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Background: In patients undergoing transcatheter aortic valve replacement (TAVR), elevated pre-procedural C-reactive protein (CRP) levels are frequently observed. Its impact on long-term results of TAVR is unclear. The aim of the study was to investigate the long-term (up to six years) clinical outcomes of TAVR patients with normal compared to elevated CRP levels before TAVR., Methods: Consecutive patients undergoing TAVR between August 2012 and January 2023 at a tertiary cardiology facility were included. Patients were divided into two cohorts based on the baseline CRP levels: normal CRP (≤ 5 mg/l) and elevated CRP (>5 mg/l). The cohorts were followed clinically for up to six years after TAVR., Results: From a total of 1000 TAVR patients (mean age 81 ± 6 years), 268 patients (27 %) were found to have elevated baseline CRP (>5 mg/l). Such patients had significantly more co-morbidities (e.g. chronic obstructive pulmonary disease, atrial fibrillation, heart failure, concomitant valvopathies). They also developed periprocedural infections more frequently (3 % vs. 1 %, p = 0.007) and required more commonly repeat hospitalizations for infections during follow-up (HR 1.97, CI 1.47-2.64, p < 0.001). All-cause mortality and development of valve dysfunction did not significantly differ between patients with elevated and normal baseline CRP levels., Conclusion: Albeit long-term results of TAVR patients with elevated pre-procedural CRP levels seem favorable in terms of survival and development of valve dysfunction, they have an increased risk for periprocedural infections and re-admissions due to infections of any type during the follow-up period., Competing Interests: Declaration of competing interest S. Toggweiler serves as a consultant and proctor for Medtronic, Boston Scientific, Edwards Lifesciences and Biosensors, as a proctor for Edwards Lifesciences and Abbott Vascular, as a consultant for Medira, Shockwave, Teleflex, atHeart Medical, Veosource, Cardiac Dimensions, ReCor Medical and Polares Medical, has received institutional research grants from Boston Scientific, Fumedica and Novartis and holds equity in Hi-D Imaging. M. Bossard received speaker and consulting fees from Abbott Vascular, Abiomed and SIS Medical. A. Attinger-Toller serves as a consultant for Boston Scientific and received speaker fees from Abbott. M. Wolfrum serves as a proctor and consultant for Biosensors., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The clinical relevance of cardiac troponin (cTn) elevation in takotsubo syndrome (TTS) remains uncertain. The present study sought to investigate the role of cardiac troponin (cTn) elevations in mortality prediction of patients with Takotsubo syndrome (TTS)., Methods: Patients enrolled in the International Takotsubo (InterTAK) Registry from January 2011 to February 2020 with available data on peak cTn levels were included in the analysis. Peak cTn levels during the index hospitalization were used to define clinically relevant myocardial injury. The threshold at which clinically relevant myocardial injury drives mortality at 1 year was identified using restricted cubic spline analysis., Results: Out of 2'938 patients, 222 (7.6%) patients died during 1-year follow-up. A more than 28.8-fold increase of cTn above the upper reference limit was identified as threshold for clinically relevant myocardial injury. The presence of clinically relevant myocardial injury was significantly associated with an increased risk of mortality at 5 years (adjusted HR 1.58, 95% CI 1.18-2.12, p =.002). Clinically relevant myocardial injury was related to an increased 5-year mortality risk in patients with apical TTS (adjusted HR 1.57, 95% CI 1.21-2.03, p =.001), in presence of physical stressors (adjusted HR 1.60, 95% CI 1.22-2.11, p =.001), and in absence of emotional stressors (adjusted HR 1.49, 95% CI, 1.17-1.89, p =.001)., Conclusion: This study for the first time determined a troponin threshold for the identification of TTS patients at excess risk of mortality. These findings advance risk stratification in TTS and assist in identifying patients in need for close monitoring and follow-up., (© 2024 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)

