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1. Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2

Author

Ponikowski, Piotr, Friede, Tim, von Bardeleben, Ralph Stephan, Butler, Javed, Shahzeb Khan, Muhammad, Diek, Monika, Heinrich, Jutta, Geyer, Martin, Placzek, Marius, Ferrari, Roberto, Abraham, William T., Alfieri, Ottavio, Auricchio, Angelo, Bayes-Genis, Antoni, Cleland, John G.F., Filippatos, Gerasimos, Gustafsson, Finn, Haverkamp, Wilhelm, Kelm, Malte, Kuck, Karl-Heinz, Landmesser, Ulf, Maggioni, Aldo P., Metra, Marco, Ninios, Vlasis, Petrie, Mark C., Rassaf, Tienush, Ruschitzka, Frank, Schäfer, Ulrich, Schulze, P. Christian, Spargias, Konstantinos, Vahanian, Alec, Zamorano, Jose Luis, Zeiher, Andreas, Karakas, Mahir, Koehler, Friedrich, Lainscak, Mitja, Öner, Alper, Mezilis, Nikolaos, Theofilogiannakos, Efstratios K., Ninios, Ilias, Chrissoheris, Michael, Kourkoveli, Panagiota, Papadopoulos, Konstantinos, Smolka, Grzegorz, Wojakowski, Wojciech, Reczuch, Krzysztof, Pinto, Fausto J., Wiewiórka, Łukasz, Streb, Witold, Adamo, Marianna, Santiago-Vacas, Evelyn, Friedrich Ruf, Tobias, Gross, Michael, Tongers, Joern, Hasenfuß, Gerd, Schillinger, Wolfgang, and Anker, Stefan D.

Published
2024
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6. Bridging the Gap∗

Author

Brian Whisenant, MD and Alec Vahanian, MD

Subjects
mitraclip, mitral stenosis, mitral valvuloplasty, rheumatic mitral stenosis, TEER, Diseases of the circulatory (Cardiovascular) system, RC666-701
Published
2023
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8. Percutaneous repair of moderate‐to‐severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE‐HF2 trial and comparison to COAPT and MITRA‐FR trials

Author

Anker, Stefan D., primary, Friede, Tim, additional, von Bardeleben, Ralph Stephan, additional, Butler, Javed, additional, Khan, Muhammad Shahzeb, additional, Diek, Monika, additional, Heinrich, Jutta, additional, Geyer, Martin, additional, Placzek, Marius, additional, Ferrari, Roberto, additional, Abraham, William T., additional, Alfieri, Ottavio, additional, Auricchio, Angelo, additional, Bayes‐Genis, Antoni, additional, Cleland, John G.F., additional, Filippatos, Gerasimos, additional, Gustafsson, Finn, additional, Haverkamp, Wilhelm, additional, Kelm, Malte, additional, Kuck, Karl‐Heinz, additional, Landmesser, Ulf, additional, Maggioni, Aldo P., additional, Metra, Marco, additional, Ninios, Vlasis, additional, Petrie, Mark C., additional, Rassaf, Tienush, additional, Ruschitzka, Frank, additional, Schäfer, Ulrich, additional, Schulze, P. Christian, additional, Spargias, Konstantinos, additional, Vahanian, Alec, additional, Zamorano, Jose Luis, additional, Zeiher, Andreas, additional, Karakas, Mahir, additional, Koehler, Friedrich, additional, Lainscak, Mitja, additional, Öner, Alper, additional, Mezilis, Nikolaos, additional, Theofilogiannakos, Efstratios K, additional, Ninios, Ilias, additional, Chrissoheris, Michael, additional, Kourkoveli, Panagiota, additional, Papadopoulos, Konstantinos, additional, Smolka, Grzegorz, additional, Wojakowski, Wojciech, additional, Reczuch, Krzysztof, additional, Pinto, Fausto J., additional, Zmudka, Krzysztof, additional, Kalarus, Zbigniew, additional, Adamo, Marianna, additional, Santiago‐Vacas, Evelyn, additional, Ruf, Tobias Friedrich, additional, Gross, Michael, additional, Tongers, Joern, additional, Hasenfuß, Gerd, additional, Schillinger, Wolfgang, additional, and Ponikowski, Piotr, additional

Published
2024
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13. Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial

Author

Messika-Zeitoun, David, Iung, Bernard, Armoiry, Xavier, Trochu, Jean-Noël, Donal, Erwan, Habib, Gilbert, Brochet, Eric, Thibault, Hélène, Piriou, Nicolas, Cormier, Bertrand, Tribouilloy, Christophe, Guerin, Patrice, Lefèvre, Thierry, Maucort-Boulch, Delphine, Vahanian, Alec, Boutitie, Florent, and Obadia, Jean-Francois

Published
2021
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18. Sex-related differences in severe native valvular heart disease: the ESC-EORP Valvular Heart Disease II survey.

