Dave Fornell, Editor DAIC
The Eve of a Paradigm Shift in Cardiology?
While there are constant advances in cardiac technologies, it is rare when one of these new ideas may rapidly challenge the standard of care in a very short period of time. However, that is exactly what has happened with the introduction of transcatheter aortic valve replacement (TAVR). In a few short years since the U.S. Food and Drug Administration’s (FDA) market clearance of the Edwards Lifesciences’ Sapien valve in 2011 and Medtronic’s CoreValve in 2012, both these devices have shown vast improvements in survival for very sick, inoperable patients. Results were also outstanding for extreme-risk and high-risk surgical patients. The CoreValve has data showing it outperforms surgical repair in patient outcomes. This has made many experts wonder if there will soon be a paradigm shift in care, when the question switches from which patients qualify for TAVR, to which patients would actually benefit from open-heart surgical aortic valve replacement (SAVR) over TAVR.
That great question has been limited up until now for very sick patients, but both devices are about to start FDA investigational device exemption (IDE) studies in 2016 to see if low-risk surgical patients fare better with TAVR than SAVR. These two trials will undoubtedly be the next blockbuster, late-breaking studies that cardiologists will be waiting on the edge of their seats for. This is the cardiology equivalent of a Hollywood blockbuster movie where fans camp in front of the theaters for days waiting to be the first in line to see the premier.
The FDA approved expanded indication trials for low-risk surgical patients using the Sapien 3 device in January and CoreValve Evolut R in February. Patients with aortic stenosis, who are at a low surgical mortality risk as determined by a heart team, will be enrolled in these trials.
If these trials show TAVR outcomes are at least equal to SAVR, open-heart valve surgery will likely see a rapid demise in the coming years. However, the final nail in the coffin for SAVR will only come after long-term follow-up. That data is needed to show the durability of TAVR valves over many years.
Come by and say “hello” to me at future TCT and ACC meetings when those presentations occur. You will find me camped out the night before in front of the doors to the main arena so I have a front row seat at the premier.
For more details on the shift in care toward TAVR, watch my video interview with Michael Reardon, M.D., about TAVR having better outcomes than SAVR at http://bit.ly/1n6OvHe.
Watch the VIDEO “How to Build An Integrated Heart Team.” Brijeshwar Maini, M.D., and Brian Bethea, M.D., from Tenet Florida’s structural heart program, explain the importance of building a good heart team and how that team should interact.