ACC and STS Issue Expert Consensus Document on Transcatheter Valve Therapy

June 27, 2011—The American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) have published an expert consensus document on transcatheter valve therapy. The document was issued on behalf of the organizations by ACC Foundation President David R. Holmes, Jr, MD, and STS President Michael J. Mack, MD, and is available online in the clinical guidelines section of the Journal of the American College of Cardiology's Web site.

According to the ACC and STS, transcatheter valve therapy is a transformational technology with the potential to significantly impact the clinical management of patients with valvular heart disease in a less-invasive manner. Although the initial experience has been positive, there is only evidence from one randomized clinical trial in patients with aortic stenosis and one in patients with mitral insufficiency. Therefore, adoption of these techniques to populations beyond those studied in the randomized trials is not appropriate at the current time. However, in view of the promising results that have been shown in these limited population subsets, further study with randomized trials in other patient groups is strongly encouraged, the document states.

The document stresses that to address the challenges ahead for the responsible diffusion of this innovative, transformational technology, it is critical that the professional societies, industry, payers, and regulatory agencies work together.

As stated in the document, its purpose is to proportionally capture all of the core elements of transcatheter valve therapy with the overarching goal of aligning the interests of all expert physicians, including cardiologists; proceduralists; heart valve, heart failure, and imaging specialists; and imaging experts with other relevant stakeholders (regulators, payers, professional societies) in delivering the best possible patient-centered care. The role of societies is to realize this goal through ongoing development of expert consensus statements, guidelines, credentialing criteria, and training paradigms, thereby ensuring responsible diffusion of this technology.

The document lists several issues that are emerging with the introduction of transcatheter valve technology:

1. How will this technology be regulated and by whom?

Will the technology be available in all centers by all physicians or only in selected regional centers? If so, how will those centers be selected?

2.How will training of physicians and centers be accomplished? What will the training paradigms be, and what experience is necessary for credentialing to be deemed proficient? Will the training be the same for cardiologists and surgeons?

3. Will clinical databases be linked to administrative databases facilitating long-term outcome assessment, comparative effectiveness research, and cost-effectiveness analysis? Will data collection be required using standardized definitions in harmonized national clinical and administrative databases and registries, and if so, from where will the resources come from to accomplish this? Can these standardized registries be used worldwide?

4. What will be the rational diffusion of the new technology to other patient groups not originally studied in randomized clinical trials?

5. How will this new technology be reimbursed? How will patient cohorts who will benefit the most and provide the most cost-effective and clinically effective treatment be identified?

The document notes that these complexities are compounded by the multiple constituents involved—patients, competing physicians and practice centers, payers, and industry—each of which may have different goals.

As outlined in the document, the leadership of the ACC and STS, in consultation with multiple leaders within the primary and interventional cardiology and cardiac surgical communities, regulators, and payers, make the following recommendations:

1. Establishment of regional centers of excellence for heart valve diseases. Criteria for centers performing interventional therapy in valvular and structural heart disease should be established, and the availability of devices and reimbursement for those procedures should be limited to centers meeting those criteria.

2. Formation of multidisciplinary heart teams within these centers led by primary cardiologists, cardiac surgeons, and interventional cardiologists. Performance of isolated procedures without construction of a dedicated valve therapy program to encompass all aspects of care including preprocedural assessment in common clinics, joint procedure performance, and common patient care pathways is not recommended.

3. Establishment of a national registry for valvular heart disease to perform postmarket surveillance, long-term outcome measurement, and comparative effectiveness research. This could be accomplished by linking the ACC National Cardiovascular Data Registry and STS clinical databases to the Social Security Death Master File and Centers for Medicare and Medicaid Services administrative databases in a national “research engine.” This will, in effect, create a national registry of valvular heart disease similar to those that exist in Great Britain and Germany. Funding for this initiative will be a concern, but it is our position that this linkage of databases is a key element of quality patient care, outcomes analysis, and comparative effectiveness.

4. Establishment of training and credentialing criteria for practitioners in this field. Formation of criteria for the formation of fellowship programs, as well as postgraduate training with appropriate experience for adequate patient care leading to guidelines for credentialing is currently underway by multiple professional societies that are working together.

5. Interpretation of the current evidence by expert consensus documents and appropriate use criteria is necessary and will be forthcoming.