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1. Multi-Modal Dataset Creation for Federated Learning with DICOM Structured Reports

Author

Tölle, Malte, Burger, Lukas, Kelm, Halvar, André, Florian, Bannas, Peter, Diller, Gerhard, Frey, Norbert, Garthe, Philipp, Groß, Stefan, Hennemuth, Anja, Kaderali, Lars, Krüger, Nina, Leha, Andreas, Martin, Simon, Meyer, Alexander, Nagel, Eike, Orwat, Stefan, Scherer, Clemens, Seiffert, Moritz, Seliger, Jan Moritz, Simm, Stefan, Friede, Tim, Seidler, Tim, and Engelhardt, Sandy

Subjects
Computer Science - Information Retrieval, Computer Science - Machine Learning
Abstract

Purpose: Federated training is often hindered by heterogeneous datasets due to divergent data storage options, inconsistent naming schemes, varied annotation procedures, and disparities in label quality. This is particularly evident in the emerging multi-modal learning paradigms, where dataset harmonization including a uniform data representation and filtering options are of paramount importance. Methods: DICOM structured reports enable the standardized linkage of arbitrary information beyond the imaging domain and can be used within Python deep learning pipelines with highdicom. Building on this, we developed an open platform for data integration and interactive filtering capabilities that simplifies the process of assembling multi-modal datasets. Results: In this study, we extend our prior work by showing its applicability to more and divergent data types, as well as streamlining datasets for federated training within an established consortium of eight university hospitals in Germany. We prove its concurrent filtering ability by creating harmonized multi-modal datasets across all locations for predicting the outcome after minimally invasive heart valve replacement. The data includes DICOM data (i.e. computed tomography images, electrocardiography scans) as well as annotations (i.e. calcification segmentations, pointsets and pacemaker dependency), and metadata (i.e. prosthesis and diagnoses). Conclusion: Structured reports bridge the traditional gap between imaging systems and information systems. Utilizing the inherent DICOM reference system arbitrary data types can be queried concurrently to create meaningful cohorts for clinical studies. The graphical interface as well as example structured report templates will be made publicly available.

Published
2024

2. Federated Foundation Model for Cardiac CT Imaging

Author

Tölle, Malte, Garthe, Philipp, Scherer, Clemens, Seliger, Jan Moritz, Leha, Andreas, Krüger, Nina, Simm, Stefan, Martin, Simon, Eble, Sebastian, Kelm, Halvar, Bednorz, Moritz, André, Florian, Bannas, Peter, Diller, Gerhard, Frey, Norbert, Groß, Stefan, Hennemuth, Anja, Kaderali, Lars, Meyer, Alexander, Nagel, Eike, Orwat, Stefan, Seiffert, Moritz, Friede, Tim, Seidler, Tim, and Engelhardt, Sandy

Subjects
Electrical Engineering and Systems Science - Image and Video Processing, Computer Science - Computer Vision and Pattern Recognition
Abstract

Federated learning (FL) is a renowned technique for utilizing decentralized data while preserving privacy. However, real-world applications often involve inherent challenges such as partially labeled datasets, where not all clients possess expert annotations of all labels of interest, leaving large portions of unlabeled data unused. In this study, we conduct the largest federated cardiac CT imaging analysis to date, focusing on partially labeled datasets ($n=8,124$) of Transcatheter Aortic Valve Implantation (TAVI) patients over eight hospital clients. Transformer architectures, which are the major building blocks of current foundation models, have shown superior performance when trained on larger cohorts than traditional CNNs. However, when trained on small task-specific labeled sample sizes, it is currently not feasible to exploit their underlying attention mechanism for improved performance. Therefore, we developed a two-stage semi-supervised learning strategy that distills knowledge from several task-specific CNNs (landmark detection and segmentation of calcification) into a single transformer model by utilizing large amounts of unlabeled data typically residing unused in hospitals to mitigate these issues. This method not only improves the predictive accuracy and generalizability of transformer-based architectures but also facilitates the simultaneous learning of all partial labels within a single transformer model across the federation. Additionally, we show that our transformer-based model extracts more meaningful features for further downstream tasks than the UNet-based one by only training the last layer to also solve segmentation of coronary arteries. We make the code and weights of the final model openly available, which can serve as a foundation model for further research in cardiac CT imaging.

Published
2024

4. Analysis of a Deep Learning Model for 12-Lead ECG Classification Reveals Learned Features Similar to Diagnostic Criteria

Author

Bender, Theresa, Beinecke, Jacqueline Michelle, Krefting, Dagmar, Müller, Carolin, Dathe, Henning, Seidler, Tim, Spicher, Nicolai, and Hauschild, Anne-Christin

Subjects
Electrical Engineering and Systems Science - Signal Processing, Computer Science - Machine Learning
Abstract

Despite their remarkable performance, deep neural networks remain unadopted in clinical practice, which is considered to be partially due to their lack in explainability. In this work, we apply attribution methods to a pre-trained deep neural network (DNN) for 12-lead electrocardiography classification to open this "black box" and understand the relationship between model prediction and learned features. We classify data from a public data set and the attribution methods assign a "relevance score" to each sample of the classified signals. This allows analyzing what the network learned during training, for which we propose quantitative methods: average relevance scores over a) classes, b) leads, and c) average beats. The analyses of relevance scores for atrial fibrillation (AF) and left bundle branch block (LBBB) compared to healthy controls show that their mean values a) increase with higher classification probability and correspond to false classifications when around zero, and b) correspond to clinical recommendations regarding which lead to consider. Furthermore, c) visible P-waves and concordant T-waves result in clearly negative relevance scores in AF and LBBB classification, respectively. In summary, our analysis suggests that the DNN learned features similar to cardiology textbook knowledge., Comment: Accepted version including new experiments on additional database

Published
2022
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5. Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up

