Nørgaard, Bjarne Linde

Objectives To explore the outcomes among patients treated with TAVI (transcatheter aortic valve implantation) in the COMPARE-TAVI 1 trial by age groups and sex. Design Cohort study. Setting Three Danish university hospitals. Participants Patients treated with TAVI in the COMPARE-TAVI 1 trial (N=1030), 60 (5.8%), 337 (32.7%), 592 (57.5%) and 41 (4.0%) were in the four age groups, < 70, 70–79, 80–89 and 90+ years while 414 (40.2%) and 616 (59.8%) were of female and male sex. Interventions Transfemoral TAVI with balloon-expandable valves (Sapien or Myval) performed between June 2020 and November 2023. Outcome measures Post hoc analyses of trial secondary outcomes that include end-point committee-adjudicated outcomes. Results In the four age groups, 1-year mortality rates were 8.3%, 5.6%, 5.6% and 7.3% while it was 5.8% in both sexes. Across the four age groups, 1-year stroke rates were 6.7%, 1.8%, 3.2% and 4.9%, and 5.1% among females and 4.7% among males. In the four age groups, 1-year new pacemaker rates were 7.5%, 15%, 19% and 13% while it was 15% among females and 18% among males. Females had smaller annuli than males and their gradients were higher and the effective orifice area lower after TAVI but their frequency of prosthesis-patient mismatch was similar at 1 year. Conclusion While comorbidity levels varied between groups, clinical outcomes were similar across age groups and between sexes. Trial registration number NCT04443023 .

Abstract Aims We aimed to compare procedural, echocardiographic, and clinical outcomes within the first year after transcatheter aortic valve implantation (TAVI) among inhospital and subacute patients to elective patients in the COMPARE-TAVI 1 cohort. Methods and results Among 1030 patients treated with TAVI, 927 (90%) had an elective procedure, 63 (6.1%) had a subacute procedure, and 40 (3.9%) had an inhospital procedure. Procedural characteristics and outcomes were comparable. Among elective, subacute, and inhospital patients, mortality at 30 days was 15 (1.6%), 0 (0%), and 0 (0%) and at 1 year 54 (5.8%), 4 (6.3%), and 2 (5.0%). Stroke at 30 days was 28 (3.0%), 0 (0%), and 3 (7.5%) and at 1 year 42 (4.5%), 5 (7.9%), and 3 (7.5%). New pacemaker at 30 days was 119 (14%), 12 (21%), and 6 (17%) and at 1 year 130 (16%), 14 (25%), and 7 (19%). Elective, subacute, and inhospital patients with LVEF ≤40%, improved their LVEF from 33% (28–37), 33% (27–37), and 28% (22–33) before TAVI to 46% (35–60), 43% (33–52), and 42% (33–55) at 30-days, and 54% (45–62), 53% (43–61), and 49% (39–63) at 1-year. Differences between the groups were not statistically significant. Conclusion After transfemoral TAVI with balloon-expandable valves in COMPARE-TAVI 1, procedural, echocardiographic, and clinical outcomes were comparable among elective, subacute, and inhospital patients within the first year.

Abstract Aims Cardiac computed tomography (CT) is increasingly utilized during follow-up after left atrial appendage closure (LAAC). Hypoattenuated thickening (HAT) is a common finding and might represent either benign device healing or device-related thrombosis (DRT). The appearance and characteristics of HAT associated with the Watchman FLX have not been previously described. Therefore, we sought to investigate cardiac CT findings during follow-up after Watchman FLX implantation with a focus on HAT and DRT. Methods and results Retrospective single-centre, observational study including all patients with successful Watchman FLX implantation and follow-up cardiac CT between March 2019 and September 2021 (n = 244). Blinded analysis of CT images was performed describing the localization, extent, and morphology of HAT and correlated to imaging and histology findings in a canine model. Relevant clinical and preclinical ethical approvals were obtained. Overall, HAT was present in 156 cases (64%) and could be classified as either subfabric hypoattenuation (n = 59), flat sessile HAT (n = 78), protruding sessile HAT (n = 16), or pedunculated HAT (n = 3). All cases of pedunculated HAT and five cases of protruding sessile HAT were considered as high-grade HAT (n = 7). Subfabric hypoattenuation and flat sessile HAT correlated with device healing and endothelialization in histological analysis of explanted devices. Conclusion Subfabric hypoattenuation and flat sessile HAT are frequent CT findings for Watchman FLX, likely representing benign device healing and endothelialization. Pedunculated HAT and protruding HAT are infrequent CT findings that might represent DRT.