Author

Mascherbauer, Julia, Kammerlander, Andreas, Nitsche, Christian, Bax, Jeroen, Delgado, Victoria, Evangelista, Arturo, Laroche, Cecile, Maggioni, Aldo Pietro, Magne, Julien, Vahanian, Alec, and Iung, Bernard

Subjects
SEX factors in disease, HEART valve diseases, MITRAL stenosis, MITRAL valve, AORTIC valve insufficiency
Abstract

Background and Aims To assess sex differences in disease characteristics and treatment of patients with severe native valvular heart disease (VHD) included in the VHD II EURObservational Research Programme. Methods A total of 5219 patients were enrolled in 208 European and North African centres and followed for 6 months [41.2% aortic stenosis (AS), 5.3% aortic regurgitation (AR), 4.5% mitral stenosis (MS), 21.3% mitral regurgitation (MR), 2.7% isolated right-sided VHD, 24.9% multiple left-sided VHD]. Indications for intervention were considered concordant if corresponding to class I recommendations specified in the 2012 ESC or 2014 AHA/ACC VHD guidelines. Results Overall, women were older, more symptomatic, and presented with a higher EuroSCORE II. Bicuspid aortic valve and AR were more prevalent among men while mitral disease, concomitant tricuspid regurgitation (TR), and AS above age 65 were more prevalent among women. On multivariable regression analysis, concordance with recommended treatment was significantly poorer in women with MS and primary MR (both P <.001). Age, patient refusal, and decline of symptoms after conservative treatment were reported significantly more often as reasons to withhold the intervention in females. Concomitant tricuspid intervention was performed at a similar rate in both sexes although prevalence of significant TR was significantly higher in women. In-hospital and 6-month survival did not differ between sexes. Conclusions (i) Valvular heart disease subtype varied between sexes; (ii) concordance with recommended intervention for MS and primary MR was significantly lower for women; and (iii) survival of men and women was similar at 6 months. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention

Author

Miura, Mizuki, Alessandrini, Hannes, Alkhodair, Abdullah, Attinger-Toller, Adrian, Biasco, Luigi, Lurz, Philipp, Braun, Daniel, Brochet, Eric, Connelly, Kim A., de Bruijn, Sabine, Denti, Paolo, Deuschl, Florian, Estevez-Loureiro, Rodrigo, Fam, Neil, Frerker, Christian, Gavazzoni, Mara, Hausleiter, Jörg, Himbert, Dominique, Ho, Edwin, Juliard, Jean-Michel, Kaple, Ryan, Besler, Christian, Kodali, Susheel, Kreidel, Felix, Kuck, Karl-Heinz, Latib, Azeem, Lauten, Alexander, Monivas, Vanessa, Mehr, Michael, Muntané-Carol, Guillem, Nazif, Tamin, Nickenig, Georg, Pedrazzini, Giovanni, Philippon, François, Pozzoli, Alberto, Praz, Fabien, Puri, Rishi, Rodés-Cabau, Josep, Schäfer, Ulrich, Schofer, Joachim, Sievert, Horst, Tang, Gilbert H.L., Thiele, Holger, Rommel, Karl-Philipp, Vahanian, Alec, Von Bardeleben, Ralph Stephan, Webb, John G., Weber, Marcel, Windecker, Stephan, Winkel, Mirjam, Zuber, Michel, Leon, Martin B., Maisano, Francesco, Hahn, Rebecca T., and Taramasso, Maurizio

Published
2020
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20. A Cardiac Computed Tomography–Based Score to Categorize Mitral Annular Calcification Severity and Predict Valve Embolization

Author

Guerrero, Mayra, Wang, Dee Dee, Pursnani, Amit, Eleid, Mackram, Khalique, Omar, Urena, Marina, Salinger, Michael, Kodali, Susheel, Kaptzan, Tatiana, Lewis, Bradley, Kato, Nahoko, Cajigas, Hector M., Wendler, Olaf, Holzhey, David, Pershad, Ashish, Witzke, Christian, Alnasser, Sami, Tang, Gilbert H.L., Grubb, Kendra, Reisman, Mark, Blanke, Philipp, Leipsic, Jonathon, Williamson, Eric, Pellikka, Patricia A., Pislaru, Sorin, Crestanello, Juan, Himbert, Dominique, Vahanian, Alec, Webb, John, Hahn, Rebecca T., Leon, Martin, George, Isaac, Bapat, Vinayak, O’Neill, William, and Rihal, Charanjit

