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1. Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication

Author

Aarnink, Errol W., Maarse, Moniek, Fierro, Nicolai, Mazzone, Patrizio, Beneduce, Alessandro, Tondo, Claudio, Gasperetti, Alessio, Pracon, Radoslaw, Demkow, Marcin, Zieliński, Kamil, de Backer, Ole, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Estévez-Loureiro, Rodrigo, Caneiro-Queija, Berenice, Benito-González, Tomás, Pérez de Prado, Armando, Nombela-Franco, Luis, Salinas, Pablo, Holmes, David, Almakadma, Abdul H., Berti, Sergio, Romeo, Maria Rita, Millan, Xavier, Arzamendi, Dabit, Alla, Venkata M., Agarwal, Himanshu, Eitel, Ingo, Paitazoglou, Christina, Freixa, Xavier, Cepas-Guillén, Pedro, Chothia, Rashaad, Badejoko, Solomon O., Spoon, Daniel B., Maddux, James T., El-Chami, Mikhael, Ram, Pradhum, Branca, Luca, Adamo, Marianna, Suradi, Hussam S., Peper, Joyce, van Dijk, Vincent F., Rensing, Benno J.W.M., Swaans, Martin J., Vireca, Elisa, Bergmann, Martin W., and Boersma, Lucas V.A.

Published
2024
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4. Treatment With an Interatrial Shunt in Heart Failure

Author

Paitazoglou, Christina, primary, Bergmann, Martin W., additional, Kilicaslan, Baris, additional, Kilic, Teoman, additional, Bartunek, Jozef, additional, Pfister, Roman, additional, Iliadis, Christos, additional, Kaya, Ergun Baris, additional, and Ozdemir, Ramazan, additional

Published
2024
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5. Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

Author

Simard, Trevor, Jung, Richard G., Lehenbauer, Kyle, Piayda, Kerstin, Pracoń, Radoslaw, Jackson, Gregory G., Flores-Umanzor, Eduardo, Faroux, Laurent, Korsholm, Kasper, Chun, Julian K.R., Chen, Shaojie, Maarse, Moniek, Montrella, Kristi, Chaker, Zakeih, Spoon, Jocelyn N., Pastormerlo, Luigi E., Meincke, Felix, Sawant, Abhishek C., Moldovan, Carmen M., Qintar, Mohammed, Aktas, Mehmet K., Branca, Luca, Radinovic, Andrea, Ram, Pradhum, El-Zein, Rayan S., Flautt, Thomas, Ding, Wern Yew, Sayegh, Bassel, Benito-González, Tomás, Lee, Oh-Hyun, Badejoko, Solomon O., Paitazoglou, Christina, Karim, Nabeela, Zaghloul, Ahmed M., Agrawal, Himanshu, Kaplan, Rachel M., Alli, Oluseun, Ahmed, Aamir, Suradi, Hussam S., Knight, Bradley P., Alla, Venkata M., Panaich, Sidakpal S., Wong, Tom, Bergmann, Martin W., Chothia, Rashaad, Kim, Jung-Sun, Pérez de Prado, Armando, Bazaz, Raveen, Gupta, Dhiraj, Valderrabano, Miguel, Sanchez, Carlos E., El Chami, Mikhael F., Mazzone, Patrizio, Adamo, Marianna, Ling, Fred, Wang, Dee Dee, O’Neill, William, Wojakowski, Wojtek, Pershad, Ashish, Berti, Sergio, Spoon, Daniel, Kawsara, Akram, Jabbour, George, Boersma, Lucas V.A., Schmidt, Boris, Nielsen-Kudsk, Jens Erik, Rodés-Cabau, Josep, Freixa, Xavier, Ellis, Christopher R., Fauchier, Laurent, Demkow, Marcin, Sievert, Horst, Main, Michael L., Hibbert, Benjamin, Holmes, David R., Jr., and Alkhouli, Mohamad

Published
2021
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6. Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure

