Elmar Kuhn

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 JenaValve Trilogy Transcatheter Heart Valve System (Trilogy) is a CE-marked transcatheter aortic valve replacement device designed for the treatment of symptomatic aortic regurgitation. Despite its unique indication, data from large cohorts remain limited. This study aimed to evaluate procedural characteristics and clinical outcomes in all-comers patients with symptomatic aortic regurgitation undergoing transfemoral transcatheter aortic valve replacement with the Trilogy valve. METHODS: This multicenter retrospective analysis included patients with symptomatic aortic regurgitation who underwent Trilogy implantation between June 2021 and June 2025 at 8 European centers. Baseline, procedural, and follow-up data were collected according to local protocols, and outcomes were defined per VARC-3 (Valve Academic Research Consortium-3). RESULTS: A total of 363 patients (median age, 81 years [interquartile range, 75–84]; 45% female patients; median European System for Cardiac Operative Risk Evaluation II, 3.4%; median left ventricular ejection fraction, 50%) were included. Transfemoral access was used in 359 (99%), and technical success was achieved in 98%. Valve embolization occurred in 5 patients: 2 managed with a second valve, 2 surgically, and 1 required valve-in-valve reintervention. Two additional technical failures involved hemodynamic instability and a vascular complication. At discharge, 86% had none or trace leakage, and the mean transvalvular gradient was 4 mm Hg. Permanent pacemaker implantation was required in 22%. In-hospital mortality was 0.3%. At 30 days, functional status had improved markedly, with 88% of patients in New York Heart Association class I or II. Kaplan-Meier estimated all-cause mortality at 6 months, 1, 2, and 3 years was 4.1%, 7.0%, 15.8%, and 25.9%, respectively, among patients with available follow-up. CONCLUSIONS: In this large analysis, transfemoral transcatheter aortic valve replacement with the Trilogy valve demonstrated high procedural success and favorable hemodynamic valve performance. These findings are encouraging and suggest a potential role for the Trilogy valve in patients with symptomatic aortic regurgitation who are unsuitable for surgery.

Background: Outcomes >2 years after transcatheter aortic valve replacement (TAVR) for bicuspid aortic valves (BAV) are scarce, and differences between balloon‐expandable transcatheter heart valves (THVs) and self‐expandable (SE‐THVs) are not yet well established. Methods: This study aims to report midterm outcomes after TAVR in patients with BAV and includes 92 patients undergoing TAVR for BAV stenosis at the University Hospital Cologne between 2018 and 2023. The primary outcomes were all‐cause death, cardiovascular death, and stroke over a mean follow‐up of 2.9 years. Results: Among 92 consecutive patients undergoing TAVR for BAV stenosis (median age: 78.8 years), the incidence of all‐cause death, cardiovascular death, and stroke was 26.1%, 18.5%, and 14.1%, respectively, at 2.9 years, with no differences between balloon‐expandable THVs and SE‐THVs. Pacemaker implantation tended to be more frequent in the SE‐THV group. Periprocedural complications were rare, as reflected by a high Valve Academic Research Consortium‐3 technical success rate of 96.7%. Postprocedural transvalvular gradients were favorable, with SE‐THV showing lower values than balloon‐expandable THV (8.0 versus 10.5 mm Hg, P =0.007). Moderate or severe paravalvular regurgitation was uncommon, with no differences between groups, although a trend toward more relevant paravalvular regurgitation with SE‐THV was observed. Conclusions: TAVR for BAV is feasible with both SE‐THV and balloon‐expandable ‐THV, achieving high technical success and low complication rates. Hemodynamic differences were observed, but mortality and stroke did not differ significantly between groups. Overall outcomes remain suboptimal, highlighting the need for randomized trials comparing valve types and TAVR with surgery for patients with BAV.

