Six Years of UK TAVI Registry Provide Insight Into Long-term Outcomes

An analysis of every TAVR case in the United Kingdom over a recent 6-year period shows a trend toward the treatment of more patients with lower LVEF in later years than before and consistent association between particular patient characteristics—rather than valve-related issues—and poorer outcomes. The report was published online January 30, 2015, ahead of print in Circulation.

Researchers led by Peter F. Ludman, MA, MD, of Queen Elizabeth Hospital (Birmingham, England), examined trends in and predictors of outcomes for 3,980 TAVR procedures performed at 33 centers in the United Kingdom from 2007 through 2012.

The patients, who account for all TAVR cases performed in the country and enrolled in the UK TAVI registry, mainly received either Sapien/Sapien XT (n = 2,036; Edwards Lifesciences) or CoreValve (n = 1,897; Medtronic) devices, with a progressive increase seen in the percentage given the Sapien device over time. A minority of patients received a Portico (n = 35; St. Jude), Direct Flow device (n = 3; Direct Flow Medical), or JenaValve (n = 3; JenaValve).

The majority of cases (71.2%) were performed using femoral access. Between the start of the study and 2012, there was an increase in patients with impaired LV function at baseline (from 5.9% to 10.2%) but no change in mean logistic EuroSCORE. However, there were fewer patients with previous stroke and peripheral vascular disease undergoing the procedure.

Survival Improves Over Time

Median postprocedural length of stay decreased from 10 to 8 days over the study period. Additionally, while the percentage of patients discharged on the third day remained stable throughout the study period (mean 5.6%), the number who could be discharged by the fifth day nearly doubled (from 16.7% to 28.5%).

Thirty-day mortality was similar for the first 50 and subsequent cases at every center (6.5% vs 6.2%; P = .70). As expected, survival fell with increasing time from TAVR (from 81.7% at 1 year to 37.3% at 6 years). There was an observed trend toward higher survival in the more recent cohorts. For example, 4-year survival was 55% for those treated in 2009 and 65% for those treated in 2011. Additionally, survival at 1, 2, and 3 years was higher for patients treated in 2012 than for those treated in all previous years.

Procedural complications also showed temporal decreases, with stroke dropping from 3.6% to 2.4% (P = .022) and major vascular injury falling from 5.2% to 2.6% (P < .0001).

On multivariate analysis, logistic EuroSCORE ≥ 40 was the only independent predictor of 30-day mortality. However, predictors of 1-year mortality were:

• Preprocedural A-fib
• Chronic obstructive pulmonary disease
• Creatinine > 200 μmol/L
• Diabetes

Predictors of 2-year mortality were the same with the exception of diabetes and the addition of CAD.

Periprocedural stroke tripled the likelihood of long-term mortality (P < .0001). In addition, nonfemoral access and postprocedural aortic regurgitation also were predictors of adverse outcomes.

Multivariate analysis showed no difference in survival at any time point between Sapien and CoreValve. There also was no relationship seen between a center’s total case volume and 30-day mortality.

Few Changes in Patients, Marked Gains in Experience

“In the present analysis of the UK TAVI registry, we show that there has been very little change in the characteristics of patients treated in the UK by TAVI from 2007 to 2012, with the only demographic shift being towards the treatment of patients with [LVEF],” the study authors write, adding that the better survival in the later cohorts likely reflects changes in patient selection.

“The multidisciplinary teams selecting patients for TAVI have gained increasing experience over time and may be better at selecting patients who are most likely to benefit from TAVI,” Dr. Ludman and colleagues write. “Yet it would be a concern if we are observing a move away from those patients who though extremely frail, may have the most to gain, as did Cohort B of the PARTNER trial.”

Results Provide Reassurance of Durability

In a telephone interview with TCTMD, Ted Feldman, MD, of Evanston Hospital (Evanston, IL), said the large numbers and required participation in the registry are important strengths of the UK TAVI registry, as well as the fact that “6 years is one of the longer follow-up reports.”

But the most interesting part of the report is not what it contains but rather what it lacks, he observed.

“There is no emergence of structural valve failure,” Dr. Feldman said. “We’re entering a period where one of the big issues in TAVR is durability. It’s not a specific endpoint that appears to have been followed in the registry, but the fact that it didn’t pop up as a problem is important and strengthens our confidence that these devices will last at least several years. It’s an inescapable fact that you can’t know the durability of any of these prosthetic devices until time passes and that is, I believe, the greatest contribution so far of this UK TAVI registry.”

Another important takeaway from the paper, Dr. Feldman noted, is that there were no apparent differences in outcomes according to need for pacemaker implantation. “That’s another point of concern that we all have about TAVR, and it’s reassuring to see that in this latest report,” he said.

Source:
Ludman PF, Moat N, de Belder MA, et al. Transcatheter aortic valve implantation in the UK: temporal trends, predictors of outcome and 6 year follow up: a report from the UK TAVI registry 2007 to 2012. Circulation. 2015;Epub ahead of print.

Disclosures:

• Dr. Ludman reports no relevant conflicts of interest.
• Dr. Feldman reports receiving consulting fees and grants from Abbott Vascular, Boston Scientific, and Edwards Lifesciences.

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