Author

Mesnier, Jules, primary, Simard, Trevor, additional, Jung, Richard G., additional, Lehenbauer, Kyle R., additional, Piayda, Kerstin, additional, Pracon, Radoslaw, additional, Jackson, Gregory G., additional, Flores-Umanzor, Eduardo, additional, Faroux, Laurent, additional, Korsholm, Kasper, additional, Chun, Julian K.R., additional, Chen, Shaojie, additional, Maarse, Moniek, additional, Montrella, Kristi, additional, Chaker, Zakeih, additional, Spoon, Jocelyn N., additional, Pastormerlo, Luigi E., additional, Meincke, Felix, additional, Sawant, Abhishek C., additional, Moldovan, Carmen M., additional, Qintar, Mohammed, additional, Aktas, Mehmet K., additional, Branca, Luca, additional, Radinovic, Andrea, additional, Ram, Pradhum, additional, El-Zein, Rayan S., additional, Flautt, Thomas, additional, Ding, Wern Yew, additional, Sayegh, Bassel, additional, Benito-González, Tomás, additional, Lee, Oh-Hyun, additional, Badejoko, Solomon O., additional, Paitazoglou, Christina, additional, Karim, Nabeela, additional, Zaghloul, Ahmed M., additional, Agarwal, Himanshu, additional, Kaplan, Rachel M., additional, Alli, Oluseun, additional, Ahmed, Aamir, additional, Suradi, Hussam S., additional, Knight, Bradley P., additional, Alla, Venkata M., additional, Panaich, Sidakpal S., additional, Wong, Tom, additional, Bergmann, Martin W., additional, Chothia, Rashaad, additional, Kim, Jung-Sun, additional, Pérez de Prado, Armando, additional, Bazaz, Raveen, additional, Gupta, Dhiraj, additional, Valderrábano, Miguel, additional, Sanchez, Carlos E., additional, El Chami, Mikhael F., additional, Mazzone, Patrizio, additional, Adamo, Marianna, additional, Ling, Fred, additional, Wang, Dee Dee, additional, O’Neill, William, additional, Wojakowski, Wojtek, additional, Pershad, Ashish, additional, Berti, Sergio, additional, Spoon, Daniel B., additional, Kawsara, Akram, additional, Jabbour, George, additional, Boersma, Lucas V.A., additional, Schmidt, Boris, additional, Nielsen-Kudsk, Jens Erik, additional, Freixa, Xavier, additional, Ellis, Christopher R., additional, Fauchier, Laurent, additional, Demkow, Marcin, additional, Sievert, Horst, additional, Main, Michael L., additional, Hibbert, Benjamin, additional, Holmes, David R., additional, Alkhouli, Mohamad, additional, and Rodés-Cabau, Josep, additional

Published
2023
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7. Predicted impact of atrial flow regulator on survival in heart failure with reduced and preserved ejection fraction

Author

Lauder, Lucas, primary, Bergmann, Martin W., additional, Paitazoglou, Christina, additional, Özdemir, Ramazan, additional, Iliadis, Christos, additional, Bartunek, Jozef, additional, Lauten, Alexander, additional, Keller, Thomas, additional, Weber, Stephan, additional, Sievert, Horst, additional, Anker, Stefan D., additional, and Mahfoud, Felix, additional

Published
2023
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8. PO-03-135 LEFT ATRIAL APPENDAGE OCCLUSION VERSUS STANDARD OF CARE IN PATIENTS WITH ATRIAL FIBRILLATION AND A PRIOR THROMBO-EMBOLIC EVENT DESPITE ORAL ANTICOAGULANT THERAPY: A PROPENSITY SCORE MATCHED COMPARISON

Author

Maarse, Moniek, primary, Seiffge, David, additional, Aarnink, Errol, additional, Fierro, Nicolai, additional, Mazzone, Patrizio, additional, Beneduce, Alessandro, additional, Gasperetti, Alessio, additional, Tondo, Claudio, additional, Pracon, Radek, additional, Demkow, Marcin, additional, Zielinski, Kamil, additional, de Backer, Ole, additional, Korsholm, Kasper, additional, Nielsen-Kudsk, Jens Erik, additional, Estevez-Loureiro, Rodrigo, additional, Benito-Gonzalez, Tomas, additional, Nombela-Franco, Luis, additional, Simard, Trevor, additional, Alkhouli, Mohamad, additional, Holmes, David R., additional, Romeo, Maria Rita, additional, Berti, Sergio, additional, Millan, Xavier, additional, Arzamendi, Dabit, additional, Alla, Venkata M., additional, Paitazoglou, Christina, additional, Eitel, Ingo, additional, Freixa-Rofastes, Xavier, additional, Badejoko, Solomon, additional, Chothia, Rashaad A., additional, Kilic, Özlem, additional, Bergmann, Martin, additional, Spoon, Daniel, additional, Ram, Pradhum, additional, El-Chami, Mikhael F., additional, Branca, Luca, additional, Adamo, Marianna, additional, Danley, Kelsey, additional, Suradi, Hussam, additional, Swaans, Martin, additional, Werring, David, additional, and Boersma, Lucas V., additional

