June 27th, 2011

TAVI: Playing in the Sandbox Together


Kudos to the the American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) for getting ahead of the game by rolling out a joint position statement regarding transcatheter aortic valve implantation (TAVI) before the FDA panel convenes in July to consider approval of the procedure.  It’s a terrific first step to avoid some of the “tugs of war” that have characterized previous transformational technologies. 

Here’s what they’re recommending:

  1. Specialized regional heart centers (with expertise and high volumes of valve procedures)
  2. “Heart teams” (composed of primary cardiologists, cardiac surgeons, interventionalists, echocardiographers, imaging specialists, and heart failure specialists)
  3. Standardized protocols for training physicians on how to use this therapy appropriately
  4. Modified cath labs or hybrid operating rooms (large rooms capable of state-of-the art angiographic imaging and valve surgery).
  5. National registries for post-market practice treatment outcomes
  6. Studies to determine if patients who are younger and lower-risk than those in current randomized trials will benefit from the procedure

This consensus statement aligns the interests of various expert physicians (e.g., cardiologists, cardiac surgeons, interventionalists, heart failure physicians, and imaging specialists) and professional societies to deliver the best possible patient-centered care.

Has your center adopted a “Heart Team” approach to coronary revascularization or valve surgery?

One Response to “TAVI: Playing in the Sandbox Together”

  1. Balanced adjudication based on patient/lesion specificity with reference to the understanding of the natural history of aortic stenosis and the interruption of that natural history by TAVI will be assured by the structure, process, outcome paradigm delineated in this manuscript. What need be developed and refined is the tools to assure patient understanding of the choices, preferences, and expectations of care. Will PCORI(Patient Centered Outcomes Research Institute) be “on time ” for this? It is given brief mention in the Outcomes subsection.

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