Key result
TAVI yields similar outcomes across valve types but bicuspid valves are linked to more 30-day strokes.
Why the study?
TAVI is most extensively documented for tricuspid valves, but comparative outcomes after TAVI in patients with tricuspid, bicuspid, and bioprosthetic valves remain unclear.
Does valve anatomy (bicuspid or bioprosthetic vs tricuspid) affect 30-day and 1-year outcomes after transfemoral TAVI?
Observational (n=1,030)
Does valve anatomy (bicuspid or bioprosthetic vs tricuspid) affect 30-day and 1-year outcomes after transfemoral TAVI?
Transfemoral TAVI yields generally similar 30-day and 1-year outcomes across tricuspid, bicuspid, and bioprosthetic valve anatomies, though bicuspid valves may be associated with higher 30-day stroke and reoperation rates.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Though COMPARE-TAVI 1 was a “state of the art, well-conducted trial” that met its noninferiority endpoint, the outcomes beyond the primary endpoint show a clear difference in performance. He expressed concerns about the increase in moderate/severe aortic regurgitation in the Myval arm between 30 days and 1 year and the higher rates of pacemaker implantation and bleeding.”
“long-term advantages of the more recent Myval THVs over the well-established SAPIEN 3 platform requires more data, especially in a younger population for whom lifetime management of aortic stenosis is crucial.”
“This trial reflects a new era in comparative valve research. The meticulous design and adherence to VARC-3 standards, including quality of life endpoints, mark it as a pivotal study. The results of the LANDMARK trial represent a meaningful advancement for the global structural heart community—and most importantly, for patients receiving TAVI.”
Similar 30-day and 1-year outcomes across valve anatomies after TAVI; extends tricuspid data but leaves open stroke and durability questions in larger cohorts.
BackgroundTranscatheter aortic valve implantation (TAVI) is most extensively documented for the treatment of aortic stenosis in patients with tricuspid valves. To compare the 30-day and 1-year outcomes after TAVI in patients with tricuspid, bicuspid and bioprosthetic valves who participated in the COMPARE-TAVI 1 trial.MethodsIn COMPARE-TAVI 1, all-comer patients treated with transfemoral TAVI were randomized to treatment with one of two balloon-expandable valves. In this study, these patients were divided into three groups based on valve anatomy. 30-day and 1-year outcomes among patients with bicuspid and bioprosthetic valves (surgical or transcatheter) were compared with outcomes among patients with tricuspid valves.ResultsPatients with tricuspid valves (N = 892, median 82 years) were slightly older than patients with bicuspid (N = 98, median 78 years) and bioprosthetic (N = 40, median 80 years) valves. Procedural outcomes were similar. There were no differences in death or bleeding at 30 days, nor in death, myocardial infarction, percutaneous revascularization, or endocarditis at 1 year. Stroke was more frequent among patients with bicuspid valves at 30 days (n = 7), while new pacemaker was less frequent among patients with bioprosthetic valves at 30 days (n = 0). The need for reoperation was more frequent among patients with bicuspid valves (n = 3).ConclusionsIn this observational study performed within the COMPARE-TAVI 1 cohort, patients with tricuspid, bicuspid or bioprosthetic valves had similar outcomes. No patients with bioprosthetic valves had a new pacemaker within 30 days after TAVI.Clinical trial registration: ClinicalTrials.gov: NCT04443023.
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Thim et al. (2026) conducted an observational in Aortic stenosis (n=1,030). Bicuspid or bioprosthetic valve anatomy vs. Tricuspid valve anatomy was evaluated on 30-day and 1-year clinical outcomes (death, bleeding, myocardial infarction, percutaneous revascularization, endocarditis). In patients undergoing TAVI, outcomes were similar across tricuspid, bicuspid, and bioprosthetic valves, though 30-day stroke was more frequent with bicuspid valves (n=7).
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