17 results on '"Maniuc O"'
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2. P1715Management and outcome in patients with non-ischemic cardiogenic shock and Impella CP use
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Maniuc, O, primary, Salinger, T, additional, Anders, F, additional, Muentze, J, additional, Liu, D, additional, Hu, K, additional, Lengenfelder, B, additional, Voelker, W, additional, Frantz, S, additional, and Nordbeck, P, additional
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- 2019
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3. P3422High precision vessel access during transfemoral aortic valve implantation - a pilot study of puncture guidance using a new navigation technique
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Maniuc, O, primary, Fischer, G, additional, Petri, N, additional, Sakas, G, additional, Kolev, V, additional, Nordbeck, P, additional, Herrmann, S, additional, Frantz, S, additional, and Voelker, W, additional
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- 2018
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4. Sex-related differences in patients presenting with heart failure-related cardiogenic shock.
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Sundermeyer J, Kellner C, Beer BN, Besch L, Dettling A, Bertoldi LF, Blankenberg S, Dauw J, Dindane Z, Eckner D, Eitel I, Graf T, Horn P, Jozwiak-Nozdrzykowska J, Kirchhof P, Kluge S, Linke A, Landmesser U, Luedike P, Lüsebrink E, Majunke N, Mangner N, Maniuc O, Möbius-Winkler S, Nordbeck P, Orban M, Pappalardo F, Pauschinger M, Pazdernik M, Proudfoot A, Kelham M, Rassaf T, Scherer C, Schulze PC, Schwinger RHG, Skurk C, Sramko M, Tavazzi G, Thiele H, Villanova L, Morici N, Winzer EB, Westermann D, and Schrage B
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- Male, Humans, Female, Stroke Volume, Ventricular Function, Left, Sex Factors, Hospital Mortality, Shock, Cardiogenic diagnosis, Shock, Cardiogenic epidemiology, Shock, Cardiogenic etiology, Heart Failure diagnosis, Heart Failure epidemiology, Heart Failure therapy
- Abstract
Background: Heart failure-related cardiogenic shock (HF-CS) accounts for a significant proportion of all CS cases. Nevertheless, there is a lack of evidence on sex-related differences in HF-CS, especially regarding use of treatment and mortality risk in women vs. men. This study aimed to investigate potential differences in clinical presentation, use of treatments, and mortality between women and men with HF-CS., Methods: In this international observational study, patients with HF-CS (without acute myocardial infarction) from 16 tertiary-care centers in five countries were enrolled between 2010 and 2021. Logistic and Cox regression models were used to assess differences in clinical presentation, use of treatments, and 30-day mortality in women vs. men with HF-CS., Results: N = 1030 patients with HF-CS were analyzed, of whom 290 (28.2%) were women. Compared to men, women were more likely to be older, less likely to have a known history of heart failure or cardiovascular risk factors, and lower rates of highly depressed left ventricular ejection fraction and renal dysfunction. Nevertheless, CS severity as well as use of treatments were comparable, and female sex was not independently associated with 30-day mortality (53.0% vs. 50.8%; adjusted HR 0.94, 95% CI 0.75-1.19)., Conclusions: In this large HF-CS registry, sex disparities in risk factors and clinical presentation were observed. Despite these differences, the use of treatments was comparable, and both sexes exhibited similarly high mortality rates. Further research is necessary to evaluate if sex-tailored treatment, accounting for the differences in cardiovascular risk factors and clinical presentation, might improve outcomes in HF-CS., (© 2024. The Author(s).)
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- 2024
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5. Association between left ventricular ejection fraction, mortality and use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock.
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Sundermeyer J, Kellner C, Beer BN, Besch L, Dettling A, Bertoldi LF, Blankenberg S, Dauw J, Dindane Z, Eckner D, Eitel I, Graf T, Horn P, Jozwiak-Nozdrzykowska J, Kirchhof P, Kluge S, Linke A, Landmesser U, Luedike P, Lüsebrink E, Majunke N, Mangner N, Maniuc O, Winkler SM, Nordbeck P, Orban M, Pappalardo F, Pauschinger M, Pazdernik M, Proudfoot A, Kelham M, Rassaf T, Scherer C, Schulze PC, Schwinger RHG, Skurk C, Sramko M, Tavazzi G, Thiele H, Villanova L, Morici N, Westenfeld R, Winzer EB, Westermann D, and Schrage B
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- Humans, Male, Middle Aged, Aged, Female, Stroke Volume, Ventricular Function, Left, Retrospective Studies, Treatment Outcome, Shock, Cardiogenic diagnosis, Shock, Cardiogenic therapy, Heart-Assist Devices
- Abstract
Background: Currently, use of mechanical circulatory support (MCS) in non-ischaemic cardiogenic shock (CS) is predominantly guided by shock-specific markers, and not by markers of cardiac function. We hypothesise that left ventricular ejection fraction (LVEF) can identify patients with a higher likelihood to benefit from MCS and thus help to optimise their expected benefit., Methods: Patients with non-ischaemic CS and available data on LVEF from 16 tertiary-care centres in five countries were analysed. Cox regression models were fitted to evaluate the association between LVEF and mortality, as well as the interaction between LVEF, MCS use and mortality., Results: N = 807 patients were analysed: mean age 63 [interquartile range (IQR) 51.5-72.0] years, 601 (74.5%) male, lactate 4.9 (IQR 2.6-8.5) mmol/l, LVEF 20 (IQR 15-30) %. Lower LVEF was more frequent amongst patients with more severe CS, and MCS was more likely used in patients with lower LVEF. There was no association between LVEF and 30-day mortality risk in the overall study cohort. However, there was a significant interaction between MCS use and LVEF, indicating a lower 30-day mortality risk with MCS use in patients with LVEF ≤ 20% (hazard ratio 0.72, 95% confidence interval 0.51-1.02 for LVEF ≤ 20% vs. hazard ratio 1.31, 95% confidence interval 0.85-2.01 for LVEF > 20%, interaction-p = 0.017)., Conclusion: This retrospective study may indicate a lower mortality risk with MCS use only in patients with severely reduced LVEF. This may propose the inclusion of LVEF as an adjunctive parameter for MCS decision-making in non-ischaemic CS, aiming to optimise the benefit-risk ratio., (© 2023. The Author(s).)
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- 2024
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6. Complications in patients with cardiogenic shock on veno-arterial extracorporeal membrane oxygenation therapy: distribution and relevance. Results from an international, multicentre cohort study.
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Beer BN, Kellner C, Goßling A, Sundermeyer J, Besch L, Dettling A, Kirchhof P, Blankenberg S, Bernhardt AM, Brunner S, Colson P, Eckner D, Frank D, Eitel I, Frey N, Eden M, Graf T, Kupka D, Landmesser U, Majunke N, Maniuc O, Möbius-Winkler S, Morrow DA, Mourad M, Noel C, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Reichenspurner H, Schulze PC, Schwinger RHG, Wechsler A, Skurk C, Thiele H, Varshney AS, Sag CM, Krais J, Westermann D, and Schrage B
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- Humans, Female, Middle Aged, Male, Shock, Cardiogenic etiology, Shock, Cardiogenic therapy, Retrospective Studies, Hospital Mortality, Extracorporeal Membrane Oxygenation methods, Myocardial Infarction
- Abstract
Aims: Veno-arterial extracorporeal membrane oxygenation therapy (VA-ECMO) restores circulation and tissue oxygenation in cardiogenic shock (CS) patients, but can also lead to complications. This study aimed to quantify VA-ECMO complications and analyse their association with overall survival as well as favourable neurological outcome (cerebral performance categories 1 + 2)., Methods and Results: All-comer patients with CS treated with VA-ECMO were retrospectively enrolled from 16 centres in four countries (2005-2019). Neurological, bleeding, and ischaemic adverse events (AEs) were considered. From these, typical VA-ECMO complications were identified and analysed separately as device-related complications. n = 501. Overall, 118 were women (24%), median age was 56.0 years, median lactate was 8.1 mmol/L. Acute myocardial infarction caused CS in 289 patients (58%). Thirty-days mortality was 40% (198/501 patients). At least one device-related complication occurred in 252/486 (52%) patients, neurological AEs in 108/469 (23%), bleeding in 192/480 (40%), ischaemic AEs in 123/478 (26%). The 22% of patients with the most AEs accounted for 50% of all AEs. All types of AEs were associated with a worse prognosis. Aside from neurological ones, all AEs and device-related complications were more likely to occur in women; although prediction of AEs outside of neurological AEs was generally poor., Conclusion: Therapy and device-related complications occur in half of all patients treated with VA-ECMO and are associated with a worse prognosis. They accumulate in some patients, especially in women. Aside from neurological events, identification of patients at risk is difficult, highlighting the need to establish additional quantitative markers of complication risk to guide VA-ECMO treatment in CS., Competing Interests: Conflict of interest: Dr Bernhardt reports personal fees from Abbott, personal fees from Abiomed, personal fees from Astra Zeneca, personal fees from Berlin Heart, personal fees from Fine Heart, personal fees from Medtronic, outside the submitted work; Dr Morrow reports grants and personal fees from Abbott Laboratories, grants from Abiomed, grants from Amgen, grants from Anthos Therapeutics, grants from ARCA Biopharma, grants from AstraZeneca, grants from Bayer Healthcare, grants from Eisai, grants, and personal fees from Merck, grants and personal fees from Novartis, grants from Pfizer, grants from Regneron Pharmaceuticals, grants and personal fees from Roche Diagnostics, grants from Siemens, personal fees from InCardia, personal fees from Inflammatix, outside the submitted work; Dr Varshney reports personal fees from Broadview Ventures, outside the submitted work. The other authors report no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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7. Clinical presentation, shock severity and mortality in patients with de novo versus acute-on-chronic heart failure-related cardiogenic shock.
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Sundermeyer J, Kellner C, Beer BN, Besch L, Dettling A, Bertoldi LF, Blankenberg S, Dauw J, Dindane Z, Eckner D, Eitel I, Graf T, Horn P, Jozwiak-Nozdrzykowska J, Kirchhof P, Kluge S, Linke A, Landmesser U, Luedike P, Lüsebrink E, Majunke N, Mangner N, Maniuc O, Möbius Winkler S, Nordbeck P, Orban M, Pappalardo F, Pauschinger M, Pazdernik M, Proudfoot A, Kelham M, Rassaf T, Reichenspurner H, Scherer C, Schulze PC, Schwinger RHG, Skurk C, Sramko M, Tavazzi G, Thiele H, Villanova L, Morici N, Winzer EB, Westermann D, Gustafsson F, and Schrage B
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- Humans, Hospital Mortality, Prognosis, Heart Failure, Shock, Cardiogenic etiology
- Abstract
Aims: Heart failure-related cardiogenic shock (HF-CS) accounts for a significant proportion of CS cases. Whether patients with de novo HF and those with acute-on-chronic HF in CS differ in clinical characteristics and outcome remains unclear. The aim of this study was to evaluate differences in clinical presentation and mortality between patients with de novo and acute-on-chronic HF-CS., Methods and Results: In this international observational study, patients with HF-CS from 16 tertiary care centres in five countries were enrolled between 2010 and 2021. To investigate differences in clinical presentation and 30-day mortality, adjusted logistic/Cox regression models were fitted. Patients (n = 1030) with HF-CS were analysed, of whom 486 (47.2%) presented with de novo HF-CS and 544 (52.8%) with acute-on-chronic HF-CS. Traditional markers of CS severity (e.g. blood pressure, heart rate and lactate) as well as use of treatments were comparable between groups. However, patients with acute-on-chronic HF-CS were more likely to have a higher CS severity and also a higher mortality risk, after adjusting for relevant confounders (de novo HF 45.5%, acute-on-chronic HF 55.9%, adjusted hazard ratio 1.38, 95% confidence interval 1.10-1.72, p = 0.005)., Conclusion: In this large HF-CS cohort, acute-on-chronic HF-CS was associated with more severe CS and higher mortality risk compared to de novo HF-CS, although traditional markers of CS severity and use of treatments were comparable. These findings highlight the vast heterogeneity of patients with HF-CS, emphasize that HF chronicity is a relevant disease modifier in CS, and indicate that future clinical trials should account for this., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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- 2024
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8. Use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock.
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Schrage B, Sundermeyer J, Beer BN, Bertoldi L, Bernhardt A, Blankenberg S, Dauw J, Dindane Z, Eckner D, Eitel I, Graf T, Horn P, Kirchhof P, Kluge S, Linke A, Landmesser U, Luedike P, Lüsebrink E, Mangner N, Maniuc O, Winkler SM, Nordbeck P, Orban M, Pappalardo F, Pauschinger M, Pazdernik M, Proudfoot A, Kelham M, Rassaf T, Reichenspurner H, Scherer C, Schulze PC, Schwinger RHG, Skurk C, Sramko M, Tavazzi G, Thiele H, Villanova L, Morici N, Wechsler A, Westenfeld R, Winzer E, and Westermann D
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- Humans, Shock, Cardiogenic etiology, Shock, Cardiogenic therapy, Stroke Volume, Retrospective Studies, Intra-Aortic Balloon Pumping methods, Ventricular Function, Left, Treatment Outcome, Heart Failure complications, Heart-Assist Devices adverse effects
- Abstract
Aims: Despite its high incidence and mortality risk, there is no evidence-based treatment for non-ischaemic cardiogenic shock (CS). The aim of this study was to evaluate the use of mechanical circulatory support (MCS) for non-ischaemic CS treatment., Methods and Results: In this multicentre, international, retrospective study, data from 890 patients with non-ischaemic CS, defined as CS due to severe de-novo or acute-on-chronic heart failure with no need for urgent revascularization, treated with or without active MCS, were collected. The association between active MCS use and the primary endpoint of 30-day mortality was assessed in a 1:1 propensity-matched cohort. MCS was used in 386 (43%) patients. Patients treated with MCS presented with more severe CS (37% vs. 23% deteriorating CS, 30% vs. 25% in extremis CS) and had a lower left ventricular ejection fraction at baseline (21% vs. 25%). After matching, 267 patients treated with MCS were compared with 267 patients treated without MCS. In the matched cohort, MCS use was associated with a lower 30-day mortality (hazard ratio 0.76, 95% confidence interval 0.59-0.97). This finding was consistent through all tested subgroups except when CS severity was considered, indicating risk reduction especially in patients with deteriorating CS. However, complications occurred more frequently in patients with MCS; e.g. severe bleeding (16.5% vs. 6.4%) and access-site related ischaemia (6.7% vs. 0%)., Conclusion: In patients with non-ischaemic CS, MCS use was associated with lower 30-day mortality as compared to medical therapy only, but also with more complications. Randomized trials are needed to validate these findings., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2023
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9. Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy.
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Schrage B, Sundermeyer J, Blankenberg S, Colson P, Eckner D, Eden M, Eitel I, Frank D, Frey N, Graf T, Kirchhof P, Kupka D, Landmesser U, Linke A, Majunke N, Mangner N, Maniuc O, Mierke J, Möbius-Winkler S, Morrow DA, Mourad M, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Radakovic D, Schulze PC, Scherer C, Schwinger RHG, Skurk C, Thiele H, Varshney A, Wechsler L, and Westermann D
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- Humans, Shock, Cardiogenic, Hospital Mortality, Heart Ventricles, Heart Failure therapy, Extracorporeal Membrane Oxygenation
- Abstract
Background: It is currently unclear if active left ventricular (LV) unloading should be used as a primary treatment strategy or as a bailout in patients with cardiogenic shock (CS) treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO)., Objectives: This study sought to evaluate the association between timing of active LV unloading and implantation of VA-ECMO with outcomes of patients with CS., Methods: Data from 421 patients with CS treated with VA-ECMO and active LV unloading at 18 tertiary care centers in 4 countries were analyzed. Patients were stratified by timing of device implantation in early vs delayed active LV unloading (defined by implantation before up to 2 hours after VA-ECMO). Adjusted Cox and logistic regression models were fitted to evaluate the association between early active LV unloading and 30-day mortality as well as successful weaning from ventilation., Results: Overall, 310 (73.6%) patients with CS were treated with early active LV unloading. Early active LV unloading was associated with a lower 30-day mortality risk (HR: 0.64; 95% CI: 0.46-0.88) and a higher likelihood of successful weaning from ventilation (OR: 2.17; 95% CI: 1.19-3.93) but not with more complications. Importantly, the relative mortality risk increased and the likelihood of successful weaning from ventilation decreased almost proportionally with the time interval between VA-ECMO implantation and (delayed) initiation of active LV unloading., Conclusions: This exploratory study lends support to the use of early active LV unloading in CS patients on VA-ECMO, although the findings need to be validated in a randomized controlled trial., Competing Interests: Funding Support and Author Disclosures Drs Schrage and Westermann were funded by the German Center for Cardiovascular Research, and Dr Schrage is also funded by the Else Kröner-Fresenius-Stiftung. This study was funded by an unrestricted research grant from Abiomed. However, Abiomed was not involved in the design of the study, the collection and analysis of the data, the writing of the manuscript, or the decision to publish. Dr Schrage has received speaker fees from Abiomed and AstraZeneca, outside of the submitted work. Dr Blankenberg has received grants and personal fees from Abbott Diagnostics, Bayer, Siemens, and Thermo Fisher; grants from Singulex; and personal fees from Abbott, AstraZeneca, AMGEN, Medtronic, Pfizer, Roche, Siemens Diagnostics, and Novartis, outside of the submitted work. Dr Eckner has received speaker fees from Abiomed, Bayer, and Daiichi Sankyo, outside of the submitted work. Dr Kirchhof has received research support for basic, translational, and clinical research projects from the European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (United Kingdom), and German Center for Cardiovascular Research; has received research support from several drug and device companies active in atrial fibrillation; has received honoraria from several such companies in the past but not in the last 3 years; and is listed as inventor on 2 patents held by the University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783; unrelated to the submitted work). Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific, outside the submitted work. Dr Mierke has received speaker fees from Abiomed, outside the submitted work. Dr Morrow has served as a member of the TIMI Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott Laboratories, Amgen, Anthos Therapeutics, Arca Biopharma, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Eisai, Intarcia, Janssen, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron, Roche, Siemens, The Medicines Company, and Zora Biosciences; and received consulting fees from Arca Biopharma, Bayer Pharma, InCarda, Inflammatix, Merck, Novartis, and Roche Diagnostics. Dr Pappalardo has served as a consultant for Abiomed. Dr Westermann has received speaker fees from Abiomed, AstraZeneca, Bayer, Berlin-Chemie, Boehringer Ingelheim, Novartis, and Medtronic, 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 © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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10. A Skill Trainer for Balloon/Stent Exchange in Percutaneous Coronary Intervention-Concept and Evaluation.
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Petri N, Weber C, Maniuc O, Oder D, Lengenfelder B, and Voelker W
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- Humans, Stents, Clinical Competence, Percutaneous Coronary Intervention
- Abstract
Background: To prevent complications, uncontrolled movement of the guidewire during a coronary intervention should be avoided. Unintentional withdrawal of the wire can result in the inability to recross a lesion with the risk of myocardial infarction. On the other hand, unintended forward pushing can lead to a coronary perforation. Thus, interventionalists in training should practice keeping the coronary guidewire in a stable position to prevent complications. For this purpose, a skill trainer has been developed, which provides the possibility of unlimited practice outside of the cath lab.The purpose of this study was to assess the effectiveness and the validity of this skills trainer., Methods: Ten novices and 10 participants with experience in diagnostic catheterization underwent training on the skills trainer consisting of 25 procedures. To assess the efficacy of the training module, the mean score of the first 3 procedures was compared with the final 3 procedures in the novice and the advanced group. To determine the construct validity of the simulator, a group of experts (E; performed >1000 percutaneous coronary interventions) also underwent evaluation on the skills trainer. For each procedure, the change in position of the guidewire as well as the time was determined and combined into a skills score with a maximum of 15 points., Results: The novice and the advanced group improved significantly throughout the training on the simulator (N: 7.1 ± 2.6 to 12.2 ± 2.0, P = 0.007; A: 8.3 ± 2.0 to 13.2 ± 1.0, P = 0.005, Wilcoxon).The experts scored significantly higher than novices or the advanced participants during their first 3 procedures (E: 12.9 ± 1.0; N: 7.1 ± 2.6, P = 0.001; A: 8.3 ± 2.0, P = 0.001; Mann-Whitney U )., Conclusions: This low-cost task trainer is a valid and effective tool to train adequate balloon/stent exchange while keeping the guidewire in a stable position. Whether the skills acquired on the task trainer can be transferred to procedures performed on patients needs further investigation., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Society for Simulation in Healthcare.)
- Published
- 2022
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11. Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study.
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Schrage B, Becher PM, Bernhardt A, Bezerra H, Blankenberg S, Brunner S, Colson P, Cudemus Deseda G, Dabboura S, Eckner D, Eden M, Eitel I, Frank D, Frey N, Funamoto M, Goßling A, Graf T, Hagl C, Kirchhof P, Kupka D, Landmesser U, Lipinski J, Lopes M, Majunke N, Maniuc O, McGrath D, Möbius-Winkler S, Morrow DA, Mourad M, Noel C, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Reichenspurner H, Sandri M, Schulze PC, H G Schwinger R, Sinning JM, Aksoy A, Skurk C, Szczanowicz L, Thiele H, Tietz F, Varshney A, Wechsler L, and Westermann D
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- Adult, Aged, Cohort Studies, Extracorporeal Membrane Oxygenation trends, Female, Humans, Male, Middle Aged, Mortality trends, Shock, Cardiogenic diagnosis, Treatment Outcome, Extracorporeal Membrane Oxygenation mortality, Internationality, Shock, Cardiogenic mortality, Shock, Cardiogenic therapy, Ventricular Function, Left physiology
- Abstract
Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality., Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort., Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63-0.98]; P =0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site-related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%)., Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.
- Published
- 2020
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12. Impella CP use in patients with non-ischaemic cardiogenic shock.
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Maniuc O, Salinger T, Anders F, Müntze J, Liu D, Hu K, Ertl G, Frantz S, and Nordbeck P
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- Acute Disease, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Retrospective Studies, Young Adult, Heart-Assist Devices, Myocardial Ischemia complications, Shock, Cardiogenic etiology, Shock, Cardiogenic therapy
- Abstract
Aims: From the various mechanical cardiac assist devices and indications available, the use of the percutaneous intraventricular Impella CP pump is usually restricted to acute ischaemic shock or prophylactic indications in high-risk interventions. In the present study, we investigated clinical usefulness of the Impella CP device in patients with non-ischaemic cardiogenic shock as compared with acute ischaemia., Methods and Results: In this retrospective single-centre analysis, patients who received an Impella CP at the University Hospital Würzburg between 2013 and 2017 due to non-ischaemic cardiogenic shock were age-matched 2:1 with patients receiving the device due to ischaemic cardiogenic shock. Inclusion criteria were therapy refractory haemodynamic instability with severe left ventricular systolic dysfunction and serum lactate >2.0 mmol/L at implantation. Basic clinical data, indications for mechanical ventricular support, and outcome were obtained in all patients with non-ischaemic as well as ischaemic shock and compared between both groups. Continuous variables are expressed as mean ± standard deviation or median (quartiles). Categorical variables are presented as count and per cent. Twenty-five patients had cardiogenic shock due to non-ischaemic reasons and were compared with 50 patients with cardiogenic shock due to acute myocardial infarction. Resuscitation rates before implantation of Impella CP were high (32 vs. 42%; P = 0.402). At implantation, patients with non-ischaemic cardiogenic shock had lower levels of high-sensitive troponin T (110.65 [57.87-322.1] vs. 1610 [450.8-3861.5] pg/mL; P = 0.001) and lactate dehydrogenase (377 [279-608] vs. 616 [371.3-1109] U/L; P = 0.007), while age (59 ± 16 vs. 61.7 ± 11; P = 0.401), glomerular filtration rate (43.5 [33.2-59.7] vs. 48 [35.75-69] mL/min; P = 0.290), C-reactive protein (5.17 [3.27-10.26] vs. 10.97 [3.23-17.2] mg/dL; P = 0.195), catecholamine index (30.6 [10.6-116.9] vs. 47.6 [11.7-90] μg/kg/min; P = 0.663), and serum lactate (2.6 [2.2-5.8] vs. 2.9 [1.3-6.6] mmol/L; P = 0.424) were comparable between both groups. There was a trend for longer duration of Impella support in the non-ischaemic groups (5 [2-7.5] vs. 3 [2-5.25] days, P = 0.211). Rates of haemodialysis (52 vs. 47%; P = 0.680) and transition to extracorporeal membrane oxygenation (13.6 vs. 22.2%; P = 0.521) were comparable. No significant difference was found regarding both 30 day survival (48 vs. 30%; P = 0.126) and in-hospital mortality (66.7 vs. 74%; P = 0.512), although there was a trend for better survival in the non-ischaemic group., Conclusions: These data suggest that temporary use of the Impella CP device might be a useful therapeutic option for bridge to recovery not only in ischaemic but also in non-ischaemic cardiogenic shock., (© 2019 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)
- Published
- 2019
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13. Oral Chaperone Therapy Migalastat for Treating Fabry Disease: Enzymatic Response and Serum Biomarker Changes After 1 Year.
