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News & Trends - Medical Technology

Medtronic adds to clinical case for using TAVR over surgery

Health Industry Hub | November 10, 2021 |
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MedTech News: Medtronic unveiled five-year clinical data from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial, which was presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation.

TAVI with a self-expanding valve provided clinical outcomes similar to those seen with surgery in an intermediate-risk population.

“Long-term outcome data from the SURTAVI randomised trial comparing early-generation TAVR to open-heart surgery are similar and encouraging for TAVR for younger, healthier patients with aortic stenosis,” said Dr Nicolas Van Mieghem, Thoraxcenter, Erasmus University Medical Centre, Rotterdam, Netherlands.

The rate of all-cause mortality or disabling stroke was no different between the TAVI and SAVR arms at 5 years. Hemodynamics remained superior with TAVI through 5 years, whereas surgery continued to hold the advantage in terms of paravalvular leak (PVL). Though rates of reintervention and permanent pacemaker implantation were higher in the TAVI arm, there were no differences in these outcomes between 2 and 5 years.

During a panel discussion following Van Mieghem’s presentation, Dr Patrick O’Gara, Brigham and Women’s Hospital, Boston, was circumspect when looking at the findings, which he called “reassuring with respect to durability among patients whose average age is 80 who receive this particular device.”

But he raised a concern about “indication creep,” stating that physicians need to be cautious in translating the outcomes to younger patients at lower risk. “It’s not really fair for us to say 60-year-old patients will fare equally well or that the tradeoff between a pacemaker implant and the need for a repeat procedure is perceived the same in folks who are 15 years younger.”

For 80-year-olds weighing the choice between TAVI and SAVR, “they’d be more than happy to put up with a pacemaker compared against a median sternotomy. I think that’s the tradeoff our patients have already made,” O’Gara said. “But let’s be careful about how we define younger patients and lower risk.”

Commenting on the results during a panel discussion, surgeon Dr Keith Allen, Saint Luke’s Mid America Heart Institute, Kansas City, said that through 5 years, SURTAVI “continues to show that if you’re not going to get a mechanical valve, TAVR is . . . a really great option, and I think it should be first in the armamentarium.”

The results are “very reassuring” for TAVI, Van Mieghem said, noting that “the added value of this less-invasive therapy is the faster recovery of these patients.” The choice between surgery and TAVI will always be made using a shared decision-making process, he said, but in the elderly population, “I think it will be quite reasonable to say that most patients would feel – and should feel – comfortable when they opt for a TAVR procedure for symptomatic severe aortic stenosis.”

When discussing TAVI in patients who are younger, lower-risk, or both, experts highlighted the need to consider how treatment choices will affect decisions several years or even decades down the road. Durability is a key consideration, Allen indicated. “How do you manage these patients when they’re 55, 58, 60? Because transcatheter valves will fail in those patients, just like surgical tissue valves fail. There’s no hint that TAVR valves are going to last longer.”


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