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Similar late outcomes with TAVR and SAVR in high-risk patients

JAMA Cardiology
Reuters Health - 09/10/2020 - Patients with severe aortic stenosis who undergo transcatheter aortic-valve replacement (TAVR) initially do better than their counterparts receiving surgical aortic-valve replacement (SAVR), but there is little difference in longer-term health status between the two groups.

As Dr. Suzanne V. Arnold told Reuters Health by email, "we found that despite differences in complications between SAVR and TAVR, patients who survive appear to maintain a reasonable quality of life through five years."

Dr. Arnold of Saint Luke's Mid America Heart Institute, in Kansas City, Missouri, and colleagues conducted a pre-specified analysis of data from the CoreValve US High Risk Pivotal Trial, in which patients at high surgical risk with severe aortic stenosis were randomized to either self-expanding TAVR or SAVR.

Baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) health status was available for 713 patients. Their mean age was 83 years and their mean KCCQ overall summary score was 47 out of 100 (best health), indicating substantial health status impairment.

Both disease-specific and generic health status improved substantially after TAVR or SAVR, the researchers report in JAMA Cardiology.

By one month, the KCCQ overall summary score was 16.8 points greater with iliofemoral TAVR than with SAVR, a significant difference. By six months, however, the difference in health status between the TAVR and SAVR groups had disappeared, and it did not reappear.

At five years, 134 of 305 patients who underwent iliofemoral TAVR (44%) and 105 of 266 who underwent SAVR (39%) were still alive. Of those for whom health-status data were available, 61% of the TAVR group and 65% of the SAVR group had a KCCQ overall summary score of more than 60. Results were similar for individual KCCQ domains and the Short-Form Health Survey.

The researchers observe that mortality was high and health status could only be assessed among the minority of patients who survived. They also point out that "there was a fair amount of missing health status data over follow-up, although missing data rates were similar between groups."

"As the long-term survival of patients with severe aortic stenosis who are high-risk for surgery is limited, focusing on the quality of life outcomes becomes more of a priority," said Dr. Arnold. "These results reassure us that use of TAVR in high-risk patients has both durable and meaningful benefits to many patients."

The CoreValve US Pivotal trial was sponsored by Medtronic and several of Dr. Arnold's coauthors report relationships with the company.

By David Douglas

SOURCE: https://bit.ly/34sCi6J JAMA Cardiology, online September 30, 2020

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