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Background: 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., Objectives: This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort., Methods: 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., Results: 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., Conclusions: 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., Competing Interests: Funding Support and Author Disclosures This work was supported by the Deutsche Forschungsgemeinschaft (397484323) to Drs Guthoff, Matti Adam and Stephan Baldus, and Mauri; PA 2409/5-2 to Drs Thurow and Pauly; the Dean’s Office, Faculty of Medicine, University of Cologne (clinician scientist position) to Dr Guthoff; and the Center for Molecular Medicine Cologne (Baldus B-02) to Dr Stephan Baldus. Dr Abdel-Wahab’s institution has received speaker honoraria and/or consultancy fees from Abbott, Boston Scientific, and Medtronic. Dr Kim has received proctor and personal fees from Abbott, Boston Scientific, Meril Life Sciences, and Shockwave Med; is a member of the advisory boards for Abbott, Boston Scientific, and HID Imaging; and Dr Kim’s institution has received fees from Boston Scientific. Dr Nombela-Franco has served as proctor for Abbott and Edwards Lifesciences. Dr Matjaz Bunc served as proctor for TAVR procedures with Edwards Lifesciences, Medtronic, Meril, and Abbott. Matjaz Bunc is a member of the advisory boards for Medtronic and Edwards Lifesciences. Dr Veulemans has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Tanja Rudolph has received lecture fees from Abbott, SIS Medical and Translumina. Dr Zeus has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Objective: Transcatheter aortic valve replacement (TAVR) is an established treatment option for patients with symptomatic severe aortic stenosis across all stages of surgical risk. Rapid pacing during the procedure and the risk for the occurrence of conduction disturbances after TAVR requires the pre-interventional insertion of a temporary pacemaker (TP). However, this approach poses risks, including the risk of infection. For this reason, the following study aimed to investigate microbial growth on temporary pacemaker leads and its association with outcome post-TAVR and to identify associated pathogens and related risk factors., Methods: A prospective study was conducted including 344 patients undergoing TAVR at the Heart Centre Bonn. Of these, 97 patients did not require TP leads as they already had permanent pacemakers; this group was considered as comparison group. The TP leads of the remaining 247 patients were removed, sonicated, and cultured to investigate bacterial growth over a period of 14 days. Finally, we compared patients without microbial growth (n = 184) and patients with microbial growth (n = 63). The primary endpoint of the study was 30-day all-cause mortality, secondary endpoints were periprocedural infections, the length of the postprocedural hospital stay, 30-day major vascular complications and the 30-day stroke rate., Results: The majority of cases (74.5%) showed no bacterial growth. In the remaining cases (25.5%), diverse microorganisms were identified, mostly non-pathogenic bacteria. The statistical analysis revealed no significant differences between groups according to microbial growth in terms of 30-day mortality (p = 0.446), postprocedural hospital stay (p = 0.401), periprocedural infections (p = 0.434), 30-day major vascular complications (p = 1.0), and 30-day stroke rate (p = 1.0). Notably, the timing of sheath insertion was significantly associated with microbial growth; sheath placement more than 2 days prior to the procedure was associated with a significantly higher risk of microbial growth (OR: 2.1; 95% CI 1.1-4.3) (p = 0.030)., Conclusions: The presence of temporary leads does not significantly impact clinical outcomes, irrespective of bacterial growth on the lead. However, the timing and duration of sheath placement plays a crucial role in contamination incidence. Thus, temporary leads/sheaths should be placed shortly before the procedure and removed promptly to reduce the risk of contamination/infection., (© 2024. The Author(s).)

Purpose: Inflammatory changes in epicardial (EAT) and pericardial adipose tissue (PAT) are associated with increased overall cardiovascular risk. Using routine, preinterventional cardiac CT data, we examined the predictive value of quantity and quality of EAT and PAT for outcome after transcatheter aortic valve replacement (TAVR)., Materials and Methods: Cardiac CT data of 1197 patients who underwent TAVR at the in-house heart center between 2011 and 2020 were retrospectively analyzed. The amount and density of EAT and PAT were quantified from single-slice CT images at the level of the aortic valve. Using established risk scores and known independent risk factors, a clinical benchmark model (BMI, Chronic kidney disease stage, EuroSCORE 2, STS Prom, year of intervention) for outcome prediction (2-year mortality) after TAVR was established. Subsequently, we tested whether the additional inclusion of area and density values of EAT and PAT in the clinical benchmark model improved prediction. For this purpose, the cohort was divided into a training (n=798) and a test cohort (n=399)., Results: Within the 2-year follow-up, 264 patients died. In the training cohort, particularly the addition of EAT density to the clinical benchmark model showed a significant association with outcome (hazard ratio 1.04, 95% CI: 1.01-1.07; P =0.013). In the test cohort, the outcome prediction of the clinical benchmark model was also significantly improved with the inclusion of EAT density (c-statistic: 0.589 vs. 0.628; P =0.026)., Conclusions: EAT density as a surrogate marker of EAT inflammation was associated with 2-year mortality after TAVR and may improve outcome prediction independent of established risk parameters., Competing Interests: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Aortic stenosis has pathophysiological similarities with atherosclerosis, including the deposition of cholesterol-containing lipoproteins. The resulting cholesterol crystals activate the NLRP3 (NOD-like receptor protein 3) inflammasome, leading to inflammation and cardiovascular diseases. We aimed to investigate the cholesterol crystal dissolution rate (CCDR) of serum in patients with aortic stenosis and to assess the prognostic value of this biomarker., Methods and Results: The study included 348 patients with aortic stenosis undergoing transcatheter aortic valve replacement. The CCDR was measured using flow cytometry to enumerate cholesterol crystals that were added to a serum solution, at baseline and after 2 hours of incubation. Based on the median CCDR, the cohort was stratified into high and low cholesterol crystal dissolvers. The incidence of the primary end point, a composite of 1-year all-cause mortality and major vascular complication, was significantly lower in the high CCDR group (7.3 per 100 person-years) compared with the low CCDR group (17.0 per 100 person-years, P =0.01). This was mainly driven by a lower 1-year mortality rate in patients with a high CCDR (7.3 versus 15.1 per 100 person-years, P =0.04). Unplanned endovascular interventions were significantly less frequent in high cholesterol crystal dissolvers (12.8 versus 22.6 per 100 person-years, P =0.04). Although low-density lipoprotein cholesterol levels were comparable in both groups (101.8±37.3 mg/dL versus 97.9±37.6 mg/dL, P =0.35), only patients with a low CCDR showed a benefit from statin treatment. In multivariate analysis, low CCDR (hazard ratio, 2.21 [95% CI, 0.99-4.92], P =0.04) was significantly associated with 1-year mortality., Conclusions: The CCDR is a novel biomarker associated with outcome in patients with aortic stenosis undergoing transcatheter aortic valve replacement. It may provide new insights into patients' anti-inflammatory capacity and additional prognostic information beyond classic risk assessment.