Author

Burkhoff, Daniel, Cohen, Howard, Brunckhorst, Corinna, O'Neill, William W., Thiele, Holger Thiele, Sick, Peter, Boudriot, Enno, Diederich, Klaus-Werner, Hambrecht, Rainer, Niebauer, Josef, Schuler, Gerhard, Seyfarth, Melchior, Sibbing, Dirk, Bauer, Iris, Fröhlich, Georg, Bott-Flügel, Lorenz, Byrne, Robert, Dirschinger, Josef, Kastrati, Adnan, Schömig, Albert, Ouweneel, Dagmar M., Eriksen, Erlend, Sjauw, Krischan D., van Dongen, Ivo M., Hirsch, Alexander, Packer, Erik J.S, Vis, M. Marie, Wykrzykowska, Joanna J., Koch, Karel T., Baan, Jan, De Winter, Robbert J, Piek, Jan J., Lagrand, Wim K, de Mol, Bas A.J.M, Tijssen, Jan G.P., Henriques, José P.S., Møller, Jacob E., Engstrøm, Thomas, Jensen, Lisette Okkels, Eiskjær, Hans, Mangner, Norman, Polzin, Amin, Schulze, P. Christian, Skurk, Carsten, Nordbeck, Peter, Clemmensen, Peter, Panoulas, Vasileios, Zimmer, Sebastian, Schäfer, Andreas, Werner, Nikos, Frydland, Martin, Holmvang, Lene, Kjærgaard, Jesper, Sørensen, Rikke, Lønborg, Jacob, Greve, Matias, Christiansen, Evald H., Linke, Axel, Woitek, Felix J., Westenfeld, Ralf, Moebius-Winkler, Sven, Wachtell, Kristian, Ravn, Hanne Berg, Lassen, Jens Flensted, Boesgaard, Søren, Gerke, Oke, Hassager, Christian, Lackermair, Korbinian, Brunner, Stefan, Orban, Mathias, Peterss, Sven, Orban, Martin, Theiss, Hans D., Huber, Bruno C., Juchem, Gerd, Born, Frank, Boulesteix, Anne-Laure, Bauer, Axel, Pichlmaier, Maximilian, Hausleiter, Jörg, Massberg, Steffen, Hagl, Christian, Guenther, Sabina P.W., Ostadal, Petr, Rokyta, Richard, Karasek, Jiri, Kruger, Andreas, Vondrakova, Dagmar, Janotka, Marek, Naar, Jan, Smalcova, Jana, Hubatova, Marketa, Hromadk, Milan, Volovar, Stefan, Seyfrydova, Miroslava, Jarkovsky, Jiri, Svoboda, Michal, Linhart, Ales, Belohlavek, Jan, Banning, Amerjeet S., Sabaté, Manel, Gracey, Jay, López-Sobrino, Teresa, Bogaerts, Kris, Adriaenssens, Tom, Berry, Colin, Erglis, Andrejs, Haine, Steven, Myrmel, Truls, Patel, Sameer, Buera, Irene, Sionis, Alessandro, Vilalta, Victoria, Yusuff, Hakeem, Vrints, Christiaan, Adlam, David, Flather, Marcus, Gershlick, Anthony H., Thiele, Holger, Zeymer, Uwe, Akin, Ibrahim, Behnes, Michael, Rassaf, Tienush, Mahabadi, Amir-Abbas, Lehmann, Ralf, Eitel, Ingo, Graf, Tobias, Seidler, Tim, Schuster, Andreas, Duerschmied, Daniel, Hennersdorf, Marcus, Fichtlscherer, Stephan, Voigt, Ingo, John, Stefan, Ewen, Sebastian, Tigges, Eike, Nordbeck, Peter Steffen, Bruch, Leonhard, Jung, Christian, Franz, Jutta, Lauten, Philipp, Goslar, Tomaz, Feistritzer, Hans-Josef, Pöss, Janine, Kirchhof, Eva, Ouarrak, Taoufik, Schneider, Steffen, Desch, Steffen, Freund, Anne, Møller, Jacob E, Henriques, Jose P S, Bogerd, Margriet, Hochadel, Matthias, and Schulze, P Christian

Published
2024
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6. The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies

Author

Hoffmann, Julia, Hanß, Sabine, Kraus, Monika, Schaller, Jens, Schäfer, Christian, Stahl, Dana, Anker, Stefan D., Anton, Gabriele, Bahls, Thomas, Blankenberg, Stefan, Blumentritt, Arne, Boldt, Leif-Hendrik, Cordes, Steffen, Desch, Steffen, Doehner, Wolfram, Dörr, Marcus, Edelmann, Frank, Eitel, Ingo, Endres, Matthias, Engelhardt, Stefan, Erdmann, Jeanette, Eulenburg, Katharina, Falk, Volkmar, Felix, Stephan B., Frank, Derk, Franke, Thomas, Frey, Norbert, Friede, Tim, Geidel, Lars, Germans, Lisa, Grabmaier, Ulrich, Halle, Martin, Hausleiter, Jörg, Jakobi, Vera, Jebran, Ahmad-Fawad, Jobs, Alexander, Kääb, Stefan, Karakas, Mahir, Katus, Hugo A., Klatt, Alexandra, Knosalla, Christoph, Krebser, Joachim, Landmesser, Ulf, Lee, Mahsa, Lehnert, Kristin, Lesser, Stephanie, Leyh, Katrin, Lorbeer, Roberto, Mach-Kolb, Stephanie, Meder, Benjamin, Nagel, Eike, Nolte, Christian H., Parwani, Abdul S., Petersmann, Astrid, Puls, Miriam, Rau, Henriette, Reiser, Maximilian, Rienhoff, Otto, Scharfe, Tabea, Schattschneider, Mario, Scheel, Heiko, Schnabel, Renate B., Schuster, Andreas, Schmitt, Boris, Seidler, Tim, Seiffert, Moritz, Stähli, Barbara-Elisabeth, Stas, Adriane, J. Stocker, Thomas, von Stülpnagel, Lukas, Thiele, Holger, Wachter, Rolf, Wakili, Reza, Weis, Tanja, Weitmann, Kerstin, Wichmann, Heinz-Erich, Wild, Philipp, Zeller, Tanja, Hoffmann, Wolfgang, Zeisberg, Elisabeth Maria, Zimmermann, Wolfram-Hubertus, Krefting, Dagmar, Kühne, Titus, Peters, Annette, Hasenfuß, Gerd, Massberg, Steffen, Sommer, Thomas, Dimmeler, Stefanie, Eschenhagen, Thomas, and Nauck, Matthias

Published
2023
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7. Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year Outcomes From the MiCLASP Study

