Valve-in-Valve TAVR Outcomes Better in Failed TAVR vs SAVR

Debra L. Beck

January 13, 2021

Transcatheter valve-in-valve replacement of a transcatheter aortic valve, so-called TAV-in-TAV, appears to offer procedural success that is better than, and procedural safety and mortality that are similar to, transcatheter valve-in-valve replacement of a surgically implanted aortic valve prostheses, known as TAV-in-SAV.

In a propensity-matched cohort, procedural success was 72.7% for TAV-in-TAV and 62.4% for TAV-in-SAV (P = .045). This difference was driven by numerically lower rates of residual high valve gradient, ectopic valve deployment, coronary obstruction, and conversion to open-heart surgery in the all transcatheter group.

That said, early procedural safety did not differ between the two procedures (70.3% and 72.1%, respectively; P =.72), nor did 30-day mortality (3.0% and 4.4%) or 1-year mortality (11.9% and 10.2%; P-values nonsignificant for both).

"Valve-in-valve plays a key role in such patients as it saves opening their chests for TAVR valve extraction or reopening it for redo-SAVR, both not easy options," said Uri Landes, MD, Tel Aviv University, Israel.

With transcatheter aortic valve replacement (TAVR) now indicated as a treatment for aortic stenosis in low-risk patients who can be reasonably expected to live longer than the lifetime of their valves, the initial valve procedural choice, transcatheter or surgical, has become an important consideration.

"No bioprosthetic valve, whether surgical or transcatheter, is resistant to degeneration over time. Usually it takes many years, but as younger, healthier patients and their caregivers choose tissue bioprostheses rather than mechanical valves in order to avoid the potential risk and discomfort of lifelong anticoagulation, the life expectancy of some patients is likely to exceed that of their valves," he explained in an interview.

In a new study published in the January 5 issue of the Journal of the American College of Cardiology, Landes and colleagues report findings from the international Redo-TAVR Registry.

The investigators collected data on 434 TAV-in-TAV cases and 624 TAV-in-SAV cases performed at 37 participating centers between April 2005 and April 2019. Of note, 223 of the TAV-in-TAV cases were done as urgent "bailout" procedures at the time of native valve TAVR and were excluded.

Propensity score matching yielded 330 (165:165) matched patients. However, propensity matching did not account for the difference in time between the first and second procedure, as doing so would exclude too many patients.

In the TAV-in-TAV group, the median time between the index and the redo procedure was 3 years, which contrasted poorly, noted Landes, with the median 9 years between index SAVR and TAV-in-SAV cases.

This difference, said Landes in an interview, is "potentially misleading" and requires explanation.

"I was troubled to publish these data given the potential confusion it can create, but we must understand that in the Registry, redo-TAVR for probable device failure constituted only 0.22% of the overall 63,876 TAVR procedures. This low rate reflects the relative durability of the valves and also the competing risk of mortality in the elderly and high-risk patients undergoing TAVR so far," said Landes, who was a fellow at St. Paul's and Vancouver General Hospital in British Columbia, Canada, at the time this research was done.

"Certainly, I think we must have more data and monitoring before performing TAVR in patients at their 60s, but in the meantime, the 5 to 8 years' good follow-up we already have is very reassuring," he added.

Valve hemodynamics appeared to favor the all TAVR approach: aortic valve area was larger (1.55 vs 1.37 cm2; P = .040), and mean residual gradient was lower (12.6 vs 14.9 mm Hg; = .011) after TAV-in-TAV.

Notably, although the rates of moderate or greater residual aortic regurgitation were similar, mild aortic regurgitation was more frequent after TAV-in-TAV (= .003).

Pros and Cons

In an editorial, Anthony A. Bavry, MD, MPH, and Dharam Kumbhani, MD, SM, both from UT Southwestern Medical Center in Dallas, called the study an important analysis from which several points can be gleaned.

"When we're sitting down with a patient, it's important information to have to explain the pros and cons of the two procedures, in terms of how we might treat that failed valve 15 or 20 years down the road," said Bavry in an interview.

Overall, he and Kumbhani write, the main message of the study is that valve-in-valve TAVR is a "feasible and associated with favorable outcomes" for patients with dysfunctional transcatheter or surgical valves.

"But we need to keep a close eye on his topic and continually reappraise the data to make sure that a TAVR valve implanted inside a TAVR or a SAVR valve is a safe way to go. Right now, it appears like it is from this study, but we need 10 years and 20 years or data to really answer that question," said Bavry.

Landes, Bavry, and Kumbhani reported no relevant conflict of interest. Several of the coauthors of the study report receiving consultant fees and/or research grants from several valve manufacturers.

J Am Coll Cardiol. 2021;77:1-14, 15-17. Full text, Editorial


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