ACC Corner | Transformational Technologies: Bumpy Road to Promising End

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 - David R. Holmes, Jr., MD, FACC
David R. Holmes, Jr., MD, FACC

Transformational technologies bring with them challenges and opportunities. Upon development and introduction of these technologies, new strategies become available for treating a wider range of patients. Some of the biggest challenges are: what to compare it with; how to reimburse for it; how to train to utilize it; and how to integrate it into the practice of cardiovascular care.

Transformational technologies result from several factors: creativity; problem solving; visioning; and the development and application of other non-related technologies to a new field. Medicine is replete with examples, including sterile techniques, antibiotics, x-rays and steroids.

Transcatheter aortic valve replacement (TAVR) includes all of these challenges and opportunities, as it was developed to meet two needs: one critical and one visionary. Given that aortic stenosis is a mechanical problem, medical therapy has proven to be ineffective. While surgical aortic valve replacement is a Class I indication, it is not utilized in up to 30 to 40 percent of patients with severe aortic stenosis because of several factors. First, as the patient population ages and as the incidence of aortic stenosis increases, the presence and extent of comorbidities also increase, making surgery either high risk or not possible. Second, patients and providers alike are gravitating toward less-invasive treatments.  

Both single and multicenter registries have documented that TAVR can be performed with excellent initial hemodynamic results similar to—or even slightly better than—surgical aortic valve replacement. The next steps are to refine patient selection, deciding in which patients it should be done or could be done. Compared with medical therapy, the PARTNER B trial, which evaluated patients with severe inoperable aortic stenosis, demonstrated that TAVR resulted in a dramatic improvement in cardiac mortality and major adverse cardiac events with a number needed to treat of five. This finding documents the benefits of this transformational technology.

The next steps with TAVR include how to reimburse for it, how to train physicians to perform it and how to integrate it into practice. For reimbursement, the Centers for Medicare & Medicaid Services (CMS) in September began a national coverage determination (NCD) analysis at the request of the American College of Cardiology (ACC) and the Society for Thoracic Surgeons (STS).  The ACC and STS believe that an NCD is necessary to ensure uniform coverage for Medicare patients who could benefit from TAVR. In addition, an NCD would ensure nationwide standards for facilities and physicians performing the procedure. In a nutshell, the goal is to identify reimbursement strategies so that payment is rendered for the appropriate patients at the appropriate times in the appropriate settings by appropriately trained physicians, surgeons and healthcare teams.

While a final NCD determination is expected no later than June 26, 2012, the ACC and STS will continue to work with the FDA, CMS and other stakeholders to answer the questions of how to train providers and how to integrate the technology into practice. Among the projects underway: a registry that will track real-world outcomes related to TAVR.  The registry, which is aimed at enrolling all patients undergoing TAVR, will link clinical and administrative/claims data for assessment of early and longer term outcomes. It also will form the basis of a new platform that could be used for FDA post-approval studies for the generations of new devices aimed at treating a variety of cardiovascular diseases.

Finally, the ACC and STS have developed a "Societal Overview" of TAVR that highlights the issues cardiology societies will face as the process of rational dispersion of this new technology moves forward. More specific documents on pre- and post-procedural issues, training and credentialing are being developed jointly by the ACC, STS and other cardiovascular and thoracic surgery societies. These documents will be released in the future. Ultimately, the lessons learned through the TAVR process will position us to help providers ensure appropriate care as more transformational technologies emerge.

Dr. Holmes is president of the American College of Cardiology.