Author

Lurz, Philipp, Schmitz, Thomas, Geisler, Tobias, Hausleiter, Jörg, Eitel, Ingo, Rudolph, Volker, Lubos, Edith, von Bardeleben, Ralph Stephan, Brambilla, Nedy, De Marco, Federico, Berti, Sergio, Nef, Holger, Linke, Axel, Hengstenberg, Christian, Baldus, Stephan, Spargias, Konstantinos, Denti, Paolo, Nickenig, Georg, Möllmann, Helge, Rottbauer, Wolfgang, Praz, Fabien, Butter, Christian, Reinthaler, Markus, Van Mieghem, Nicolas M., Sherif, Mohammad, Swaans, Martin, Witkowski, Adam, Buch, Mamta, Seidler, Tim, Iñiguez, Andrés, Thiele, Holger, Eißmann, Mareike, Schreieck, Juergen, Näbauer, Michael, Marcoff, Leo, Koulogiannis, Konstantinos, Rassaf, Tienush, and Luedike, Peter

Published
2024
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9. Cardiac fibrosis as a predictor for sudden cardiac death after transcatheter aortic valve implantation

Author

Alnour, Fouzi, primary, Beuthner, Bo E., additional, Hakroush, Samy, additional, Topci, Rodi, additional, Vogelgesang, Anja, additional, Lange, Torben, additional, Seidler, Tim, additional, Kutschka, Ingo, additional, Toischer, Karl, additional, Schuster, Andreas, additional, Jacobshagen, Claudius, additional, Leha, Andreas, additional, Zabel, Markus, additional, Hasenfuß, Gerd, additional, Puls, Miriam, additional, and Zeisberg, Elisabeth M., additional

Published
2024
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10. Direct proteomic and high-resolution microscopy biopsy analysis identifies distinct ventricular fates in severe aortic stenosis

Author

Brandenburg, Sören, Drews, Lena, Schönberger, Hanne-Lea, Jacob, Christoph F., Paulke, Nora Josefine, Beuthner, Bo E., Topci, Rodi, Kohl, Tobias, Neuenroth, Lisa, Kutschka, Ingo, Urlaub, Henning, Kück, Fabian, Leha, Andreas, Friede, Tim, Seidler, Tim, Jacobshagen, Claudius, Toischer, Karl, Puls, Miriam, Hasenfuß, Gerd, Lenz, Christof, and Lehnart, Stephan E.

Published
2022
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13. Routine extracorporeal life support in infarct-related cardiogenic shock: 1-year results of the ECLS-SHOCK trial.

Author

Desch, Steffen, Zeymer, Uwe, Akin, Ibrahim, Behnes, Michael, Duerschmied, Daniel, Rassaf, Tienush, Mahabadi, Amir Abbas, Lehmann, Ralf, Eitel, Ingo, Graf, Tobias, Seidler, Tim, Schuster, Andreas, Thevathasan, Tharusan, Skurk, Carsten, Clemmensen, Peter, Hennersdorf, Marcus, Fichtlscherer, Stephan, Voigt, Ingo, Seyfarth, Melchior, and John, Stefan

Subjects
MYOCARDIAL infarction, MEDICAL personnel, CARDIOGENIC shock, PATIENT selection, MEDICAL care, EXTRACORPOREAL membrane oxygenation, INTRA-aortic balloon counterpulsation
Abstract

The ECLS-SHOCK trial, published in the European Heart Journal, investigated the use of extracorporeal life support (ECLS) in patients with cardiogenic shock (CS) related to acute myocardial infarction (AMI). The trial found that routine ECLS did not improve 1-year survival compared to standard medical care alone. The study also revealed no significant differences in secondary endpoints such as neurological outcome, myocardial reinfarction, repeat revascularization, or rehospitalization for heart failure between the two groups. The trial highlights the need for further research on the role of ECLS in the management of AMI-CS. [Extracted from the article]

Published
2024
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15. Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up

Author

Thiele, Holger, Møller, Jacob E, Henriques, Jose P S, Bogerd, Margriet, Seyfarth, Melchior, Burkhoff, Daniel, Ostadal, Petr, Rokyta, Richard, Belohlavek, Jan, Massberg, Steffen, Flather, Marcus, Hochadel, Matthias, Schneider, Steffen, Desch, Steffen, Freund, Anne, Eiskjær, Hans, Mangner, Norman, Pöss, Janine, Polzin, Amin, Schulze, P Christian, Skurk, Carsten, Zeymer, Uwe, Hassager, Christian, Burkhoff, Daniel, Cohen, Howard, Brunckhorst, Corinna, O'Neill, William W., Thiele, Holger Thiele, Sick, Peter, Boudriot, Enno, Diederich, Klaus-Werner, Hambrecht, Rainer, Niebauer, Josef, Schuler, Gerhard, Seyfarth, Melchior, Sibbing, Dirk, Bauer, Iris, Fröhlich, Georg, Bott-Flügel, Lorenz, Byrne, Robert, Dirschinger, Josef, Kastrati, Adnan, Schömig, Albert, Ouweneel, Dagmar M., Eriksen, Erlend, Sjauw, Krischan D., van Dongen, Ivo M., Hirsch, Alexander, Packer, Erik J.S, Vis, M. Marie, Wykrzykowska, Joanna J., Koch, Karel T., Baan, Jan, De Winter, Robbert J, Piek, Jan J., Lagrand, Wim K, de Mol, Bas A.J.M, Tijssen, Jan G.P., Henriques, José P.S., Møller, Jacob E., Engstrøm, Thomas, Jensen, Lisette Okkels, Eiskjær, Hans, Mangner, Norman, Polzin, Amin, Schulze, P. Christian, Skurk, Carsten, Nordbeck, Peter, Clemmensen, Peter, Panoulas, Vasileios, Zimmer, Sebastian, Schäfer, Andreas, Werner, Nikos, Frydland, Martin, Holmvang, Lene, Kjærgaard, Jesper, Sørensen, Rikke, Lønborg, Jacob, Greve, Matias, Christiansen, Evald H., Linke, Axel, Woitek, Felix J., Westenfeld, Ralf, Moebius-Winkler, Sven, Wachtell, Kristian, Ravn, Hanne Berg, Lassen, Jens Flensted, Boesgaard, Søren, Gerke, Oke, Hassager, Christian, Lackermair, Korbinian, Brunner, Stefan, Orban, Mathias, Peterss, Sven, Orban, Martin, Theiss, Hans D., Huber, Bruno C., Juchem, Gerd, Born, Frank, Boulesteix, Anne-Laure, Bauer, Axel, Pichlmaier, Maximilian, Hausleiter, Jörg, Massberg, Steffen, Hagl, Christian, Guenther, Sabina P.W., Ostadal, Petr, Rokyta, Richard, Karasek, Jiri, Kruger, Andreas, Vondrakova, Dagmar, Janotka, Marek, Naar, Jan, Smalcova, Jana, Hubatova, Marketa, Hromadk, Milan, Volovar, Stefan, Seyfrydova, Miroslava, Jarkovsky, Jiri, Svoboda, Michal, Linhart, Ales, Belohlavek, Jan, Banning, Amerjeet S., Sabaté, Manel, Orban, Martin, Gracey, Jay, López-Sobrino, Teresa, Massberg, Steffen, Kastrati, Adnan, Bogaerts, Kris, Adriaenssens, Tom, Berry, Colin, Erglis, Andrejs, Haine, Steven, Myrmel, Truls, Patel, Sameer, Buera, Irene, Sionis, Alessandro, Vilalta, Victoria, Yusuff, Hakeem, Vrints, Christiaan, Adlam, David, Flather, Marcus, Gershlick, Anthony H., Thiele, Holger, Zeymer, Uwe, Akin, Ibrahim, Behnes, Michael, Rassaf, Tienush, Mahabadi, Amir-Abbas, Lehmann, Ralf, Eitel, Ingo, Graf, Tobias, Seidler, Tim, Schuster, Andreas, Skurk, Carsten, Duerschmied, Daniel, Clemmensen, Peter, Hennersdorf, Marcus, Fichtlscherer, Stephan, Voigt, Ingo, Seyfarth, Melchior, John, Stefan, Ewen, Sebastian, Linke, Axel, Tigges, Eike, Nordbeck, Peter Steffen, Bruch, Leonhard, Jung, Christian, Franz, Jutta, Lauten, Philipp, Goslar, Tomaz, Feistritzer, Hans-Josef, Pöss, Janine, Kirchhof, Eva, Ouarrak, Taoufik, Schneider, Steffen, Desch, Steffen, and Freund, Anne

