iCVCT 8: TAVR Trials. Remaining Questions, Challenges, Controversies in Approval Pathways
Monday December 7th: 6:30 – 8:00 pm
The advent of transcatheter aortic valve replacement (TAVR) constitutes a paradigm shift in the care of patients with severe symptomatic aortic stenosis. Data from large-scale randomized clinical trials have compared TAVR with conservative treatment and with surgical aortic valve replacement (SAVR). The aggregate evidence suggests that clinical outcomes with TAVR (using transfemoral access) are comparable or superior to SAVR. Outcomes are consistent across the entire risk spectrum suggesting that surgical risk estimation is no longer the basis to guide the choice between TAVR and SAVR. However, important evidence gaps remain, but questions need to be answered before new trials are initiated.
This session will be chaired by Dr. Michael Mack and Prof. Stephan Windecker, two of the most renowned interventional cardiologists in the world. Dr. Mack is from the Baylor Scott & White Heart Hospital – Plano Research Center, in Plano, USA. He is a pioneer in the field of cardiothoracic surgery. Prof. Windecker is from the Swiss Cardiovascular Center in Bern, Switzerland, and is the current President-Elect of the European Association of Percutaneous Coronary Interventions (EAPCI).
Recent trials among low-risk populations have had some short comings. They did not systematically study younger patients with severe symptomatic aortic stenosis (<70 years of age), follow-up was limited to 2 years, and exclusion criteria prevented enrollment of patients with more complex anatomic valvular conditions (particularly patients with bicuspid aortic valve morphology). Follow-up studies of bioprosthetic valve failure are inadequate to assess the true durability of these devices. While trials suggest favourable outcomes for up to 6 years, long-term data at 10 to 15 years are still needed. Devices to mitigate the risk of cerebrovascular accidents during the intervention require careful investigation in terms of patient population and device type. Recent trials provide new insights into adjunctive pharmacotherapy post-TAVR for patients with or without atrial fibrillation and shed light on the issue of subclinical valve thrombosis. Finally, valve-versus-valve studies will increasingly become important to identify differences in outcomes such as valve-in-valve procedures, coronary access, repeat TAVR, and pacemaker implantation.
Joining our co-chairs are: Vinod Thourani (Atlanta, USA), Patrick O’Gara (Boston, USA), Roxana Mehran (New York, USA), and Howard Herrmann (Philadelphia, USA). Nina Goodheart from Medtronic, USA will provide industry viewpoints, and Jennifer Bastijanic from the US FDA will discuss regulatory considerations for new valves and adjunctive devices. Finally, the moderated multi-stakeholder debate promises to live up to the session title and generate a lot of controversy.