Transcatheter aortic valve implantation (TAVI) is predominantly documented for treatment of aortic stenosis in patients with tricuspid native valves. The COMPARE-TAVI 1 cohort provided an opportunity to compare early and 1-year outcomes after transfemoral TAVI among patients with tricuspid, bicuspid, and bioprosthetic (surgical or transcatheter) valves. The objective reported in the source was to compare 30-day and 1-year outcomes across these valve-anatomy groups.
COMPARE-TAVI 1 randomized all-comer patients treated with transfemoral TAVI to one of two balloon-expandable transcatheter heart valves. For the analysis described in the source, participants were divided into three groups according to valve anatomy: tricuspid, bicuspid, and bioprosthetic valves. Outcomes at 30 days and at 1 year after the procedure were compared between the bicuspid and bioprosthetic groups versus the tricuspid group.
Group sizes and reported median ages from the abstract were: tricuspid valves, N = 892 (median age 82 years); bicuspid valves, N = 98 (median age 78 years); and bioprosthetic valves, N = 40 (median age 80 years). The source notes that patients with tricuspid valves were slightly older than those with bicuspid and bioprosthetic valves. No additional baseline comorbidity or anatomic detail beyond group counts and median ages was reported in the abstract.
The source states that procedural outcomes were similar across the three valve-anatomy groups. The abstract does not provide device-specific procedural metrics, fluoroscopy times, contrast use, or procedural complication rates beyond the higher-level statement that procedural outcomes did not differ among groups.
At 30 days after TAVI, the analysis reported no differences between groups in rates of death or bleeding. Two specific subgroup findings noted in the abstract were:
No further numerical breakdowns, confidence intervals, or p values for these endpoints were provided in the abstract.
At 1 year, the source reports no differences among tricuspid, bicuspid, and bioprosthetic groups in the following outcomes: death, myocardial infarction, percutaneous coronary revascularization, or endocarditis. The abstract does not supply absolute event counts or statistical comparisons for these 1-year endpoints.
Reoperation after the index TAVI procedure was more frequent among patients with bicuspid valves; the abstract reports three reoperations in the bicuspid group (n = 3). In contrast, the bioprosthetic group had zero patients receiving a new pacemaker within 30 days. The abstract does not elaborate on indications for reoperation, timing, or specifics of pacemaker indications.
Within this observational analysis embedded in the COMPARE-TAVI 1 randomized cohort, patients with tricuspid, bicuspid, or bioprosthetic valves had broadly similar short- and mid-term outcomes after transfemoral balloon-expandable TAVI. Notable exceptions described in the abstract included a higher frequency of 30-day stroke and reoperation in the bicuspid group and the absence of new pacemaker implantation in the bioprosthetic group at 30 days.
Important limitations based on the content of the source abstract: the report is observational with subgroup comparisons; detailed numerical event rates, formal statistical testing, device-specific results, procedural details, and longer-term outcomes beyond 1 year were not reported in the abstract. Where the abstract does not provide additional data or statistical detail, those elements are not available in this source.
The clinical trial registration cited in the abstract is ClinicalTrials.gov NCT04443023. Keywords provided in the source include: aortic stenosis; TAVI; THV; balloon-expandable valves; bicuspid; and bioprosthesis.