Early TAVI Valve Deterioration More Likely in Younger Patients, Smaller Annuli

Hemodynamic valve deterioration (HVD) occurs in at least 6% of patients 1 year after undergoing TAVI and is more frequent in those who receive smaller valve sizes as well as valve-in-valve procedures, according to 10 years of retrospective data from a single institution.

In all, 131 of 2,123 patients exhibited signs of stage 2 moderate HVD as defined by Valve Academic Research Consortium 3 (VARC 3) criteria. Compared with those without HVD, these patients were significantly younger and more likely to have smaller aortic annuli (23 vs 24 mm; P < 0.01). Notably, the researchers found no difference in HVD rates in patients with bicuspid versus tricuspid valves.

“Most folks talk about valve durability after TAVI as a long-term issue, but if you’re already seeing hemodynamic valve deterioration as early as 1 year in more than 6% of patients, that’s a signal we need to pay attention to, particularly as we expand this into younger and lower-risk patients who may live with these valves for decades,” senior author Ibrahim Sultan, MD (University of Pittsburgh, PA), told TCTMD.

“The message from our perspective is not all patients are the same,” he continued. “The annular anatomy, sinus segment anatomy, valve anatomy, valve size, and prior open surgical valve or prior transcatheter heart valve—these all matter. And TAVI is an excellent solution for majority of the patients above the age of, let’s say 75, but . . . I think this challenges the conventional thinking.”

Commenting on the findings for TCTMD, Danny Dvir, MD (Shaare Zedek Medical Center, Jerusalem, Israel), said that “while few reversible risk factors for valve dysfunction have been identified, the finding that larger valve implants are associated with less dysfunction suggests that implanting larger valves—when feasible in borderline cases—may be beneficial during TAVR procedures.”

There was a decline in HVD rates observed over the study period, from about 10% in the early years of TAVI in 2012-2014 to 4% to 7% in 2015-2022. “Although the reasons are not entirely clear, this improvement may reflect advances in valve technology and growing operator experience,” said Dvir.

The study, which was led by Eishan Ashwat, MD (University of Pittsburgh), was published online last month in the Annals of Thoracic Surgery.

HVD Differences

The analysis included a little less than half of all patients who underwent TAVI in a single health system between 2012 and 2022 with complete 1-year echocardiographic follow-up. Those with evidence of HVD were younger on average (81 vs 82 years; P = 0.05), and they more often had a prior AVR (17.6% vs 8.3%; P < 0.01) and prior stroke or TIA (19.1% vs 11.9%; P = 0.02).

Also, those with early HVD received a wider range of valve sizes compared to those without HVD, but there was no significant difference in HVD prevalence between self-expanding and balloon-expandable valves. Moderate paravalvular leak rates, though, were higher in patients with early HVD compared with non-HVD patients (16.8% vs 0.2%; P < 0.01).

On echocardiography, patients with early HVD had higher aortic valve mean gradients at both 1 month and 1 year compared to those without HVD (P < 0.05 for both). Rates of both moderate and severe aortic regurgitation also were higher in patients with HVD at these time points, as was the frequency of clinically significant paravalvular leak (P < 0.01 for all).

Multivariate analysis identified larger implanted valve size as associated with decreased odds of early HVD (HR 0.88 for each additional mm in diameter; 95% CI 0.80-0.97) and prior AVR (either SAVR or TAVI) as linked to an increased risk (HR 2.15; 95% CI 1.26-3.66).

Over a median follow-up of 3.6 years, there was a trend toward an increased mortality risk in the HVD patients compared with non-HVD patients (HR 1.18; 95% CI 0.90-1.54), and there were no differences observed between the cohorts in 1- and 5-year rates of heart failure readmission. However, reintervention procedures were more common in those with evidence of HVD (2.3% vs 0.6%; P = 0.02).

‘Durability Matters’

Sultan stressed the importance of being “thoughtful” when planning TAVI procedures in patients with small aortic annuli, which was recently confirmed in the SMART trial. Valve-in-valve patients also deserve this kind of additional discussion and planning, he added.

For all patients, Sultan continued, “we need to be really careful” about lifetime management and planning for secondary valve procedures, adding that life expectancy should be the true guidepost for planning treatments.

“Now, our goal is to think about the way we’re going refine patient selection,” he said. “The way we’re going to help provide these data is just strengthen our surveillance; that is the only way we can then match therapy with the patient to give them the best available long-term outcome. . . .  At the end of the day, our goal as docs and operators is not just to get the patients through the procedures. It’s to get them a valve that’s going to last, and this again is another reminder that durability matters.”