Transcatheter Valve Replacement for Aortic Stenosis - Balancing Benefits, Risks, and Expectations

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Transcatheter Valve Replacement for Aortic Stenosis - Balancing Benefits, Risks, and Expectations


Chintan S. Desai, M.D., and Robert O. Bonow, M.D., of the Northwestern University Feinberg School of Medicine, Chicago, write that “transcatheter aortic valve replacement (TAVR) represents a transformative technology with potential for the management of complex patients with aortic stenosis, including those who are not considered candidates for surgical aortic valve replacement because of age and medical comorbidities. Currently, more than 50,000 TAVR procedures have been performed worldwide, with mounting enthusiasm for the ‘rational dispersion’ of transcatheter therapies.”

The authors note that “the increasing consumer expectations that this therapy might become available soon for even young, low-risk patients requiring valve replacement must be balanced against safety concerns that have arisen in both clinical trials and registries.”


(JAMA. 2012;308[6]:573-574.


The Importance of Potential Studies That Have Not Existed and Registration of Observational Data Sets


John P. A. Ioannidis, M.D., D.Sc., of the Stanford University School of Medicine, Stanford, Calif., examines the issue of potential studies that do not exist, studies that could readily have been conducted. “Is it possible to know the unknowable? It is important to consider why studies have not been conducted and what could be done about them. Related to this phenomenon is the continuing problem of unregistered, exploratory observational studies often derived from large data sets.”

“When the number of potential studies that have not existed is large, then the published literature is mostly a reflection of what is considered plausible and reasonable by experts in the field. Thousands of scientists could have data-peeked; their decision to generate and publish a full study with specific results is molded by their expectations and the expectations of peers. Although researchers often come across unexpected, implausible findings, data shaped into publishable studies are mostly those that seem orthodox to peers— plus some extravagant studies in which investigators venture bold claims. When only 1 percent of the potential studies see the light of day, this 1 percent is often a conformity sample, not a random one.”

(JAMA. 2012;308[6]:575-576.


Payment Reform for Primary Care Within the Accountable Care Organization - A Critical Issue for Health System Reform


Allan H. Goroll, M.D., of Harvard Medical School and Massachusetts General Hospital, Boston, and Stephen C. Schoenbaum, M.D., M.P.H., of the Josiah Macy Jr. Foundation, New York, write that “primary care, the foundation of the accountable care organizations (ACOs), requires payment reform to enable and make durable its transformation into a high-performance model such as the patient-centered medical home.”

The authors examine the major barriers to primary care payment reform and the measures needed to address these impediments.

“Payment reforms must overcome the suspicions and distrust of change that have built up over the last 2 decades within much of the physician community. There must be, and physicians must have confidence in, a commitment by new organizations such as ACOs to provide practices with the supports necessary for them to do their jobs well and to pay commensurately with the value they create. Such payment reform can provide the basis for a new social contract between the profession and society and help achieve the goal needed by the nation of better health care at lower cost.”

(JAMA. 2012;308[6]:577-578.