Christophe Dubois

Background: Despite high procedural success of transcatheter mitral valve replacement (TMVR), mortality remains substantial, and conventional risk scores inadequately reflect the specific risk profile of this high-risk population. Artificial intelligence (AI)-derived analysis may enable TMVR-specific risk assessment using routinely acquired computed tomography (CT). Methods: In a retrospective European multicenter registry, AI-based segmentation of harmonized real-world pre-procedural cardiac CT with variable thoracic and upper-abdominal coverage was applied in patients undergoing TMVR with the Tendyne^TM system (134 patients; 346 CT-derived variables retained for high-dimensional screening). One-year cardiovascular mortality was assessed using Cox proportional hazards models with Benjamini–Hochberg false discovery rate correction. STS- and EuroSCORE II-adjusted analyses and a targeted coronary-ventricular coupling analysis were performed. Results: In the STS-adjusted Cox analysis, nine AI-derived CT parameters met the 10% FDR discovery threshold for cardiovascular mortality, spanning skeletal (n = 3), muscular (n = 1), and cardiopulmonary phenotypes (n = 5), whereas three parameters met this threshold in CT-only analyses. Coronary–ventricular coupling, defined as coronary artery volume relative to left ventricular end-diastolic volume, was significantly associated with lower 1-year cardiovascular mortality in the CT-only analysis (HR per IQR 0.47, 95% CI 0.22–1.00; p = 0.049) and after EuroSCORE II adjustment (HR 0.47, 95% CI 0.22–0.99; p = 0.046), while the STS-adjusted estimate remained directionally consistent but did not reach statistical significance (HR 0.49, 95% CI 0.23–1.05; p = 0.067). Conclusions: AI-based CT phenotyping identifies imaging-derived markers associated with cardiovascular mortality beyond information captured by conventional surgical risk scores in TMVR patients. Coronary-ventricular coupling emerges as a promising automated CT-derived imaging marker with a biologically plausible pathophysiological basis, linking coronary arterial volume to ventricular size in mitral valve disease.

BACKGROUND: The prognostic value of rapid atrial pacing (RAP)-induced Wenckebach atrioventricular block (W-AVB) as a diagnostic test for predicting permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) remains unclear and requires further validation. The objective of this study was to evaluate the predictive value of RAP-induced W-AVB for PPI and sudden cardiac death within 30 days post-TAVR. METHODS: This prospective, investigator-initiated, multicenter study (PACE-TAVR) included 640 patients undergoing TAVR across 12 centers. RAP was performed before and after TAVR to assess for W-AVB. Using negative predictive values and negative likelihood ratios, the predictive value of W-AVB was evaluated for the primary end point: sudden cardiac death or guideline-based indications for PPI, including complete AVB or alternating bundle branch block (Class I), and preexisting conduction disturbances with new ECG changes, new-onset left bundle branch block, a positive electrophysiology study, or sinus node dysfunction (Class II). RESULTS: RAP was successfully performed post-TAVR in 556 patients, with RAP-induced W-AVB observed in 192 (34.5%). W-AVB was associated with baseline conduction disturbances, amiodarone use, pre-TAVR RAP-induced W-AVB, and anesthesia type. The primary end point was more frequent in patients with W-AVB (15.6% versus 9.3%; odds ratio, 1.80 [95% CI, 1.06–3.04]; P =0.029). However, the absence of W-AVB had a negative predictive value of only 90.7% and a poor negative likelihood ratio (0.79). The test’s utility declined in subgroups at high risk for PPI, including self-expanding valve recipients (odds ratio, 1.47 [95% CI, 0.84–2.58]; negative predictive value, 88.4%; negative likelihood ratio, 0.86) and patients with a baseline or new left bundle branch block (odds ratio, 1.14 [95% CI, 0.54–2.42]; negative predictive value, 81.3%; negative likelihood ratio, 0.95). CONCLUSIONS: RAP-induced W-AVB demonstrates limited utility in predicting post-TAVR PPI or sudden cardiac death, particularly in patients at high risk for PPI. Clinicians should be cautious when using this test for post-TAVR rhythm management. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05278585.