Abstract

Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS.

Published
2024
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16. Mitral Valve Transcatheter Edge-to-Edge Repair:1-Year Outcomes From the MiCLASP Study

Author

Lurz, Philipp, Schmitz, Thomas, Geisler, Tobias, Hausleiter, Jörg, Eitel, Ingo, Rudolph, Volker, Lubos, Edith, von Bardeleben, Ralph Stephan, Brambilla, Nedy, De Marco, Federico, Berti, Sergio, Nef, Holger, Linke, Axel, Hengstenberg, Christian, Baldus, Stephan, Spargias, Konstantinos, Denti, Paolo, Nickenig, Georg, Möllmann, Helge, Rottbauer, Wolfgang, Praz, Fabien, Butter, Christian, Reinthaler, Markus, Van Mieghem, Nicolas M., Sherif, Mohammad, Swaans, Martin, Witkowski, Adam, Buch, Mamta, Seidler, Tim, Iñiguez, Andrés, Thiele, Holger, Eißmann, Mareike, Schreieck, Juergen, Näbauer, Michael, Marcoff, Leo, Koulogiannis, Konstantinos, Rassaf, Tienush, Luedike, Peter, Lurz, Philipp, Schmitz, Thomas, Geisler, Tobias, Hausleiter, Jörg, Eitel, Ingo, Rudolph, Volker, Lubos, Edith, von Bardeleben, Ralph Stephan, Brambilla, Nedy, De Marco, Federico, Berti, Sergio, Nef, Holger, Linke, Axel, Hengstenberg, Christian, Baldus, Stephan, Spargias, Konstantinos, Denti, Paolo, Nickenig, Georg, Möllmann, Helge, Rottbauer, Wolfgang, Praz, Fabien, Butter, Christian, Reinthaler, Markus, Van Mieghem, Nicolas M., Sherif, Mohammad, Swaans, Martin, Witkowski, Adam, Buch, Mamta, Seidler, Tim, Iñiguez, Andrés, Thiele, Holger, Eißmann, Mareike, Schreieck, Juergen, Näbauer, Michael, Marcoff, Leo, Koulogiannis, Konstantinos, Rassaf, Tienush, and Luedike, Peter

Abstract

Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. Methods: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee–adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory–assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Results: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). Conclusions: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

Published
2024

20. Challenges in developing and validating machine learning models for TAVI mortality risk prediction: reply

Author

Leha, Andreas, primary, Huber, Cynthia, additional, Friede, Tim, additional, Bauer, Timm, additional, Beckmann, Andreas, additional, Bekeredjian, Raffi, additional, Bleiziffer, Sabine, additional, Herrmann, Eva, additional, Möllmann, Helge, additional, Walther, Thomas, additional, Beyersdorf, Friedhelm, additional, Hamm, Christian, additional, Künzi, Arnaud, additional, Windecker, Stephan, additional, Stortecky, Stefan, additional, Kutschka, Ingo, additional, Hasenfuß, Gerd, additional, Ensminger, Stephan, additional, Frerker, Christian, additional, and Seidler, Tim, additional

Published
2023
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21. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock

Author

Thiele, Holger, primary, Zeymer, Uwe, additional, Akin, Ibrahim, additional, Behnes, Michael, additional, Rassaf, Tienush, additional, Mahabadi, Amir Abbas, additional, Lehmann, Ralf, additional, Eitel, Ingo, additional, Graf, Tobias, additional, Seidler, Tim, additional, Schuster, Andreas, additional, Skurk, Carsten, additional, Duerschmied, Daniel, additional, Clemmensen, Peter, additional, Hennersdorf, Marcus, additional, Fichtlscherer, Stephan, additional, Voigt, Ingo, additional, Seyfarth, Melchior, additional, John, Stefan, additional, Ewen, Sebastian, additional, Linke, Axel, additional, Tigges, Eike, additional, Nordbeck, Peter, additional, Bruch, Leonhard, additional, Jung, Christian, additional, Franz, Jutta, additional, Lauten, Philipp, additional, Goslar, Tomaz, additional, Feistritzer, Hans-Josef, additional, Pöss, Janine, additional, Kirchhof, Eva, additional, Ouarrak, Taoufik, additional, Schneider, Steffen, additional, Desch, Steffen, additional, and Freund, Anne, additional

Published
2023
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22. Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real‐world scenario: First global, multicenter experience

Author

Holzamer, Andreas, primary, Bedogni, Francesco, additional, van Wyk, Pieter, additional, Barwad, Parag, additional, Protasiewicz, Marcin, additional, Ielasi, Alfonso, additional, Nombela‐Franco, Luis, additional, Seidler, Tim, additional, and Hilker, Michael, additional

Published
2023
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24. Obesity in heart failure with preserved ejection fraction: Insights from the REDUCE LAP‐HF II trial.