Published
2020
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22. Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry

Author

Taramasso, Maurizio, Gavazzoni, Mara, Pozzoli, Alberto, Alessandrini, Hannes, Latib, Azeem, Attinger-Toller, Adrian, Biasco, Luigi, Braun, Daniel, Brochet, Eric, Connelly, Kim A., de Bruijn, Sabine, Denti, Paolo, Deuschl, Florian, Estevez-Louriero, Rodrigo, Fam, Neil, Frerker, Christian, Ho, Edwin, Juliard, Jean-Michel, Kaple, Ryan, Kodali, Susheel, Kreidel, Felix, Kuck, Karl-Heinz, Lauten, Alexander, Lurz, Julia, Monivas, Vanessa, Mehr, Michael, Nazif, Tamin, Nickening, Georg, Pedrazzini, Giovanni, Praz, Fabien, Puri, Rishi, Rodés-Cabau, Josep, Schäfer, Ulrich, Schofer, Joachim, Sievert, Horst, Tang, Gilbert H.L., Khattab, Ahmed A., Thiele, Holger, Unterhuber, Matthias, Vahanian, Alec, Von Bardeleben, Ralph Stephan, Webb, John G., Weber, Marcel, Windecker, Stephan, Winkel, Mirjam, Zuber, Michel, Hausleiter, Jörg, Lurz, Philipp, Maisano, Francesco, Leon, Martin B., and Hahn, Rebecca T.

Published
2020
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25. A Phase 3 Randomized Clinical Trial of Chemotherapy With or Without Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

Author

Hewitt, Daniel Brock, Nissen, Nicholas, Hatoum, Hassan, Musher, Benjamin, Seng, John, Coveler, Andrew L., Al-Rajabi, Raed, Yeo, Charles J., Leiby, Benjamin, Banks, Joshua, Balducci, Lodovico, Vaccaro, Gina, LoConte, Noelle, George, Thomas J., Brenner, Warren, Elquza, Emad, Vahanian, Nicholas, Rossi, Gabriela, Kennedy, Eugene, Link, Charles, and Lavu, Harish

Published
2022
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26. Outcomes After Current Transcatheter Tricuspid Valve Intervention: Mid-Term Results From the International TriValve Registry

Author

Taramasso, Maurizio, Alessandrini, Hannes, Latib, Azeem, Asami, Masahiko, Attinger-Toller, Adrian, Biasco, Luigi, Braun, Daniel, Brochet, Eric, Connelly, Kim A., Denti, Paolo, Deuschl, Florian, Englmeier, Andrea, Fam, Neil, Frerker, Christian, Hausleiter, Jörg, Himbert, Dominique, Ho, Edwin C., Juliard, Jean-Michel, Kaple, Ryan, Kreidel, Felix, Kuck, Karl-Heinz, Ancona, Marco, Lauten, Alexander, Lurz, Philipp, Mehr, Michael, Nazif, Tamin, Nickening, Georg, Pedrazzini, Giovanni, Pozzoli, Alberto, Praz, Fabien, Puri, Rishi, Rodés-Cabau, Josep, Schäfer, Ulrich, Schofer, Joachim, Sievert, Horst, Sievert, Kolja, Tang, Gilbert H.L., Tanner, Felix C., Vahanian, Alec, Webb, John G., Windecker, Stephan, Yzeiray, Ermela, Zuber, Michel, Maisano, Francesco, Leon, Martin B., and Hahn, Rebecca T.

