Global TAVR Market Poised to Exceed DES Market by 2025
By 2025, the global market for TAVR is expected to have increased substantially, possibly exceeding that of DES, said TCT Course Director Martin B. Leon, MD, of NewYork-Presbyterian Hospital/Columbia University Medical Center in New York, N.Y., during a didactic symposium at TCT 2015.
Multiple speakers explained that keys to reaching that potential include continuing to employ multidisciplinary heart teams to manage patients with aortic stenosis and successfully addressing challenges such as paravalvular leak, pacemaker implantation, perioperative and postoperative stroke and subclinical leaflet thrombosis.
Leon said that the number of TAVR procedures worldwide is estimated to grow from 71,000 in 2015 to 289,000 in 2025. “I believe TAVR is a breakthrough technology,” he said. “I think no one would argue that there has been dramatic global growth and universal acceptance with seemingly unlimited potential.”
According to Leon, the growth has come from five primary factors: management by a multidisciplinary heart team, commitment to evidence-based medicine, rapid technology enhancement, a “striking” reduction in complications in recent years and the simplification of the procedure.
“It’s astounding how quickly this technology has grown,” he said. “It’s equally astounding to see how some of the disturbing complications we confronted in the early days have been reduced over time. In high-risk and inoperable patients, [there has been] a dramatic reduction in 30-day mortality over the course of less than a decade, a dramatic reduction in stroke rates … and almost an elimination of paravalvular regurgitation, a significant clinical problem, with the newest versions of this technology.”
For example, the overall 30-day stroke rate in the PARTNER I and II trials declined from 5.6% with the first-generation balloon-expandable TAVR device (Sapien, Edwards Lifesciences) to 1.5% in high-risk patients and 2.6% in intermediate-risk patients with the third-generation device (Sapien 3, Edwards Lifesciences). In addition, the overall 30-day rate of moderate to severe paravalvular leak dropped 11.5% with the Sapien device to 2.9% in high-risk patients and 4.2% in intermediate-risk patients with the Sapien 3 device.
The next steps, he said, include determining whether TAVR is appropriate for patients at low surgical risk, what further technological enhancements are necessary and what knowledge gaps need to be addressed.
Success obvious and sustained
Michael J. Mack, MD, of Baylor, Scott & White Health, in Dallas, Texas, said that as a cardiac surgeon, he never could have conceived of a concept such as TAVR, but when he first observed it in animal studies in 2001, he knew it would be a success.
The reason, he said, is that it incorporated three factors crucial to the future of medicine: image-guided instead of directly visualized procedures, reconstruction without suturing and access via natural orifice or blood vessel instead of incision.
Success has been sustained, he added, because the technology is user-friendly, is easy to teach to new operators and its value has been repeatedly demonstrated through rigorous clinical study.
TAVR was estimated to account for 20% of aortic valve replacement procedures in 2014. That percentage will rise as its efficacy is proven in intermediate- and low-risk populations, he predicted, noting that it could eventually achieve penetration similar to endovascular aortic aneurysm repair, which now accounts for almost 80% of aortic aneurysm repairs.
Before that shift occurs, several issues need to be resolved, Mack said. These include the risk for stroke and paravalvular leak, which have declined with new iterations of the devices; new pacemaker implantation in conjunction with the procedure; durability; and leaflet immobility and thrombosis.
“The future is that we’re going to hear about intermediate-risk trials soon,” he said. “The next trial design … will be all-comer, low risk. I think it’s important that the heart team stays together. The train has already left the station, and it ain’t coming back.”
Research has been, will be crucial
Eberhard Grube, MD, of Medical School Bonn and University Hospital Bonn, in Bonn, Germany, noted that TAVR challenged the conventional wisdom that aortic stenosis could not be treated via a percutaneous strategy.
Crucial to its status today was establishment of registries in the early stages of development and the excellent design of randomized controlled trials for Sapien and CoreValve (Medtronic), he said.
In the future, continued success will depend on extensive discussion of how to overcome complications and designing new generations of valves that achieve these milestones, according to Grube. “We don’t know at this time what [valve] thrombosis and reduced leaflet motion means,” he said. “We do have to study it.”
However, he said, “I do believe that given the facts that we have today, given the results that we have up to today, that the TAVR implant technology will be the standard of care in the very near future, hopefully replacing surgery in the context of most patients with aortic stenosis, independent of the risks involved.”
Indications may expand
Robert O. Bonow, MD, of Northwestern University, in Chicago, Ill. said that noninvasive cardiologists and their patients have come to appreciate the value of TAVR and referrals for it are increasing rapidly.
“TAVR provides treatment options for patients who previously had no options other than a predictably very poor short-term outcome,” he said. “All patients want this.”
He added that the increased availability of TAVR as a result of extensive clinical research is likely to inform new indications for the technology, including symptomatic patients with primary cardiomyopathy and moderate aortic stenosis, those with asymptomatic severe stenosis and possibly even patients with asymptomatic moderate stenosis.
For these milestones to be accomplished, the heart team will need to remain at the forefront of clinical decisions, U.S. and European guidelines will need to remain concordant and appropriate use criteria and performance measures will be needed to define quality, he said.
- Bonow reports no relevant conflicts of interest.
- Grube and Leon report relationships with multiple device companies.
- Mack reports serving on the executive committee of the PARTNER trial, sponsored by Edwards Lifesciences, but receiving only travel expense compensation.