Background: Malnutrition is associated with adverse outcomes in patients with aortic stenosis. The Triglycerides × Total Cholesterol × Body Weight Index (TCBI) is a simple scoring model to evaluate the status of nutrition. However, the prognostic relevance of this index in patients undergoing transcatheter aortic valve replacement (TAVR) is unknown. This study aimed to evaluate the association of the TCBI with clinical outcomes in patients undergoing TAVR., Methods: A total of 1377 patients undergoing TAVR were evaluated in this study. The TCBI was calculated by the formula; triglyceride (mg/dL) × total cholesterol (mg/dL) × body weight (kg)/1000. The primary outcome was all-cause mortality within 3 years., Results: Patients with a low TCBI, based on a cut-off value of 985.3, were more likely to have elevated right atrial pressure (p = 0.04), elevated right ventricular pressure (p < 0.01), right ventricular systolic dysfunction (p < 0.01), tricuspid regurgitation ≥ moderate (p < 0.01). Patients with a low TCBI had a higher cumulative 3-year all-cause (42.3% vs. 31.6%, p < 0.01; adjusted HR 1.36, 95% CI 1.05-1.77, p = 0.02) and non-cardiovascular mortality (15.5% vs. 9.1%, p < 0.01; adjusted HR 1.95, 95% CI 1.22-3.13, p < 0.01) compared to those with a high TCBI. Adding a low TCBI to EuroSCORE II improved the predictive value for 3-year all-cause mortality (net reclassification improvement, 0.179, p < 0.01; integrated discrimination improvement, 0.005, p = 0.01)., Conclusion: Patients with a low TCBI were more likely to have right-sided heart overload and exhibited an increased risk of 3-year mortality. The TCBI may provide additional information for risk stratification in patients undergoing TAVR., (© 2023. The Author(s).)

Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction., Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes., Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated., Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027)., Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered., Competing Interests: Funding Support and Author Disclosures Dr Whisenant is a consultant for Edwards Lifesciences. Dr Unbehaun is a proctor for Edwards Lifesciences. Dr Erlebach has received speaker honoraria from Medtronic and Abbott; and is a proctor for Abbott. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Bruschi is a consultant for Abbott. Dr Rudolph has received speaker honoraria from Edwards Lifesciences; and is a proctor for Edwards Lifesciences. Dr Andreas is a consultant for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Zoll, and AbbVie; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Dvir is a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Left ventricular reverse remodeling (LVRR) is associated with improved outcome in patients with heart failure. Factors associated with and predictive of LVRR in patients with low-flow low-gradient aortic stenosis (LFLG AS) after transcatheter aortic valve implantation (TAVI) and its impact on outcome were assessed., Methods: Pre- and postprocedural left ventricular (LV) function and volume were investigated in 219 patients with LFLG. LVRR was defined as an absolute increase of ≥10% in LV ejection fraction (LVEF) and reduction of ≥15% in LV end-systolic volume (LVESV). The primary endpoint was the combination of all-cause mortality and rehospitalization for heart failure., Results: The mean LVEF was 35.0 ± 10.0%, with a stroke volume index (SVI) of 25.9 ± 6.0 mL/m 2 and LVESV of 94.04 ± 46.0 mL. At a median of 5.2 months (interquartile range, 2.7-8.1 months), 77.2% (n = 169) of the patients showed echocardiographic evidence of LVRR. A multivariate model revealed three independent factors for LVRR after TAVI: SVI of <25 mL/m 2 (hazard ratio [HR], 2.31; 95% confidence interval [CI], 1.08-3.58; p < 0.01), LVEF of <30% (HR, 2.76; 95% CI, 1.53-2.91; p < 0.01), and valvulo-arterial impedance (Z va ) of <5 mmHg/mL/m 2 (HR, 5.36; 95% CI, 1.80-15.98; p < 0.01). Patients without evidence of LVRR showed a significantly higher incidence of the 1-year combined endpoint (32 [64.0%] vs. 75 [44.4%], p < 0.01)., Conclusions: The majority of patients with LFLG AS show LVRR after TAVI, which is associated with favorable outcomes. An SVI of <25 mL/m 2 , LVEF of <30%, and Z va < 5mmHg/mL/m 2 represent predictors of LVRR., (Copyright © 2023 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Background: We aimed to evaluate echocardiographic parameters to predict calcific aortic valve disease (CAVD) progression. CAVD ranges from aortic valve sclerosis (ASc) with no functional impairment of the aortic valve to severe aortic stenosis (AS). It remains uncertain, which patients with ASc have a particularly high risk of developing AS., Methods: We included a total of 153 patients with visual signs of ASc and peak flow velocity (Vmax) below 2.5 m/s at baseline echocardiography. Progression of CAVD to AS was defined as an increase in Vmax ≥ 2.5 m/s with a delta of ≥ 0.1 m/s; stable ASc was defined as Vmax below 2.5 m/s and a delta < 0.1 m/s. Finally, we compared clinical and echocardiographic parameters between these two groups., Results: The mean age at baseline was 73.5 ( ± 8.2) years and 66.7% were of male sex. After a mean follow-up of 1463 days, 57 patients developed AS, while 96 patients remained in the ASc group. The AS group showed significantly more calcification ( p < 0.001) and thickening ( p < 0.001) of the aortic valve cusps at baseline, although hemodynamics showed no evidence of AS in both groups (ASc group: Vmax 1.6 ± 0.3 m/s versus AS group: Vmax 1.9 ± 0.3 m/s; p < 0.001). Advanced calcification (odds ratio [OR]: 4.8, 95% confidence interval [CI]: 1.5-15.9; p = 0.009) and a cusp thickness > 0.26 cm (OR: 16.6, 95% CI: 5.4-50.7; p < 0.001) were independent predictors for the development of AS., Conclusions: The acquisition of simple echocardiographic parameter may help to identify patients with particularly high risk of developing AS., Competing Interests: Prof. Baldus received research grants and speaker honoraria from Abbott, and Edwards Lifesciences. Dr. V. Veulemans has received speaker honoraria, grants or travel supports from Medtronic, Boston Scientific and Edwards Lifesciences. The other authors report no conflicts of interest., (Copyright: © 2023 The Author(s). Published by IMR Press.)