Author

Litwin, Sheldon E., Komtebedde, Jan, Seidler, Tim, Borlaug, Barry A., Winkler, Sebastian, Solomon, Scott D., Eicher, Jean‐Christophe, Mazimba, Sula, Khawash, Rami, Sverdlov, Aaron L., Hummel, Scott L., Bugger, Heiko, Boenner, Florian, Hoendermis, Elke, Cikes, Maja, Demers, Catherine, Silva, Guillherme, van Empel, Vanessa, Starling, Randall C., and Penicka, Martin

Subjects
VENTRICULAR ejection fraction, HEART failure, OBESITY, VASCULAR resistance, CARDIAC output, BODY mass index
Abstract

Aims: Obesity is causally related to the development of heart failure with preserved ejection fraction (HFpEF) but complicates the diagnosis and treatment of this disorder. We aimed to determine the relationship between severity of obesity and clinical, echocardiographic and haemodynamic parameters in a large cohort of patients with documented HFpEF. Methods and results: The REDUCE LAP‐HF II trial randomized 626 patients with ejection fraction ≥40% and exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg to atrial shunt or sham procedure. We tested for associations between body mass index (BMI), clinical characteristics, cardiac structural and functional abnormalities, physical limitations, quality of life and outcomes with atrial shunt therapy. Overall, 60.9% of patients had BMI ≥30 kg/m2. As the severity of obesity increased, symptoms (Kansas City Cardiomyopathy Questionnaire score) and 6‐min walk distance worsened. More severe obesity was associated with lower natriuretic peptide levels despite more cardiac remodelling, higher cardiac filling pressures, and higher cardiac output. Lower cut points for E/e′ were needed to identify elevated PCWP in more obese patients. Strain measurements in all four chambers were maintained as BMI increased. Pulmonary vascular resistance at rest and exercise decreased with higher BMI. Obesity was associated with more first and recurrent heart failure events. However, there was no significant interaction between obesity and treatment effects of the atrial shunt. Conclusions: Increasing severity of obesity was associated with greater cardiac remodelling, higher right and left ventricular filling pressures, higher cardiac output and increased subsequent heart failure events. Despite significant obesity, many HFpEF patients have preserved right heart and pulmonary vascular function and thus, may be appropriate candidates for atrial shunt therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Aortic valve calcification and myocardial fibrosis determine outcome following transcatheter aortic valve replacement

Author

Evertz, Ruben, primary, Hub, Sebastian, additional, Beuthner, Bo Eric, additional, Backhaus, Sören J., additional, Lange, Torben, additional, Schulz, Alexander, additional, Toischer, Karl, additional, Seidler, Tim, additional, von Haehling, Stephan, additional, Puls, Miriam, additional, Kowallick, Johannes T., additional, Zeisberg, Elisabeth M., additional, Hasenfuß, Gerd, additional, and Schuster, Andreas, additional

Published
2023
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27. Development and Validation of Explainable Machine Learning Models for Risk of Mortality in TAVI - TRIM Scores

Author

Leha, Andreas, primary, Huber, Cynthia, additional, Friede, Tim, additional, Bauer, Timm, additional, Beckmann, Andreas, additional, Bekeredjian, Raffi, additional, Bleiziffer, Sabine, additional, Herrmann, Eva, additional, Möllmann, Helge, additional, Walther, Thomas, additional, Beyersdorf, Friedhelm, additional, Hamm, Christian, additional, Künzi, Arnaud, additional, Windecker, Stephan, additional, Stortecky, Stefan, additional, Kutschka, Ingo, additional, Hasenfuß, Gerd, additional, Ensminger, Stephan, additional, Frerker, Christian, additional, and Seidler, Tim, additional

Published
2023
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28. Concomitant latent pulmonary vascular disease leads to impaired global cardiac performance in heart failure with preserved ejection fraction

Author

Schuster, Andreas, primary, Schulz, Alexander, additional, Lange, Torben, additional, Evertz, Ruben, additional, Hartmann, Finn, additional, Kowallick, Johannes T., additional, Hellenkamp, Kristian, additional, Uecker, Martin, additional, Seidler, Tim, additional, Hasenfuß, Gerd, additional, and Backhaus, Sören J., additional

Published
2023
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31. A Phase 2a dose‐escalation study of the safety, tolerability, pharmacokinetics and haemodynamic effects of BMS‐986231 in hospitalized patients with heart failure with reduced ejection fraction

Author

Tita, Cristina, Gilbert, Edward M., Van Bakel, Adrian B., Grzybowski, Jacek, Haas, Garrie J., Jarrah, Mohammad, Dunlap, Stephanie H., Gottlieb, Stephen S., Klapholz, Marc, Patel, Parag C., Pfister, Roman, Seidler, Tim, Shah, Keyur B., Zieliński, Tomasz, Venuti, Robert P., Cowart, Douglas, Foo, Shi Yin, Vishnevsky, Alexander, and Mitrovic, Veselin

Published
2017
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33. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