Objectives: This study aims to review short- to intermediate-term outcomes after transapical transcatheter mitral valve replacement (TMVR) using the Tendyne valve system in patients with mitral annular calcification (MAC), including off-label use in severe MAC. Methods: This retrospective sub-analysis of the multicenter Tendyne European Experience (TENDER) registry included fifty-three MAC patients who underwent commercial Tendyne-TMVR in 15 European heart centers between 01/2020 and 06/2022. Patients were assigned to the mild (n = 16), moderate (n = 17), and severe MAC (n = 20) cohorts according to Guerrero’s MAC score. Additionally, the predictive value of detailed computed tomography-derived, quantitative, and qualitative MAC characteristics on clinical outcome was tested. Results: In this overall multimorbid patient population, predominantly treated for severe mitral regurgitation (MR), technical success rates were comparable among cohorts (mild MAC: 93.8% vs. moderate MAC: 88.2%vs. severe MAC: 95%, p = 0.720). Complete MR abolishment was achieved in 88.7% of patients, with no significant difference between cohorts in the incidence of residual MR >1+ (n = 1 in moderate MAC; p = 0.350) or paravalvular leakage >1+ (PVL; n = 2 in moderate MAC, p = 0.118) at discharge. All three in-hospital deaths occurred in patients with moderate MAC (p = 0.034). There were no significant differences in 1-year cardiovascular mortality (mild MAC: 23.1% vs. moderate MAC: 6.3% vs. severe MAC: 0%, p = 0.085) and overall mortality (mild MAC: 38.5% vs. moderate MAC: 43.8% vs. severe MAC: 18.8%, p = 0.291) between the cohorts, including in patients with off-label severe MAC. The rate of heart failure hospitalization at 1 year was significantly higher in the moderate MAC cohort (mild MAC: 10% vs. moderate MAC: 61.5%, severe MAC: 21.4%, p = 0.017). Further quantitative and qualitative MAC parameters showed no significant impact on 1-year survival or hemodynamic prosthetic performance. Conclusions: This MAC-focused analysis suggests that Valve-in-MAC using the Tendyne valve system is safe, technically feasible, and associated with satisfying hemodynamic and clinical outcomes, irrespective of MAC morphology.

Ischaemic cerebrovascular events (CVEs) are a major complication of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis. We aimed to determine the incidence and risk factors for CVE at 30 days and 1 year after TAVI in a large, real-world patient cohort and evaluate the association of these events with all-cause mortality at 1 year. All consecutive patients undergoing TAVI at a single centre between April 2008 and February 2024 were included in the analysis. CVE were defined as a composite of stroke and transient ischaemic attack. One thousand and three patients (mean age 81.8 ± 7.0 years, 52.6% male, median EuroSCORE II 6% [Q1 = 3.51%; Q3 = 10.9%]) underwent TAVI with a self-expandable valve (SEV) (n = 275; 27.4%) or balloon-expandable valve (BEV) (n = 728; 72.6%). The cumulative incidence of CVE was 3.6% (95% confidence interval (95% CI) = [2.6%; 4.9%], n = 36) at 30 days (77.8% within 48 h) and 6.2% (95% CI = [4.8%; 7.8%], n = 62) at 1 year. Risk factors associated with a lower risk of CVE at 30 days included BEV vs. SEV (OR 0.32 [0.16-0.63], p = 0.0009) and larger baseline aortic valve area (AVA) (OR_{Unit = 0.1 cm2} 0.74 [0.61-0.91], p = 0.0035), while the risk was higher in the case of new-onset atrial fibrillation (AF) (OR 3.19 [1.18-8.59], p = 0.0218), diabetes (OR 2.00 [1.01-3.97], p = 0.0484), and conversion to sternotomy (OR 16.57 [4.62-59.48], p < 0.0001). Analysis at 1-year follow-up identified the same associations. Finally, the occurrence of CVE significantly increased 1-year all-cause mortality (OR 2.44 [1.32-4.50], p = 0.0045). CVE after TAVI were associated with double the odds of 1-year all-cause mortality. Risk factors associated with CVE include the use of a SEV, new-onset AF, diabetes, conversion to sternotomy, and a smaller AVA.

Since its introduction in clinical practice, patient selection and procedural technique for transcatheter aortic valve implantation (TAVI) have continued to evolve. We investigated temporal trends in patient profiles, procedural, 30-day and 1-year clinical outcomes in all consecutive patients undergoing TAVI at our centre from March 2008 to February 2024 (n = 1000). Patients were stratified into eight consecutive 2-year calendar cohorts. Outcomes were reported according to VARC-III criteria. Median age was 82 y (53% male). Over the consecutive cohorts, we observed significant decreases in STS score (8.1 ± 3.1 to 4.4 ± 2.6%) and EuroSCORE II (10.2 ± 8.0 to 6.4 ± 7.0; p < 0.001 for both). In-hospital death rates decreased significantly (9.4% to 1.3%; p = 0.030). The incidence of major vascular complications, life-threatening bleeding, and cardiac tamponade decreased significantly over time (p < 0.05 for all). Enhanced learning and a shift to a minimalist approach resulted in reduced need for intensive care (from 4 [3-5] to 0 days) and shorter hospital stay (from 13 [8-19] to 2 [2-4] days) (p < 0.001 for both). Overall 30-day survival was 96.4%, with significant improvement across cohorts (93.4% to 98.7%), while 1-year survival was 88.1% with a similar gradual increase (81.3% to 90.2%). Composite VARC-III endpoints demonstrated high technical success and significant improvements in device success and early safety across the eight 2-year cohorts. Over 15 years we observed a shift from very high-risk towards predominantly intermediate- to high-risk patients, together with substantial procedural simplification and a marked reduction in in-hospital complications and length of stay. These improvements translated into a significant increase in 30-day and 1-year survival.