Background: Vascular injury and bleeding complications remain frequent after transcatheter aortic valve replacement (TAVR). Whether the access-site of preprocedural coronary angiography (CAG) affects TAVR-related complications is not known. The aim of this study was to evaluate the impact of transradial (TRA) versus transfemoral access (TFA) for preprocedural CAG on outcomes in patients undergoing subsequent TAVR., Methods: The study cohort included 1002 patients undergoing transfemoral TAVR, of whom 39.4% (395/1002) had undergone radial and 60.6% (607/1002) femoral access for pre-TAVR CAG. The primary endpoint was a composite of 30-day mortality and major vascular complications after TAVR. Key secondary endpoints included VARC-3-defined complications., Results: The primary endpoint occurred less frequently in patients with prior TRA (3.3%) as compared to patients with prior TFA (6.3%, p = 0.04), which was mainly driven by significantly lower rates of major vascular complications (0.8% vs 2.5%, p = 0.05). Moreover, incidences of periprocedural access-related vascular injury and unplanned endovascular interventions were lower in TRA patients (13.2% vs 18.0%, p = 0.05). The rate of major bleeding tended to be lower in the TRA (1.5%) as compared to the TFA group (3.5%) but was not significantly different (p = 0.07). Moreover, the rate of life-threatening bleeding was comparable between both groups (0.5% vs 0.8%, p = 0.71)., Conclusion: Transradial access for preprocedural CAG was associated with significantly lower rates of vascular complications following subsequent TAVR as compared to transfemoral access. However, despite the tendency to lower major bleedings with transradial access, no significant association was detectable between the access-site of coronary angiography and TAVR-related bleeding complications., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Georg Nickenig reports financial support was provided by German Research Foundation. Drs. Grube, Zimmer, Adam, and Nickenig have received speaker honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Veulemans has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Kelm has received institutional grant support and/or personal fees from Philips, Abbott, Medtronik, Boston Scientific, Mars, Boehringer Ingelheim, Daiichi-Sanyko GmbH, Amgen, Ancora Heart, and B. Braun. Dr. Grube is a proctor for Boston Scientific and Medtronic. The other authors report no conflicts of interest., (© 2023 The Authors.)

Background: Recently, the Chronic Kidney Disease-Epidemiology Collaboration working group has published new formulas for race-independent estimation of glomerular filtration rate (GFR). We investigated the old and new eGFR equations in patients transcatheter aortic valve implantation (TAVI)., Methods: We conducted a retrospective analysis based on the data from a prospective registry of patients who underwent TAVI from January 2008 to May 2019. The primary endpoint was 30-day mortality after TAVI, and the secondary endpoints included one- and three-year mortality., Results: In total, 1792 patients undergoing TAVI were included in the present analysis. The thirty-day mortality was 4.6 % (95 % CI 3.8-5.7 %), and the one- and three-year mortality were 17.5 % (95 % CI 15.7-19.4 %) and 34.4 % (95 % CI 32.0-37.0 %). After the application of the new eGFR formula, 12.0 % of patients were reclassified within the GFR category in CKD, while 13.2 % of patients were reclassified within the GFR categories of the EuroSCORE II. Hazard ratios for 30-day, one-year, and three-year mortality increased after introduction of the new creatine-based eq. (1.51, 1.52, 1.49 vs. 1.87, 1.79, 1.74, respectively). Compared to the old equation, the new eGFR <60 ml/min/1.73 m 2 had a better discrimination ability for the 30-day mortality (Harell's C: 0.563 (95 % CI 0.518-0.608) vs, 0.583 (95 % CI 0.546-0.636); delta Harell's C, 0.031 ± 0.022, p < 0.001). Similar findings were consistently observed in the cystatin creatinine-based equations., Conclusions: The application of the new race-independent estimators of GFR results in the reassessment of renal function in a significant proportion of TAVI patients and may influence the risk stratification of this population., Competing Interests: Conflict of interest Georg Nickenig has received research funding from Edwards Lifesciences, Medtronic, and St Jude Medical and has received honoraria for lectures or advisory boards from Edwards Lifesciences, Medtronic, and St Jude Medical. The other authors have no conflicts of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)

In this prospective observational study, we investigated the impact of geriatric syndromes and frailty on mortality and evaluated the prognostic value of different frailty, nutritional, and geriatric assessment tools in high-risk patients with severe mitral valve regurgitation (MR) who were evaluated for mitral valve therapies including surgical, interventional, and conservative treatment options. We prospectively assessed multiple parameters including the CONUT Score, the Katz Index of independence in activities of daily living (ADL), the Fried Frailty Phenotype (FFP), and the Essential Frailty Toolset (EFT) Score in 127 patients with severe symptomatic MR requiring surgical/interventional treatment versus conservative monitoring. We compared their predictive value on mortality including multivariate regression analysis to identify the most suitable tool to predict outcomes in these patient groups. The frailty syndrome as assessed with the CONUT Score, Katz Index, EFT Score, and FFP was associated with higher rates of comorbidities, significantly higher risk scores such as logistic EuroSCORE, EuroSCORE II, and STS-PROM, and significantly higher mortality rates. The EFT Score and FFP were independent predictors of one-year all-cause mortality in our study cohort (EFT Score: HR 1.9, 95% CI 1.2 to 3.2; p = 0.01; FFP: HR 1.8, 95% CI 1.1 to 3.1; p = 0.015). Geriatric syndromes and frailty are associated with increased mortality in high-risk patients with symptomatic severe MR. The EFT Score and the FFP were independent predictors of one-year all-cause mortality., (© 2022. The Author(s).)

Background: The deployment process of the largest self-expandable device (STHV-34) during transcatheter aortic valve implantation (TAVI) might be challenging due to stabilization issues. Whether the use of different TAVI-guidewires impact the procedural success and outcome is not well-known. Therefore, we sought to evaluate the impact of non-Lunderquist (NLu) vs. the Lunderquist (Lu) guidewires during TAVI using the STHV-34 on the procedural and 30-day outcomes., Methods: The primary study endpoint was defined as the final implantation depth (ID) depending on the selected guidewire strategy. Key secondary endpoints included VARC-3-defined complications., Results: The study cohort included 398 patients of four tertiary care institutions, of whom 79.6% (317/398) had undergone TAVI using NLu and 20.4% (81/398) using Lu guidewires. Baseline characteristics did not substantially differ between NLu and Lu patients. The average ID was higher in the Lu cohort (NLu vs. Lu: -5.2 [-7.0-(-3.5)] vs. -4.5 [-6.0-(-3.0)]; p = 0.022 * ). The optimal ID was reached in 45.0% of patients according to former and only in 20.1% according to nowadays best practice recommendations. There was no impact of the guidewire use on the 30-day outcomes, including conduction disturbances and pacemaker need (NLu vs. Lu: 15.1 vs. 18.5%; p = 0.706)., Conclusion: The use of the Lunderquist TM guidewire was associated with a higher ID during TAVI with the STHV-34 without measurable benefits in the 30-day course concerning conduction disturbances and associated pacemaker need. Whether using different guidewires might impact the outcome in challenging anatomies should be further investigated in randomized studies under standardized conditions., Competing Interests: VV, CJ, and TZ have received consulting fees, travel expenses, or study honoraria from Medtronic, Edwards Lifesciences, and Boston Scientific. GN and MA have received speaker honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences. SB has received speaker honoraria from Abbott Medical and Edwards LifeSciences and has received research grants from Abbott Medical. NVM has grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, Daiichi Sankyo, Pie Medical. MK has received institutional grant support and/or personal fees from Philips, Abbott, Medtronik, Boston Scientific, Mars, Boehringer Ingelheim, Daiichi-Sanyko GmbH, Amgen, Ancora Heart, and B. Braun. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Veulemans, Wilde, Wienemann, Adrichem, Hokken, Al-Kassou, Shamekhi, Mauri, Maier, Jung, Horn, Adam, Nickenig, Baldus, Van Mieghem, Kelm, Sedaghat and Zeus.)

Background: Despite major advances, transcatheter aortic valve replacement (TAVR) is still associated with procedure-specific complications. Although previous studies reported lower bleeding rates in patients receiving protamine for heparin reversal, the optimal protamine-to-heparin dosing ratio is unknown., Hypothesis: The aim of this study was a comparison of two different heparin antagonization regimens for the prevention of bleeding complications after TAVR., Methods: The study included 1446 patients undergoing TAVR, of whom 623 received partial and 823 full heparin antagonization. The primary endpoint was a composite of 30-day mortality, life-threatening, and major bleeding. Safety endpoints included stroke and myocardial infarction at 30 days., Results: Full antagonization of heparin resulted in lower rates of the primary endpoint as compared to partial heparin reversal (5.6% vs. 10.4%, p < .01), which was mainly driven by lower rates of life-threatening (0.5% vs. 1.6%, p = .05) and major bleeding (3.2% vs. 7.5%, p < .01). Moreover, the incidence of major vascular complications was significantly lower in patients with full heparin reversal (3.5% vs. 7.5%, p < .01). The need for red-blood-cell transfusion was lower in patients receiving full as compared to partial heparin antagonization (10.4% vs. 15.9%, p < .01). No differences were observed in the incidence of stroke and myocardial infarction between patients with full and partial heparin reversal (2.2% vs. 2.6%, p = .73 and 0.2% vs. 0.4%, p = .64, respectively)., Conclusions: Full heparin antagonization resulted in significantly lower rates of life-threatening and major bleeding after TAVR as compared to partial heparin reversal. The occurrence of stroke and myocardial infarction was low and comparable between both groups., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: Liver dysfunction is associated with an increased risk of mortality after cardiac interventions. The Fibrosis-4 (FIB-4 index), a marker of hepatic fibrosis, has been associated with a worse prognosis in heart failure. The prognostic relevance of the index in patients undergoing transcatheter aortic valve replacement (TAVR) is unknown. The aim of this study was to evaluate the clinical implications associated with the FIB-4 index in patients undergoing TAVR., Methods: Between May 2012 and June 2019, 941 patients undergoing TAVR were stratified into a low or high FIB-4 index group, based on a cutoff value that was determined according to a receiver operating characteristic curve predicting 1-year all-cause mortality., Results: Patients with a high FIB-4 index (n = 480), based on the cutoff value of 1.82, showed higher rates of pulmonary hypertension (43.8% vs. 31.8%, p < 0.01), right-ventricular systolic dysfunction (29.5% vs. 19.2%, p < 0.01) and larger inferior vena cava diameter (1.6 ± 0.6 cm vs. 1.3 ± 0.6 cm, p < 0.01) than patients with a low FIB-4 index (n = 461). Furthermore, a high FIB-4 index was associated with a significantly higher cumulative 1-year all-cause mortality (17.5% vs. 10.2%, p < 0.01) and non-cardiovascular mortality (12.1% vs. 2.5%, p < 0.01), compared to a low FIB-4 index. Multivariable analysis revealed that a high FIB-4 index was independently associated with all-cause mortality (HR: 1.75 [95% CI: 1.18-2.59], p < 0.01)., Conclusions: A high FIB-4 index is associated with right-sided heart overload and an increased risk of mortality in patients undergoing TAVR. The FIB-4 index may be useful as an additional predictor of outcomes in these patients., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: A significant number of patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) suffer from extra-aortic cardiac damage. Few studies have investigated strategies to quantify cardiac damage and stratify patients accordingly in different risk groups. The aim of this retrospective multicenter study was to provide a user-friendly simplified staging system based on the proposed classification system of Généreux et al. as a tool to evaluate the prognosis of patients undergoing TAVR more easily. Moreover, we analyzed changes in cardiac damage after TAVR., Methods: We assessed cardiac damage in patients, who underwent TAVR at the Heart Center Bonn or Düsseldorf, using pre- and postprocedural transthoracic echocardiography. Patients were assigned to the staging system proposed by Généreux et al. according to the severity of their baseline cardiac damage. Based on the established system, we created a simplified staging system to facilitate improved applicability. Finally, we compared clinical outcomes between the groups and evaluated changes in cardiac damage after TAVR., Results: A total of 933 TAVR patients were included in the study. We found a significant association between cardiac damage and 1-year all-cause mortality (stage 0: 0% vs. stage 1: 3% vs. stage 2: 6.6%; p &lt; 0.009). In multivariate analysis, cardiac damage was an independent predictor of 1-year all-cause mortality (hazard ratio: 2.0, 95% confidence interval: 1.1-3.8; p = 0.03)., Conclusions: In patients undergoing TAVR, cardiac damage is associated with enhanced mortality. A simplified staging system can help identify patients at high risk for an adverse outcome., (© 2022 Wiley Periodicals LLC.)