Transcatheter aortic valve implantation (TAVI) has evolved into the dominant therapeutic option for severe aortic stenosis, with procedural refinements and expanding indications increasingly supporting shorter post-procedural monitoring and discharge. International evidence from randomized trials, multi-center registries, and consensus guidelines demonstrates that reduced length of stay (LOS), including next-day or early discharge, can be safely achieved in selected patients when supported by standardized workflows, careful patient selection, and structured outpatient monitoring. In Germany, LOS remains among the longest in Europe, driven by structural, reimbursement, and cultural barriers. With increasing TAVI volumes, demographic pressures, and workforce constraints, these barriers inhibit health system sustainability, procedural capacity, and patient experience. Early discharge below the currently defined thresholds often results in financial disadvantages under the Diagnosis-Related Group (DRG) reimbursement mechanism, thereby disincentivizing standardized adoption and pathway innovation. Yet, a reduction in LOS would yield meaningful system-level advantages, including increased procedural capacity, improved resource allocation, and lower post-procedural bed occupancy costs, all leading to better and more efficient patient pathways. This narrative, practice- and policy-oriented critical perspective evaluates the current German landscape and outlines pragmatic strategies to enable safe early discharge. It synthesizes relevant international evidence, identifies system-level barriers specific to Germany, and proposes a structured roadmap including: (1) standardized eligibility criteria, (2) protocolized peri- and post-procedural pathways, (3) pilot implementation in carefully selected centers with outcome reporting, and (4) reimbursement realignment to avoid wrong financial incentives. Supported by professional medical societies and aligned with international standards, early discharge pathways could enhance efficiency and improve patient-centered care, offering Germany a timely opportunity to modernize TAVI experience and delivery. Graphical Abstract The alternative text for this image may have been generated using AI.

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.

Background: Exercise training is generally discouraged in patients with severe symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) due to safety concerns. However, whole-body vibration (WBV) exercise could offer a novel approach to improve exercise capacity and quality of life, though its effects remain unclear in this population. Methods: Thirty patients with AS scheduled for TAVI were prospectively and randomly assigned to either the WBV group (12 sessions, 30 min each over 4 weeks) or a control group. Assessments of cardiopulmonary exercise testing (CPET), 6-min walking distance (6MWD) and health-related quality of life (HRQoL) questionnaires were conducted at baseline (V1), one day before TAVI (V2) and at short-term follow-up (V3). WBV was conducted between V1 and V2. Results: For the analysis at V1 and V2 16 patients in the WBV group and 14 in the control group were included. Mean age was 79.7 ± 5.22 years, with a mean aortic valve area of 0.75 ± 0.21 cm². Peak V’O₂ increased by 0.3 mL*min^-1*kg^-1 in the WBV group versus a decrease of − 1.4 mL*min^-1*kg^-1 in the control group (difference, 1.7 mL*min^-1*kg^-1; 95% CI, [0.2 to 3.2], p = 0.03). Peak power improved by 5.1 W in the WBV group compared to a decline of − 4.5 W in the control group (difference, 9.6 W; 95% CI, [2.1 to 17.1], p = 0.01). The WBV group also showed a non-significant improvement in 6MWD (34 m vs. − 8 m in the control group; difference, 42 m; 95% CI, [-10 to 93], p = 0.11). No serious adverse events occurred in the WBV group. Conclusion: This pilot study demonstrated that a WBV exercise program is feasible, safe, and showed potential to preserve exercise capacity as well as physical performance in AS patients scheduled for TAVI. Graphical

Background: The Valve Academic Research Consortium (VARC) has updated criteria for periprocedural bleeding after transcatheter aortic valve replacement. However, clinical validation of the VARC‐3 bleeding definition is scarce. The aim of this study was to evaluate incidence, associated variables, and clinical impact of VARC‐3 bleeding. Methods: The study included 2227 patients with severe aortic stenosis undergoing transcatheter aortic valve replacement between 2018 and 2023 at the University Hospital Cologne. VARC‐3 bleeding during the index hospitalization were analyzed. Incidence, variables associated with bleeding, and impact on 30‐day mortality were evaluated by comparison to the VARC‐2 criteria. All data were prospectively collected. Results: VARC‐3 bleeding was 2.5 times more prevalent than VARC‐2 (13.9% versus 34.4%), as VARC‐3 includes nonattributable blood loss >3 g/dL as a bleeding event. Chronic kidney disease, thoracotomy access, dual antiplatelet therapy ( P P =0.023) were variables associated with VARC‐3 bleedings. Type 3 bleeding (VARC‐3) was associated with an increased 30‐day mortality (hazard ratio [HR], 2.89 [95% CI, 1.35–6.19], P =0.006). VARC‐2 major and life‐threatening bleeding events were associated with increased 30‐day mortality as well (HR, 2.74 [95% CI, 1.26–5.95], P =0.011 and HR, 29.60 [95% CI, 17.42–50.30], P <0.001). Conclusions: The VARC‐3 criteria present a refined classification for bleeding with prognostic relevance. However, the VARC‐2 criteria demonstrate precision and clear correlation with increasing mortality risk proportional to the severity of bleeding too, showing even greater predictive accuracy in the transfemoral cohort. These findings require further validation with similar or even larger patient cohorts.

