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 is positive, evidence exists from only 1 randomized clinical trial in patients with aortic stenosis and 1 in patients with mitral insufficiency. Adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time. However, in view of the promising results obtained in these limited population subsets, conduct of further randomized trials in other patient groups is strongly encouraged. In order 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. The leadership of the ACCF and STS in consultation with multiple leaders within the primary and interventional cardiology and cardiac surgical communities, regulators, and payers make the following recommendations (Table 2). 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 those 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 pre-procedural assessment in common clinics, joint procedure performance, and common patient care pathways is not recommended. 3. Establishment of a national registry of valvular heart disease to perform post-market surveillance, longterm outcome measurement, and comparative effectiveness research. This could be accomplished by linking the ACC-NCDR and STS clinical databases to the Social Security Death Masterfile and Centers for Medicare & 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 under way by multiple professional societies working together. 5. Interpretation of the current evidence by expert consensus documents and appropriate use criteria is necessary and will be forthcoming. The ACCF and STS are committed as professional societies to work with the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services to address all issues that are crucial to the safe and efficacious introduction of transcatheter valve therapy into clinical practice. Forthcoming will be multisocietal guidelines for training and credentialing, an expert consensus document, and grant proposals for creation of a national registry. This is an exciting time with the introduction of new technology and techniques to care for our patients with valvular heart disease. With society leadership, multidisciplinary partnerships, and cooperation, a reasoned, balanced introduction of this new therapy can be accomplished.
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine