Feature | Developing a Program in Structural Heart Disease

The field of cardiology, like most disciplines in medicine, is undergoing a rapid expansion in available treatments. Structural heart disease (SHD), in particular, has seen multiple exciting new therapies altering how previously intractable or challenging cardiac problems are evaluated and treated. However, for many cardiologists, the term "structural heart disease" is not well-defined and most associate it with specific procedures such as transcatheter aortic valve replacements (TAVR). The field encompasses multiple disciplines within and outside cardiology and a more inclusive approach is needed to develop programs that may need to be novel and customized to each institution.

Aside from the technical aspect of performing the procedure, there are multiple layers that go into developing a viable, robust program. Unlike coronary interventions, an SHD program has additional adjunct components that must come together. These components require institutional support and equipment as well as support from other service lines including cardiothoracic surgery, echocardiography, imaging, electrophysiology, anesthesiology and radiology. There is often overlap between procedures performed for acquired SHD such as degenerated valves, left atrial appendage clots and adult congenital procedures. A thorough understanding of the anatomy and hemodynamics is necessary and most clinicians who were trained in an adult program have not received the sufficient training to safely and appropriately intervene on these patients.

Since there are no specific COCATS requirements for SHD, significant variability exists in training for these procedures and results in different skill and comfort levels with the interventions. Several recommendations specific to procedures and the field in general are now available related to operator requirements. Aside from the technical competence of the clinician such as training and commitment, an administrative element is vital to program success. While most current literature focuses on the clinical training aspect to SHD programs, this paper considers the program building side that goes beyond the physician-specific considerations related to training.

When building a program, a good foundation is needed at the start to avoid having the program be a prohibitive drain on resources. Most of these procedures have published specific initial and ongoing requirements that are associated with improved patient outcomes but preclude many smaller or less experienced programs from being realistically involved to a great extent. In the case of TAVR, for example, both a coordinator and registry support are integral. The TVT registry requires an average of five hours of data entry per patient, similar to the registries for the mitral clip and left atrial appendage device. A nurse is needed for the work and a higher clinical understanding is required when collating the information and working with the clinical team. A dedicated workspace for the coordinator is also needed as it is in the best interest of an SHD program to be considered as a separate program with its own unique demands. Low-volume programs have a higher likelihood of producing sub-optimal patient outcomes due to both physician and staff experience. The infrastructure also allows a program to quickly manage patients before a procedure, directing them through the process and afterwards in case of adverse events.

Another major consideration is procedure room time. Most of these procedures are done in the cardiac catheterization laboratory and operational costs directly impact the programs margin, which in turn affects institutional support and likelihood for its long-term success. Careful tracking of cardiac catheterization procedural, room turn-over time and patient recovery can go a long way towards maintaining good outcomes while keeping the case footprint and costs down. This is also directly impacted by involving other services such as echocardiography for use of a transesophageal echocardiography (TEE) and anesthesiology for intubation, along with general anesthesia monitoring and post-operative care.

The role of imaging is variable between procedures. Some programs have dispensed with the use of intra-procedural TEEs in TAVRs, while others continue to use them. Often, depending on the experience of the operators, procedures may be performed under conscious sedation and intra-cardiac echo (ICE). In the case of patent foramen ovale and atrial septal defects, simplifying the process this way allows the procedure to be done without having to involve anesthesiology or calling an echocardiography specialist. Most patients can then be discharged on the same or next day. While patient selection is important, this should be only performed in cases where the anatomy is well understood and the interventionist is both familiar with the tools and comfortable with the procedure. It is not uncommon for some institutions that have been performing a procedure for a while to look at competing products such as alternative valves or closure devices. While there can be advantages for some devices over others, this should be weighed carefully against patient outcomes and physician familiarity with the devices. It is better to maintain greater familiarity and a higher level of skill with one device rather than dilute the experience by alternating between different ones. Furthermore, having several different devices on the shelf presents storage and tracking challenges, and some of the implants are quite costly and require careful inventory management.

