TAVR Stays Its Course as 10-Year Durability Data Trickle In

PARIS -- Extended follow-up data were reassuring for transcatheter aortic valve replacement (TAVR, or TAVI) durability beyond 10 years, investigators found.

In the U.K. TAVI registry, there was a 5.9% incidence of severe structural valve degeneration (SVD) flagged at a median 7.8 years (range 5.1 to 12.7 years) after the procedure, according to Noman Ali, BMBS, PhD, a structural intervention fellow at St. Michael's Hospital in Toronto.

Three cases were attributed to aortic regurgitation and 10 to aortic stenosis. Ultimately, five of the 13 affected patients had a valve-related re-intervention or died, Ali told the audience at this year's EuroPCR conference.

The 221 TAVR patients included in the study had a median 7 years of follow-up, and 43 of them even had data beyond 10 years -- meaning that this analysis included more patients with ≥10-year transthoracic echocardiographic follow-up than any other report to date.

This 10-year group had hemodynamic function and aortic regurgitation grades stay stable over this long follow-up.

These are "encouraging" data, Ali said, given TAVR's expansion to younger, lower-risk patients with longer life expectancies, who are more prone to TAVR degeneration.

Cardiac surgeon Michael Reardon, MD, of Houston Methodist, agreed that the data regarding TAVR durability "remain encouraging." In an interview, he cited his group's recent report that CoreValve devices performed well against surgery in terms of 5-year SVD in the CoreValve U.S. Pivotal and SURTAVI trials.

Even so, it would really take 10-year data from the large low-risk randomized trials -- namely PARTNER 3 and Evolut Low Risk -- to inform decision-making for young patients with aortic stenosis.

Notably, those newer trials used TAVR devices that were different than the ones offered to people back in 2007-2011, the study period of the present U.K. analysis.

A lot of the device innovations since then have not been leaflet-related, said session panelist Jonathan Schwartz, MD, an interventional cardiologist at Sanger Heart & Vascular Institute in Charlotte, North Carolina. As such, he asked if newer-generation products should be expected to offer better durability.

Reardon's opinion is yes, he told MedPage Today. He cited a report showing that the second-generation Sapien XT showed more SVD than surgery at 5 years, whereas the newer Sapien 3 had the same amount. However, the caveat of this paper was that people had been randomized to Sapien XT or surgery, whereas the Sapien 3 had not been randomized.

"We have to look at TAVR randomized against surgery," said Reardon, who was not involved with Ali's study.

Ali and colleagues had analyzed people who had received TAVR at one of 11 centers and had sufficient echocardiographic data recorded in the U.K. registry. Mean age was 79.4 years for the overall cohort, and 53% were men.

About two-thirds received a self-expanding CoreValve, and nearly one-third a balloon-expandable Sapien prosthetic. Between the two devices, Sapien was associated with more severe SVD over follow-up (11.9% vs 3.5%, P=0.02).

This disadvantage of balloon-expandable TAVR valves is in line with previous reports, commented interventional cardiologist Danny Dvir, MD, of Shaare Zedek Hospital Center in Jerusalem.

But that doesn't mean CoreValve for all young people -- whereas these self-expanding devices may degenerate more slowly, it may still be a good idea to use Sapien as a first valve for people who may subsequently require valve-in-valve procedures. The challenge is to balance these two conflicting factors, Ali said.

His group defined severe SVD as large increases in mean gradient and peak velocity from baseline, and severe or worsening intraprosthetic aortic regurgitation.

TAVR was performed with transfemoral access in 79% of registry cases. After the procedure, 6.6% had been left with moderate or worse aortic regurgitation right after TAVR.

Reardon said both the nonrandomized nature of the study as well as the median 7 years of follow-up make it hard to comment on the true long-term durability of TAVR. A comparison with surgery is not possible either, he said, given the different SVD definition preferred by surgeons.

In addition, collecting data from only a certain group out of the whole TAVR cohort may have introduced some selection bias in this analysis, Dvir warned.

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