Citations

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.

BACKGROUND Patients with severe aortic stenosis (AS) exhibit heterogeneous flow-gradient hemodynamics and ventricular remodeling, which may influence symptomatic, functional, and structural responses to transcatheter aortic valve implantation (TAVI). Thus, we evaluated differences in functional recovery and reverse remodeling after transfemoral TAVI across flow-gradient phenotypes. METHODS In this sub-study of the COMPARE-TAVI 1 trial, 975 patients undergoing transfemoral TAVI were classified as classical low-flow low-gradient (cLFLG, 9.1%), paradoxical low-flow low-gradient (pLFLG, 7.7%), low-flow high-gradient (24.7%), normal-flow low-gradient (NFLG, 13.0%), and normal-flow high-gradient (45.4%). The primary functional outcome was longitudinal change in six-minute walk test distance (6MWTD) from baseline to 1 year follow-up. Secondary endpoints included changes in NYHA functional class and reverse remodeling from baseline to 1 year follow-up along with the incidence and risk of all-cause death and a composite MACE-endpoint. RESULTS Mean 6MWTD increased by 59±4 meters at 1-month (p=0.000) with no additional improvement at 1-year, but with heterogeneity between groups (p=0.000). Improvements among NFLG, cLFLG and low-flow high-gradient AS were comparable with normal-flow high-gradient AS, while pLFLG AS exhibited significantly increments at 1-year (−28±15 meters, p=0.007). Patients with NFLG, cLFLG and pLFLG were more symptomatic at baseline (NYHA ≥III: 40.5%, 57.3% and 50.6%, respectively, p=0.000). NYHA improved in all groups at 1-year follow-up (p=0.000), although persistent symptoms at 1-year were most frequent in pLFLG (NYHA ≥II; 38.7%, p=0.012). Reverse remodeling was also comparable between normal-flow high-gradient AS and NFLG, cLFLG, and low-flow high-gradient AS, respectively, but attenuated in pLFLG AS in both unadjusted and adjusted analyses. No differences were observed in the incidence and risk of all-cause death or the composite MACE-endpoint. CONCLUSION TAVI associates with functional recovery across all flow-gradient phenotypes, although with heterogeneous responses. Patients with NFLG showed comparable functional recovery and reverse remodeling at 1-year follow-up compared with normal-flow high-gradient AS, whereas pLFLG demonstrated attenuated benefits across all parameters.

Abstract Objectives The study aimed to compare long-term outcomes of the David and Yacoub valve-sparing aortic root replacement (VSARR) procedures in a nationwide, low-volume setting. Methods All patients undergoing elective VSARR in Denmark between January 2010 and April 2022 were identified using the Danish registries. The primary end-point was all-cause death. Secondary end-points included stroke, reoperation, a composite of death or reoperation, and long-term echocardiographic outcomes. Analyses were performed in both crude and propensity score-matched (PSM) populations and compared with outcomes from a control group comprised of all elective composite root replacement procedures performed at the contributing centres in the study period. Results A total of 160 patients underwent VSARR (median age; David vs Yacoub; 49.7 [SD 14.1] years vs 51.5 [SD 14.3] years; P = .42) with the David (n = 92, 57.5%; median follow-up 8.2 [SD 3.6] years) or Yacoub (n = 68, 42.5%; median follow-up 7.1 [SD 2.4] years) procedure. Ten-year all-cause death was similar (David 9.3% [95% CI: 2.3-15.2] vs Yacoub 8.8% [95% CI: 3.6-20.6]; log-rank P = .54). Reoperation rates (log-rank P = .12), stroke incidence (P = .41), and the composite end-point of death or reoperation (log-rank P = .63) were comparable, with consistent findings in the PSM cohort. Long-term echocardiographic follow-up demonstrated no difference in recurrent regurgitation, stenosis, or valve-related complications. Compared to elective composite root replacement (CRR) (n = 486), VSARR demonstrated lower rate of all-cause death (P = .027) and stroke (P = .026), while reoperation rate was higher (13.8% vs 4.3%; P &lt; .001). However, the risk of reoperation was comparable between procedures when accounting for competing risk of death (log-rank P = .17). Conclusions Long-term outcomes following elective VSARR using the David and Yacoub procedure were comparable. VSARR was associated with lower risk of all-cause death and stroke compared to elective CRR, supporting the two VSARR procedures as durable options when performed in experienced centres with careful patient selection, even in low-volume settings.

Abstract Aims Aortic valve-sparing root replacement is recommended over composite root replacement for aortic root aneurysms, especially in younger patients, but long-term outcomes in low-volume nationwide settings remain unclear. The objectives are to compare long-term survival, stroke, and reoperation rates between the two procedures in a low-volume national setting. Methods and results Patients were identified from the Western Danish Heart Registry and the Danish Heart Registry. Cases were validated by review of operative descriptions. The primary outcome was long-term survival from all-cause mortality; secondary outcomes included stroke, reoperation, recurrent aortic regurgitation, and aortic stenosis. Groups were balanced using propensity score matching. Echocardiographic data were provided for the matched cohort. We identified 760 patients treated with composite root replacement and 179 patients with aortic valve-sparing root replacement between January 2010 and April 2022. Mean follow-up was 6.5 years. Composite root replacement patients were younger [50.7 years (SD 14.1) vs. 55.2 (SD 13.5), P &lt; 0.001], but more comorbid with a median EuroSCOREII of 5.5 [interquartile range (IQR): 3.3–11.7] vs. 3.4 (IQR: 2.6–5.0) (P &lt; 0.001). After matching 157 patients per group, aortic valve-sparing root replacement showed improved 10-year survival [91.2%, 95% confidence interval (CI) 82.3–95.8 vs. 80.4%, 95% CI 70.0–87.5, log-rank P = 0.026], with lower 10-year stroke risk (4.9%, 95% CI 1.8–13.0 vs. 18.9%, 95% CI 11.7–29.9, log-rank P = 0.007). Risk of reoperation was nonsignificant (log-rank P = 0.12), which was consistent in the crude population when accounting for competing risk of death (log-rank P = 0.09). Conclusion In this nationwide study, aortic valve-sparing root replacement was associated with better long-term survival and lower stroke risk, supporting its role as a durable surgical option for selected patients.