Transcatheter Valve Therapy: A Professional Society Overview From the American College of Cardiology Foundation and the Society of Thoracic Surgeons
The following are 10 points to remember about this expert consensus document on transcatheter valve therapy:
1. Transcatheter valve therapy is a transformational technology with the potential to significantly impact the clinical management of patients with valvular heart disease.
2. Although the initial experience is positive, evidence exists from only one randomized clinical trial in patients with aortic stenosis and one in patients with mitral insufficiency.
3. Adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time.
4. It will be important to establish 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.
5. The heart team approach should be used with formation of multidisciplinary heart teams within these centers led by primary cardiologists, cardiac surgeons, and interventional cardiologists.
6. 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.
7. A national registry of valvular heart disease to perform post-market surveillance, long-term outcome measurement, and comparative effectiveness research should be established. This could be accomplished by linking the ACC’s NCDR® and STS clinical databases to the Social Security Death Master file 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.
8. Training and credentialing criteria for practitioners in this field need to be developed. Development 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 working together.
9. Interpretation of the current evidence by expert consensus documents and appropriate use criteria need to be developed.
10. With society leadership, multidisciplinary partnerships, and cooperation, a reasoned, balanced introduction of this new therapy can be accomplished.
Keywords: Heart Diseases, Registries, Mitral Valve Insufficiency, Cardiology, Heart Valve Diseases, United States, Leadership
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