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Müntze J, Gensler D, Maniuc O, Liu D, Cairns T, Oder D, Hu K, Lorenz K, Frantz S, Wanner C, and Nordbeck P
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- 1-Deoxynojirimycin administration & dosage, 1-Deoxynojirimycin pharmacokinetics, Adult, Biomarkers blood, Creatinine blood, Drug Monitoring methods, Enzyme Replacement Therapy methods, Female, Glomerular Filtration Rate drug effects, Humans, Male, Middle Aged, Organ Size drug effects, Prospective Studies, Treatment Outcome, 1-Deoxynojirimycin analogs & derivatives, Fabry Disease blood, Fabry Disease drug therapy, Fabry Disease enzymology, Glycolipids blood, Myocardium pathology, Sphingolipids blood, alpha-Galactosidase metabolism
- Abstract
Long-term effects of migalastat therapy in clinical practice are currently unknown. We evaluated migalastat efficacy and biomarker changes in a prospective, single-center study on 14 patients with Fabry disease (55 ± 14 years; 11 men). After 1 year of open-label migalastat therapy, patients showed significant changes in alpha-galactosidase-A activity (0.06-0.2 nmol/minute/mg protein; P = 0.001), left ventricular myocardial mass index (137-130 g/m
2 ; P = 0.037), and serum creatinine (0.94-1.0 mg/dL; P = 0.021), accounting for deterioration in estimated glomerular filtration rate (87-78 mL/minute/1.73 m2 ; P = 0.012). The enzymatic increase correlated with myocardial mass reduction (r = -0.546; P = 0.044) but not with renal function (r = -0.086; P = 0.770). Plasma globotriaosylsphingosine was reduced in therapy-naive patients (10.9-6.0 ng/mL; P = 0.021) and stable (9.6-12.1 ng/mL; P = 0.607) in patients switched from prior enzyme-replacement therapy. These first real-world data show that migalastat substantially increases alpha-galactosidase-A activity, stabilizes related serum biomarkers, and improves cardiac integrity in male and female patients with amenable Fabry disease mutations., (© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)- Published
- 2019
- Full Text
- View/download PDF
14. Accessory pulmonary vein insertion into the left atrial appendage revealed during intended interventional left atrial appendage occlusion.
- Author
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Maniuc O, Müntze J, Moritz M, and Nordbeck P
- Subjects
- Atrial Appendage diagnostic imaging, Atrial Fibrillation complications, Atrial Fibrillation physiopathology, Echocardiography, Transesophageal, Electrocardiography, Humans, Male, Middle Aged, Stroke etiology, Tomography, X-Ray Computed, Atrial Appendage surgery, Atrial Fibrillation surgery, Cardiac Catheterization methods, Heart Rate physiology, Pulmonary Veins surgery, Stroke prevention & control
- Published
- 2019
- Full Text
- View/download PDF
15. Value of the CHA 2 DS 2 -VASc score and Fabry-specific score for predicting new-onset or recurrent stroke/TIA in Fabry disease patients without atrial fibrillation.
- Author
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Liu D, Hu K, Schmidt M, Müntze J, Maniuc O, Gensler D, Oder D, Salinger T, Weidemann F, Ertl G, Frantz S, Wanner C, and Nordbeck P
- Subjects
- Adult, Cohort Studies, Feasibility Studies, Female, Follow-Up Studies, Humans, Ischemic Attack, Transient epidemiology, Male, Middle Aged, Predictive Value of Tests, Retrospective Studies, Risk Factors, Stroke epidemiology, Young Adult, Fabry Disease complications, Ischemic Attack, Transient etiology, Risk Assessment methods, Stroke etiology
- Abstract
Objectives: To evaluate potential risk factors for stroke or transient ischemic attacks (TIA) and to test the feasibility and efficacy of a Fabry-specific stroke risk score in Fabry disease (FD) patients without atrial fibrillation (AF)., Background: FD patients often experience cerebrovascular events (stroke/TIA) at young age., Methods: 159 genetically confirmed FD patients without AF (aged 40 ± 14 years, 42.1% male) were included, and risk factors for stroke/TIA events were determined. All patients were followed up over a median period of 60 (quartiles 35-90) months. The pre-defined primary outcomes included new-onset or recurrent stroke/TIA and all-cause death., Results: Prior stroke/TIA (HR 19.97, P < .001), angiokeratoma (HR 4.06, P = .010), elevated creatinine (HR 3.74, P = .011), significant left ventricular hypertrophy (HR 4.07, P = .017), and reduced global systolic strain (GLS, HR 5.19, P = .002) remained as independent risk predictors of new-onset or recurrent stroke/TIA in FD patients without AF. A Fabry-specific score was established based on above defined risk factors, proving somehow superior to the CHA
2 DS2 -VASc score in predicting new-onset or recurrent stroke/TIA in this cohort (AUC 0.87 vs. 0.75, P = .199)., Conclusions: Prior stroke/TIA, angiokeratoma, renal dysfunction, left ventricular hypertrophy, and global systolic dysfunction are independent risk factors for new-onset or recurrent stroke/TIA in FD patients without AF. It is feasible to predict new or recurrent cerebral events with the Fabry-specific score based on the above defined risk factors. Future studies are warranted to test if FD patients with high risk for new-onset or recurrent stroke/TIA, as defined by the Fabry-specific score (≥ 2 points), might benefit from antithrombotic therapy. Clinical trial registration HEAL-FABRY (evaluation of HEArt invoLvement in patients with FABRY disease, NCT03362164).- Published
- 2018
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16. Two-dimensional transesophageal echocardiography for aortic annular sizing in patients undergoing transcatheter aortic valve implantation.
