Nissen, Henrik

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.

Background The hemodynamic profile and remodeling patterns of paradoxical low‐flow, low‐gradient aortic stenosis are well understood. However, some patients with severe aortic stenosis exhibit eccentric remodeling with enlarged left ventricular cavities, enabling a normal flow, low ejection fraction ( NF ‐ LEF ) phenotype. We assessed the prevalence, hemodynamic characteristics, and post‐transcatheter aortic valve implantation outcomes of NF ‐ LEF . Methods In this substudy of the COMPARE‐TAVI 1 trial, 979 patients undergoing transfemoral transcatheter aortic valve implantation were stratified by left ventricular ejection fraction (LVEF) (< or ≥50%) and stroke volume index (< or ≥35 mL/m 2 ) into 4 groups: normal flow, normal LVEF, NF‐LEF, low flow, normal ejection fraction, and low flow, low ejection fraction. Results NF‐LEF was observed in 10.7% of patients. Reduced LVEF was associated with previous myocardial infarction, pacemakers, New York Heart Association class >2, atrial fibrillation, moderate or worse mitral regurgitation, and larger left ventricular cavities ( P <0.001) with eccentric hypertrophy ( P =0.004). Compared with low‐flow, low‐ejection fraction, patients with NF‐LEF more frequently had moderate or worse aortic regurgitation ( P =0.007), whereas low flow, low ejection fraction showed poorer diastolic indices, suggesting diastolic dysfunction with high left ventricular filling pressures. Patients with low flow, normal ejection fraction were the most symptomatic and showed less improvement in 6‐minute walk distance at 1 year compared with normal flow, normal ejection fraction. During follow‐up, both low‐flow groups demonstrated significant increases in stroke volume index ( P <0.001), whereas LVEF also improved among patients with reduced LVEF ( P <0.001). Conclusions NF‐LEF is a prevalent aortic stenosis phenotype characterized by preserved flow despite reduced LVEF, likely driven by eccentric remodeling with moderate or worse aortic regurgitation and more favorable diastolic properties, with similar survival and time‐to‐event outcomes across phenotypes after transcatheter aortic valve implantation at long‐term follow‐up. Despite higher comorbidity burdens, patients with NF‐LEF showed functional and clinical improvements comparable with normal flow, normal ejection fraction, indicating a severe aortic stenosis phenotype.

Abstract Aims This study aims to investigate the prognostic role of Stage 3 and 4 cardiac damage (CD) after transcatheter aortic valve intervention (TAVI), dependent on whether comorbidities contributing to right heart dysfunction were present. Methods and results Patients with severe aortic stenosis (AS) undergoing TAVI were included. Patients were divided into three groups: Stage 0–2 CD; Stage 3–4 CD, isolated AS (Stage 3–4 CD without significant concomitant chronic obstructive pulmonary disease, mitral annular calcification, mitral stenosis, mitral regurgitation, previous coronary artery bypass graft surgery, or cardiac amyloidosis); Stage 3–4 CD, AS with comorbidities (Stage 3–4 CD with ≥ 1 of these comorbidities). Futility was defined as death or Stage 3–4 New York Heart Association class dyspnoea 1 year after TAVI. Of 985 included patients, 822 (83%) had Stage 1–2 CD; 101 (10%) had Stage 3–4 CD, isolated AS; and 62 (6%) had Stage 3–4 CD, AS with comorbidities. Futility was not more common in Stage 3–4 CD groups (Stage 1–2 CD, 10%; Stage 3–4 CD, isolated AS, 17%; Stage 3–4 CD, AS with comorbidities, 15%, P = 0.09). Baseline and 1-year NYHA class were higher in Stage 3–4 CD compared with Stage 1–2 CD (P &lt; 0.01). The 6 min walking test distance increased similarly in all groups at 1 year. Conclusion Potential comorbidities contributing to right heart dysfunction were common among patients in Stage 3–4 CD undergoing TAVI. Stage 3–4 CD was not associated with a significantly higher risk of futility, irrespective of comorbidities, and they experienced a similar functional improvement after TAVI.

Abstract Background Transcatheter Aortic Valve Implantation (TAVI) is commonly used to deploy new bioprosthetic valves inside degenerated surgically implanted aortic valves in high risk patients. The three scoring systems used to assess risk of postprocedural mortality are: Logistic EuroSCORE (LES), EuroSCORE II (ES II), and Society of Thoracic Surgeons (STS). Objective The purpose of this study is to analyze the accuracy of LES, ES II, and STS in estimating all‐cause mortality after transcatheter aortic valve‐in‐valve (ViV) implantations, which was not assessed before. Methods Using the Valve‐in‐Valve International Data (VIVID) registry, a total of 1,550 patients from 110 centers were included. The study compared the observed 30‐day overall mortality vs. the respective predicted mortalities calculated by risk scores. The accuracy of prediction models was assessed based on calibration and discrimination. Results Observed mortality at 30 days was 5.3%, while average expected mortalities by LES, ES II and STS were 29.49 (± 17.2), 14.59 (± 8.6), and 9.61 (± 8.51), respectively. All three risk scores overestimated 30‐day mortality with ratios of 0.176 (95% CI 0.138–0.214), 0.342 (95% CI 0.264–0.419), and 0.536 (95% CI 0.421–0.651), respectively. 30‐day mortality ROC curves demonstrated that ES II had the largest AUC at 0.722, followed by STS at 0.704, and LES at 0.698. Conclusions All three scores overestimated mortality at 30 days with ES II showing the highest predictability compared to LES and STS; and therefore, should be recommended for ViV procedures. There is a need for a dedicated scoring system for patients undergoing ViV interventions.