BCIS Autumn Meeting, Crewe, September 2008 Transcatheter Aortic Valve Intervention: How do we take it forward in the UK? Mark de Belder President, British Cardiovascular Intervention Society TAVI is simply the latest new technology in a long line of new technologies The real question is: How do we introduce new technologies and take them forward in the UK? with specific comments related to TAVI Introduction of new technologies Clinicians Identify the problem to be solved Scientists Identify the pathophysiological mechanisms at play and potential means of solving the problem Industry Seeks investment to develop and implement solutions Government Regulates quality of product, safety issues and assesses clinical and cost-effectiveness National Societies Encourage and possibly organise appropriate training in procedures Develop a view on how the treatment should be delivered on a national scale (Guidelines) Assist regulation by collecting audit data with appropriate feedback loops Testing of new technologies Pre-clinical:Animal studies Phase I:Initial human experience - Isolated groups working closely with industrial partners; may need to work on redesigns Phase II:Experience in selected units - Can the technique be taught to a larger group? - Initial registries and randomised trials Phase III:Wider take-up - Larger trials demonstrating worth - Followed by widespread uptake Phase IV:Fine-tuning - Are there subsets of patients not previously considered for treatment who could be? Trials should not be done too early (during the learning curve) but they should be done Principles of cost-effectiveness Less effective More expensive Not appropriate More effective More expensive Use depends on magnitude of differences Less effective Less expensive Use depends on magnitude and clinical significance of differences More effective Less expensive Should take over from conventional therapy What are you comparing with what? Vs Surgery? Vs Conservative medical therapy? New technologies: Some make it, some dont! Directional atherectomy Brachytherapy PICVA? LAA occlusion devices? PFO occlusion for migraine? TAVI: Potential candidates Patients in whom surgery is deemed too risky (Euroscore >20? >10?) Risk of surgery outweighs benefits or is not accepted Prognosis on continuing conservative treatment is poor What is the actual risk in these patients of a percutaneous treatment? Will the treatment prove efficacious (benefits outweigh risks)? Patients in whom the risk of surgery is in the uncomfortable range (Euroscore 5-10) Patients at low risk with surgical AVR (Euroscore