Registries Demonstrate Positive Long-Term Outcomes with TAVR

MIAMI BEACH, FLA.—Data from a large-scale German registry have shown in-hospital mortality rates with TAVR to be comparable to surgical aortic valve replacement in high-risk patients, while an Italian registry indicated low mortality and complication rates with the transcatheter approach.

Researchers also created a scoring system that was found to be more accurate than the standard EuroSCORE.

“The German Aortic Valve Registry, or GARY, is the first large-scale registry comparing surgical and catheter-based procedures,” Hans-Reiner Figulla, MD, of University Heart Center Jena, Germany, said at TCT 2012. “The AKL score reflects a better outcome than EuroSCORE, and in higher-risk patients, in-hospital mortality with TAVR is at least as good as with surgical AVR.

“In the high-risk group, we found a trend that transfemoral TAVR has a lower risk than transapical TAVR,” he said.

Follow-up for the registry was conducted in-hospital, at 30 days and at 1, 3 and 5 years. “All patients undergoing an invasive therapy for acquired aortic valve disease are included,” Figulla said. The only exclusion criterion was a lack of informed consent.  Figulla noted that compared with surgical patients, more TAVR patients were over age 75 at baseline.

Mortality over time

According to Figulla, mortality was separately evaluated in surgical patients with and without CABG and in patients treated with transvascular and transapical TAVR.

In-hospital mortality was 2.1% and 4.5% in the surgical group with and without CABG, respectively. In the transvascular TAVR group, in-hospital mortality was 5.1% compared with 7.7% in the transapical TAVR group.

Cerebrovascular events were 2.2% and 3.6% in surgical patients with and without CABG, respectively, and 3.7% and 3.5% for patients treated with transvascular and transapical TAVR, respectively.

There was a significant difference between predicted and observed in-hospital mortality rates utilizing the EuroSCORE. “The EuroSCORE was inappropriate in determining the outcome so we came up with the AKL score, which evaluates 21 different features,” Figulla said. Compared with EuroScore, risk prediction by AKL score was more accurate (see Figure).

CoreValve registries

Anna Sonia Petronio MD, University of Pisa, Italy, reported results from the Italian CoreValve registry of 1,334 patients as of October 1, 2012. The registry showed an overall survival of 55.7% and a rate of survival free from cardiac death of 79.7% at 48 months. Petronio noted a strong predictive link between paravulvular leak and late mortality up to 1 year.

Additionally, Ian T. Meredith, MD, PhD, of Monash Heart, Victoria, Australia, presented findings from the CoreValve Australia-New Zealand study of 441 patients. One-year rates of cardiac mortality were 7.4% and the rate of MACCE was 22.1%, he said.

“[This registry] is one of the largest prospectively collected, independently monitored and adjudicated datasets on the CoreValve system [Medtronic] to date,” Meredith said. “We have shown low mortality and complication rates, promising hemodynamic results associated with improvement in functional status compared with baseline, and improvements that were observed through 2 years.”