Why is this study important?  

SURTAVI five-year results reaffirmed that in older patients at intermediate surgical risk (STS predicted risk of mortality = 4.5% ± 1.6%) treatment with Medtronic CoreValve TAVR yields similar outcomes to open SAVR.  The primary endpoint of all-cause mortality or disabling stroke after 5 years were similar (31.3% for TAVR and 30.8% for surgery (hazard ratio [HR], 1.02; 95% CI, 0.85-1.22; P = 0.85)

Should I change my practice because of these findings?

No. TAVR is now so well established it’s become the de facto standard of care. As often occurs in new device evolution and long-term evaluation, the SURTAVI 5-year data represent earlier generations of the CoreValve platform; newer TAVR platforms and implantation techniques may further enhance TAVR performance, especially the incidence of pacemaker implantation and PVL.

What question was this study supposed to answer?  

The original SURTAVI endpoints were aimed at 2-year outcomes. This report adds to those findings by providing longer follow up.

What did the study show?

SURTAVI compared CoreValve TAVR with open SAVR in intermediate-risk patients. In addition to the primary endpoint, other outcomes data were reported: the Kansas City Cardiomyopathy Questionnaire summary scores and New York Heart Association Class were similar in the two groups, while TAVR patients experienced greater need for pacemakers (35.8% vs. 14.6% (P < 0.001), all attributable to events during the first two years (30.9% vs. 9.8%, P < 0.001) since rates did not differ between years two and five between 2 and 5 years. TAVR patients also had more paravalvular leaks, especially mild leaks (27.1 vs 2.7 P<0.001). Reinterventions over five years were required more often among TAVR patients (3.5% vs. 1.9%, P = .02) seemingly driven by the need for early valve reintervention within the first two years (2.5% vs. 0.2%, P = .002)

How good was the approach/methodology?

This was a large, multicenter, international randomized trial by experienced investigators. 1,660 patients (864 TAVR, 796 SAVR) averaging 79.8 ± 6.2 years of age with a risk of death during surgery between 3% and 15% were studied. Independent adjudication committees and core laboratories were used. The trial was funded by Medtronic.
 

All Editors: Steven R. Bailey, MD, MSCAI; Jordan Safirstein, MD, FSCAI; Kirk N. Garratt, MD, MSc, MSCAI; and David A. Cox, MD, MSCAI

Other Specialist Resources for Structural Heart Disease

Including recently published studies, coverage of late-breaking science, updates from clinical trials and registries, and complex case presentations. 

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