Why is the study important?
There is an unmet need for a transcatheter solution to isolated aortic regurgitation (AR), as existing TAVR platforms have a number of pitfalls when trying to treat these patients off-label.
Should I change my practice because of these findings?
The Trilogy heart valve system is not yet FDA-approved and, therefore would not yet change practice in the management of AR.
What question was the study supposed to answer?
Is the Trilogy heart valve safe and effective for the treatment of AR in high surgical risk patients?
What did the study show?
The ALGIN-AR trial was a multicenter, nonblinded, single-arm study assessing the safety and efficacy of the Trilogy transcatheter heart valve for the treatment of AR in high-surgical risk patients. 180 patients at high surgical risk with >= 3+ AR and NYHA class III-IV symptoms were enrolled in the study. The study met its safety performance goal at 30-days (26.7%, p for noninferiority <0.0001) and 12-month performance goal for all-cause mortality (7.8%, p for noninferiority <0.0001). The pacemaker rate was 24%, although in the later portion of the study, this rate fell to 14%. The rate of technical success was >92%, with no intraprocedural deaths, valve embolization 2.2%, and aortic dissection 0.6%. The echocardiographic and hemodynamic results were excellent.
How good was the approach/methodology?
Data presented at TCT 2023 and full-text manuscript are not yet available for review.
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