Background: The perception of takotsubo syndrome (TTS) has evolved significantly over the years, primarily driven by increased recognition of acute complications and mortality., Objectives: This study aimed to explore temporal trends in demographic patterns, risk factors, clinical presentations, and outcomes in patients with TTS., Methods: Patients diagnosed with TTS between 2004 and 2021 were enrolled from the InterTAK (International Takotsubo) registry. To assess temporal trends, patients were divided into 6 groups, each corresponding to a 3-year interval within the study period., Results: Overall, 3,957 patients were included in the study. There was a significant demographic transition, with the proportion of male patients rising from 10% to 15% (P = 0.003). Although apical TTS remained the most common form, the diagnosis of midventricular TTS increased from 18% to 28% (P = 0.018). The prevalence of physical triggers increased from 39% to 58% over the years (P < 0.001). There was a significant increase in 60-day mortality over the years (P < 0.001). However, a landmark analysis excluding patients who died within the first 60 days showed no differences in 1-year mortality (P = 0.150)., Conclusions: This study of temporal trends in TTS highlights a transition in patients demographic with a growing prevalence among men, increasing recognition of midventricular TTS type, and increased short-term mortality and rates of cardiogenic shock in recent years. This transition aligns with the rising prevalence of physical triggers, as expression of increased recognition of TTS in association with acute comorbidities., Competing Interests: Funding Support and Author Disclosures Dr Templin has received institutional grants from Abbott Vascular, Medtronic, and SMT; and has received consulting grants from Biotronik, Microport, and Innova. Dr Airaksinen has received grants or has contracts with the Finnish Foundation for Cardiovascular Research; and has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bayer, Pfizer, Boehringer Ingelheim, and AstraZeneca. Dr Bauersachs has received grants from or has contracts with Abiomed, CVRx, Norgine, Roche, and Zoll; holds patents PCT/EP2007/008772 and PCT/EP2009/051986 for microRNA and downstream targets for diagnostics and therapeutic purposes; has received consulting fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Cardior, Corvia, CVRx, Edwards, Norgine, Novartis, Pfizer, Roche, and Vifor; and has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Cardior, CVRx, Norgine, Novartis, Pfizer, and Vifor. Dr Boehm has received grants from or has contracts with Deutsche Forschungsgemeinschaft research support (DFG, SFB-TTR 219, S-01); has received speaker honoraria from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Medtronic, Novartis, Servier, and Vifor; and is on the advisory board of Amgen, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, Pfizer, ReCor, Servier, and Vifor. Dr Ferreira has received payments for lectures, presentations, speakers bureaus, manuscript writing, or educational events from A Menarini, Medinfar, Bayer, AstraZeneca, Biotronik, and Medtronic; and has received payments for participation on a Data Safety Monitoring Board or Advisory Board from Medtronic. Dr Dichtl has received consulting fees from Reata. Dr Kaiser has received consulting fees from the Swiss Federal Office of Public Health; and has received support for attending meetings and/or travel from Medtronic, Abbott, and Europa Organization. Dr Kobza has received institutional grants on behalf of the Luzerner Kantonsspital from Biosense Webster, Boston Scientific, Biotronik, Medtronik, and Sis-Medical; and has received consulting fees from Biosense Webster, Biotronik, and Medtronic. Dr Koenig has received grants and provision of reagents to the institution from Singulex, Dr.Beckmann Pharma, Abbott, and Roche Diagnostics; has received consulting fees from AstraZeneca, Novartis, Amgen, Pfizer, The Medicines Company, DalCor Pharmaceuticals, Kowa, Corvidia Therapeutics, OMEICOS, Daiichi-Sankyo, Novo Nordisk, New Amsterdam Pharma, TenSixteen Bio, Esperion, and Genentech; and has received lecture fees from Bristol Myers Squibb, Novartis, Amgen, Berlin-Chemie, Sanofi, and AstraZeneca. Dr Lüscher has received research or educational grants to the institution from Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Novartis, Novo Nordisk, Sanofi, and Vifor; is the president elect of the European Society of Cardiology; is chairman of the research committee of the Swiss Heart Foundation; is President of the Board of the Zurich Heart House; and is Trustee of the London Heart House. Dr Karakas has received grants or has contracts with Vifor Pharma and Daiichi-Sankyo; has received consulting fees or payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Vifor, Pharmacosmos, and Sphingotec; and has received equipment, materials, drugs, medical writing, gifts or other services from Sphingotec and Vifor Pharma. Dr Niederseer has received consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Gerson Lehmann Group (GLG) Consulting, Novo Nordisk, Pfizer and Zoll; has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Novartis, Novo Nordisk, and Pfizer; and has received support for attending meetings and/or travel from Abbott, Amgen, Bayer, and Novo Nordisk. Dr Roffi has received institutional research grants from Boston Scientific, Cordis, Terumo, Biotronik, and Medtronic. Dr Ruschitzka has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; the Department of Cardiology (University Hospital of Zurich/University of Zurich), however, reports research, educational, and/or travel grants from Abbott, Abiomed, Alexion, Amgen, AstraZeneca, At the Limits Ltd, Bayer, Berlin Heart, B. Braun, Biosense Webster, Biosensors Europe AG, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, Boston Scientific, Bracco, Cardinal Health Switzerland, Concept Medical, Corteria, CSL, Daiichi-Sankyo, Diatools AG, Edwards Lifesciences, Guidant Europe NV, Hamilton Health Sciences, IHF, Innosuisse, Johnson/Johnson, Kaneka Corporation, Kantar, Kiniksa, Labormedizinisches Zentrum, MedAlliance, Medical Education Global Solutions, Medtronic, MicroPort, MSD, Mundipharma Medical Company, Novartis, Novo Nordisk, Orion, Pfizer, Quintiles Switzerland Sarl, RecorMedical, Roche Diagnostics, Roche Pharma, Sahajanand IN, Sanofi, Sarstedt AG, Servier, SIS Medical, Sorin CRM SAS, SSS International Clinical Research, Stromal, Terumo Deutschland, Trama Solutions, V-Wave, Vascular Medical, Vifor, Wissens Plus, and ZOLL. Prof Ruschitzka has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; remuneration for the time spent in the following consulting activities were made directly to the University of Zurich and do not impact on his personal remuneration: AstraZeneca (IMC), Bayer, Boehringer Ingelheim, Citi Research, Klub Class, Novo Nordisk, Radcliffe Group, Stiftung Pfizer Forschungspreis, and Vifor; remuneration for the following lectures were made directly to the University of Zurich and do not impact on his personal remuneration: Abbott, Amgen, AstraZeneca (A+ Science AB), Bayer (At the Limits), Boehringer Ingelheim, Boston Scientific (CCE Services), Brigham and Women’s Hospital Boston, C.T.I GmbH, FomF, Hôpitaux Universitaires des Genève (GECORE), Luzerner Kantonsspital, Sanofi-Aventis, Servier, Medcon, Medscape (WebMD), Medtronic, Medworld, Novartis, Roche, Ruwag, Swiss Heart Failure Academy, The Hong Kong Heart Failure Society, Trama Solutions SL, Inselspital Bern, Charité–Universitätsmedizin Berlin (Medical Education Global Solutions), Romanian Society of Cardiology, ÖKG Österreichische Gesellschaft für Kardiologie, and Zoll; has received support for attending meetings and/or travel from AstraZeneca (IMC/A+ Science AB), Boehringer Ingelheim, Centro Hospitaler de Vila Nova de Gaia, C.T.I. GmbH (Universitätsklinikum Düsseldorf), European Society of Cardiology, Monocle, Novartis, Spektar Putovanja, Austrian Heart Failure Association, and Heart Failure Association of the ESC; remuneration for following Advisory Boards were made directly to the University of Zurich and do not impact on his personal remuneration: Bayer, Roche, IMC/AstraZeneca, and Amgen; and he has received secretarial and administrative support of the HFA for his role as President/Past-President for 2018 to 2020. Dr Schunkert has received consulting fees from Amgen, Daiichi-Sankyo, Merck Sharp and Dohme, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Servier; has received honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events and support for attending meetings and/or travel from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Merck Sharp and Dohme, Novartis, Sanofi Aventis, Servier, and Synlab; and has received honoraria for his participation on a Data Safety Monitoring Board or Advisory Board of Boehringer Ingelheim, Daiichi-Sankyo, Novartis, and Amgen. Dr Wolfrum has received consulting fees from NVT/Biosensors as well as payments for lectures, presentations, speakers bureaus, manuscript writing, or educational events from NVT/Biosensors; and has equities in Hi-D Imaging, Winterthur, Switzerland. Dr Crea has received personal fees from Amgen, AstraZeneca, Abbott, Menarini, Chiesi, and Daiichi-Sankyo, outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is increasingly performed for the treatment of aortic stenosis. Computed tomography (CT) analysis is essential for pre-procedural planning. Currently available software packages for TAVR planning require substantial human interaction. We describe development and validation of an artificial intelligence (AI) powered software to automatically rend anatomical measurements and other information required for TAVR planning and implantation., Methods: Automated measurements from 100 CTs were compared to measurements from three expert clinicians and TAVR operators using commercially available software packages. Correlation coefficients and mean differences were calculated to assess precision and accuracy., Results: AI-generated annular measurements had excellent agreements with manual measurements by expert operators yielding correlation coefficients of 0.97 for both perimeter and area. There was no relevant bias with a mean difference of -0.07 mm and - 1.4 mm 2 for perimeter and area, respectively. For the ascending aorta measured 5 cm above the annular plane, correlation coefficient was 0.95 and mean difference was 1.4 mm. Instruction for use-based sizing yielded agreement with the effective implant size in 87-88 % of patients for self-expanding valves (perimeter-based sizing) and in 88 % for balloon-expandable valves (area-based sizing)., Conclusions: A fully automated software enables accurate and precise anatomical segmentation and measurements required for TAVR planning without human interaction and with high reliability., Competing Interests: Declaration of competing interest Relationship with industry: ST has received honoraria from Medtronic, Boston Scientific, Biosensors, Hi-D Imaging, Abbott Vascular, Medira, Shockwave, Teleflex, atHeart Medical, Cardiac Dimensions, Polares Medical, Amarin, Sanofi, AstraZeneca, ReCor Medical, Daiichi Sankyo, has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Fumedica, Novartis, Boehringer Ingelheim, Polares Medical, and holds equity in Hi-D Imaging. MCWVB is a consultant for Hi-D Imaging, Boston Scientific, Medtronic Inc., and Sanamedi Inc. FM is a consultant for Hi-D Imaging. UG holds equity in Hi-D Imaging. MW is a proctor and consultant for Biosensors and holds equity in Hi-D Imaging. WK received personal fees from Abbott, Boston Scientific Edwards Lifesciences, Meril Life Sciences, is consultant to Hi-D imaging and received institutional fees from Boston Scientific., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