The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives., (© 2022. The Author(s).)

Objectives: This study aimed to investigate early haemodynamic and clinical performance of the SAPIEN 3 Ultra (S3 Ultra) transcatheter heart valve (THV) system in comparison to its precursor, the SAPIEN 3 (S3). Previous studies have indicated potential haemodynamic differences between the S3 Ultra and S3. Such differences may impact clinical outcome after transcatheter aortic valve implantation (TAVI)., Methods: Postprocedural haemodynamic performance and 30-day clinical outcome were compared in patients who underwent TAVI receiving either the S3 or the new S3 Ultra prostheses. Multivariable analysis and propensity score matching (PSM) were used to identify factors associated with higher mean transvalvular gradients., Results: We included 697 patients (S3 Ultra: n=314, S3: n=383) from the multicentre RhineHeart TAVI Registry. Patients receiving the S3 Ultra prosthesis showed significantly higher postprocedural mean transvalvular gradients (14.2±4.8 vs 10.2±4.4 mm Hg; p<0.01). Multivariable logistic regression analyses and additional PSM revealed the use of the S3 Ultra to be associated with higher postprocedural mean transvalvular gradients (p<0.01). 30-day clinical outcomes, such as mortality, myocardial infarction, permanent pacemaker implantation and vascular complications were comparable between the groups., Conclusions: The new S3 Ultra THV was associated with a higher postprocedural mean transvalvular gradient compared with the S3 system, while there was no difference in mortality or adverse clinical outcomes at 30 days. These echocardiographic differences will require long-term studies to assess the clinical relevance of this finding., Competing Interests: Competing interests: MA received speakers’ honoraria from Medtronic. SB received research funding from Abbott Vascular and Edwards Lifesciences. GN has received research funding from Edwards Lifescienes and Medtronic and has received honoraria for lectures or advisory boards from Abbott, Edwards Lifesciences and Medtronic. VV and TZ have received consulting fees, travel expenses or study honoraria from Medtronic and Edwards Lifesciences. All other authors have nothing to disclose with regard to this project. All other authors declare that there is no conflict of interest regarding this manuscript., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The change in right-ventricular function (RVF) after transcatheter mitral valve repair is still poorly understood. We assessed the early response of RVF to the MitraClip procedure and its clinical relevance., Methods: We analyzed consecutive patients who underwent a MitraClip procedure to treat MR between August 2010 and March 2019 in the Heart Failure Network Rhineland registry. RVF was assessed before and after the procedure. Impaired RVF was defined as an RV fractional area change (RVFAC) < 35% or tricuspid annular plane systolic excursion (TAPSE) < 16 mm., Results: 816 eligible patients (77 ± 9 years, 58.5% male) were included in the analysis. Baseline values of RVF were: RVFAC 38.6 (IQR 29.7-46.7) % and TAPSE 17.0 (IQR 14.0-21.0) mm. At a median time of 3 (IQR 2-5) days after the procedure, the RVF remained normal in 34% (n = 274), normalized in 17% (n = 140), deteriorated in 15% (n = 125), and was persistently impaired in 34% (n = 277) of patients. The RVF response was significantly associated with a composite outcome of all-cause mortality and hospitalization due to heart failure within a 2-year follow-up. Compared to stable/normal RVF, the adjusted hazard ratios for the outcome were 1.78 (95% CI 1.10-2.86) for normalized RVF, 1.89 (95% CI 1.34-3.15) for deteriorated RVF, and 2.25 (95% CI 1.47-3.44) for persistently impaired RVF. Changes in TAPSE and RVFAC as continuous variables were significantly correlated with the outcome., Conclusion: An early change in RVF following transcatheter mitral valve repair is predictive of mortality and hospitalization due to heart failure during follow-up. Early response of RVF after MitraClip and its clinical significance. An acute, early change in RVF can be observed following the MitraClip procedure, which is associated with the risk of mortality and hospitalization for HF., (© 2021. The Author(s).)

Background: Clinical data regarding the association between the left atrial function index (LAFI) and outcome in patients undergoing transcatheter aortic valve replacement (TAVR) are limited., Objectives: We aimed to investigate the association between the left atrial function index (LAFI) and outcome in patients undergoing TAVR., Methods: In this retrospective multicenter study, we assessed baseline LAFI in 733 patients undergoing TAVR for severe aortic stenosis in two German high-volume centers between 2008 and 2019. Based on receiver operating characteristic curves, patients were stratified according to their baseline LAFI into two groups (LAFI ≤ 13.5 vs. LAFI > 13.5) and assessed for post-procedural outcome. The primary endpoint of our study was the 1-year all-cause mortality., Results: Patients with a LAFI ≤ 13.5 had significantly more often atrial fibrillation (p < 0.001), lower LVEF (p < 0.001) and higher levels of NT-proBNP (p < 0.001). After TAVR, a significant improvement in the LAFI as compared to baseline was observed at 12 months after the procedure (28.4 vs. 32.9; p = 0.001). Compared to patients with a LAFI > 13.5, those with a LAFI ≤ 13.5 showed significantly higher rate of 1-year mortality (7.9% vs. 4.0%; p = 0.03). A lower LAFI has been identified as independent predictor of mortality in multivariate analysis (HR (95% CI) 2.0 (1.1-3.9); p = 0.03)., Conclusion: A reduced LAFI is associated with adverse outcome and an independent predictor of mortality in TAVR patients. TAVR improves LAFI within 12 months after the procedure. Left Atrial Function Index (LAFI) in Patients undergoing Transcatheter Aortic Valve Implantation. A Kaplan-Meier survival analysis of 1-year all-cause mortality in patients with LAFI ≤ 13.5 compared with patients with LAFI > 13.5. Comparing rates of 1-year all-cause mortality between the different LAFI groups, we found a significant association between left atrial function and mortality. LAFI Left atrial function index. B Comparison of the mean LAFI before and after TAVR. After long-term follow-up the LAFI improved significantly. LAFI Left atrial function index; FU follow-up. C Assessment of the left atrial function index using the pre-procedural transthoracic echocardiography. A Measurement of the minimal left atrial volume (LAEDV). B Assessment of the maximal left atrial volume (LAESV)., (© 2022. The Author(s).)

