Objective: To assess temporal trends of patient baseline characteristics, risk profile and outcome of transcatheter aortic valve implantation (TAVI) between 2013 and 2020. Background: Guideline recommendations and increasing confidence in TAVI therapy may have changed the selection of TAVI patients. Methods: Baseline risk profile and VARC-2 outcome of 15,344 patients undergoing TAVI at 5 high volume centers in Germany over the time period 2013–2020 was analyzed. Results: Over the 8 years, annual TAVI volumes more than doubled from 1071 in 2013 to 2996 in 2020. The baseline surgical risk estimated by the Society of Thoracic Surgeons (STS) score declined from 7.2 ± 6.2% to 4.6 ± 3.7% (P < 0.001) as a consequence of lower comorbidity burden, whereas mean age remained unchanged (2013 81.0 ± 6.1; 2020 80.8 ± 6.4; P = 0.976) with patients ≥ 80 years accounting for about two-third of the treated cohort. Periprocedural complications including bleeding (2013 24.5%; 2020 12.1%; P < 0.001), vascular complications (2013 20.7%; 2020 11.7%; P < 0.001) and new permanent pacemaker implantation (2013 20.1%; 2020 13.8%, P < 0.001) decreased significantly. Similarly, the 30-day mortality decreased from 5.4% to 2.1% (P < 0.001), but remained high in high-risk patients (STS > 8% 2013 7.5%; 2020 6.9%; P = 0.778). Conclusion: From 2013 to 2020, mortality and burden of complications following TAVI procedure significantly decreased in a large multicenter registry from Germany. Proportion of elderly patients remained stable, while the surgical risk profile decreased. Graphical

Objective: Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. Methods: 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. Results: PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR. Conclusions: The susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics.

Objective: The objective of this study was to assess imaging predictors of mitral regurgitation (MR) improvement and to evaluate the impact of MR regression on long-term outcome in patients undergoing transcatheter aortic valve replacement (TAVR). Background: Concomitant MR is a frequent finding in patients with severe aortic stenosis but usually left untreated at the time of TAVR. Methods: Mitral regurgitation was graded by transthoracic echocardiography before and after TAVR in 677 consecutive patients with severe aortic stenosis. 2-year mortality was related to the degree of baseline and discharge MR. Morphological echo analysis was performed to determine predictors of MR improvement. Results: 15.2% of patients presented with baseline MR ≥ 3 +, which was associated with a significantly decreased 2-year survival (57.7% vs. 74.4%, P < 0.001). MR improved in 50% of patients following TAVR, with 44% regressing to MR ≤ 2 +. MR improvement to ≤ 2 + was associated with significantly better survival compared to patients with persistent MR ≥ 3 +. Baseline parameters including non-severe baseline MR, the extent of mitral annular calcification and large annular dimension (≥ 32 mm) predicted the likelihood of an improvement to MR ≤ 2 +. A score based on these parameters selected groups with differing probability of MR ≤ 2 + post TAVR ranging from 10.5 to 94.4% (AUC 0.816; P < 0.001), and was predictive for 2-year mortality. Conclusion: Unresolved severe MR is a critical determinant of long term mortality following TAVR. Persistence of severe MR following TAVR can be predicted using selected parameters derived from TTE-imaging. These data call for close follow up and additional mitral valve treatment in this subgroup. Graphic Factors associated with MR persistence or regression after TAVR

The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system. The study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations. The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10_only, P10/Ace_Gen1 (introduction of Ace), and P10/Ace_Prec (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years). A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10_only, 945 P10/Ace_Gen1, and 560 P10/Ace_Prec. Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10_only: 66% [n = 422 of 638], P10/Ace_Gen1: 73% [n = 661 of 906], P10/Ace_Prec: 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations. Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.

Secondary mitral regurgitation (SMR) has 2 phenotypes: atrial (aSMR) and ventricular (vSMR). The role of mitral valve transcatheter edge-to-edge repair (M-TEER) in aSMR remains less defined, with limited evidence on the PASCAL implant (Edwards Lifesciences). The authors sought to evaluate and compare outcomes of SMR phenotypes undergoing M-TEER. REPAIR (REgistry of PAscal for mItral Regurgitation) is an investigator-initiated, multicenter registry of patients undergoing M-TEER. aSMR was defined by left atrial dilation with preserved left ventricular size and ejection fraction. Outcomes included MR ≤1+ at discharge, technical success, NYHA functional class improvement, and 1-year survival. Among 915 patients (166 [18%] aSMR, 749 [82%] vSMR), the median follow-up was 491 days (Q1-Q3: 360-833 days). MR ≤1+ was achieved in 77.2% vs 71.4% (P = 0.162), with technical success in 97.0% vs 98.3% (P = 0.446). NYHA functional class improved in both phenotypes (P < 0.001), with 61.2% vs 61.3% in functional class ≤II at follow-up (P > 0.999). One-year survival was 88.4% (95% CI: 82.8%-94.4%) vs 86.0% (95% CI: 83.1%-89.0%; P = 0.346). In aSMR patients, 1-year survival was significantly lower in patients with baseline tricuspid regurgitation (TR) grade ≥moderate compared with those with <moderate TR (84.3% [95% CI: 77.0%-92.3%] vs 100.0% [95% CI: 100.0%-100.0%]; P = 0.041). In vSMR patients, survival was similar between ≥moderate and <moderate baseline TR (83.9% [95% CI: 79.8%-88.2%] vs 89.3% [95% CI: 85.0%-93.8%]; P = 0.051). M-TEER effectively reduces MR to ≤1+ and improves symptoms in both aSMR and vSMR. Particularly in aSMR, ≥moderate baseline TR is linked to worse outcomes, warranting consideration as an additional treatment target.

Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear. This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort. The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality. The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality. PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics.