Johanne Frank

Objective: Self-expanding (SE) transcatheter aortic prostheses (THV) have been associated with an increased risk of new permanent pacemaker implantation (PPMI), particularly with deeper implantations in the left ventricular outflow tract (LVOT) that result in more atrioventricular conduction system damage, leading to higher rates of post-procedural conduction disturbances (CDs) and subsequently more PPMIs. The cusp-overlap technique (COT) is designed to provide better visualisation of the LVOT during implantation, aiming to achieve a shallower implantation depth (ID) and potentially reduce both post-procedural CDs and PPMIs. This study seeks to compare the traditional three-cusp coplanar view technique (3CT) with the newer COT in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: From March 2018 to April 2020, a total of 586 patients underwent TAVR at the university clinic in Kiel. Among them, 226 patients who received SE prostheses were included in the study. After applying exclusion criteria, a final cohort of 203 patients was analysed. Of these, 106 patients underwent TAVR using the COT, while 97 patients underwent TAVR using the 3CT. The primary endpoints of the study were the occurrence of new CD and PPMI within 30 days post-procedure. Secondary endpoints included various post-TAVR events as defined by the Valve Academic Research Consortium 3 (VARC-3) safety criteria. A specific focus was placed on assessing the risk of high valve implantation according to VARC-3 criteria, specifically paravalvular insufficiency, valve embolisation, and coronary occlusion. Statistical analysis was conducted to compare outcomes between the COT and 3CT groups. Results: Implantation depths were significantly lower in the COT group compared to the 3CT group, with ID values from the NCC and LCC being 2.7 mm (±1.5) and 2.8 mm (±1.5) for the COT, and 5.4 mm (±3) and 6.6 mm (±2.6) for the 3CT (p < 0.001 for both). The incidence of high-grade CD, particularly Atrioventricular Block (AVB) II and III, was significantly higher in the 3CT group (26.8%) compared to the COT group (13.2%) (p = 0.023). The overall 30-day PPMI rate was 18.2% (n = 37), with a significant difference between the COT and 3CT groups (12.2% vs. 24.7%, p = 0.021). The primary indication for PPMI was permanent high-grade AVB occurring during or after TAVR, accounting for 95% of cases. No cases of TAVR embolisation, acute coronary occlusion or related syndromes were observed within the first 30 days post-procedure. There were no significant differences in 30-day mortality or post-procedural paravalvular insufficiency between the groups. In multivariable logistic regression analysis, the COT remained independently associated with lower odds of new post-procedural CD after adjustment for prior right bundle branch block (RBBB), prior first-degree AVB, predilatation, valve size and coronary artery disease (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.24–0.82, p = 0.009). For 30-day PPMI, the cusp-overlap technique demonstrated a borderline association with lower adjusted odds (OR 0.46, 95% CI 0.20–1.02, p = 0.057), while prior RBBB was independently associated with increased PPMI risk (OR 3.54, 95% CI 1.22–10.28, p = 0.020). Conclusions: The COT was associated with shallower implantation depth and lower rates of new post-procedural CD after multivariable adjustment. The association with reduced 30-day PPMI remained directionally consistent but was borderline after adjustment. These findings support the potential value of COT as a procedural strategy to reduce conduction-related complications after TAVR with self-expanding prostheses.

Objective: This analysis compares new (G2) versus old (G1) generations of transcatheter heart valves (THVs) in transcatheter aortic valve replacement (TAVR) procedures, focusing on key outcomes: post-procedural conduction disturbance (CD) and permanent pacemaker implantation (PPMI). We aim to determine whether G2 valves reduce these specific complications and thereby improve patient outcomes compared with G1. Methods: From February 2015 to September 2022, 1468 patients underwent TAVR at the university clinic in Kiel. After applying exclusion criteria, a final cohort of 1182 patients were analysed. Among these, 782 patients underwent TAVR with G1, whereas 400 underwent TAVR with G2. The primary study endpoints were the occurrence of new CD and PPMI within 30 days post-procedure. The secondary endpoints included diverse post-TAVR events as defined by the safety criteria of Valve Academic Research Consortium 3 (VARC III). A statistical analysis compared outcomes between the G1 and G2 groups. Results: Out of 1182 patients, 12.1% required PPMI within 30 days. Rates showed no statistical difference between G2 and G1 for PPMI (10.3% vs. 13.0%, IPTW-weighted p = 0.31) or CD (15.3% vs. 21.48%, IPTW-weighted p = 0.08). Among G2, the Sapien 3 Ultra valve had the lowest PPMI rate (4.8%). Overall, G2 and G1 had similar post-procedural and 30-day mortality rates. Conclusion: G2 valves may reduce post-procedure CD, but the difference is not statistically significant. Differences between specific valve types—such as the Sapien 3 Ultra’s lower rates—are notable, but overall, PPMI and safety profiles remain similar between G1 and G2. Patient and procedural factors still play a significant role. Careful valve and patient selection is essential, and ongoing research will guide further improvements.