Background: In patients with severe mitral regurgitation (MR) who are scheduled for transcatheter mitral valve repair (TMVR), risk stratification is predominantly based on surgical risk scores., Aims: We sought to characterise and define stages of right heart remodelling in patients undergoing TMVR and evaluate the impact of this staging classification on survival., Methods: According to echocardiographic parameters, 929 patients undergoing MitraClip treatment were classified into three stages: severe MR without right heart damage (stage 0), with moderate-to-severe tricuspid regurgitation (TR) (stage 1), with right ventricular dysfunction defined as a reduced fractional area change <35% and a tricuspid annular plane systolic excursion <17 mm, or with increased right atrial area >25 cm 2 and/or indexed right ventricular volume >30 ml/m 2 (stage 2). We compared clinical outcomes and performed a multivariate analysis to evaluate the predictive value of the extent of cardiac damage., Results: Rates of one-year all-cause mortality increased with more advanced stages of right heart remodelling (stage 0: 8% vs stage 1: 9.7% vs stage 2: 18.1%; p<0.001). In the multivariate analysis, advanced cardiac damage was an independent predictor of one-year all-cause mortality (stage 2: p=0.007)., Conclusions: A simple staging classification objectively characterises the extent of right heart remodelling caused by MR and allows risk prediction in patients undergoing a MitraClip procedure.

Objective: To evaluate whether the serum C-reactive protein to albumin ratio (CAR) could be used for risk stratification of patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS)., Patients and Methods: Frailty is a predictor of poor outcomes in patients undergoing AS interventions. The CAR reflects key components of frailty (systemic inflammation and nutrition) and could potentially be implemented into assessment and management strategies for patients with AS. From March 1, 2010, through February 29, 2020, 1836 patients were prospectively enrolled in an observational TAVR database. Patients (prospective development cohort, n=763) were grouped into CAR quartiles to compare the upper quartile (CAR Q4) with the lower quartiles (CAR Q1-3). Primary end point was all-cause mortality. Results were verified in an independent retrospective cohort (n=1403)., Results: The CAR Q4 had a higher prevalence of impaired left ventricular function, atrial fibrillation, diabetes, and cerebrovascular disease and a higher median logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) vs CAR Q1-3. After median follow-up of 15.0 months, all-cause mortality was significantly higher in CAR Q4 vs CAR Q1-3 (P<.001). In multivariable analyses, risk factors for all-cause mortality were CAR Q4 (>0.1632; hazard ratio, 1.45; 95% confidence interval, 1.05 to 2.00; P=.03), N-terminal pro-B-type natriuretic peptide Q4 (>3230 pg/mL [to convert to ng/L, multiply by 1), high-sensitivity troponin T Q4 (>0.0395 ng/mL [to convert to μg/L, multiply by 1]), above-median logistic EuroSCORE (16.1%), myocardial infarction, Acute Kidney Injury Network stage 3, and life-threatening bleeding., Conclusion: Elevated CAR was associated with increased risk of all-cause mortality in patients undergoing transfemoral TAVR. The CAR, a simple, objective tool to assess frailty, could be incorporated into assessing patients with AS being considered for TAVR., (Copyright © 2021. Published by Elsevier Inc.)

Background: Pulmonary hypertension (pH) has a prognostic impact on patients undergoing transcatheter aortic valve replacement (TAVR). Pulmonary artery (PA) dilatation assessed by multidetector computed tomography (MDCT) has the potential to predict PH. The aim of the study was to evaluate the clinical parameters associated with PA dilatation and to investigate its prognostic relevance in patients undergoing TAVR., Methods: In 770 patients undergoing TAVR between February 2016 and July 2019, PA diameter was measured by MDCT before TAVR. Additionally, PA diameter divided by ascending aorta diameter or body surface area (BSA) was calculated., Results: Of all the CT-derived parameters compared with a receiver operating characteristic curve, the value for PA/BSA with a median of 1.68 (IQR 1.47, 1.91) cm/m2 showed the greatest area-under-the-curve (0.75) for predicting PH at baseline. Based on this median, patients were assigned to a small PA/BSA (n = 386) or a large PA/BSA (n = 384) group. Hereby, a large PA/BSA was independently associated with PH at baseline (OR:8.39 [5.36-13.14], p < 0.001) and after TAVR (OR:1.73 [1.18-2.53], p = 0.005). A large PA/BSA was associated with a significantly higher cumulative two-year all-cause mortality compared to small PA/BSA (30.0% vs. 13.7%, p < 0.001), which was supported in the multivariable model (HR:1.87; 95%CI, 1.12-3.04; p = 0.017)., Conclusion: Patients with a large PA/BSA on MDCT are more likely to have PH at baseline and after TAVR. Large PA/BSA is associated with an increased risk of mortality and could provide additional information for risk stratification in patients undergoing TAVR., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Frailty is a multidimensional syndrome that affects mortality after aortic valve replacement (AVR). Malnutrition is often associated with the development of frailty. However, data regarding the association of frailty with nutritional status and underlying endocrinological dysregulation in patients with severe aortic valve stenosis are limited., Objectives: We aimed to systematically screen for frailty and malnutrition, to evaluate for underlying endocrinological disorders and inflammation, and to assess the ability of these parameters to predict outcomes after AVR., Methods: Our study included 373 patients undergoing transcatheter and surgical AVR. Frailty was assessed using the Fried Frailty Phenotype (FFP), Essential Frailty Toolset, Lawton-Brody, and Katz Index. Malnutrition was measured using the Mini Nutritional Assessment (MNA-LF) and Controlling Nutritional Status. Outcomes of interest were 30-day and one-year mortality., Results: The prevalence of frailty ranged from 6.4% to 65.7% and malnutrition from 5.9% to 10.5%, depending on the evaluation tool. Both parameters were associated with higher levels of cortisol and parathormone as well as lower levels of IGF-1, testosterone, DHEAS, and c-reactive protein. Malnutrition was associated with increased 30-day mortality, and both frailty and malnutrition with increased one-year mortality. In a multivariate analysis, malnutrition measured by the MNA-LF (OR: 2.32 [95%CI: 1.19-4.53], p = 0.01) and frailty as assessed by the FFP (OR: 1.42 [95%CI: 1.02-1.96], p = 0.03) were independent predictors of one-year mortality., Conclusion: The prevalence of frailty and malnutrition varies significantly depending on the assessment tool. Both syndromes share common endocrinological alterations. Frailty and malnutrition are independent risk factors for mortality after AVR., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