This scoping review aims at giving an overview of the possible influence of neurodevelopmental disorders (NDDs) on cognitive-behavioral neurodegenerative diseases (CBNDs). Based on the PRISMA-ScR checklist, it details the methods of NDDs screening, the identified NDDs-CBNDs associations, as well as the criteria and types of association. The last literature search was performed in June 2023. In the final study, 32 articles were included. Analysis first showed that NDDs were mainly detected through medical records screening. Second, the association of specific learning disorders and major or mild neurocognitive disorder due to Alzheimer's disease was the most investigated. Third, associations were mostly based on prevalence comparisons. Finally, 66 % of studies reported a positive association between NDDs and CBNDs. Notably, up to 67 % of positive associations were observed with atypical forms of certain CBNDs. Authors' interpretations suggest that NDDs could constitute a risk factor for CBNDs. However, the influence of NDDs on CBNDs still lacks evidence and biological support, possibly due to the heterogeneity of methods and criteria employed. Developing validated assessment tools for all NDDs and conducting cohort studies could be beneficial for research, and clinical practice. Indeed, this review also underlines the importance of adopting a life-span approach regarding CBNDs., Competing Interests: Declaration of Competing Interest This research was funded by the French National Research Agency (ANR-21-CE28–0020–01)., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: In transcatheter aortic valve replacement (TAVR), transfemoral (TF) access offers several advantages over alternative access routes. Advances in sheaths and valve delivery technology have catalyzed the feasibility of TF-TAVR, even in challenging anatomies., Aims: Report procedural characteristics and outcomes of a TAVR program aiming for a 100% TF access rate., Methods: Consecutive patients undergoing TAVR were enrolled in a prospective registry. Equipment used to facilitate TF-access in challenging anatomies included low-profile sheaths, dilatators, peripheral balloons, covered and uncovered self-expanding and balloon-expandable stents, and intravascular lithotripsy (IVL)., Results: A total of 400 patients with a mean age of 81 ± 6 years (42% female) were analyzed. Minimal iliofemoral artery diameter (MLD) of the main access side was <5 mm in 42 (10.5%), extreme tortuosity was present in 65 (16.3%), and severe calcification in 59 (14.8%). TF-access was successful in 399 (99.8%) patients. A transaxillary access was used in one patient. In multivariable analysis, an MLD < 5 mm was the strongest predictor for vascular complications (11.9% vs. 3.9%, OR: 3.86, 95% CI: 1.38-10.8, p = 0.01). Such patients also had more major/life-threatening bleeding (14.2% vs. 3.1%, p < 0.001) and required more planned and unplanned peripheral interventions to enable TF access (35.8% vs. 3.4%, p < 0.001)., Conclusion: Our study shows that utilization of dedicated sheaths, peripheral balloons, stents, and IVL enables TAVR via TF access in >99% of patients. However, rates of vascular and bleeding complications in patients with narrow iliofemoral arteries (MLD < 5 mm) were high., (© 2024 Wiley Periodicals LLC.)

Objectives: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders., Methods: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up., Results: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively., Conclusions: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

Background: Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis., Methods and Results: From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%, P =0.002) and more often had pulmonary disorders (21% versus 13%, P =0.046) and atrial fibrillation (32% versus 20%, P =0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%, P =0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID., Conclusions: This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.

Objectives: Despite the introduction of improved drug eluting stents (DES), the rate of repeat revascularization procedures following percutaneous coronary interventions (PCI) in coronary chronic total occlusions (CTO) remains high. By leaving vessels uncaged and limiting length of stented segments, drug-coated balloons (DCB) represent an appealing alternative to DES for CTO-PCI. Since data supporting the use of DCBs in CTO-PCI is scarce, we compared the outcomes of patients undergoing CTO-PCI involving DCBs vs DES only., Methods: From 2 prospective registries, outcomes of patients undergoing CTO-PCI involving DCBs and those undergoing PCI with DES only were compared. Outcomes included major adverse cardiac and cerebrovascular events (MACCE) and cardiovascular death (CV-death)., Results: Overall, 157 patients were studied; 112 (71%) underwent CTO-PCI involving DCBs and 45 (29%) were treated with DES only. Mean J-CTO score was 1.84 ± 0.7. Most CTO-lesions involved the right coronary artery, 88 (56%), and 26 (17%) cases were in-stent occlusions. In the DCB group, 46 (41%) lesions were treated with DCBs alone. Mean lengths of the stented segments in the DCB vs DES cohorts were 59 ± 28 mm vs 87 ± 37 mm (P less than .001), respectively. After 12 months, the MACCE rate was higher in the DES only vs DCB group (26% vs 11%, P=.03). Length of the stented segment was an independent predictor for MACCE (HR 1.15 [95% CI, 1.05-1.26] per 10-mm stent length)., Conclusions: Revascularization of CTO lesions involving DCBs appears safe and potentially lowers MACCE rates compared to treatment with DES alone. Importantly, using DCBs for CTO treatment may reduce total stent length, which determines PCI outcomes.

