need to be in attendance for these meetings. We also try to involve the referring physicians, along with other physicians that provide care specifically to the patient we are covering, to truly have a shared decision-making process. At these meetings, we review a PowerPoint presentation, which I prepare with information that needs to be covered. I also note which members are in attendance and the time of our meetings, along with the content covered and decisions made, as this information is formatted into a progress note that becomes a part of the patient's medical record. We now have a sign-in sheet for every meeting that I attach to our meeting minutes and then upload onto the certification site. As I would complete a document for the certification, the TAVR physicians would review and make changes as needed. Our chief medical officer, Dr. Manley Jordan, was also very involved in our certification process, as he would review the documents and offer input, especially with a program charter, root cause analysis, and quality assurance and performance improvement plan. Throughout the certification process, we realized how vital it was to utilize the strengths of our team members. It truly is a multidisciplinary process and requires buy-in and support, especially from the TAVR physicians, TAVR team, and hospital administration. We sought out individuals throughout the facility for their assistance. By doing this, we were able to brainstorm ways to improve processes in order to become more efficient. There was a multitude of departments that also helped with this process, including nursing administration, cath lab, OR, anesthesia, ICU, pharmacy, biomed, IT, purchasing, marketing, radiology, radiation oncology, and education. This also brought our TAVR team together even more and gave a sense of accomplishment to those throughout the facility that helped with the process. This process also helped us to better structure our valve clinic and program by creating processes and policies. We found that we had a lot of the processes already in place, such as our shared decision making, TAVR CTA, or TAVR inventory management, but it was not properly documented in the form of a policy, protocol, or procedure. I would utilize the expertise of our TAVR team members to assist me in writing the policies, then would go through the necessary steps to get approval. By implementing changes that we will discuss on the next slide, we also noted improvement in our TBT metrics, patient outcomes, and program throughput. Our process for TAVR staff education also needed direction and was streamlined with the ACC's guidance. We were able to implement program changes by creating a Root Cause Analysis and Quality Assurance and Performance Improvement, or QAPI, plan. The Root Cause Analysis is a requirement for the certification based on a facility's TBT metrics, if there were any below a certain percentile, and an action plan to improve. This was also a useful document to explain that our TBT quarterly report, released close to the time we were going through the certification, was incorrect due to a billing issue and being unable to enter data. We regularly review our TBT metrics during our HART team meetings when the quarterly reports are released. Our CMO, Dr. Manley Jordan, also has access to these reports and reviews them on a regular basis. I monitor and analyze our real-time data, including overall referrals, program throughput, procedural data, readmissions, follow-up echo results, etc., in the form of spreadsheets and pivot tables, which I absolutely love. This information is reviewed with our HART team and during our Cardiovascular Surgery Service Line meeting called Pink Floyd. We usually have about 40 to 50 members throughout the facility who attend this meeting, which is now occurring via Zoom due to COVID-19. For team members unable to attend either of these meetings, I still try to keep them updated on what our current metrics are, and we brainstorm ideas to continually improve. Our VP of Quality, Robin Odom, was also very helpful when we were creating our QAPI plan and provided direction and oversight. This document also outlined our requirements for staff education, program goals, and scope, as well as plans for program leadership and performance improvement, or PI initiatives. The next few slides focus on specific improvements that we noted after working on these documents. Starting with vascular complications, we came up with different ideas in the root cause analysis to help improve these metrics. 56% of our TAVR patients have had PAD, or peripheral arterial disease, compared to the TBT average of 27%. The process map on the right side outlines how we determine a patient's TAVR access, which includes the valve company analyzing the CTA images and the TAVR physicians independently reviewing the images. We then compare and discuss to determine the best option for the individual patient. A new closure device was utilized beginning in September 2019 that is specifically designed for large bore, femoral, percutaneous arterial access sites to help decrease the incidences of vascular complications. For patients with marginal vascular access, the need for cut-down closure or alternative access is closely evaluated and considered preoperatively to decrease the need for subsequent procedures to repair complications. Going into each TAVR case, we select a bailout plan specific to the patient, whether it is to do a trans-femoral cut-down or alternative access approach if there's a complication with the initial planned access. Towards the bottom of the slide on the left is a breakdown of our overall TAVR accesses, which include 81% for trans-femoral percutaneous, 15% for trans-femoral cut-down, and 4% for alternative access. The graph at the bottom references total vascular complications, which include minor and major occurring intraoperatively and within 30 days of TAVR. Our complication percentage in 2018 was largely due to a small sample size as we began our program midway through that year. Even so, by implementing these changes, we were able to decrease our total vascular complications from 16% in 2018 to 11% in 2019 and now 3% in 2020. Our intraoperative contrast amount is something else that we continue to work on and brainstorm ideas to improve, as outlined in our QAPI plan. By decreasing the amount of contrast used when obtaining images and limiting the number of aortic root images after implantation, we have been able to continue to improve on this number, with our goal being below 90 milliliters per case. In 2018, we were at 171 milliliters on average per case. That was decreased to 135 milliliters on average per case in 2019. We are currently at 99 milliliters per case on average in 2020, with 70 milliliters being our current average administered per case since June of this year. So you can see this is something that we are continuing to work on and try to improve. Our total procedure time was