Published
2023
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9. Hemodynamic Assessment in Takotsubo Syndrome

Author

Stiermaier, Thomas, primary, Reil, Jan-Christian, additional, Sequeira, Vasco, additional, Rawish, Elias, additional, Mezger, Matthias, additional, Pätz, Toni, additional, Paitazoglou, Christina, additional, Schmidt, Tobias, additional, Frerker, Christian, additional, Steendijk, Paul, additional, Reil, Gert-Hinrich, additional, and Eitel, Ingo, additional

Published
2023
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10. Left atrial appendage closure in end‐stage renal disease and hemodialysis: Data from a German multicenter registry

Author

Fink, Thomas, primary, Paitazoglou, Christina, additional, Bergmann, Martin W., additional, Sano, Makoto, additional, Keelani, Ahmad, additional, Sciacca, Vanessa, additional, Saad, Mohammed, additional, Eitel, Charlotte, additional, Heeger, Christian‐Hendrik, additional, Skurk, Carsten, additional, Landmesser, Ulf, additional, Thiele, Holger, additional, Stiermaier, Thomas, additional, Fuernau, Georg, additional, Reil, Jan‐Christian, additional, Frey, Norbert, additional, Kuck, Karl‐Heinz, additional, Tilz, Roland R., additional, Sandri, Marcus, additional, and Eitel, Ingo, additional

Published
2023
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11. Atrial Giant Cell Myocarditis as a Cause of Heart Failure

Author

Paitazoglou, Christina, Bergmann, Martin W., Tiemann, Katharina, Wiese, Andrea, Schäfer, Ulrich, Schwarz, Arne, Eitel, Ingo, and Montenbruck, Moritz

Subjects
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

13. Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

Author

Fauchier, Grégoire, Bisson, Arnaud, Bodin, Alexandre, Herbert, Julien, Semaan, Carl, Angoulvant, Denis, Ducluzeau, Pierre Henri, Lip, Gregory, Fauchier, Laurent, Deharo, Pierre, Cuisset, Thomas, Lacour, Thibaud, Etienne, Christophe Saint, Jaussaud, Nicolas, Morera, Pierre, Spychaj, Jean-Charles, Porto, Alizée, Collart, Frederic, Theron, Alexis, Bernard, Anne, Bourguignon, Thierry, Simard, Trevor, Jung, Richard, Lehenbauer, Kyle, Piayda, Kerstin, Pracoń, Radoslaw, Jackson, Gregory, Flores-Umanzor, Eduardo, Faroux, Laurent, Korsholm, Kasper, Chun, Julian K.R., Chen, Shaojie, Maarse, Moniek, Montrella, Kristi, Chaker, Zakeih, Spoon, Jocelyn, Pastormerlo, Luigi, Meincke, Felix, Sawant, Abhishek, Moldovan, Carmen, Qintar, Mohammed, Aktas, Mehmet, Branca, Luca, Radinovic, Andrea, Ram, Pradhum, El-Zein, Rayan, Flautt, Thomas, Ding, Wern Yew, Sayegh, Bassel, Benito-González, Tomás, Lee, Oh-Hyun, Badejoko, Solomon, Paitazoglou, Christina, Karim, Nabeela, Zaghloul, Ahmed, Agrawal, Himanshu, Kaplan, Rachel, Alli, Oluseun, Ahmed, Aamir, Suradi, Hussam, Knight, Bradley, Alla, Venkata, Panaich, Sidakpal, Wong, Tom, Bergmann, Martin, Chothia, Rashaad, Kim, Jung-Sun, Pérez de Prado, Armando, Bazaz, Raveen, Gupta, Dhiraj, Valderrabano, Miguel, Sanchez, Carlos, El Chami, Mikhael, Mazzone, Patrizio, Adamo, Marianna, Ling, Fred, Wang, Dee Dee, O’neill, William, Wojakowski, Wojtek, Pershad, Ashish, Berti, Sergio, Spoon, Daniel, Kawsara, Akram, Jabbour, George, Boersma, Lucas V.A., Schmidt, Boris, Nielsen-Kudsk, Jens Erik, Rodés-Cabau, Josep, Freixa, Xavier, Ellis, Christopher, Demkow, Marcin, Sievert, Horst, Main, Michael, Hibbert, Benjamin, Holmes, David, Alkhouli, Mohamad, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Trousseau [Tours], Éducation Éthique Santé EA 7505 (EES), Université de Tours (UT), EA4245 - Transplantation, Immunologie, Inflammation [Tours] (T2i), University of Liverpool, Aalborg University [Denmark] (AAU), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital de la Timone [CHU - APHM] (TIMONE), Nutrition, obésité et risque thrombotique (NORT), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Marseille, Département de Cardiologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut de neurophysiopathologie (INP), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), University of Ottawa [Ottawa], Université Laval [Québec] (ULaval), National Institute for Research and Development in Microtechnologies (IMT-Bucharest), Graduate School, Cardiology, and ACS - Heart failure & arrhythmias