Objectives: The Allegra-THV is a novel, self-expanding THV with supra-annular bovine leaflets. The valve is available in 3 different sizes and is delivered through an 18 French sheath. To determine the safety and efficacy of the Allegra transcatheter heart valve (THV; Biosensors) for the treatment of severe aortic valve stenosis under real-world conditions., Methods: Consecutive patients undergoing transcatheter aortic valve replacement (TAVR) at the Heart-Centre Lucerne with the Allegra-THV were included. Echocardiographic data were collected at baseline, before discharge, and at 1-year follow-up; clinical outcomes were recorded for up to 3 years. Clinical endpoints were defined according to the definitions of the Valve-Academic-Research-Consortium., Results: One hundred-three patients (age 81 ± 7 years, 63% women) were enrolled. Median European System for Cardiac Operative Risk Evaluation II score was 4.1% (IQR 1.8%-4.2%). Mean aortic valve gradient was 6.9 ± 3.3 mm Hg and 7.7 ± 3.3 mm Hg, and an effective orifice area was 2.1 ± 0.5 cm2 and 2.0 ± 0.5 cm2 at 30 days and 1-year follow-up, respectively. More than mild paravalvular leak was observed in 2.0% of patients at 30 days and 3.3% at 1 year. At 1-year follow-up, 14.7% of patients required implantation of a new permanent pacemaker, 1 patient had endocarditis with an uneventful clinical course and good THV-function after antibiotic therapy, and no thrombosis, structural-valve-detoriation (SVD), or non-SVD had occurred. At 3-year follow-up, rates of all-cause and cardiovascular mortality were 31.4% and 18.8%, respectively., Conclusions: Transfemoral implantation of the Allegra-THV resulted in favorable clinical and echocardiographic outcomes at up to 3-year follow-up. Head-to-head randomized clinical trials are necessary to determine if the Allegra-THV valve performs as well as current generation valves.

Aims: Takotsubo syndrome (TTS) is associated with a substantial rate of adverse events. We sought to design a machine learning (ML)-based model to predict the risk of in-hospital death and to perform a clustering of TTS patients to identify different risk profiles., Methods and Results: A ridge logistic regression-based ML model for predicting in-hospital death was developed on 3482 TTS patients from the International Takotsubo (InterTAK) Registry, randomly split in a train and an internal validation cohort (75% and 25% of the sample size, respectively) and evaluated in an external validation cohort (1037 patients). Thirty-one clinically relevant variables were included in the prediction model. Model performance represented the primary endpoint and was assessed according to area under the curve (AUC), sensitivity and specificity. As secondary endpoint, a K-medoids clustering algorithm was designed to stratify patients into phenotypic groups based on the 10 most relevant features emerging from the main model. The overall incidence of in-hospital death was 5.2%. The InterTAK-ML model showed an AUC of 0.89 (0.85-0.92), a sensitivity of 0.85 (0.78-0.95) and a specificity of 0.76 (0.74-0.79) in the internal validation cohort and an AUC of 0.82 (0.73-0.91), a sensitivity of 0.74 (0.61-0.87) and a specificity of 0.79 (0.77-0.81) in the external cohort for in-hospital death prediction. By exploiting the 10 variables showing the highest feature importance, TTS patients were clustered into six groups associated with different risks of in-hospital death (28.8% vs. 15.5% vs. 5.4% vs. 1.0.8% vs. 0.5%) which were consistent also in the external cohort., Conclusion: A ML-based approach for the identification of TTS patients at risk of adverse short-term prognosis is feasible and effective. The InterTAK-ML model showed unprecedented discriminative capability for the prediction of in-hospital death., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

We study theoretically the mechanisms of square wave formation of a vertically emitting micro-cavity operated in the Gires-Tournois regime that contains a Kerr medium and that is subjected to strong time-delayed optical feedback and detuned optical injection. We show that in the limit of large delay, square wave solutions of the time-delayed system can be treated as relative homoclinic solutions of an equation with an advanced argument. Based on this, we use concepts of classical homoclinic bifurcation theory to study different types of square wave solutions. In particular, we unveil the mechanisms behind the collapsed snaking scenario of square waves and explain the formation of complex-shaped multistable square wave solutions through a Bykov T-point. Finally, we relate the position of the T-point to the position of the Maxwell point in the original time-delayed system., (© 2023 Author(s). Published under an exclusive license by AIP Publishing.)

Background: Motion artifacts in planning computed tomography (CT) for transcatheter aortic valve implantation (TAVI) can potentially skew measurements required for procedural planning. Whether such artifacts may affect safety or efficacy has not been studied., Methods: We conducted a retrospective analysis of 852 consecutive patients (mean age, 82 years; 47% women) undergoing TAVI-planning CT at a tertiary care center. Two independent observers divided CTs according to the presence of motion artifacts at the annulus level (Motion vs. Normal group). Endpoints included surrogate markers for inappropriate valve selection: annular rupture, valve embolization or misplacement, need for a new permanent pacemaker, paravalvular leak (PVL), postprocedural transvalvular gradient, all-cause death., Results: Forty-six (5.4%) patients presented motion artifacts on TAVI-planning CT (Motion group). These patients had more preexisting heart failure, moderate-severe mitral regurgitation, and atrial fibrillation. Interobserver variability of annular measurement (Normal vs. Motion group) did not differ for mean annular diameter but was significantly different for perimeter and area. Presence of motion artifacts on planning CT did not affect the prevalence of PVL (≥moderate PVL 0% vs. 2.5% p = 0.5), mean transvalvular gradient (6±3 mmHg vs 7±5 mmHg, p = 0.1), or the need for additional valve implantation (0% vs. 2.8%, p = 0.6). One annular rupture occurred (Normal group). Pacemaker implantation, procedural duration, hospital stay, 30-day outcomes, and all-cause mortality did not differ between the groups., Conclusions: Motion artifacts on planning CT were found in about 5% of patients. Measurements for valve selection were possible without the need for repeat CT, with mean diameter-derived annulus measurement being the most accurate. Motion artifacts were not associated with worse outcomes., Competing Interests: Mathias Wolfrum serves as a proctor for Biosensors. Matthias Bossard has received speaker fees from Abbott Vascular, Amgen, Astra Zeneca, Bayer, Daichii-Sankyo, Mundipharma, and SIS Medical. Stefan Toggweiler serves as a proctor and consultant for Abbott, Biosensors, Boston Scientific, and Medtronic, as a consultant for Shockwave, Teleflex, Medira, atHeart, and Veosource, has received institutional research grants from Boston Scientific and Fumedica AG, and holds equity in Hi-D Imaging. The other authors declare no conflict of interest., (© 2023 The Author(s).)

Background: Growing interest in neuroprotection in transcatheter aortic valve replacement (TAVR) has catalyzed the development of cerebral protection systems (CPS)., Objectives: Report insights from consecutive real-world patients undergoing TAVR with the Sentinel-CPS., Methods: Patients with severe aortic stenosis undergoing TAVR from April 2019 to May 2022 were enrolled in a prospective registry. The reason for unsuccessful Sentinel-CPS deployment and the amount of debris captured by the filters were prospectively recorded., Results: The Sentinal CPS was successfully deployed in 330 patients (85%, Group 1). Deployment was not attempted, unsuccessful or only partially successful in 59 patients (15%, Group 2), caused by anatomical factors such as tortuosity, heavy calcification or small dimensions of radial or brachial artery in 46, technical aspects such as puncture failure or dissection in 5 or use of right radial access for the pigtail in 6. Debris was captured in 98% of patients in Group 1. In 40%, the amount of debris was graded moderate or extensive. Predictors for moderate/extensive debris were moderate/severe aortic calcification (OR 1.50, CI 1.05-2.15, p = 0.03), pre- and postdilatation (OR 1.97, CI 1.02-3.79, p = 0.04 and OR 1.71, CI 1.01-2.89, p = 0.048). The risk of stroke was numerically lower in patients who underwent TAVR with the Sentinel CPS (2.1 vs. 5.1%, respectively, p = 0.15). There was no stroke during CPS deployment, but one patient had a stroke immediately after device retrieval., Conclusions: The Sentinel-CPS was successfully deployed in 85% of patients. Predictors for moderate/extensive debris captured were moderate/severe aortic calcification, pre- and postdilatation., (© 2023 Wiley Periodicals LLC.)

Subclinical leaflet thrombosis, identified as hypoattenuated leaflet thickening (HALT) on cardiac computed tomography scan, has been observed after transcatheter aortic valve replacement (TAVR). However, data on HALT after the implant of the supra-annular ACURATE neo/neo2 prosthesis are limited. This study aimed to determine the prevalence and risk factors for the development of HALT after TAVR with the ACURATE neo/neo2. A total of 50 patients who received the ACURATE neo/neo2 prosthesis were prospectively enrolled. Patients underwent a contrast-enhanced multidetector row cardiac computed tomography scan at before, after, and 6 months after TAVR. At the 6-month follow-up, HALT was detected in 16% (8 of 50 patients). These patients had a lower implant depth of the transcatheter heart valve (8 ± 2 mm vs 5 ± 2 mm, p = 0.001), less calcified native valve leaflets, a better expansion of the frame at the level of the left ventricular outflow tract, and were less often hypertensive. Thrombosis of the sinus of Valsalva occurred in 18% (9/50). There was no difference in the anticoagulation regimen between patients with and without thrombotic findings. In conclusion, HALT was present in 16% of patients at 6 months follow-up, patients presenting with HALT had a lower implant depth of the transcatheter heart valve, and HALT was detected in patients on oral anticoagulation therapy., Competing Interests: Declaration of Competing Interest Dr. Toggweiler is a consultant and proctor for Boston Scientific, Medtronic, Edwards Lifesciences, Abbott, and Biosensors; a consultant for Medira, Atheart Medical, Veosource, Shockwave, Teleflex, Polares Medical, Cardiac Dimensions, ReCor Medical; has received institutional research grants from Boston Scientific, Novartis, and Fumedica AG; and holds equity in Hi-D Imaging. Dr. Stämpfli has received consulting, proctoring, or speaker fees from Abbott, Alnylam, Amgen, AstraZeneca, Bayer-Myers Squibb, Fumedica, Novartis, Polares Medical, Pfizer, and Takeda. Dr. Bossard received speaker and consulting fees from Abbott Vascular, Abiomed, and SIS Medical. Dr. Wolfrum is a proctor for Biosensors. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR., Methods: Eligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD)., Results: A total of 4066 patients from 4 RCTs (3'506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48-0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 - -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17-0.65. ARD: -0.9%, 95% CI: -1.5 - -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16-0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62-1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35-1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33-1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37-1.50, p = 0.40) were similar., Conclusions: The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively., (© 2023. The Author(s).)