another improvement that we wanted to make in order to become more efficient. As you can see on the right side, the top graph outlines our case times from our very first TAVR day, which was on May 22, 2018, in which all cases were transfemoral approaches with general anesthesia. As you can see, we thought it would be a good idea to have three cases, and it was quite a long day. Since then, we have implemented changes through our QAPI plan to decrease our procedure times, focusing on the total procedure time and the stick-to-out-of-room time, which is what the TBT registry tracks. The graphs at the bottom of the slide outline our improvements since 2018. In 2018, our total procedure time was 149 minutes. In 2019, that decreased to 119 minutes, and currently it is 111 minutes in 2020. Our stick-and-out-of-room time improvements are largely due to using moderate sedation, or MAC, instead of general anesthesia. In 2018, our average time for stick-to-out-of-room was 95 minutes, decreased to 68 minutes in 2019, and is currently 66 minutes in 2020. Our overall percentage of moderate sedation is 80% compared to 20% of general anesthesia. Additional changes we have made include having the first patient arrive to the hospital earlier, moving up or to have a briefing meeting, having the anesthesiologist insert the arterial line and central line in ICU, and having the venous sheets removed postoperatively once the patient exits the procedure room. We also decreased the number of staff members present in the room from 17 staff members in 2018 to currently 10 or 11 members in 2020. You can see the bottom graph on the right side, which includes times from a recent TAVR day, outlining our quicker procedure time and turnover time. This is something that we are continuing to keep track of and improve on, but we are already very proud of the improvements we have been able to make with this. Our program throughput, which is the amount of time that patients wait from TAVR referral to actually having the TAVR procedure, was something else that we closely monitored and tried to improve on through the QAPI plan. In 2018, we had a large backlog of patients that were waiting when we began our program. Since then, we have added additional TAVR days to decrease the amount of time that patients are having to wait. By improving on our procedure times, we were also able to add more cases on in a day. We also streamlined a referral process by completing the non-invasive TAVR testing and CBT surgeon evaluation on the same day. One additional visit is required for evaluation with the interventional cardiologist and for the patient to complete the preoperative process, such as lab work and registering. Our average in 2020 has been affected due to COVID-19 and now Hurricane Laura, but this is something that we are continuing to work on and monitor. As you can see the graph on the right-hand side, in 2018, our total throughput average was 52.9 days. That was decreased to 30.2 days in 2019, and we are currently at 32.9 days on average in 2020, which we are still happy with considering all that has occurred this year. The last process that I wanted to discuss is regarding our TAVR staff education. The ACC's certification process really helped us to streamline the education provided to team members to ensure they are as educated and prepared as possible. This process is outlined in our QAPI plan, and the department-specific managers and directors are aware of the expectations. We have specific TAVR members from our OR, cath lab, and non-invasive cardiology that are present for each case. We require that the applicable staff members remain up-to-date with our BLS and ACLS certifications, and that new staff members complete online modules specific to the valve being used. They also train with an experienced TAVR team member until they are able to perform the duties independently that are outlined on their specific competency. The ACC provided guidance to create competencies for each individual during the TAVR case, which has helped the staff members be aware of their expectations from the beginning. We require that staff members remain current on department-specific education and have annual education provided on new or updated TAVR clinical guidelines, devices, procedures, and equipment. We also have a biannual emergency simulation with the team members to be prepared if an emergency were to happen during a TAVR case, and we review their individual specific roles in the event that were to happen. Lastly, the department-specific manager or director evaluates the staff members annually based on their TAVR-specific competency. Our team members have been very receptive and proactive to this, as they will even bring forth different TAVR articles they come across or complete TAVR-specific CEs to continue to further their knowledge. In conclusion, it's vital to have a site champion to take ownership of the certification process and to keep the process on track. Involving the TAVR physicians and hospital administration from the beginning is also the key to the success. It's important to utilize your team and their individual strengths. I can't thank our TAVR team enough for all of their hard work and dedication. They truly are exceptional, and it is amazing the work that can be done when everyone comes together. By the way, the TAVR team picture on the right was taken prior to COVID-19. I highly encourage sites pursuing the certification to create a timeline to keep the process on track and aim to have it completed prior to one year. I can't stress enough how important it is to know your program's data. Access and review your TBT reports and metrics with your HART team and other applicable departments on a regular basis. Also, start recording your minute meetings now. Trust me on this one. And continue to brainstorm ways to improve and always strive for excellence. If you would like additional information or have questions regarding the transcatheter valve certification, please visit cbquality.acc.org or email accreditationinfo at acc.org. Questions regarding the TBT registry can be emailed to ncdr at acc.org. Again, that correct email is ncdr at acc.org. Thank you all so much for your time, and I hope this was helpful in answering some questions that you may have all had. I want to sincerely thank our TAVR physicians again, Dr. Edward Bergen, Dr. Gregory Lugo, and Dr. Christopher Thompson, along with our practice director, Karen Kleinman, and our hospital administration. This truly has been such a wonderful experience, and I would highly recommend any TAVR program to pursue this certification, as it is amazing the changes that we have seen afterwards, the connections we've been able to make with the ACC, and the collaboration and sense of accomplishment that our team has been able to achieve. Thank you all again.

transcatheter valve certification

Lake Charles Memorial Hospital

ACC

TAVR program

patient care

staff education