Subjects
Male, Cardiac Catheterization, Time Factors, Percutaneous, left atrial appendage occlusion, Septal Occluder Device, medicine.medical_treatment, Transesophageal, [SHS]Humanities and Social Sciences, Pulmonary vein, Postoperative Complications, Risk Factors, Interquartile range, Atrial Fibrillation, Registries, Embolization, ComputingMilieux_MISCELLANEOUS, Watchman, Incidence, Atrial fibrillation, Europe, Survival Rate, Treatment Outcome, Echocardiography, Cardiology, Female, Watchman FLX, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Heart Diseases, ACP, Amplatzer cardiac plug, Amulet, DRT, LAAO, device-related thrombus, Aged, Atrial Appendage, Echocardiography, Transesophageal, Follow-Up Studies, Humans, Thrombosis, Left atrial appendage occlusion, Internal medicine, medicine, Risk factor, Thrombus, business.industry, medicine.disease, business
Abstract

Background: Device-related thrombus (DRT) has been considered an Achilles’ heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

Published
2021

15. Effect of allogeneic adipose tissue‐derived mesenchymal stromal cell treatment in chronic ischaemic heart failure with reduced ejection fraction – the SCIENCE trial.

Author

Qayyum, Abbas Ali, van Klarenbosch, Bas, Frljak, Sabina, Cerar, Andraz, Poglajen, Gregor, Traxler‐Weidenauer, Denise, Nadrowski, Pawel, Paitazoglou, Christina, Vrtovec, Bojan, Bergmann, Martin W., Chamuleau, Steven A. J., Wojakowski, Wojtek, Gyöngyösi, Mariann, Kraaijeveld, Adriaan, Hansen, Kristian Schultz, Vrangbæk, Karsten, Jørgensen, Erik, Helqvist, Steffen, Joshi, Francis Richard, and Johansen, Ellen Mønsted

Subjects
BRAIN natriuretic factor, STROMAL cells, HEART failure, VENTRICULAR ejection fraction, ADIPOSE tissue diseases, CARDIAC patients
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. [ABSTRACT FROM AUTHOR]

Published
2023
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20. 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

Paitazoglou, Christina, Bergmann, Martin W., Özdemir, Ramazan, Pfister, Roman, Bartunek, Jozef, Kilic, Teoman, Lauten, Alexander, Schmeisser, Alexander, Zoghi, Mehdi, Anker, Stefan D., Sievert, Horst, and Mahfoud, Felix

Subjects
*HEART failure patients, *LEFT heart atrium, *HEART assist devices, *HEART failure, *REST, *PATIENTS' attitudes, *QUALITY of life
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. [ABSTRACT FROM AUTHOR]

Published
2021
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22. 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

Paitazoglou, Christina, primary, Özdemir, Ramazan, additional, Pfister, Roman, additional, Bergmann, Martin W., additional, Bartunek, Jozef, additional, Kilic, Teoman, additional, Lauten, Alexander, additional, Schmeisser, Alexander, additional, Zoghi, Mehdi, additional, Anker, Stefan, additional, Sievert, Horst, additional, and Mahfoud, Felix, additional

Published
2019
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23. Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE).

Author

Paitazoglou, Christina, Bergmann, Martin W., Vrtovec, Bojan, Chamuleau, Steven A.J., van Klarenbosch, Bas, Wojakowski, Wojtek, Michalewska‐Włudarczyk, Aleksandra, Gyöngyösi, Mariann, Ekblond, Annette, Haack‐Sørensen, Mandana, Jaquet, Kai, Vrangbæk, Karsten, Kastrup, Jens, Ciosek, Joanna, Dworowy, Sebastian, Jadczyk, Tomasz, Kozłowski, Michal, Nadrowski, Pawel, Sagalski, Ronja, and Schlegel, Esther

Subjects
*STEM cell treatment, *HEART diseases
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 × 106 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. [ABSTRACT FROM AUTHOR]

Published
2019
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