Author

Gragnano, Felice, primary, Zwahlen, Marcel, additional, Vranckx, Pascal, additional, Heg, Dik, additional, Schmidlin, Kurt, additional, Hamm, Christian, additional, Steg, Philippe Gabriel, additional, Gargiulo, Giuseppe, additional, McFadden, Eugene P., additional, Onuma, Yoshinobu, additional, Chichareon, Ply, additional, Benit, Edouard, additional, Möllmann, Helge, additional, Janssens, Luc, additional, Leonardi, Sergio, additional, Zurakowski, Aleksander, additional, Arrivi, Alessio, additional, Van Geuns, Robert Jan, additional, Huber, Kurt, additional, Slagboom, Ton, additional, Calabrò, Paolo, additional, Serruys, Patrick W., additional, Jüni, Peter, additional, Valgimigli, Marco, additional, Windecker, Stephan, additional, Abdellaoui, Mohamed, additional, Adlam, David, additional, Akin, Ibrahim, additional, Gonzalez‐Trevilla, Agustin Albarran, additional, Almeida, Manuel, additional, Neto, Pedro Alves Lemos, additional, Aminian, Adel, additional, Anderson, Richard, additional, Andreae, Rick, additional, Angioi, Michael, additional, Asano, Taku, additional, Barbato, Emanuele, additional, Barlis, Peter, additional, Barraud, Pascal, additional, Bertrand, Olivier, additional, Beygui, Farzin, additional, Bolognese, Leonardo, additional, Botelho, Roberto, additional, Bouwman, Coby, additional, Bressers, Marco, additional, Brunel, Philippe, additional, Buszman, Pawel, additional, Buysschaert, Ian, additional, da Silva, Pedro Canas, additional, Carrie, Didier, additional, Cequier, Angel, additional, Chang, Chun Chin, additional, Chowdhary, Saqib, additional, Collet, Carlos, additional, Colombo, Antonio, additional, Cotton, James, additional, Ferreira, Rui Cruz, additional, Curello, Salvatore, additional, Curzen, Nick, additional, de Bot, Judith, additional, de Vreede, Tone, additional, Karth, Georg Delle, additional, Dijksma, Lynn, additional, Dominici, Marcello, additional, Édes, István, additional, Eeckhout, Eric, additional, Eitel, Ingo, additional, Faluközy, József, additional, Fath‐Ordoubadi, Farzin, additional, Ferrario, Maurizio, additional, Fontos, Geza, additional, Diaz, Jose Francisco, additional, Quintella, Edgard Freitas, additional, Frey, Bernhard, additional, Friedrich, Guy, additional, Galasko, Gavin, additional, Galuszka, Grzegorz, additional, Ribeiro, Vasco Gama, additional, Garg, Scot, additional, Geisler, Tobias, additional, Gelev, Valeri, additional, Ghandilyan, Art, additional, Goicolea, Javier, additional, Gori, Tommaso, additional, Gragnano, Felice, additional, Guimarães, Ana, additional, Haude, Michael, additional, Heijke, Pieter, additional, Antolin, Rosa Ana Hernández, additional, Hildick‐Smith, David, additional, Hillen, Dorien, additional, Hoekman, Ina, additional, Hofma, Sjoerd, additional, Holmvang, Lene, additional, Hoole, Stephen, additional, Horváth, Iván, additional, Hugense, Annemarie, additional, Ibrahim, Karim, additional, Iñiguez, Andres, additional, Isaaz, Karl, additional, Jambrik, Zoltán, additional, Jasionowicz, Pawel, additional, Jonk, Judith, additional, Jung, Werner, additional, Katagiri, Yuki, additional, Kogame, Norihiro, additional, Koh, Tian Hai, additional, Koning, René, additional, Konteva, Mariana, additional, Kőszegi, Zsolt, additional, Krackhardt, Florian, additional, Kreuger, Yvonne, additional, Kukreja, Neville, additional, Ladan, Boudijn, additional, Lantelme, Pierre, additional, Leandro, Sergio, additional, Leibundgut, Gregor, additional, Liebetrau, Christoph, additional, Lindeboom, Wietze, additional, Miguel, Carlos Macaya, additional, Mach, François, additional, Magro, Michael, additional, Maillard, Luc, additional, Manavifar, Negar, additional, Mauri, Laura, additional, McFadden, Eugene, additional, Merkely, Bela, additional, Miyazaki, Yosuke, additional, Młodziankowski, Adam, additional, Moccetti, Tiziano, additional, Modolo, Rodrigo, additional, Möllman, Helge, additional, Morelle, Jean‐François, additional, Moschovitis, Aris, additional, Ottesen, Michael Munndt, additional, Muurling, Martin, additional, Naber, Christoph Kurt, additional, Neumann, Franz‐Josef, additional, Oldroyd, Keith, additional, Ong, Paul, additional, Palsrok, Sanne, additional, Petrov, Ivo, additional, Plante, Sylvain, additional, Prokopczuk, Janusz, additional, Rademaker‐Havinga, Tessa, additional, Raffel, Christopher, additional, Rensing, Benno, additional, Roffi, Marco, additional, Royaards, Kees‐Jan, additional, Sabate, Manel, additional, Schächinger, Volker, additional, Seidler, Tim, additional, Peñaranda, Antonio Serra, additional, Serruys, Patrick, additional, Sikarulidze, Lali, additional, Soliman, Osama I, additional, Sousa, Amanda, additional, Spitzer, Ernest, additional, Stables, Rod, additional, Steg, Gabriel, additional, Steinwender, Clemens, additional, Subkovas, Eduardas, additional, Suryapranata, Harry, additional, Takahashi, Kuniaki, additional, Talwar, Suneel, additional, Teiger, Emmanuel, additional, Weele, Addy Ter, additional, Teurlings, Eva, additional, Thury, Attila, additional, Tijssen, Jan, additional, Tonev, Gincho, additional, Trendafilova‐Lazarova, Diana, additional, Tumscitz, Carlo, additional, Umans, Victor, additional, Ungi, Imre, additional, Valkov, Veselin, additional, van der Harst, Pim, additional, van Geuns, Robert Jan, additional, van Meijeren, Cokky, additional, Vassilev, Dobrin, additional, Velchev, Vasil, additional, Velthuizen, Esther, additional, Verheugt, Freek, additional, Vlcek, Natalia, additional, Dahl, Jürgen Vom, additional, Vrolix, Mathias, additional, Walsh, Simon, additional, Werner, Nikos, additional, Witsenburg, Maarten, additional, Zaman, Azfar, additional, Żmudka, Krzysztof, additional, Zrenner, Bernhard, additional, and Zweiker, Robert, additional

