9 results on '"Paitazoglou, Christina"'
Search Results
2. Predicted impact of atrial flow regulator on survival in heart failure with reduced and preserved ejection fraction.
- Author
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Lauder L, Bergmann MW, Paitazoglou C, Özdemir R, Iliadis C, Bartunek J, Lauten A, Keller T, Weber S, Sievert H, Anker SD, and Mahfoud F
- Subjects
- Humans, Female, Aged, Male, Stroke Volume, Ventricular Function, Left, Prospective Studies, Heart Failure, Atrial Fibrillation, Ventricular Dysfunction, Left
- Abstract
Aims: We aim to assess the theoretical impact of the atrial flow regulator (AFR) on survival in heart failure., Methods and Results: The prospective, multicentre, open-label, non-randomised PRELIEVE study (NCT03030274) assessed the safety and efficacy of the Occlutech AFR device in patients with symptomatic heart failure with reduced ejection fraction (HFrEF) (left ventricular ejection fraction (LVEF) ≥ 15% and <40%) or heart failure with preserved ejection fraction (HFpEF) (LVEF ≥40% and <70%) and elevated PCWP (≥15 mmHg at rest or ≥25 mmHg during exercise). In this analysis, after the first 60 patients completed 12 months of follow-up, the theoretical impact of AFR implantation on survival was assessed by comparing the observed mortality rate with the median predicted probability for one-year mortality. Each subject's risk of mortality was predicted from individual baseline data using the Meta-Analysis Global Group in Chronic HF (MAGGIC) prognostic model. A total of 87 patients (46% female, median age 69 years [IQR 62-74]) had undergone successful device implantation for the treatment of HFrEF (53%) and HFpEF (47%). Sixty patients had a complete 12 month follow-up. The median follow-up was 351 days (interquartile range [IQR] 202-370). Six (7%) patients died during follow-up (8.6 deaths per 100 patient-years; 95% confidence interval [CI] 2.7 to 15.5), all of which had HFrEF. The median predicted mortality rate for the overall study population was 12.2 deaths per 100 patient-years (95% CI 10.2 to 14.7). While the observed mortality rate (0 deaths per 100 patient-years) was significantly lower than the median predicted mortality rate (9.3 deaths per 100 patient-years; 95% CI 8.4 to 11.1) in patients with HFpEF (-9.3 deaths per 100 patient-years; 95% CI -11.1 to -8.4), there was no difference in patients with HFrEF (-3.6 deaths per 100 patient-years; 95% CI -9.5 to 3.0). Four deaths were HF-related deaths (5.7 HF-related deaths per 100 patient-years; 95% CI 1.4 to 11.9; 10.8 HF-related deaths per 100 patient-years; 95% CI 2.5 to 23.1 in the HFrEF subgroup)., Conclusions: In patients with HFpEF, the mortality rate following AFR implantation was lower than the predicted mortality rate. Dedicated randomised, controlled trials are needed - and currently ongoing - to investigate whether the AFR improves mortality., (© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
3. Effect of allogeneic adipose tissue-derived mesenchymal stromal cell treatment in chronic ischaemic heart failure with reduced ejection fraction - the SCIENCE trial.
- Author
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Qayyum AA, van Klarenbosch B, Frljak S, Cerar A, Poglajen G, Traxler-Weidenauer D, Nadrowski P, Paitazoglou C, Vrtovec B, Bergmann MW, Chamuleau SAJ, Wojakowski W, Gyöngyösi M, Kraaijeveld A, Hansen KS, Vrangbaek K, Jørgensen E, Helqvist S, Joshi FR, Johansen EM, Follin B, Juhl M, Højgaard LD, Mathiasen AB, Ekblond A, Haack-Sørensen M, and Kastrup J
- Subjects
- Humans, Chronic Disease, Quality of Life, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Double-Blind Method, Heart Failure, Hematopoietic Stem Cell Transplantation, Mesenchymal Stem Cells
- Abstract
Aims: The aim of the SCIENCE trial was to investigate whether a single treatment with direct intramyocardial injections of adipose tissue-derived mesenchymal stromal cells (CSCC_ASCs) was safe and improved cardiac function in patients with chronic ischaemic heart failure with reduced ejection fraction (HFrEF)., Methods and Results: The study was a European multicentre, double-blind, placebo-controlled phase II trial using allogeneic CSCC_ASCs from healthy donors or placebo (2:1 randomization). Main inclusion criteria were New York Heart Association (NYHA) class II-III, left ventricular ejection fraction (LVEF) <45%, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels >300 pg/ml. CSCC_ASCs or placebo (isotonic saline) were injected directly into viable myocardium. The primary endpoint was change in left ventricular end-systolic volume (LVESV) at 6-month follow-up measured by echocardiography. A total of 133 symptomatic HFrEF patients were included. The treatment was safe without any drug-related severe adverse events or difference in cardiac-related adverse events during a 3-year follow-up period. There were no significant differences between groups during follow-up in LVESV (0.3 ± 5.0 ml, p = 0.945), nor in secondary endpoints of left ventricular end-diastolic volume (-2.0 ± 6.0 ml, p = 0.736) and LVEF (-1.6 ± 1.0%, p = 0.119). The NYHA class improved slightly within the first year in both groups without any difference between groups. There were no changes in 6-min walk test, NT-proBNP, C-reactive protein or quality of life the first year in any groups., Conclusion: The SCIENCE trial demonstrated safety of intramyocardial allogeneic CSCC_ASC therapy in patients with chronic HFrEF. However, it was not possible to improve the pre-defined endpoints and induce restoration of cardiac function or clinical symptoms., (© 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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- 2023
- Full Text
- View/download PDF
4. Lack of correlation between different congestion markers in acute decompensated heart failure.
- Author
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Haag S, Jobs A, Stiermaier T, Fichera CF, Paitazoglou C, Eitel I, Desch S, and Thiele H
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- Humans, Stroke Volume, Prospective Studies, Hospitalization, Natriuretic Peptide, Brain, Peptide Fragments, Prognosis, Biomarkers, Ventricular Function, Left, Heart Failure diagnosis
- Abstract
Background: Hospitalizations for acute decompensated heart failure (ADHF) are commonly associated with congestion-related signs and symptoms. Objective and quantitative markers of congestion have been identified, but there is limited knowledge regarding the correlation between these markers., Methods: Patients hospitalized for ADHF irrespective of left ventricular ejection fraction were included in a prospective registry. Assessment of congestion markers (e.g., NT-proBNP, maximum inferior vena cava diameter, dyspnea using visual analogue scale, and a clinical congestion score) was performed systematically on admission and at discharge. Telephone interviews were performed to assess clinical events, i.e., all-cause death or readmission for cardiovascular cause, after discharge. Missing values were handled by multiple imputation., Results: In total, 130 patients were prospectively enrolled. Median length of hospitalization was 9 days (interquartile range 6 to 16). All congestion markers declined from admission to discharge (p < 0.001). No correlation between the congestion markers could be identified, neither on admission nor at discharge. The composite endpoint of all-cause death or readmission for cardiovascular cause occurred in 46.2% of patients. Only NT-proBNP at discharge was predictive for this outcome (hazard ratio 1.48, 95% confidence interval 1.15 to 1.90, p = 0.002)., Conclusion: No correlation between quantitative congestion markers was observed. Only NT-proBNP at discharge was significantly associated with the composite endpoint of all-cause death or readmission for cardiovascular cause. Findings indicate that the studied congestion markers reflect different aspects of congestion., (© 2022. The Author(s).)
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- 2023
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5. One-year results of the first-in-man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study.
- Author
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Paitazoglou C, Bergmann MW, Özdemir R, Pfister R, Bartunek J, Kilic T, Lauten A, Schmeisser A, Zoghi M, Anker SD, Sievert H, and Mahfoud F
- Subjects
- Cardiac Catheterization, Heart Atria, Humans, Prospective Studies, Quality of Life, Stroke Volume, Heart Failure
- Abstract
Aims: Attenuating exercise-induced elevated left atrial pressure with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF)., Methods and Results: PRELIEVE was a prospective, non-randomised, multicentre, first-in-man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg during exercise. Here, we provide follow-up data up to 1 year after implantation of the Atrial Flow Regulator (AFR) device. The AFR was successfully implanted in 53 patients (HFrEF n = 24 and HFpEF n = 29). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolisation into the left atrium, which required surgical removal. One patient experienced a serious procedure-related adverse event (post-procedural bleeding and syncope). All patients with sufficient echocardiography readout confirmed device patency with left-right shunt both at 3 (n = 47/51, 92%) and 12 (n = 45/49, 92%) months. At 3 months, rest PCWP decreased by 5 (-12, 0) mmHg (P = 0.0003, median Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of pulmonary artery pressure. Six (6/53, 11%) patients were hospitalised for worsening of HF and three (3/53, 6%) patients died. We observed improvements in New York Heart Association functional class, 6-min walking distance and quality of life (Kansas City Cardiomyopathy Questionnaire) in certain patients., Conclusions: Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the 1-year follow-up, with clinical improvements in certain patients., (© 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2021
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6. The atrial flow regulator: current overview on technique and first experience.
- Author
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Paitazoglou C and Bergmann MW
- Subjects
- Heart Failure diagnosis, Heart Failure physiopathology, Humans, Recovery of Function, Treatment Outcome, Atrial Function, Left, Atrial Pressure, Cardiac Catheterization instrumentation, Heart Failure therapy, Heart-Assist Devices
- Published
- 2020
- Full Text
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7. The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction.
- Author
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Paitazoglou C, Özdemir R, Pfister R, Bergmann MW, Bartunek J, Kilic T, Lauten A, Schmeisser A, Zoghi M, Anker S, Sievert H, and Mahfoud F
- Subjects
- Atrial Pressure, Humans, Pilot Projects, Prospective Studies, Stroke Volume, Heart Failure
- Abstract
Aims: Reducing elevated left atrial pressure with an atrial septum shunt device is a possible treatment option in symptomatic heart failure patients. This study aimed to investigate the safety and feasibility of the Atrial Flow Regulator (AFR) in heart failure patients., Methods and Results: AFR-PRELIEVE is a prospective, non-randomised, open-label, multicentre study in patients with symptomatic heart failure NYHA Class III or IV and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg at exercise irrespective of left ventricular ejection fraction (EF ≥15%). Here we report on procedural and three-month follow-up data for a total of thirty-six enrolled patients. Sixteen (44.5%) patients with reduced EF (HFrEF: EF 15-39%) and twenty (55.5%) patients with preserved EF (HFpEF: EF ≥40%) were enrolled. Implantation success rate and device patency with left-right shunt was 100% (post procedure and at three months) in both patient groups, with one SADE in the HFpEF group which completely resolved. Three (3/36, 8.3%) patients were hospitalised for worsening of heart failure (two HFrEF patients, one HFpEF patient). Individual patients from both the HFrEF and HFpEF groups showed improvement in symptoms and surrogate parameters of heart failure (NYHA class, six-minute walking distance, Kansas City Cardiomyopathy Questionnaire, PCWP, NT-proBNP)., Conclusions: Implantation of the AFR device in heart failure patients is feasible and safe; shunt patency at three months was confirmed in the study. The atrial shunt improved symptoms and surrogate parameters of heart failure in some but not all patients in both the HFpEF and HFrEF groups.
- Published
- 2019
- Full Text
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8. Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE).
- Author
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Paitazoglou C, Bergmann MW, Vrtovec B, Chamuleau SAJ, van Klarenbosch B, Wojakowski W, Michalewska-Włudarczyk A, Gyöngyösi M, Ekblond A, Haack-Sørensen M, Jaquet K, Vrangbaek K, and Kastrup J
- Subjects
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Echocardiography, Europe, Female, Heart Failure diagnosis, Heart Failure physiopathology, Humans, Male, Mesenchymal Stem Cell Transplantation, Middle Aged, Myocardium, Retrospective Studies, Treatment Outcome, Cell- and Tissue-Based Therapy methods, Heart Failure therapy, Stroke Volume physiology, Ventricular Function, Left physiology
- Abstract
Aims: Ischaemic heart failure (IHF) patients have a poor prognosis even with current guideline-derived therapy. Intramyocardial injections of autologous or allogeneic mesenchymal stromal cells might improve cardiac function leading to better clinical outcome., Methods: The SCIENCE (Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE) consortium has initiated a Horizon 2020 funded multicentre phase II study in six European countries. It is a double-blind, placebo-controlled trial testing the safety and efficacy of allogeneic Cardiology Stem Cell Centre Adipose-derived Stromal Cells (CSCC_ASC) from healthy donors or placebo in 138 symptomatic IHF patients. Main inclusion criteria are New York Heart Association class II-III, left ventricular ejection fraction < 45% and N-terminal pro-B-type natriuretic peptide levels > 300 pg/mL. Patients are randomized in a 2:1 pattern to receive intramyocardial injections of either CSCC_ASC or placebo. CSCC_ASC and placebo treatments are prepared centralized at Rigshospitalet in 5 mL vials as an off-the-shelf product. Vials are distributed to all clinical partners and stored in nitrogen vapour tanks ready to be used directly after thawing. A total of 100 × 10
6 CSCC_ASC or placebo are injected directly into viable myocardium in the infarct border zone using the NOGA XP system (BDS, Cordis, Johnson & Johnson, USA). Primary endpoint is a centralized core-laboratory assessed change in left ventricular end-systolic volume at 6-month follow-up measured by echocardiography. The trial started in January 2017, 58 patients were included and treated until July 2018., Conclusion: The SCIENCE trial will provide clinical data on efficacy and safety of intramyocardial cell therapy of allogeneic adipose-derived stromal cells from healthy donors in patients with IHF., (© 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)- Published
- 2019
- Full Text
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9. Atrial Giant Cell Myocarditis as a Cause of Heart Failure
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Paitazoglou, Christina, Bergmann, Martin W., Tiemann, Katharina, Wiese, Andrea, Schäfer, Ulrich, Schwarz, Arne, Eitel, Ingo, and Montenbruck, Moritz
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atrial giant cell myocarditis ,AF, atrial fibrillation ,RA, right atrium ,heart failure ,Case Report ,TEE, transesophageal echocardiography ,HF, heart failure ,Ig, immunoglobulin ,LA, left atrium ,cardiac magnetic resonance ,Clinical Case ,CMR, cardiac magnetic resonance ,ANCA, antineutrophil cytoplasmic antibody ,cardiovascular system ,magnetic resonance imaging ,GCM, giant cell myocarditis ,Cardiology and Cardiovascular Medicine - Abstract
We present a patient with acute heart failure and new onset atrial fibrillation secondary to giant cell myocarditis with lone atrial involvement. The diagnosis was managed with cardiac magnetic resonance and confirmed by interventionally guided biopsy. In the future, diagnosis could be managed noninvasively for this rare entity as the gold standard. (Level of Difficulty: Advanced.), Graphical abstract
- Published
- 2022
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