Background: Covered coronary stent (CS) implantation is associated with a high risk for in-stent restenosis (ISR) and stent thrombosis (ST). We describe the outcomes after overstenting ("burying") CS using contemporary drug-eluting stents (DES)., Methods: We analyzed short- and long-term outcomes of consecutive patients who had had a CS implanted, which was consecutively covered ("buried") with a third-generation DES. CSs were primarily post-dilated and then covered with a longer DES overlapping the proximal and distal edges of the CS. To ensure optimal stent expansion and appositions, all lesions were post-dilated using adequately sized non-compliant balloons., Results: Between 2015 and 2020, 23 patients (mean age 67 ± 14 years, 74% males) were treated using this novel approach. Reasons for implanting CS included treatment of coronary aneurysms (n = 7; 30%), coronary perforations (n = 13; 57%), and aorto-ostial dissections (n = 3; 13%). All CSs were successfully deployed, and no peri-procedural complications occurred. The median time of follow-up was 24.5 (interquartile range [IQR] 11.7-37.9) months. All patients had a 1-month follow-up (FU) and 19/23 (83%) patients had 12-month FU (FU range 1-60 months). No probable or definite STs occurred, and no cardiovascular deaths were observed. Among patients undergoing angiographic FU (11/23 [48%]), 1/23 showed angiographically significant ISR 6 months post CS implantation., Conclusions: Burying a coronary CS under a DES appears to be a safe and promising strategy to overcome the limitations of the currently available CS devices, including a relatively high risk for target lesion failure due to ISR and ST.

Background: Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population., Methods: From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE)., Results: Totally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died., Conclusions: For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials., Competing Interests: Declaration of competing interest AAT has received consulting and speaker fees from SIS Medical. RK has received institutional grants from Abbott, Biosense-Webster, Biotronik, Boston-Scientific, Medtronic, SIS Medical and act as a consultant for Biosense-Webster, Biotronik and Medtronic. MB has received consulting and speaker fees from Abbott Vascular, Abiomed and SIS Medical. FC has received consulting and speaker fees from SIS Medical, Abiomed and Abbott Vascular. All other authors have no conflicts of interest to declare., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Conflicts of interest: All authors declare that they have no conflicts of interest.

The increasing prevalence of aortic stenosis (AS) and the increasing number of patients indicated for transcatheter aortic valve implantation (TAVI) can lead to increased hospital constraints. This study aimed to compare, from the hospital perspective, the costs, resource use, and 30-day clinical outcomes of patients who underwent TAVI under an optimized or standard clinical pathway. A single-center, retrospective study was conducted among patients with native AS who underwent TAVI between January 2018 and March 2021. Patients who underwent optimized lean TAVI were propensity-score matched 1:1 to those who underwent standard TAVI. In-hospital costs and 30-day clinical outcomes were compared between the 2 groups. A total of 182 patients (91 in each group) were included in the final analysis. Baseline covariates were well balanced after matching. Patients who underwent lean TAVI had shorter length of stay (median [interquartile range] 3.0 days [2.0 to 6.0] vs 6.0 days [5.0 to 9.0], p <0.001). Patients in the lean TAVI group incurred lower total costs than did those in the standard TAVI group (mean ± SD: $41,346 ± 10,062 vs $50,471 ± 15,115, p = 0.002). There was no between-group difference in 30-day all-cause mortality (2.2% vs 1.1%, p = 0.573) and pacemaker implantations (5.5% vs 6.6%, p = 0.788). Rates of procedural complications were comparable between groups. In conclusion, lean TAVI leads to hospital efficiencies without compromising patient safety. Efforts to streamline the TAVI procedure should be encouraged to improve access to TAVI for patients with AS, amid resource constraints., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: Patients with severe mitral regurgitation (MR) frequently present with concomitant right ventricular (RV) dysfunction and tricuspid regurgitation (TR). We aimed to investigate the prognostic relevance of RV function, RV dimension, and TR in patients undergoing percutaneous intervention for MR., Methods: Consecutive patients undergoing percutaneous mitral valve intervention were enrolled in the prospective MitraSwiss registry. Tricuspid annular plane systolic excursion (TAPSE), pulmonary artery systolic pressure (PASP), right ventricular pulmonary arterial coupling (RVC, defined as TAPSE/ PASP ratio), indexed tricuspid annulus (TA) dimension, and TR severity grade were analyzed at baseline, post procedure, and at 6-month follow-up. The endpoints of all-cause mortality, hospitalization for heart failure, and the combined endpoint of the 2 were observed during long-term follow-up (up to 4 years)., Results: We analyzed 218 patients (mean age, 76 ± 9 years; 36% female). Edge-to-edge mitral valve repair resulted in an increase in TAPSE and RVC ratio and a decrease in indexed TA and PASP, but concomitant TR did not change significantly. In multivariable analysis, RV dysfunction and moderate/severe TR were independently associated with increased all-cause mortality (hazard ratio, 1.61; 95% confidence interval, 1.05-2.46; P=.03 and hazard ratio, 2.10; 95% confidence interval, 1.34-3.29; P<.01, respectively) and moderate/severe TR was further an independent predictor for hospitalization for heart failure and for the combined endpoint., Conclusion: Treatment of MR resulted in favorable changes of RV function and dimension but did not reduce TR in the majority of patients. TR at baseline remained the strongest predictor for outcomes, outperforming parameters of RV function and dimension.

