Multisociety Consensus Statement Tackles the Classification of Heart Valve Centers

More and more hospitals are beginning to offer valvular heart disease procedures, raising questions over how to structure care delivery on a system-wide level. To add some clarity, a multidisciplinary group recently created a consensus document that delineates between primary and comprehensive centers.

With guidance on what each type of center—whether Level I or II—should be capable of doing, the document also describes how these facilities could work together to optimize diagnosis, treatment, and outcomes. It was written as a joint effort by the American Association for Thoracic Surgery, American College of Cardiology (ACC), American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons, and published online today in the Journal of the American College of Cardiology.

According to the writing committee, co-chaired by Rick A. Nishimura, MD (Mayo Clinic, Rochester, MN) and Patrick T. O’Gara, MD (Harvard Medical School, Boston, MA), an interconnected system of valvular heart disease providers and centers “may help strike the right balance between access and quality outcomes.”

They stress that the “focus of this document is not to ask whether there are too many, too few, or just the right number of self-designated advanced valve centers, but rather to initiate a discussion regarding whether a regionalized, tiered system of care for patients with [valvular heart disease] that accounts for the differences in valve center expertise, experience, and resources constitutes a more rational delivery model than one left to expand continuously without direction.”

Commenting to TCTMD, Hemal Gada, MD (UPMC Pinnacle, Harrisburg, PA), said the recommendations make practical sense given the amount of valvular heart disease, both recognized and underrecognized, that exists.

“From a public health standpoint, it offers some advantages simply because of the creation of these constructs and designations,” he said, adding that it is “a well-thought-out, detailed proposal.”

Level I and Level II Designations

Nishimura, O’Gara, and colleagues advocate for a systems approach similar to programs that have been used successfully in patients with stroke and trauma. Valve centers would be designated as either comprehensive (Level I) or primary (Level II).

Level I centers would be expected to have advanced imaging modalities such as 3-D echocardiography and cardiac MRI. Level II centers should have “at a minimum, the expertise and resources to perform transfemoral TAVR and surgical procedures such as isolated SAVR. The ability to perform a durable mitral valve repair in patients with primary MR due to posterior leaflet pathology is desirable but not mandatory.” Level II centers capable of complex valve procedures would be expected to have the same performance standards and expected outcomes as Level I centers. Valve interventionalists at both Level II and Level I centers would be capable of performing transfemoral TAVR and percutaneous balloon aortic valve dilation, with those at Level I centers expected to have additional expertise, including ability to perform atrial septal puncture and percutaneous closure of atrial septal defects.

The document also goes into further detail about alternative access sites, valve-in-valve procedures, mitral interventions, and other structural heart techniques.

Importantly, the purpose here “is not to limit the number of centers per se but rather to set performance and quality goals for a valve center to meet benchmarks to be considered either comprehensive or primary in a manner that would be more objective than simple self-designation,” the authors note.

Gada said the surgical proficiencies expected of Level I centers are of particular importance because they move the conversation about specialized centers away from delineating on the basis of the ability to perform “TAVR versus TAVR-plus” to a more comprehensive view of valvular heart disease and its complexities.

The document also discusses new imaging modalities and the need for advanced imaging expertise at Level I centers, as well as the need for both types of centers to have an ICU, cardiac anesthesia, vascular surgery, cardiac electrophysiology services for pacemaker implantation, and the ability to provide temporary mechanical circulatory support like a left ventricular assist device or extracorporeal membrane oxygenation (ECMO).

“The temporary mechanical support inclusion is a very interesting one, because I think a lot of places do have intra-aortic balloon pumps and potentially percutaneous support devices like Impella, but putting someone on ECMO and having a dedicated team involved is an additional thing that I think a lot of centers do not have currently,” Gada observed. “Being able to convert a case over to ECMO rapidly, and have perfusion in the room that would assist with that is a pretty tall ask for a primary valve center, but I think it’s absolutely necessary for complex procedures.”

Teamwork at a System Level

Open communication and collaboration ideally should exist between Level I and Level II centers, the writing committee advises. “Ideally, patient movement within such a system would be predicated on the desire to match the complexity of disease with the appropriate resources while placing a premium on maintaining relationships between patients and their longstanding healthcare providers.”

Gada said this aspect of the plan will be particularly important going forward “simply because some of the things a primary valve center is supposed to be able to do, they may not be able to do in individual contexts.”

Another argument for a systems approach, the document notes, is to ensure continuity of care so that centers designated as having valvular heart disease expertise are not only capable of performing certain procedures, but also have multidisciplinary teams available to assess and manage patients according to evidence-based guidelines and allow for shared decision-making.

Recognizing that gaps exist in the identification and treatment patients with valvular heart disease, the committee says professional societies and individual valve centers need to take responsibility for providing education, support, and guidance.

In addition to 2014 guidelines and a 2017 focused update, both issued by the ACC and the American Heart Association, several ongoing efforts are expected to produce concise and relevant tools for diagnosing and treating patients with valvular heart disease, including the Managing Aortic Stenosis and Emerging Mitral Regurgitation Clinical Care initiatives. The document’s authors also call on valve centers and professional societies to develop and implement “a scientifically rigorous approach for performance measurement and quality assessment” including performance metrics and potentially public reporting.

Volume recommendations, in particular, “must be incorporated carefully and selectively into any determination of which hospitals are designated as [valvular heart disease] centers,” they stress.