The LAAO Program at The University of Kansas Health System: Current Strategies, Protocols, Quality Metrics, and Research

The cardiac electrophysiology (EP) program at The University of Kansas Health System (KU) in Kansas City is one of the largest electrophysiology programs in the Midwest offering comprehensive services in all domains in electrophysiology. The program owes its continued growth to a comprehensive approach to patient care, adoption of innovative technology, dedication to scientific research, and most importantly, an enthusiastic group of individuals motivated by a desire to provide the highest quality care to patients in the Midwest. The KU EP Division in the main campus in Kansas City includes 8 board-certified cardiac electrophysiologists and a total of 90 personnel, including mid-level providers, nurse managers, clinical nurse coordinators, registered nurses, nurse navigators, and EP technicians.

In addition, the KU Health System includes 2 satellite hospitals, each staffed by a board-certified electrophysiologist and an EP lab in both locations. The University of Kansas Hospital in Kansas City is a large, quaternary care, academic medical center with ~900 licensed beds, including a ~200-bed heart center with 50 cardiologists working out of one hospital. 

Program Structure and Personnel

When The University of Kansas Health System was restructured in July 2018, it established a new department of cardiovascular medicine, division of cardiac electrophysiology, and division of interventional cardiology, among others. The Left Atrial Appendage Occlusion (LAAO) Program is a clinical and research program structured between the EP and interventional cardiology divisions, with Dr. Madhu Reddy and Dr. Matthew Earnest as the co-directors of the program. One of the first steps of the program was to establish a LAAO committee to oversee program implementation and growth, evaluate challenges, and monitor quality. The LAAO committee is comprised of the physician implanters, EP lab director, cath lab director, vice chair of clinical affairs, director of clinical practice, EP and cath lab nurse managers, LAAO nurse navigator, ambulatory nurse manager, and the quality and safety coordinator. For the first 3 months, the committee met every 2 weeks to create protocols, workflow, metrics for quality control, and initiatives for education. Currently, the committee meets monthly to review and discuss volume trends, quality outcomes, research protocols, referral pipeline, and any potential challenges related to the program. Institutional guidelines were created to identify the timing for training new LAAO implanters to be added to the program.

Program Navigation 

One of the highlights of the KU LAAO program is the presence of a dedicated full-time LAAO nurse navigator. The nurse navigator (Shannon Wilson, RN) is a registered nurse with additional training in patient navigation. Her responsibilities include referral intake and tracking, care coordination, data reporting, referral communication, and program awareness. The navigator ensures that the patient experience through the various steps of the program is fluid, timely, and achieves patient satisfaction goals. The navigator’s role starts with the receipt of patient referral (from internal and external sources) and ends with completion of 1-year post-implant follow-up. The navigator reviews the appropriateness of the referral and schedules consultation visits with appropriate physicians (as well as pre-procedural imaging, implantation procedure, post-procedural imaging, and follow-up visits). The navigator also implements educational programs for other providers and patients, and communicates with the referring provider.

Procedural Day Workflow 

The LAAO program at KU is truly a multidisciplinary program that integrating teams across various areas in the hospital, including cardiac anesthesia, cardiothoracic surgery, perioperative services, cardiac electrophysiology, interventional cardiology, and cardiovascular imaging, among others. To make the program workflow predictable, the team identified 3 cardiologists (Dr. Madhu Reddy, Dr. Matthew Earnest, and Dr. Raghuveer Dendi) to be the designated implanters for the percutaneous LAAO. In addition, 4 structural cardiac imaging specialists were identified to perform intraprocedural transesophageal echocardiograms (TEEs). Every Monday is assigned as “LAAO day.” One of the implanters and one of the structural imaging cardiologists are assigned for performing LAAO procedures that day. Two cardiovascular labs, including a hybrid OR, are assigned for the procedures with a cardiac anesthesia team for each. Typically, 6 LAAO procedures (alternating between the 2 assigned cardiovascular labs) are scheduled per day. 

Over the last several years, the type of LAAO procedure being performed has evolved. Before 2015, the primary percutaneous LAAO device that we implanted was the LARIAT Suture Delivery Device (AtriCure). Since FDA approval of the WATCHMAN Device (Boston Scientific) in 2015, the primary LAAO device used at KU has been the WATCHMAN. The Amplatzer Amulet LAA Closure Device (Abbott) was also being implanted as a part of the AMULET-IDE study. LARIAT devices are being implanted primarily as a part of the aMAZE trial and Continued Access Protocol. Prior to 2018, almost all LAAO device procedures involved 2 implanters, but this has since changed to a single operator, except when proctoring a new implanter. 