Published
2022
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34. REAL-TIME CMR IMAGING FOR NON-INVASIVE CHARACTERISATION OF HFPEF: MEDIUM-TERM OUTCOMES OF THE HFPEF STRESS TRIAL

Author

Backhaus, Sören Jan, primary, Rösel, Simon F., additional, Schulz, Alexander, additional, Lange, Torben, additional, Hellenkamp, Kristian, additional, Gertz, Roman, additional, Wachter, Rolf K., additional, Steinmetz, Michael, additional, Kutty, Shelby, additional, Raaz, Uwe, additional, Friede, Tim, additional, Seidler, Tim, additional, Uecker, Martin, additional, Hasenfuss, Gerd, additional, and Schuster, Andreas, additional

Published
2022
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37. Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study: The TriBAND study 30-day outcomes

Author

Nickenig, Georg, Friedrichs, Kai, Baldus, Stephan, Arnold, Martin, Seidler, Tim, Hakmi, Samer, Linke, Axel, Schäfer, Ulrich, Dreger, Henryk, Reinthaler, Markus, von Bardeleben, Ralph, Möllmann, Helge, Weber, Marcel, Roder, Fabian, Körber, Maria, Landendinger, Melanie, Wolf, Frieder, Alessandrini, Hannes, Sveric, Krunoslav, Schewel, Dimitry, Romero-Dorta, Elena, Kasner, Mario, Dahou, Abdellaziz, Hahn, Rebecca T., and Windecker, Stephan

Subjects
Heart Valve Prosthesis Implantation, Cardiac Catheterization, Time Factors, Treatment Outcome, Clinical Research, Quality of Life, Humans, Prospective Studies, Severity of Illness Index, Tricuspid Valve Insufficiency, Follow-Up Studies
Abstract

BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p

Published
2021

39. Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study

Author

Nickenig, Georg, primary, Friedrichs, Kai P., additional, Baldus, Stephan, additional, Arnold, Martin, additional, Seidler, Tim, additional, Hakmi, Samer, additional, Linke, Axel, additional, Schäfer, Ulrich, additional, Dreger, Henryk, additional, Reinthaler, Markus, additional, von Bardeleben, Ralph Stephan, additional, Möllmann, Helge, additional, Weber, Marcel, additional, Roder, Fabian, additional, Körber, Maria Isabel, additional, Landendinger, Melanie, additional, Wolf, Frieder, additional, Alessandrini, Hannes, additional, Sveric, Krunoslav, additional, Schewel, Dimitry, additional, Romero-Dorta, Elena, additional, Kasner, Mario, additional, Dahou, Abdellaziz, additional, Hahn, Rebecca T., additional, and Windecker, Stephan, additional

Published
2021
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41. First Experience With the Synergy Micro-Pump in Patients in INTERMACS Class 1–2 as a Bridge to Transplantation: Pushing the Limits?

Author

Sabashnikov, Anton, Popov, Aron-Frederik, Bowles, Christopher T., Weymann, Alexander, Mohite, Prashant N., Wahlers, Thorsten, Wittwer, Thorsten, Zych, Bartlomiej, Garcia-Saez, Diana, Patil, Nikhil P., Fatullayev, Javid, Amrani, Mohamed, Banner, Nicholas R., Seidler, Tim, Unsoeld, Bernhard, Bireta, Christian, Schoendube, Friedrich A., and Simon, André R.

Published
2015
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43. Applications of artificial intelligence/machine learning approaches in cardiovascular medicine: a systematic review with recommendations

Author

Friedrich, Sarah, primary, Groß, Stefan, additional, König, Inke R, additional, Engelhardt, Sandy, additional, Bahls, Martin, additional, Heinz, Judith, additional, Huber, Cynthia, additional, Kaderali, Lars, additional, Kelm, Marcus, additional, Leha, Andreas, additional, Rühl, Jasmin, additional, Schaller, Jens, additional, Scherer, Clemens, additional, Vollmer, Marcus, additional, Seidler, Tim, additional, and Friede, Tim, additional

Published
2021
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44. Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock-Design and rationale of the ECLS-SHOCK trial

Author

Thiele, Holger, Freund, Anne, Gimenez, Maria Rubini, de Waha-Thiele, Suzanne, Akin, Ibrahim, Poss, Janine, Feistritzer, Hans-Josef, Fuernau, Georg, Graf, Tobias, Nef, Holger, Hamm, Christian, Bohm, Michael, Lauten, Alexander, Schulze, P. Christian, Voigt, Ingo, Nordbeck, Peter, Felix, Stephan B., Abel, Peter, Baldus, Stephan, Laufs, Ulrich, Lenk, Karsten, Landmesser, Ulf, Skurk, Carsten, Pieske, Burkert, Tschope, Carsten, Hennersdorf, Marcus, Wengenmayer, Tobias, Preusch, Michael, Maier, Lars S., Jung, Christian, Kelm, Malte, Clemmensen, Peter, Westermann, Dirk, Seidler, Tim, Schieffer, Bernhard, Rassaf, Tienush, Mahabadi, Amir-Abbas, Vasa-Nicotera, Mariuca, Meincke, Felix, Seyfarth, Melchior, Kersten, Alexander, Rottbauer, Wolfgang, Boekstegers, Peter, Muellenbach, Ralf, Dengler, Thomas, Kadel, Christoph, Schempf, Benjamin, Karagiannidis, Christian, Hopf, Hans-Bernd, Lehmann, Ralf, Bufe, Alexander, Baumanns, Stefan, Oner, Alper, Linke, Axel, Sedding, Daniel, Ferrari, Markus, Bruch, Leonhard, Goldmann, Britta, John, Stefan, Mollmann, Helge, Franz, Jutta, Lapp, Harald, Lauten, Philipp, Noc, Marko, Goslar, Tomaz, Oerlecke, Ilka, Ouarrak, Taoufik, Schneider, Steffen, Desch, Steffen, Zeymer, Uwe, Thiele, Holger, Freund, Anne, Gimenez, Maria Rubini, de Waha-Thiele, Suzanne, Akin, Ibrahim, Poss, Janine, Feistritzer, Hans-Josef, Fuernau, Georg, Graf, Tobias, Nef, Holger, Hamm, Christian, Bohm, Michael, Lauten, Alexander, Schulze, P. Christian, Voigt, Ingo, Nordbeck, Peter, Felix, Stephan B., Abel, Peter, Baldus, Stephan, Laufs, Ulrich, Lenk, Karsten, Landmesser, Ulf, Skurk, Carsten, Pieske, Burkert, Tschope, Carsten, Hennersdorf, Marcus, Wengenmayer, Tobias, Preusch, Michael, Maier, Lars S., Jung, Christian, Kelm, Malte, Clemmensen, Peter, Westermann, Dirk, Seidler, Tim, Schieffer, Bernhard, Rassaf, Tienush, Mahabadi, Amir-Abbas, Vasa-Nicotera, Mariuca, Meincke, Felix, Seyfarth, Melchior, Kersten, Alexander, Rottbauer, Wolfgang, Boekstegers, Peter, Muellenbach, Ralf, Dengler, Thomas, Kadel, Christoph, Schempf, Benjamin, Karagiannidis, Christian, Hopf, Hans-Bernd, Lehmann, Ralf, Bufe, Alexander, Baumanns, Stefan, Oner, Alper, Linke, Axel, Sedding, Daniel, Ferrari, Markus, Bruch, Leonhard, Goldmann, Britta, John, Stefan, Mollmann, Helge, Franz, Jutta, Lapp, Harald, Lauten, Philipp, Noc, Marko, Goslar, Tomaz, Oerlecke, Ilka, Ouarrak, Taoufik, Schneider, Steffen, Desch, Steffen, and Zeymer, Uwe