Background: The Tendyne™ transcatheter heart valve (THV) system is a promising option for high-risk patients with severe mitral regurgitation (MR) who are ineligible for surgery or transcatheter edge-to-edge repair (TEER). As most fatal complications occur within the first 90 days, this study aimed to identify anatomical predictors of in-hospital mortality after transcatheter mitral valve replacement (TMVR). Methods: In this subanalysis of the TENDER registry, data from 110 patients who underwent TMVR across 26 centers between January 2020 and June 2022 were evaluated. Preprocedural imaging parameters were analyzed, including transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and cardiac 4D computed tomography (CT). Results: We identified LVEDDi as a significant predictor of in-hospital mortality (p = 0.022), with lower values in non-survivors (26.42 ± 3.76 mm/m²) than in survivors (30.37 ± 5.58 mm/m²). Both indexed and absolute LVEDDi predicted in-hospital complications (p < 0.001 and p = 0.008). In multivariate analysis, LVEDDi (p = 0.048; OR = 0.856) and STS score (p = 0.038; OR = 1.114) remained independent predictors of in-hospital mortality. In an extended model, only LVEDDi persisted as a significant predictor (p = 0.007), highlighting its robustness. Conclusions: This analysis identified a small LVEDDi as a novel, clinically relevant risk factor in TMVR and showed its added value alongside conventional markers. Its easy calculation supports incorporating LVEDDi thresholds into screening to improve patient selection and outcomes.

Background: Mitral transcatheter edge-to-edge repair (M-TEER) has been established as a treatment for severe mitral regurgitation (MR). However, recurrent MR may occur after successful primary M-TEER. Repeat M-TEER procedures are challenging or even anatomically unfeasible. Therefore, novel techniques like electrosurgical laceration from the anterior leaflet and stabilization (ELASTA) of M-TEER devices are important. Case summary: An 85-year-old male presented with recurrent cardiac decompensations and relevant dyspnoea [New York Heart Association (NYHA) functional Class III–IV] caused by severe MR and heart failure. Four years earlier, the patient underwent M-TEER with two PASCAL devices due to severe primary MR. Echocardiography revealed two significant regurgitation jets, representing severe recurrent MR. Repeated M-TEER was prohibitive due to an elevated mean transvalvular gradient (6.2 mmHg) and surgery was deemed unfeasible. A computed tomography (CT) was performed using software based on artificial intelligence (AI) for automatic analysis of the mitral valve anatomy. The heart team then decided to perform an ELASTA of the two PASCAL devices with subsequent transapical transcatheter mitral valve implantation (TMVI). The procedure was performed without complications and achieved optimal haemodynamic outcomes. Discussion: The frequency of M-TEER procedures will rise, leading to a corresponding increase of recurrent MR requiring treatment. However, additional edge-to-edge repair is often not feasible due to space limitations, elevated inflow gradients, or progressive calcification of valve leaflets. Emerging electrosurgical techniques, such as ELASTA, combined with subsequent TMVI, offer promising solutions for recurrent MR. Computed tomography imaging plays a critical role in procedural planning, and AI-driven programs have the potential to significantly improve and optimize these analyses.

Background: Benchmark best practices have been shown to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI), but the impact in diverse health systems is unknown. Aims: We evaluated the impact of Benchmark best practices implementation in Germany, Austria, France, Spain, and Italy. Methods: International, multicentre registry of severe symptomatic aortic stenosis (AS) patients undergoing TAVI with a balloon-expandable valve, before and after Benchmark best practices implementation. Objectives were to reduce overall and intensive care unit (ICU) length of stay (LoS), and to document 30-day safety. Results: A total of 890 patients were analysed in France, 454 in Spain, 362 in Germany, 300 in Italy, and 176 in Austria. Patients had the highest surgical risk in Germany (EuroSCORE II 6.8 ± 7.3%) and lowest in Spain (3.8 ± 2.6%). Austrian patients reported higher rates of prior myocardial infarction, severe pulmonary hypertension, and aortic valve-related symptoms at baseline. After the implementation of Benchmark best practices, the median hospital LoS was significantly reduced in France (5 vs. 3 days, p < 0.001), Spain (6 vs. 4, p < 0.001), Germany (9 vs. 6, p < 0.001), and Italy (7 vs. 5, p < 0.001); reductions in median ICU LoS were reported in France (1.1 vs. 0 days, p < 0.001), Spain (1.9 vs. 1, p < 0.001), and Germany (1 vs. 0.9, p = 0.004). Across all countries, 30-day safety outcomes were uncompromised and reduced rates of major vascular complications rates were observed in Germany (5.9 vs. 0.0%, p < 0.001). Conclusion: The implementation of Benchmark best practices in diverse European healthcare systems resulted in reduced hospital and ICU LoS without compromising patient safety. Trial registration: ClinicalTrials.gov NCT04579445, September 28th, 2020