The pathophysiology of thrombocytopenia after transcatheter aortic valve implantation (TAVI) thrombocytopenia is still poorly understood. We assessed the association of spleen size with acquired thrombocytopenia in patients undergoing TAVI. We included 732 patients who underwent TAVI with new generation transcatheter heart valves (THVs) at our center from February 2016 to July 2019. We measured splenic volume index in consecutive patients derived from multidetector row computed tomographic datasets. Patients were stratified according to post-TAVI thrombocytopenia, which was defined as a decline in platelet count (DPC) ≥50% at nadir, and evaluated regarding baseline characteristics and outcome parameters. After the procedure, platelet counts declined from 212.9 ± 67.4 × 10 9 /L at baseline to 138.8 ± 49.8 × 10 9 /L at nadir after a median of 2 days (interquartile range [IQR] 2 to 3). Of all patients, 10.1% showed a DPC ≥50%. Compared with patients with DPC <50%, patients with DPC ≥50% had significantly lower splenic volume index (95.5 ml/m 2 [IQR 78.0 to 123.7] vs 85.8 ml/m 2 [IQR 71.4 to 102.6], p = 0.008). A multivariable analysis revealed that the splenic volume index was negatively associated with a DPC ≥50% (OR 0.89, 95% CI 0.82 to 0.97, p = 0.005), independent of the type of THV (balloon-expandable THV: OR 2.06, 95% CI 1.13 to 3.76, p = 0.02), major bleeding (OR 13.40, 95% CI 3.58 to 50.40, p <0.001), blood transfusion (OR 3.63, 95% CI 1.54 to 8.56, p = 0.003), or postprocedural paravalvular leakage ≥moderate (OR 5.48, 95% CI 1.23 to 24.40, p = 0.03). Furthermore, DPC ≥50% was independently associated with 1-year mortality (HR 3.36, 95% CI 1.66 to 6.81, p <0.001). In conclusion, acquired thrombocytopenia remains prevalent in modern TAVI patients. Spleen size appears to be associated with the occurrence of thrombocytopenia after TAVI, which is independently correlated with 1-year mortality., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Chronic kidney disease (CKD) is a frequent comorbidity of aortic valve stenosis (AVS). Circulating chaperones have emerged as both effectors and prognostic markers for various diseases. We investigated the role of circulating chaperones in patients with severe AVS undergoing transcatheter aortic valve replacement (TAVR). In this observational cohort study, 159 consecutive patients undergoing TAVR were included and serum levels of Glucose-regulated protein 78 (GRP78) and heat shock protein 27 (HSP27) were measured by ELISA. The primary end point was defined as 1-year mortality. Patients with lower levels of circulating GRP78 (<1347 ng/mL) had an increased 1-year mortality rate compared to patients with higher levels of GRP78 (25.0% vs 10.3%, P = 0.026). GRP78 was associated with lower 1-year mortality in a univariate analysis (HR 0.354, P = 0.047). After adjusting for age, sex, several comorbidities and biomarkers, GRP78 (HR 0.295, P = 0.024) and CKD (HR 2.809, P = 0.044) remained independent predictors of the primary end point of 1-year mortality in a multivariate analysis. Patients with concomitant CKD had significantly higher levels of HSP27 compared to patients without CKD (1690 pg/mL vs 1076 pg/mL, P = 0.0109). In patients with CKD, elevated HSP27 was identified as a protective marker (1-year mortality: 9.6% vs 31.4%, log-rank P = 0.0166). Using cut-off values for GRP78 and HSP27 we were able to stratify patients with CKD undergoing TAVR into 4 groups with distinct mortality rates (50% vs 22.2% vs 24% vs 7.9%, log-rank P = 0.0170). GRP78 is an overall predictor of mortality after TAVR, while the combination of GRP78 and HSP27 helps to predict mortality in patients with CKD receiving TAVR., (Copyright © 2021. Published by Elsevier Inc.)

Background: Malnutrition is a hallmark of frailty, is common among elderly patients, and is a predictor of poor outcomes in patients with severe symptomatic aortic stenosis (AS). The Geriatric Nutritional Risk Index (GNRI) is a simple and well-established screening tool to predict the risk of morbidity and mortality in elderly patients. In this study, we evaluated whether GNRI may be used in the risk stratification and management of patients undergoing transcatheter aortic valve replacement (TAVR)., Methods: Patients with symptomatic severe AS (n = 953) who underwent transfemoral TAVR at the University Hospital Schleswig-Holstein Kiel, Germany, between 2010 and 2019 (development cohort) were divided into two groups: normal GNRI ≥ 98 (no nutrition-related risk; n = 618) versus low GNRI < 98 (at nutrition-related risk; n = 335). The results were validated in an independent (validation) cohort from another high-volume TAVR centre (n = 977)., Results: The low-GNRI group had a higher proportion of female patients (59.1% vs. 52.1%), higher median age (82.9 vs. 81.8 years), prevalence of atrial fibrillation (50.4% vs. 40.0%), median logistic EuroSCORE (17.5% vs. 15.0%) and impaired left ventricular function (<35%: 10.7% vs. 6.8%), lower median estimated glomerular filtration rate (50 vs. 57 mL/min/1.73 m 2 ) and median albumin level (3.5 vs. 4.0 g/dL) compared with the normal-GNRI group. Among peri-procedural complications, Acute Kidney Injury Network (AKIN) Stage 3 was more common in the low-GNRI group (3.6% vs. 0.6%, p = 0.002). After a mean follow-up of 21.1 months, all-cause mortality was significantly increased in the low-GNRI group compared with the normal-GNRI group (p < 0.001). This was confirmed in the validation cohort (p < 0.001). Low GNRI < 98 was identified as an independent risk factor for all-cause mortality (hazard ratio 1.44, 95% CI 1.01-2.04, p = 0.043). Other independent risk factors included albumin level < median of 4.0 g/dL, high-sensitive troponin T in the highest quartile (> 45.0 pg/mL), N-terminal pro-B-type natriuretic peptide in the highest quartile (> 3595 pg/mL), grade III-IV tricuspid regurgitation, pulmonary arterial hypertension, life-threatening bleeding, AKIN Stage 3 and disabling stroke., Conclusions: Low GNRI score was associated with an increased risk of all-cause mortality in patients undergoing TAVR, implying that this vulnerable group may benefit from improved preventive measures., (© 2021 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of Society on Sarcopenia, Cachexia and Wasting Disorders.)