Abstract

Background In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) venoarterial extracorporeal membrane oxygenation provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. Study Design The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. Conclusions The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

Published
2021

45. Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: the TriBAND study

Author

Nickenig, Georg, Friedrichs, Kai P., Baldus, Stephan, Arnold, Martin, Seidler, Tim, Hakmi, Samer, Linke, Axel, Schaefer, Ulrich, Dreger, Henryk, Reinthaler, Markus, von Bardeleben, Ralph Stephan, Moellmann, Helge, Weber, Marcel, Roder, Fabian, Koerber, Maria Isabel, Landendinger, Melanie, Wolf, Frieder, Alessandrini, Hannes, Sveric, Krunoslav, Schewel, Dimitry, Romero-Dorta, Elena, Kasner, Mario, Dahou, Abdellaziz, Hahn, Rebecca T., Windecker, Stephan, Nickenig, Georg, Friedrichs, Kai P., Baldus, Stephan, Arnold, Martin, Seidler, Tim, Hakmi, Samer, Linke, Axel, Schaefer, Ulrich, Dreger, Henryk, Reinthaler, Markus, von Bardeleben, Ralph Stephan, Moellmann, Helge, Weber, Marcel, Roder, Fabian, Koerber, Maria Isabel, Landendinger, Melanie, Wolf, Frieder, Alessandrini, Hannes, Sveric, Krunoslav, Schewel, Dimitry, Romero-Dorta, Elena, Kasner, Mario, Dahou, Abdellaziz, Hahn, Rebecca T., and Windecker, Stephan

Abstract

Background: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. Aims: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. Methods: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. Results: Sixty-one patients had >= severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ?severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved <= moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved <= moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). Conclusions: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ?severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

Published
2021

46. Exercise Stress Real-Time Cardiac Magnetic Resonance Imaging for Noninvasive Characterization of Heart Failure With Preserved Ejection Fraction The HFpEF-Stress Trial

Author

Backhaus, Soeren J., Lange, Torben, George, Elisabeth F., Hellenkamp, Kristian, Gertz, Roman J., Billing, Marcus, Wachter, Rolf, Steinmetz, Michael, Kutty, Shelby, Raaz, Uwe, Lotz, Joachim, Friede, Tim, Uecker, Martin, Hasenfuss, Gerd, Seidler, Tim, Schuster, Andreas, Backhaus, Soeren J., Lange, Torben, George, Elisabeth F., Hellenkamp, Kristian, Gertz, Roman J., Billing, Marcus, Wachter, Rolf, Steinmetz, Michael, Kutty, Shelby, Raaz, Uwe, Lotz, Joachim, Friede, Tim, Uecker, Martin, Hasenfuss, Gerd, Seidler, Tim, and Schuster, Andreas

Abstract

BACKGROUND: Right heart catheterization using exercise stress is the reference standard for the diagnosis of heart failure with preserved ejection fraction (HFpEF) but carries the risk of the invasive procedure. We hypothesized that real-time cardiac magnetic resonance (RT-CMR) exercise imaging with pathophysiologic data at excellent temporal and spatial resolution may represent a contemporary noninvasive alternative for diagnosing HFpEF. METHODS: The HFpEF-Stress trial (CMR Exercise Stress Testing in HFpEF; URL: ; Unique identifier: NCT03260621. URL: ; Unique identifier: DZHK-17) prospectively recruited 75 patients with echocardiographic signs of diastolic dysfunction and dyspnea on exertion (E/e '>8, New York Heart Association class >= II) to undergo echocardiography, right heart catheterization, and RT-CMR at rest and during exercise stress. HFpEF was defined according to pulmonary capillary wedge pressure (>= 15 mm Hg at rest or >= 25 mm Hg during exercise stress). RT-CMR functional assessments included time-volume curves for total and early (1/3) diastolic left ventricular filling, left atrial (LA) emptying, and left ventricular/LA long axis strain. RESULTS: Patients with HFpEF (n=34; median pulmonary capillary wedge pressure at rest, 13 mm Hg; at stress, 27 mm Hg) had higher E/e ' (12.5 versus 9.15), NT-proBNP (N-terminal pro-B-type natriuretic peptide; 255 versus 75 ng/L), and LA volume index (43.8 versus 36.2 mL/m(2)) compared with patients with noncardiac dyspnea (n=34; rest, 8 mm Hg; stress, 18 mm Hg; P <= 0.001 for all). Seven patients were excluded because of the presence of non-HFpEF cardiac disease causing dyspnea on imaging. There were no differences in RT-CMR left ventricular total and early diastolic filling at rest and during exercise stress (P >= 0.164) between patients with HFpEF and noncardiac dyspnea. RT-CMR revealed significantly impaired LA total and early (P<0.001) diastolic emptying in patients with HFpEF during exercise stress. RT-CMR exer

Published
2021

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