In 2020, the sutureless Perceval PLUS aortic valve was introduced, featuring a new anticalcification treatment (FREE) and a shorter inflow ring in the XL size. We aimed to evaluate its early outcomes compared to earlier Perceval S design. We retrospectively analyzed 1136 patients who received the Perceval bioprosthesis between 2007 and 2022, including 222 implanted with the Perceval PLUS. Patients implanted with the Perceval S were divided into two groups (S-OLD and S-NEW) depending on the sizing strategy. Survival, hemodynamic performance, and pacemaker implantation rates were assessed. The cohort had a mean age of 77 years and a EuroSCORE II of 6.3%. The observed thirty-day mortality was similar across groups (3.7%, p = .326). Perceval PLUS demonstrated significantly improved hemodynamics, with lower peak (20.44 ± 8.95 mmHg) and mean gradients (11.44 ± 5.12 mmHg) compared to the S design (p < .001). A permanent pacemaker implantation (PPI) rate of 5.3% was achieved in minimally invasive aortic valve replacement in the PLUS group. Early results from the Perceval PLUS show a secure profile with maintained benefits from the Perceval platform. The Perceval PLUS shows improved hemodynamics in comparison with the Perceval S and achieves low PPI rate.

Long-term data on hemodynamic performance and valve durability are essential to guide bioprosthetic valve selection and to safely expand transcatheter aortic valve implantation (TAVI) to lower-risk patients with severe aortic stenosis (AS). This study aimed to assess the hemodynamic valve performance in a large cohort of patients undergoing TAVI with balloon-expandable (BEV) or self-expandable valves (SEV) and identify possible predictors of bioprosthetic valve degeneration (BVD). All patients undergoing TAVI for native AS in a single centre between March 2008 and September 2023 underwent sequential echocardiographic follow-up at 30 days, 6 months and yearly thereafter. BVD was categorised as moderate or severe according to the Valve Academic Research Consortium 3 criteria. 784 patients (82 ± 7 years, 53.1% male, median EuroSCORE II 6.0% (3.6;10.7)) were treated with BEV (n = 584; 74.5%) or SEV (n = 200; 25.5%). Patients treated with BEV had a significantly higher 30-day mean transprosthetic gradient (TPG) (10.8 (95% CI 10.4-11.2) vs 6.8 mmHg (95% CI 6.3-7.4), p < 0.0001), but fewer more-than-mild aortic regurgitation as compared with SEV. Moderate/severe BVD were observed in 29 and 8 patients respectively, corresponding with a 6-year cumulative incidence of 7.3% (95% CI 5.0-10.1%). BVD was significantly associated with all-cause mortality for moderate (HR 2.2, 95% CI 1.3-4.0, p = 0.0051) and severe BVD (HR 4.5, 95% CI 1.4-14.1, p = 0.0105). Both a mean post-implantation TPG > 9 mmHg (HR 2.2; 95% CI 1.0-5.0, p = 0.0456) and implantation of the 20 mm SAPIEN BEV (n = 4) (HR 6.8; 95% CI 1.5-30.3, p = 0.0114) were associated with an increased incidence of BVD. BVD is a rare complication in elderly intermediate-to-high risk patients undergoing TAVI. However, BVD is associated with increased mortality.

Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasingly used for the treatment of surgical bioprosthetic valve degeneration (sBVD). We investigated clinical outcomes and hemodynamic valve performance in all consecutive patients undergoing ViV-TAVI for sBVD in a single centre and assessed differences in patients who received a balloon-expandable (BEV) versus self-expandable valve (SEV) at 1, 6 and 12 months (m), and annually thereafter. Between 25 November 2011 and 4 September 2023, 86 patients (mean age 80.3 ± 6.6y; 53.5% female; median STS score 5.1% (3.7%;8.6%) underwent ViV-TAVI with BEV (n = 53) or SEV (n = 33). Overall, the cumulative incidences of all-cause and cardiovascular mortality at 12 m were 7.4% (3.4%;15.8%) and 3.6% (0.9%; 9.3%), respectively (comparison of SEV versus BEV within the first year: p = 0.253 and p = 0.168, and comparison for the entire follow-up (median 2.6 (0.9;4.6) years): p = 0.962 and p = 0.942). Aortic valve area (AVA) and peak and mean transprosthetic gradients (TPG) improved significantly from baseline to 1, 6 and 12 m follow-up (p < 0.001 for all). Peak and mean TPG were 10.5 (1.8;19.2) and 7.1 (1.6;12.7) mmHg lower in SEV as compared with BEV at 1 m (p = 0.019 and 0.012, respectively). Similarly, AVA of SEV was 0.23 (0.03;0.44) and 0.54 (0.28;0.81) cm² larger as compared with BEV at 1 and 6 m (p = 0.027 and p < 0.001, respectively). No significant differences in hemodynamic valve performance between BEV and SEV were observed during further follow-up. ViV-TAVI is a safe and effective treatment for patients presenting sBVD. Improved hemodynamic valve performance with SEV over BEV observed during early follow-up did not translate into long-term lower mortality rates.