Published
2019
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29. Phase II trial of the IDO pathway inhibitor indoximod plus pembrolizumab for the treatment of patients with advanced melanoma

Author

Ramses Sadek, Mohammed Milhem, Olivier Rixe, David Munn, Christopher M Smith, Yousef Zakharia, Joseph Drabick, Kenneth F Grossmann, Robert R McWilliams, Montaser F Shaheen, Ravindra Kolhe, Rafal Pacholczyk, Lucinda L Tennant, Eugene P Kennedy, Charles J Link Jr, Nicholas N Vahanian, Jiayi Yu, Steven S Shen, Erik L Brincks, and Gabriela R Rossi

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background The indoleamine 2,3-dioxygenase (IDO) pathway is a key counter-regulatory mechanism that, in cancer, is exploited by tumors to evade antitumor immunity. Indoximod is a small-molecule IDO pathway inhibitor that reverses the immunosuppressive effects of low tryptophan (Trp) and high kynurenine (Kyn) that result from IDO activity. In this study, indoximod was used in combination with a checkpoint inhibitor (CPI) pembrolizumab for the treatment for advanced melanoma.Methods Patients with advanced melanoma were enrolled in a single-arm phase II clinical trial evaluating the addition of indoximod to standard of care CPI approved for melanoma. Investigators administered their choice of CPI including pembrolizumab (P), nivolumab (N), or ipilimumab (I). Indoximod was administered continuously (1200 mg orally two times per day), with concurrent CPI dosed per US Food and Drug Administration (FDA)-approved label.Results Between July 2014 and July 2017, 131 patients were enrolled. (P) was used more frequently (n=114, 87%) per investigator’s choice. The efficacy evaluable population consisted of 89 patients from the phase II cohort with non-ocular melanoma who received indoximod combined with (P).The objective response rate (ORR) for the evaluable population was 51% with confirmed complete response of 20% and disease control rate of 70%. Median progression-free survival was 12.4 months (95% CI 6.4 to 24.9). The ORR for Programmed Death-Ligand 1 (PD-L1)-positive patients was 70% compared with 46% for PD-L1-negative patients. The combination was well tolerated, and side effects were similar to what was expected from single agent (P).Conclusion In this study, the combination of indoximod and (P) was well tolerated and showed antitumor efficacy that is worth further evaluation in selected patients with advanced melanoma.

Published
2021
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31. Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement in Severe Mitral Annular Calcification: An Analysis of the Transcatheter Mitral Valve Replacement in Mitral Annular Calcification Global Registry

Author

El Sabbagh, Abdallah, Al-Hijji, Mohammed, Wang, Dee Dee, Eleid, Mackram, Urena, Marina, Himbert, Dominique, Chakravarty, Tarun, Holzhey, David, Pershad, Ashish, Fang, H. Kenith, Nejjari, Mohammed, Zahr, Firas, Dvir, Danny, Sardar, Muhammad Rizwan, Cheema, Asim N., Alnasser, Sami, Iyer, Vijay, Kaddissi, Georges, Webb, John, Makkar, Raj, Vahanian, Alec, O’Neill, William, Rihal, Charanjit, and Guerrero, Mayra

Published
2021
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38. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

Author

Vahanian, Alec, Beyersdorf, Friedhelm, Praz, Fabien, Milojevic, Milan, Baldus, Stephan, Bauersachs, Johann, Capodanno, Davide, Conradi, Lenard, De Bonis, Michele, De Paulis, Ruggero, Delgado, Victoria, Freemantle, Nick, Gilard, Martine, Haugaa, Kristina H., Jeppsson, Anders, Jüni, Peter, Pierard, Luc, Prendergast, Bernard D., Sádaba, J. Rafael, Tribouilloy, Christophe, and Wojakowski, Wojtek

Published
2022
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39. Guía ESC/EACTS 2021 sobre el diagnóstico y tratamiento de las valvulopatías: Desarrollada por el Grupo de Trabajo de la Sociedad Europea de Cardiología (ESC) y la European Association for Cardio-Thoracic Surgery (EACTS) sobre el diagnóstico y tratamiento de las valvulopatías

Author

Vahanian, Alec, Beyersdorf, Friedhelm, Praz, Fabien, Milojevic, Milan, Baldus, Stephan, Bauersachs, Johann, Capodanno, Davide, Conradi, Lenard, De Bonis, Michele, De Paulis, Ruggero, Delgado, Victoria, Freemantle, Nick, Gilard, Martine, Haugaa, Kristina H., Jeppsson, Anders, Jüni, Peter, Pierard, Luc, Prendergast, Bernard D., Rafael Sádaba, J., Tribouilloy, Christophe, and Wojakowski, Wojtek

Published
2022
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40. Unmet needs in valvular heart disease

Author

David Messika-Zeitoun, Helmut Baumgartner, Ian G Burwash, Alec Vahanian, Jeroen Bax, Philippe Pibarot, Vince Chan, Martin Leon, Maurice Enriquez-Sarano, Thierry Mesana, and Bernard Iung

Subjects
Cardiology and Cardiovascular Medicine
Abstract

Valvular heart disease (VHD) is the next epidemic in the cardiovascular field, affecting millions of people worldwide and having a major impact on health care systems. With aging of the population, the incidence and prevalence of VHD will continue to increase. However, VHD has not received the attention it deserves from both the public and policymakers. Despite important advances in the pathophysiology, natural history, management, and treatment of VHD including the development of transcatheter therapies, VHD remains underdiagnosed, identified late, and often undertreated with inequality in access to care and treatment options, and there is no medication that can prevent disease progression. The present review article discusses these gaps in the management of VHD and potential actions to undertake to improve the outcome of patients with VHD.