Background: Heavy calcifications in severe aortic stenosis (AS) pose a major challenge in patients undergoing transcatheter aortic valve replacement (TAVR). Only a few studies have addressed the performance of different transcatheter heart valves (THV) in this subgroup of patients. Objectives: We aimed to investigate the outcomes of the self-expanding Medtronic CoreValve Evolut valve frame and the balloon-expandable Edwards SAPIEN-3/3 Ultra THV in this challenging patient population. Materials and methods: This was a multicenter registry including a total of 1513 patients with heavily calcified AS undergoing TAVR. The primary endpoint was the incidence and degree of paravalvular leak (PVL) after TAVR. Secondary endpoints were post-implant hemodynamics as well as clinical endpoints according to the VARC-3 definitions. Results: The CoreValve Evolut R but not the Evolut PRO showed significantly higher rates of PVL compared to the SAPIEN-3/3 Ultra (44.8% vs. 29.5% for mild PVL, p < 0.001), while there was no significant difference in ≥ moderate PVL between both groups (p = 0.399). The CoreValve Evolut R and Evolut PRO showed superior THV hemodynamics compared to the SAPIEN-3/3 Ultra group. These findings were confirmed in a propensity score-matched analysis. There were no significant differences regarding short-term outcomes including permanent pacemaker implantation and all-cause mortality between the three groups. Conclusion: In patients with severely calcified AS, both CoreValve Evolut PRO and SAPIEN-3/3 Ultra THV showed lower rates of PVL than the CoreValve Evolut R. The self-expanding CoreValve platform had superior post-implant hemodynamics than the SAPIEN-3/3 Ultra system. Graphical

Background: Calculated plasma volume status (PVS) reflects volume overload based on the deviation of the estimated plasma volume (ePV) from the ideal plasma volume (iPV). Calculated PVS is associated with prognosis in the context of heart failure. This single-center study investigated the prognostic impact of PVS in patients undergoing transcatheter aortic valve implantation (TAVI). Methods: A total of 859 TAVI patients had been prospectively enrolled in an observational study and were included in the analysis. An optimal cutoff for PVS of −5.4% was determined by receiver operating characteristic curve analysis. The primary endpoint was a composite of all-cause mortality or heart failure hospitalization within 1 year after TAVI. Results: A total of 324 patients had a PVS < −5.4% (no congestion), while 535 patients showed a PVS ≥ −5.4% (congestion). The primary endpoint occurred more frequently in patients with a PVS ≥ −5.4% compared to patients with PVS < −5.4% (22.6% vs. 13.0%, p < 0.001). After multivariable adjustment, PVS was confirmed as a significant predictor of the primary endpoint (HR 1.53, 95% CI 1.05–2.22, p = 0.026). Conclusions: Elevated PVS, as a marker of subclinical congestion, is significantly associated with all-cause mortality and heart failure hospitalization within 1 year after TAVI.

Background: Elevated pre-procedural high-sensitivity troponin T (hs-TnT) levels predict adverse outcomes in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). It is unknown whether elevated troponin levels still provide prognostic information during follow-up after successful TAVR. We evaluated the long-term implications of elevated hs-TnT levels found at 1-year post-TAVR. Methods and results: The study included 349 patients who underwent TAVR for severe AS from 2010–2019 and for whom 1-year hs-TnT levels were available. Any required percutaneous coronary interventions were performed > 1 week before TAVR. The primary endpoint was survival time starting at 1-year post-TAVR. Optimal hs-TnT cutoff for stratifying risk, identified by ROC analysis, was 39.4 pg/mL. 292 patients had hs-TnT < 39.4 pg/mL (median 18.3 pg/mL) and 57 had hs-TnT ≥ 39.4 pg/mL (median 51.2 pg/mL). The high hs-TnT group had a higher median N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, greater left ventricular (LV) mass, higher prevalence of severe diastolic dysfunction, LV ejection fraction < 35%, severe renal dysfunction, and more men compared with the low hs-TnT group. All-cause mortality during follow-up after TAVR was significantly higher among patients who had hs-TnT ≥ 39.4 pg/mL compared with those who did not (mortality rate at 2 years post-TAVR: 12.3% vs. 4.1%, p = 0.010). Multivariate analysis identified 1-year hs-TnT ≥ 39.4 pg/mL (hazard ratio 2.93, 95% CI 1.91–4.49, p < 0.001), NT-proBNP level > 300 pg/mL, male sex, an eGFR < 60 mL/min/1.73 m² and chronic obstructive pulmonary disease as independent risk factors for long-term mortality after TAVR. Conclusions: Elevated hs-TnT concentrations at 1-year after TAVR were associated with a higher long-term mortality. Graphic