TAVI Mortality Higher vs SAVR in Intermediate-Risk Patients: GARY Registry

Larry Hand

NEW ORLEANS, LA — Among intermediate-surgical-risk patients with aortic stenosis in a German registry, adjusted mortality at 1 year was significantly higher for those undergoing transcatheter aortic valve implantation (TAVI) compared to surgical aortic-valve replacement (SAVR), in a study presented here at the American Heart Association (AHA) 2016 Scientific Sessions^[1].

Still, "patients can undergo TAVI in a real-world scenario with a relatively low in-hospital mortality risk below 4%," Dr Nicholas Werner (Klinikum Ludwigshafen, Germany) told heartwire from Medscape.

Werner and colleagues analyzed data from the German Aortic Valve Registry (GARY) on almost 6000 patients who underwent TAVI (n=4101) or SAVR (n=1896) at 89 sites between 2011 and 2013. TAVI patients were older and more likely to be female and have higher risk scores.

Strong predictors of a TAVI procedure included older age (81.8 vs 75.9 years), previous cardiac decompensation, and moderate to severe regurgitation.

The performance of TAVI varied considerably among sites, from 0% to 100%.

Unadjusted mortality rates at 1-year came to 16.6% for TAVI and 8.9% for SAVR (P < 0.001). After propensity score analysis, mortality rates were 15.5% for TAVI and 10.9% for SAVR, a difference of 4.6% (P=0.002).

When researchers compared mortality rates for transfemoral TAVI only and SAVR, the rates were 14.3% and 10.8%, respectively (P=0.021).

"Results from the propensity analysis show that TAVI patients have a persistently higher mortality rate at 1-year follow-up compared with the surgical group, but we're dealing with two very heterogeneous populations," Werner told heartwire . "We have to be very careful interpreting the data. In our opinion, the difference still persisting after propensity score analysis is most likely caused by additional confounders we were not able to adjust."

Werner was unsure of the generalizability of the data. "We started very early in Germany with the TAVI program. A high number of TAVI procedures were performed, so I’m not sure how you can apply our information to other countries," he cautioned.

Dr Craig Smith (Columbia University, New York), discussant at the presentation, said, "The overall risk here was lower than in PARTNER II, especially in the surgical group, so it's hard to make comparisons. There was excellent mortality in both groups,and the stroke rate was similar to PARTNER II."

The stroke rate in this study was 1.5% for TAVI and 1.3% for SAVR.

"The site-dependent effects are potentially very confounding," he said. "One of the things they did to try to correct for that was a propensity analysis. I think the propensity scoring they used was the best way to attempt to do that."

GARY is supported by the German Cardiac Society, German Society for Thoracic and Cardiovascular Surgery, and German Heart Foundation. Werner and Smith did not reported any relevant financial relationships.

Source: Medscape