Transcatheter aortic valve replacement (TAVR) may be associated with higher rates of mortality than surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis at intermediate surgical risk, according to the results of the GARY Trial presented Nov. 14 during AHA 2016.

In a large real-world multicenter registry, Nicolas Werner, MD, et al., compared the efficacy and outcomes of intermediate-risk patients who were treated by TAVR or conventional SAVR in Germany over three years in daily clinical practice. A total of 5,997 patients at intermediate surgical risk underwent isolated TAVR (4,101) or SAVR (1,896) at 88 sites in Germany between 2011 and 2013. Patients treated by TAVR were significantly different in baseline characteristics (older, more often female and had higher risk scores) from patients treated by surgical aortic valve replacement.

The results of the trial show that in-hospital and one-year death rates were significantly higher in TAVR patients than SAVR patients: 3.8 percent for in-hospital TAVR patients vs. 2.6 among in-hospital surgical patients and 16.6 percent at one year after TAVR vs. 8.9 percent one year after surgical replacement. The unadjusted death rate was higher after TAVR, and a significant difference in one-year mortality rate persisted between the two groups.

According to the authors, for differences in specific complication rates between TAVR and SAVR, an individualized therapeutic decision by a dedicated heart team, based on the clinical situation of the patient and the associated procedural risk, may be the best approach for the group of patients at intermediate surgical risk. However, they note that the retrospective analysis from registry data is not the method of choice to compare two treatment strategies as it should only be done by randomized controlled trials.

"Selection bias of preferring TAVR for higher-risk patients within this construct could easily explain the differences in outcomes," commented Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org.

Keywords: AHA16, American Heart Association, AHA Annual Scientific Sessions, Aortic Valve, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Prospective Studies, Registries, Risk, Heart Valve Prosthesis

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