Published
2023
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41. Costs and cost-effectiveness of cervical cancer screening strategies in women living with HIV in Burkina Faso: The HPV in Africa Research Partnership (HARP) study.

Author

Angela Devine, Alice Vahanian, Bernard Sawadogo, Souleymane Zan, Fadima Yaya Bocoum, Helen Kelly, Clare Gilham, Nicolas Nagot, Jason J Ong, Rosa Legood, Nicolas Meda, Alec Miners, Philippe Mayaud, and HARP Consortium

Subjects
Medicine, Science
Abstract

IntroductionThis study estimated the costs and incremental cost per case detected of screening strategies for high-grade cervical intraepithelial neoplasia (CIN2+) in women living with HIV (WLHIV) attending HIV clinics in Burkina Faso.MethodsThe direct healthcare provider costs of screening tests (visual inspection with acetic acid (VIA), VIA combined visual inspection with Lugol's iodine (VIA/VILI), cytology and a rapid HPV DNA test (careHPV)) and confirmatory tests (colposcopy, directed biopsy and systematic four-quadrant (4Q) biopsy) were collected alongside the HPV in Africa Research Partnership (HARP) study. A model was developed for a hypothetical cohort of 1000 WLHIV using data on CIN2+ prevalence and the sensitivity of the screening tests. Costs are reported in USD (2019).ResultsThe study enrolled 554 WLHIV with median age 36 years (inter-quartile range, 31-41) and CIN2+ prevalence of 5.8%. The average cost per screening test ranged from US$3.2 for VIA to US$24.8 for cytology. Compared to VIA alone, the incremental cost per CIN2+ case detected was US$48 for VIA/VILI and US$814 for careHPV. Despite higher costs, careHPV was more sensitive for CIN2+ cases detected compared to VIA/VILI (97% and 56%, respectively). The cost of colposcopy was US$6.6 per person while directed biopsy was US$33.0 and 4Q biopsy was US$48.0.ConclusionDepending on the willingness to pay for the detection of a case of cervical cancer, decision makers in Burkina Faso can consider a variety of cervical cancer screening strategies for WLHIV. While careHPV is more costly, it has the potential to be cost-effective depending on the willingness to pay threshold. Future research should explore the lifetime costs and benefits of cervical cancer screening to enable comparisons with interventions for other diseases.

Published
2021
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43. Dismal Outcomes and High Societal Burden of Mitral Valve Regurgitation in France in the Recent Era: A Nationwide Perspective

Author

David Messika‐Zeitoun, Pascal Candolfi, Alec Vahanian, Vincent Chan, Ian G. Burwash, Jean‐François Philippon, Jean‐Manuel Toussaint, Patrick Verta, Ted E. Feldman, Bernard Iung, David Glineur, Thierry Mesana, and Maurice Enriquez‐Sarano

Subjects
mitral valve regurgitation, outcomes, management, cost, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Although US recent data suggest that mitral regurgitation (MR) is severely undertreated and carries a poor outcome, population‐based views on outcome and management are limited. We aimed to define the current treatment standards, clinical outcomes, and costs related to MR at the nationwide level. Methods and Results In total, 107 412 patients with MR were admitted in France in 2014 to 2015. Within 1 year, 8% were operated and 92% were conservatively managed and constituted our study population (68% primary MR and 32% secondary MR). The mean age was 77±15 years; most patients presented with comorbidities. In‐hospital and 1‐year mortality rates were 4.1% and 14.3%, respectively. Readmissions were common (63% at least once and 37% readmitted ≥2 times). Rates of 1‐year mortality or all‐cause readmission and 1‐year mortality or heart failure readmission were 67% and 34%, respectively, and increased with age, Charlson index, heart failure at admission, and secondary MR etiology; however, the event rate remained notably high in the primary MR subset (64% and 28%, respectively). The mean costs of hospital admissions and of readmissions were 5345±6432 and 10 080±10 847 euros, respectively. Conclusions At the nationwide level, MR was a common reason for admission and affected an elderly population with frequent comorbidities. Less than 10% of patients underwent a valve intervention. All subsets of patients who were conservatively managed incurred high mortality and readmissions rates, and MR represented a major societal burden with an extrapolated annual cost of 350 to 550 million euros (390–615 million US dollars). New strategies to improve the management and outcomes of patients with both primary and secondary MR are critical and warranted.

