Author + information
- Vasilis Babaliaros, MD, FACC, Associate Editor, JACC: Cardiovascular Interventions∗ ()
- ↵∗Address correspondence to:
Dr. Vasilis Babaliaros, Structural Heart and Valve Center, Emory University Hospitals, 1364 Clifton Road, Suite F606, Atlanta, Georgia 30322.
“Our wretched species is so made that those who walk on the well-trodden path always throw stones at those showing a new road.”
“If at first the idea is not absurd, then there will be no hope for it.”
—Albert Einstein (2)
It was the spring of 2005 in Rouen, France. We carefully looked over the data to try to assemble a cohesive, midterm results paper on the first 36 patients who underwent a transcatheter aortic valve replacement (TAVR). Ten years ago it was not called TAVR and the procedure itself did not even have an acronym, only a device: the percutaneous heart valve. The patients were implanted using 2 different approaches, and the delivery system was makeshift, constructed out of available wires, balloons, and sheaths. This was the world’s first experience with the new procedure, and the results were representative of early technology, with 59% mortality at 6 months (3).
In 2005 TAVR was nothing if not polarizing. It was not uncommon to overhear members of the cardiaque soins intensifs (cardiac care unit) staff discussing their concerns about patient outcomes in the hallways. There were serious doubts in the cardiac surgery world about patient safety and whether catheter-based valve replacement was even in the realm of possibility. Still, there were the dreamers, those of us who were encouraged by a procedure and a device that could dramatically alter the scope and usefulness of cardiac intervention. More importantly, patients and their families believed enough in the promise of this new therapy to take a risk.
Ten years later as I write this editorial, the procedure now has 2 acronyms (TAVR/TAVI [transcatheter aortic valve implantation] and all of the debates that ensue of replacement vs. implantation), prospective randomized multicenter trials have been performed with 2 different TAVR devices, there are 7 different approaches for implantation and more than 7 different TAVR manufacturers, and JACC: Cardiovascular Interventions has a focus issue on TAVR with 9 original research papers. We have come a long way in the last decade.
In JACC: Cardiovascular Interventions this month, multiple registries report long-term data that is a major improvement from the initial midterm results reported in JACC. The Source XT registry reports 1-year mortality that is better than the 30-day data from 10 years ago (3). The 5-year mortality from the UK TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry is 55%, besting 6-month mortality reported with early experience (3). The hemodynamics of TAVR are superior to the latest surgical sutureless valves, and complication management with stroke prevention devices and paravalvular leak plugging have improved the safety of the procedure even further. There is a greater understanding of the effect of these devices on patients as reports of valve thrombosis, recovery of von Willebrand multimers, and ventricular improvement in patients with low flow, low gradient aortic stenosis with TAVR and coronary revascularization emerge. In addition, advanced imaging with cardiac computed tomography has illuminated the interaction of the aortic annulus with the newest TAVR technology and possibly predicted long-term valve performance. All of these reports are within 1 snapshot of JACC: Cardiovascular Interventions this month.
So what is absurd about the idea of TAVR today? Perhaps it is the fact that we still do not have any prospective data on patients with intermediate surgical risk and TAVR, although risk creep has been occurring in Europe over the last 4 years. Perhaps it is also that a low-risk trial comparing TAVR and surgical aortic valve replacement has not already begun. Perhaps it is that the only thing innovative in TAVR today is a caval-aortic approach or the combination of TAVR with other established procedures. It seems that the innovative luster of TAVR has worn and has not yet been replaced with another groundbreaking procedure.
It is with relief, excitement, and some sadness that I have watched TAVR develop and expand into the mainstream over the past decade. To the skeptics, we say thank you. The adversity created by this group has certainly fueled solutions to the problems encountered with TAVR. As part of that initial group of dreamers, I wait with anticipation for the rise of another wave of transcatheter therapy that will invigorate us for the next decade.
- American College of Cardiology Foundation
- Cribier A.,
- Eltchaninoff H.,
- Tron C.,
- et al.