Competing Interests: Declaration of competing interest ST is a consultant and proctor for Boston Scientific, Medtronic, Edwards Lifesciences, Abbott and Biosensors, a consultant for Medira, Atheart Medical, Veosource, Shockwave, Teleflex, Polares Medical, has received institutional research grants from Boston Scientific and Fumedica AG and holds equity in Hi-D Imaging. MW is a proctor for Biosensors. SFS has received consulting and speaker fees from Alnylam, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Pfizer, and Takeda. MBo received speaker and consulting fees from Abbott Vascular, Abiomed and SIS Medical. RK received institutional grants from Abbott, Biosense-Webster, Biotronik, Boston Scientific, Medtronic and Sis-Medical and is consultant for Biosense-Webster, Biotronik and Medtronic.

Background: Left ventricular (LV) unloading via the percutaneous micro-axial Impella pump is increasingly used in patients with anterior ST-segment elevation myocardial infarction (STEMI) and overt cardiogenic shock. In this context, the evolution of cardiac function and dimensions beyond hospital discharge remains uncertain. We aimed to characterize echocardiographic changes over time in patients with acute anterior STEMI treated with an Impella device., Methods: From an ongoing prospective registry, consecutive patients with acute anterior STEMI managed with an Impella device were extracted. Transthoracic echocardiography was performed at index hospitalization and at first outpatient follow-up. Predictors of response, defined as a ≥ 10% absolute increase in left ventricular ejection fraction (LVEF) at follow-up, were sought., Results: A total of 66 patients (89.4% male, aged 64.3 ± 11.6 years) with anterior STEMI were treated with an Impella device in the first 24 hours of hospitalization, from 2014 to 2022. In-hospital mortality was 24%. Major bleeding and vascular complications requiring surgery occurred in 24% and 11% of patients, respectively. At baseline, mean LVEF was 34% ±12%. At follow-up, survivors showed a significant increase in LVEF ( P < 0.0001), whereas LV dimensions, diastolic parameters, and measures of right ventricular dimension and function remained stable. Overall, 28 patients had a ≥ 10% absolute increase in LVEF at follow-up. Baseline creatinine was the only significant predictor of response at univariate analysis., Conclusions: Among patients with anterior STEMI requiring mechanical hemodynamic support with an Impella device, the majority of survivors showed a sustained increase in LV function, without evidence of adverse remodelling. This signal warrants further investigation in dedicated trials., (© 2022 The Authors.)

Objectives: During the past few years, physicians have optimized transcatheter aortic valve replacement and its periprocedural management, with the minimalist approach becoming popular. We aimed to further simplify the procedure using a single femoral access (the "all-in-one" technique). Here, we report a multicenter experience with TAVR with Acurate neo/neo2 transcatheter heart valves (Boston Scientific) through a single, large-bore, femoral sheath., Methods: Patients underwent TAVR with the Acurate neo or neo2 through a single femoral access at 4 centers. The large sheath was used for both the delivery catheter and the pigtail used to visualize the aortic root., Results: A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo2 (n = 57). The procedure was successfully performed through a single large sheath in all patients. Median duration of hospitalization stay was 2 days (interquartile range, 1-3 days). On echocardiography before discharge, the mean gradient was 7 ± 3 mm Hg and 7 patients (4.4%) had more than mild paravalvular leak. At 30 days, a major vascular complication had occurred in 2 patients (1.3%), 2 patients (1.3%) had suffered a stroke, and only 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died., Conclusions: An all-in-one access technique allows safe implantation of Acurate neo and neo2 transcatheter heart valves, with low rates of periprocedural complications and favorable short-term outcomes.

We show how solitary states in a system of globally coupled FitzHugh-Nagumo oscillators can lead to the emergence of chimera states. By a numerical bifurcation analysis of a suitable reduced system in the thermodynamic limit we demonstrate how solitary states, after emerging from the synchronous state, become chaotic in a period-doubling cascade. Subsequently, states with a single chaotic oscillator give rise to states with an increasing number of incoherent chaotic oscillators. In large systems, these chimera states show extensive chaos. We demonstrate the coexistence of many of such chaotic attractors with different Lyapunov dimensions, due to different numbers of incoherent oscillators.

To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24-69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01-0.50; p = 0.001), and there was no significant difference in vascular complications between the two groups (p = 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications., (© 2022. The Author(s).)