Background: Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs)., Objectives: The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures., Methods: Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs., Results: A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups)., Conclusions: In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up., Competing Interests: Funding Support and Author Disclosures Dr. Alperi was supported by a grant from the Fundación Alfonso Martin Escudero (Madrid, Spain). Dr. Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions, and has received institutional research grants from Edwards Lifesciences and Medtronic. Dr. Montorfano is a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr. Adam has received personal fees from Edwards Lifesciences and Boston Scientific; and has received grants and personal fees from Medtronic during the conduct of the study. Dr. Noble has received institutional research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic; and is a proctor for Medtronic. Dr. Erlebach has received fees from Medtronic. Dr. Kempfert has received fees from Medtronic, Edwards Lifesciences, and Abbott. Dr. Pilgrim has received institutional research grants from Biotronik, Boston Scientific, and Edwards Lifesciences; has received speaker fees from Biotronik and Boston Scientific; has received consultancy fees from HighLife SAS (CEC); and has performed proctoring for Medtronic and Boston Scientific. Dr. Kim has received personal fees from, performed proctoring for, and has served on advisory boards for Abbott Vascular, Boston Scientific, Edwards Lifesciences, Meril, Medtronic, and Shockwave Med. Dr. Hildick-Smith has served as a proctor and advisor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr. Dvir has provided consulting for Edwards Lifesciences, Medtronic, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Surgical risk prediction models are routinely used to guide decision-making for transcatheter aortic valve replacement (TAVR). New and updated TAVR-specific models have been developed to improve risk stratification; however, the best option remains unknown., Objective: To perform a comparative validation study of six risk models for the prediction of 30-day mortality in TAVR METHODS AND RESULTS: A total of 2946 patients undergoing transfemoral (TF, n = 2625) or transapical (TA, n = 321) TAVR from 2008 to 2018 from the German Rhine Transregio Aortic Diseases cohort were included. Six surgical and TAVR-specific risk scoring models (LogES I, ES II, STS PROM, FRANCE-2, OBSERVANT, GAVS-II) were evaluated for the prediction of 30-day mortality. Observed 30-day mortality was 3.7% (TF 3.2%; TA 7.5%), mean 30-day mortality risk prediction varied from 5.8 ± 5.0% (OBSERVANT) to 23.4 ± 15.9% (LogES I). Discrimination performance (ROC analysis, c-indices) ranged from 0.60 (OBSERVANT) to 0.67 (STS PROM), without significant differences between models, between TF or TA approach or over time. STS PROM discriminated numerically best in TF TAVR (c-index 0.66; range of c-indices 0.60 to 0.66); performance was very similar in TA TAVR (LogES I, ES II, FRANCE-2 and GAVS-II all with c-index 0.67). Regarding calibration, all risk scoring models-especially LogES I-overestimated mortality risk, especially in high-risk patients., Conclusions: Surgical as well as TAVR-specific risk scoring models showed mediocre performance in prediction of 30-day mortality risk for TAVR in the German Rhine Transregio Aortic Diseases cohort. Development of new or updated risk models is necessary to improve risk stratification.

Background: The benefit of TAVI in cancer patients is currently unclear., Objectives: The purpose of this study is to investigate prognostic impact of cancer status (active cancer or previous cancer) in severe aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI)., Methods: Consecutive TAVI patients in the Heart Center Bonn were enrolled and we stratified the patients into three groups: current cancer (active cancer), non-current cancer (previous cancer), or no cancer. The primary outcome was all-cause death within a 5-year follow-up. We evaluated mean aortic pressure gradient (mPG) values following TAVI (baseline mPG) and at the final follow-up (follow-up mPG)., Results: In total, 1568 TAVI patients were eligible and 298 patients (19.0%) had active or previous cancer. At the 5-year follow-up, cancer patients had a significantly worse prognosis than non-cancer patients (log rank, P < 0.001). In a multivariable analysis, previous cancer was a significant predictor for 5-year mortality (hazard ratio [HR], 1.56; P < 0.001). Estimated mortality rates at 5-year follow-up rates among active cancer, previous cancer, and non-cancer were 84.0%, 65.8%, and 50.2% (long-rank P < 0.001), respectively. The hazard ratios of active cancer and previous cancer for 5-year mortality were 2.79 (P < 0.001) and 1.38 (P = 0.019) compared to non-cancer patients. We found significantly higher mPG during follow-up than at baseline in cancer patients (follow-up 8.10 vs baseline 7.40 mmHg; Wilcoxon P = 0.012)., Conclusions: Active, and also previous, cancer status are associated with less beneficial long-term prognosis in TAVI patients.

Objectives: The aim of this observational study was to evaluate the impact of concomitant coronary artery disease (CAD) on outcomes in patients undergoing percutaneous valve repair with the MitraClip system., Background: Mitral valve regurgitation and CAD are often coexistent in elderly patients undergoing percutaneous mitral valve repair. The impact of CAD and revascularization on outcomes in this patient cohort, however, remains uncertain., Methods: In 444 MitraClip patients, CAD severity was assessed, represented by the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), as well as the residual SS (rSS) and SYNTAX score II (SS-II). Patients were stratified according to CAD severity and SS-II values (SS ≤3 vs. SS >3 and SS-II ≤45 vs. SS-II >45) and according to remaining CAD burden into 2 groups (rSS = 0 vs. rSS >0) to compare 1-year all-cause mortality., Results: Higher SS, rSS, and SS-II were associated with mortality (22% for SS >3 vs. 9.6% for SS ≤3 [p < 0.001], 31.4% for rSS >0 vs. 9.6% for rSS = 0 [p < 0.001], and 17.1% for SS-II > 45 vs. 11.2% for SS-II ≤45 [p = 0.044]). The rSS was an independent predictor of 1-year all-cause mortality (p = 0.001) in multivariate analysis., Conclusions: The complexity of CAD, as assessed using the SS, is associated with outcomes in patients undergoing MitraClip procedures. The burden of residual CAD after percutaneous coronary intervention is an independent predictor of 1-year all-cause mortality. Patients undergoing complete revascularization had the most favorable outcomes independent of mitral regurgitation etiology., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)