All patients have preprocedural imaging performed along with a preprocedural anesthesia clinic visit well before the procedure day. Protocols delineating the periprocedural management of anticoagulation and other common medications exist, and are readily available for everyone involved in the clinical care of the patient. Intra- and post-procedural workflow is also well defined, documented, and readily available. In brief, after endocardial LAAO implantation, patients have a “figure of 8” suture placed in the lab after removing the sheath; this is followed by routine 6-hour bed rest, and then ambulation. All patients stay in the hospital overnight, and undergo a chest x-ray and limited transthoracic echocardiogram to rule out device embolization and pericardial effusion, respectively. Post hemostasis, all patients are initiated on postprocedural anticoagulation. 

Postprocedural Follow-Up

Anticoagulation protocols are standardized, and 6-week follow-up TEEs are scheduled with a same-day clinic visit to minimize patient travel. As dictated by the TEE, almost all patients undergo discontinuation of the anticoagulation and initiation of dual antiplatelet therapy. Subsequent follow-up visits are scheduled at 6-month and 1-year post implant. The 1-year post implant visit is accompanied by another follow-up TEE. Questions regarding anticoagulation and antiplatelet management during any time of the follow-up period are directed to the nurse navigator or the implanting physician to minimize ambiguity in management. 

Research

Being a leading academic center with the highest volume in the region, the LAAO program at KU is uniquely positioned to perform high-quality LAAO research. KU is a site for 5 ongoing sponsored LAAO clinical trials, including aMAZE (and the aMAZE trial Continued Access Registry), AMULET IDE, OPTION, DEA-LAA, and WAVECREST 2 studies. The program is also in the startup process for the CHAMPION-AF and CATALYST trials. Three full-time EP research coordinators work closely with the LAAO nurse navigator, EP lab coordinator, and the principal investigators and subinvestigators to screen and educate patients for these studies. In addition, there are several ongoing multicenter investigator-initiated trials, with collaboration from other reputed academic institutions in the country. Overall, there are more than 10 ongoing observational studies, including the national registry studies evaluating real-world outcomes. Several of the studies have been presented at annual sessions of the American College of Cardiology, Heart Rhythm Society, and American Heart Association, and are in the process of being published in major cardiovascular journals.   

Referral and Education

The LAAO program at KU is the highest volume LAAO program in the region. With the above-mentioned structural changes, the program’s volume continues to grow while maintaining high quality and safety outcomes. While striving to continue to improve patient experience, the program has embarked on several educational events over the last couple of years. Large educational events for patients who are interested in a more detailed understanding of the atrial fibrillation (AF) disease process and the role of LAAO are invited for AF seminars on AF awareness day (the second Saturday of September). In addition to educational sessions on AF screening and prevention, more than 150 patient registrants have the opportunity to come into the EP lab and have hands-on experience with the tools and techniques used for LAAO. Multiple separate educational sessions are arranged throughout the year for cardiologists, cardiology advanced practice providers, neurologists, gastroenterologists, oncologists, and primary care physicians to raise the awareness of the available options of LAAO in AF patients who cannot tolerate long-term anticoagulation. 

Quality and Safety

Safety outcomes are an integral part of any procedural program. The LAAO program at KU prides itself on excellent quality and safety outcomes. It all starts with having a robust database managed by a dedicated quality and safety coordinator, who is an experienced registered nurse in cardiac electrophysiology. Every patient who is scheduled for a LAAO procedure is included in a large institutional database. The LAAO program at KU participated in the NCDR’s LAAO registry, and in addition to those NCDR data points, additional safety endpoints and outcomes are collected prospectively and regularly reviewed. The quality metrics, including appropriateness of indication as per CMS guidelines, compliance with shared decision-making tools, success of implantation, periprocedural complications, postprocedural anticoagulation utilization, readmission rates, compliance with 45-day and 1-year TEE, and long-term complications, are all collected prospectively and benchmarked with national numbers. The LAAO program at KU is proud to say that it has performed much better than both the national average and when compared to volume-matched groups across the country. 

With its nationally recognized, well-structured, high-volume, research-oriented, quality-driven LAAO program, The University of Kansas Health System remains at the forefront of the LAA field.

Disclosures: The authors have no conflicts of interest to report regarding the content herein.