Why is this study important?
The CHOICE-CLOSURE trial provides new randomized data to inform decision making about vascular access closure after TAVR.
Should I change my practice because of these findings?
Operators may choose suture-based closure as the default option based on the safety data from this trial.
What question was the study supposed to answer?
The goal of the study was to show that a plug-based closure strategy is safe and effective compared to suture-based.
What did the study show?
The CHOICE-CLOSURE trial randomized 516 patients to receive a suture-based closure strategy (Perclose ProGlide®, Abbott Vascular) vs. a plug-based closure strategy (Manta®, Teleflex) following TAVR. Within the suture-based strategy arm, supplemental use of a small collagen plug device (Angioseal®, Terumo) was allowed. There were no significant differences between groups in peripheral vascular disease or BMI. The primary endpoint of access-site or access-related major and minor vascular complications was higher 19.4% in the plug-based group versus the suture-based group 12.0% (p=0.029). Major vascular complications by 30-days were also more common in the plug-based group (5.4% vs. 2.3%) but not statistically significant. There was no difference in life-threatening bleeding at 30-days (0.8% vs. 0%). Time to hemostasis was significantly shorter in the plug-based group 80 vs. 240 seconds (p=0.001).
How good was the approach/methodology?
This is the first large scale randomized trial comparing post-TAVR vascular closure strategies. The study is an important addition to the TAVR literature.
All editors: Jared M. O'Leary, MD
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