Coordinating different areas and scheduling across services is challenging for the TAVR team. For most institutions where cardiac cath labs times are limited, specifying days when those procedures can be scheduled is quite helpful. This system allows supporting services such as anesthesiology to routinely schedule coverage. Echocardiography and cardiothoracic surgery can then also manage their schedules to make the appropriate physicians available. We have found that instituting specific days in the week as structural interventional days significantly improved workflow, avoided schedule conflicts and reduced the workload on the coordinators of the program. This required compliance from all involved physicians and services. Depending on the volume of procedures expected, more than one allocated day a week may be needed. Should there be a day where SHD cases are not scheduled, a mechanism ought to be in place to release the room for use by other services as early as possible without disrupting SHD case workflow. The same can be said of the outpatient clinics. As most of these structural procedures require consultations with multiple specialties, evaluation should be done on a consistent SHD clinic day in coordination with a multidisciplinary team to improve the patient experience and communication between members of the treatment team.

When developing an SHD program, specific areas should be considered and respective departments invited to participate in the program. Cardiac computed tomography and magnetic resonance angiography have become vital in the assessment of many structural procedures. TEE, for example, is a pivotal part of several procedures such as the mitral clip, peri-valvular leak closures, ventricular septal defect closures, left atrial appendage closures and others. In addition, ICE allows the operator to directly control imaging but trades the convenience of having the imaging directly in-hand for more limited anatomic views and narrower aspect-angles. Constant feedback from echocardiographers, anesthesiologists, patient care areas and staff adjusts each procedure to the specific requirements of the patient and catheterization lab. It is ideal to start with protocols and shared experiences from other successful facilities and then adapt them incrementally to suit the specific demands of the local lab and SHD program.

Previously, we described the importance of creating a multidisciplinary team involved in all phases of the SHD work-up and procedure. This involves reviewing the imaging, clinical history, hemodynamics, risk assessment and a plan that all members of the team agree on. Members of the team must remain engaged during the intervention by having alternating roles and direct contributions in each case, which is a requirement for billing for some procedures.

Developing cohesion and team building is also important in maintaining referrals and a smooth workflow. Few adult cardiologists understand complex congenital anatomy and hemodynamics as well as pediatric and congenitally-trained physicians. Planning complex interventions with these congenital specialists as part of the team brings about the best patient outcomes and highest likelihood for success. A multidisciplinary approach with a wide set of skills enables the team to assess patients more thoroughly and manage unexpected findings and adverse events. Developing a model for shared reimbursement, responsibility and credit at the start promotes this team approach and shifts the focus away from competing specialties to patient-centric care. In addition, a wholistic program includes staff who focus on other aspects of patient care such as rehabilitation therapists and social workers complementing the clinical aspects. An indispensable part of the program is to have dedicated time set aside for regular multidisciplinary meetings with all stakeholders. In those meetings, patient selection, assessment and appropriate therapies should be considered. Program development plans and work-up algorithms can then be made in a collaborative approach, easing the burden on the program coordinator and cardiologists.

Finally, mentorship is a vital aspect in advancing early and mid-career clinicians. A complex program presents many challenges that are best faced with supportive colleagues. Mentors help guide the operator with more routine procedures and complex interventions as the physician gains in experience and the program develops the infrastructure to manage these often-challenging cases. This applies not only to the clinical aspects of the procedure but also in developing a framework for patient care, process improvement and handling administrative challenges. While some of this support will be from academic educators in the clinician's background, industry and institution-sponsored educational programs for both the clinicians and staff are invaluable and can help connect with peers in the field.

While developing an SHD program may be a daunting endeavor, it is quite rewarding for clinicians and all members of the team. The available and upcoming SHD therapies present significant outcome improvements for patients with previously limited options. Good outcomes, low costs and a collegial environment is needed to create a robust program supported by the institution and clinicians. The key aspect of a successful program involves a collaborative approach to members of the institution and community at large.

This article was authored by Islam Abudayyeh, MD, FACC, cardiologist at Loma Linda University Medical Center in Loma Linda, CA.