Published
2020
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44. Phase Ia study of the indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor navoximod (GDC-0919) in patients with recurrent advanced solid tumors

Author

Asha Nayak-Kapoor, Zhonglin Hao, Ramses Sadek, Robin Dobbins, Lisa Marshall, Nicholas N. Vahanian, W. Jay Ramsey, Eugene Kennedy, Mario R. Mautino, Charles J. Link, Ray S. Lin, Stephanie Royer-Joo, Xiaorong Liang, Laurent Salphati, Kari M. Morrissey, Sami Mahrus, Bruce McCall, Andrea Pirzkall, David H. Munn, John E. Janik, and Samir N. Khleif

Subjects
Phase I, IDO1, Navoximod, Kynurenine, Tryptophan, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Indoleamine-2,3-dioxygenase 1 (IDO1) catalyzes the oxidation of tryptophan into kynurenine and is partially responsible for acquired immune tolerance associated with cancer. The IDO1 small molecule inhibitor navoximod (GDC-0919, NLG-919) is active as a combination therapy in multiple tumor models. Methods This open-label Phase Ia study assessed safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of navoximod in patients with recurrent/advanced solid tumors, administered as 50-800 mg BID on a 21/28 day and at 600 mg on a 28/28 day schedule. Plasma kynurenine and tryptophan were longitudinally evaluated and tumor assessments were performed. Results Patients (n = 22) received a median of 3 cycles of navoximod. No maximum tolerated dose was reached. One dose-limiting toxicity of Grade 4 lower gastrointestinal hemorrhage was reported. Adverse events (AEs) regardless of causality in ≥20% of patients included fatigue (59%), cough, decreased appetite, and pruritus (41% each), nausea (36%), and vomiting (27%). Grade ≥ 3 AEs occurred in 14/22 patients (64%), and were related to navoximod in two patients (9%). Navoximod was rapidly absorbed (Tmax ~ 1 h) and exhibited dose-proportional increases in exposure, with a half-life (t1/2 ~ 11 h) supportive of BID dosing. Navoximod transiently decreased plasma kynurenine from baseline levels with kinetics consistent with its half-life. Of efficacy-evaluable patients, 8 (36%) had stable disease and 10 (46%) had progressive disease. Conclusions Navoximod was well-tolerated at doses up to 800 mg BID decreasing plasma kynurenine levels consistent with its half-life. Stable disease responses were observed. Trial registration ClinicalTrials.gov identifier: NCT02048709.

Published
2018
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45. Association of Age and Sex With Use of Transcatheter Aortic Valve Replacement in France

Author

Prosperi-Porta, Graeme, primary, Nguyen, Virginia, additional, Willner, Nadav, additional, Dreyfus, Julien, additional, Eltchaninoff, Helene, additional, Burwash, Ian G., additional, Michel, Morgane, additional, Durand, Eric, additional, Gilard, Martine, additional, Dindorf, Christel, additional, Iung, Bernard, additional, Cribier, Alain, additional, Vahanian, Alec, additional, Chevreul, Karine, additional, and Messika-Zeitoun, David, additional

Published
2023
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48. The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair?

Author

Taramasso, Maurizio, Hahn, Rebecca T., Alessandrini, Hannes, Latib, Azeem, Attinger-Toller, Adrian, Braun, Daniel, Brochet, Eric, Connelly, Kim A., Denti, Paolo, Deuschl, Florian, Englmaier, Andrea, Fam, Neil, Frerker, Christian, Hausleiter, Joerg, Juliard, Jean-Michel, Kaple, Ryan, Kreidel, Felix, Kuck, Karl Heinz, Kuwata, Shingo, Ancona, Marco, Malasa, Margarita, Nazif, Tamim, Nickenig, Georg, Nietlispach, Fabian, Pozzoli, Alberto, Schäfer, Ulrich, Schofer, Joachim, Schueler, Robert, Tang, Gilbert, Vahanian, Alec, Webb, John G., Yzeiraj, Ermela, Maisano, Francesco, and Leon, Martin B.

Published
2017
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