Transcript Below :
Question 1 : What are the origins of TAVR and why was it needed in the first place?
TAVR really began out of need because we had an ageing population of patients who had severe aortic stenosis and were not candidates for surgery and we had no other therapy, so we used a lot of the work that had been done with stents, a lot of the work that was done with ballon valvuloplasty. Combine the two and created a new therapy that could address this urgent need in these elderly, frail and difficult patients who had no other treatment alternatives.
Question 2 : Can you remember your first TAVR case? Can you describe how this was performed compared to modern TAVR?
Our first TAVR was in June of 2005. It was really a primitive procedure using what we called an antegrade approach, extremely difficult, with high-profile devices, only a single-valve size. We didn't have CT imaging to correctly understand the anatomy. The outcome was reasonable but nothing close to what we currently achieve. So, it truly was a primitive procedure with very early-stage and rudimentary devices that have evolved extraordinarily over the past 10 or 15 years.
Question 3 : What are the most important innovations in TAVR that have made it evolve from a niche therapy to standard-of-care?
We first felt the TAVR was truly going to be a therapy only as a niche for the sickest, highest risk patients. Then we began to understand that with improved technology, a simplified procedure, an extraordinary emphasis on the heart team, which is a multi-disciplinary effort to correctly make decisions in these patients and an avalanche of clinical trial data then suddenly we had a therapy that was only not good as a niche for the highest risk patients, but had performed extremely well, in fact as good as or even better than surgery in intermediate and even low-risk patients.
Question 4 : What were the most important trials to provide validation data?
Well there had been now 24 randomised trials that had been completed or ongoing in the field of TAVR. Many of which compare the new therapy versus surgery or to standard-of-care or to other devices and I think this series of randomised trials really has defined the field. I would point out that the partner trials which began in 2007 and are still ongoing have already published seven manuscripts in the "New England Journal of Medicine" and the self-expanding version of TAVR which is the Evolut have also contributed very importantly with multiple randomised trials showing very similar outcomes.
Question 5 : Should TAVR be the default treatment for patients with symptomatic aortic stenosis over surgery now?
I believe in the early days, we suggested that TAVR would be a good therapy in those patients who could not have surgery. Now we've completely turned that on it's head and we believe that if a patient has the correct clinical indications and has good anatomy where we can expect a good TAVR result that, that should be the first therapy or what you would call the default therapy versus surgery.