- Author
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Sherif MA, Ince H, Maniuc O, Reiter T, Voelker W, Ertl G, and Öner A
- Subjects
- Aged, Aged, 80 and over, Algorithms, Balloon Valvuloplasty, Cardiac Catheterization adverse effects, Cardiac Catheterization methods, Female, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods, Humans, Image Interpretation, Computer-Assisted, Male, Observer Variation, Predictive Value of Tests, Reproducibility of Results, Severity of Illness Index, Tomography, X-Ray Computed, Treatment Outcome, Aortic Valve diagnostic imaging, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis therapy, Bioprosthesis, Cardiac Catheterization instrumentation, Echocardiography, Transesophageal, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Prosthesis Design
- Abstract
Background: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we examined the accuracy of a novel method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus., Methods: We evaluated the theoretical impact of the measurement of the annulus diameter and area using the circumcircle of a triangle method on the decision to perform the procedure and choice of the prosthesis size., Results: Sixty-three consecutive patients were scheduled for TAVI. Mean age was 82 ± 4 years, and 25 patients (55.6 %) were female. Mean aortic annulus diameter was 20.3 ± 2.2 mm assessed by TEE on the mid-esophageal long-axis view and 23.9 ± 2.3 mm using CT (p < 0.001). There was a tendency for the TEE derived areas using the new method to be higher (p < 0.001). The TEE measurements were on average 42.33 mm(2) higher than the CT measurements without an evidence of a systematic over- or under-sizing (p = 1.00). Agreement between TEE and CT chosen valve sizes was good overall (kappa = 0.67 and weighted kappa = 0.71). For patients who turned out to have no AR, the two methods agreed in 84.6 % of patients., Conclusions: CT remanis the gold standard in sizing of the aortic valve annulus. Nevertheless, sizing of the aortic valve annulus using TEE derived area may be helpful. The impact of integration of this method in the algorithm of aortic annulus sizing on the outcome of patients undergoing TAVI should be examined in future studies.
- Published
- 2015
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17. Feasibility of a new method using two-dimensional transesophageal echocardiography for aortic annular sizing in patients undergoing transcatheter aortic valve implantation; a case-control study.
- Author
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Sherif MA, Herold J, Voelker W, Maniuc O, Ertl G, Praast C, and Braun-Dullaeus RC
- Subjects
- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve surgery, Case-Control Studies, Feasibility Studies, Female, Humans, Male, Retrospective Studies, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency surgery, Echocardiography methods, Echocardiography, Transesophageal methods, Transcatheter Aortic Valve Replacement methods
- Abstract
Background: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we validated a new method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus prior to TAVI., Methods: We analysed 124 patients who underwent successful TAVI using a self-expandable prosthesis, divided equally into two groups; in the study group we used the cross sectional short axis 2D-TEE for measurement of the aortic annulus and in the control group we used the long axis 2D-TEE., Results: Both groups were comparable regarding the clinical parameters. On the other hand, patients in the study group had less left ventricular ejection fraction (38.9 % versus 45.6 %, p = 0.01). The aortic valve annulus was, although not statistically significant, smaller in the study group (21.58 versus 23.28 mm, p = 0.25). Post procedural quantification of the aortic regurgitation revealed that only one patient in both groups had severe aortic regurgitation (AR), in this patient the valve was implanted deep. The incidence of significant AR was higher in the control group (29.0 % versus 12.9 %, p = 0.027)., Conclusions: Sizing of the aortic valve annulus using cross-sectional 2D-TEE offers a safe and plausible method for patients undergoing TAVI using the self-expandable prosthesis and is significantly superior to using long axis 2D-TEE.
- Published
- 2015
- Full Text
- View/download PDF
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