At the ACC meetings yesterday, several “late-breaking clinical trial” presentations provided substantial reasons to be enthusiastic about transcutaneous aortic valve replacement (TAVR) in comparison to standard surgical AV replacement (SAVR).
Five Year Results of First Generation TAVR Show Durability
Michael Mack, from Baylor, presented the 5 year follow-up of the ground breaking PARTNER trial results and they were simultaneously published here.
This study randomized high risk surgical patients with severe aortic stenosis to treatment with a balloon-expandable bovine pericardial tissue valve employed by either a transfemoral (2/3) or transapical approach or a standard surgical aortic valve replacement.
There was no difference in death rate at 5 years between TAVR (68%) and SAVR (62%) in this trial of Edwards Lifescience’s first generation Sapien device.
Interestingly, follow up with echocardiography showed durability of both surgical and catheter-implanted aortic valves with the mean gradient staying at 11 mm Hg and aortic valve areas at around 1.5 cm2.
Two Year Mortality/Stroke Rates Show Superiority of Corevalve TAVR over SAVR
The very next presentation at this session came from another surgeon from Texas named Mike, the cocky and folksy Mike Reardon, on the two year results of a competing technology in the TAVR field.
The Corevalve TAVR device made by Medtronic is self-expandable as opposed to the balloon-expanded Sapien device and Dr. Reardon declared the results with this device so good that they were “unique and provocative”. Slides of presentation available here.
Indeed, the Corevalve TAVR two year follow up results showed a significantly lower mortality rate for TAVR (22%) versus SAVR (29%) and a LOWER stroke rate for TAVR (11%) versus (17%).
There was no difference in major stroke between the approaches.
TAVR had a lower mortality plus major stroke rate (24%) versus SAVR (32.5%).
These were dramatic results, indicating for the first time that TAVR may be a superior approach for aortic stenosis in patients who are high AND intermediate in their risk for surgery.
In the discussion that followed, Dr. Reardon asserted that TAVR using the Corevalve approach should be considered the preferred approach to high and intermediate surgical risk patients with severe aortic stenosis.
Will TAVR Become The Procedure of Choice for Severe Aortic Stenosis?
These studies suggest to me for the first time that TAVR may ultimately replace SAVR for all patients with severe aortic stenosis, low to high in their risk for surgery.
Clearly, we need ongoing follow up of these patients and more long term data, but as these devices improve and the operators gain more experience it is likely that results will only get better.
This represents a huge paradigm shift in our approach to valvular heart disease.